Dr. Robert Jarvik had his moments of fame promoting his Jarvik-7 artificial heart. When it failed, he turned to promoting the heart drug Lipitor. (NBC's Robert Bazell opines.)
Dr. Howard Torman had a few moments of fame as a CBS News medical correspondent. When that dried up, he turned to doing TV ads for Viagra. Those ads are running currently, including a tight shot of Torman's name badge on his white coat, as if that means anything to millions who never heard of him or did but forgot.
Four years ago, ABC News medical correspondent Dr. Nancy Snyderman was suspended without pay for a week by the network after she recorded a radio commercial for Tylenol. She left ABC a few months later to become vice president of medical affairs at Johnson & Johnson—the company that makes Tylenol. Now she's back on the air, as NBC chief medical editor. When you read Snyderman's bio on a speaker's bureau website, you'll see that the NBC gig shares top billing with her former J&J drug company work.
Celebrity may be lucrative for these doctors-turned-salespeople. But there's also a price for celebrity. Is integrity part of the price?
The FDA has approved another wrinkle filler, and the Wall Street Journal (subscription required) reports that it has touched off competing claims from makers of other wrinkle fillers.
An exec of the new product's company says his product "will cost a patient roughly $850 a year versus $2,400 for comparable enhancement" with another product.
I hope for two things regarding this story:
1. My insurance company doesn't cover these "treatments."
2. There is no one in my insurance pool who asks for or pursues these "treatments."
I will not smile if my premiums go up because lots of people ask for these products (or lots of doctors recommend them) to "temporarily correct smile lines." Maybe a frown is appropriate in this case.
The Wall Street Journal (subscription required) reports on another questionable editorial decision by the editors of the New England Journal of Medicine.
The WSJ reports: "The New England Journal of Medicine last month published studies warning that aggressive efforts to treat anemia in kidney-disease patients with the drug erythropoietin, or EPO, as recommended by the National Kidney Foundation, appear to increase the risk of heart failure and the need for dialysis. But the medical journal spiked an opinion piece commissioned from one of its senior writers that was critical of the foundation's reliance on multimillion-dollar donations from the companies that make such drugs.
The journal did run a less-critical editorial on the studies co-authored by Julie Ingelfinger, a nephrologist and deputy editor at the journal who is the immediate past president of the Massachusetts-based chapter of the National Kidney Foundation and a member of the state group's medical advisory board. The editorial that ran made no mention of the foundation's industry funding, and Dr. Ingelfinger's relationship with the foundation wasn't disclosed.
Meanwhile, the author of the spiked editorial, Dr. Robert Steinbrook, submitted it to one of the journal's chief rivals, the British medical journal Lancet, which ran a version on its Web site on Nov. 17, a day after the New England Journal published its reports on the matter.
Dr. Steinbrook's article said that the foundation's guidelines have been questioned because of the group's close relationship with the drug industry. The article also noted that in fiscal 2005, the foundation received more than half of its support from "corporate and organizational partners," and, in the calendar-year 2005, it received $4.1 million from Amgen Inc. and $3.6 million from Johnson & Johnson's Ortho Biotech, the current marketers of EPO in the U.S. Of the 18 members of the group that formulated the guidelines, two-thirds disclosed financial associations with Amgen or other EPO manufacturers or marketers, he noted.
Dr. Steinbrook commented that "given the billions of dollars at stake for the drug and dialysis, such guidance is likely to receive the broadest acceptance if developed without industry support and by experts without relevant financial associations."
The editorial that was published in the New England Journal also expressed doubt about the kidney foundation guidelines -- saying "these recommendations are not based on persuasive randomized, controlled trials" -- but made no mention of the industry funding of the kidney foundation."
Two years ago, I wrote about how the Minneapolis Star Tribune had acted like a cheerleader on behalf of a local company whose product was a mesh-like sock to go around the heart in hopes of combating heart failure.
Over two straight days, the paper reported on the company's trial results with the sock. The stories did not have one comment from an independent medical source. But they did promote the company's "bullish" attitude about "the future of their unsual device as well as the company's prospects."
When the paper reported on a trial, in which the sock group was compared with a non-sock group of patients, the paper said the sock group scored better in "improvement" (not defined). There was no mention of complication rates. There was no discussion of whether the results were statistically significant, or whether they could have been due to chance.
The Wall Street Journal also reported on the sock study, but pointed out that the "sock didn't lead to a significant improvement in ejection fraction, the percent of blood that is pumped out of the left ventricle during a beat and a widely used measure of the strength of the heart."
