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.