With the Congressional debate over health care reaching a crescendo, I find myself particularly baffled by the behavior of two influential Senators. Why, I wonder, would Sen. Max Baucus, a Democrat from Montana, and Sen. Charles Grassley, a Republican from Iowa, oppose a public health insurance option that could compete with private insurers? Baucus, after all, has worked closely on health-care reform with Senator Edward Kennedy, a stout supporter of a public option. And Grassley, who has taken the lead in investigating doctors on the take from pharmaceutical and medical device companies, must surely understand the corrosive influence of the for-profit motive in health care.
Grassley says he opposes a public plan for fear it would eventually put private insurance plans out of business, according to an excellent overview of the debate in The New York Review of Books. But isn't that the idea? Are we not the only developed country in the western hemisphere that permits for-profit health insurance? Why should Grassley and Baucus care so much about the fate of for-profit medicine?
Here's one reason why: both Senators have received tons of money from PACs and individuals representing the health-care industry in recent years. Indeed, the two or three top industries contributing to Grassley and Baucus's campaign chests from 2003 to 2008 are, you guessed it, insurance companies and health professionals. According to the Center for Responsive Politics, health professionals donated $812,077 to Grassley between 2003 and 2008, while insurance companies gave him a total of $643,643. Similarly, health professionals contributed $851,141 to Max Baucus over the same period of time, while insurance companies gave him $784,185. (Pharmaceutical companies, who are similarly opposed to a public health option because it will eat into their profits) also contributed $852,813 to Baucus' war chest during the same years).
And if you look at the top individual donors to these Senators, you see the same pattern: on both Grassley and Baucus's top 20 list, you will find the American Hospital Association, the American Health Care Association (which represents nursing homes), a number of health insurers, such as Blue Cross/Blue Shield and Aetna, and several organizations representing medical professionals. As I noted in a previous blog, many doctors don't want a public health option because it will eat into their profits, since Medicare and Medicaid tend to reimburse doctors (and pharmaceutical companies) at lower rates than private insurers do.
Now you can view this as just one more sad illustration of the power that moneyed interests have over our Congressional leaders. But if I were a voter in Montana or Iowa worried about paying my medical bills, I might want to pick up the phone and ask Senator Baucus or Grassley just who exactly they are representing: me or corporate America?
Monday, June 29, 2009
Friday, June 19, 2009
Most Americans support government-run health plan
We're taking advantage of the end of school to do some traveling to Philadelphia and Washington to scout out colleges for our son. And speaking of the nation's capital, it was good to see that a robust majority of Americans support a government-run health insurance plan to compete with private insurers, according to the latest poll by The New York Times and CBS. Most Americans also think government could do a better job of holding health-care costs than the private sector. Are you listening, Congress?
I will resume blogging next week.
I will resume blogging next week.
Wednesday, June 17, 2009
Freedom Center: The "mad pride" approach to mental illness needs your support
Caty Simon was 15 when she tried to kill herself by swallowing some pills. A smart, precocious student at an Orthodox Jewish day school in the Boston area, Simon says the pressures on her -- to succeed academically and fit into a culture where women were not considered equal to men -- had been building for months. What Simon needed was someone she could talk to, a shoulder to cry on. Instead, she found herself in the locked juvenile ward of a mental hospital, diagnosed as paranoid schizophrenic and bipolar and doped up with drugs like Zyprexa, Prozac and Depakote.
"The next couple of years were horribly dysfunctional for me," Simon recalls. "The Depakote made me incredibly depressed, it really knocked me out. I spent my senior year in bed."
For years, Simon says she bought into what her psychiatrists told her: that she had a lifelong, biogenetic mental illness that could only be treated with potent psychoactive drugs. But then she began reading books by Persimmon Blackridge (Prozac Highway) and Dr. Peter Breggin, author of Toxic Psychiatry, among many other books, and she eventually stopping taking the drugs. She later dropped out of college (Bryn Mawr) and moved to Northampton, Massachusetts, where she became involved in activism. (In recent years, Simon has worked on many social justice issues and was instrumental in convincing the Northampton officials to reject an ordinance that would have outlawed pan-handling in the city). But as Simon recounts in an article posted on The Icarus Project, she knew she still needed help with her "emotional extremes."
When she was 22, Simon stumbled upon the Freedom Center, a psychiatric survivor group in Northampton that had been founded a few years prior by two other former mental patients, Will Hall and Oryx Cohen. In Simon's words, "The Freedom Center is the area's only group run by and for people labeled with severe 'mental illnesses.'" The center is opposed to involuntary treatment and what it calls "forced drugging," and it supports treatment alternatives such as yoga, meditation, exercise, nutrition and access to peer-run support groups. The Freedom Center puts its money where its mouth is: offering members free yoga, acupuncture, exercise and nutrition sessions, as well as entry to its weekly support groups.
Simon has been attending the Freedom Center's support groups on and off for the last six years and helping to spread the word about its mission.
"One can't say enough about what a difference it makes to work through one's problems among peers rather than trying to solve them within a hierarchial model," she writes in her Icarus Project article. "In our support groups, we try to help people make their own decisions based no their own values rather than judging them according to an APA approved notion of what is 'adjusted,' 'functional,' and 'mentally healthy.'
Simon is quick to point out that the Freedom Center is not anti-drugs. "We fully support people if they are firm believers in the biochemical model of mental illness, if that's the model that helps them live the lives they want to lead," she says. "By acknowledging that people are experts when it comes to their own selves, we create an environment in which people are best able to help themselves progress toward recovery."
In her book, Agnes's Jacket, psychology professor Gail Hornstein devotes an entire chapter to the Freedom Center, citing it as one of the most successful models in this country of what she terms the psychiatric survivor movement. And Newsweek recently wrote about the center's involvement in the growing "mad pride" movement.
The Freedom Center, however, is currently in financial straits, a fact that Caty Simon finds sadly ironic. "Just as we're getting so much press, we're really struggling financially to keep our core services alive," she says. To raise awareness about the center, Simon and other members of the center are organizing a speakout later this summer at which psychiatric survivors will get together and tell their stories. "There's something really empowering about people telling their stories, for example, about being mistreated and force medicated," she says. "This spoken presentation is amazingly powerful."
In the meantime, if you want to learn more about the Freedom Center and make a donation, just click here. Your support could help someone else find the inner strength and stability that Caty Simon has.
"The next couple of years were horribly dysfunctional for me," Simon recalls. "The Depakote made me incredibly depressed, it really knocked me out. I spent my senior year in bed."
For years, Simon says she bought into what her psychiatrists told her: that she had a lifelong, biogenetic mental illness that could only be treated with potent psychoactive drugs. But then she began reading books by Persimmon Blackridge (Prozac Highway) and Dr. Peter Breggin, author of Toxic Psychiatry, among many other books, and she eventually stopping taking the drugs. She later dropped out of college (Bryn Mawr) and moved to Northampton, Massachusetts, where she became involved in activism. (In recent years, Simon has worked on many social justice issues and was instrumental in convincing the Northampton officials to reject an ordinance that would have outlawed pan-handling in the city). But as Simon recounts in an article posted on The Icarus Project, she knew she still needed help with her "emotional extremes."
When she was 22, Simon stumbled upon the Freedom Center, a psychiatric survivor group in Northampton that had been founded a few years prior by two other former mental patients, Will Hall and Oryx Cohen. In Simon's words, "The Freedom Center is the area's only group run by and for people labeled with severe 'mental illnesses.'" The center is opposed to involuntary treatment and what it calls "forced drugging," and it supports treatment alternatives such as yoga, meditation, exercise, nutrition and access to peer-run support groups. The Freedom Center puts its money where its mouth is: offering members free yoga, acupuncture, exercise and nutrition sessions, as well as entry to its weekly support groups.
Simon has been attending the Freedom Center's support groups on and off for the last six years and helping to spread the word about its mission.
"One can't say enough about what a difference it makes to work through one's problems among peers rather than trying to solve them within a hierarchial model," she writes in her Icarus Project article. "In our support groups, we try to help people make their own decisions based no their own values rather than judging them according to an APA approved notion of what is 'adjusted,' 'functional,' and 'mentally healthy.'
Simon is quick to point out that the Freedom Center is not anti-drugs. "We fully support people if they are firm believers in the biochemical model of mental illness, if that's the model that helps them live the lives they want to lead," she says. "By acknowledging that people are experts when it comes to their own selves, we create an environment in which people are best able to help themselves progress toward recovery."
In her book, Agnes's Jacket, psychology professor Gail Hornstein devotes an entire chapter to the Freedom Center, citing it as one of the most successful models in this country of what she terms the psychiatric survivor movement. And Newsweek recently wrote about the center's involvement in the growing "mad pride" movement.
The Freedom Center, however, is currently in financial straits, a fact that Caty Simon finds sadly ironic. "Just as we're getting so much press, we're really struggling financially to keep our core services alive," she says. To raise awareness about the center, Simon and other members of the center are organizing a speakout later this summer at which psychiatric survivors will get together and tell their stories. "There's something really empowering about people telling their stories, for example, about being mistreated and force medicated," she says. "This spoken presentation is amazingly powerful."
In the meantime, if you want to learn more about the Freedom Center and make a donation, just click here. Your support could help someone else find the inner strength and stability that Caty Simon has.
Thursday, June 11, 2009
More doctors disagreeing with AMA over universal health care
As Congress steps up its efforts to craft a comprehensive health care reform bill, Senator Edward Kennedy (in absentia) is leading the charge for a public health insurance option that can compete with private insurers. As far as I can tell, this would not only involve the expansion of Medicaid to cover people who are currently uninsured and earning below a certain income, but it would also offer a cost-based health plan administered by the government or a nonprofit cooperative (the details haven't been worked out yet) to folks who have had it up to here with private for-profit health plans.
The Republications, of course, are screaming socialized medicine. And rushing to their side is the powerful doctors group, the American Medical Association. According to The New York Times today, the AMA opposes the creation of a government-sponsored insurance plan, claiming it will restrict patient choice by eventually driving out private insurers.
What the AMA is really concerned about are profits -- a public health plan, much as Medicare and Medicaid now do, would reimburse doctors for tests and treatment at a lower rate than private insurers and that would threaten many doctors' six and seven-figure salaries. God forbid!
Fortunately, as Robert Pear in theTimes article and Doug Bremner's blog notes, the AMA no longer speaks for many doctors. Indeed, there is a large group, the Physicians for a National Health Program, which supports a single-payer system of insurance, in which a single public entity would pay for health services but most care would still be delivered by private doctors and hospitals. As Pear notes, many doctors have become so fed up with the administrative hassles of private insurance that they are looking for alternatives.
In an op-ed piece in The Boston Globe earlier this week, Dr.Steven Bergman, a psychiatrist and author of The House of God, expressed these sentiments with particular eloquence. Under a universal, government-run health care system, Bergman says, doctors would no longer "have to spend an evening filling out dozens of different insurance forms -- and then submit them a month later when they are denied or reduced."
What Bergman doesn't mention is how fed up many consumers (who don't have a powerful lobbying group like the AMA to give them voice) have become with for-profit health plans that charge them high premiums and then don't really cover them when they need care. I wrote about the millions of Americans who are grappling with unaffordable medical bills as a result of such deliberate under-insurance for The Boston Globe last year. This problem has only become more acute, as health insurers seek to hold onto their excessive profits,
As Bergman points out, the administrative cost for a private, for profit health insurance system is approximately 33 percent ($300 billion annually), while the administrative cost for the the two government-run health systems, the VA and Medicare, is about 3 percent. Yet "the level of satisfaction with these two nonprofit systems is high; that of the for-profit is low," he notes.
Bergman then asks the pertinent question: Why in the world should health care be for profit? Why indeed. The U.S. is currently the only developed nation in the western world that allows for-profit health systems. Yet despite all the evidence in favor of public health insurance, Bergman is concerned that Congress will fold before the combined juggernaut of for-profit health insurers and powerful doctors trying to protect their profits. If that happens, and there is a strong likelihood it will, Bergman calls on doctors and other health care professionals to go on a nationwide strike. Hear hear!
So what can you, the consumer, do? Call your Congressional representative and tell them that you want a public health plan option as part of the current overhaul. And then call your doctor and make sure he or she is ready to man the balustrades.
The Republications, of course, are screaming socialized medicine. And rushing to their side is the powerful doctors group, the American Medical Association. According to The New York Times today, the AMA opposes the creation of a government-sponsored insurance plan, claiming it will restrict patient choice by eventually driving out private insurers.
What the AMA is really concerned about are profits -- a public health plan, much as Medicare and Medicaid now do, would reimburse doctors for tests and treatment at a lower rate than private insurers and that would threaten many doctors' six and seven-figure salaries. God forbid!
Fortunately, as Robert Pear in theTimes article and Doug Bremner's blog notes, the AMA no longer speaks for many doctors. Indeed, there is a large group, the Physicians for a National Health Program, which supports a single-payer system of insurance, in which a single public entity would pay for health services but most care would still be delivered by private doctors and hospitals. As Pear notes, many doctors have become so fed up with the administrative hassles of private insurance that they are looking for alternatives.
In an op-ed piece in The Boston Globe earlier this week, Dr.Steven Bergman, a psychiatrist and author of The House of God, expressed these sentiments with particular eloquence. Under a universal, government-run health care system, Bergman says, doctors would no longer "have to spend an evening filling out dozens of different insurance forms -- and then submit them a month later when they are denied or reduced."
What Bergman doesn't mention is how fed up many consumers (who don't have a powerful lobbying group like the AMA to give them voice) have become with for-profit health plans that charge them high premiums and then don't really cover them when they need care. I wrote about the millions of Americans who are grappling with unaffordable medical bills as a result of such deliberate under-insurance for The Boston Globe last year. This problem has only become more acute, as health insurers seek to hold onto their excessive profits,
As Bergman points out, the administrative cost for a private, for profit health insurance system is approximately 33 percent ($300 billion annually), while the administrative cost for the the two government-run health systems, the VA and Medicare, is about 3 percent. Yet "the level of satisfaction with these two nonprofit systems is high; that of the for-profit is low," he notes.
Bergman then asks the pertinent question: Why in the world should health care be for profit? Why indeed. The U.S. is currently the only developed nation in the western world that allows for-profit health systems. Yet despite all the evidence in favor of public health insurance, Bergman is concerned that Congress will fold before the combined juggernaut of for-profit health insurers and powerful doctors trying to protect their profits. If that happens, and there is a strong likelihood it will, Bergman calls on doctors and other health care professionals to go on a nationwide strike. Hear hear!
So what can you, the consumer, do? Call your Congressional representative and tell them that you want a public health plan option as part of the current overhaul. And then call your doctor and make sure he or she is ready to man the balustrades.
Monday, June 1, 2009
The fish rots from the head: conflicts of interest at Partners and Harvard Medical School
Much has been written about prominent doctors who fail to disclose their lucrative financial ties with pharmaceutical and medical device companies. Yet there has been less focus on hospitals and other leading institutions who have similar conflicts of interest -- until now. In The Boston Globe Sunday, long-time investigative reporter Steve Kurkjian turns the spotlight on the enmeshed relationships between the long-time chairman of Partners, New England largest health-care company, and the pharmaceutical industry.