The Star Tribune coverage felt naive and pro-local-business.
Last week, the cheerleading ended. The Star Tribune was forced to report, "The future of a New Brighton medical technology company remains unclear after a U.S. Food and Drug Administration panel ruled Friday that it may need to conduct a new clinical trial for the firm's sole product -- a unique device that treats heart failure. ...The company based its initial FDA application on a 300-patient trial. A similar study, if required by the regulatory agency, could cost Acorn an additional $20 million and take about three years to complete."
Journalists should review data and evidence and seek independent analysis of ideas in medicine, not local companies' bullish attitudes about their own products.
The Cleveland Plain Dealer reports on a new case of apparent conflict of interest with an influential Cleveland Clinic surgeon.
According to the Plain Dealer, the surgeon "pioneered and promoted a new treatment for spinal fractures after he was offered valuable stock options in the company that made the equipment used in the procedure. ... (This) provides another local chapter in what is playing out as a national saga: The potential for conflict between physicians' financial interests and their duties to patients."
The paper reports that the Clinic says the surgeon did not tell his patients about his financial conflict of interest unless asked. Meantime, the paper explains, "records indicate that there has been a disproportionate increase in reported deaths nationally associated with the procedure (called kyphoplasty) in the last three years."
Penn bioethicist Art Caplan is quoted: "This is a classic tale of why you wind up with a lot of technologies that are marginally better or turn out not to be better at all than what you already had - because you rely on reports from innovators who have economic dogs in the fight."
It's another story of questionable promotion of a screening test, of "off-label" promotion of a drug, of risk-benefit decisions, and of behind-the-scenes drug company wrangling for broader use of one of its drugs.
The Wall Street Journal (subscription required) reports on a controversial push by some doctors for testing all pregnant women for genital herpes to reduce infections in newborns. Of course, it would also mean a boost for GlaxoSmithKline, which has a herpes drug, and which supports the "continuing medical education" lectures promoting the screening.
The WSJ reports: "Advocates of screening point to a stark reality: Babies born to a woman whose herpes infection is active can end up blind or with cerebral palsy, and some die. An estimated one-quarter of pregnant women in the U.S. carry the herpes virus in their bodies.
Yet only a small fraction of these women are at any risk of passing the virus to their babies. It's not clear whether treating infected women with herpes drugs would reduce this number. Meanwhile, most pregnant women who have the virus don't even know it. And they aren't routinely tested to find out.
Federal health agencies that have studied the possibility of universal screening of pregnant women for genital herpes have come down against it. So has the American College of Obstetricians and Gynecologists. Opponents see little benefit but potential risks if large numbers of women tested positive and began taking herpes drugs. Their side effects can range from allergic reactions to hypertension.
Glaxo says it doesn't market its herpes drug, called Valtrex, in any way for pregnant women. The company couldn't promote the drug to prevent neonatal herpes in any case, because the Food and Drug Administration hasn't approved it for that purpose.
Doctors, however, aren't restricted in how they use an approved drug, nor in what they can say about it in talks to other medical professionals. And currently, about 10 doctors are fanning out across the U.S. making the case for universal genital-herpes screening of pregnant women. Glaxo funds these talks by giving grants to hospitals and other institutions that host them."
One Ob-Gyn in the story said, "A screening program will be horribly inefficient and almost entirely ineffective and highly cost-ineffective. There are a few people who have made careers out of neonatal herpes and they are the ones pushing screening."
It's a messy story, well-reported by the WSJ.
The New York Times reports that drugmaker "Eli Lilly encouraged primary care physicians to use Zyprexa, a powerful drug for schizophrenia and bipolar disorder, in patients who did not have either condition, according to internal Lilly marketing materials."
The Times reports the campaign was first called "Viva Zyprexa." "Lilly considered ways to convince primary care doctors that they should use Zyprexa on their patients. In one document, an unnamed Lilly marketing executive wrote that these doctors 'do treat dementia' but 'do not treat bipolar; schizophrenia is handled by psychiatrists,' " according to the Times report.
The Times explains: "The issue of off-label marketing is controversial in the drug industry. Nearly every company is under either civil or criminal investigation for alleged efforts to expand the use of its drugs beyond the specific illness or condition for which they are approved. Lilly faces federal and state investigations over its marketing of Zyprexa."
The paper also reports that sales of Zyprexa doubled between 1999 and 2002, rising from $1.5 billion to $3 billion in the United States.
A primer on off-label drug use and promotion is available on the HealthNewsReview.org website.
