While French officials tighten regulations about conflicts of interest, US legislators are heading in the opposite direction…

Posted on December 12, 2011 by

I almost choked over my tea this morning when reading this The New York Times story, the gist of which was that French regulations governing conflicts of interest in medicine are considerably more lax than our own. If only that were true.

The NYT article described how a recent scandal over Mediator, a French drug belatedly withdrawn from the market after causing a number of deaths and severe heart problems, has prompted widespread calls for change in the French regulatory system. But while the piece mentioned in passing that the French have passed a package of reforms, it failed to note just what those reforms consisted of: that in response to this scandal, the French National Assembly has already passed a strict law mandating the disclosure of conflicts of interest among scientists who advise government officials about new drugs — see Pharmalot. This law requires external experts and health ministry staffers to declare all conflicts or face a $40,000 fine. The French response is far stricter than anything our own regulatory officials at the FDA or NIH have come up with so far.

The Times article points out there are no penalties for voting members of the French equivalent to the FDA who fail to disclose conflicts of interest, while it is a crime to do so here. While it may be against the law for FDA officials to have undisclosed conflicts of interest, it is not a crime for advisory members of the FDA or other researchers who fail to disclose such conflicts. Indeed, not a whole lot happens to the vast majority of academic researchers who fail to disclose the fact that they are getting payments on the side from the same drug companies whose drugs they are touting in medical journals and conferences or on FDA advisory panels. As I and others have blogged about before here and here, that’s primarily because it is left up to universities to sanction these researchers, and universities don’t want to bite the hand that feeds them. The only academic who was asked to step down because of failing to report egregious conflicts of interest was Charles Nemeroff at Emory. As we all know, Nemeroff was promptly scooped up by the University of Miami School of Medicine who was more than happy to have a pharmaceutical company rainmaker on its payroll.

What today’s Times piece also failed to note is that the FDA’s conflict of interest regulations are under attack in Congress. According to Pharmalot, several U.S. Senators has introduced a bill that would reverse FDA regulations that bar experts with financial ties to drug or device makers from serving on the committees without a waiver.

So at the very time that the French are tightening their regulations to better protect the public health, officials on this side of the Atlantic are trying to weaken U.S. consumer protections. But you wouldn’t know that from reading today’s New York Times.

Posted in Uncategorized | 2 Comments

Deceptive drug research practices explain why over-medicating of children still going on

Posted on December 2, 2011 by

A new report from the U.S. Government Accountability office confirms something that Rose Firestein, the eponymous prosecutor in the title of Side Effects: A Prosecutor, a Whistleblower and Bestselling Antidepressant on Trial noticed way back in the ’90s: that children in foster care were being over-medicated with antidepressants and atypical anti-psychotic drugs. Indeed, that’s why Firestein decided to probe the deceptive marketing of these psychoactive drugs when she went to work for the New York State Attorney General’s office in 2002.

Now, of course, comes the GAO report finding that foster children have been prescribed such psychotropic drugs at rates 2.7 to 4.5 times higher than children not in foster homes, despite the lack of evidence about their safety or effectiveness in this age group. This isn’t news to those of us who have been writing and blogging for years about how drug companies have deliberately targeted the off-label use of these drugs in children to reap blockbuster profits.

So why do these johnny-come-lately government reports matter? For two reasons: because physicians and parents in the foster care system continue to use these drugs as chemical strait-jackets, and because the pharmaceutical industry is still employing the same deceptive tactics to sell new anti-psychotic drugs for use in children and adults, as oneboringoldman demonstrates in his blogs this week. Dr. Mickey Nardo, the psychiatrist behind oneboringoldman, tells the story of how the maker of Latuda, a schizophrenia drug, paid a CRO to run a shoddy clinical trial on the drug and hire a few for-sale psychiatrists to slap their names on the study, which was then published in the American Journal of Psychiatry.

The results from this trial were then used to convince the FDA to approve Latuda for use in schizophrenia. As a result, it can now be prescribed off-label as a drug for bipolar disorder to replace anti-psychotic drugs like Seroquel, Risperdal and Zyprexa, which were found to cause severe problems in children (like diabetes and obesity) only after they were also heavily marketed off-label for this age group. In fact, as I and many others have blogged about here and here, the illegal marketing of these drugs earned the makers of these drugs record fines.