Kurkjian's eye-opening account reveals that Partners failed to disclose that its long-time chairman, Jack Connors, has owned several lucrative businesses that profited from their close ties both to Partners' teaching hospitals and Harvard Medical School, which provides the faculty and residents that staff Partners hospitals. One of Connors' businesses was a company that received millions of dollars in funding from pharmaceutical companies to provide continuing medical education to doctors affiliated with both Partners and Harvard Medical School. Indeed, as Kurkjian notes, Connors' company, M/C Communications, "profited hugely from an exclusive commercial relationship it maintained with Harvard Medical School." But Partners didn't think it important to disclose that enormous conflict of interest to its own board or the public. Nor did Partners disclose the fact that Connors (after he sold M/C Communications in 2004 for a whopping $450 million) founded another for-profit home-care company that has solicited business from Partners hospitals. If that's not a conflict, I don't know what it is.
Connors, as this fawning 2007 article in The Boston Globe magazine shows, has long been one of Boston's best-connected and wealthiest power brokers. As the founder, long-time executive and now chairman emeritus of Hill Holiday Connors, Cosmopolos, (Partners' advertising firm, by the way) Connors has been at the epicenter of many a lucrative business and political deal in our fair city. For example, back in the '90s, Connors helped engineer a smear campaign against Lois Pines, then running for attorney general against Thomas Reilly. Remember him? {He crashed and burned running for governor of Massachusetts).
A few years back, Connors was even floated as a possible purchaser of The Boston Globe, along with Jack Welch and Mike Barnicle, who was fired by the newspaper for plagiarizing and making stuff up. Can you imagine these three as owners of Boston's paper of record? Perish the thought!
In this case, Connors' undisclosed conflicts of interest are emblematic of the larger flaws that exist in health care today. The kind of profitable and conflicted relationships that he symbolizes go a long way toward explaining why both Partners (which owns Mass. General Hospital) and Harvard Medical School have been so loathe to strengthen their own conflict of interest policies and take action against compromised doctors like Joseph Biederman (a big gun at MGH), despite pressure from students and some faculty. After all, if Partners' own chairman is allowed to get away with undisclosed conflicts of interest, how honest can the folks at the helm of either institution be? Who was it that said the fish rots from the head?
Kurkjian's eye-opening account reveals that Partners failed to disclose that its long-time chairman, Jack Connors, has owned several lucrative businesses that profited from their close ties both to Partners' teaching hospitals and Harvard Medical School, which provides the faculty and residents that staff Partners hospitals. One of Connors' businesses was a company that received millions of dollars in funding from pharmaceutical companies to provide continuing medical education to doctors affiliated with both Partners and Harvard Medical School. Indeed, as Kurkjian notes, Connors' company, M/C Communications, "profited hugely from an exclusive commercial relationship it maintained with Harvard Medical School." But Partners didn't think it important to disclose that enormous conflict of interest to its own board or the public. Nor did Partners disclose the fact that Connors (after he sold M/C Communications in 2004 for a whopping $450 million) founded another for-profit home-care company that has solicited business from Partners hospitals. If that's not a conflict, I don't know what it is.
Connors, as this fawning 2007 article in The Boston Globe magazine shows, has long been one of Boston's best-connected and wealthiest power brokers. As the founder, long-time executive and now chairman emeritus of Hill Holiday Connors, Cosmopolos, (Partners' advertising firm, by the way) Connors has been at the epicenter of many a lucrative business and political deal in our fair city. For example, back in the '90s, Connors helped engineer a smear campaign against Lois Pines, then running for attorney general against Thomas Reilly. Remember him? {He crashed and burned running for governor of Massachusetts).
A few years back, Connors was even floated as a possible purchaser of The Boston Globe, along with Jack Welch and Mike Barnicle, who was fired by the newspaper for plagiarizing and making stuff up. Can you imagine these three as owners of Boston's paper of record? Perish the thought!
In this case, Connors' undisclosed conflicts of interest are emblematic of the larger flaws that exist in health care today. The kind of profitable and conflicted relationships that he symbolizes go a long way toward explaining why both Partners (which owns Mass. General Hospital) and Harvard Medical School have been so loathe to strengthen their own conflict of interest policies and take action against compromised doctors like Joseph Biederman (a big gun at MGH), despite pressure from students and some faculty. After all, if Partners' own chairman is allowed to get away with undisclosed conflicts of interest, how honest can the folks at the helm of either institution be? Who was it that said the fish rots from the head?
Thursday, May 28, 2009
Why our health care costs are so high and what we can do about it
In order to truly stabilize the economy and rescue Medicare from financial collapse, the Obama administration knows it has to do something about the elephant in the room: ever-rising health care costs. In this week's New Yorker, surgeon-writer Atul Gawande presents an eye-opening discourse on why American health care costs have ballooned in the last decade and what can done about it.
To make his case, Gawande visits McAllen, Texas, which is one of the most expensive health-care markets in the country. In 2006, Medicare spent $15,000 per enrollee in McAllen (almost twice the national average); only Miami, Gawande reports, spent more per person on health care. The reason? Too much medicine. Doctors in McAllen prescribe far more tests, treatments and surgery than doctors in a nearby Texas town and nationwide. Yet the quality of health care is no better in McAllen, and Gawande cites research showing that such overuse of medicine may actually make patients worse.
So why are doctors in McAllen so aggressive? After interviewing everyone in sight, Gawande concludes that many doctors in this Texas town, unlike doctors in more conservative cities like Seattle, Sacramento, Boise and even nearby El Paso, see their practice as a money-making "revenue stream." They recognize that the more tests and treatments they prescribe, the more procedures they do, the more money they'll make.
The solution? Gawande argues that rather penalizing the money-savvy docs of McAllen, the Obama administration should begin rewarding the doctors and non-profit institutions (hospitals like the Mayo Clinic and health plans like Intermountain and Kaiser) that band together to practice a more preventative, conservative type of medicine and discourage "overtreatment...and sheer profiteering."
Gawande notes that "we are witnessing a battle for the soul of American medicine" and concludes that unless we begin rewarding "the leaders who are trying to a build a new generation of Mayos...McAllen won't be an outlier. It will be our future."
This is a scary article and a must read.
To make his case, Gawande visits McAllen, Texas, which is one of the most expensive health-care markets in the country. In 2006, Medicare spent $15,000 per enrollee in McAllen (almost twice the national average); only Miami, Gawande reports, spent more per person on health care. The reason? Too much medicine. Doctors in McAllen prescribe far more tests, treatments and surgery than doctors in a nearby Texas town and nationwide. Yet the quality of health care is no better in McAllen, and Gawande cites research showing that such overuse of medicine may actually make patients worse.
So why are doctors in McAllen so aggressive? After interviewing everyone in sight, Gawande concludes that many doctors in this Texas town, unlike doctors in more conservative cities like Seattle, Sacramento, Boise and even nearby El Paso, see their practice as a money-making "revenue stream." They recognize that the more tests and treatments they prescribe, the more procedures they do, the more money they'll make.
The solution? Gawande argues that rather penalizing the money-savvy docs of McAllen, the Obama administration should begin rewarding the doctors and non-profit institutions (hospitals like the Mayo Clinic and health plans like Intermountain and Kaiser) that band together to practice a more preventative, conservative type of medicine and discourage "overtreatment...and sheer profiteering."
Gawande notes that "we are witnessing a battle for the soul of American medicine" and concludes that unless we begin rewarding "the leaders who are trying to a build a new generation of Mayos...McAllen won't be an outlier. It will be our future."
This is a scary article and a must read.
Wednesday, May 20, 2009
Denis Maltez is the reason we need to know who is shilling for Big Pharma
On his Pharma Marketing blog today, John Mack recaps the controversy over the patient who was paid hundreds of thousands of dollars by Bristol Myers Squibb to promote Abilify and then changed his tune. (Andy Behrman, aka "Electroboy," began talking out about the serious effects he had suffered while taking the anti-psychotic). In his blog, Mack asks the question: “Is this done often by all pharmaceutical companies or is it just something unique to BMS?”
Why do I have the feeling that Mack already knows the answer? It's not exactly a state secret that drug companies routinely pay doctors and patients, the higher the profile the better, big bucks to hawk their drugs. Look at Bob Dole and Viagra, heart doctor Robert Jarvik and Lipitor. The list goes on and on. The drug companies would, of course, prefer to pay key opinion leaders in medicine (KOLs as they are known) and celebrities to promote their wares, but they will pay anyone whom they think has a shred of credibility with the population they are trying to target. As I reveal in Side Effects and on my blog, a number of drug giants including Eli Lilly, GlaxoSmithKline and Pfizer paid Jim McNulty, past president of the National Alliance for the Mentally Ill (NAMI), thousands of dollars to promote their antidepressants. In his talks around the country, McNulty billed himself as a patient since he took the drugs to combat bipolar disorder. But he never disclosed to his audience or the members of NAMI that he was getting all this money on the side from Big Pharma.
So why does this matter? For an answer, one has only to read the heartrenching story in The Miami Herald today about yet another young boy in Florida who died after being given a cocktail of potent psychoactive drugs. According to a wrongful death lawsuit filed by his mother, Denis Maltez, 12, who was living a state-funded group home and had been diagnosed as autistic, was on Seroquel and Zyprexa (atypical anti-psychotics), as well as Depakote, an anti-seizure drug, and Clonazepam, a tranquilizer. Denis apparently died of serotonin syndrome, according to a 2007 autopsy by the Miami-Dade Medical Examiner’s office. As reported in The Herald, that condition occurs when a combination of drugs causes the brain to produce an excess of serotonin, a neurotransmitter in the brain.
Maltez’s mother says she sent her son to the group home after he tried to choke his younger sister. Her lawsuit comes in the midst of a high-profile investigation by Florida authorities into the death last month of a 7-year-old foster child who had also been taking a cocktail of psychoactive drugs.
Why, you might ask, do some psychiatrists prescribe these potentially lethal drugs to young children and then not monitor them for side effects? I can't answer that question. What I do know is that many doctors and consumers think these drugs are safe and effective for such off-label uses in large part because drug companies have paid big bucks both to KOLs and "patients" like Andy Behrmann and Jim McNulty to shill for them. And that's precisely why we need public disclosure laws like the one that the Vermont Legislature passed this week -- see New York Times article here -- so that everyone knows who the shills are and can take what they say with a hefty dose of skepticism. Here's hoping Congress passes the Physician Payment Sunshine Act and makes this a national trend.
Why do I have the feeling that Mack already knows the answer? It's not exactly a state secret that drug companies routinely pay doctors and patients, the higher the profile the better, big bucks to hawk their drugs. Look at Bob Dole and Viagra, heart doctor Robert Jarvik and Lipitor. The list goes on and on. The drug companies would, of course, prefer to pay key opinion leaders in medicine (KOLs as they are known) and celebrities to promote their wares, but they will pay anyone whom they think has a shred of credibility with the population they are trying to target. As I reveal in Side Effects and on my blog, a number of drug giants including Eli Lilly, GlaxoSmithKline and Pfizer paid Jim McNulty, past president of the National Alliance for the Mentally Ill (NAMI), thousands of dollars to promote their antidepressants. In his talks around the country, McNulty billed himself as a patient since he took the drugs to combat bipolar disorder. But he never disclosed to his audience or the members of NAMI that he was getting all this money on the side from Big Pharma.
So why does this matter? For an answer, one has only to read the heartrenching story in The Miami Herald today about yet another young boy in Florida who died after being given a cocktail of potent psychoactive drugs. According to a wrongful death lawsuit filed by his mother, Denis Maltez, 12, who was living a state-funded group home and had been diagnosed as autistic, was on Seroquel and Zyprexa (atypical anti-psychotics), as well as Depakote, an anti-seizure drug, and Clonazepam, a tranquilizer. Denis apparently died of serotonin syndrome, according to a 2007 autopsy by the Miami-Dade Medical Examiner’s office. As reported in The Herald, that condition occurs when a combination of drugs causes the brain to produce an excess of serotonin, a neurotransmitter in the brain.
Maltez’s mother says she sent her son to the group home after he tried to choke his younger sister. Her lawsuit comes in the midst of a high-profile investigation by Florida authorities into the death last month of a 7-year-old foster child who had also been taking a cocktail of psychoactive drugs.
Why, you might ask, do some psychiatrists prescribe these potentially lethal drugs to young children and then not monitor them for side effects? I can't answer that question. What I do know is that many doctors and consumers think these drugs are safe and effective for such off-label uses in large part because drug companies have paid big bucks both to KOLs and "patients" like Andy Behrmann and Jim McNulty to shill for them. And that's precisely why we need public disclosure laws like the one that the Vermont Legislature passed this week -- see New York Times article here -- so that everyone knows who the shills are and can take what they say with a hefty dose of skepticism. Here's hoping Congress passes the Physician Payment Sunshine Act and makes this a national trend.
Thursday, May 14, 2009
Senior citizens wising up to Big Pharma
I had the pleasure of speaking to a large group of senior citizens yesterday at a Jewish community center in the Boston area. I had been invited there to talk about Side Effects, and while the focus of my talk (like my book) was how drug companies deceived the American public about the safety and effectiveness of SSRI antidepressants in treating children, the seniors very quickly made the leap to how this issue affects them. During the Q&A, a number of them spoke up about the difficulties they’d had in getting a straight answer out of their doctors about potential side effects. They talked candidly of their confusion in not knowing whom to trust and where to get accurate, objective information about the drugs they were being prescribed.
This was a savvy, educated bunch of people, mostly in their 70s and 80s, and it was clear they took the business of their health seriously. A number of those in attendance said they didn’t always accept their doctor’s word that a particular drug was safe, and they seemed to have no problem understanding how pharm-bred gifts, free meals, junkets, not to mention lucrative consulting and speaking fees, could compromise the most devoted doctor's judgment.
One woman, for example, told me that two different doctors in recent months had prescribed neurontin, a drug approved for epileptic seizures, to ease her chronic pain, even though there is little scientific evidence it works as a painkiller. Indeed, four years ago, Pfizer paid a whopping $430 million fine for illegally marketing neurontin for off-label uses such as pain and anxiety. (The drug company essentially paid academics to put their names on research papers prepared by the company to promote these uses – shades of the Vioxx court saga currently shadowing Merck). Fortunately, the woman at the JCC had taken the time to ask around about neurontin and a family member who is in the health care field discouraged her from taking the drug. So she didn’t. She found a safer and more effective alternative.
In fact, I was surprised at the level of skepticism these seniors seemed to share about their doctors and the medical establishment as a whole. And it made me think: If this age group, which has witnessed some true miracles in medicine over their life span, is so cynical about the current state of health care, perhaps the time really is ripe for reform, and I’m not just talking about reform in the way medical care is paid for and delivered, but also in how new drugs and medical devices are tested and brought to market.
Indeed, it appears as if the senior set has already taken matters into their own hands. According to Medco’s annual report on drug spending, released yesterday, spending on drugs actually fell among people age 65 and older. Medco attributed the drop in spending among this age group to its increased use of generic drugs. Now maybe this has something to do with the economic climate, but it could also be attributed to the fact that senior citizens, along with other consumers, are wising up to the misleading blandishments of the pharmaceutical industry. And at the risk of generalizing from the comments and questions I heard yesterday, it appears as if they want their doctors to wise up too.
This was a savvy, educated bunch of people, mostly in their 70s and 80s, and it was clear they took the business of their health seriously. A number of those in attendance said they didn’t always accept their doctor’s word that a particular drug was safe, and they seemed to have no problem understanding how pharm-bred gifts, free meals, junkets, not to mention lucrative consulting and speaking fees, could compromise the most devoted doctor's judgment.
