Monday, December 28, 2009

America's dangerous addiction to prescription drugs

As we start the countdown to a new decade, I have a question for you: why doesn't the US media run comprehensive stories like this piece in The Guardian about our youth's dangerous dependence on prescription drugs? Sure, there were a few short news stories noting that a plethora of legal drugs had been found in the bedroom of Brittany Murphy, the 32-year-old actress found dead in her home last week. But the mainstream media here seems averse to putting the pieces together, as The Guardian did, not only by pointing out that "prescription drugs are becoming America's new addiction," but examining why that is so.

Sure, a few bloggers (myself included) have tackled the subject. But as one of only two nations in the developed world that allow the pharmaceutical industry to advertise directly to consumers, perhaps it's time to more widely re-examine our cavalier approach to popping pills. Brittany Murphy's untimely death is one more poignant example of the truism: just because a doctor prescribes something does not mean it is safe, particularly when taken in combination with other powerful drugs. As one professor of clinical pharmacology noted in The Guardian piece: "Many of these people simply do not realize that all drugs – no matter how beneficial – are poisonous at some level."

On another note, I'm taking a short break from blogging. Will be back Jan. 11.

Monday, December 21, 2009

Christmas comes early for 3,700 US doctors on GlaxoSmithKline's payroll

GlaxoSmithKline became the third pharmaceutical giant to start disclosing all the speaking and consulting payments it makes to US doctors, and its list is an eye-popping illustration of the rampant corruption that runs through our current system of medical research. While the majority of the doctors on Glaxo's payroll, which covers a mere three months in the second quarter of 2009, received between $1,000 and $6,000 for speaking gigs, 134 doctors netted payments of $15,000 or more, and a goodly number received very handsome payouts indeed. (In all, GSK paid out a princely sum of $14.6 million to 3,700 doctors in just three months; one can only wonder how much they dispensed for the entire year).

The highest-paid doctor on this list is Dr. Lawrence DuBuske, a clinical instructor in medicine at Harvard Medical School and director of the Immunology Research Institute of New England. DuBuske specializes in allergies and works with medical researchers throughout Eastern Europe on clinical studies of new allergy drugs. He received a whopping $99,375 from GSK in the second quarter of 2009.

For what, you might ask? That's a question better put to DuBuske, but I can tell you that a quick scrutiny of journal articles published this past year reveals that he was the lead author of a review article published in March 2009 in a respected medical journal (Current Allergy and Asthma Reports), which extolled the effectiveness of several drugs for the treatment of allergic rhinitis (the running nose and other bothersome symptoms that occur when you breathe in something you're allergic to).

Surprise, surprise, one of the drugs given an enthusiastic thumb's up in this review is Xyzal, an antihistamine made by GlaxoSmithKline. The other two are drugs made by Schering-Plough (now owned by Merck) and Sanofi-Aventis. And sure enough, DuBuske is not only on Glaxo's speaker bureau; he is also getting speaking bucks from Schering-Plough, Merck and Sanofi-Aventis. Indeed, as the disclosures in his March review indicate, DuBuske is basically on the speaking payroll of every pharmaceutical company that makes or markets allergy drugs in this country.

Gee, I wonder what Harvard Medical School or Brigham & Women's Hospital, where DuBuske is coordinator of the allergy fellowship program and a consultant, have to say about the good doctor's conflicts of interest.

Here's another example of the way Big Pharma has corrupted the way doctors get their information about new drugs: Another well-paid physician on GSK's stocking list this year was Dr. Timothy Beard, a general surgeon and director of research for Bend Memorial Clinic in Bend, Oregon. Beard received $61,380 from GSK in the second quarter of 2009 (and he's not even one of the five highest paid). As a quick Google search reveals, Dr. Beard has done clinical research on a drug called ENTEREG, made by GlaxoSmithKline, and in August 2009, he gave a presentation to the annual meeting of the Northwest Society of Colon and Rectal surgeons about how well ENTEREG works in aiding the recovery of patients who have had bowel resection surgery. Not a bad day's work for $61,380.

Now, as an unpaid blogger, I only had time to connect a few dots, but I have a feeling there is much more to be gleaned from the treasure trove of doctor payments that Glaxo and other drug companies are now disclosing (in anticipation that Congress, as part of health reform, will pass the Physician Payment Sunshine Act and require such disclosures in the future). So I hope that some of the journalists who get paid to do this will take a closer look at more of the happy beneficiaries of the pharmaceutical industry's largesse.

In the meantime, take a minute and check to see if your doctor is on Glaxo's Christmas list. Ho ho ho.

Hat tip to Pharmalot for alerting me to the GSK list.

Monday, December 14, 2009

Too many overdrugged kids, or the story of a dead-eyed little boy in Chelsea

In Chelsea (a stone's throw from Boston Harbor), there lives a nine-year-old boy with curly black hair whose eyes are dead because he is on drugs, the legal kind. His single mother, who is on welfare and long-term disability (she has serious health problems) can't control her son, so she feeds him a cocktail of powerful psychoactive drugs that include an anti-psychotic (Seroquel), a stimulant for attention deficit disorder (Vyvanse), and a mood stabilizer (Depakote), along with two other drugs. His mouth is purple-black from all the drugs he has to take every day.

I was reminded of this little boy when I read The New York Times article about a new finding that children covered by Medicaid are given anti-psychotics four times as often as children whose parents have private insurance. The study, by researchers at Columbia and Rutgers universities, also found that children on Medicaid are more likely to receive these drugs for less severe conditions than children whose parents are privately insured.

As the NYT reporter noted, these findings, published online in Health Affairs, "are almost certain to add fuel to a long-running debate: Do too many children from poor families receive powerful psychiatric drugs not because they actually need them — but because it is deemed the most efficient and cost-effective way to control problems that may be handled much differently for middle-class children?"

The answer is an unequivocal yes. Children from poor families, whether they live in Chelsea, New York City or rural Appalachia, are much less likely to get the kind of care and attention they need to forestall problems at home and in school. Many of them live in chaotic households headed by single mothers who are overwhelmed and sometimes on drugs (legal and illicit) themselves. The fathers, for the most part, are out of the picture, and even if the mother (as was the case in Chelsea) tries to get her child intensive therapy, Medicaid won't pay for it. So the only other solution is to give such unruly children powerful psychoactive drugs that often have dangerous long-term side effects, such as weight gain and diabetes (in the case of anti-psychotics) and permanent stunted growth (in the case of Ritalin and other stimulants).

Now let me make this crystal-clear: I am not blaming the Chelsea mom for this state of affairs or any single mother who is trying to hold her family together against all odds. I am blaming the system, a system that turns a blind eye to the problems of children in the poorest nooks and crannies of our country, a system that allows pharmaceutical giants to market and sell dangerous drugs as the answer for broken families and inadequate services, a system that favors drug cocktails over the kind of intensive therapy and attention that could really make a difference in some children's lives.

With all this over-prescribing going on, is it any wonder so many American teenagers are lost every day to illegal drugs such as heroin, crack or meth? Big Pharma, after all, got them hooked early on, and how are they to tell the difference between a legal or illegal substance? Indeed, as any forensic expert will tell you, the abuse of legal drugs like Ritalin and Oxycontin are a fast- growing corner of the street market. (According to a fascinating analysis by British researchers, reported in The Boston Globe yesterday, there is evidence that some legal drugs are far more dangerous than some illicit drugs -- like pot -- for the consuming public. It seems our public policy with regard to drug enforcement is also seriously skewed).

But getting back to the little boy in Chelsea, what can we do? These are complex problems and they won't be solved overnight. But we as taxpayers can start demanding our government provide more of the right kind of resources to help poor families and troubled children. And we can push back against a pharmaceutical industry that profits from dead-eyed little boys. In the meantime, if you know of an overstressed family or child in need, refer them to the Children's Emotional Health Link, where the first order of business won't be a hastily written prescription for Depakote.

Wednesday, December 9, 2009

Medical groups' conflicts of interest under Congressional spotlight

Mere days after several bloggers (including myself) spotlighted the conflicts of interest among medical societies criticizing the new mammography guidelines, Senator Charles Grassley (R-Iowa) has asked these groups (and quite a few others) for information about the financial backing they get from the pharmaceutical, medical device and insurance industries.

As my blog noted, the most vociferous critics of the new breast screening guidelines included top officers at organizations like the American College of Radiology and the American Cancer Society, which receive substantial funding from the makers of mammography machines, including Johnson & Johnson, Siemens and Hologic. Grassley's inquiry includes these two prominent medical societies along with 31 others, according to the The New York Times.

