Kudos to The Boston Globe for revealing a big loophole in Massachusetts' new disclosure rules for health professionals: doctors who receive lucrative consulting and research funding from drug companies do not need to disclose these payments under the proposed regulations.
The new rules would require Massachusetts physicians from accepting free meals, gifts and vacation junkets from drug companies and mandate that they report any money they receive to promote drug company products. However, according to a memo from the Health and Human Services' deputy general counsel, the proposed regulations 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.
In other words, the disclosure requirements won't cover the kind of back-room payments to doctors that create the conflicts of interest that health advocates worry about most. As Tufts University professor Jerome Kassirer, author of On the Take: How Medicine's Complicity with Big Business can endanger your Health told The Boston Herald yesterday, "We shouldn't be hiding any kind of personal relationships between pharmaceutical companies and physicians, because of the possibility that any kind of money that goes to physicians could produce some sort of bias."
Not could, does. Research shows that doctors who receive personal payments from drug companies are much more likely to report and promote positive findings about the company's products than doctors who don't have these conflicts.
In a statement, Massachusetts Public Health Commissioner John Auerbach said the state's public health council allowed the loophole to keep clinical trials in the state. In other words, it caved into pressure from the drug and medical device companies.
It looks like we're going to have to wait for passage of the national Physician Payment Sunshine Act to get any kind of meaningful reform. That law, introduced by Sen. Chuck Grassely last year, would require companies to disclose any payment they made to health professionals in excess of $500 per year (back story). Unless, of course, Massachusetts citizens decide they've had enough and make their voices heard at the two public hearings being held on the new regs in January; see press release.
Wouldn't that be a hoot?
Thursday, December 11, 2008
Wednesday, December 3, 2008
New study confirms: bias in the publication of drug trials is widespread
In its landmark lawsuit against GlaxoSmithKline, the New York State Attorney General accused the pharmaceutical giant of consumer fraud for not publishing negative findings about its antidepressant, Paxil, in essence, for not giving doctors and consumers the full story about its blockbuster drug.
Now comes a new study showing that the practice of selectively publishing only positive results and suppressing negative findings is an industry-wide habit. In a study published last week in PLoS Medicine, researchers at the University of California San Francisco discovered that only three-quarters of the randomized drug trials submitted for New Drug Applications (NDAs) between 2001 and 2002 were eventually published. Even more worrisome, trials with favorable outcomes were nearly five times more likely to be published than those with negative outcomes.
Furthermore, the researchers found evidence that primary outcomes were changed between the time the results were submitted to the FDA as NDAs and the time the studies were published. And when that happened, the results were invariably altered to favor the test drug, the researchers found.
These findings demonstrate that "the information that is readily available in the scientific literature to health care professionals is incomplete and potentially biased," the UCSF researchers conclude.
In an accompanying editorial, a scientist for the Mayo Clinic who previously worked with the World Health Organization's International Clinical Trials Registry Platform, agreed that the "trial literature is biased" and declared that the "the time has come to tackle the challenge of making key trial documents public."
Fortunately, drug companies are now required by law to post the results of all their clinical trials, negative as well as positive, on a publicly available website. And the fact that the leading medical journals now require pretrial registration -- i.e. researchers must post their trial protocols on a public website -- should help cut down on the tendency to change primary outcome measures to favor drug results.
However, drug company-sponsored researchers still don't have to publish the results of all randomized drug trials in medical journals. And since that is where doctors and consumers get most of their information, the full story about the safety and effectiveness of new drugs remains untold.
Now comes a new study showing that the practice of selectively publishing only positive results and suppressing negative findings is an industry-wide habit. In a study published last week in PLoS Medicine, researchers at the University of California San Francisco discovered that only three-quarters of the randomized drug trials submitted for New Drug Applications (NDAs) between 2001 and 2002 were eventually published. Even more worrisome, trials with favorable outcomes were nearly five times more likely to be published than those with negative outcomes.