And now, according to oneboringoldman, we have a new entry in the anti-psychotic sweepstakes. All of which makes me wonder: How long before we see foster children over-medicated with Latuda?

Posted in antidepressants, antipsychotic drugs, clinical trials, conflicts of interest, drug marketing, FDA, ghostwriting, pharmaceutical industry | Tagged , , , , , , | 2 Comments

International group seeks Brown University’s help in retracting controversial Paxil study

Posted on November 18, 2011 by

The international research organization Healthy Skepticism has called on Brown University to help convince a psychiatric journal to retract the controversial Paxil trial that I wrote about in Side Effects, according to the Brown Daily Herald. The principal investigator of this multi-center study is Brown professor of psychiatry Martin Keller, the former chief of psychiatry at Brown School of Medicine.

As the Herald notes:

Healthy Skepticism expressed concern that the study, which identified the drug Paxil as an effective combatant of depression in children, “seriously misrepresented both the effectiveness and the safety” of the drug. The authors added that the study’s continued citation was harmful to children, since some children committed suicide after being prescribed Paxil.

As I’ve blogged about here, The Journal of the American Academy of Child and Adolescent Psychiatry has so far refused to retract the trial, known as study 329, despite evidence of misrepresented data, ghostwriting and failure to disclose conflicts of interest on the part of its authors.

According to the Daily Herald, the dean of the medical school has declined to comment on whether Brown has even opened an investigation into Healthy Skepticism’s contention of scientific misconduct in the study. But Paul Thacker, the former Congressional aide who investigated Keller’s conflicts of interest for the Senate Finance committee, noted that even if University officials found evidence of misconduct, “they would likely ignore them, since Keller’s research has provided a steady source of University funding,” the Herald reported. Thacker went on to say that “he does not think the University should continue to receive any federal funding if it does not publicly address the Keller case.”

In case you missed it, GlaxoSmithKline, the maker of Paxil, was hit with a massive $3 billion fine earlier this month for the deceptive and off-label marketing of Paxil and other drugs in the United States. The $3 billion settlement is intended to cover a number of criminal and civil investigations into the off-label marketing of Paxil, Avandia (its anti-diabetes drug) and seven other drugs, and is the largest recorded fine against a pharmaceutical company to date, according to The Washington Post.

As I and others have pointed out, study 329 was among the deceptive marketing materials used by the Glaxo sales force to promote the use of Paxil in children and make it into a blockbuster drug.

Full disclosure: I’m quoted in the Daily Herald article.

Posted in antidepressants, conflicts of interest, drug marketing, ghostwriting, pharmaceutical industry, scientific journal retractions, scientific misconduct | Tagged , , , , , , , | 3 Comments

New drug industry partnership with hospitals could jeopardize patient care

Posted on November 17, 2011 by

We’ve all signed those vague privacy statements when visiting our local hospital for medical care. But how many of us have actually read the fine print and understand that the most sensitive details of our medical lives may be shared with drug companies for research purposes? And that we, as patients, may be asked to take part in a clinical trial that not only brings financial benefits for the company doing the trial but for the hospital that shared our data in the first place?

A recently announced partnership between drug companies and 13 New York state hospitals to mine patient data for clinical trials brings such questions into sharp focus, raising troubling ethical and privacy concerns, according to several consumer and privacy advocates. As Businessweek reports, this project is just one of many new initiatives being created “as medical providers, software vendors, and health data businesses seek ways to profit from the flood of clinical data now being gathered electronically.”

This particular partnership, dubbed PACeR, spearheaded by such pharm giants as Pfizer, Merck, Roche and Johnson & Johnson, would be brokered by Quintiles, a CRO that does clinical trials, and it would work like this:

The participating hospitals would provide patient data scrubbed of key identifiers (like names, addresses, social security numbers etc.) to Quintiles, and drug companies could then mine that data for potential clinical trial candidates for a huge fee (between $50,000 and $250,000 per query), a hefty portion of which would accrue back to the hospitals. Quintiles would then let the hospitals know which patients the companies would like to recruit for trials, and the hospitals would ask the doctors of those patients to see if their patients were interested in participating in the clinical trial. According to Businessweek, only the hospitals would have access to the patients’ specific identification and patients would have the final say over whether they wanted to be recruited for the study.

All well and good? Not really, privacy and consumer advocates say. First of all, there is the issue of the transparency. Most patients have no idea that their medical data is being shared with commercial entities interested in doing research. Nor do they know that the hospitals involved in this partnership stand to benefit handsomely from sharing that data.

