Health Articles

Canadian “drug policy reform” effort driven by Pharma funds

A CanWest news report shows how a “drug policy reform” push from a self-described patient advocacy group is actually totally funded by drug companies.

The story begins:

“Louise Binder is HIV-positive and chairwoman of a coalition that fights for drug-policy reform in Canada. During a recent visit to the nation’s capital she urged members of Parliament to rewrite the rules governing prescription drugs that would increase the access patients have to new, expensive medications and require the government to foot the bill.

One thing she didn’t mention during that visit is the fact her association, the Best Medicines Coalition, receives 100 per cent of its funding from Canada’s pharmaceutical companies - the very industry that stands to profit most from a governmental decision to approve new and expensive drugs for use and coverage in Canada.”

Disciplined Docs Still on Pharma Payroll

The New York Times has a terrific and troubling story on doctors who have been disciplined or criticized by a medical board but later paid by drugmakers. The Times reports:

“An analysis of state records by the New York Times found more than 100 such doctors in Minnesota, at least two with criminal fraud convictions. While Minnesota is the only state to make its records publicly available, the problem, experts say, is national.”

One physician profiled, whose license was suspended for seven months and restricted for two years, has been paid by at least a dozen drugmakers after these disciplinary actions.

One expert interviewed in the story said:

“Clinical trial investigators must be culled from only the finest physicians in the country since they work on the frontiers of new knowledge. That drugmakers are scraping the bottom of the medical barrel is an outrage.”

Cancer crusading takes an ugly turn

The New York Times reports:

“Two prominent prostate cancer experts have been threatened for opposing approval of a controversial new drug and are being protected by bodyguards as they attend the nation’s largest cancer conference here.

The experts, Dr. Howard Scher of Memorial Sloan-Kettering Cancer Center and Dr. Maha Hussain of the University of Michigan, received e-mail and other threats, according to spokeswomen for Sloan-Kettering and for the cancer conference.

It is not known who sent the threats. However, it is clear that the doctors’ public stance against the drug, Provenge, has inflamed the passions of some men with prostate cancer and patient advocates, who say the drug would offer hope to desperate patients with few or no alternatives.

Many investors also have made big bets on the stock of the drug’s developer, Dendreon, a Seattle biotechnology company, whose stock has fluctuated wildly along with the prospects for the drug. Some investors stood to profit if the drug was approved, and others if it was rejected.

The Food and Drug Administration said in May that it would not approve Provenge without more evidence that it was safe and effective. “

What a sad commentary if men of science, acting on their interpretation of evidence, must face threats in this manner. We hope that authorities root out those making the threats. And we wish that evidence, not emotion, would influence the public. As the Times reports:

“…both Dr. Scher and Dr. Hussain, who, unlike most of the panel members, actually treat patients with prostate cancer, … argued that the evidence fell short of proving that the drug worked, and that they did not want to give patients false hope. Each doctor later wrote a letter to the F.D.A. reiterating their arguments.”

How can we trust drug trials?

If we needed more evidence of questionable clinical trial ethics and publications resulting therefrom, we have it, in an article in PLoS Medicine. Cut to the conclusion:

“Randomized clinical trials of head-to-head comparisons of statins with other drugs are more likely to report results and conclusions favoring the sponsor’s product compared to the comparator drug. This bias in drug-drug comparison trials should be considered when making decisions regarding drug choice.”

So, as the San Francisco Chronicle put it, “money talks — and very loudly when a drug company is funding a clinical trial involving one of its products.” The paper quotes study author Lisa Bero: “If I’m a clinician or funder of health care, I really want to know within a class of drug which one works better. What our study shows is that depends on who funds the study.”

About a third of the statin trials did not disclose any funding source. Trials with no disclosed funding source were less likely to favor the so-called test drug than those with industry funding, researchers found.

Politicizing drug safety

See Merrill Goozner’s blog for an account of the politicization of the Congressional hearing on the safety of the diabetes drug Avandia.

It sounded ugly: politicians pontificating as if they knew science better than Steve Nissen of the Cleveland Clinic, who has raised questions about Avandia’s safety, just as he did with Vioxx.

Gooz writes: “What is the reform that Nissen is pushing? Complete transparency of clinical trial data, from the earliest pre-approval trials to all trials conducted after a drug hits the market. The Avandia case is just the latest in a long line of examples (Vioxx, anti-depressants in children) showing why this change is badly needed.”

