The editor of the New England Journal of Medicine says three large drug companies have made a mockery of efforts to create transparency in clinical trials.
Journal editors last year pushed for drug companies to register trials in a public database, disclosing what each study is supposed to evaluate, how many patients will be studied, and who is funding the study.
Dr. Jeffrey Drazen says that Pfizer, GlaxoSmithKline and Merck are giving "nonsense details" and not providing enough useful information when they do register trials at www.clinicaltrials.gov.
See journalist Merrill Goozner's column about a new study describing drug company research contracts with academic medical centers prohibiting researchers from disclosing trial results.
The lesson for journalists and the public is: Do NOT accept journal articles or news stories about journal articles as gospel. Disclosure of conflicts of interest in journal articles and in news stories about journal articles IS important.
The author of the study in question was quoted saying, "These results are really bothersome. Some investigators may be willing to accept constraints just to maintain good relations with the company."
So why do some journalists continue to live off journal stories as fodder for stories each and every week?
WebMD posted one of those stories that makes my skin crawl. The formula: use a cute, sexy headline and lead sentence, then follow with weak caveats, leaving the reader with nothing useful at the end.
The story is headlined, "Levitra a Day May Keep the Doctor Away." It promotes Levitra use with its lead sentences, "Men now have two new reasons to take erection-enhancing drugs every day. Those reasons: The drugs may lower a man's risk of heart disease and of noncancerous prostate symptoms." But then it follows with, "This provocative speculation is based on short-term data from a small study." And it ends with, "But it's not yet time to start popping those little pills along with your daily vitamins. The study findings... are preliminary."
How do you justify the headline and the lead with the caveats? And this story was reviewed by a physician? Perhaps the editorial and physician review team need to be reminded of the number of preliminary findings presented at scientific meetings (as this was) that never pan out. And when that happens, journalists like these aren't around to correct the record.
Chalk it up as a waste of time and space. Come back when you have large-scale, long-term findings to report.
FDA officials met with Guidant Corporation representatives because of a company defibrillator that malfunctioned in 26 cases, including one in which a college student died.
The New York Times reports that "the meeting followed the disclosure that Guidant had not informed doctors for three years about a design flaw in the implantable defibrillator." The device is a heart shocker implanted to bring a poorly-beating heart back to functional rhythm.
The Times reports: "Guidant sent out an advisory to doctors nationwide about the device and recommended that it not be removed because of the electrical problem. Guidant said it believed that a substitute device would not perform better ... and that the implant procedure posed risks."
Editor's note: amidst all the discussion about drug safety, consumers should not lose sight of the questions about device safety, and about the number of problems that are only recognized once a product is approved and in widespread use.
Newsday and the AP report that more than 400 convicted sex offenders in New York and Florida were covered by Medicaid for getting Viagra.
They report that "the Centers for Medicare & Medicaid Services acted swiftly Monday, one day after the New York comptroller's office said audits from 2000 through March found that 198 rapists and other high-risk sex offenders in the state received Medicaid-reimbursed Viagra after their convictions. Their crimes included offenses against children as young as 2, Comptroller Alan Hevesi said. The report sent the Bush administration scrambling to find a way to close the loophole."
A recent New York Times column addressed innumeracy - "the arithmetic equivalent of illiteracy." The columnist asked, "Why do so many people have trouble with the notion of probability and chance? ... Simply put, people are uncomfortable with mathematical concepts like probability because they never learned them in the first place. Innumeracy explains much of the public's confusion about the risks of various drugs and medical treatments."
Innumeracy is fed by even some respected conduits of health information, such as the Journal of the American Medical Association, which sent out a video news release last week headlined, “IN BREAST CANCER PATIENTS, WALKING 3-5 HOURS PER WEEK MAY REDUCE RISK OF DEATH FROM BREAST CANCER BY UP TO 50 %." But 50% of what absolute risk? Did 2 in 10,000 become 1 in 10,000?
That kind of incomplete math doesn't help. JAMA should do better.
Former BMJ editor Richard Smith, now Chief Executive of UnitedHealth Europe, says “I must confess that it took me almost a quarter of a century editing for the BMJ to wake up to what was happening.” What is happening, in short, he says, is that journals are being manipulated by drug companies.
Smith has an editorial in the journal PLoS Medicine. An excerpt:
“ “Journals have devolved into information laundering operations for the pharmaceutical industry”, wrote Richard Horton, editor of the Lancet, in March 2004. In the same year, Marcia Angell, former editor of the New England Journal of Medicine, lambasted the industry for becoming “primarily a marketing machine” and co-opting “every institution that might stand in its way”. Medical journals were conspicuously absent from her list of co-opted institutions, but she and Horton are not the only editors who have become increasingly queasy about the power and influence of the industry. Jerry Kassirer, another former editor of the New England Journal of Medicine, argues that the industry has deflected the moral compasses of many physicians, and the editors of PLoS Medicine have declared that they will not become “part of the cycle of dependency…between journals and the pharmaceutical industry”. Something is clearly up.”