Furthermore, the researchers found evidence that primary outcomes were changed between the time the results were submitted to the FDA as NDAs and the time the studies were published. And when that happened, the results were invariably altered to favor the test drug, the researchers found.
These findings demonstrate that "the information that is readily available in the scientific literature to health care professionals is incomplete and potentially biased," the UCSF researchers conclude.
In an accompanying editorial, a scientist for the Mayo Clinic who previously worked with the World Health Organization's International Clinical Trials Registry Platform, agreed that the "trial literature is biased" and declared that the "the time has come to tackle the challenge of making key trial documents public."
Fortunately, drug companies are now required by law to post the results of all their clinical trials, negative as well as positive, on a publicly available website. And the fact that the leading medical journals now require pretrial registration -- i.e. researchers must post their trial protocols on a public website -- should help cut down on the tendency to change primary outcome measures to favor drug results.
However, drug company-sponsored researchers still don't have to publish the results of all randomized drug trials in medical journals. And since that is where doctors and consumers get most of their information, the full story about the safety and effectiveness of new drugs remains untold.
Tuesday, November 25, 2008
Biederman's conflicts: a crime against troubled children and the State?
If I were the parent of a child diagnosed with bipolar disorder by doctors at Massachusetts General Hospital and prescribed anti-psychotic drugs with serious side effects, how would I feel upon learning that the head honcho of MGH's child psychiatry department not only was on the take from the makers of these powerful drugs but pushed for the establishment of a drug company-funded center at MGH whose stated "rationale" was "to generate and disseminate data supporting use" of these drugs in children?
Betrayed is how I would feel, horribly betrayed.
Moving beyond the issue of betrayal, the actions of Joseph Biederman, as revealed today in The New York Times and The Boston Globe, raise the specter of criminality. By pushing Johnson & Johnson, the maker of Risperdal, to fund a center at MGH whose stated goal was to support the use of Risperdal and "move forward the commercial goals of J&J," the question emerges: did Biederman help Johnson & Johnson illegally market the off-label use of its anti-psychotic drug in children and adolescents?
While it is legal for doctors to prescribe drugs for uses not approved by the FDA, it is illegal for companies to actively market those off-label drugs. As a number of recent books, Side Effects included, show, drug makers routinely got around that restriction by recruiting and paying key opinion leaders to promote the off-label use of their products at medical conferences, company-sponsored meetings and in medical journals. By taking millions of dollars, both personally and to fund his MGH center, Biederman seems to have raised the art of off-label promotion to an entirely new level.
As The New York Times reports, "Biederman's work helped to fuel a 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder and a rapid rise in the use of powerful, risky and expensive anti-psychotic medicines in children... Biederman had a vast influence on the field largely because of his position at one of the most prestigous medical institutions in the world."
Earlier this summer, Congressional investigators led by Senator Charles E. Grassley accused Biederman of failing to disclose at least $1.4 million in personal payments from companies that make anti-psychotic drugs, such as Risperdal, Zyprexa, Abilify and Seroquel (back story). Now comes the news, as revealed in documents unsealed in a lawsuit, that Biederman repeatedly pushed Johnson & Johnson to fund a center at MGH whose stated purpose was to spread the word about Risperdal in treating bipolar disorder in children. Emails unsealed from the multi-state lawsuit also reveal that Biederman was asked to author a study of Risperdal ghost-written by Johnson & Johnson that purported to show the drug was more effective than a placebo in treating children.
In other words, we give you money to fund your center and line your pockets and you spread the word about our wonderful drugs, medical objectivity be damned.
Here is another example of how the tort system that the drug company lawyers are pushing to abolish helps consumers. The reason these documents came to light is because thousands of parents sued J&J, AstraZeneca (the maker Seroquel) and Eli Lilly (the maker of Zypreca), claiming that the companies minimized the risks of the anti-psychotic drugs given to their children. Attorneys representing these families demanded reams of documents from the companies, and while nearly all of these documents remain under seal, a select few that mentioned Biederman became public as part of an effort to compel the MGH psychiatrist to testify under oath as a witness in the legal proceedings. (The plaintiffs won and Biederman is expected to be deposed sometime in January, according to The Boston Globe).