“In order for privacy to work, you’ve got to have complete transparency,” says Lillie Coney, associate director of the Electronic Privacy Information Center, a nonpartisan research center in Washington, D.C. “You have to tell patients why you’re collecting their information and what you are going to do with it.” Just getting patients to sign a vague privacy statement when they enter the hospital doesn’t cut it, says Coney, especially when the hospital stands to benefit financially from sharing your data.

“These patients are being contacted by hospitals or doctors who have a [financial] incentive here,” Coney says. “How free is the doctor going to be to say they don’t want to do this? After all, they have to practice at the hospital.”

Not only does this kind of arrangement put pressure on doctors to sign up patients for clinical trials; it also puts pressure on the patients themselves, who may not want to antagonize their physicians by saying no.

This kind of ethical dilemma, of course, predates the existence of electronic medical records. Some ethicists believe that doctors should never be paid or pressured to recruit patients for research because that blurs their roles as caregivers and puts the doctors in a position of doing something that may not be in the best interests of their patients. (For example, patients being recruited for these trials may be taking drugs that the researchers know nothing about, leading to potentially troublesome drug interactions). And PACeR raises the ante on such troubling conflicts because it introduces big profit incentives for hospitals as well as doctors.

There is another big problem with the project, and it lies in the nature of the all-seeing Web. The founders of PACeR make a big deal about how the data will be scrubbed of identifiers in compliance with HIPAA, so the drug companies won’t know who the individual patients are. However, new technologies make it very easy for computers to link the available patient data with other public information that’s out there on the Web, allowing companies to identify individual patients.

“I think that’s a valid concern given today’s technology,” says Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group. “According to HIPAA, there are 20 identifiers that have to be removed before the data is shared for research purposes, such as name, address, social security numbers, date of admission, etc. But with today’s technology, that may not be enough. Maybe nothing is truly private no matter how stripped it is.”

In sum, both Carome and Coney agree, the hospitals participating in this ambitious project should think long and hard about whether they really want to be involved in this kind of endeavor, which could jeopardize their core mission: confidential patient care.

 

 

 

Posted in biotech industry, clinical trials, conflicts of interest, patient care, pharmaceutical industry, Uncategorized, university industry collaboration | Tagged , , , , , , , | 1 Comment

Allegations of fraud and extensive ghostwriting form core of upcoming Texas case against Johnson & Johnson

Posted on November 2, 2011 by

On November 28, the Texas Attorney General is expected to begin a landmark trial against Johnson & Johnson on charges that the pharmaceutical giant “subverted scientific integrity” by paying off academic psychiatrists and state officials to boost the use of its atypical antipsychotic Risperdal among children and adults in that state. The case against J&J, for misleading doctors and consumers about the safety and effectiveness of its atypical antipsychotic Risperdal, has been reported before — by 1boringoldman, pharmalot and several Texas newspapers.

But a comprehensive report by an expert for the plaintiffs — Dr. David Rothman, a professor of social medicine and history at Columbia University — recently came to my attention, and what amazed me about Rothman’s findings, beyond the malfeasance of academic psychiatrists who sold their scientific integrity for thousands of dollars in speaking fees — was the sheer scope of the ghost-writing campaign that J&J (via its subsidiary, Janssen) embarked on to peddle Risperdal to doctors and patients throughout the country. Rothman cites 12 cases in which Janssen hired ghostwriting contractors to draft positive articles about Risperdal and then found academics willing to put their names on the articles, which were then published in supposedly respected medical journals, like the New England Journal of Medicine and the British Journal of Psychiatry.

Rothman reports that in most of these journal articles, which included clinical trials, there was no acknowledgment of the work of the ghostwriter (Excerpta Medica, a medical communications company). Nor were there any disclosures by the authors that they had financial conflicts (in other words, were receiving thousands of dollars in speaking or consulting fees from J&J). In one 2005 study published in the British Journal of Psychiatry that found Risperdal more effective than placebo in the treatment of acute mania, the role of the academic authors was so minimal that Excerpta Medica (whose role was not acknowledged) billed J&J $5,100 for composing a reply to a letter to the editor about the study.