One woman, for example, told me that two different doctors in recent months had prescribed neurontin, a drug approved for epileptic seizures, to ease her chronic pain, even though there is little scientific evidence it works as a painkiller. Indeed, four years ago, Pfizer paid a whopping $430 million fine for illegally marketing neurontin for off-label uses such as pain and anxiety. (The drug company essentially paid academics to put their names on research papers prepared by the company to promote these uses – shades of the Vioxx court saga currently shadowing Merck). Fortunately, the woman at the JCC had taken the time to ask around about neurontin and a family member who is in the health care field discouraged her from taking the drug. So she didn’t. She found a safer and more effective alternative.
In fact, I was surprised at the level of skepticism these seniors seemed to share about their doctors and the medical establishment as a whole. And it made me think: If this age group, which has witnessed some true miracles in medicine over their life span, is so cynical about the current state of health care, perhaps the time really is ripe for reform, and I’m not just talking about reform in the way medical care is paid for and delivered, but also in how new drugs and medical devices are tested and brought to market.
Indeed, it appears as if the senior set has already taken matters into their own hands. According to Medco’s annual report on drug spending, released yesterday, spending on drugs actually fell among people age 65 and older. Medco attributed the drop in spending among this age group to its increased use of generic drugs. Now maybe this has something to do with the economic climate, but it could also be attributed to the fact that senior citizens, along with other consumers, are wising up to the misleading blandishments of the pharmaceutical industry. And at the risk of generalizing from the comments and questions I heard yesterday, it appears as if they want their doctors to wise up too.
Thursday, May 7, 2009
The media storm over swine flu: one more reason why good health journalism matters
As The Boston Globe's unions vote on whether to bow to the inevitable and make the financial concessions demanded to keep their newspaper alive, it seems a sad but apropos time to bring attention to a new survey on the declining state of health care journalism. The survey, authored by Gary Schwitzer, a professor at the University of Minnesota School of Journalism and founder of the Schwitzer Health News Blog, shows how financial pressures on the media are hurting the quality of health care reporting.
Health care journalists themselves are the first to acknowledge this disturbing trend. Fully 94 percent of the reporters interviewed agree that media downsizing has seriously hurt the quality of health news coverage. Here are some of the other key findings of the survey, according to Hot Topics in Journalism and Mass Communcation :
• Forty percent of the reporters surveyed say the number of health reporters at their organization has gone down since they’ve been there, and 11 percent say they personally have been laid off over the past few years due to downsizing.
• Nearly nine in ten respondents think health care coverage leans too much toward short “quick hit” stories, and two-thirds say the trend toward shorter stories has gotten worse in the past few years.
• A majority of respondents say there is too much coverage of consumer or lifestyle health, and too little of health policy, health care quality, and health disparities.
• Just under half of the journalists surveyed say that their organization sometimes or frequently bases stories on news releases without substantial additional reporting.
And if all of that is not alarming enough, here’s a really scary finding:
• About one in 10 journalists in the survey say his or her own organization sometimes or frequently allows advertisers, sales staff or sponsors to influence story selection or content. Yikes! What's happening to the separation of editorial and business -- a bedrock principle of journalism?
You might ask: why does any of this matter? For the answer, one has only to look at the difference in the way media organizations have covered the current swine flu outbreak. While newspapers with experienced health reporters like The New York Times and The Boston Globe provided thoughtful and measured coverage of the epidemic, other media outlets have been less circumspect. Here’s some interesting commentary by Stacey Woelfel, chairman of the Association of Electronic Journalists, berating her fellow television journalists for sensationalizing the current outbreak and literally beating the story to death in the race for ratings.
Despite such sensationalistic coverage, health officials in the current administration have so far refrained for insisting that Americans get inoculated against the latest flu strain. Perhaps the public health community learned its lesson from the last swine flu scare in the 1970s, when the Ford administration ramped up production of a poorly designed vaccine. In the end, the vaccine ended up killing and crippling more people than the flu itself.
The 1970s debacle is precisely why good health coverage matters. We need experienced science and medical journalists who can provide the kind of accurate and authoritative coverage that allows policy makers to make wise decisions about the public's health. This time around, the nation's top health advisors managed to ignore the media cacophony and do what they thought was right. Next time, we may not be so lucky.
Health care journalists themselves are the first to acknowledge this disturbing trend. Fully 94 percent of the reporters interviewed agree that media downsizing has seriously hurt the quality of health news coverage. Here are some of the other key findings of the survey, according to Hot Topics in Journalism and Mass Communcation :
• Forty percent of the reporters surveyed say the number of health reporters at their organization has gone down since they’ve been there, and 11 percent say they personally have been laid off over the past few years due to downsizing.
• Nearly nine in ten respondents think health care coverage leans too much toward short “quick hit” stories, and two-thirds say the trend toward shorter stories has gotten worse in the past few years.
• A majority of respondents say there is too much coverage of consumer or lifestyle health, and too little of health policy, health care quality, and health disparities.
• Just under half of the journalists surveyed say that their organization sometimes or frequently bases stories on news releases without substantial additional reporting.
And if all of that is not alarming enough, here’s a really scary finding:
• About one in 10 journalists in the survey say his or her own organization sometimes or frequently allows advertisers, sales staff or sponsors to influence story selection or content. Yikes! What's happening to the separation of editorial and business -- a bedrock principle of journalism?
You might ask: why does any of this matter? For the answer, one has only to look at the difference in the way media organizations have covered the current swine flu outbreak. While newspapers with experienced health reporters like The New York Times and The Boston Globe provided thoughtful and measured coverage of the epidemic, other media outlets have been less circumspect. Here’s some interesting commentary by Stacey Woelfel, chairman of the Association of Electronic Journalists, berating her fellow television journalists for sensationalizing the current outbreak and literally beating the story to death in the race for ratings.
Despite such sensationalistic coverage, health officials in the current administration have so far refrained for insisting that Americans get inoculated against the latest flu strain. Perhaps the public health community learned its lesson from the last swine flu scare in the 1970s, when the Ford administration ramped up production of a poorly designed vaccine. In the end, the vaccine ended up killing and crippling more people than the flu itself.
The 1970s debacle is precisely why good health coverage matters. We need experienced science and medical journalists who can provide the kind of accurate and authoritative coverage that allows policy makers to make wise decisions about the public's health. This time around, the nation's top health advisors managed to ignore the media cacophony and do what they thought was right. Next time, we may not be so lucky.
Thursday, April 30, 2009
Is Science a self-correcting process? I (and the Institute of Medicine) think not.
For years, many scientists and doctors have argued that it was not necessary to police conflicts of interest and other irregularities in scientific research, Money, they argued, couldn't possibly taint their scientific judgment. And even if it did, science was essentially a "self-correcting" process. If some researchers allowed bias into their work and skewed their data as a result, the thinking went, other scientists would eventually expose them because they would not be able to reproduce their results.
Unfortunately, this long-held dogma turns out not to be true (if it ever was). As science becomes more complicated and specialized with dozens of authors weighing in on a single paper, no one has time to reproduce the vast amount of results reported in scientific papers. Nor do most scientists have the inclination to prove wrongdoing, especially when the results favor their own purposes or pocketbooks. In her fascinating new book, Plastic Fantastic, science writer Eugenie Samuel Reich explores the notorious case of Hendrik Schon, a young Bell Labs researcher from Germany who forged data on a number of significant papers detailing supposed breakthroughs in high-performance computer transistors. Reich concludes that in this case, the "self-correcting process" of science turned out to be far less systematic than many scientists think it is. Schon's forgeries were eventually caught in 2002 not by researchers in his own lab but by a few skeptical outliers in other labs who transformed themselves into whistle blowers and refused to accept the assurances of Schon's supervisors that his work was genuine.
Schon, Reich reveals, began fudging data as a graduate student and just dug himself deeper and deeper into a fantasy world in large part to please his supervisors and cover up his inadequacies as an original thinker. While Schon's work (if it had been authentic) certainly had commercial implications, he wasn't necessarily motivated by commercial pressures, she concludes.
The same, however, cannot be said of clinical drug research, where there are tremendous commercial pressures -- to report favorable results about a new drug or medical device. And that is why the national Institute of Medicine (IOM) has weighed in so decisively in its report on conflicts of interest in research and what needs to be done to ensure the integrity of the scientific process. A good overview of the IOM report and its conclusions can be found in this week's New England Journal of Medicine.
Basically, the IOM report calls for Congress to pass legislation (like Grassley's Physician Payment Sunshine Act) that would require pharmaceutical, medical device and biotechnology companies to publicly report payments to physicians and other health care professionals. But the IOM recommendations go beyond the Sunshine Act and call for legislation that would also require professional societies and patient advocacy groups, like NAMI, which have their own blatant conflicts of interest -- see here -- to publicly disclose them.
The IOM report also concludes, as I have argued in Side Effects, that disclosure is not enough. "Academic medical centers and research institutions should "restrict participation of researchers with financial conflicts of interest in research with human participants," the report says. That means if a particular researcher is getting lots of money in consulting and speaking fees from a drug or medical device company, he or she should not be involved in clinical trials of products made by that company. That would rule out the participation of many of the conflicted doctors I've written about here, including Martin Keller, Charles Nemeroff, Alan Schatzberg, Karen Wagner, Graham Emslie, Robert Robinson. The list goes on and on.
The IOM report also calls on medical societies to reform their continuing medical education programs so that they are "free of industry influence..." And it urges physicians to reject gifts or other "items of material value" from pharmaceutical, medical device and biotechnology companies. It also suggests that advisory groups that issue clinical guidelines about medical treatment restrict industry influence and conflicts of interest among panel members.
In sum, the nation's most respected medical body is acknowledging that financial conflicts of interest corrupt scientific research and harm public health in the process. And even in the absence of financial conflicts, scientists have to do more to ensure the integrity of the scientific process. Trust alone just doesn't cut it.
Unfortunately, this long-held dogma turns out not to be true (if it ever was). As science becomes more complicated and specialized with dozens of authors weighing in on a single paper, no one has time to reproduce the vast amount of results reported in scientific papers. Nor do most scientists have the inclination to prove wrongdoing, especially when the results favor their own purposes or pocketbooks. In her fascinating new book, Plastic Fantastic, science writer Eugenie Samuel Reich explores the notorious case of Hendrik Schon, a young Bell Labs researcher from Germany who forged data on a number of significant papers detailing supposed breakthroughs in high-performance computer transistors. Reich concludes that in this case, the "self-correcting process" of science turned out to be far less systematic than many scientists think it is. Schon's forgeries were eventually caught in 2002 not by researchers in his own lab but by a few skeptical outliers in other labs who transformed themselves into whistle blowers and refused to accept the assurances of Schon's supervisors that his work was genuine.
Schon, Reich reveals, began fudging data as a graduate student and just dug himself deeper and deeper into a fantasy world in large part to please his supervisors and cover up his inadequacies as an original thinker. While Schon's work (if it had been authentic) certainly had commercial implications, he wasn't necessarily motivated by commercial pressures, she concludes.
The same, however, cannot be said of clinical drug research, where there are tremendous commercial pressures -- to report favorable results about a new drug or medical device. And that is why the national Institute of Medicine (IOM) has weighed in so decisively in its report on conflicts of interest in research and what needs to be done to ensure the integrity of the scientific process. A good overview of the IOM report and its conclusions can be found in this week's New England Journal of Medicine.
Basically, the IOM report calls for Congress to pass legislation (like Grassley's Physician Payment Sunshine Act) that would require pharmaceutical, medical device and biotechnology companies to publicly report payments to physicians and other health care professionals. But the IOM recommendations go beyond the Sunshine Act and call for legislation that would also require professional societies and patient advocacy groups, like NAMI, which have their own blatant conflicts of interest -- see here -- to publicly disclose them.
The IOM report also concludes, as I have argued in Side Effects, that disclosure is not enough. "Academic medical centers and research institutions should "restrict participation of researchers with financial conflicts of interest in research with human participants," the report says. That means if a particular researcher is getting lots of money in consulting and speaking fees from a drug or medical device company, he or she should not be involved in clinical trials of products made by that company. That would rule out the participation of many of the conflicted doctors I've written about here, including Martin Keller, Charles Nemeroff, Alan Schatzberg, Karen Wagner, Graham Emslie, Robert Robinson. The list goes on and on.
The IOM report also calls on medical societies to reform their continuing medical education programs so that they are "free of industry influence..." And it urges physicians to reject gifts or other "items of material value" from pharmaceutical, medical device and biotechnology companies. It also suggests that advisory groups that issue clinical guidelines about medical treatment restrict industry influence and conflicts of interest among panel members.
In sum, the nation's most respected medical body is acknowledging that financial conflicts of interest corrupt scientific research and harm public health in the process. And even in the absence of financial conflicts, scientists have to do more to ensure the integrity of the scientific process. Trust alone just doesn't cut it.
Monday, April 20, 2009
Conflicted psychiatrists strike back -- against the media
Anyone keeping up with the news knows that a number of prominent psychiatrists have been under seige of late after Congressional allegations that they failed to disclose lucrative payments from drug companies whose products they were studying and promoting on the medical circuit. Now comes evidence that some of these key opinion leaders (KOLs as they are known in the industry) are pushing back, accusing the press of launching a "witch-hunt" and trying to intimidate some of the media messengers.
To wit: One of the featured topics at the November 2009 conference of the International Forum on Mood and Anxiety Disorders in Monaco is Making sense of media attacks on experts: is this a wanton witch hunt?” According to my sources, the forum is essentially an "astroturf creation" of Pharma directed by two prominent psychiatrists with industry ties in Europe. The invited speaker list includes the usual list of KOL suspects, including our very own Alan Schatzberg, who is stepping down as chair of psychiatry at Stanford University.
Schatzberg and Stanford insist that his departure has nothing to do with the media blitz that occurred after a probe by Sen. Charles Grassley uncovered evidence that Schatzberg had failed to disclose he owned $4.8 million in stocks in a company he cofounded -- Corcept Therapeutics -- at a time when he was principal investigator of a NIH-funded study of Corcept's drug for treating depression. Stanford fully disclosed Schatzberg's stock ownership to Grassley's team only after The New York Times, Business Week and other media took note of the Congressional investigation, according to my sources. Shortly thereafter, Stanford asked Schatzberg to step down as principal investigator of the NIH study. And now it has come to light that Stanford is looking for a new chair of its psychiatry department. University officials insist Schatzberg decided to step down long before the conflict of interest contratemps. I'll leave it to you, dear reader, to decide if you believe them.
Schatzberg may be on his way out, but in the meantime, he and Stanford have been busy haranguing the likes of the New York Review of Books (for publishing Marcia Angell's article on medical corruption) in which she noted Schatzberg's conflicts;CBS, which reported on Stanford's problems, and the Corporate Crime Reporter, which recently published an interview with me here about conflicts of interest in medicine. Stanford media relations demanded corrections from all three media, insisting that Stanford fully disclosed Schatzberg's conflicts of interest. Last I heard, there have been no corrections issued.
Schatzberg, it turns out, is no stranger to litigation. A few years ago, he sued University of Massachusetts psychiatrist Anthony Rothschild alleging that Rothschild had libeled and defamed him. Among other juicy items, the lawsuit, which was filed in California Superior Court (Santa Clara County), alleges that Rothschild, using a fake email and name, reported on a Yahoo message board that Schatzberg was using his position at chair of psychiatry at Stanford to promote Corcept's drug and that he and his cofounder knew the drug didn't work (for depression) as far back as 2005 and were selling stock in the company.