So the question becomes: how long will Mass. General and Harvard Medical School allow such unethical and possibly criminal behavior to tarnish their reputations? Hopefully not long.
Betrayed is how I would feel, horribly betrayed.
Moving beyond the issue of betrayal, the actions of Joseph Biederman, as revealed today in The New York Times and The Boston Globe, raise the specter of criminality. By pushing Johnson & Johnson, the maker of Risperdal, to fund a center at MGH whose stated goal was to support the use of Risperdal and "move forward the commercial goals of J&J," the question emerges: did Biederman help Johnson & Johnson illegally market the off-label use of its anti-psychotic drug in children and adolescents?
While it is legal for doctors to prescribe drugs for uses not approved by the FDA, it is illegal for companies to actively market those off-label drugs. As a number of recent books, Side Effects included, show, drug makers routinely got around that restriction by recruiting and paying key opinion leaders to promote the off-label use of their products at medical conferences, company-sponsored meetings and in medical journals. By taking millions of dollars, both personally and to fund his MGH center, Biederman seems to have raised the art of off-label promotion to an entirely new level.
As The New York Times reports, "Biederman's work helped to fuel a 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder and a rapid rise in the use of powerful, risky and expensive anti-psychotic medicines in children... Biederman had a vast influence on the field largely because of his position at one of the most prestigous medical institutions in the world."
Earlier this summer, Congressional investigators led by Senator Charles E. Grassley accused Biederman of failing to disclose at least $1.4 million in personal payments from companies that make anti-psychotic drugs, such as Risperdal, Zyprexa, Abilify and Seroquel (back story). Now comes the news, as revealed in documents unsealed in a lawsuit, that Biederman repeatedly pushed Johnson & Johnson to fund a center at MGH whose stated purpose was to spread the word about Risperdal in treating bipolar disorder in children. Emails unsealed from the multi-state lawsuit also reveal that Biederman was asked to author a study of Risperdal ghost-written by Johnson & Johnson that purported to show the drug was more effective than a placebo in treating children.
In other words, we give you money to fund your center and line your pockets and you spread the word about our wonderful drugs, medical objectivity be damned.
Here is another example of how the tort system that the drug company lawyers are pushing to abolish helps consumers. The reason these documents came to light is because thousands of parents sued J&J, AstraZeneca (the maker Seroquel) and Eli Lilly (the maker of Zypreca), claiming that the companies minimized the risks of the anti-psychotic drugs given to their children. Attorneys representing these families demanded reams of documents from the companies, and while nearly all of these documents remain under seal, a select few that mentioned Biederman became public as part of an effort to compel the MGH psychiatrist to testify under oath as a witness in the legal proceedings. (The plaintiffs won and Biederman is expected to be deposed sometime in January, according to The Boston Globe).
So the question becomes: how long will Mass. General and Harvard Medical School allow such unethical and possibly criminal behavior to tarnish their reputations? Hopefully not long.
Wednesday, November 19, 2008
Drug Industry Mantra: If you can't buy them, bully them?
I found a disturbing common thread emerge this week from news coverage of the medical-pharmaceutical industry, a thread that can be summed in these words: If you can't buy them, bully them.
First off, we have reports in The New York Times and Pharmalot that an FDA advisory panel concluded that powerful anti-psychotic drugs are being prescribed much too readily to children; the panel called on the FDA to do more to discourage the use of these drugs in children diagnosed with bipolar disorder. As Gardiner Harris of The New York Times notes, "the leading advocate for the bipolar diagnosis is Dr. Joseph Biederman, a child psychiatrist at Harvard University whose work is under a cloud after a Congressional investigation revealed he had failed to report at least $1.4 million in outside income from the makers of antipsychotic medicines."