In the 2002 NEJM study Rothman cites, the lead author was not even a member of the clinical research team that did the study but was recruited well after the manuscript had been drafted and revised by the ghostwriter and J&J employees. (The lead author, Dr. John Csernansky, was, however, a long-time member of J&J’s speakers bureau). The published article was used to market Risperdal with doctors as being more effective than other anti-psychotics over the long term.

In yet another egregious example of ghostwriting outlined by Rothman, Excepta Medica drafted a study purportedly showing that Risperdal was the established treatment in children and adolescents with severe behavioral disorders and then went looking for some key opinion leaders (KOLs) to attach their names to the article. They finally found Dr. Peter Jensen, a pediatric psychiatrist (who was paid more than $80,000 by J&J in consulting and speaking fees between 2002 and 2004) to attach his name to the study, which was published in The European Journal of Child and Adolescent Psychiatry in 2007, again with no acknowledgement of the ghostwriter’s role. Rothman cites example after example of overlap between the ghostwriter’s draft and the published piece and concludes that “the authors improperly put their name on it and failed to credit EM’s work.”

In yet another case, Rothman cites evidence that J&J made the authors of one study water down language about cardiovascular side effects from Risperdal. He also notes that the company decided not to publish a study showing an increased incidence of prolactin-induced side effects among patients on the drug. From what I understand, the plaintiffs in the upcoming trial in Texas plan to introduce evidence that J&J knew that Risperdal induced the development of breast tissue and milk production in some male patients taking the drug, but hid such negative side effects from doctors and patients for years.

Rothman’s report on J&J is painfully reminscent of what companies like GlaxoSmithKline, Eli Lilly, Pfizer and Forest Labs did to make their antidepressants blockbuster drugs (which I wrote about in Side Effects). I suspect Rothman’s detailed findings are part of what led a South Carolina Judge earlier this summer to call J&J’s actions in deceiving the public about Risperdal “detestable” in his $327 million ruling against the company — see Pharmalot.

Even so, Rothman’s 86-page report makes for disturbing reading. It is an indictment not only of J&J but of academic psychiatry and all the doctors and patient advocacy groups who were all too willing to sell their soul for money.

 

 

 

 

Posted in antipsychotic drugs, conflicts of interest, drug marketing, ghostwriting, patient care, pharmaceutical industry, scientific misconduct, Uncategorized | Tagged , , , , | 6 Comments

Drug and medical device industry launches push to weaken FDA oversight

Posted on October 28, 2011 by

With the Obama administration hobbled by a Republican-led Congress, the pharmaceutical and medical device industry seems to have launched a concerted push to roll back regulatory initiatives designed to protect consumers from unproven or unsafe drugs and medical devices. I’ve already written about the industry pressure that led to weakened NIH rules governing conflicts of interest here, but now deputies for the industry have trained their sights on regulatory actions taken by the Food and Drug Administration (FDA).

Here are two case examples. First: the effort by venture capitalists and their Congressional lackeys to further weaken the FDA’s already feeble approval process for new medical devices. As the New York Times reported this week, venture capitalists have intensified their lobbying in Congress in an effort to speed up the approval of new medical devices. This push, with millions of dollars going into the campaign coffers of friendly Congressmen and political action committees aimed at easing regulatory oversight, comes at the very time when press reports have shown that the FDA failed to adequately monitor medical devices that turned out to be harmful to patients, such as metal to metal hip replacements, spinal fusion products and some heart stents. As I’ve blogged about before, the FDA needs to beef up its oversight of new medical devices, not weaken it further.

The second case example involves a “working paper” that has been circulating about the impact of the FDA’s black box warnings that call attention to the increased rate of suicidal thoughts and behaviors among young patients taking antidepressants. The FDA imposed those black box warnings in late 2004 after discovering data in clinical trials done by the antidepressant makers themselves, which showed an increased risk of suicidality. (As I revealed in Side Effects, the drug makers hid this dangerous side effect from doctors and consumers for years, causing untold harm to thousands of children and young people).

The drug industry and its handmaidens in the psychiatry profession have tried for years to argue that the black box warnings led to an uptick in suicide rates among adolescents, a claim that has been thorough debunked by me and many others — see here, here and here. Yet this week, Pharmalot wrote about a working paper from an institution called the National Bureau on Economic Research that not only perpetuated this falsehood but also tried to link the black box warnings to poorer academic performance in depressed teenage girls who weren’t taking antidepressants.