There is a history here, of course: In the late 1980s, Rothschild and Schatzberg worked together at Harvard's McLean Hospital, where they came up with the idea of using a drug to block the stress hormone cortisol as a possible treatment for depression. Their brainstorm was to use the abortion drug RU-486, whose main ingredient is mifepristone, a chemical known to block cortisol. But then Schatzberg became chair of psychiatry at Stanford in 1991 and apparently took the idea with him, co-founding Corcept a few years later. At one point in this bizarre saga, Partners, which owns McLean Hospital, even sued Stanford over the patent for Corcept's drug (the case was settled in mediation from what I gather).
What all this shows is that Schatzberg is not afraid to throw lawyers at his critics. I wonder if that's the kind of aggressive action he'll advise at the wanton witch-hunt session in Monaco. What I want to know is: who's paying for his trip there?
To wit: One of the featured topics at the November 2009 conference of the International Forum on Mood and Anxiety Disorders in Monaco is Making sense of media attacks on experts: is this a wanton witch hunt?” According to my sources, the forum is essentially an "astroturf creation" of Pharma directed by two prominent psychiatrists with industry ties in Europe. The invited speaker list includes the usual list of KOL suspects, including our very own Alan Schatzberg, who is stepping down as chair of psychiatry at Stanford University.
Schatzberg and Stanford insist that his departure has nothing to do with the media blitz that occurred after a probe by Sen. Charles Grassley uncovered evidence that Schatzberg had failed to disclose he owned $4.8 million in stocks in a company he cofounded -- Corcept Therapeutics -- at a time when he was principal investigator of a NIH-funded study of Corcept's drug for treating depression. Stanford fully disclosed Schatzberg's stock ownership to Grassley's team only after The New York Times, Business Week and other media took note of the Congressional investigation, according to my sources. Shortly thereafter, Stanford asked Schatzberg to step down as principal investigator of the NIH study. And now it has come to light that Stanford is looking for a new chair of its psychiatry department. University officials insist Schatzberg decided to step down long before the conflict of interest contratemps. I'll leave it to you, dear reader, to decide if you believe them.
Schatzberg may be on his way out, but in the meantime, he and Stanford have been busy haranguing the likes of the New York Review of Books (for publishing Marcia Angell's article on medical corruption) in which she noted Schatzberg's conflicts;CBS, which reported on Stanford's problems, and the Corporate Crime Reporter, which recently published an interview with me here about conflicts of interest in medicine. Stanford media relations demanded corrections from all three media, insisting that Stanford fully disclosed Schatzberg's conflicts of interest. Last I heard, there have been no corrections issued.
Schatzberg, it turns out, is no stranger to litigation. A few years ago, he sued University of Massachusetts psychiatrist Anthony Rothschild alleging that Rothschild had libeled and defamed him. Among other juicy items, the lawsuit, which was filed in California Superior Court (Santa Clara County), alleges that Rothschild, using a fake email and name, reported on a Yahoo message board that Schatzberg was using his position at chair of psychiatry at Stanford to promote Corcept's drug and that he and his cofounder knew the drug didn't work (for depression) as far back as 2005 and were selling stock in the company.
There is a history here, of course: In the late 1980s, Rothschild and Schatzberg worked together at Harvard's McLean Hospital, where they came up with the idea of using a drug to block the stress hormone cortisol as a possible treatment for depression. Their brainstorm was to use the abortion drug RU-486, whose main ingredient is mifepristone, a chemical known to block cortisol. But then Schatzberg became chair of psychiatry at Stanford in 1991 and apparently took the idea with him, co-founding Corcept a few years later. At one point in this bizarre saga, Partners, which owns McLean Hospital, even sued Stanford over the patent for Corcept's drug (the case was settled in mediation from what I gather).
What all this shows is that Schatzberg is not afraid to throw lawyers at his critics. I wonder if that's the kind of aggressive action he'll advise at the wanton witch-hunt session in Monaco. What I want to know is: who's paying for his trip there?
Thursday, April 16, 2009
Where's the conflict of interest here, Mr. Robinson?
Remember the flap a few weeks ago between researcher Jonathan Leo and the Journal of the American Medical Association, whereby JAMA's editors got egg all over their face after trying to intimidate Leo? Leo, a professor of neuroanatomy at Lincoln Memorial University in Harrogate, Tenn., had written a letter to the British Medical Journal, pointing out that the author of a study published in JAMA failed to disclose he had a financial relationship with the drug company whose product he was reporting on. As it turned out, Leo had first brought the undisclosed conflict of interest to the attention of JAMA, but when he didn't hear back from them for five months, he published it online in BMJ. JAMA editors then insisted they were about to issue the correction themselves (which they did here) and blasted Leo for acting precipitously (is waiting five months precipitous?). According to an article by David Armstrong in the Wall Street Journal, Catherine D'Angelis, editor in chief of JAMA, went so far as to call Leo "a nobody and a nothing."
Now there's a new twist to this saga: Robert Robinson, the researcher who originally failed to disclose his conflict of interest, published a letter yesterday in BMJ where he accuses Leo of having a conflict of his own. Leo, he said, was a board member of the International Center for the Study of Psychiatry and Psychology (ICSPP), a group "that is strongly opposed to the blanket use of psychopharmacological treatments." Neither accusation happens to be true: Leo is no longer a board member of ICSPP, and the ICSPP is not opposed to the use of drugs. Indeed, the group's website says, "we are not against the use of psychoactive drugs by competent adults who have been thoroughly informed of their value, potential side effects, and alternatives."
What Robinson seems not to understand is what a conflict of interest really consists of. According to Tufts University's Sheldon Krimsky and other experts, conflicts of interest are widely understood to be financial interests or ties to companies whose products you are studying. As Krimsky told me when I was researching my book, Side Effects, "The integrity of the scientific endeavor is tarnished by the quantity of the money [a particular researcher] is getting as well as the lack of disclosure." Research done by Krimsky and others shows that financial conflicts of interest do bias the recipients of such largesse and their work. And that's why JAMA and other leading medical journals require researchers to disclose financial conflicts of interest, which Robinson failed to do. (Robinson now acknowledges that he was getting personal payments from Forest Labs, the maker of Lexapro, which he should have disclosed in the JAMA study finding that Lexapro was effective in helping treat depression in stroke victims).
But where is financial conflict of interest with regard to Leo? Yes, he was once a board member of ICSSP, an unpaid position, but while that may shed light on where he stands about the indiscriminate use of powerful psychoactive drugs, it is not a conflict of interest. Get real, Robinson.
Full disclosure: I have been asked to speak at the ICSPP's annual meeting next fall (Oct. 9) in Syracuse. And while I am being reimbursed for my travel expenses, I am not being paid a speaker's fee. Would that I were!
Now there's a new twist to this saga: Robert Robinson, the researcher who originally failed to disclose his conflict of interest, published a letter yesterday in BMJ where he accuses Leo of having a conflict of his own. Leo, he said, was a board member of the International Center for the Study of Psychiatry and Psychology (ICSPP), a group "that is strongly opposed to the blanket use of psychopharmacological treatments." Neither accusation happens to be true: Leo is no longer a board member of ICSPP, and the ICSPP is not opposed to the use of drugs. Indeed, the group's website says, "we are not against the use of psychoactive drugs by competent adults who have been thoroughly informed of their value, potential side effects, and alternatives."
What Robinson seems not to understand is what a conflict of interest really consists of. According to Tufts University's Sheldon Krimsky and other experts, conflicts of interest are widely understood to be financial interests or ties to companies whose products you are studying. As Krimsky told me when I was researching my book, Side Effects, "The integrity of the scientific endeavor is tarnished by the quantity of the money [a particular researcher] is getting as well as the lack of disclosure." Research done by Krimsky and others shows that financial conflicts of interest do bias the recipients of such largesse and their work. And that's why JAMA and other leading medical journals require researchers to disclose financial conflicts of interest, which Robinson failed to do. (Robinson now acknowledges that he was getting personal payments from Forest Labs, the maker of Lexapro, which he should have disclosed in the JAMA study finding that Lexapro was effective in helping treat depression in stroke victims).
But where is financial conflict of interest with regard to Leo? Yes, he was once a board member of ICSSP, an unpaid position, but while that may shed light on where he stands about the indiscriminate use of powerful psychoactive drugs, it is not a conflict of interest. Get real, Robinson.
Full disclosure: I have been asked to speak at the ICSPP's annual meeting next fall (Oct. 9) in Syracuse. And while I am being reimbursed for my travel expenses, I am not being paid a speaker's fee. Would that I were!
Thursday, April 9, 2009
Why didn't Brown axe Martin Keller years ago?
Brown University's student newspaper, The Daily Herald, reported this week that Martin Keller had announced his decision to step down as Brown's chair of psychiatry in August 2007. In a letter he apparently sent to faculty in his department, Keller said he would be stepping down in June 2009 to devote more time to research and allow the university to take the time to find a "world-class new chair."
However, according to sources, Keller was then asked to stay on as chair until Brown's affiliate hospitals could complete a merger with Lifespan Hospital. "The thinking was that they couldn't recruit a chair of psychiatry until the merger was decided," said a Brown faculty member who asked not to be named. The merger, of course, hasn't happened yet, and Brown officials apparently decided to revert to the original timetable for Keller's departure in the wake of publicity over Keller's misrepresentation of data in Paxil study 329 -- see back story here -- and Sen. Grassley's probe into his extensive financial ties to the pharmaceutical industry; see story here.
As several Brown faculty members note, it doesn't really matter when Keller was asked to step down as chair. What matters is the fact that the university let Keller stay on the faculty long after they were made aware of his scientific misconduct. Brown officials were first made aware of allegations about Keller's misrepresentation of data in Paxil study 329 when I was doing research for Side Effects in early 2007, and again in 2008, when David Egilman, a Brown faculty member, filed an ethics complaint against Keller, and Side Effects was published.
"[Keller] omitted evidence that showed that Paxil increased the risk of suicide attempts from his published papers," Egilman, a clinical associate professor at Brown, said in a recent interview. “He manipulated the data to show the drug was an effective treatment for depression when the data really showed it was no better than a sugar pill. GSK, the manufacturer of Paxil, wrote up the results and Keller claimed authorship." See back story here.
Egilman continues: "If my student does that, it’s called plagiarism and he gets thrown out; if a faculty member does it, the University runs a protection racket for him.”
Brown should have disciplined Keller as soon as they knew about his manipulation of data, Egilman says. "The fact that they cleared him of wrongdoing shows that the university relies on faculty to police themselves," he says. "Brown has no standards whatsoever for the work that the faculty does."
However, according to sources, Keller was then asked to stay on as chair until Brown's affiliate hospitals could complete a merger with Lifespan Hospital. "The thinking was that they couldn't recruit a chair of psychiatry until the merger was decided," said a Brown faculty member who asked not to be named. The merger, of course, hasn't happened yet, and Brown officials apparently decided to revert to the original timetable for Keller's departure in the wake of publicity over Keller's misrepresentation of data in Paxil study 329 -- see back story here -- and Sen. Grassley's probe into his extensive financial ties to the pharmaceutical industry; see story here.
As several Brown faculty members note, it doesn't really matter when Keller was asked to step down as chair. What matters is the fact that the university let Keller stay on the faculty long after they were made aware of his scientific misconduct. Brown officials were first made aware of allegations about Keller's misrepresentation of data in Paxil study 329 when I was doing research for Side Effects in early 2007, and again in 2008, when David Egilman, a Brown faculty member, filed an ethics complaint against Keller, and Side Effects was published.
"[Keller] omitted evidence that showed that Paxil increased the risk of suicide attempts from his published papers," Egilman, a clinical associate professor at Brown, said in a recent interview. “He manipulated the data to show the drug was an effective treatment for depression when the data really showed it was no better than a sugar pill. GSK, the manufacturer of Paxil, wrote up the results and Keller claimed authorship." See back story here.
Egilman continues: "If my student does that, it’s called plagiarism and he gets thrown out; if a faculty member does it, the University runs a protection racket for him.”
Brown should have disciplined Keller as soon as they knew about his manipulation of data, Egilman says. "The fact that they cleared him of wrongdoing shows that the university relies on faculty to police themselves," he says. "Brown has no standards whatsoever for the work that the faculty does."
NAMI exposed: the drug money behind this supposedly grassroots group
Earlier this week, Senator Charles Grassley announced a probe into the nation's largest advocacy group for people with mental illness, the National Alliance for Mental Illness, asking the nonprofit group to disclose the funding it has received in recent years from the drug industry. The fact that NAMI is heavily dependent on drug company money is old news, but Grassley's investigation, first reported in Bloomberg News, may shed a welcome spotlight on an lobbying organization that masquerades as grassroots.
In Side Effects, I reveal that drug company contributions have always been a substantial portion of NAMI's revenues. I also tell the story of how Jim McNulty, president of NAMI from 2002 to 2004, failed to disclose the fact that he was being paid thousands of dollars from drug makers for promoting their products to NAMI members and others at various speaking engagements. In a particularly intriguing twist, McNulty laundered this drug company money through a state chapter of NAMI.
This is how the scheme worked, according to McNulty himself and others in the know. He would be paid thousands of dollars to speak about the benefits of various antidepressants -- McNulty himself suffered from depression -- and rather than pay him directly, companies such as Eli Lilly, the maker of Prozac, Pfizer, the maker of Zoloft, and GlaxoSmithKline, which made Paxil, would give his speaking fees to the Rhode Island chapter of NAMI, which would then cut McNulty a check. When I asked McNulty why he was paid this way, he said, "Paperwork. It was simpler that way."
McNulty, of course, never disclosed these conflicts to his constituents or to the NIH (which appointed him to sit on influential advisory boards that rendered opinions about the safety and efficacy of the drugs he was being paid to promote).
NAMI continues to receive hefty contributions from the drug industry but it no longer reveals the specific donors in its annual report, published online. So Grassley's team has asked the organization to disclose the specifics of its funding so that people with mental illness and their families can see for themselves how conflicted this advocacy group is. At FDA hearings over the years held to examine the safety and effectiveness of antidepressants like Prozac and Paxil, NAMI was always quick to come to the defense of these drugs. And NAMI opposed the black box warnings the FDA required drug makers to put on the labels of antidepressants in 2004 about their increased risk of suicidal thoughts and behaviors. Now that Grassley's team is looking into NAMI's books, perhaps the group's members -- people with mental illness and their families -- will cast a more skeptical eye on its credibility.
In Side Effects, I reveal that drug company contributions have always been a substantial portion of NAMI's revenues. I also tell the story of how Jim McNulty, president of NAMI from 2002 to 2004, failed to disclose the fact that he was being paid thousands of dollars from drug makers for promoting their products to NAMI members and others at various speaking engagements. In a particularly intriguing twist, McNulty laundered this drug company money through a state chapter of NAMI.
This is how the scheme worked, according to McNulty himself and others in the know. He would be paid thousands of dollars to speak about the benefits of various antidepressants -- McNulty himself suffered from depression -- and rather than pay him directly, companies such as Eli Lilly, the maker of Prozac, Pfizer, the maker of Zoloft, and GlaxoSmithKline, which made Paxil, would give his speaking fees to the Rhode Island chapter of NAMI, which would then cut McNulty a check. When I asked McNulty why he was paid this way, he said, "Paperwork. It was simpler that way."
