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.
Friday, March 27, 2009
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.
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