"It's a number that's just shocking," says Iowa Republican Representative Steve King in the Washington Times.
That's the cost estimate from the Congressional Budget Office for how much Medicare will spend in a decade just for covering impotence drugs. King is sponsoring a bill to stop most impotence drug sales under Medicare.
I have seen the future of TV news and it is promising – IF the students like those we just sent off in commencement ceremonies last weekend are given their chance to shine. The storytelling and creative work of the graduating class of 2005 at the University of Minnesota School of Journalism & Mass Communication was the best I’ve seen. The “News Team” was a group we’ll remember for a long time. And I hope to see their work on the air for years to come. Franchise, Tour Guide, Scoop, Ghost, Sarah I-Won’t-Change-My-Name, Rabbi(t), Green Bay Girl, Crispy Lacey, Clark Kent, Jesse James, SS, Big Dan and many more. Don’t forget my Al McGuire stories. They are the essence of life. Seashells and balloons. And remember, “It’s not the gorillas that get you; it’s the ducks nibbling at your ankles.”
A study in the Journal of the National Cancer Institute shows how celebrity endorsements of cancer screening influence people -- perhaps in harmful ways.
The authors write: "Whether to undergo cancer screening is a complex decision - early detection of cancer will help some people, but it can create problems for others, such as unnecessary testing and treatment. Consequently, screening is increasingly recognized as a two-edged sword." But the celeb endorsements don't present both sides. They "typically consist of one-sided messages that either assert that the celebrity's life was saved by a cancer screening test (Rudy Giuliani example) or suggest that the life of a loved one was lost due to a failure to be screened (Katie Couric example)."
The authors conclude: "The goal should not be to persuade but to inform. Thus, we see no obvious role for celebrity endorsement of cancer screening."
Jessie Gruman, Ph.D., of the Center for the Advancement of Health, offers a column on the dangers of television health news and information. Excerpt:
“In Oklahoma City, a popular new local television program based on the ABC network’s “Extreme Makeover” takes women eager for a new look and sets them up with plastic surgeons, Lasik practitioners and cosmetic dentists.
In Baltimore, a local news program airs community service features about new developments in pediatric care and women’s health.
In Washington, D.C., a station gravely reports on the prognosis for Peter Jennings (who airs on a competing channel) and then suggests free CT lung scans at a local hospital for long-time smokers.
What is wrong here?
In the first instance, the makeover artists are licensed health care practitioners and a university medical center paying for the “right” to inflict medically unnecessary and risky cosmetic surgery. In the second instance, two large hospitals — one a university medical center — are buying time on the newscast with the hope of luring high-paying or well insured patients to boost the bottom line in a competitive market. In the third case, viewers are not told that the free lung scans are part of an international clinical trial that by its very nature entails some measure of risk.
It would seem there is another health risk at work here — the local broadcast news media.”
A recent story in the Wall Street Journal revealed arrangements between CT and MRI scanning centers that make doctors rich, but which may be illegal. In the arrangements, doctors are billed a flat fee for referring patients for scans, but then bill insurers at a much higher rate.
An excerpt from the story: "For an MRI , the company would charge doctors $375. It pegged the average reimbursement in the region at $706.31.After deducting the cost of having the scan interpreted, the paperwork said, the doctors would net $234.77 from each MRI . It showed that a group practice could clear $122,078 a year if it referred two patients a day for scans, or $610,390 annually if it referred 10 a day. For a less-common kind of screening known as PET scans, profits would be higher: $525,200 a year to the doctors if they made two daily referrals, or $2.6 million annually for 10 a day."
Think about that the next time you see a news story or an ad promoting the latest CT, MRI or PET scanner in your community. Follow the money. And then start to question whether all the scans are necessary.
Three of my former Dartmouth colleagues published an excellent review in the Washington Post on how news coverage last year "probably misled readers about both the size and certainty of the benefit of aspirin in preventing breast cancer."
More than just pointing a finger, the researchers explain how the research was misinterpreted and offer some lessons about interpreting medical research.
Since they cite stories that appeared in the Washington Post, the Wall Street Journal, the New York Times, USA Today and the major television networks, it is a lesson worth learning.
A letter to the editor in yesterday's Star Tribune:
"We are going to throw 30,000 Minnesotans off health care so that we can protect the taxes of the wealthiest 42,000 Minnesotans from going up (Star Tribune, May 6). Gov. Tim Pawlenty and the House Republicans are telling us that protecting William W. McGuire, the CEO of United Health Care, and his $124.5 million salary package is more important than the health coverage of working class Minnesotans making $35 to $40,000 a year. Explain "profoundly stupid" to me again."
