The New York Times reports on the testing and approval of an artificial spinal disc - the Prodisc. The Times says the case "provides a stark example of conflicts of interest among clinical researchers — conflicts that are seldom evident to doctors and patients trying to weigh the value of a new device or drug. Instead of serving as objective gatekeepers who can screen out potentially harmful or ineffective new devices or drugs, clinical researchers with conflicts may have incentives to overstate the value of a new product for patients."
I've been meaning to blog about this for some time.
Paul Goldberg of The Cancer Letter allowed the PRWatch.org website to post one of his columns about how the Amgen drug company seemed to try to circumvent regulations on off-label claims about drugs by inviting patient testimonials on a website called ProtectCancerPatients.org.
Goldberg wrote:
Though the Internet designation ".org" suggests that the site is operated by an advocacy group, the "privacy policy" section notes that "this site is owned and operated by Amgen Inc." and can be used for communications with the company.On the home page, the site is described as "online headquarters of a national campaign to protect cancer patients on Medicare from a decision denying them ... coverage for needed medicines."
"Amgen's mission is to serve patients, which is why we openly support the Protect Cancer Patients website," Kelley Davenport, an Amgen spokesman, said in an email. "The site educates cancer patients on Medicare and their caregivers about a Medicare policy that impacts cancer patients, so that their voices and concerns are heard by government policymakers.
"As evidenced by the personal testimonials on the site, the current Medicare policy will have a significant, direct impact to cancer patients on chemotherapy, and will limit the ability of physicians to make well-informed treatment decisions for their patients," Davenport said.
In testimonials, patients and their family members wrote that ESAs alleviated symptoms of anemia, improved quality of life, and were essential for survival. (Excerpts from the testimonials appear below.)
Considering that ESAs are approved only as a substitute for blood transfusions in solid tumors, many of these letters were discussing off-label uses, thereby potentially exposing the company to an FDA enforcement action, said several attorneys familiar with regulation of drug promotion.
"The question is Amgen's control over what went on there," said a former FDA attorney, who spoke on condition that his name wouldn't be used. "Unless Amgen gave a blind grant to somebody and had no idea that this was going to happen, they have potential liability."
When pharmaceutical companies are caught making claims beyond the label, punishment is usually limited to warning letters and the public embarrassment they create, lawyers say. "On a lobbying campaign like this, a company like Amgen views this as just one battle in the campaign," said Sheldon Rampton, research director of the Center for Media and Democracy and author of books on the public relations industry. "It's conceivable that they may end up suffering some minor consequence, but if the rest of the effort succeeds in overturning the CMS decision, they will have lost this battle but won the war."
The Integrity in Science Watch project of the Center for Science in the Public Interest has a weekly e-newsletter that includes cheers and jeers for certain aspects of health care journalism. This week's:
* Jeer to Alicia Chang of the Washington Post for failing to mention that the authors of a study supporting the off-label use of drug-eluting stents received funding from Cordis, Boston Scientific and Abbott Vascular, all manufacturers of drug-eluting stents.* Cheer to Stephanie Saul of the New York Times for noting that the American Heart Association, which has defended the cholesterol drug Vytorin in recent weeks, receives $2 million a year from Merck/Schering-Plough Pharmaceuticals, the joint venture that markets Vytorin.
I'm drooling, but I shouldn't be. John Carey of BusinessWeek has the cover story this week, entitled, "Do Cholesterol Drugs Do Any Good?" I'm not going to post an excerpt because I want everyone to read the entire article. It's that good - and that rare. I'm drooling over it but I shouldn't be, because the themes he explores should be part of all news stories making claims about new ideas in health care.
Carey explores absolute vs. relative risk statistics - showing how the latter are abused and are misleading to the general public to trump up drug benefits. But he also is one of the only journalists I've ever seen explore and explain another statistical tool - the Number Needed to Treat or NNT.
See his insert on this important statistic. It will raise questions about the way drugs are promoted and sold to hundreds of thousands of people who won't benefit from their use.