Biederman, as this and many other blogs have noted, is just one of many doctors who failed to fully disclose the extent of their earnings from the makers of drugs whom they were, at the same time, studying and touting to colleagues. As I reveal in Side Effects, this is simply the way the drug industry does business: they recruit prominent doctors, called key opinion leaders (KOLs), and pay them lots of money to promote new drugs to other doctors. Such blatant conflicts of interest are only now being widely publicized due to the diligence of Sen. Chuck Grassley's Finance Committee. That's the carrot side of the equation.
Now, we find that the drug industry also used the stick to intimidate doctors who spoke up about the worrisome side effects of some drugs. The Wall Street Journal and Pharmalot today reported that GlaxoSmithKline attempted to intimidate a physician at a Maryland hospital to stop her from voicing concerns about its antidiabetes drug, Avandia. In 2000, Dr. Mary Money and several colleagues at Washington County Hospital in Hagerstown raised concerns with both the company and the FDA that Avandia increased the risk of heart failure. GlaxoSmithKline dismissed their concerns and then wrote a letter to the hospital's chief of staff demanding he take immediate steps to "stop the dissemination of unsubstantiated information by your medical staff."
We also learn that another physician from Duke University testified before Congress that he too had been attacked as a liar and threatened with a lawsuit by the drug company when he raised concerns about Avandia. It was not until 2007, after The New England Journal of Medicine published a meta-analysis showing an increased risk of heart failure among patients taking Avandia, that the FDA put black box warnings on the drug. (It's worth noting that researchers would never have been able to do this meta-analysis if not for the New York State Attorney General's lawsuit against GlaxoSmithKline for deceiving physicians and consumers about another of its drugs, the antidepressant Paxil; as part of settling that lawsuit, Glaxo agreed to post the findings of all its clinical trials, including those about Avandia).
So what's the common theme in all of this? If the drug industry can't buy doctors to promote their new drugs, then they will do what they can to bully them into silence. For shame.
First off, we have reports in The New York Times and Pharmalot that an FDA advisory panel concluded that powerful anti-psychotic drugs are being prescribed much too readily to children; the panel called on the FDA to do more to discourage the use of these drugs in children diagnosed with bipolar disorder. As Gardiner Harris of The New York Times notes, "the leading advocate for the bipolar diagnosis is Dr. Joseph Biederman, a child psychiatrist at Harvard University whose work is under a cloud after a Congressional investigation revealed he had failed to report at least $1.4 million in outside income from the makers of antipsychotic medicines."
Biederman, as this and many other blogs have noted, is just one of many doctors who failed to fully disclose the extent of their earnings from the makers of drugs whom they were, at the same time, studying and touting to colleagues. As I reveal in Side Effects, this is simply the way the drug industry does business: they recruit prominent doctors, called key opinion leaders (KOLs), and pay them lots of money to promote new drugs to other doctors. Such blatant conflicts of interest are only now being widely publicized due to the diligence of Sen. Chuck Grassley's Finance Committee. That's the carrot side of the equation.
Now, we find that the drug industry also used the stick to intimidate doctors who spoke up about the worrisome side effects of some drugs. The Wall Street Journal and Pharmalot today reported that GlaxoSmithKline attempted to intimidate a physician at a Maryland hospital to stop her from voicing concerns about its antidiabetes drug, Avandia. In 2000, Dr. Mary Money and several colleagues at Washington County Hospital in Hagerstown raised concerns with both the company and the FDA that Avandia increased the risk of heart failure. GlaxoSmithKline dismissed their concerns and then wrote a letter to the hospital's chief of staff demanding he take immediate steps to "stop the dissemination of unsubstantiated information by your medical staff."