McNulty, of course, never disclosed these conflicts to his constituents or to the NIH (which appointed him to sit on influential advisory boards that rendered opinions about the safety and efficacy of the drugs he was being paid to promote).
NAMI continues to receive hefty contributions from the drug industry but it no longer reveals the specific donors in its annual report, published online. So Grassley's team has asked the organization to disclose the specifics of its funding so that people with mental illness and their families can see for themselves how conflicted this advocacy group is. At FDA hearings over the years held to examine the safety and effectiveness of antidepressants like Prozac and Paxil, NAMI was always quick to come to the defense of these drugs. And NAMI opposed the black box warnings the FDA required drug makers to put on the labels of antidepressants in 2004 about their increased risk of suicidal thoughts and behaviors. Now that Grassley's team is looking into NAMI's books, perhaps the group's members -- people with mental illness and their families -- will cast a more skeptical eye on its credibility.
Monday, April 6, 2009
Brown psychiatry chief Martin Keller to step down in June...
Martin Keller is finally stepping down as the long time chief of psychiatry at Brown University. Brown University officials made the announcement in a Dear Colleagues letter dated today from Edward J. Wing, Brown's new Dean of Medicine and Biological Sciences.
Keller is the latest psychiatry kingpin to fall. In recent months, Emory University forced its psychiatry chief Charles Nemeroff to step down and Stanford is looking for a new head to replace Alan Schatzberg after reports that these two prominent psychiatrists, like Keller, failed to disclose years of lucrative financial payments from the pharmaceutical industry.
While Brown officials insist that the decision to step down was Keller's, my understanding from several sources is that the university has been under pressure to take action against him for months.
As I have reported in Side Effects and my blog here and here, Keller not only failed to disclose the millions of dollars he has received over the years from companies whose drugs he was studying and promoting in medical journals and at conferences. But there is evidence that Keller and his co-authors misrepresented data in a clinical trial of Paxil to make the antidepressant look safer and more effective than it really was. This trial, known as study 329 and funded by GlaxoSmithKline, was published in 2001 and used by the drug company to heavily market Paxil for off-label use in children and adolescents.
Yet as it turns out, the data in this trial do not corroborate the company's claims that Paxil was more effective than a placebo or sugar pill in treating depression in adolescents. The 2001 study also under-estimated the rate of suicidal thoughts and behaviors among participants taking Paxil in the study (in a 2006 paper, GlaxoSmithKline acknowledged that those taking the drug were five times more likely to be suicidal than those taking the placebo). GlaxoSmithKline is now under investigation by federal Department of Justice officials, and Keller himself has been deposed by attorneys in Boston's U.S. attorney's office, according to sources.
I also understand that the NIH recently refused to renew a long-term research grant submitted by Keller, in large part because of the allegations about Keller's scientific misconduct and his failure to disclose his conflicts of interest. Although Brown officials refused to confirm the NIH action, if you search the federal database for NIH grants (CRISP), you can see that Keller currently has three long-term research grants with National Institute of Mental Health; one of those grants, for a study comparing psychotherapy to drugs in treating depression, runs out this June. Another grant, for a long-term collaborative study of depression, ends in January.
Until recently, Keller was a major rainmaker for Brown, bringing in millions in research funding from the NIH and pharmaceutical companies to the university's medical school. Indeed, in a 2006 deposition, Keller said his department of psychiatry received $50 million in research funding, a significant hunk of change. Some have speculated that is why Brown has been reluctant to move against him. But now that NIH is no longer renewing Keller's research grants, one might speculate that his usefulness to Brown has diminished.
All of this may explain why come June, Martin Keller will join Nemeroff and Schatzberg on the growing roster of once-powerful psychiatry chiefs who have toppled from grace.
Keller is the latest psychiatry kingpin to fall. In recent months, Emory University forced its psychiatry chief Charles Nemeroff to step down and Stanford is looking for a new head to replace Alan Schatzberg after reports that these two prominent psychiatrists, like Keller, failed to disclose years of lucrative financial payments from the pharmaceutical industry.
While Brown officials insist that the decision to step down was Keller's, my understanding from several sources is that the university has been under pressure to take action against him for months.
As I have reported in Side Effects and my blog here and here, Keller not only failed to disclose the millions of dollars he has received over the years from companies whose drugs he was studying and promoting in medical journals and at conferences. But there is evidence that Keller and his co-authors misrepresented data in a clinical trial of Paxil to make the antidepressant look safer and more effective than it really was. This trial, known as study 329 and funded by GlaxoSmithKline, was published in 2001 and used by the drug company to heavily market Paxil for off-label use in children and adolescents.
Yet as it turns out, the data in this trial do not corroborate the company's claims that Paxil was more effective than a placebo or sugar pill in treating depression in adolescents. The 2001 study also under-estimated the rate of suicidal thoughts and behaviors among participants taking Paxil in the study (in a 2006 paper, GlaxoSmithKline acknowledged that those taking the drug were five times more likely to be suicidal than those taking the placebo). GlaxoSmithKline is now under investigation by federal Department of Justice officials, and Keller himself has been deposed by attorneys in Boston's U.S. attorney's office, according to sources.
I also understand that the NIH recently refused to renew a long-term research grant submitted by Keller, in large part because of the allegations about Keller's scientific misconduct and his failure to disclose his conflicts of interest. Although Brown officials refused to confirm the NIH action, if you search the federal database for NIH grants (CRISP), you can see that Keller currently has three long-term research grants with National Institute of Mental Health; one of those grants, for a study comparing psychotherapy to drugs in treating depression, runs out this June. Another grant, for a long-term collaborative study of depression, ends in January.
Until recently, Keller was a major rainmaker for Brown, bringing in millions in research funding from the NIH and pharmaceutical companies to the university's medical school. Indeed, in a 2006 deposition, Keller said his department of psychiatry received $50 million in research funding, a significant hunk of change. Some have speculated that is why Brown has been reluctant to move against him. But now that NIH is no longer renewing Keller's research grants, one might speculate that his usefulness to Brown has diminished.
All of this may explain why come June, Martin Keller will join Nemeroff and Schatzberg on the growing roster of once-powerful psychiatry chiefs who have toppled from grace.
Thursday, April 2, 2009
A new approach to treating mental illness?
When people exhibit signs of psychosis – they hear voices, they think someone is out to get them – more often than not, they are referred to psychiatrists who immediately put them on powerful drugs like Haldol, Depakote, Abilify or Seroquel. These drugs sometimes tamp down the voices and other psychotic symptoms (and sometimes they don’t). Such medications also make many people feel like zombies and carry a plethora of severe side effects such as excessive weight gain and an increased risk of diabetes and heart problems. Too often, their benefits are short-lived, and many people experiencing psychosis end up in a vicious cycle of hospitalization and isolation – unable to hold down a productive job and stigmatized by the world at large.
In her new book, Agnes’s Jacket, Gail Hornstein, a professor of psychology at Mount Holyoke College, offers an intriguing alternative to dealing with psychosis: support groups that allow people to discuss and deal with the voices they are hearing without medication, in a caring and empathetic environment. She explores this “psychiatric survivor movement” in great depth in her book, chronicling the Hearing Voices network and other support groups that have made this movement possible. She presents vivid examples of people who were previously labeled psychotic and slapped on drugs, but who, with the help of support groups, have learned how to live with and control the voices they hear inside their heads. Some of these people have gone on to live rich, productive lives without the need for medication or hospitalization. As Hornstein writes in her book, “Sharing experiences in peer support groups has led them to a whole different way of understanding their distress…Psychiatric survivor groups teach patients that emotional difficulties, no matter how severe, can coped with."
Hornstein makes a persuasive case for the power of peer support and the importance of understanding psychotic symptoms in the context of the trauma that many people with such symptoms have experienced in their lives. And she rightly points out that psychiatrists -- under the sway of the pharmaceutical industry and managed care – have been much too quick to put their patients on powerful drugs instead of exploring other therapeutic alternatives first.
Just one quibble. In her book, Hornstein seems to sweep all American psychiatrists into the same boat, ignoring those who remain committed to psychotherapy (despite inadequate reimbursement from insurers) and to developing the kind of positive, trusting relationships that put patients on the road to recovery.
Last year, for example, I had the opportunity to attend a meeting of the International Society for the Psychological Treatments of the Schizophrenias and other Psychoses (ISPS), where I heard a previously psychotic patient talk about how his relationship with his psychiatrist enabled him to recover from years of mental illness. As a young man, Mark had been labeled schizophrenic because he heard voices all the time. He was repeatedly hospitalized, put on Haldol and Clozaril, powerful anti-psychotics that made it difficult for him to function. For years, Mark couldn’t hold down a job or live on his own.
Over the past 10 years, however, Mark has been in therapy with the same psychiatrist, and they have developed such a strong relationship, one based on mutual respect and trust, that Mark is no longer psychotic. He now has a job, lives by himself and, judging by what he had to say at the ISPS meeting, is a thoughtful, articulate man. He credits the relationship he has developed with this particular psychiatrist for his recovery, noting: “When you feel good about the people you’re working with, you generally want to stay healthy.”
And that, of course, is precisely what makes the support groups that Hornstein extols so effective as well. Regardless of what experiences people are sharing and who they share it with, they are much more likely to recover from mental illness when they are surrounded by understanding, empathy and respect. And that’s not something you can get from a pill.
In her new book, Agnes’s Jacket, Gail Hornstein, a professor of psychology at Mount Holyoke College, offers an intriguing alternative to dealing with psychosis: support groups that allow people to discuss and deal with the voices they are hearing without medication, in a caring and empathetic environment. She explores this “psychiatric survivor movement” in great depth in her book, chronicling the Hearing Voices network and other support groups that have made this movement possible. She presents vivid examples of people who were previously labeled psychotic and slapped on drugs, but who, with the help of support groups, have learned how to live with and control the voices they hear inside their heads. Some of these people have gone on to live rich, productive lives without the need for medication or hospitalization. As Hornstein writes in her book, “Sharing experiences in peer support groups has led them to a whole different way of understanding their distress…Psychiatric survivor groups teach patients that emotional difficulties, no matter how severe, can coped with."
Hornstein makes a persuasive case for the power of peer support and the importance of understanding psychotic symptoms in the context of the trauma that many people with such symptoms have experienced in their lives. And she rightly points out that psychiatrists -- under the sway of the pharmaceutical industry and managed care – have been much too quick to put their patients on powerful drugs instead of exploring other therapeutic alternatives first.
Just one quibble. In her book, Hornstein seems to sweep all American psychiatrists into the same boat, ignoring those who remain committed to psychotherapy (despite inadequate reimbursement from insurers) and to developing the kind of positive, trusting relationships that put patients on the road to recovery.
Last year, for example, I had the opportunity to attend a meeting of the International Society for the Psychological Treatments of the Schizophrenias and other Psychoses (ISPS), where I heard a previously psychotic patient talk about how his relationship with his psychiatrist enabled him to recover from years of mental illness. As a young man, Mark had been labeled schizophrenic because he heard voices all the time. He was repeatedly hospitalized, put on Haldol and Clozaril, powerful anti-psychotics that made it difficult for him to function. For years, Mark couldn’t hold down a job or live on his own.
Over the past 10 years, however, Mark has been in therapy with the same psychiatrist, and they have developed such a strong relationship, one based on mutual respect and trust, that Mark is no longer psychotic. He now has a job, lives by himself and, judging by what he had to say at the ISPS meeting, is a thoughtful, articulate man. He credits the relationship he has developed with this particular psychiatrist for his recovery, noting: “When you feel good about the people you’re working with, you generally want to stay healthy.”
And that, of course, is precisely what makes the support groups that Hornstein extols so effective as well. Regardless of what experiences people are sharing and who they share it with, they are much more likely to recover from mental illness when they are surrounded by understanding, empathy and respect. And that’s not something you can get from a pill.
Friday, March 27, 2009
Negative findings about ADHD drugs downplayed by researchers on drug companies' payroll
Thanks to unsealed documents from legal proceedings, we now know that many drug makers routinely hid negative findings about antidepressants and anti-psychotics (ranging from Paxil to Seroquel) from doctors and consumers. Now comes evidence that the researchers who conducted a long-term study on the effectiveness of drugs for attention-deficit disorder (ADHD) also sought to play down results showing that these drugs are not particularly effective over the long haul.
According to an article in The Washington Post today, researchers involved in a large federally funded study knew by 2007 that drugs like Concerta and Adderall are not effective in treating ADHD over the long term (i.e., the children in the drug group did no better than a control group who received no medication). This negative data came from a study that followed up on a well-publicized 1999 report showing that these drugs were initially effective in treating ADHD. The 2007 followup study also showed that children who took these drugs for 36 months were about an inch shorter and six pounds lighter than those who did not.
While the 2007 data were duly reported in a medical journal, a news release from the National Institute of Mental Health (NIMH) presented the study in a far more favorable light than it deserved, playing down the negative findings about the drugs' lack of long-term efficacy as well as their disconcerting side effects, according to The Washington Post article by Shankar Vedantam.
In reading Mr. Vedantum's excellent story, I couldn't help but wonder whether any of the researchers in this study, some of whom continue to minimize the drugs' negative effects, were getting paid on the side by the companies who sell them. Sure enough, a quick glance at the latest published results of the federal study in the Journal of the American Academy of Child and Adolescent Psychiatry show that seven of the principal researchers disclosed myriad conflicts of interest. For example, Peter Jensen, the former Columbia University researcher who so fervently defends the drugs in The Post article reports receiving consulting and speaking fees from Shire (which makes Adderall), Janssen (which makes Concerta) and a host of other drug companies.
Indeed, the list of conflicts disclosed by these researchers takes up a sizable chunk of fine print at the end of the article. If you're a subscriber to JAACAP, you can see for yourself at MTA at 8 Years: Prospective Follow-up of Children Treated for Combined-Type ADHD in a Multisite Study. Hat tip to Peggi Johnson for alerting me to The Washington Post article.
On a completely different note, I was asked to write a piece for the spring issue of the Nieman Reports about whether the blogosphere will be able to reproduce the watchdog role that newspapers have so honorably fulfilled over the last 100 years (now that many of them can no longer afford to perform that function). Here is my answer: Blogs, Watchdog Reporting and Scientific Malfeasance.
According to an article in The Washington Post today, researchers involved in a large federally funded study knew by 2007 that drugs like Concerta and Adderall are not effective in treating ADHD over the long term (i.e., the children in the drug group did no better than a control group who received no medication). This negative data came from a study that followed up on a well-publicized 1999 report showing that these drugs were initially effective in treating ADHD. The 2007 followup study also showed that children who took these drugs for 36 months were about an inch shorter and six pounds lighter than those who did not.
While the 2007 data were duly reported in a medical journal, a news release from the National Institute of Mental Health (NIMH) presented the study in a far more favorable light than it deserved, playing down the negative findings about the drugs' lack of long-term efficacy as well as their disconcerting side effects, according to The Washington Post article by Shankar Vedantam.