I teach my classes - even undergrads - that if I could change just one thing about the way in which research news is communicated to the public - for the sake of public understanding - it would be to include absolute risk/benefit data in each story or each message - not just relative risk/benefit data. On the HealthNewsReview.org website, we evaluate stories on whether they include absolute data. We also offer a brief primer on the topic. Failing to include absolute data may make the outcome seem much larger than it really is.
But even medical journals don't do a good job of demanding that absolute data be included in article submissions, according to a review in this week's BMJ. In it, Dartmouth/VA researchers looked at 222 articles over a year's time in six journals: Annals of Internal Medicine, BMJ, Journal of the American Medical Association, Journal of the National Cancer Institute, Lancet, and New England Journal of Medicine.
They found that 68% of articles failed to report the underlying absolute risks in the abstract of the article, and half of these didn't report absolute data anywhere in the article.
The authors' conclusion: "Absolute risks are often not easily accessible in articles reporting ratio measures and sometimes are missing altogether—this lack of accessibility can easily exaggerate readers' perceptions of benefit or harm."
The relative inaccessibility of absolute data is no excuse for journalists. If you're going to cover research news, you need to do it completely and correctly, and that includes getting at the absolute data - even if the journal article upon which you base your story doesn't include such data. Journalists should demand it from researchers they cover, just as journals should demand it from researchers submitting articles.
Competition among news organizations is a good thing. Readers and viewers already get far too many reports that are regurgitated in similar fashion from the same source.
But big media companies increasingly are going in the other direction: hiring big media names to serve two masters simultaneously.
The latest is CNN's Dr. Sanjay Gupta, who, according to Broadcasting & Cable magazine, will begin contributing up to 10 medical reports a year to the CBS Evening News.
OK, to whom does he give his best stuff? How would we know it's his best stuff? Is he saving a little extra for the CNN folks who gave him his break in TV news? Or does he save his "A" game for new viewers in his shot at one of the Big 3 audiences?
And CBS already has Dr. Jon LaPook, Katie Couric's doctor-friend. When might they hire a real medical journalist, rather than a doctor playing one on TV?
The U.S. is one of only two countries that allows direct-to-consumer prescription drug ads. And the U.S. General Accounting Office says the FDA isn't reviewing enough ads completely enough or fast enough, according to the Associated Press.
Key points about the GAO report, according to AP:
"From 2002 through 2005, it took the Food and Drug Administration four months on average to draft, approve and send warning letters and other correspondence to companies that were in violation of the rules."
"The FDA lacks an effective way to screen, review and track the more than 10,000 ads and Web sites brought to the agency's attention each year. The amount has doubled in just four years."
The report says the FDA has only six people reviewing these ads.
We have screening tests that find "pre-cancerous" conditions - the true danger of which we know little.
We have defined a new category of "pre-hypertension" - labeling millions more Americans with "a condition."
And now read this column claiming that one in six Americans - "54 million of us" - have "pre-diabetes."
I am relieved to see one journalist who caught disease-mongering in full bloom. Pam Kelley of the Charlotte Observer was peeved by a Wall Street Journal health column on "female sexual dysfunction." In her article, "Don't tag all libido swings as disorders," Kelley wrote that the WSJ column "cites a study that found 42 percent of women in early menopause 'had scores indicating sexual dysfunction.' In late menopause, 88 percent 'had scores below the cut-off for sexual dysfunction.' "
Kelley continued, "Why does a decline in sexual desire mean you're dysfunctional? And if almost everyone in a study -- 88 percent -- scores the same way, how come they're the dysfunctional ones?"
More journalists and more consumers need to be armed for the onslaught of disease-mongering campaigns - some from well-intentioned caregivers and some from profit-motivated drug companies.
The Center for Science in the Public Interest (CSPI) reports on multiple waivers of conflicts of interest on three recent FDA advisory panels. Three experts with financial conflicts were allowed on this week's advisory panel on adult suicide risk from antidepressants. According to CSPI, one received between $10,000 and $50,000 per year from one of the companies affected by the panel hearing.
Last week, seven waivers were granted to members of a panel discussing safety concerns about Sanofi-Aventis' antibiotic Ketek.
And the FDA gave financial conflict-of-interest waivers to six physicians who sat on the advisory panel that evaluated the safety of drug-eluting stents made by Johnson & Johnson and Boston Scientific.
CSPI does a tremendous public service by disclosing what's going on at the FDA. The public - and many journalists - don't know the extent to which conflicts of interest may impact the integrity of science and of health care recommendations. We need to have a deep and ongoing public discussion about what these conflicts mean, how to judge them, and how to ensure unbiased review of new drugs and devices given the prevalence of conflicts of interest among America's physician-researchers.