Grassley's latest inquiry comes amidst the growing realization that many medical associations receive substantial funding from industry and that this often undisclosed largesse sways such groups to lobby on industry's behalf. Consider, as another example, the influence that the pharmaceutical industry has long held over the nation's largest advocacy group for people with mental illness, NAMI. As I was the first to report in Side Effects, drug industry donations to NAMI accounted for at least half of this group's annual revenues, a fact that NAMI never bothered to share with its constituents. A few months after my book was released, Grassley's team asked NAMI for a detailed accounting of its corporate funding, and NAMI publicly acknowledged that more than two-thirds of its donations do indeed come from the pharmaceutical industry.

I look forward to similar eye-opening disclosures now that Grassley, the ranking Republican on the Senate Finance Committee has turned his spotlight onto other groups like the American Medical Society, the American Cancer Society, the American Academy of Orthopedic Surgeons and the American Academy of Family Physicians (which was in the headlines recently because of all the money it's getting from Coca Cola); you can find the full list of groups Grassley is gunning for here.

This is scary stuff. We rely on these physician groups for unbiased and informed medical judgments about all aspects of our health care. After all, if you can't trust the American Cancer Society and the American College of Radiology when it comes to the truth about the benefits and risks of mammography screening, who can you trust? Certainly not your doctors, who get most of their information from the medical societies they belong to. This is a scary state of affairs indeed.

Monday, November 30, 2009

Conflicts galore among critics of new mammography guidelines

This Wednesday, the House Committee on Energy and Commerce will hold a hearing on the new breast cancer screening recommendations, in response no doubt to the storm of criticism that greeted the recent guidelines issued by the US Preventative Services Task Force. I just hope the committee (or rather its subcommittee on health) takes a close look not just at the task force, an independent panel appointed by the federal Agency for Healthcare Research and Quality, but at the myriad conflicts of interest among the loudest critics of its new recommendations.

As you'll recall, the Task Force concluded that routine screening mammograms for women 40-to-49 years old was not necessary, and called for screening every two years for women 50 to 74. So it comes as no surprise to learn that while Task Force members are specifically prohibited from having “substantial conflicts of interest," their critics are not similarly constrained. Many of the most vociferous critics of the new screening guidelines either stand to benefit directly from rolling back the new guidelines or belong to organizations with financial ties to companies that do, according to an article published in Bioethics Forum. As Adrianne Fugh-Berman and Alicia Bell point out in this article, key critics quoted in the press in recent weeks are either professors with patents to breast imaging devices or stock in companies that make them (academics like Daniel Kopans and Robert Schmidt), or they are top officers at organizations like the American College of Radiology and the American Cancer Society, which receive substantial funding from the makers of mammography machines, including Johnson & Johnson, Siemens and Hologic.

The press, by and large, has done a lousy job of highlighting these conflicts of interest and the greed-ridden agendas behind much of the criticism. And as Gary Schwitzer notes, media coverage of the new guidelines has also been less than objective and fully informed; to my mind, Fugh-Berman and Bell do a much better job of capsuling the reasoning behind the Task Force's long-considered recommendations.

So I can only hope at its hearing on Wednesday, the House Committee on Energy and Commerce fully explores the issue of just whose ox is being gored by the new screening recommendations. I also hope the reporters covering the hearing do their homework and check not only the financial ties of the speakers but of the Congressional committee members themselves. This wouldn't be the first time that grandstanding legislators turn out to be the recipients of largesse from the very industries they wax so eloquently in defense of.

Hat tip to gooznews for alerting me to Wednesday's hearing.

Monday, November 23, 2009

New study finds link between TV ads and higher drug prices

We've got family coming in for Thanksgiving and I have much to do. So this week, I'd just like to point my faithful readers to three items of interest:

1. Gary Schwitzer's great blog, which goes a long way to explaining why there was such an unholy ruckus about the new mammography guidelines issued last week despite the fact that the US Preventative Task Force's recommendations were based on the clear weight of scientific evidence.

2. The HHS Inspector General's finding that very few universities report the financial conflicts of their researchers, as required, to the government. Even when such conflicts are reported, university administrators rarely require researchers to eliminate or reduce such conflicts, according to the audit as reported in The New York Times and The Chronicle of Higher Education. The Inspector General's audit is the latest in a series that have criticized both universities and the National Institutes of Health (which distributes $24 billion a year in research money) for not being more serious about curbing blatant conflicts of interest. Yet, as the audit concludes, "It is vital to public health and safety that this research not be biased by researchers' conflicts."

3. An interesting new finding in the Archives of Internal Medicine today that direct to consumer advertising may be associated with increased drug prices. Researchers studied consumer advertising for Plavix, a heavily marketed anti-platelet agent that is widely prescribed to treat heart ailments. They found that while television advertising aimed at consumers did not actually increase the use of the drug, it may have been responsible for an increase in the reimbursement cost of Plavix for Medicaid patients, which of course is paid for by taxpayers. So not only does such advertising mislead consumers about the benefits and risks of many new drugs, as I've blogged about here, but it may waste precious taxpayer dollars.

Hmmm. Perhaps it's time for Congress to start thinking seriously about a ban on such counterproductive drug marketing tactics.

Monday, November 16, 2009

A solution to the problem of scientific misconduct?

Talk about synergy. Just a few days ago, my health and science journalism class at Brandeis was discussing ethics in science, using as a template an old case example involving scientific fraud in the University of Michigan laboratory then headed by Dr. Francis Collins. Back in 1996, Collins, who is now director of the National Institute of Health (NIH), investigated the allegations as soon as he was alerted to a tampered image in a paper he had submitted to the cancer journal Oncogene. After discovering that one of his graduate students was guilty of systematic fraud in five papers that he and Collins had co-authored, Collins alerted university and NIH authorities and fired the culpable student.

I've blogged before about this 1996 case here, and I teach this case not to cast aspersions on Collins, but to examine important questions about how well our current system of scientific publication (in which ambitious and overextended senior researchers routinely slap their names on scientific data they are not intimately familiar with) works in rooting out errors and outright fraud. I have also blogged about the issue here and here because now that Collins is director of NIH, he has the power to really make a difference. And yet I haven't heard peep from him about the pervasive problems in the research system, ranging from financial conflicts of interest among medical researchers to the widespread practice of ghostwriting, all of which are impairing public confidence in the scientific process.

Which is why I was gratified to see that a group of 96 ethicists, researchers and clinicians have signed and sent a letter to Collins asking him to fund more studies on these ethical conundrums. As the letter from Pharmed Out notes:

NIH funds a substantial portion of the generation and dissemination of evidence, but the uptake of that evidence and its translation into clinical practice is strongly affected by the complex web of relationships that exists among industry, academicians, medical educators and clinicians. There is growing evidence that each strand of this web is compromised by ethical lapses and financial conflicts of interest. The recent disclosure of ghostwritten articles, physician payoffs, and the use of academic opinion leaders to increase markets for FDA-regulated products indicate that ethical lapses may permeate biomedical research.

I am eager to hear Collins' response to this appeal, spearheaded by Dr. Adriane Fugh-Berman, an associate professor at Georgetown University Medical Center. In the meantime, I would like to tender an idea proffered by one of my students during class (we were discussing whether there is a need for a standard system of quality control for scientific research independent of the peer review process). My student, who by the way is pre-med, suggested that perhaps an auditing system should be put in place by the NIH or the FDA to randomly examine data in scientific labs around the country, much like the IRS randomly audits tax returns. These audits would be of the actual raw data that have led to published research in key medical and scientific journals and the very nature of their randomness might just propell scientists to clean up their act.

I think this is a brilliant suggestion but of course I think all my students are brilliant. What do you think, Dr. Collins?

Monday, November 9, 2009

Was the Fort Hood shooter taking antidepressants?

In the days since the Fort Hood shooting, I have wondered whether the gunman, Major Nidal Malik Hasan, was taking antidepressants in the weeks or months before he sprayed a medical clinic with bullets, killing 13 people. I hesitated to raise that question since there is at present no evidence Hasan was on SSRI antidepressants, which have been linked to violent and suicidal actions, as I've blogged about here. (Nor, in fact, is there much hard information of any kind about his motives, although a story in The Boston Globe today raises questions about his link to a radical iman.)