But just what is the National Bureau on Economic Research and who funds it? As psychiatrist-blogger Mickey Nardo (1boringold man) noted this week, the head of the National Bureau on Economic Research until recently was none other than Martin Feldstein, a Harvard professor who has been on the board of Eli Lilly (the maker of several antidepressants) for years. In 2010 alone, Feldstein, who stepped down as head of NBER in 2008 and is still a research associate there, earned $301,000 from sitting on Eli Lilly’s board, according to this Forbes article.

According to Nardo’s research, the Bureau has received generous funding from Eli Lilly and other drug makers. Most recently, Karen Horn, another Eli Lilly board member and chair of its compensation committee, joined the board of NBER, as this article shows.

In addition, two of the authors of the NBER working paper – Susan Busch and Ellen Meara — have received grant funding from Eli Lilly for their research.

I guess we can’t fault the drug industry for trying to spin coverage and sell products. My question is: why do media outlets, like Reason magazine, which was the first to report on the results of this un-peer-reviewed and obviously biased working paper, keep falling prey to industry propaganda?

 

Posted in antidepressants, conflicts of interest, FDA, medical devices, suicide rates | Tagged , , , , , | 2 Comments

Sex offender laws are creating public health problems, not solving them, research shows

Posted on October 13, 2011 by

Reading Russell Banks’ fascinating new novel, The Lost Memory of Skin, has inspired me to blog about a public health problem that strays from my usual mandate. Banks’ book is about a 21-year-old man who was convicted of having sex with a 14-year-old girl (statutory rape), and he now finds himself homeless and living under a causeway in a southern Florida city that is a dead ringer for Miami. The sex offender, a naive and lonely young man who was raised by a neglectful single mother, is befriended by a university professor who is doing research on sex offenders and has some dark secrets of his own.

Banks, an award-winning novelist who has written 17 books, obviously did his homework for this book because his observations about the misguided ways we treat sex offenders are right on target, according to recent studies and experts who treat sex offenders.

Banks makes the persuasive case, for example, that the Megan laws that have sprung up in every city, town and state in the country and prohibit sex offenders from living with miles of any school or public place that attracts children are actually making things worse, not better. And he’s right, says Tim App, who runs a national sex offender management program.

The residency and electronic monitoring requirements instituted by the Megan laws are doing nothing to reduce sex offenses, App says. Instead, they’ve spawned a surge of homelessness among convicted sex offenders and made it more difficult for many of them to get treatment and live without offending.

“The residency requirements are driving them underground so they become detached from what keeps them stable,” says App, who is CEO of the Counseling and Psychotherapy Center and a former prison superintendent and law enforcement officer. “When you isolate sex offenders, they become lonely and stressed and are more likely to re-offend.”

App says many in law enforcement now recognize that the residency laws are counterproductive, as is much of the focus on electronic monitoring — making sex offenders wear electronic ankles (as the youthful offender in Banks’ novel does).

“The ankle is not going to prevent sexual assaults,” he says. “I would put all that money into mandatory treatment and supervision.”

The right kind of treatment, App and others say, can be very effective in keeping sex offenders from re-offending. Even though sex offenders typically have high rates of recidivism, he notes that the recidivism rate among convicted offenders in his program is only two percent.

” Sex offending behavior is much like alcoholism,” he notes. “You can treat it and reach recovery and as long as you keep the support system intact, you can prevent a relapse.”

App cites a highly successful Maine program that his group runs, where convicted offenders are in a four-year program with the first two years in a 24/7 therapeutic environment. They are then transitioned into the community, where they are supervised by a “containment team” of four professionals, a sex offender specific probation officer, a sex offender clinician, a victim advocate and a polygraph officer who does periodic polygraph tests to ensure offenders aren’t lying about their behavior.

So far “we’ve had 50 offenders transition to the street and we’ve not had any new assaults,” he says. Like Banks, App believes that sex offenders need to be identified and treated like average citizens who have gone astray, not “cast out like pariahs.”

You might want to read Banks’ gripping book and see if you agree. Even if you don’t, I think you’ll find it’s a great read.

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Taxpayers lose out in Supreme Court ruling on who owns federally funded research

Posted on September 30, 2011 by

The current issue of the New England Journal of Medicine contains a thoughtful essay about who owns federally funded research: the universities who receive the funding or the private companies who contract with academic researchers to develop a specific innovation for commercial use. The two authors, who are affiliated with Harvard Medical School and the consulting firm McKinsey, discuss a recent Supreme Court ruling that decided that a private company (Roche Molecular) had superior rights to a commonly used diagnostic test for HIV over a university (Stanford), even though the test was developed at Stanford by a scientist using federal research funds.