In reading Mr. Vedantum's excellent story, I couldn't help but wonder whether any of the researchers in this study, some of whom continue to minimize the drugs' negative effects, were getting paid on the side by the companies who sell them. Sure enough, a quick glance at the latest published results of the federal study in the Journal of the American Academy of Child and Adolescent Psychiatry show that seven of the principal researchers disclosed myriad conflicts of interest. For example, Peter Jensen, the former Columbia University researcher who so fervently defends the drugs in The Post article reports receiving consulting and speaking fees from Shire (which makes Adderall), Janssen (which makes Concerta) and a host of other drug companies.
Indeed, the list of conflicts disclosed by these researchers takes up a sizable chunk of fine print at the end of the article. If you're a subscriber to JAACAP, you can see for yourself at MTA at 8 Years: Prospective Follow-up of Children Treated for Combined-Type ADHD in a Multisite Study. Hat tip to Peggi Johnson for alerting me to The Washington Post article.
On a completely different note, I was asked to write a piece for the spring issue of the Nieman Reports about whether the blogosphere will be able to reproduce the watchdog role that newspapers have so honorably fulfilled over the last 100 years (now that many of them can no longer afford to perform that function). Here is my answer: Blogs, Watchdog Reporting and Scientific Malfeasance.
Friday, March 20, 2009
Is psychiatry more corrupt than other medical specialties?
At a talk I gave Wednesday at George Washington University, someone in the audience asked why there seemed to be an inordinate number of psychiatrists on the take to the drug industry. Was it something about the specialty of psychiatry itself or the individuals involved? I have often pondered the same, especially since this is not simply an anecdotal observation. In 2007, The New York Times examined the payments made to all doctors in Minnesota in the years since that state passed one of the first laws in the nation requiring the public disclosure of payments from the pharmaceutical industry. Based on that investigation, Times reporters concluded that as a specialty, psychiatry topped the list in lucrative drug company payments.
So what's going on? A couple of things, I think. First off, there's a reason why drugs like Paxil, Zoloft, Prozac and Lexapro are top sellers: it's easier to expand the criteria for who might benefit from these drugs. After all, almost everyone has experienced depressive or anxious symptoms at one time or the other, so if the makers of these drugs can reach psychiatrists and persuade them to prescribe pills for such universal symptoms, we're talking real profits here. And what better way to influence psychiatrists' prescribing behavior than to put their most prominent colleagues -- the key opinion leaders (KOLs) -- on your payroll?
Secondly, as someone who came to the talk astutely noted, psychiatrists have been squeezed by managed care into the role of pill prescribers. Unlike other medical specialties, doctors in psychiatry don't get adequately reimbursed for treating the whole patient -- by doing psychotherapy, for instance -- so all they can do these days is prescribe drugs. In a sense, psychiatrists are gatekeepers for the pharmaceutical industry, much like surgeons (who put in stents and other devices) are gatekeepers for the medical device industry.
Because of these trends, partnering with the drug industry has become a pervasive part of the psychiatric culture in recent years. It has become, for example, common practice for drug companies to bankroll symposia at the specialty's top medical conferences, at which psychiatrists on their payroll extoll the benefits of their products (without disclosing their conflicts of interest). As I reported in a previous blog, Nada Stotland, the current president of the American Psychiatric Association (APA), initially took umbrage when Sen. Charles Grassley questioned the organization's incestuous ties with the drug industry. In a memo to APA members, Stotland wrote: "Long traditions and established practices are not only being questioned, but also criticized across the board." As I said then, it almost sounded like Stotland's problem was with the criticism of these longstanding practices, not the practices themselves.
And that is why I was gratified to see in the Carlat Psychiatry blog, that the APA has officially decided to phase out all industry-funded symposia that take place at their annual meetings.
That's a good first step to reform. But there is still a long way to go, as evidenced by the news reported today in The New York Times that court documents appear to indicate that Dr. Joseph Biederman promised a drug company (Johnson & Johnson) positive results about its drug Risperdal from studies that had not been undertaken. Biederman, as has already been reported, not only earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 (the bulk of which he failed to report), but also received funding from J&J for a research center at Massachusetts General Hospital, which he headed.
Like Martin Keller, the psychiatrist I expose in my book, Biederman is one more example of how science can be skewed and public interest harmed when doctors are the beneficiaries of industry largesse. Psychiatry may be particularly vulnerable to such corporate blandishments, but I would argue that it's time for all medical specialties to take a good look at the way they do business and start healing.
So what's going on? A couple of things, I think. First off, there's a reason why drugs like Paxil, Zoloft, Prozac and Lexapro are top sellers: it's easier to expand the criteria for who might benefit from these drugs. After all, almost everyone has experienced depressive or anxious symptoms at one time or the other, so if the makers of these drugs can reach psychiatrists and persuade them to prescribe pills for such universal symptoms, we're talking real profits here. And what better way to influence psychiatrists' prescribing behavior than to put their most prominent colleagues -- the key opinion leaders (KOLs) -- on your payroll?
Secondly, as someone who came to the talk astutely noted, psychiatrists have been squeezed by managed care into the role of pill prescribers. Unlike other medical specialties, doctors in psychiatry don't get adequately reimbursed for treating the whole patient -- by doing psychotherapy, for instance -- so all they can do these days is prescribe drugs. In a sense, psychiatrists are gatekeepers for the pharmaceutical industry, much like surgeons (who put in stents and other devices) are gatekeepers for the medical device industry.
Because of these trends, partnering with the drug industry has become a pervasive part of the psychiatric culture in recent years. It has become, for example, common practice for drug companies to bankroll symposia at the specialty's top medical conferences, at which psychiatrists on their payroll extoll the benefits of their products (without disclosing their conflicts of interest). As I reported in a previous blog, Nada Stotland, the current president of the American Psychiatric Association (APA), initially took umbrage when Sen. Charles Grassley questioned the organization's incestuous ties with the drug industry. In a memo to APA members, Stotland wrote: "Long traditions and established practices are not only being questioned, but also criticized across the board." As I said then, it almost sounded like Stotland's problem was with the criticism of these longstanding practices, not the practices themselves.
And that is why I was gratified to see in the Carlat Psychiatry blog, that the APA has officially decided to phase out all industry-funded symposia that take place at their annual meetings.
That's a good first step to reform. But there is still a long way to go, as evidenced by the news reported today in The New York Times that court documents appear to indicate that Dr. Joseph Biederman promised a drug company (Johnson & Johnson) positive results about its drug Risperdal from studies that had not been undertaken. Biederman, as has already been reported, not only earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 (the bulk of which he failed to report), but also received funding from J&J for a research center at Massachusetts General Hospital, which he headed.
Like Martin Keller, the psychiatrist I expose in my book, Biederman is one more example of how science can be skewed and public interest harmed when doctors are the beneficiaries of industry largesse. Psychiatry may be particularly vulnerable to such corporate blandishments, but I would argue that it's time for all medical specialties to take a good look at the way they do business and start healing.
Friday, March 13, 2009
Massachusetts fraud case exposes deep flaws in our system of medical research and publication
The news that a Massachusetts anesthesiologist fabricated data in at least 21 studies (and probably more) is disturbing on several counts. First, it raises serious questions about the credibility of the peer review process at all the supposedly respectable journals this doctor published in. Second, it sets in sharp relief what happens when journals do not require researchers to disclose their conflicts of interest, i.e., their financial ties to the drug or medical device companies who stand to benefit from their work. And third, it makes you wonder: where were the institutional review boards at Baystate Medical Center and Tufts Medical School when Dr. Scott S. Reuben (who was affiliated with both institutions) was faking all this research?
In sum, the case of Dr. Reuben, who has been apparently been faking research data for more than a decade, highlights the serious shortcomings in our current system of conducting and disseminating medical research. It also spotlights why the much-heralded disclosure regulations recently promulgated by the state of Massachusetts are not as effective and far-reaching as state officials would have us believe.
The facts first. Baystate Medical Center in Springfield discovered Reuben's extensive fraud last spring after a routine audit of research summaries revealed that Reuben had failed to obtain approval of the hospital's institutional review board for two of his newer studies. As Anesthesiology News was the first to report,"What ensued was the unraveling of what medical ethicists are calling one of the largest instances of research fraud ever reported, a massive scandal that has led to the withdrawal of as many as 21 journal articles."
Many of the studies that were found to have been fabricated are positive findings about painkillers like Vioxx, Celebrex, Bextra and Oxycontin, two of which have since been withdrawn from market because of their untenable side effects (an increased risk of heart failure). Also tainted is a study purportedly showing the value of Effexor, an antidepressant, in reducing pain among patients who underwent a mastectomy because of breast cancer. Now, Reuben may or may not have been getting money from Wyeth, the maker of Effexor, but we do know that, according to The Boston Globe, he was a long-time member of Pfizer's speaker bureau. That means he was getting speaking fees from the drug company that makes Celebrex and Bextra at the very same time he was reporting positive findings about the drugs. Yet none of these conflicts of interest were disclosed in the journal articles he published about these controversial painkillers.
That, to me, is an egregious oversight. It's all well and good if the leading medical journals like the New England Journal of Medicine and JAMA require conflict of interest disclosures from their researchers. But most doctors publish their work in less rigorous journals, among them Dr. Reuben, who published the bulk of his phony research in such second-tier journals as Anesthesia and Analgesia and the Journal of Pain and Symptom Management. The fact that Reuben's results did not raise red flags at these journals says as much about the inadequacy of their peer-review process as it does about their shoddy disclosure policies around conflicts of interest.
The Reuben case is just one more pressing reason why we need a federal Physician Payment Sunshine Act that requires drug and medical device companies to routinely disclose such conflicts of interest to the American public. If Reuben's conflicts of interest had been more transparent, there's a possibility that someone in the field of pain medicine might have questioned sooner why all of his studies seemed to find positive benefits to the drugs he was studying. (Obviously, this kind of scrutiny was not going to come from Pfizer and other drug companies who were only too happy to reward Reuben for his glowing results).
The Reuben case also illustrates the weaknesses in Massachusetts' new regulations banning free gifts to doctors and requiring the disclosure of payments (over $50) to health-care professionals involved in sales and marketing of drugs or medical devices. There is a big loophole in these regulations: they exempt the disclosure of payments to doctors "in conjunction with genuine research and clinical trials," according to the rules posted on the state's Department of Public Health website. What this means is that Reuben (or any researcher) could have been paid a consulting fee to help drug companies plan and disseminate the results of his research to other doctors (at conferences and in journals) and these payments might not have to be disclosed. In an interview, Tom Lyons, a spokesman for the Mass Department of Public Health, said he thinks that consulting payments after a clinical trial is finished would have to be disclosed, but payments while the trial was ongoing would not have to be. "This kind of thing will have to be decided on a case by case basis as questions come up," he said.
One other thing: in the interview with Anesthesiology News, Baystate officers insisted that no patients were harmed by Reuben's fraud. That's a ridiculous assertion. Based on research done by Reuben and others, many patients were given drugs like Vioxx, Celebrex and Bextra, all of which have serious side effects, and they may well have been harmed as a result. If I were a patient who had a heart attack after taking one of these nonsteroidal anti-inflammatory painkillers, I might want to re-examine the culpability of all of the players in this horrendous case of scientific fraud.
In sum, the case of Dr. Reuben, who has been apparently been faking research data for more than a decade, highlights the serious shortcomings in our current system of conducting and disseminating medical research. It also spotlights why the much-heralded disclosure regulations recently promulgated by the state of Massachusetts are not as effective and far-reaching as state officials would have us believe.
The facts first. Baystate Medical Center in Springfield discovered Reuben's extensive fraud last spring after a routine audit of research summaries revealed that Reuben had failed to obtain approval of the hospital's institutional review board for two of his newer studies. As Anesthesiology News was the first to report,"What ensued was the unraveling of what medical ethicists are calling one of the largest instances of research fraud ever reported, a massive scandal that has led to the withdrawal of as many as 21 journal articles."
Many of the studies that were found to have been fabricated are positive findings about painkillers like Vioxx, Celebrex, Bextra and Oxycontin, two of which have since been withdrawn from market because of their untenable side effects (an increased risk of heart failure). Also tainted is a study purportedly showing the value of Effexor, an antidepressant, in reducing pain among patients who underwent a mastectomy because of breast cancer. Now, Reuben may or may not have been getting money from Wyeth, the maker of Effexor, but we do know that, according to The Boston Globe, he was a long-time member of Pfizer's speaker bureau. That means he was getting speaking fees from the drug company that makes Celebrex and Bextra at the very same time he was reporting positive findings about the drugs. Yet none of these conflicts of interest were disclosed in the journal articles he published about these controversial painkillers.
That, to me, is an egregious oversight. It's all well and good if the leading medical journals like the New England Journal of Medicine and JAMA require conflict of interest disclosures from their researchers. But most doctors publish their work in less rigorous journals, among them Dr. Reuben, who published the bulk of his phony research in such second-tier journals as Anesthesia and Analgesia and the Journal of Pain and Symptom Management. The fact that Reuben's results did not raise red flags at these journals says as much about the inadequacy of their peer-review process as it does about their shoddy disclosure policies around conflicts of interest.
The Reuben case is just one more pressing reason why we need a federal Physician Payment Sunshine Act that requires drug and medical device companies to routinely disclose such conflicts of interest to the American public. If Reuben's conflicts of interest had been more transparent, there's a possibility that someone in the field of pain medicine might have questioned sooner why all of his studies seemed to find positive benefits to the drugs he was studying. (Obviously, this kind of scrutiny was not going to come from Pfizer and other drug companies who were only too happy to reward Reuben for his glowing results).
The Reuben case also illustrates the weaknesses in Massachusetts' new regulations banning free gifts to doctors and requiring the disclosure of payments (over $50) to health-care professionals involved in sales and marketing of drugs or medical devices. There is a big loophole in these regulations: they exempt the disclosure of payments to doctors "in conjunction with genuine research and clinical trials," according to the rules posted on the state's Department of Public Health website. What this means is that Reuben (or any researcher) could have been paid a consulting fee to help drug companies plan and disseminate the results of his research to other doctors (at conferences and in journals) and these payments might not have to be disclosed. In an interview, Tom Lyons, a spokesman for the Mass Department of Public Health, said he thinks that consulting payments after a clinical trial is finished would have to be disclosed, but payments while the trial was ongoing would not have to be. "This kind of thing will have to be decided on a case by case basis as questions come up," he said.
One other thing: in the interview with Anesthesiology News, Baystate officers insisted that no patients were harmed by Reuben's fraud. That's a ridiculous assertion. Based on research done by Reuben and others, many patients were given drugs like Vioxx, Celebrex and Bextra, all of which have serious side effects, and they may well have been harmed as a result. If I were a patient who had a heart attack after taking one of these nonsteroidal anti-inflammatory painkillers, I might want to re-examine the culpability of all of the players in this horrendous case of scientific fraud.
Friday, March 6, 2009
Sales Tactics in the Drug Industry: Plus Ca Change
Not a week goes by without news of the growing concern -- among consumer advocates, medical students and Congressional watchdogs -- about the financial conflicts of interest that bind doctors to the pharmaceutical industry and may bias their judgment about new drugs. Several drug companies, hoping to forestall federal legislation, have announced their intention of disclosing these conflicts of interest -- which take the form of lucrative personal payments to prominent doctors and researchers (key opinion leaders or KOLs in the industry vernacular) who are in a position to influence other doctors.
But within the industry itself, status quo reigns.