Now, however, Dr. Peter Breggin has raised the drug issue in a provocative column for The Huffington Post:

The odds are that Dr. Hasan was self-medicating with antidepressants and tranquilizers that were causing his increasing disinhibition, at least in his pronouncements, until his final Allahu Akbar before he began shooting. In my book Medication Madness , I describe dozens of cases that I have personally evaluated involving relatively normal individuals who committed murder, mayhem and suicide while taking psychiatric drugs, especially antidepressants and tranquilizers. One of these cases involves a psychiatrist who began by self-medicating himself, then came under another psychiatrist's care who continued to give him antidepressants, until he ended up in a manic state assaulting a helpless woman. Before being driven mad by antidepressants, he was a relatively stable and highly accomplished doctor with no special inclination toward violence. These psychiatric drugs will have an even greater triggering effect on someone like Hasan who was already ideologically and psychologically primed to explode in violence.

While Breggin's speculation about self-medication is intriguing and worth investgiating, I have to take issue with his screed against all psychiatrists. He writes:

Modern psychiatry is not about counseling and empowering people. It's about controlling and suppressing them, and that's a dismal affair for patients and doctors alike.

I happen to know psychiatrists who do an amazing job of counseling and empowering their patients. Yes, there are many doctors (not only psychiatrists) who rely too heavily on drugs with serious side effects to medicate people with only mild symptoms of depression or anxiety, without considering other alternatives first. But there are many others who listen carefully to their patients and work with them to live full lives with or without medication.

Obviously, Major Hasan was grappling with a number of powerful demons before he went on his tragic rampage. I just hope that Congressional investigators don't let the Army, for its own reasons, suppress factual information about Hasan's medication usage or any other details that might help explain his wholly despicable actions.

Hat tip to Furious Seasons for alerting me to Breggin's post.

Monday, November 2, 2009

Amgen and Aranesp: One more example of how drug companies make huge profits by misleading consumers

Just in case you didn't read the Saturday papers, let me call your attention to this article in The Boston Globe about the chickens coming home to roost for Amgen, the California biotech that makes Aranesp, an anti-anemia drug for people with cancer and kidney disease. The Globe's Elizabeth Cooney reports on a study published online in the New England Journal of Medicine finding that Aranesp not only does not reduce cancer deaths or cardiovascular problems in patients (which was the drug's claim to fame), but that people who took it were almost twice as likely to have strokes as patients given a placebo or dummy pill. The results were even worse for people with kidney disease who either had a previous history of cancer or were diagnosed with the disease during the trial; those taking Aranesp had a statistically significant increase in cancer mortality, according to gooznews.

These results, which came from the kind of randomized study considered the gold standard of research and which counter years of aggressive marketing by Amgen, were released hours after the attorneys general from Massachusetts and 14 other states sued Amgen in federal court alleging that the company offered kickbacks to doctors to boost sales of Aranesp. These lawsuits have been several years in the making -- indeed, in an op-ed piece I wrote for The Boston Globe in June 2008, I noted that both Amgen,the maker of Aranesp and another anti-anemia drug Epogen, and Johnson & Johnson, which makes Procrit, a similar drug, have given doctors millions of dollars in rebates over the years for prescribing their drugs. And then I asked: Is it any surprise that all three became blockbuster drugs, with combined sales of nearly $14 billion in 2006?

The Aranesp/Epogen/Procrit scam, which by the way probably caused heart attacks and deaths in many unwitting patients, is a perfect example of the longstanding tendency among medical researchers (who are paid by the drug companies) to ignore or suppress risk information when publishing the results of new drug trials in prominent medical journals. This pattern, which I wrote about in Side Effects, was the topic of a major new study published last week in the Archives of Internal Medicine. As Gooznews first reported, the study found that 47 percent of 133 trials reported in journals like the New England Journal of Medicine, the Journal of the American Medical Association, the British Medical Journal and Lancet omitted numbers of study withdrawals because of adverse effects, while 27 percent failed to describe the seriousness of the adverse effects that were observed.

In an editorial accompanying this finding, the physician researcher John Ioannidis explains why this may be happening: "Perhaps conflicts of interest and marketing rather than science have shaped even the often accepted standard that randomized trials study primarily effectiveness, whereas information on harms from medical interventions can wait for case reports and nonrandomized studies."

Obviously, the state prosecutors who sued Amgen last week agree that marketing and money once again got in the way of giving American consumers what they deserve: the full story about the safety and effectiveness of costly new drugs.

Monday, October 26, 2009

Is there a link between antidepressants and violence?

The recent murder suicide of an elderly couple in Newton, Massachusetts brought to mind a horrific story I heard while attending the ICSSP conference in Syracuse a few weeks ago. In 2006, David Crespi, a former banking executive with no criminal record or history of violence, killed his twin five-year-old daughters, stabbing them multiple times with a kitchen knife. He then called the police and sat with his daughters, blood all over him, until they arrived. Crespi, who was living with his wife and family in Charlotte, North Carolina (they have three other children), pled guilty to avoid the death penalty and is now serving a life sentence for the murders.

What wasn't mentioned at the time is the fact that Crespi was taking Prozac when he killed his daughters, along with the sleeping pill Ambien. He was taking the drugs (and had previously taken Zoloft and Paxil) because he couldn't sleep and was very anxious about losing his job with Wachovia Bank. Crespi became agitated and delusional on Prozac, according to his wife, Kim. Seven days after starting the drug, he killed their twin daughters, Tess and Samantha.

In the 25 years since Prozac and the other SSRI antidepressants have been on the market, there has been a long litany of cases like Crespi's, where someone with no history of violence, became agitated and violent after taking these drugs, either killing themselves or their loved ones. Indeed, as I write in Side Effects, Dr. Martin Teicher and his colleagues at McLean Hospital in Belmont, first reported on the phenomenon of akathasia among several patients on Prozac in a seminal case study published in the American Journal of Psychiatry in 1990.

In 2001, a Wyoming jury ordered GlaxoSmithKline, the maker of Paxil, to pay $6.5 million to the relatives of Donald Schell, who two days after starting the drug, murdered his wife, daughter and granddaughter before killing himself. And just last week, a Kansas jury acquitted a prisoner of beating a corrections officer, essentially buying the prisoner's defense that high doses of Prozac made him go ballistic; for more on this case, read Furious Seasons.

Which brings me back to the murder suicide in Newton last week. I have no idea if William Wyman was on antidepressants -- family members and police aren't talking -- but that could explain why this 86-year-old man would take a knife with a three-inch blade to his wife (also 86), stabbing her repeatedly in the neck and then killing himself in the same brutal manner. According to The Boston Globe and the Newton Tab, Wyman and his wife had health issues. So he could have decided to end both their lives for that reason alone. But most elderly people who kill themselves because of poor health and an uncertain future don't do it quite so violently. They usually take an overdose of pills or they leave the car running and the garage door closed.

My heart goes out to the Wyman family, as it does to Kim Crespi and her three surviving children. Kim says she has filed an appeal based on the argument that the public attorneys who defended her husband were incompetent (they're the ones who convinced David Crespi to plead guilty and didn't raise the issue of his medication history).

While the FDA has insisted on black box warnings about the suicidal risks of these antidepressants, there has been no similar warnings about their link to violence, even though it is well-documented that these drugs cause some people to become agitated and unbalanced. So I just have one question: when is the FDA going to insist that the drug companies, who continue to earn billions from the sale of these antidepressants, do the kind of large-scale post-approval safety studies that can resolve this issue one way or the other?

Wednesday, October 21, 2009

Why scientific fraud is on the rise

At the NASW annual conference this past weekend, I happened to sit next to a scientist who studies ethical violations in scientific papers. Over lunch, Harold (Skip) Garner, a professor of biochemistry and internal medicine at the Unviersity of Texas Southwestern Medical Center, told me and the other folks at our table that research shows an increase in the incidence of data manipulation in published papers, ranging from manipulating results on submitted manuscripts and images to plagiarism, duplication and fabrication.

I've blogged about this problem before here, and it is, of course, not news to the many medical journals who have had to invest in sophisticated software to unearth such shenanigans. (It was with software like this that the editors of the New England Journal of Medicine discovered that the researchers who submitted a seminal trial of Vioxx to them in 2000 had erased data showing that the Cox-2 painkiller increased the risk of heart problems among patients. (Unfortunately, the journal only discovered that manipulation years later).

Even so, I was curious as to what Garner thought might be beyond this growth industry in cheating. Garner offered a two-fold reason. First, the opportunity is there: ever more sophisticated technologies allow scientists to cut and paste and slice and alter data submitted electronically. Second, as funding for NIH grants grows scarcer, there is greater competition and more pressure on scientists to publish and win those grants. Garner himself admits to such pressures. "We're always worried about getting the next grant," he said.