On the HealthNewsReview.org website, we're making a new effort to compare how different news organizations did in covering the same story. Our broadest analysis yet is now posted in a Publisher's Note on that site.
It covers eight different stories by seven different news organizations on the recent study published in the New England Journal of Medicine on CT scan screening of smokers.
Summary:
* 6 of 8 failed to adequately discuss potential harms of such screening, which can include radiation exposure, needless anxiety after receiving a potentially false positive result and significant medical complications associated with biopsies.
* 6 of 8 stories failed to adequately address the availability of CAT scan machines that can be used for the lung cancer screening described.
* 4 of 8 stories failed to discuss the costs of such screening, which were discussed in the journal article upon which the stories were based. Estimates range from $200 to $1,000 per scan, so this is a significant issue that half the stories ignored.
* 5 of 8 stories relied on a single source (relying only on authors of the published study) and/or failed to present balanced, independent perspectives.
Several news organizations - the Wall Street Journal and American Public Media's Marketplace - have reported that the Food and Drug Administration has reached an agreement with the pharmaceutical industry that would require companies, for the first time, to pay fees to the FDA for the work of reviewing their TV drug ads, in exchange for speedier reviews. The Wall Street Journal story included this line: “The FDA is unusual among federal agencies because it negotiates with the companies it regulates, which are represented by their major trade organizations, over the amount and use of fees the industry pays to the agency.“
“Unusual” is mild. Controversial is more direct and appropriate. The current system of industry user fees has been criticized because of the potential pressure and conflict of interest it places on reviewers. In the Marketplace piece, Professor Steven Schondelmeyer of the University of Minnesota says, "It does create sort of a provider-client relationship where the agency begins to view that they're working for the industry that they're regulating, moreso than they're working for the public as a whole."
Don’t expect this move, if it happens, to put much more than a little speed-bump in the path of the runaway and troublesome TV drug ad business.
Advertising Age reports that such advertising budgets have boomed in the past ten years, from $12 million to $4.1 billion.
I was on a panel yesterday kicking off the University of MInnesota's celebration of the 40th anniversary of pancreas transplantation. But this panel was on “The First Face Transplant: Clinical, Ethical and Media Perspectives.” It featured French surgeon Dr. Jean-Michel Dubernard, who performed a partial face transplant one year ago.
That procedure, and Dubernard's earlier hand transplant work, are spectacular technical achievements. But Dubernard complained about the multiple levels of ethics committee oversight that he faces.
Such oversight is essential. Many questions should be and are being raised about patient selection, about informed consent, about alternatives, about evidence of harms and benefits, about costs, about access to such procedures.
I was on the panel to discuss issues of news media ethical issues surrounding coverage of such innovative surgical experiments. I argued that such coverage should be comprehensive and proportional: comprehensive in covering the range of issues outlined above and proportional in considering that there are 47-million Americans without insurance who have problems accessing basic preventive care much less costly experimental procedures.
A study in Health Affairs shows that more than half of the nation’s uninsured are ineligible for public programs such as Medicaid but do not have enough resources to purchase coverage themselves.
In a Health Affairs news release, lead author Lisa Dubay, now a research scientist at the Johns Hopkins Bloomberg School of Public Health, said, "Sometimes you hear arguments that all but a small minority of the uninsured could either purchase coverage or are already eligible for assistance. But our study shows that the affordability problem is far more serious than that.”
This study was released more than a week ago and I have seen very little news coverage of it. There are 47 million uninsured Americans. It's the job of journalism to give voice to the voiceless, to comfort the afflicted and to afflict the comfortable. It ain't happening on this issue.
Isn't it ironic? The "consumer-directed" health plan (CDHP) movement, which is supposed to promote consumer choice, may actually be fostered in an environment that limits consumer choice.
A national study released by the Center for Studying Health System Change shows that 4 in 10 workers who were in such plans in 2006 had no choice of another type of plan.
"While consumer-directed health plan proponents often assert that the high-deductible plans linked to savings accounts offer enrollees greater choice and autonomy in the health care marketplace, 39 percent of the estimated 2.7 million workers enrolled in employer-sponsored CDHPs had no choice of another type of plan in 2006."
The report concludes: "In the employer-based market CDHP enrollment may ultimately take off in a manner similar to the early experience of PPOs. For the moment, however, CDHPs have gained only a toehold in the employer-based market, and health plans appear to be more enthusiastic about consumer-directed health care than are employers, who in turn are more enthusiastic than employees."