One need only glance at the flyer for an upcoming conference targeting the industry's army of salesmen and women. Dubbed "the premier event in pharma sales," the May sales force effectiveness summit in Princeton, New Jersey, features several seminars on how sales agents can improve their access to physicians and "connect directly" with them, in order to promote new products. Five "key opinion leader physicians" will be on hand to lead one seminar (highlighted in bright yellow) and instruct attendees on what works the best with their busy medical colleagues. (I'm sure these KOLs are being paid handsomely to attend; I'm equally sure that KOLs who are currently under Congressional investigation such as Charles Nemeroff, Martin Keller and Alan Schatzberg will probably not be in attendance, but I could be wrong).
Attendees can also learn how to maximize the use of software to sort through doctors' prescribing practices to determine which doctors to hit on and how best to capitalize on all this lovely data for sales. In the conference organizers' own words: "Enhance your [sales] reps' interpretation of patient-level data to ensure increased success with physicians." Why do I have the feeling that patient privacy is not going to be high on the agenda here?
In sum, the two-day conference boasts a virtual smorgasbord of tips for getting close to doctors in order to maximize drug sales. The price of entry may be a bit steep -- fees range from $1,795 to $2,895 depending on whether you buy a platinum, gold or just a silver pass -- but don't worry: if you're a hard-hitting pharmaceutical sales rep, your company will no doubt pick up the tab.
Hat tip to Marilyn Mann for spotting this brochure and sending it my way.
But within the industry itself, status quo reigns.
One need only glance at the flyer for an upcoming conference targeting the industry's army of salesmen and women. Dubbed "the premier event in pharma sales," the May sales force effectiveness summit in Princeton, New Jersey, features several seminars on how sales agents can improve their access to physicians and "connect directly" with them, in order to promote new products. Five "key opinion leader physicians" will be on hand to lead one seminar (highlighted in bright yellow) and instruct attendees on what works the best with their busy medical colleagues. (I'm sure these KOLs are being paid handsomely to attend; I'm equally sure that KOLs who are currently under Congressional investigation such as Charles Nemeroff, Martin Keller and Alan Schatzberg will probably not be in attendance, but I could be wrong).
Attendees can also learn how to maximize the use of software to sort through doctors' prescribing practices to determine which doctors to hit on and how best to capitalize on all this lovely data for sales. In the conference organizers' own words: "Enhance your [sales] reps' interpretation of patient-level data to ensure increased success with physicians." Why do I have the feeling that patient privacy is not going to be high on the agenda here?
In sum, the two-day conference boasts a virtual smorgasbord of tips for getting close to doctors in order to maximize drug sales. The price of entry may be a bit steep -- fees range from $1,795 to $2,895 depending on whether you buy a platinum, gold or just a silver pass -- but don't worry: if you're a hard-hitting pharmaceutical sales rep, your company will no doubt pick up the tab.
Hat tip to Marilyn Mann for spotting this brochure and sending it my way.
Thursday, February 26, 2009
DOJ lawsuit against Forest Labs: a bold new attack on a longstanding practice
The New York Times today reported that the Justice Department has sued Forest Labs for defrauding the government of millions of dollars by illegally marketing Celexa and Lexapro, its two blockbuster antidepressants. The fraud complaint is based on allegations that Forest Labs concealed negative findings that showed that these drugs were not only ineffective in children but caused an increased risk of suicidal thoughts and behaviors in some pediatric patients.
Sound familiar? That's because they were same allegations that formed the basis of New York State Attorney General's landmark case in 2004 against GlaxoSmithKline, which became the subject of my book, Side Effects. Just like Forest Labs, GlaxoSmithKline with-held negative findings about its blockbuster drug, Paxil, and instead published and heavily marketed one study that purported to show that Paxil was effective in treating depression in adolescents. It turns out that the data in this study did not show efficacy either (which is one of the reasons why the AG's office sued Glaxo for consumer fraud) and the story of how the detective-attorneys in the AG's office discovered this fraud is quite a tale!
Shortly after the New York AG's office launched the suit against Glaxo, it also began investigating Forest Labs for with-holding the results of several studies that found citalopram, the generic ingredient in both Celexa and Lexapro, to be no more effective than a placebo in treating depression in children. As I report in my book, the AG's office, then under the direction of Eliot Spitzer, used this investigation to force Forest Labs to post the results of all its clinical trials, negative as well as positive, on a publicly available website, from 2000 onward. By then, of course, GlaxoSmithKline had already agreed to do the same in order to settle the AG's widely publicized lawsuit against it. At the time, these settlements were seen as a major victory for health consumers and the next year, Congress passed a law requiring all drug companies to post all the results of their Phase 3 and 4 clinical trials online, putting an end to the widespread industry practice of concealing negative data about drugs from the public.
Now, the Justice Department has put an ambitious new twist on this case by charging Forest Labs with defrauding the government of millions of dollars. It is essentially saying to Forest Labs: you knew these drugs were not effective in treating depression in children and yet you went ahead and illegally marketed them (for off-label use) to minors anyway, costing government health plans like Medicare and Medicaid loads of money. The federal lawsuit is seeking to recover up to three times the amount of money spent by government programs to pay for pediatric prescriptions of Celexa and Lexapro, according to The New York Times .
Federal prosecutors have also charged that Forest Labs paid kickbacks in the form of baseball tickets, gift certificates and paid vacations to doctors who prescribed these drugs and that the company ran seeding trials that were really marketing efforts to promote the drugs' use by doctors.
Just think: if this case is successful, the steep fines levied against Forest Labs (and other drug companies who did the same) could go a long way toward helping fund health care reform.
Sound familiar? That's because they were same allegations that formed the basis of New York State Attorney General's landmark case in 2004 against GlaxoSmithKline, which became the subject of my book, Side Effects. Just like Forest Labs, GlaxoSmithKline with-held negative findings about its blockbuster drug, Paxil, and instead published and heavily marketed one study that purported to show that Paxil was effective in treating depression in adolescents. It turns out that the data in this study did not show efficacy either (which is one of the reasons why the AG's office sued Glaxo for consumer fraud) and the story of how the detective-attorneys in the AG's office discovered this fraud is quite a tale!
Shortly after the New York AG's office launched the suit against Glaxo, it also began investigating Forest Labs for with-holding the results of several studies that found citalopram, the generic ingredient in both Celexa and Lexapro, to be no more effective than a placebo in treating depression in children. As I report in my book, the AG's office, then under the direction of Eliot Spitzer, used this investigation to force Forest Labs to post the results of all its clinical trials, negative as well as positive, on a publicly available website, from 2000 onward. By then, of course, GlaxoSmithKline had already agreed to do the same in order to settle the AG's widely publicized lawsuit against it. At the time, these settlements were seen as a major victory for health consumers and the next year, Congress passed a law requiring all drug companies to post all the results of their Phase 3 and 4 clinical trials online, putting an end to the widespread industry practice of concealing negative data about drugs from the public.
Now, the Justice Department has put an ambitious new twist on this case by charging Forest Labs with defrauding the government of millions of dollars. It is essentially saying to Forest Labs: you knew these drugs were not effective in treating depression in children and yet you went ahead and illegally marketed them (for off-label use) to minors anyway, costing government health plans like Medicare and Medicaid loads of money. The federal lawsuit is seeking to recover up to three times the amount of money spent by government programs to pay for pediatric prescriptions of Celexa and Lexapro, according to The New York Times .
Federal prosecutors have also charged that Forest Labs paid kickbacks in the form of baseball tickets, gift certificates and paid vacations to doctors who prescribed these drugs and that the company ran seeding trials that were really marketing efforts to promote the drugs' use by doctors.
Just think: if this case is successful, the steep fines levied against Forest Labs (and other drug companies who did the same) could go a long way toward helping fund health care reform.
Thursday, February 19, 2009
Attacks on stimulus funding to compare medical treatment: Sound familiar?
In a long-overdue step toward health care reform, the massive economic stimulus bill that the Obama administration approved on Tuesday includes $1.1 billion to compare the effectiveness of drugs, medical devices, surgery and other medical procedures. The money will fund not only systematic reviews of published studies but also be used to pay for clinical trials that compare different drugs and treatments. This means that for the first time in decades, clinical trials will be funded by the government, not by drug or medical device companies with a vested interest in the research outcomes. As Robert Pear noted in The New York Times, such funding should help answer important medical questions including whether talk therapy and/or prescription drugs are more effective in treating depression.
This is very good news for doctors and consumers, not to mention those of us who have written about the conflicts and skewing of scientific data that emerge when clinical research is paid for by the makers of drugs and medical devices. Predictably, however, this part of the economic stimulus bill has been roundly attacked by conservative groups that derive some of their funding from, guess what, the drug and medical device industry. In Pear's Times article, for example, he quotes Betsy McCaughey, whom he identifies as a former lieutenant governor of New York, complaining that the new legislation will lead to rationing. What isn't mentioned is the fact that McCaughey now works for the Hudson Institute, a conservative think tank in Washington, D.C. that gets funding from drug and medical device companies.
Obviously, the drug and medical device industry is not looking forward to independent research that compares expensive new drugs or procedures to older and less expensive treatments, especially if it turns out there is little or no difference between the two. So it comes as no surprise to see that they have trotted out old warhorses like McCaughey, who was a principal critic of the Clinton administration's failed health-care reform efforts in the early 90s. McCaughey, of course, has a right to say whatever she wants, but don't the readers of the Times deserve to know who is behind her attacks?
And keep in mind this is just a foretaste of the blitzkrieg that will be unleashed when the Obama administration gets around to tackling health-care reform in earnest.
This is very good news for doctors and consumers, not to mention those of us who have written about the conflicts and skewing of scientific data that emerge when clinical research is paid for by the makers of drugs and medical devices. Predictably, however, this part of the economic stimulus bill has been roundly attacked by conservative groups that derive some of their funding from, guess what, the drug and medical device industry. In Pear's Times article, for example, he quotes Betsy McCaughey, whom he identifies as a former lieutenant governor of New York, complaining that the new legislation will lead to rationing. What isn't mentioned is the fact that McCaughey now works for the Hudson Institute, a conservative think tank in Washington, D.C. that gets funding from drug and medical device companies.
Obviously, the drug and medical device industry is not looking forward to independent research that compares expensive new drugs or procedures to older and less expensive treatments, especially if it turns out there is little or no difference between the two. So it comes as no surprise to see that they have trotted out old warhorses like McCaughey, who was a principal critic of the Clinton administration's failed health-care reform efforts in the early 90s. McCaughey, of course, has a right to say whatever she wants, but don't the readers of the Times deserve to know who is behind her attacks?
And keep in mind this is just a foretaste of the blitzkrieg that will be unleashed when the Obama administration gets around to tackling health-care reform in earnest.
Monday, February 2, 2009
GlaxoSmithKline takes a $400 million hit
The health blog of The Wall Street Journal was the first to report Jan. 29 that GlaxoSmithKline is taking a $400 million hit related to federal and state probes into the drug giant's research and marketing shenanigans. Glaxo announced the charge in its fourth quarter filings to the SEC but was coy about which drugs and investigations the money is slated for, or when a legal settlement can be expected. Jeanne Whalen followed the blog report up with an article in Friday's Wall Street Journal in which she named two of Glaxo's drugs that are currently under investigation: Paxil and Wellbutrin.
As a number of news outlets have reported in recent months, the U.S. Department of Justice has been focusing on Glaxo's aggressive efforts to market Paxil, an SSRI antidepressant, for off-label uses in chidren and adolescents. As I've reported in this blog before (back story), DOJ officials are not only looking into off-label marketing (which is illegal) but into whether Glaxo officials pressured researchers to skew scientific data to make Paxil look safer and more effective in children and adolescents than it really was. (Such allegations are explored in some depth in my book, Side Effects). Given the latest news, I can only speculate that GlaxoSmithKline is getting ready to settle the Paxil probe to the tune of a $400 million fine.
A postscript: Now that I'm back to teaching, I am going to be taking a short hiatus from publishing this blog on a regular basis. I still hope to comment on key news items in the medical-pharmaceutical industry as they occur, but please don't expect a weekly posting until the new semester's dust settles down. Thanks for your understanding!
As a number of news outlets have reported in recent months, the U.S. Department of Justice has been focusing on Glaxo's aggressive efforts to market Paxil, an SSRI antidepressant, for off-label uses in chidren and adolescents. As I've reported in this blog before (back story), DOJ officials are not only looking into off-label marketing (which is illegal) but into whether Glaxo officials pressured researchers to skew scientific data to make Paxil look safer and more effective in children and adolescents than it really was. (Such allegations are explored in some depth in my book, Side Effects). Given the latest news, I can only speculate that GlaxoSmithKline is getting ready to settle the Paxil probe to the tune of a $400 million fine.
A postscript: Now that I'm back to teaching, I am going to be taking a short hiatus from publishing this blog on a regular basis. I still hope to comment on key news items in the medical-pharmaceutical industry as they occur, but please don't expect a weekly posting until the new semester's dust settles down. Thanks for your understanding!
Tuesday, January 27, 2009
Connect the dots between medical groups and pharm and medical device industry
On Saturday, The Boston Globe ran a front-page story about how three medical groups have threatened to pull their annual meetings out of Boston if the state of Massachusetts restricts drug and medical device promotions at medical meetings and requires the industry to publicly disclose the money it gives to medical groups and prominent physicians in research, consulting and educational fees. What the article neglected to mention was that all three of the medical societies named in the article -- The American Academy of Allergy, Asthma and Immunology, the American Society of Gene Therapy and the Heart Rhythm Society -- have received major funding from the pharmaceutical and medical device industry over the years.
Hmmm...could it be that the pharmaceutical and medical device industry had something to do with these rather unsubtle threats?
Spokespeople for two of the groups quoted in The Globe article said they were concerned that the proposed guidelines won't allow presentations by drug company employees at meetings in Massachusetts. According to local public health officials, that's simply not true. The regulations do allow company scientists to present at meetings but the presentations must be objective and cannot be used to flagrantly promote company's products. What a marvelous concept -- and a major departure from business as usual.
One need only visit the medical groups' websites to see the extent of industry funding behind these groups. In the March 2008 annual meeting program of the American Academy of Asthma, Allergy and Immunology, for example, the list of commercial supporters filled a full page, ranging from pharm companies such as GlaxoSmithKline, Merck, Schering Plough and AstroZenica to biotechs like Sepracor, Genentech and Teva Specialty.
Likewise, the Heart Rhythm Society's list of supporters for its May 2008 meeting in San Francisco includes all the major makers of cardiac medical devices: Medtronic, Boston Scientific and sanofi aventis (labeled Diamond Level sponsors), Boehringer Ingelheim (an Emerald Level Sponsor) and Biosense Webster, a subsidiary of Johnson and Johnson (alas only Ruby Level).
Similarly, the American Society of Gene Therapy listed Genzyme as its "partner" for its annual meeting last May in Boston and 15 biotech and medical device companies as major contributors and patrons.
So if The Boston Globe really wanted to do its homework, it could ask these three medical groups just how much money all this corporate sponsorship translates into every year and what kind of pressure the industry put on them to howl about regulations that were, by the way, designed to protect consumers.
Hmmm...could it be that the pharmaceutical and medical device industry had something to do with these rather unsubtle threats?
Spokespeople for two of the groups quoted in The Globe article said they were concerned that the proposed guidelines won't allow presentations by drug company employees at meetings in Massachusetts. According to local public health officials, that's simply not true. The regulations do allow company scientists to present at meetings but the presentations must be objective and cannot be used to flagrantly promote company's products. What a marvelous concept -- and a major departure from business as usual.
