Schwitzer health news blog

Journal editor bemoans bird flu scare mongering

BMJ deputy editor Tony Delamothe writes in this week's issue:

"Somewhere, I imagine, there's a small group of people proud to be counted among the Friends of Avian Flu, or FAF for short. I suspect they have a catchy mission statement, such as "Keeping the nightmare alive," and lapel badges of vaguely bird-like shape.

Their challenge is to keep bird flu forever in the public eye. This should be getting harder, as influenza H5N1 is proving particularly resistant to undergoing the killer mutation that would allow efficient human to human transmission of the virus. Ten years after the strain first appeared in humans, it has killed just 191 people. This is despite the most propitious of circumstances: millions of people and poultry living in very close proximity in South East Asia. Although these deaths are a tragedy for the victims and their families, it's as well to remember that a similar number of people die on the roads world wide every 84 minutes.

Traditionally, we've blamed the drug companies for talking up the risks of diseases, or even inventing diseases, but this is not the case with bird flu. The track record of oseltamivir (Tamiflu) as a treatment for H5N1 is decidedly mixed, and its use in seasonal flu has been linked to suicides and neuropsychiatric symptoms in Japanese teenagers. FAF has incorporated this pharmaceutical failure into its story for bird flu: The Drugs Don't Work. Be afraid. Be very afraid.

FAF knows that the best way to generate column inches is high profile scientific conferences with well oiled media machines, and in this week's BMJ Richard Smith, our previous editor, reports on a session he chaired at a conference of Health Technology Assessment International. Some of the observations were familiar: the inevitability of the pandemic and the possibility of drug resistance. But others were relatively new: the terminological mutation from "avian flu" to "pandemic flu," in recognition of H5N1's failure to mutate genetically.

H5N1 had been groomed for stardom, but now it can be any influenza strain that becomes pandemic, further details unknown. As influenza pandemics occurred in 1918, 1957, and 1968, another one is likely. But why should we be any more worried in 2007 than in 1997 or 2017? Couldn't those responsible for planning for the next pandemic do their planning less publicly and put the frighteners on the rest of us at the appropriate time?"

Vitamin D & Thee

My Canadian friend Alan Cassels co-authors a column in the Toronto Globe and Mail about how drug companies have countered news about what Vitamin D can do. Excerpt:

"...For decades, the data have been building, showing that larger amounts of vitamin D are good for you. Animal studies and large human studies have shown that taking a lot more vitamin D than 400 units is both safe and beneficial.

You don't have to dig too deeply to find evidence that the drug companies habitually wield science in a way that benefits, above all, their investors. Spinning the science has shaped the minds of regulators, members of the medical profession and, of course, the consumer against this simple, cheap and remarkably effective vitamin.

But how might the thinking unroll in the executive suite of a large company manufacturing patented drugs?

First: You know vitamin D is good, but you can't make any money out of it because you can't patent the damn stuff. No promise of sizable profits means unhappy shareholders. Can't have that.

Second: If vitamin D actually stops people from getting sick, it can take a serious chunk out of the market for the patented medicines we currently make. Can't have that, either.

Third: If people increase their production or intake of vitamin D (and a host of other key nutrients, through diet and lifestyle, or supplements), they might stop worrying so much about their health. So, the market for fear-based products —drugs that lower "nasty" cholesterol, alter blood pressure and improve blood sugar — could well shrink. This is definitely not good for shareholders.

Given this fact pattern, how have the leaders in corporate medicine responded to this potentially difficult competitor?

First: They've worked on promoting the message with regulators and doctors (and you, dear reader) saying too much vitamin D could be bad for you. Reinforcing the "recommended daily allowance" message (despite being based on outdated and unscientific assertions) prevents people from taking vitamins in doses large enough to compete with patented products. Despite scant evidence to this effect, they've suggested that a host of micro-nutrients will make people sick if taken in too large amounts.

Second: They've played down the dangers associated with patented products with the message that prescribed drugs must be "safe" because they are rigorously studied by our companies, approved by Health Canada, prescribed by competent physicians and dispensed by helpful pharmacists. You can't say the same about vitamin D, right?

Third: They've used their giant drug studies (which the regulator requires them to do, in order to license their patented medicine) and flooded medical journals, inserted themselves into physician education and made sure the media got the right spin on those products. The punchline: Drug good, vitamin bad."

Lots of interesting reader comments are linked at the end of the online column. One writes, "MUCH better use of valuable space in the (paper) than all that crap about Paris whats-her-name."

Pharma's growing influence on continuing medical education

The Washington Post reports on a troubling trend:

Drug companies have become the biggest sponsors of continuing medical education courses in recent years, even at the nation's top medical schools, a development that critics say raises health-care costs, skews doctors' treatment decisions and allows the industry to skirt laws against advertising "off-label" uses for its products.

The trend accelerated after the government backed off a plan to limit commercial sponsorships in 2002 at the urging of the industry, Senate investigators said.

Now, nearly two-thirds of the cost of continuing education courses sponsored by medical schools, popular for their prestige, are paid for by drug and medical device companies and other commercial interests, figures show. Overall, commercial sponsors pick up about half of the $2.25 billion annual cost of the courses doctors must attend to keep their licenses.

"Most of what doctors know about drugs comes from the industry, and that's not healthy," said Jerry Avorn, a Harvard Medical School professor and critic of the sponsorships. "Academic organizations lend their names to courses that are nothing more than infomercials."

Jeer to Alzheimer's Association statement

The Integrity In Science Project of the Center for Science in the Public Interest delivers a "jeer to the article in the June issue of the AARP Bulletin highlighting Alzheimer’s Disease drugs under development. The story prominently quoted Sam Gandy, chair of the National Medical and Scientific Advisory Council of the Alzheimer's Association and director of the Farber Institute for Neurosciences in Philadelphia, unequivocally stating that disease-altering drugs will be available within three years with Neurochem’s Alzhemed possibly approved as early as next year. What the 20 million-circulation paper didn’t report is that the Farber Institute is one of many sites conducting final clinical trials on Neurochem’s Alzhemed."

In the article, Gandy says, "Within three years, it's all but certain we'll have disease-modifying drugs that fundamentally change the nature of Alzheimer's."

Nothing in science is all but certain three years out.

No cure for Reader's Digest hype

The cover of the July Reader’s Digest refers to back pain “cures.” The inside headline refers to seven “breakthroughs.”

C’mon Reader’s Digest: stop the hype. Here are the seven:

1. A neurostimulator for which RD provides not one shred of evidence – only anecdote.
2. An infrared belt which the inventor “is trying to get approved.” Cost: $2,335!
3. A “magic” spine wand. (I’m not into the Harry Potter School of Health Care Devices.)
4. A flexible spine support system as an alternative to fusion. Again, no evidence provided, only anecdotes.
5. Stem cells to regenerate damaged disks. The story admits that human trials are two years away. Kinda early to be talking “cures” and “breakthroughs.”
6. A “grow a new backbone” idea that’s only been tested in rats and mice. Good news for rodents with back pain.
7. Get a new bed. Even the article admits “it sounds like cheerleading from bedding companies” and discloses the study was partly sponsored by a sleep products trade group.

Final score:
Headline hype: 7
Cures & breakthroughs: 0

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.

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.

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 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."

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.

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."

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.

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."

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."