Avandia critic says drugmaker tried to shut him up

The Washington Post reports on how North Carolina researcher John Buse, the incoming president of the American Diabetes Association, says he was intimidated by the maker of Avandia in 1999 when he began questioning the drug’s safety. Excerpt:

“Buse said company officials considered his actions “scurrilous” and implied that he might be held accountable for a $4 billion drop in the drug firm’s stock.

“I was characterized as a liar and I was characterized as being for sale,” Buse told the House Oversight and Government Reform Committee, which released a letter that he wrote in response.

“Please call off the dogs. I cannot remain civilized much longer under this kind of heat,” Buse wrote.

Moncef Slaoui of GlaxoSmithKline, the company’s new name after a merger, expressed regret about the episode, attributing it to the “passion” of officials at the time.”

Passionate, indeed. But nothing stirs pharma’s passion like threats to the bottom line.

Journal Watch tracks conflict of interest

It may become easier to discover journal article authors’ potential conflicts of interest, through the web site, Journal Watch.

The Wall Street Journal reports the system adopted by Journal Watch “was the latest move to toughen disclosure after a series of cases in which authors’ ties to the pharmaceuticals industry weren’t disclosed. Journal Watch is owned by the Massachusetts Medical Society, publisher of the New England Journal of Medicine. Under Journal Watch’s new system, to be adopted later this month, online readers will be able to click on an author’s name and instantly see disclosures about his or her financial ties to drug makers and other sources of support. The site, aimed at doctors, summarizes significant articles on recent medical journals.”

Consumer-driven plans faltering?

The Wall Street Journal reports that despite President Bush’s and big employers’ push for so called “consumer-directed” health plans, consumer discomfort with the idea is rising to the surface.

The Journal speculates that “low enrollment and low satisfaction among workers who are offered them raise the question of whether consumer-directed plans will stall before they ever hit the mainstream. Few employers are focusing on the costly measures — such as offering better coverage or more consumer education — that may be needed to accelerate these plans.”

The newspaper goes on to report:

“In a survey published last month by Towers Perrin, an employee-benefits firm, employees enrolled in them said they felt less capable of finding a quality doctor or hospital, though they often were in the same network as colleagues in other plans. Only 29% said they tried to save money in their accounts for future medical expenses.

Though the consulting firm says consumer-directed plans have much potential, its executives were surprised consumer responses were so negative.

“If I were a product manager in any other industry and saw scores this low in customer satisfaction and understanding, I’d be thinking of pulling that product from the shelves or retooling it,” says David Guilmette, managing director of Towers Perrin’s health-care consulting practice.

One reason for the frustration is the uphill battle many consumers describe in trying to shop for their health care.”

Journal article imbalance on mammography’s benefits vs. harms

A study in the journal BMC Medicine concludes that scientific articles on mammography screening tend to emphasize the major benefits over its major harms. Not surprisingly, the imbalance is related to the authors’ affiliation. In other words, benefits (not harms) were emphasized by authors who worked with screening.

The authors also wrote:

“Overdiagnosis and overtreatment were often downplayed as negligible by authors working with screening, but they are not. Assuming a reduction in breast cancer mortality of about 15%, as estimated in the two most recent systematic reviews, and 30% overdiagnosis as indicated by the randomised trials, screening 2000 women over 10 years would prevent one breast cancer fatality but turn 10 healthy women into cancer patients unnecessarily.”

“Scientific articles on mammography screening favour information on the mortality reduction, and prefer to present this as a relative risk reduction rather than an absolute risk reduction. A relative risk reduction appears more impressive, but tends to make lay people, as well as health professionals, overestimate the obtainable benefit. This problem is known from scientific articles in general, and is particularly important in a screening setting as so few will benefit of the total number screened.”

Since news stories are often based on journal articles, it is easy to see how easily journalists fall into this pattern of emphasizing benefits and minimizing harms of screening. It’s a journalistic trend we’ve reported, and it’s one that does not serve the public well.

Mirror Award goes to HealthNewsReview.org

Just back from New York, where one of the inaugural Mirror Awards honoring excellence in media industry reporting was given to HealthNewsReview.org.

The other awards went to:

Clive Thompson, New York Magazine

Philip Weiss, New York Magazine

David Carr, The New York Times

Andreas Kluth, The Economist

American Journalism Review

Dean Miller, Nieman Reports

Lifetime Achievement Award: Peter Bart, editor-in-chief, Variety

Details, including links to the winning work, are on the Mirror Awards website.

It’s been an eventful first year for HealthNewsReview - winner of a Knight-Batten Award for Innovations in Journalism, an e-Healthcare Leadership Award, and now the Mirror Award.