As the authors of the NEJM piece note, the Supreme Court ruling essentially contravened a common interpretation of the seminal 1980 Bayh-Dole Act, which opened the door for nonprofit universities and medical schools to patent the results of publicly funded research and license them to the highest bidder. In June, the authors say, the current Supreme Court decided that Bayh-Dole:

“does not give universities primary claim to federally funded inventions patented by members of their faculties. Rather, writing for a seven-to-two majority, Chief Justice John Roberts noted that since the original Patent Act of 1790, the inventor has always held the primary position.”

Why is this so disturbing? Because it will only exacerbate a problematic trend. Even though the Bayh-Dole Act stipulated that products developed from the partnership between academia and industry must be made available to the public “under reasonable terms,” this provision is almost universally ignored today, in large part because universities that license their research to industry have no control over the prices companies set.

As Dr. Marcia Angell, former editor of the New England Journal of Medicine and author of The Truth about Drug Companies, noted in a recent interview, taxpayers end up paying twice as a result. “They pay for the research and then they pay for drugs that cost an exorbitant amount,” she says.

And indeed, the authors of the NEJM essay acknowledge this problem. They suggest two remedies: one, that a legislative amendment to Bayh-Dole be enacted to make clear that the fruits of federally funded research belong to universities that receive the funds, not to the companies who contract with individual academic researchers. And two, that “universities should reexamine and perhaps revamp their licensing practices to ensure that they are indeed acting as stewards of the public good, rather than simply seeking to maximize their own licensing revenues.”

In other words, universities — being the primary beneficiaries of federal research funds — should start looking out for the taxpaying Americans who provide all that largesse.

Posted in health care costs, university industry collaboration | Tagged , , , , , | 1 Comment

New heart medication study was too flawed for publication, former journal editor says

Posted on September 23, 2011 by

At a Harvard event last night honoring the former Grassley investigator Paul Thacker, someone in the audience wanted to know how the topic of Thacker’s talk — Dollars for Doctors: Who owns your physician? — was related to the soaring cost of medical care in this country.

As Thacker noted at the outset of his talk, Medicare and Medicaid are now a larger portion of the federal budget than the Pentagon and health care now equal 23 percent of all federal expenditures. Part of the problem, he noted, is the fact that our medical system is stacked towards the widespread adoption of expensive new drugs over older generics even when the new agents are not necessarily safer or more effective than cheaper drugs.

It was left to Dr. Arnold Relman, professor emeritus at Harvard Medical School, to showcase a fresh-off-the-page example of how studies that are funded by drug makers and conducted by researchers who have financial ties to the industry present skewed research results that favor expensive new drugs over generics.

His case in point: The New England Journal of Medicine published a study last week concluding that a new anticoagulant known as apixiban (brand name: Eliquis) was superior to the generic drug warfarin in preventing stroke and deaths in patients with atrial fibrillation (abnormal heart rhythm). The study was funded by Bristol Myers Squibb and Pfizer, which jointly manufacture Eliquis, and featured a lengthy roster of authors, many of whom have extensive financial ties to the drug industry (in the form of speaking and consulting fees). At least three of the authors were Bristol Myers Squibb employees, as the fine print at the end of the study disclosed.

The issue Relman, a former editor of the New England Journal, raised was how these financial conflicts may have influenced the way the paper itself was skewed in favor of the new drug. He noted two major omissions in the discussion section of the study. One was the fact that the anticoagulant showed no efficacy over the much cheaper warfarin generic in the 7,000 patients recruited in Europe (this was a multi-center trial involving 18,000 patients from the U.S., Latin America, Asia and Europe). Two, 35 percent of the patients on warfarin were not taking a therapeutic dose of the drug, which, he said, could explain why they had a higher rate of blood clotting and stroke than patients taking the new anticoagulant.

Yet neither of these key limitations were mentioned in the study’s discussion, a glaring omission, according to Relman. He said that the journal itself was remiss in publishing the study without mentioning these limitations.

“This study was not well peer reviewed,” Relman said. “Neither [Dr. Marcia Angell, also a former editor of NEJM] nor I would have accepted this paper for publication.”

Yet as a result of its publication, many heart doctors will now be steered toward prescribing a much more expensive drug when the cheaper generic would do just as well in many cases.