We also learn that another physician from Duke University testified before Congress that he too had been attacked as a liar and threatened with a lawsuit by the drug company when he raised concerns about Avandia. It was not until 2007, after The New England Journal of Medicine published a meta-analysis showing an increased risk of heart failure among patients taking Avandia, that the FDA put black box warnings on the drug. (It's worth noting that researchers would never have been able to do this meta-analysis if not for the New York State Attorney General's lawsuit against GlaxoSmithKline for deceiving physicians and consumers about another of its drugs, the antidepressant Paxil; as part of settling that lawsuit, Glaxo agreed to post the findings of all its clinical trials, including those about Avandia).
So what's the common theme in all of this? If the drug industry can't buy doctors to promote their new drugs, then they will do what they can to bully them into silence. For shame.
Thursday, November 6, 2008
New Zoloft study: an eerie case of deja vu
Between teaching journalism and working on my master's thesis, I have only now found the time to scrutinize the much-heralded Zoloft study published last Friday in the online version of The New England Journal of Medicine. And I have a few bones to pick with it, some of which have already been picked by commentators on Pharmalot.
The study found that a combined regimen of Zoloft and cognitive behavior therapy was more effective than either the drug or therapy alone in treating anxiety in children (age 7 to 17). It also concluded that Zoloft and CBT by themselves were more effective than placebo. News accounts of the study trumpeted the fact that none of the children in this trial committed suicide and that there was no significant increase in suicidal thoughts among those taking Zoloft. By highlighting these findings, the study's researchers no doubt intended to add weight to the argument that the FDA acted too hastily back in 2004 in putting black box warnings on Zoloft and other antidepressants.
Not so fast please. If you look closely at the data in this study, there are indications that a number of children taking Zoloft did have adverse reactions to the drug and experienced "a worsening" of psychiatric behaviors, in one case so severe that the child required hospitalization. Indeed of the three children in thte study who had serious adverse effects, two of them were in the Zoloft only arm of the study and one in the combination arm. Yet the study researchers dismiss the case requiring psychiatric hospitalization as being "unrelated to the study treatment."
This language of blithe dismissal is eerily reminscient of another antidepressant trial: Paxil study 329, which is currently under investigation by the U.S. Department of Justice back story. In study 329, researchers not only dismissed some adverse effects as being unrelated to Paxil, but they also concluded that Paxil was more effective than placebo, when in fact the data showed it was not. (As I reveal in my book, Side Effects, Brown University researchers also misrepresented data in the trial, coding teenagers who were suicidal as being "noncompliant."
Indeed, as Doug Bremner, professor of psychiatry at Emory University, points out on Pharmalot, the results of this study are not that different from the non-statistically significant results in the Paxil study. In that study, Paxil was found to be no more effective than placebo on the two primary outcome measures. In the more recent Zoloft study, Bremner notes that when you look at the actual data on one of the primary outcomes, the Pediatric Anxiety scale, the difference in improvement between the patients in the Zoloft only arm and the patients in the placebo group are also not statistically significant. Bremner dissects problems with the Zoloft study in greater depth on his blog.
There's more. The Zoloft study also minimizes the fact that of the 14 patients who withdrew from either treatment or the study due to adverse side effects, most of them were in the Zoloft only group. While its authors make much of the finding that there were no patients with suicidal thoughts in the Zoloft only group, they gloss over the fact that there were five patients who expressed suicidal ideation in the combined Zoloft/CBT group.
The researchers also ignore the finding that overall, there were many fewer side effects among the children in the cognitive behavior therapy group alone; patients in the latter group reported fewer cases of insomnia, fatigue, sedation, restlessness and fidgeting than those in the Zoloft study. That makes a lot of sense given the research showing that there is an increased risk of akathasia (agitation and restlessness) among patients who take SSRI antidepressants like Zoloft, Prozac and Paxil.