A third reason Garner didn't mention is the increasing commercialization of science and medicine, which has spawned an army of researchers on the take from health product companies. And a fourth reason is an appalling lack of enforcement by federal and state agencies that are supposed to monitoring scientific misconduct. According to The New York Times, a new Congressional report shows that the FDA takes years to investigate researchers accused of scientific fraud, which means that many of these scientists remain eligible to conduct research even after they have been convicted of fraud by local law enforcement.

Similarly, the Office of Research Integrity at the NIH only investigates one in 100 cases of suspected data manipulation and it rarely resolves the cases it does investigate. The commitment to policing scientific fraud should come from the top, but I haven't heard anything about this problem from Francis Collins, the new director of the NIH.

The NIH can certainly do far more to investigate allegations of fraud and restrict grants to labs and universities where there is evidence of irregularities. But it can't clean house by itself. Universities and academic institutional review boards (IRBs) have got to get a lot tougher in policing ongoing research studies and requiring the disclosure of financial conflicts of interest that tempt researchers into manipulating data in the first place.

Btw, I'm glad to see that Ed Silverman has Pharmalot up and running again, if only for news nuggets like this. You go Congresswoman McCollum!

Monday, October 12, 2009

Pushing back against the drugging of our nation's youth

When my son was in kindergarten, he wrestled with his classmates and bit one of them, and his teacher (who was one or two years out of school) suggested that I get him tested for "neurological issues." I ran her suggestion past my son's pediatrician, and he said that my son's behavior was well within normal range for an active five-year-old. "He doesn't need to be tested," he said.

My son is now a healthy, well-adjusted 20-year-old excelling in college. But that long-ago episode came back to me this weekend when I was listening in on several panel sessions at the ICSSP conference in Syracuse (where I had been invited to speak). The theme of the conference was how to help parents deal with difficult children through "evidence-based" interventions rather than medicating them.

The 150 doctors, therapists and school counselors in attendance were concerned not only about the deleterious side effects of many psychoactive drugs (like Risperdal, Seroquel, Zyprexa, Ritalin, Paxil, Zoloft, Prozac etc.). But they also had a lot to say about the bankrupt promise of biological psychiatry and the role that the pharmaceutical industry has played in promoting this model. One neurologist noted that there is no evidence that the educational outcome of children labeled with mental disorders and prescribed drugs is any better than those children similarly labeled who don't take medications. In fact, he said, children who are diagnosed as ADHD and prescribed stimulants like Ritalin often do worse in school than those similarly diagnosed but not on drugs.

Yet in session after session, therapists talked about how hard it was to resist the presumption that the only way to deal with unruly children was to put them on meds. As Dr. Jock McLaren, a psychiatrist at Australia, said, "It takes an extremely brave parent to stand up to the assembled multitude of nurses and school officials insisting on drugs and operating under a spurious biomedical model."

Yet many of the therapists at the conference seemed determined to help parents do just that. And toward that end, speaker after speaker presented research showing the effectiveness of alternative methods of treatment for troubled children, ranging from family therapy to positive behavior modification to interventions in residential care.

Listening in on some of these presentations, it struck me anew how lucky I was, as a young mother, to have found a pediatrician who viewed the biological model (then just gaining steam) with skepticism and understood the importance of spending time talking to parents. Rather than whipping out his pen and writing my son a prescription, he took the time to chat with me and suggest safer, more effective ways of dealing with my son's behavior. This pediatrician, Dr. Howard King, has since emerged as a champion of working with families, and he spearheads a pilot project called the Children's Emotional Health Link.

I will always be grateful for this one doctor's wisdom, and this weekend in Syracuse I was gratified to see that many other health-care professionals and parents have joined the fight and are pushing back against the wholesale drugging of our nation's youth. To paraphrase Hillel: If not them, then who?

Monday, October 5, 2009

Will younger doctors be more resistant to drug company blandishments?

A week or so ago, I gave a talk to about 120 senior citizens at Brandeis University's Lifelong Learning Institute. The crowd was largely receptive to the topic -- how American consumers have been routinely misled about the safety and effectiveness of new drugs and treatments. They asked intelligent questions, and one retired psychiatrist even stood up to say how much he regretted having taken money from a drug company -- in the form of a free junket to a tropical locale -- to hear speeches about how wonderful its SSRI antidepressant was. He wouldn't do that now, he said, and he was sorry he had done it then.

But there were at least two people in the audience who didn't like what I had to say at all. In my talk, I had suggested a number of needed reforms, including passage of the Physician Payment Sunshine Act, which I've blogged about here. I even suggested that until that bill is passed, consumers might ask their doctors if they are getting any payments from drug companies that could possibly skew their prescribing habits.

During the Q&A, one man, who said he was a retired doctor, said that if a patient of his ever asked a question like that, he or she would be shown the door. Another doctor, a retired ob-gyn, took issue with what I'd said about the industry's longstanding practice of misleading consumers about new drugs, going back to the hype over hormone replacement therapy (HRT) on up to the current aggressive promotion of cervical vaccines like Gardasil. He accused me of exaggerating the dangers of HRT and practicing "sensationalistic journalism."

Rather than engage in verbal fisticuffs. I merely cited the recent studies showing that HRT increases the risk of breast cancer in women and repeated my concern that parents of young girls now targeted for the Gardasil vaccine in this country and Cervarix in the UK may not be getting the full story about the risks and benefits of these vaccines in treating cervical cancer. (For more on this issue, read Schwitzer health news and Gooznews).

But what struck me (and others in the audience) was the inability of these two doctors to understand that the winds of change are blowing and that the way they once practiced medicine -- with absolute deference from patients who viewed them as gods -- is a thing of the past. Consumers are waking up to the fact that doctors are human and thus susceptible to the same human frailties that tempt all of us. Money talks and can taint a doctor's judgement as much as it can anyone else's.

This was a major theme of Side Effects, and in the talks I've given since the book came out, I have stressed the need for full disclosure of financial conflicts and called for a ban on researchers receiving consulting and speaking fees from drug companies. Which is why it was so good to see the editorial in The Boston Globe last Thursday calling for much the same reforms. (The editorial followed an excellent article by Liz Kowalczyk earlier in the week).

Change is never easy. But I'd like to think that the newer generation of doctors are more savvy about the ways in which drug makers try to influence their judgement -- and a little more understanding of their patients' desire for transparency.

Monday, September 28, 2009

Birds of a feather at Brown University party for Martin Keller

A festschrift is defined by Wikipedia as "a book honoring a respected person, especially an academic, and presented during his or her lifetime," usually on the occasion of the honoree's retirement. offers much the same definition for this term of German origin.

So it comes as bit of a surprise to see that Brown University's School of Medicine is throwing a festschrift of sorts on October 8 to honor none other than Martin Keller, the former chief of psychiatry at Brown who is being investigated by the Senate Finance Committee for failing to disclose major conflicts of interest. As I've reported in Side Effects and my blog here and here, Keller not only failed to disclose the millions of dollars he received over the years from companies whose drugs he was studying and promoting in medical journals and at conferences. But there is evidence that Keller and his co-authors misrepresented data in a clinical trial of Paxil to make the antidepressant look safer and more effective than it really was. This trial, known as study 329 and funded by GlaxoSmithKline, was published in 2001 and used by the drug company to heavily market Paxil for off-label use in children and adolescents.

The festschrift for Keller at Brown's Butler campus will feature a talk by none other than Alan Schatzberg, another disgraced former psychiatry chief (of Stanford) who, like Keller, stepped down after extensive publicity about his own conflicts of interest. What got Schatzberg into trouble was his failure to properly disclose the millions of dollars in stock he owned in a company whose drug he was studying and promoting; for more detail, see here.

Also presiding at the festschrift is Robert Hirschfeld, the chief of psychiatry at Texas Medical Branch at Galveston, which has had its own share of bad publicity (see here); and Lewis Judd, a former director of the National Institute of Mental Health, the federal agency that threw so much research money Keller's way over the years despite his blatant conflicts of interest and the evidence of scientific misconduct.

All of which raises a number of questions in my mind. Why at a time of university budget cutbacks, is Brown spending good money to throw a party for Keller? And does he really fit the definition of a respected academic? I'll leave that to you to decide.

All I can conclude is: birds of a feather do flock together.