One need only visit the medical groups' websites to see the extent of industry funding behind these groups. In the March 2008 annual meeting program of the American Academy of Asthma, Allergy and Immunology, for example, the list of commercial supporters filled a full page, ranging from pharm companies such as GlaxoSmithKline, Merck, Schering Plough and AstroZenica to biotechs like Sepracor, Genentech and Teva Specialty.
Likewise, the Heart Rhythm Society's list of supporters for its May 2008 meeting in San Francisco includes all the major makers of cardiac medical devices: Medtronic, Boston Scientific and sanofi aventis (labeled Diamond Level sponsors), Boehringer Ingelheim (an Emerald Level Sponsor) and Biosense Webster, a subsidiary of Johnson and Johnson (alas only Ruby Level).
Similarly, the American Society of Gene Therapy listed Genzyme as its "partner" for its annual meeting last May in Boston and 15 biotech and medical device companies as major contributors and patrons.
So if The Boston Globe really wanted to do its homework, it could ask these three medical groups just how much money all this corporate sponsorship translates into every year and what kind of pressure the industry put on them to howl about regulations that were, by the way, designed to protect consumers.
Wednesday, January 21, 2009
Stringent privacy safeguards a must for electronic medical records
It's good to see that our new President is eager to fund the installation of an ambitious electronic medical records system that links doctors and hospitals with patient records, according to The New York Times. But as a number of legislators and consumers advocates quoted in this article warn, the problem of protecting the privacy of these records is not one to be taken lightly. I agree.
When I was a medical reporter for The Boston Globe, someone sent me the medical records of a Kennedy who had recently been hospitalized for drug addiction (no it wasn't Ted or Caroline). The records of this patient, who was at the time an elected official, had been sent by accident to a health-care professional who passed them along to me as an example of how porous the system of medical records security was. I convinced my editors that we should not disclose this person's identity or his addiction and there the matter rested.
However, if such sensitive medical information is posted online, one can only imagine the heightened potential for abuse. Anyone who has ever had their credit card number and/or identity stolen knows that information stored online remains far from secure. As fast as IT specialists come up with ways to secure online information, through encryption, passwords, what have you, intrepid hackers (often backed up organized crime syndicates) figure out ways around the security. Anyone who doesn't think this will happen with electronic medical records is fooling themselves.
Sensitive medical information -- about public and private figures -- will be stolen not only by crackers bent in selling them to interested parties, but will be available for viewing (and potential theft) by all the people within the health-care system who are currently allowed under law to see those records, including claims clerks, hospital personnel, researchers, pharmacies and law enforcement personnel.
A few years ago, a low-level employee at a LA hospital who had access to Farah Fawcett's medical records leaked information about her cancer recurrence to a gossip rag before the actress had had a chance to inform her family. That was bad and the employee was rightfully fired. But think about how many more prying eyes will have access to celebrity medical records when Obama's ambitious medical records project gets off the ground.
This is why stringent privacy safeguards must be put in place to protect electronic medical records. Not only should it be a major felony to sell any personal health information without the patient's consent but patients should be apprised of any disclosures of their electronic data for unauthorized purposes. Patients should also be able to demand that sensitive information, about treatment for drug addiction and psychological ailments, abortions and HIV tests, for example, be segregated from the rest of their medical records. And as Robert Pear in the Times article notes, patients -- or state officials acting on their behalf -- should be able to recover damages from any entity that improperly uses or discloses personal health information.
Finally, such privacy safeguards should be made into law by Congress, not left up to the federal Health and Human Services department, where regulations are often watered down as a result of aggressive lobbying by insurance companies and other interested parties. It's the least we should do to protect our right to privacy.
When I was a medical reporter for The Boston Globe, someone sent me the medical records of a Kennedy who had recently been hospitalized for drug addiction (no it wasn't Ted or Caroline). The records of this patient, who was at the time an elected official, had been sent by accident to a health-care professional who passed them along to me as an example of how porous the system of medical records security was. I convinced my editors that we should not disclose this person's identity or his addiction and there the matter rested.
However, if such sensitive medical information is posted online, one can only imagine the heightened potential for abuse. Anyone who has ever had their credit card number and/or identity stolen knows that information stored online remains far from secure. As fast as IT specialists come up with ways to secure online information, through encryption, passwords, what have you, intrepid hackers (often backed up organized crime syndicates) figure out ways around the security. Anyone who doesn't think this will happen with electronic medical records is fooling themselves.
Sensitive medical information -- about public and private figures -- will be stolen not only by crackers bent in selling them to interested parties, but will be available for viewing (and potential theft) by all the people within the health-care system who are currently allowed under law to see those records, including claims clerks, hospital personnel, researchers, pharmacies and law enforcement personnel.
A few years ago, a low-level employee at a LA hospital who had access to Farah Fawcett's medical records leaked information about her cancer recurrence to a gossip rag before the actress had had a chance to inform her family. That was bad and the employee was rightfully fired. But think about how many more prying eyes will have access to celebrity medical records when Obama's ambitious medical records project gets off the ground.
This is why stringent privacy safeguards must be put in place to protect electronic medical records. Not only should it be a major felony to sell any personal health information without the patient's consent but patients should be apprised of any disclosures of their electronic data for unauthorized purposes. Patients should also be able to demand that sensitive information, about treatment for drug addiction and psychological ailments, abortions and HIV tests, for example, be segregated from the rest of their medical records. And as Robert Pear in the Times article notes, patients -- or state officials acting on their behalf -- should be able to recover damages from any entity that improperly uses or discloses personal health information.
Finally, such privacy safeguards should be made into law by Congress, not left up to the federal Health and Human Services department, where regulations are often watered down as a result of aggressive lobbying by insurance companies and other interested parties. It's the least we should do to protect our right to privacy.
Thursday, January 15, 2009
Are newspapers under the financial gun getting sloppy with health coverage?
We've all heard the ominous reports about newspapers: as their print advertising disappears under the double whammy of the Internet (craiglist etc) and the recession, metropolitan newspapers are being forced to downsize, lay off veteran writers and cut back on coverage. Over the last few years, these financial woes have had a direct effect on the dwindling resources that newspapers like The Boston Globe can devote to investigative and enterprise reporting. And now, alas, the belt-tightening seem to be cutting into the very bone of news coverage and analysis -- at least at The Globe (where I worked for 13 years).
Consider these two examples. On Saturday, The Globe ran an opinion piece on its op-ed page about Massachusetts' proposed regulations requiring disclosure of financial ties between doctors and the pharmaceutical industry. The piece was written by Peter J. Pitts, who identified himself as president of the Center for Medicine in the Public Interest and a former associate commissioner of the FDA. Pitts neglected to mention that he is also senior vice president for global health affairs at the PR firm Manning Selvage & Lee, which represents Eli Lilly, GlaxoSmithKline, Pfizer and more than a dozen other pharmaceutical companies. In addition, the Center for Medicine in the Public Interest (which Pitts founded) receives the bulk of its funding from the pharmaceutical industry. Indeed, the fact that Pitts’ close ties to the drug industry went undisclosed when he was a guest on Fred Goodwin’s Infinite Mind show (which runs on several NPR affiliate stations) was a big part of the controversy that erupted over this NPR show last fall, according to Slate.
In his op-ed piece, Pitts said he favored limiting disclosure of financial conflicts to the industry's "marketing efforts," which would mean that drug and medical device companies would not have to disclose payments to medical researchers for consulting, speaking or anything to do with the research of their products. And, in fact, the regulations, as currently written, do not cover "bona fide services" for drug and medical device manufacturers such as consulting services, research, participation on advisory boards, company-sponsored presentations and education (back story). In other words, the regulations exempt much of the payments to doctors that create the conflicts of interest that health advocates worry about most.
As a shill for Pharma, Pitts is entitled to his opinion. The question in my mind is why The Globe's editorial page ran his piece without vetting Pitts' conflicts and making readers aware of them. I can only speculate that this kind of sloppiness might not have happened with a more fully staffed board of veteran editorial writers.
I draw my second example from a news story published today in, again, The Globe about new evidence that atypical antipsychotics -- drugs like Zyprexa, Risperdal and Seroquel -- have the same level of heart risks as older antipsychotics do. As The New York Times reported, the finding (published yesterday in The New England Journal of Medicine) is the latest in a string of reports contradicting the long-held assumption that these new antipsychotics are safer than the older and much less expensive drugs that they replaced. As it turns out, the new atypical antipsychotics, which have become blockbuster drugs prescribed for all kinds of off-label uses, double the risk of sudden cardiac death in patients.
The Globe article (written by a correspondent, not one of newspaper's regular medical writers) failed to put the latest finding in the context of the growing controversy over these drugs. For example, there is no mention in the article about earlier findings that drugs like Zyprexa, Seroquel and Risperdal are no more effective than the older antipsychotics in treating schizophrenia or dementia-related psychosis in elderly people. Or that the makers of these drugs are under investigation for illegally marketing these drugs for off-label uses to vulnerable patients (such as children and the elderly) in whom the previously known side effects (excessive weight gain and diabetes) are particularly risky.
Ironically, readers had to plow through to the Business section of The Globe to find that Eli Lilly, the maker of Zyprexa, is about to announce a $1.4 billion settlement with federal and state investigators over allegations that the drug company knew about the drug's dangerous side effects but launched an aggressive campaign to market Zyprexa for myriad off-label uses anyway.
In an earlier, less financially constrained, era, would a veteran medical writer or editor have thought to put these two pieces of news together in one place to give readers a fuller picture of the story? One can't help but wonder.
Consider these two examples. On Saturday, The Globe ran an opinion piece on its op-ed page about Massachusetts' proposed regulations requiring disclosure of financial ties between doctors and the pharmaceutical industry. The piece was written by Peter J. Pitts, who identified himself as president of the Center for Medicine in the Public Interest and a former associate commissioner of the FDA. Pitts neglected to mention that he is also senior vice president for global health affairs at the PR firm Manning Selvage & Lee, which represents Eli Lilly, GlaxoSmithKline, Pfizer and more than a dozen other pharmaceutical companies. In addition, the Center for Medicine in the Public Interest (which Pitts founded) receives the bulk of its funding from the pharmaceutical industry. Indeed, the fact that Pitts’ close ties to the drug industry went undisclosed when he was a guest on Fred Goodwin’s Infinite Mind show (which runs on several NPR affiliate stations) was a big part of the controversy that erupted over this NPR show last fall, according to Slate.
In his op-ed piece, Pitts said he favored limiting disclosure of financial conflicts to the industry's "marketing efforts," which would mean that drug and medical device companies would not have to disclose payments to medical researchers for consulting, speaking or anything to do with the research of their products. And, in fact, the regulations, as currently written, do not cover "bona fide services" for drug and medical device manufacturers such as consulting services, research, participation on advisory boards, company-sponsored presentations and education (back story). In other words, the regulations exempt much of the payments to doctors that create the conflicts of interest that health advocates worry about most.
As a shill for Pharma, Pitts is entitled to his opinion. The question in my mind is why The Globe's editorial page ran his piece without vetting Pitts' conflicts and making readers aware of them. I can only speculate that this kind of sloppiness might not have happened with a more fully staffed board of veteran editorial writers.
I draw my second example from a news story published today in, again, The Globe about new evidence that atypical antipsychotics -- drugs like Zyprexa, Risperdal and Seroquel -- have the same level of heart risks as older antipsychotics do. As The New York Times reported, the finding (published yesterday in The New England Journal of Medicine) is the latest in a string of reports contradicting the long-held assumption that these new antipsychotics are safer than the older and much less expensive drugs that they replaced. As it turns out, the new atypical antipsychotics, which have become blockbuster drugs prescribed for all kinds of off-label uses, double the risk of sudden cardiac death in patients.
The Globe article (written by a correspondent, not one of newspaper's regular medical writers) failed to put the latest finding in the context of the growing controversy over these drugs. For example, there is no mention in the article about earlier findings that drugs like Zyprexa, Seroquel and Risperdal are no more effective than the older antipsychotics in treating schizophrenia or dementia-related psychosis in elderly people. Or that the makers of these drugs are under investigation for illegally marketing these drugs for off-label uses to vulnerable patients (such as children and the elderly) in whom the previously known side effects (excessive weight gain and diabetes) are particularly risky.
Ironically, readers had to plow through to the Business section of The Globe to find that Eli Lilly, the maker of Zyprexa, is about to announce a $1.4 billion settlement with federal and state investigators over allegations that the drug company knew about the drug's dangerous side effects but launched an aggressive campaign to market Zyprexa for myriad off-label uses anyway.
In an earlier, less financially constrained, era, would a veteran medical writer or editor have thought to put these two pieces of news together in one place to give readers a fuller picture of the story? One can't help but wonder.
Thursday, January 8, 2009
Inauspicious omen for journalism's fate
I came back from vacation this week only to be greeted with bad news: Pharmalot, Ed Silverman's blog on the pharmaceutical industry, is no more. How disappointing! The demise of Pharmalot not only creates a big hole in coverage -- for me and many other reporters and bloggers -- but it is an inauspicious omen. If a large metropolitan daily like the Star Ledger (owned by Newhouse, a publishing powerhouse) can not see its way toward continuing such an incredibly useful source of news, one has to wonder what that augers for the future of good journalism overall.
Sure, there are plenty of other good health blogs, but Pharmalot was unique. To begin with, it was one of the few blogs that hewed to some form of objectivity, posting good and bad news about the pharmaceutical industry day in and day out. Silverman also covered the industry with greater depth than most other news-oriented blogs, such as the WSJ's health blog (which tends to cover a broader range of health news).
Equally important, Silverman was bolder than the Wall Street Journal and The New York Times in consistently delivering scoops about malfeasance in the drug and medical device industry. For example, as Senator Charles Grassley's investigations into conflicts of interest among doctors and researchers on the industry's payroll began to unfold last summer, Pharmalot was usually the first to post the news, followed by the mainstream press.
Finally, Silverman's inexhaustible postings were almost always accurate and fairly presented. As a result, Pharmalot developed a loyal following, as can been seen by the potporri of comments that were posted after each salacious scoop.
Now that Pharmalot has ceased to exist, I, along with many other health bloggers, will have to work that much harder to sift through and break news about the pharmaceutical industry -- a reality that industry executives will no doubt welcome. No, this is not a good start to the New Year at all.
Sure, there are plenty of other good health blogs, but Pharmalot was unique. To begin with, it was one of the few blogs that hewed to some form of objectivity, posting good and bad news about the pharmaceutical industry day in and day out. Silverman also covered the industry with greater depth than most other news-oriented blogs, such as the WSJ's health blog (which tends to cover a broader range of health news).
Equally important, Silverman was bolder than the Wall Street Journal and The New York Times in consistently delivering scoops about malfeasance in the drug and medical device industry. For example, as Senator Charles Grassley's investigations into conflicts of interest among doctors and researchers on the industry's payroll began to unfold last summer, Pharmalot was usually the first to post the news, followed by the mainstream press.
Finally, Silverman's inexhaustible postings were almost always accurate and fairly presented. As a result, Pharmalot developed a loyal following, as can been seen by the potporri of comments that were posted after each salacious scoop.
Now that Pharmalot has ceased to exist, I, along with many other health bloggers, will have to work that much harder to sift through and break news about the pharmaceutical industry -- a reality that industry executives will no doubt welcome. No, this is not a good start to the New Year at all.
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