Finally, the Zoloft trial shares another disturbing similarity with Paxil study 329: in the fine print at the end of the NEJM report, its researchers disclose a myriad of financial ties to the pharmaceutical industry, including extensive consulting and speaking fees from companies that make SSRI antidepressants. So as several of the Pharmalot commentators ask, why should we trust the conclusions of this study? Why indeed.
The study found that a combined regimen of Zoloft and cognitive behavior therapy was more effective than either the drug or therapy alone in treating anxiety in children (age 7 to 17). It also concluded that Zoloft and CBT by themselves were more effective than placebo. News accounts of the study trumpeted the fact that none of the children in this trial committed suicide and that there was no significant increase in suicidal thoughts among those taking Zoloft. By highlighting these findings, the study's researchers no doubt intended to add weight to the argument that the FDA acted too hastily back in 2004 in putting black box warnings on Zoloft and other antidepressants.
Not so fast please. If you look closely at the data in this study, there are indications that a number of children taking Zoloft did have adverse reactions to the drug and experienced "a worsening" of psychiatric behaviors, in one case so severe that the child required hospitalization. Indeed of the three children in thte study who had serious adverse effects, two of them were in the Zoloft only arm of the study and one in the combination arm. Yet the study researchers dismiss the case requiring psychiatric hospitalization as being "unrelated to the study treatment."
This language of blithe dismissal is eerily reminscient of another antidepressant trial: Paxil study 329, which is currently under investigation by the U.S. Department of Justice back story. In study 329, researchers not only dismissed some adverse effects as being unrelated to Paxil, but they also concluded that Paxil was more effective than placebo, when in fact the data showed it was not. (As I reveal in my book, Side Effects, Brown University researchers also misrepresented data in the trial, coding teenagers who were suicidal as being "noncompliant."
Indeed, as Doug Bremner, professor of psychiatry at Emory University, points out on Pharmalot, the results of this study are not that different from the non-statistically significant results in the Paxil study. In that study, Paxil was found to be no more effective than placebo on the two primary outcome measures. In the more recent Zoloft study, Bremner notes that when you look at the actual data on one of the primary outcomes, the Pediatric Anxiety scale, the difference in improvement between the patients in the Zoloft only arm and the patients in the placebo group are also not statistically significant. Bremner dissects problems with the Zoloft study in greater depth on his blog.
There's more. The Zoloft study also minimizes the fact that of the 14 patients who withdrew from either treatment or the study due to adverse side effects, most of them were in the Zoloft only group. While its authors make much of the finding that there were no patients with suicidal thoughts in the Zoloft only group, they gloss over the fact that there were five patients who expressed suicidal ideation in the combined Zoloft/CBT group.
The researchers also ignore the finding that overall, there were many fewer side effects among the children in the cognitive behavior therapy group alone; patients in the latter group reported fewer cases of insomnia, fatigue, sedation, restlessness and fidgeting than those in the Zoloft study. That makes a lot of sense given the research showing that there is an increased risk of akathasia (agitation and restlessness) among patients who take SSRI antidepressants like Zoloft, Prozac and Paxil.
Finally, the Zoloft trial shares another disturbing similarity with Paxil study 329: in the fine print at the end of the NEJM report, its researchers disclose a myriad of financial ties to the pharmaceutical industry, including extensive consulting and speaking fees from companies that make SSRI antidepressants. So as several of the Pharmalot commentators ask, why should we trust the conclusions of this study? Why indeed.
Tuesday, October 28, 2008
Exposing the drug industry's bogus $800 million cost estimate... and other sordid tales
In 2003. researchers at Tufts University published a study showing that it cost drug companies approximately $800 million to develop a new drug and get it approved by the FDA. In the intervening years, the drug industry has used that mind-boggling cost estimate to justify not only the high cost of new prescription drugs but also the need for expedited drug approvals and long patent protection once their drugs were approved.