Why medical researchers often fail to disclose conflicts of interest

In response to the recent storm of publicity over the failure of many medical researchers to disclose the lucrative personal payments they get from the drug and medical device companies that also fund their research, many medical journals have developed written policies requiring disclosure of such conflicts of interest. That's the good news. The bad news is that many of these new policies lack the kind of scope and specificity that would really make a difference.

That at least is the conclusion of a rigorous new study, published online in the journal Accountability in Research, which found that more than 75 percent of the 227 medical and toxicology journals studied had minimal levels of specificity in their written conflict of interest policies. For example, most journals do not specify what they mean by a conflict of interest, so it's up to the researcher-author to decide if, say, the consulting gig they have with a drug company that is also funding their research, poses a conflict of interest or not.

"People have very different ideas about what constitutes a conflict of interest and what doesn't, so that gives authors a lot of latitude not to disclose," said Tufts University professor Sheldon Krimsky, who is the lead author of the new study.

Likewise, most of the journals did not specify what type of content researchers need to disclose conflicts of interest for. Whether, for example, they are required to disclose when they were submitting an original article, or a review or commentary article. And very few journals provided a monetary threshold for when disclosure is a must.

As a result of such lack of specificity, many researchers make their own decisions about when and what they should disclose. Such findings may explain why previous studies have found big gaps and inconsistencies in who discloses what to medical journals.

"This explains why many researchers disregard the requirement and simply don't report conflicts of interest," Krimsky said.

As a typical example, Krimsky cites the written COI policy of the International Journal of Cancer Research, which merely states: "Authors must include financial support received for research. Acknowledgements for financial support must be stated." The policy says nothing about consulting or speaking gigs. Nor does it specify what kind of financial support it's referring to or for what type of submissions the authors should disclose this support.

The solution? Journals have got to got more specific in what they mean by conflicts of interest and when authors should disclose these conflicts. As Krimsky notes, "Journals have to take responsibility for what is not being reported and should be reported."

The American public (who funds much of this research) deserves no less.

Monday, September 21, 2009

Obama's OSHA pick under fire from right wing

Over the years, David Michaels, the George Washington epidemiologist who is President Obama's pick to head OSHA, has developed a reputation as a fair-minded proponent of using the best available science to protect workers and the environment. As Effect Measure points out, Michaels has made important scientific contributions in the area of popcorn workers lung and beryllium poisoning. He has also championed the cause of workers who became ill after working in nuclear weapons programs, and he has pushed for transparency in the disclosure of conflicts of interest among scientists taking money from chemical and drug manufacturers.

So it should come as no surprise to hear that these corporations and their rightwing attack dogs are trying to scuttle Michaels' nomination with typically outrageous smears. In one of the least egregious examples, a recent editorial in The Washington Times accused Michaels of being "virulently anti-business" and "an anti-gun zealot." What someone's position on guns has to do with an agency that is supposed to protect people in the workplace, I don't know. (While there's no question that better gun control laws would protect workers from colleagues who go postal, such legislation would certainly not be coming out of OSHA).

The Times editorial goes on to say that if appointed to OSHA, Michaels would be overly aggressive in enforcing workplace safety regulations. As far as I'm concerned, that sounds like an endorsement for the guy.

But don't take my word for it. Michaels deserves the appointment for a host of reasons (beyond the ones mentioned above). To begin with, he already has executive branch experience, having served as Assistant Secretary for Environment, Safety and Health at the Department of Energy in the Clinton years.

In 2006, Michaels received the American Association for the Advancement of Science's Scientific Freedom and Responsibility Award for his "commitment to obtain justice for workers whose health suffered from working in nuclear weapons programs, and for advocating scientific integrity in public policy making." And in November, Sigma Xi, the Scientific Research Society, will give him the John P. McGovern Science and Society Award.

Full disclosure: David Michaels invited me to speak to George Washington's School of Public Health while I was on my book tour for Side Effects. But that's not why I'm writing this blog. Michaels' scientific credentials and his record of championing people harmed in the workplace speaks for themselves.

Monday, September 14, 2009

Why doctors are still "crazy" about antidepressants

I just received a wrenching email from a woman in North Carolina who was prescribed a SSRI antidepressant because she was having trouble eating due to a "horrible metallic taste" in her mouth. After her blood work came back negative, her doctor decided the problem must be "emotional" and prescribed the antidepressant. Now I'm not a doctor, but I know from personal experience that a metallic taste can be caused by any number of things, such as a reaction to surgery or another drug. Why this lady's doctor would automatically link a bad taste in her mouth to depression is beyond me. Perhaps he decided that her real problem was anxiety and that an SSRI might ease that, I don't know.

What I do know is that an inordinate number of women continue to be given antidepressants at the drop of a hat, as I've written about here. And indeed, the North Carolina woman writes:

I know so many women on SSRI antidepressants that it's mind boggling! I hear friends talk about how they "need a little something" because they are feeling stressed out so they go to the doc and get a prescription.

Of course, this problem of overmedication is not limited to SSRI antidepressants or women, for that matter. As Philip Dawdy notes in Furious Seasons, 60 percent of antipsychotics prescribed in the VA system in 2007 were prescribed off-label for conditions such as post-traumatic stress disorder, depression and anxiety. This disturbing data comes from a new study in Psychiatric Services, in which the authors themselves conclude:

Given that these drugs are expensive, have potentially severe side effects, and have limited evidence supporting their effectiveness for off-label usage, they should be used with greater caution.

So why do so many doctors continue to prescribe such potent psychoactive drugs with limited efficacy and potentially dangerous side effects? Or as the North Carolina woman put it, why are so many doctors still "crazy about the SSRIs?" It all comes back to the aggressive marketing of these drugs by the drug industry and the reality that so many key opinion leaders in psychiatry are on the pharm companies' dole. It also has a lot to do with the fact that an astonishing percentage of studies published in supposedly reputable medical journals are ghost-written, usually by paid writers for the drug industry. For example, as much as 10.9 percent of studies published in the prestigious New England Journal of Medicine were ghost-written, according to a new study released at an international meeting of journal editors in Vancouver and first reported in The New York Times.

This kind of disclosure doesn't inspire much confidence in the way doctors get their medical information, does it?

This latest wrinkle on ghostwriting didn't, of course, make much difference to my North Carolina pen pal; she had already taken matters into her own hands. After imbibing the prescribed antidepressant for a week and experiencing some weird side effects -- bad mood swings and shaking -- she went off the drug and is now working with her doctor to find another way to deal with her symptoms. Getting off the SSRI is a good start.

Tuesday, September 8, 2009

Side Effects wins NASW Science in Society Award

Forgive me for tooting my own horn but this is such a great honor I had to post the news: Side Effects has been named a winner of the 2009 NASW Science in Society Awards. Here's an excerpt from the official press release:

The winners of the 2009 Science in Society Journalism Awards, sponsored by the National Association of Science Writers, are: Alison Bass for her book Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial (Algonquin Books); Jason Felch and Maura Dolan for their Los Angeles Times series, "Genes as Evidence"; Michael J. Berens and Ken Armstrong for their Seattle Times series "Culture of Resistance"; and Pamela Ronald for her commentary "The New Organic," which appeared on, the web site of the Boston Globe.

NASW established the Science in Society awards to provide recognition -- without subsidy from any professional or commercial interest -- for investigative or interpretive reporting about the sciences and their impact for good and bad. The awards are intended to encourage critical, probing work that would not receive an award from an interest group. Beginning with the first award in 1972, NASW has highlighted innovative reporting that goes well beyond the research findings and considers the associated ethical problems and social effects. The awards are especially prestigious because they are judged by accomplished peers. NASW currently awards prizes in four categories: books, science reporting, science reporting with a local or regional focus, and commentary or opinion.

* In Side Effects, Alison Bass, an investigative journalist who has covered medicine, science, and technology for The Boston Globe and other publications, tells the story of how pharmaceutical giant GlaxoSmithKline systematically misled physicians and consumers about the safety and efficacy of Paxil, a popular antidepressant. "It's a very complicated issue, and the author conveyed this like a mystery story," said one of the judges, noting that, "Her investigations led to changes in policy in many areas of public health, not only nationally but internationally."

The four winners each will receive a cash prize of $2,500 at a reception on October 18, 2009 during NASW's ScienceWriters2009 meeting and workshop, which this year will be in Austin, Texas.

Thursday, September 3, 2009

Pfizer's $2.3 billion fine is only the tip of the iceberg

When I was writing Side Effects, I learned that the New York State Attorney General's office had sued Pfizer for the illegal off-label marketing of Bextra, its Cox-2 painkiller. (If you'll recall, Bextra, like Vioxx, was withdrawn from the market because of evidence that it increased the risk of heart failure in patients). Sources at the AG's office told me that other prosecutors were also going after Pfizer for its deceptive marketing tactics and asked me to keep this information under my hat for the time being.