When I wrote the Statement of Principles of the Association of Health Care Journalists, I urged health care journalists to "consider explaining the 'number needed to treat' - the number of people you would have to treat with the experimental intervention (compared with the control) to prevent one event." And I included tips on how to do that. But it rarely, VERY rarely ever happens.
Carey and BusinessWeek hit a home run with this cover story. Kudos to them. Keep up the good work. Let's hope other journalists - and certainly consumers of news and health care - learn from this excellent piece of work.
Journalist Jeanne Lenzer was interviewed on NPR's On The Media program last weekend, talking about drug compression suppression of negative data.
Her main points:
1.) Some patient deaths are considered "trade secrets" and are not reported
2.) New England Journal of Medicine reported last week that 97% of positive studies of antidepressants were published but only 8% of negative studies were reported as negative (the rest were either spun as positive or not reported at all).
3.) Data suppression is pervasive and affects far more than just antidepressant trials.
On his blog, Merrill Goozner (author of The $800 Million Pill) writes about drug company profits at 20% of sales.
Excerpt:
"The industry may be dogged by expiring patents, a collapsing new drug pipeline, and a steady drumbeat of bad news on its best-selling drugs like Vytorin, but none of it appears to have affected the bottom line. Only beverage and tobacco companies came close to the drug industry's profit margins. Even with $3-a-gallon gasoline, the oil and gas industry lagged far behind with profits at 8.7 percent of sales.Perhaps the pummeling the drug companies are taking on the campaign trail from the leading Democrats signals the salad days are behind the industry. Each of the leading candidates is promising to give Medicare the right to negotiate drug pricing, which, given the larger role the government is playing in overall drug sales because of the senior drug benefit, should put a dent in those profit margins."
Although I said I was on a blog break until January 22 because I'm on vacation and should be out on the beach, when I read about this, I had to share it with those who may not have seen it.
An Eau Claire, Wisconsin newspaper reports the following:
"One year after being hired as WEAU TV-13 news director, Glen Mabie has resigned because of a disagreement with station management regarding coverage of medical topics.According to Mabie and other sources close to the situation, station management attempted in recent weeks to negotiate a deal with Sacred Heart Hospital in which TV-13 would run medical stories featuring personnel from that hospital and its affiliates but not employees of other Chippewa Valley hospitals or clinics.
That didn't sit well with Mabie, who said an exclusive deal with Sacred Heart posed an obvious conflict of interest that called the newsroom's objectivity into question. Mabie said he was unsure whether the hospital would pay TV-13 as part of the agreement.
"My problem with this is it was going to dictate newsroom content," said Mabie, whose last day at TV-13 was Friday. "I told myself that I could not with a clear conscience go into that newsroom and tell the staff that this was a good thing."
If this went down as the newspaper reports, my hat goes off to Glen Mabie, the only news executive I've heard of in this country who spoke up and stood up against this very common practice. Health news is being sold to the highest bidder in many communities.
In the past, I've blogged about this practice and how widespread it is. How and why the Radio-Television News Directors Association - whose code of ethics clearly addresses such practices - fails to address this directly and openly should be a source of embarrassment to that organization.
And to all other station managers and news executives who - unlike Glen Mabie in little Eau Claire, Wisconsin - have looked the other way and allowed this practice to continue, shame on you. Viewers of these stations should turn away from your "product" and never come back.
Princeton economist Uwe Reinhardt writes in this week's BMJ (subscription required for full text) about a humbling visit to see "Taiwan's highly efficient system of national health insurance."
Excerpts:
"Taiwan introduced its national health insurance system on 1 March 1995, after less than a decade of planning that went ahead in textbook fashion. After visiting the health systems of numerous other nations, Taiwan’s policy planners used the insights gained to develop what has been described as "a car made from many parts produced abroad but assembled in Taiwan." It took only 18 months for the plan to make its way through the legislative chambers in 1993-4. At the behest of Taiwan’s then president, Lee Teng-hui, it was implemented in less than a year. Overnight, health insurance coverage in Taiwan jumped from roughly 57% of the population before 1 March 1995 to virtually the entire population. For US policy makers and presidential contenders—who for half a century now have engaged in a perpetual "national conversation" on universal health insurance, only to see the number of uninsured people grow apace over the years—the speed of Taiwan’s move to a national health insurance system seems downright surreal. ...In the absence of national health insurance Taiwan would today probably have a highly stratified healthcare system, with top tier, US style care for the rich funded by private insurance, a social insurance system for the employed middle class with highly variable quality of care, and much less or nothing for millions of uninsured poorer citizens. ...