Well, guess what? As it turns out, the study by researchers for the Tufts Center for the Study of Drug Development was deeply flawed and wildly inflated the actual cost of developing a new drug from start to finish. The study’s flaws and the undisclosed conflicts on the part of its authors were dissected both in a book by Merrill Goozner, the author of gooznews and in a paper that two bioethicists tried to get published in the Journal of Health Economics, which ran the original $800 million estimate.
In a tale that rivals anything out of Machiavelli, the editors of this supposedly respectable journal insisted on massive revisions and cuts in the bioethicists’ submission and only agreed to publish a milder version of their critique after the two threatened to sue the journal for violating academic freedoms. The JHE editors were particularly adamant about cutting from the critique the fact that authors of the $800 million estimate had failed to disclose in their study that they and the Tufts Center for the Study of Drug Development are heavily dependent on drug industry funding (although it didn't fund the cost estimate study).
The two bioethicists, Donald Light, a professor at the University of Medicine and Dentistry in New Jersey, and Rebecca Warburton, a health economist at the University of London, chronicle their convoluted efforts to publish their critique -- in an entertaining piece in the current issue of the Harvard Health Policy Review. They hold their experience up as an example of the need for higher ethical standards on the part of many conflict-ridden healthcare journals.
But wait – the story doesn’t end there. According to Gooznews, the editor of the student-run Harvard Health Policy Review yanked the entire issue of HHPR off the web last week after getting a steamed email from Richard Frank, one of the editors of JHE who also happens to be the Harvard review's faculty advisor and a big-time health economics professor at Harvard Medical School. In his email, Frank said he no longer wanted to be affiliated with the review. As the student editors now admit, “we panicked.”
The current issue is now back online along with an abject apology from the student editors for not having fact-checked the Light/Warburton critique to ensure the veracity of their claims. Apparently, what most incensed Richard Frank was that the HHPR didn’t contact the JHE editors for rebuttal before running the critique.
Funny how some powerful journal editors don't enjoy being on the receiving end of their own medicine.
Well, guess what? As it turns out, the study by researchers for the Tufts Center for the Study of Drug Development was deeply flawed and wildly inflated the actual cost of developing a new drug from start to finish. The study’s flaws and the undisclosed conflicts on the part of its authors were dissected both in a book by Merrill Goozner, the author of gooznews and in a paper that two bioethicists tried to get published in the Journal of Health Economics, which ran the original $800 million estimate.
In a tale that rivals anything out of Machiavelli, the editors of this supposedly respectable journal insisted on massive revisions and cuts in the bioethicists’ submission and only agreed to publish a milder version of their critique after the two threatened to sue the journal for violating academic freedoms. The JHE editors were particularly adamant about cutting from the critique the fact that authors of the $800 million estimate had failed to disclose in their study that they and the Tufts Center for the Study of Drug Development are heavily dependent on drug industry funding (although it didn't fund the cost estimate study).
The two bioethicists, Donald Light, a professor at the University of Medicine and Dentistry in New Jersey, and Rebecca Warburton, a health economist at the University of London, chronicle their convoluted efforts to publish their critique -- in an entertaining piece in the current issue of the Harvard Health Policy Review. They hold their experience up as an example of the need for higher ethical standards on the part of many conflict-ridden healthcare journals.
But wait – the story doesn’t end there. According to Gooznews, the editor of the student-run Harvard Health Policy Review yanked the entire issue of HHPR off the web last week after getting a steamed email from Richard Frank, one of the editors of JHE who also happens to be the Harvard review's faculty advisor and a big-time health economics professor at Harvard Medical School. In his email, Frank said he no longer wanted to be affiliated with the review. As the student editors now admit, “we panicked.”
The current issue is now back online along with an abject apology from the student editors for not having fact-checked the Light/Warburton critique to ensure the veracity of their claims. Apparently, what most incensed Richard Frank was that the HHPR didn’t contact the JHE editors for rebuttal before running the critique.
Funny how some powerful journal editors don't enjoy being on the receiving end of their own medicine.