If you read today's New York Times or Washington Post, you'll see that these legal actions have culminated in a record $2.3 billion fine against Pfizer for the illegal marketing not only of Bextra but of three other drugs as well. As The Washington Post reports:

The Pfizer unit Pharmacia & Upjohn pleaded guilty to a single felony charge that accused the company of marketing its anti-inflammatory drug Bextra for broader uses and higher dosages than those approved by the Food and Drug Administration.

The company allegedly enticed doctors to prescribe the drug for pain relief by taking them on lavish trips, created sham requests for medical information as an excuse to send unsolicited advertising materials to physicians, and drafted articles promoting the pills without disclosing its role in preparing the stories.

In connection with the settlement, Pharmacia & Upjohn consented to pay $1.3 billion in fines and forfeiture, the biggest criminal penalty ever imposed in the United States, prosecutors said. Pfizer paid an additional $1 billion to state and federal authorities to resolve civil allegations of improper marketing over Bextra and three more drugs: Geodon, an antipsychotic medicine; Zyvox, an antibiotic; and Lyrica, an epilepsy medicine.

This is Pfizer's fourth settlement for illegal marketing activities since 2002 and prosecutors said they factored that "recidivism" into the steep penalty announced yesterday. Yet, as Gardiner Harris in The New York Times notes, the $2.3 billion penalty amounts to less than three weeks of Pfizer's sales.

Deja vu, anyone? A few days ago, Forest Labs was in the news for spending lots of money on doctors in medical conferences, consulting fees, junkets and free meals to convince them that the antidepressant Lexapro was much better than its off-patient antidepressant Celexa (even though the chemical make-up of the two drugs are nearly identical). And now we have Pfizer dunned for doing much the same thing with several of its blockbuster drugs.

It's good to see the Obama administration and various states getting serious about such health care fraud. But it's not enough to fine drug companies for deceptive and illegal marketing tactics. There has to be real reform in the medical research establishment. Until universities and doctors stop taking money that taints their scientific judgment and refrain from putting their names on papers they didn't write, how can the American public trust any health professional when it comes to the safety and effectiveness of prescribed drugs?

Monday, August 31, 2009

Are meds always the answer for stressed-out moms?

I can relate to Katherine Snow Smith, the mom in Florida who wrote in the St. Petersburg Times about how she lost it with her kids one time too many. But what I can't relate to is Smith's decision that she needs to take a potent psychoactive drug to calm herself down.

Smith talks about how a friend of hers had gone on a "girls' weekend" with eight mothers she casually knew:

"She later told me six of them were on some kind of meds. They compared the benefits and side effects Paxil, Lexapro, Cymbalta, Prozac and others. Some made you gain weight, some made you lose. Some decreased sex drive. All of them, it seemed, made them feel like they were better moms, wives and daughters."

This may indeed be true. After all, a relative of mine went on Paxil for much the same reason: because she was yelling too much at her kids and her husband and she found that she is calmer and less anxious on 10 milligrams of the SSRI antidepressant. I'm sure there are times when my husband and sons wish I were on Paxil too, especially in the evening after a long day when they've pushed my buttons once too often.

But are drugs the answer? As Philip Dawdy puts it (a hat tip to him for alerting me to Smith's column) in Furious Seasons:

What the hell is going on with this country and its people that we're getting all doped-up on SSRIs and the like over the stresses of daily life and parenting and think that's making us better? Where has this kind of thing gone on before?

Oh, wait. It was in America in the 50s, 60s and 70s when stressed out, agitated, anxiety-riddled Americans were taking Miltown, Valium and all those other benzos and downers and whatnot. We know how that turned out: Miltown pulled from the market and Valium junkies all over the place.

Is the same thing happening all over again with the new generation of antidepressants? We all know that the SSRIs, especially Paxil, cause serious withdrawal problems and have a host of other unpleasant side effects, including weight gain, decline in sex drive, changes in cognitive alertness, and in some people, an increased risk of suicidal thoughts and behaviors. Does the benefit really outweigh the risks?

As one occasionally stressed-out mom, I would hope that Smith and all these other overburdened mothers consider other alternatives first. Like yoga, meditation, exercise, or dare I say it, a husband who travels a little less and is home more often? Personally, I find aerobics and the occasional dinner out with friends a welcome salve.

At the end of her column, Smith rationalizes her decision to take drugs by saying, "I want to enjoy every minute of it as much as I can." Given what we know about how these drugs can numb the mind, let me add this postscript: be careful what you wish for.

Wednesday, August 26, 2009

Radio Interview: the story behind the deceptive marketing of Paxil

Madness Radio, the radio station affiliated with Freedom Center, a nonprofit advocacy group for people with mental illness, interviewed me about Side Effects, the story behind the deceptive marketing of Paxil, and the ongoing battle to clean up corruption in the medical profession and drug industry. A podcast of the 50-minute interview, which aired today, can be found here.

Monday, August 24, 2009

New study: Antidepressant warnings did not affect suicide rates in young people

Many mental health professionals remain concerned that the regulatory warnings put on antidepressants in this and other countries have had a deleterious effect, possibly leading to an increase in depression and suicides among young people. This concern has been stoked by recent journal articles written by researchers with ties to the drug industry, which I've blogged about here.

Now comes a fairly convincing international finding that there has been no overall effect on suicide rates among young people as a result of the regulatory warnings on antidepressants. As you may recall, the warnings were required by the FDA and other regulatory agencies, beginning in late 2003 and 2004, because of evidence of an increased risk of suicidal thoughts and behaviors among children and young adults on SSRI antidepressants.

The latest study, published in the July issue of Pharmacoepidemiology and Drug Safety, is based on suicide data from 2004 to 2006 provided by 22 nations, including the US, to the World Health Organization. The researchers, from the University of Bristol, found no clear evidence of a beneficial effect on population suicide rates as a result of the warnings. Equally importantly, they did not find evidence of an adverse effect on suicide rates either.

Interestingly, they did find "weak evidence" for a slight increase in suicide rates in young women, aged 15-19, but not in young men. The researchers were at a loss as to how to explain this gender difference. But they did note that in the UK, this slight increase might reflect the two to three-fold higher levels of antidepressant prescribing among young women. In the US, they found the strongest inverse association between SSRI prescribing and suicide mortality among boys under the age of 15; in other words, between 2004 and 2006, when SSRI prescriptions for this age group dropped, as it did for other age groups in wake of the warnings, fewer boys in the U.S. committed suicide.

Not exactly a ringing endorsement of the beneficial effect of antidepressants, is it?

Wednesday, August 19, 2009

Ghostwriting in drug research back in the spotlight

It's good to see The New York Times maintain a spotlight on the widespread practice of ghostwriting in drug research. In her article today, Natasha Singer focuses on Wyeth's use of a ghostwriting firm to prepare an estimated 60 articles favorable to its hormone drugs.

Wyeth's use of ghostwriters to prepare favorable studies and then find doctors willing to put their names on them is, of course, only the latest in a long string of drug industry campaigns to present new products in the most positive light possible. The makers of the SSRI antidepressants were masters at this tactic. As I reveal in Side Effects, GlaxoSmithKline hired a ghostwriting firm, Scientific Therapeutics, to write the first draft of the controversial Paxil study 329. That draft concluded that Paxil was effective and well tolerated in adolescents, even though the actual data in the clinical trial showed otherwise. See back story here. Indeed, in its re-examination of clinical trial data for all the antidepressants, the FDA labeled study 329 a negative study, finding that Paxil was no more effective than placebo in treating depression in adolescents. Yet Martin Keller, the principal investigator of the Paxil study, and his co-authors, did not object to the ghostwritten version of the study and despite its inaccuracies (which were flagged by peer reviewers), the study was published in The Journal of the American Academy of Child and Adolescent Psychiatry in 2001 and used by GlaxoSmithKline to heavily flog the drug for use in children and adolescents.

Why were the authors of study 329 so lax in attaching their names to a study they didn't write? Could it have had anything to do with the fact that Keller and several of his co-authors were getting paid huge amounts of money in consulting and speaking fees by GlaxoSmithKline?

In its marketing of Zoloft, another blockbuster SSRI antidepressant, Pfizer did much the same thing, as I've reported in previous blogs here.