Loss of health insurance and fear of bankruptcy over medical bills is a growing fear among millions of Americans; it has not been in Taiwan since 1995. In a globalised economy that subjects Taiwan’s low skilled workers to ever fiercer foreign competition from low cost labour elsewhere in Asia, the safety net of the national health insurance system represents one of Taiwan’s major public assets."
Pfizer, battling for its Lipitor drug which is now facing generic competition from simvastatin, has trotted out one-time artificial heart inventor Dr. Robert Jarvik for what have become ubiquitous TV ads. But the Wall Street Journal's health blog reports a new twist to the Dr. J story. Excerpt:
Now Congress has seen enough of Jarvik to ask Pfizer some questions about his qualifications to be recommending the cholesterol buster.The House Committee on Energy and Commerce said today that it is investigating the use of celebrity endorsements in marketing prescription drugs directly to consumers. And Jarvik is Celebrity No. 1 on the list.
“In the ads, Dr. Jarvik appears to be giving medical advice, but apparently, he has never obtained a license to practice or prescribe medicine,” John Dingell (D-Mich.), chairman of the committee, said in a press release.
I'm late in drawing attention to an article from several weeks ago in U.S. News & World Report.
It was headlined, "Who's Behind the Bible of Mental Illness: Critics say that touted efforts against conflicts fall short." Excerpt:
In what is arguably the most important mental-health development since the early 1990s, the American Psychiatric Association will spend the next five years producing a new edition of the psychiatrist's "bible," the official guidebook for diagnosing mental problems. The Diagnostic and Statistical Manual of Mental Disorders, as it is known, is hugely influential because it determines what is and is not a mental disorder. In turn, it is responsible for much of the sales growth in prescription drugs.The most recent edition of the DSM, published in 1994, drew controversy because it turned what had once been a thin guidebook into an 886-page tome that significantly expanded the definition of mental illness. Traits once associated with shyness, for example, became symptoms of "social anxiety disorder." And drug companies went on to spend millions promoting medicines for those problems. Eyebrows were further raised in 2006 when a study showed that more than half of the researchers who worked on the manual had at least one financial tie to the drug industry.
This time around, pledging to avoid even the appearance of conflicts, the APA has instituted screening procedures for the 27 members of its DSM task force, asking them for detailed financial information about stocks, honoraria, and consulting fees from drug interests. It calls the effort the "most transparent" in the medical industry. Yet the summaries of the disclosure statements that were recently released to the public are remarkably spare; they show only the existence of corporate connections, not their dollar amount or their duration. The result is a document that even an APA board member suggested is not very revealing. In a 2006 memo to the board obtained by U.S. News, William Carpenter wrote: "Simple listing of all relationships is not very informative and does not identify potential conflicts that may need to be resolved."
Last year I published an article documenting several instances of U.S. journalists' apparent bias in favor of certain screening tests - in the absence of evidence supporting such tests in they way they were being promoted.
Now it's just come to my attention that an Australian team published an article in November describing an analysis of Australian news coverge of prostate cancer screening. Their conclusion:
"Australian men are exposed to unbalanced and often non-evidence-based appeals to seek PSA testing. There is a disturbing lack of effort to redress this imbalance."
Of special note is how the authors documented the "widespread, overwhelmingly negative" reaction to a statement by the head of an Australian cancer agency who told a newspaper that, at age 59, he chose not to have a PSA test.
And journalists seemed to join in the ad hominem attacks. All because the man spoke from a perspective of evidence and science, not faith and emotion.
We will continue to follow journalism's role in promoting non-evidence-based approaches and will address it whenever we see it.