The study, Relman said, is a prime example of why the disclosure of conflicts of interest (which most leading journals now require) is not enough to curb bad or biased science. He suggested that medical institutions simply prohibit their faculty from doing research on drugs when they are receiving lucrative speaking and consulting payments from industry. (Research shows a clear link between a company funding a trial and favorable results for that company’s drug — see here and here.)

“The real solution is for medical institutions to get rid of these unethical practices,” Relman said. “Disclosure is not a solution.”

Thacker, who is now an investigator for the Project on Government Oversight (POGO), agreed. The Physician Payment Sunshine Act, which he helped shepherd into law and requires drug companies to disclose all payments to doctors, should be considered a first step, he said.

“It’s a way to get a handle on just how widespread the problem of financial conflicts of interest are, so we can start to make real changes,” he said.

If the documented harm to patients from such conflicts of interest is not enough of a reason, perhaps the unsustainable costs to our overburdened health care system will eventually tip the balance toward change.

 

 

 

Posted in conflicts of interest, health care costs | Tagged , , , , , , , , | 9 Comments

Coverage of Rick Perry’s vaccine misadventure misses the point

Posted on September 14, 2011 by

Recent media coverage of the heated debate over Texas Governor Rick Perry’s endorsement of mandatory HPV vaccinations for school-age girls in his state seems to be missing a few crucial points. First, many of the medical groups who strongly endorsed the vaccine to prevent cervical cancer received funding from Merck, the maker of the vaccine in question, Gardasil. And two, Merck’s aggressive marketing campaign to sell the vaccine as a preventative measure against a relatively rare type of cancer (cervical cancer) in middle-class teenage girls completely ignored poorer populations that are at much higher risk of developing this cancer.

Such concerns were amplified in a thoughtful 2009 paper in JAMA, and reported by Gary Schwitzer’s healthnewsreview blog and Gooznews.

As the JAMA researchers noted:

As marketing of this HPV (short for human papilloma virus) vaccine demonstrates, pharmaceutical company campaigns can undercut the most cost-effective and appropriate use of new agents to the detriment of adolescent health. By making this vaccine’s target disease cervical cancer, the sexual transmission of HPV was minimized, the threat of cervical cancer to all adolescents maximized, and the subpopulations most at risk practically ignored.

Recent news reports do mention that Perry himself had substantial conflicts of interest when he signed an executive order mandating HPV vaccines for school-age girls, making him the only governor in the union to do so. As the San Francisco Chronicle notes, Perry has received at least $23,500 in campaign contributions from Merck, including $5,000 in 2006, the year before he ordered girls throughout the state to take the HPV vaccine. Merck also has donated about $500,000 to the Republican Governors Association, a group which Perry headed twice and has been among his most generous campaign donors. As the Chronicle and the New York Times also point out, Perry issued the executive order at a time when his former chief of staff was a lobbyist for Merck.

But the Times article fails to note the egregious conflicts of interest among key physician groups that strongly endorsed the vaccine for school-age girls. As the 2009 JAMA article pointed out, Merck provided educational grants to groups like the American College of Obstetricians and Gynecologists, the American Society for Colposcopy and Cervical Pathology (ASCCP), the Society of Gynecologic Oncologists (SGO), and the American College Health Association (ACHA), all of whom strongly recommended the vaccine in school-age girls.

The recent coverage also doesn’t explore the public health costs and benefits of mandating vaccines for affluent school-age girls, which, as Gooznews notes, doesn’t make  a lot of financial sense. About 3,600 women die from cervical cancer every year — compared to approximately 40,000 who die from breast cancer annually. Yet Merck itself estimated it would cost $1.4 to $1.6 billion to immunize young girls from the disease, which can be picked up fairly easily (and much more cheaply) with regular pap smears.

As the JAMA researchers were the first to note, it would make far more sense to spend the money paying for pap smears for poorer women who have multiple partners but no health insurance.

I have to say I find it ironic that Perry is being lambasted by his Republican rivals for mandating something they say should have been left up to families to decide, which is the primary focus of today’s piece. But I wish the media would use this opportunity to explore the public health ramifications of allowing a drug manufacturer to aggressively target the wrong population for an expensive and possibly unnecessary vaccine.

Posted in health care costs, media coverage, pharmaceutical industry | Tagged , , , , | Leave a comment