Hence, I'm glad to see that the Senate Finance Committee seems to be putting pressure on the National Institutes of Health to crack down on the practice of ghostwriting and undisclosed conflicts of interest; see letter from Senator Grassley here. As Singer notes, active enforcement by the NIH is crucial since "many of the nation’s top doctors depend on federal grants to support their work, and attaching fresh conditions to those grants could be a powerful lever for enforcing new ethical guidelines..."

Up till now, NIH has been reluctant to take a more pro-active role on the issue of ghostwriting or do much to enforce its own conflict of interest policy (which has been on the books since the mid-90s). So I'm eager to see how Frances Collins, the new director of NIH, handles the issue. Stay tuned...

Monday, August 17, 2009

Now's the time to speak up about meaningful health care reform

It looks like the Obama administration may be backing off its insistence on a public health plan option in the health care reform bill wending its way through Congress. I'm sorry to hear that because I believe that the inclusion of a government-run plan (like Medicare) is the most effective way to both reduce health care costs and provide adequate insurance to many of the 47 million Americans currently uninsured. And while the option that the administration has signaled it would accept in lieu of a public plan -- non-profit cooperatives -- isn't the end of the world, a number of experts point to problems with such cooperatives, the biggest one being their lack of scalability. The few cooperatives that now exist in places like Seattle are relatively small, local affairs, and some question whether they could effectively scale up to compete with private insurers. White House officials raised that concern in The New York Times today, even as they acknowledged that the president might be willing to accept cooperatives in lieu of a public plan.

If this compromise is destined to happen, and I sincerely hope it isn't, then at the very least, the administration should make darn sure there are rules around how these health cooperatives can operate. As Gooznews noted today, such cooperatives should be required to be nonprofit and their members should be allowed to join a pre-paid group practice where physicians are paid annual salaries, rather than getting reimbursed by fee for service, a far more expensive and wasteful practice. In fact, wouldn't it be grand if all physicians in the U.S. were on salary, instead of getting paid for the number of tests, procedures and patient visits they conduct? That's an idea whose time has come and in my opinion, it would come a lot faster if Obama stuck to his guns and insisted on a government-run health plan option.

So for all those of you who want meaningful health care reform, now's the time to call your elected representatives and tell them what you want, especially if you live in states (like Montana, Kentucky, Missouri and Iowa) dominated by lawmakers who are determined to put the kibosh on a public health plan option.

Thursday, August 13, 2009

Study confirms that antidepressants double suicide risk In young adults

In recent weeks, researchers with ties to the drug industry have once again tried to drum up opposition to the FDA's black box warnings on antidepressants for children and young adults. The latest dart came in an Archives of General Psychiatry study in June trumpeting a "persistent decline" in the diagnoses of depression among children and adults in the years after the FDA warned that antidepressant usage in children and young adults can increase the risk of suicidal thoughts and behaviors. As one of the study authors (who by the way consults for several SSRI makers) told WebMD, this proves that the FDA warnings have had dangerous "unintended consequences" and should be repealed.

Not so fast. Leaving aside the contention that a drop in depression diagnoses is a terrible thing -- some bloggers like Philip Dawdy at Furious Seasons argue otherwise -- now comes a definitive new study published in the British Medical Journal, confirming the increased risk in suicidal thoughts and behaviors among young adults taking antidepressants. After examining proprietary data from 372 clinical trials and almost 100,000 patients, the authors (FDA staffers) conclude that the "risk of suicidality associated with use of antidepressants is strongly age dependent. Compared with placebo, the increased risk for suicidality and suicidal behaviour among adults under 25 approaches that seen in children and adolescents." The study also found a smaller, less significant risk in adults between 25 and 64 and that antidepressants actually reduced the risk of suicidal thoughts and behaviors in those aged 65 and up.

Aside from these findings, which largely confirm earlier research, what I found particularly revelatory about the BMJ study was its refutation of the idea (espoused by many psychiatrists) that the increased risk of suicidal ideation among people taking antidepressants comes from a lessening of their depression (which allows patients to entertain and report suicidal thoughts). As the authors note, this "ascertainment bias cannot easily explain the observed age relatedness of the findings or the stronger apparent increase in suicidality in non-depressed psychiatric patients."

The authors go on to note that "these findings support the idea that antidepressant drugs can have two separate effects: an undesirable effect in some patients that promotes suicidal ideation or suicidal behaviour and a therapeutic effect in others that alleviates depression and reduces suicidal sequelae from depression." Doctors, they conclude, should take into account the "age dependent increase in suicidality" in deciding if the benefits of antidepressants outweigh the risks.

Obviously, FDA researchers have an inherent interest in supporting their agency's actions. But it's hard to argue with raw data from 372 clinical trials done over the years by the drug companies themselves (who, after all, have a vested interest in making their drugs look safe).

Wednesday, August 5, 2009

Is the financial meltdown of the media becoming a public health threat?

At a conference I attended yesterday in Boston on Reinventing Journalism, the talk was all about how online social media tools are introducing new models of sharing information and helping journalists do their jobs better. The panelists made scant reference to the financial meltdown of the mainstream press and only one speaker mentioned in passing his concern that this crisis is impairing the ability of journalists to dig up important facts and connect the dots -- i.e. do the kind of investigative reporting that newspapers used to be known for.

Yet the evidence that this is happening is all around us and its impact is particularly glaring to me (as a longtime medical news junkie) in health coverage. As once-respected newspapers like The Boston Globe close their health and science sections and fewer papers report the reality behind the news coming out of medical journals and conferences, what we have left are television talk shows and wire services giving us a shallow and unskeptical view of new drugs and technologies.

On his HealthnewsReview blog yesterday, Gary Schwitzer makes a convincing argument that the palaver provided by the network television morning shows is actually a public health threat. Their health segments, he argues, "unquestioningly promote new drugs and new technologies" and give viewers false expectations about new treatments that may actually do more harm than good. As just one example, Schwitzer points to ABC Good Morning America's recent segment on an experimental obesity drug that it presented as a silver bullet for people wanting to drop a few pounds, without examining the possible side effects or conflicts of interest among the drug's researchers.

Another case in point: this AP story on a newly published study in the Archives of General Psychiatry announcing the existence of chronic depression in preschoolers. The AP story quotes experts saying that children as young as 3 have a chemical imbalance that predisposes them to chronic depression, the inference being that they need to be treated with potent antidepressants. And indeed, the AP story ends by noting that a "rising numbers of preschoolers are taking psychiatric drugs, including Prozac, which is used to treat depression."

As Philip Dawdy at Furious Seasons, notes with a wee bit of sarcasm: "AP just swallows the chemical imbalance theory of depression wholesale. That's some nice skeptical journalism there."

Friday, July 24, 2009

Congress puts off action on health care reform...

Since Congress isn't going to pass a health care reform bill any time soon, this looks like a good time to take some vacation. I will resume blogging the week of August 3.

Tuesday, July 21, 2009

Is scientific fraud more common than we'd like to think?

In response to my blog on Frances Collins last week, a reader pointed out that the kind of data image manipulation that Collins belatedly discovered in his own lab is more common than many scientists would like to admit: as much as 25 percent of scientific papers submitted for publication contain such image manipulation.

For example, in manuscripts accepted by the American Journal of Respiratory Cell and Critical Care Medicine, the American Thoracic Society found that “approximately 23 percent of images had undergone some alteration “including ‘erasure,’ ‘filling in,’ ‘splicing and ‘cloning.’” In addition, the journals of Cell Biology and Blood have both reported that 20-28 percent of accepted manuscripts had signs of image manipulation, according to The Scientist.

Yet, according to these sources, the Office of Research Integrity at the NIH, which Obama has appointed Collins to direct, only investigates one in 100 cases of suspected data manipulation and thus far only 17 of those investigations have been resolved. Sounds like Collins has some cleaning up to do, should he be confirmed for the post.

On another note, it was good to see The Washington Post enlarging upon some of the reporting I and other bloggers have done on the health care industry's generous contributions to senators like Max Baucus and Chuck Grassley, who are playing a pivotal role in the current health care reform effort.

It was also nice to see The Boston Globe weigh on the same problem, since it was a Globe reporter who first revealed that the biotech Amgen had given $1 million to the planned Edward Kennedy Institute at the University of Massachusetts in Boston. Kennedy aides, of course, say there is no connection between Amgen's healthy donation and the fact that Kennedy's health committee recently voted out a bill that would give biotech and pharm companies a 12-year patent monopoly on new biologic drugs before the drugs become generic. But one can't help but wonder. What's obvious is who the losers will be if this bill passes: American consumers who have to pay top price for new drugs when much cheaper generics should and could be available.