A new article in PLoS Medicine, "The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States," concludes that:
"...it appears that pharmaceutical companies spend almost twice as much on promotion as they do on R&D. These numbers clearly show how promotion predominates over R&D in the pharmaceutical industry, contrary to the industry's claim. ...(This) confirms the public image of a marketing-driven industry and provides an important argument to petition in favor of transforming the workings of the industry in the direction of more research and less promotion."
Here are a couple of online guides to presidential candidates' positions on health care reform.
The Kaiser Family Foundation offers Health08.org.
The Association of Health Care Journalists has posed journalists' questions to candidates. At this point only three have responded, but all responses are posted online.
WebMD has a "Health Matters in the 2008 Election" section.
This is not a complete list - just a few that caught my eye with features many people may find helpful.
The drug industry often claims that the free samples of prescription drugs they give to doctors help the uninsured or those with low incomes. But - no big surprise - a study published in the American Journal of Public Health shows those people are the least likely to get the freebies.
A Reuters story quotes co-author Dr. Sara Cutrona: "Our findings suggest the free samples serve as a marketing tool, not a safety net." Other excerpts from that story:
"About $16.4 billion in drug samples were given out in the United States in 2004, up from $4.9 billion in 1996, the study said. Distributed by sales representatives, samples are nearly always the newest, most expensive drugs, the report said.Critics have said that in addition to steering doctors and patients to pricey drugs, samples can lead to medications being used for conditions they were not intended to treat.
Drugmakers are forbidden from recommending drugs for uses for which they have not been approved by the U.S. Food and Drug Administration, but doctors can prescribe drugs for any use.
The now-recalled painkiller Vioxx, made by Merck & Co, was the most frequently distributed free drug sample in 2002, the study found.
Vioxx was often prescribed beyond its approved uses before it was withdrawn from the marketplace because of a link to an increased rate of heart attacks and death."
Jeff Cohen and Norman Solomon have posted their 2007 P.U.-litzer Prizes for "the year's stinkiest media performances."
Two health-news-related pieces made the list. Here's what the judges said:
"AMERICANS DON'T WANT UNIVERSAL HEALTHCARE" AWARD -- Jeff Greenfield of CBS, et al.Reflecting what became mainstream media's conventional wisdom in the wake of Michael Moore's "SiCKO" documentary, CBS correspondent Greenfield explained that the U.S. lacks a universal healthcare system not because of the powerful insurance lobby -- but because "Americans are just different." He quoted an academic who said Americans, unlike Canadians and Europeans, don't want government involvement in healthcare: "It's a cultural difference."
Actually, CBS's own poll of Americans had found 64 percent supporting the view that the federal government should "guarantee health insurance for all" -- with 60 percent approving of higher taxes to pay for it. A CNN poll found 64 percent American support for the idea that "government should provide a national health insurance program for all Americans, even if this would require higher taxes."
"IT'S TRUE BECAUSE WE SAID IT" AWARD -- CNN's Lou DobbsTo prove his claim that illegal immigrants were bringing "once eradicated diseases" into our country, Dobbs featured a CNN reporter in 2005 who claimed that the United States had seen only 900 cases of leprosy for 40 years -- but that "there have been 7,000 in the past three years." This year, in May, Dobbs was challenged on the shocking statistic by Lesley Stahl on 60 Minutes, who cited a federal report saying there were 7,000 leprosy cases over the last 30 years. Dobbs' response: "If we reported it, it's a fact."
Stahl: "How can you guarantee that to me?"
Dobbs: "Because I'm the managing editor, and that's the way we do business. We don't make up numbers, Lesley. Do we?"
You do, Lou. The Centers for Disease Control report that new leprosy cases in the United States have been on the decline for close to 20 years (with 166 cases in 2005).
Bioethicist Carl Elliott has a terrific and disturbing article in The New Yorker (subscription required for full text) about the demand for healthy human subjects for drug safety trials. Elliott quotes an attorney representing volunteers injured at commercial testing sites: "This is something the poor do so that the rich can get better drugs."