There are no high quality data to support the common recommendation that people get dental checkups every 6 months, according to The Cochrane Collaboration, which reviews literature on the relative effectiveness of different health care practices.
Reviewing the best available data led the Cochrane Authors to conclude that there is not enough evidence to draw any conclusions regarding the potential effects, good or bad, of altering the recall interval between dental check-ups.
“There is insufficient evidence to support or refute the practice of encouraging patients to attend for dental check-ups at six-monthly intervals,” says the review’s lead author.
Congressman Henry Waxman yesterday released an analysis of over 20,000 documents indicating that Merck sent more than 3,000 highly trained representatives into doctor's offices and hospitals armed with misleading information about Vioxx's risks.
Waxman said, in a statement, "Merck and the drug industry say that the role of drug representatives is to educate doctors about new products and new medical research. But the documents tell a different story. The goal was sales, not education. Merck representatives were instructed to use subtle gestures to subconsciously gain the trust of physicians. They were permitted to use only "approved" journal articles, defined by Merck as articles that "provide solid evidence as to why [doctors] should prescribe Merck products.' And health risks were viewed as "obstacles" that the sales force was instructed to surmount."
A Kaiser Family Foundation survey shows that more Americans are worried about health care costs than about losing their job, paying their rent or mortgage, losing money in the stock market, or being a victim of a terrorist attack. ( March/April Kaiser Health Poll Report tracking survey.)
Now, let’s see…..did our last election year campaign discussions reflect this?
U.S. Health and Human Services secretary Michael Leavitt this week made unsubstantiated and unseemly comments about how Medicare could save money if more seniors wrote living wills.
Saving money should not be a goal of living wills. Bureaucratic bean-counters drooling over potential cost savings are out of line on this topic. Living wills are a matter for individuals, their families and their caregivers to discuss with accurate, balanced and complete information. It's a matter of individual values and preferences, not the bottom line.
Old school journalistic values are still important: it’s vital to try to preserve objectivity and distance from your subject and sources. You may not always achieve it, but you don’t throw these values away willy-nilly.
Then comes TV news ratings/sweeps periods.
KSTP-TV in Minneapolis began a two-part series on one of their reporter’s ovarian cancer last night, two days into a new ratings period. I’m quoted in the Star Tribune criticizing the decision. Station executives use predictable defenses to justify their decision.
What’s not in the paper are some of my other concerns:
1. Who says her case is representative of other cancer patients or even of other ovarian cancer patients? Then why is it newsworthy?
2. Why is it newsworthy? What editorial decision-making took place to lift her story to air worthiness? What’s the last story they did on ovarian cancer? Does it take someone on the on-air staff being diagnosed with something to get a station to report on it? What were the factors that made this newsworthy?
3. In weighing newsworthiness before a sweeps period, did they give any thought to covering the 20-30,000 Minnesotans who might lost MinnesotaCare coverage under current legislative proposals? Are the 30,000 less important than the one in-house story?
4. The station says that there is important public education to be achieved by publicizing such a case. If that’s so, what was the last story they did on ovarian cancer prior to this?
This is not an isolated case. It’s just the latest of many, in which TV people think their celebrity status is at such a level that their stories rise to newsworthiness, whereas the plight of the great unwashed remain unknown.
CNN, in a new struggle with the definition and practice of credibility, played matador in allowing questionable statistics on the air in a debate over a Texas legislative move to prevent same-sex couples from becoming foster parents. CNN allowed a supporter of the legislation to claim that research showed that children in foster homes with same-sex parents are 11 times as likely to be sexually abused as those with heterosexual parents.
“The Numbers Guy” column in the Wall Street Journal nailed the shady stat: “To get on CNN, that number snaked through a twisting path, from a little-noticed Illinois study published by an antigay scientist/activist in a psychological journal, to several conservative Web sites, to, finally, the attention of a Texas activist who presented her misinterpretation of the study on national television, essentially unchallenged. It's a textbook example of how flawed numbers can gain national attention if advocates work hard enough -- especially when there aren't widely-known conflicting estimates.”
The CNN anchor, supposedly moderating the debate, allowed the claim to go unchallenged. Jon Stewart of The Daily Show showed up CNN by capturing the moment on the air, and archiving it on his website (see Gaywatch video section).
When one reader saw my posting about CNN's declaration that a pediatric surgeon was a "god" doing "miracles," he referred me to a similar story in the Onion, entitled "Amazing New Hyperbolic Chamber Greatest Invention In the History of Mankind Ever."
Read it. It may remind you of something you've seen in TV health news.