Monday, July 13, 2009

Has Francis Collins, Obama's pick as NIH director, learned his lesson?

When the news broke last week that President Obama had selected Francis Collins to be the new director of the National Institutes of Health, I didn't immediately think of this noted geneticist in connection with a case study in ethics that a visiting scientist had discussed with my health and science journalism class this past spring. It wasn't until I read The New York Times article on Collins' appointment that I remembered the scientist's astute analysis and decided to share it with a wider audience.

The topic of my class this particular afternoon was ethics in science, and in the context of discussing several case studies, my guest speaker, a distinguished geneticist in his own right, brought up an incident that had happened in Collins' lab in the mid-90s when he was director of the National Center for Human Genome Research at the NIH. In August 1996, Collins was notified by the journal Oncogene that a reviewer who was reading an unpublished manuscript about leukemia genes submitted by Collins and a graduate student in his lab at the University of Michigan had discovered data that looked like a "cut and paste job," raising questions of intentional deception. Collins started checking into these allegations and discovered an extensive body of systematically fabricated data by this one graduate student of his. He confronted the suspected perpetrator, who confessed, and wrote a letter to about 100 colleagues whose own work might be affected by the falsified data. In the end, two published papers that contained fake data were retracted in toto and three others corrected. The scandal was covered by a number of major news outlets, including The New York Times.

In the NYT article, Lawrence Altman noted that "Dr. Collins rejected the idea that closer supervision would have prevented the problem because the trainee 'got quite a bit of attention from me' and with others in the laboratory." Interestingly enough, that was precisely the point around which my guest speaker wove his ethical case study. Collins' name was on all the papers that were found to contain falsified data, the guest speaker noted. He then asked my students, "Can a person with Collins' enormous management responsibilities (he was not only overseeing the $189 million human genome project at the time but still operating his lab at the University of Michigan) pay adequate attention to the daily operation of his lab, ensure the quality of the data produced, and guarantee that the papers published under his name are valid?" The conclusion we reached together was no. Collins was juggling too many responsibilities and should not have put his name on these scientific papers because he didn't really have the time to scrutinize the data. What Collins was guilty of, the visiting scientist said, was both a lack of judgment and a conflict of effort.

He then asked an even more thought-provoking question: what does this incident say about the contention that science polices and corrects its own errors through peer review? If this and more recent cases of extensive scientific fraud (I'm thinking here of the Massachusetts anesthesiologist case I wrote about in my blog and the former Army scientist and Medtronics consultant currently in the news) are any indication, the answer is: maybe. Eventually, most cases of extensive fraud may be exposed but only after a great deal of harm has been done to patients and the credibility of the medical research process. Our current system of peer review is far from foolproof in ferreting out fraud, especially when we have star scientists, like Collins, who are too busy trying to burnish their reputations to pay much attention to what is going on beneath their noses.

I can only hope that Collins, if he becomes the next director of the NIH, has taken to heart the lessons from his own lab.

Wednesday, July 8, 2009

Conflicts galore: Statin study authors on the take from statin makers

Just yesterday, Senators Charles Grassley and Herbert Kohl announced that language requiring the public disclosure of payments to doctors from drug and medical device companies has been included in the draft bills for health care reform now being debated in the House and Senate. In case you haven't been convinced by the parade of doctors on the take (who in some cases were found to have skewed scientific data as a result of their conflicts of interest), here's one more reason why public disclosure of such conflicts is so important.

On June 30, the British Medical Journal published a meta-analysis purporting to show that cholesterol-lowering statins reduce the risk of heart attacks and improve survival rates in people without established heart disease. Up till now, evidence that statins like Lipitor, Crestor, Zocor and Pravachol prevent heart attacks in people without known heart risks remains ambiguous at best. And there is little evidence that statins reduce the risk of heart attacks in women, since most of the clinical trials have been in men. Now comes a meta-analysis that examines 10 previous clinical trials and concludes that lo and behold, statins do improve survival rates for men and women and other groups not previously shown to be helped by these drugs.

But before you break out the champagne, please consider these caveats. First off, as Gary Schwitzer pointed out in his health news blog, not everyone is convinced this meta-analysis shows what its authors claim it does. As one online commentator noted, if you look carefully at the data in the study, there is no evidence that the benefits of statins are significant for all 4 end points listed in women, people over the age of 65 and patients with diabetes. And as other commentators noted, the study also doesn't pay much attention to the serious side effects of statins or the fact that there are safer ways to reduce cardiovascular risk, such as exercise and dietary changes.

But what bothers me most about this meta-analysis are the substantial conflicts of interest among six of its 12 authors, most of whom are doctors. According to the fine print at the end of the BMJ study itself, six of the authors are consultants for one or more of the drug companies that make statins, which, by the way, are among the top five classes of drugs sold in the US today. For example, two of the authors are consultants for Merck, which makes Zocor; another researcher, a professor at Cornell University, consults for Bristol-Myers Squibb, which makes Pravachol, another statin; a third has received speaking fees from Pfizer, which makes Lipitor, and a fourth researcher has consulted for Astra-Zeneca, which makes Crestor, as well as Merck. One of the authors (who like six of his colleagues hails from the Netherlands) also sits on the board of two biotech-pharm companies (Aegerion and Arisaph), which are developing cholesterol-lowering drugs. Still another co-author (the one who consults for both Merck and Astra-Zeneca) has developed cardiovascular biomarkers that have been licensed to Siemens and Astra-Zeneca.

In sum, what we have here is a study rife with conflicts of interest. But what we don't know from the fine print is how much these fine fellows are making from their ties to the statin industry; is it $10,000 a year, $100,000 or a $1 million? As I've reported in previous blogs and Side Effects, even a little money can affect the outcome of clinical research and a lot of money can affect it a lot.

That's why we so badly need public disclosure of the financial ties between specific health professionals and health product companies. So consumers can see for themselves just how conflicted the researchers of a particular study are and decide for themselves how much weight they want to give the study's results. In the absence of such key information, I'd have to agree with one of the online commentators on the BMJ study: that the jury is still out when it comes to the benefit of statins in reducing the risk of heart attacks in folks without known heart problems.

Monday, June 29, 2009

Money talks: Key senators swayed by health industry contributions

With the Congressional debate over health care reaching a crescendo, I find myself particularly baffled by the behavior of two influential Senators. Why, I wonder, would Sen. Max Baucus, a Democrat from Montana, and Sen. Charles Grassley, a Republican from Iowa, oppose a public health insurance option that could compete with private insurers? Baucus, after all, has worked closely on health-care reform with Senator Edward Kennedy, a stout supporter of a public option. And Grassley, who has taken the lead in investigating doctors on the take from pharmaceutical and medical device companies, must surely understand the corrosive influence of the for-profit motive in health care.

Grassley says he opposes a public plan for fear it would eventually put private insurance plans out of business, according to an excellent overview of the debate in The New York Review of Books. But isn't that the idea? Are we not the only developed country in the western hemisphere that permits for-profit health insurance? Why should Grassley and Baucus care so much about the fate of for-profit medicine?

Here's one reason why: both Senators have received tons of money from PACs and individuals representing the health-care industry in recent years. Indeed, the two or three top industries contributing to Grassley and Baucus's campaign chests from 2003 to 2008 are, you guessed it, insurance companies and health professionals. According to the Center for Responsive Politics, health professionals donated $812,077 to Grassley between 2003 and 2008, while insurance companies gave him a total of $643,643. Similarly, health professionals contributed $851,141 to Max Baucus over the same period of time, while insurance companies gave him $784,185. (Pharmaceutical companies, who are similarly opposed to a public health option because it will eat into their profits) also contributed $852,813 to Baucus' war chest during the same years).

And if you look at the top individual donors to these Senators, you see the same pattern: on both Grassley and Baucus's top 20 list, you will find the American Hospital Association, the American Health Care Association (which represents nursing homes), a number of health insurers, such as Blue Cross/Blue Shield and Aetna, and several organizations representing medical professionals. As I noted in a previous blog, many doctors don't want a public health option because it will eat into their profits, since Medicare and Medicaid tend to reimburse doctors (and pharmaceutical companies) at lower rates than private insurers do.

Now you can view this as just one more sad illustration of the power that moneyed interests have over our Congressional leaders. But if I were a voter in Montana or Iowa worried about paying my medical bills, I might want to pick up the phone and ask Senator Baucus or Grassley just who exactly they are representing: me or corporate America?