Wednesday, October 22, 2008
New study of suicide rates reveals: the emperor has no clothes
A bewildered tone seemed to permeate the news reports this week that suicide rates among middle-aged Americans rose sharply from 1999 to 2005. Even the authors of the new analysis in the American Journal of Preventive Medicine said they had no idea why the suicide rate climbed 19 percent among white women ages 40 to 64 and 16 percent among white men of the same age during those six years. As Susan Baker, an epidemiologist at Johns Hopkins School of Public Health said in The Boston Globe yesterday, “I have no idea what’s going on with this age group.”
Could it be that some of the confusion stems from the fact that this new data puts the lie to the drug industry’s long-held contention that antidepressants known as selective serotonin reuptake inhibitors (SSRIs) lead to fewer suicides? After all, during roughly the same time period, antidepressant prescriptions in the United States rose 10 percent, according to a survey by the federal Agency for Healthcare Research and Quality. In a statistical brief published in June 2008, the AHRQ noted that the number of antidepressants purchased in the U.S. rose from 154 million in 2002 to 170 million in 2005. So if antidepressant prescriptions and suicide rates among middle-aged adults were both rising during the first five years of the 21st century, drugs like Prozac, Paxil, Zoloft and Celexa are obviously not stemming the tide.
So what does explain the sharp rise in suicide rates among folks that (unlike teenagers and the elderly) are not known for having a high risk of self-in jury? One explanation could be the economy. Research has shown that suicide rates tend to rise during periods of economic hard times and decline during good times. And as we all know, with the burst of the dot com bubble in 2000, the American economy slid into a recession for the next three or four years.
That correlation has prompted some observers to voice concerns about what might happen with the current financial meltdown. Newsday quoted Alan Berman, executive director of the American Association of Suicidology (AAS), saying he feared the struggling economy could accelerate the trend. “We know that unemployment affects suicide rates and that when people feel a severe economic strain, suicide rates tend to increase among people experiencing this trend,” Berman said.
I find it interesting that neither Berman nor any of the experts quoted in the news raised the issue of antidepressants and what role they may (or may not) play in the rising suicide rates. No one, it seems, least of all organizations like the AAS, which derives a lot of its funding from drug companies, are eager to call attention to the likelihood that the Emperor has no clothes.
Could it be that some of the confusion stems from the fact that this new data puts the lie to the drug industry’s long-held contention that antidepressants known as selective serotonin reuptake inhibitors (SSRIs) lead to fewer suicides? After all, during roughly the same time period, antidepressant prescriptions in the United States rose 10 percent, according to a survey by the federal Agency for Healthcare Research and Quality. In a statistical brief published in June 2008, the AHRQ noted that the number of antidepressants purchased in the U.S. rose from 154 million in 2002 to 170 million in 2005. So if antidepressant prescriptions and suicide rates among middle-aged adults were both rising during the first five years of the 21st century, drugs like Prozac, Paxil, Zoloft and Celexa are obviously not stemming the tide.
So what does explain the sharp rise in suicide rates among folks that (unlike teenagers and the elderly) are not known for having a high risk of self-in jury? One explanation could be the economy. Research has shown that suicide rates tend to rise during periods of economic hard times and decline during good times. And as we all know, with the burst of the dot com bubble in 2000, the American economy slid into a recession for the next three or four years.
That correlation has prompted some observers to voice concerns about what might happen with the current financial meltdown. Newsday quoted Alan Berman, executive director of the American Association of Suicidology (AAS), saying he feared the struggling economy could accelerate the trend. “We know that unemployment affects suicide rates and that when people feel a severe economic strain, suicide rates tend to increase among people experiencing this trend,” Berman said.
I find it interesting that neither Berman nor any of the experts quoted in the news raised the issue of antidepressants and what role they may (or may not) play in the rising suicide rates. No one, it seems, least of all organizations like the AAS, which derives a lot of its funding from drug companies, are eager to call attention to the likelihood that the Emperor has no clothes.
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