The current issue of Health Affairs is a special edition on the eroding relationships between many hospitals and physicians. Here's an excerpt from the lead article, out of the Center for Studying Health System Change in Washington.
"Because many services performed in hospitals can safely and conveniently be performed in ambulatory settings, physicians have become owners of entities directly competing with hospitals for patients in a new medical arms race. Hospitals and medical staff physicians face growing tensions as a result of physicians' growing reluctance to take emergency department call and the consequences of hospitalists replacing physicians in the care of inpatients. Although there are increasing expectations that health system challenges will lead hospitals and physicians to collaborate, in many markets the willingness and ability for hospitals and physicians to work together is actually eroding.
...A major source of wasted spending lies in unwarranted intensity of hospital and physician services, particularly for patients in their last months of life. Yet instead of working together to address excessive health care spending, physicians and hospitals have renewed a "medical arms race" that is driving up costs even faster, sometimes as collaborators but increasingly as competitors.
The health care system has relied on hospitals to serve as providers of last resort for uninsured patients with emergencies. Hospitals in turn have relied on community physicians to be on call to their EDs. But that reliance is now called into question as even more insured and uninsured patients seek care in EDs that have problems assuring physician coverage."
Not a pretty picture and not one most health care consumers are aware of. This is an issue that should be explored in the mainstream news media.
The New York Times reports on a trend of urologists purchasing I.M.R.T. radiation therapy equipment, and suggests that the expanded use may due to the fact that doctors can make much higher profit using this technology than doing surgery. I.M.R.T.stands for intensity modulated radiation therapy. The Times reports, “Critics see a potential conflict of interest on the part of urologists, the specialists who typically help prostate patients choose a course of treatment. The critics say that urologists who can profit from the new form of therapy may be less likely to recommend other proven approaches, which for some older men can involve forgoing treatment altogether. …But because there is little research directly comparing I.M.R.T. with the other treatments, there is little consensus among urologists about which approach is best. … The one certainty about I.M.R.T. is that for doctors who own the technology, it can be much more lucrative than alternative treatments. Medicare and other insurers typically pay urologists only $2,000 or less for performing surgery to remove the prostate or for implanting radioactive seeds. The insurers say the much higher I.M.R.T. payments, which in some cases exceed $50,000, are based on the technology’s cost.”
Wouldn’t it be interesting to hear the “shared decision-making” discussion between physician and patient when IMRT is brought up as the recommended treatment option?
In a letter to the editor of the Wall Street Journal (subscription required), Princeton economist Uwe Reinhardt asks, "Should Corporate Chiefs Get Lifetime Health Care?" Here is the letter:
"In your Nov. 20 editorial "AHIP Hop" on the health-insurance proposal recently unveiled by America's Health Insurance Plans (AHIP), you lament the fact that "individuals generally aren't sensitive to the price of their treatment decisions." For that reason, you have long supported high-deductible health insurance that puts patients' "skin in the game," to use the colorful metaphor for "high deductibles."
Economists, who generally believe that fiscal incentives drive human behavior, can resonate with this prescription, but as one such I would ask: What does it tell us about the health-insurance coverage of highly paid corporate executives? Does it not imply that these executives should never have the corporation buy health insurance of any sort for them, lest these executives become too insensitive to the cost of their health care?
Instead, we find that corporate executives routinely insist that their companies purchase for them and their spouses generous health insurance for life, and many of them even insist that the company cover all out-of-pocket expenses built into such policies.
Is that at all defensible on the "skin in the game" theory you espouse?"
A new Kaiser Family Foundation survey of people enrolled in "consumer-driven" health plans shows that half say they would switch out of the plans if they had the chance.
The Washington Post summarized the survey. Excerpt: "More than 60 percent of people in the plans said it is hard to find good information about the cost of doctors' services and hospital care; and about 50 percent said information on quality of care is hard to come by. Half of those enrolled in the plans said they would switch out if given the choice, compared with a third of those in traditional plans. And they were twice as likely as those in traditional plans to say that they went without care because of cost.
Gail Shearer, director of health policy analysis at Consumers Union, noted that the survey found that people in the new plans tend to be wealthier, healthier and more educated than their counterparts in traditional plans, and were more likely to be white.
"Instead of our health system moving towards one where we're all in this together, this type of option is leading to more splitting the population into different segments and, to me, that's an unhealthy thing," Shearer said. She added that poorer, sicker consumers could get left behind."