The Star Tribune newspaper finally - 10 days after I submitted it - published my op-ed piece countering a feature story entitled, How To Be A Screen Queen. I give the paper credit for publishing my response, although they edited my submission and did not share with me in advance what the final published version would be. This is more than a little troubling to me - since what was published was not what I submitted.
One thing they left out was the broader context of such media advocacy pieces crusading for screening tests in the absence of the best evidence, something I reported on in a piece entitled, "Unhealthy Advocacy: Journalists & Health Screening Tests."
I'm going to continue to track news coverage of health screening tests and will continue to report on the results on this blog and in whatever venue I can find.
Australian journalist Ray Moynihan writes in the BMJ about “the invisible influence of drug company sponsorhip” of doctors’ educational seminars. He writes that:
“it is not uncommon for drug company sponsors to suggest speakers at sessions that are assumed by the thousands of general practitioners who attend them to be totally independent. Drug industry representatives have confirmed that similar practices take place in the United Kingdom, where roughly half of all education for doctors is sponsored by drug companies.In the case of one popular Australian provider of medical education, HealthEd, leaked documents and emails from a range of sources show drug company sponsors having input into the selection of some speakers at seminars held in recent years, despite the fact that these have been aggressively sold to general practitioners in brochures claiming that "all content is independent of industry influence."
Meantime, today's Star Tribune reports on a U.S. Senate hearing called "Surgeons For Sale." Excerpt:
Wine-tasting outings to California's Napa Valley. Ski trips to Colorado. Tickets to sporting events. Gourmet meals at swanky restaurants. Forays to "adult entertainment" clubs. Fat checks for what some see as questionable work.Such payments to doctors by medical device companies -- often disguised as "consulting agreements" meant to encourage use of their products -- were the subject of a packed, daylong hearing Wednesday before the U.S. Senate Special Committee on Aging.
I've blogged earlier about something being smelly about the ENHANCE trial, comparing the cholesterol drug Zetia plus Zocor versus Zocor alone.
This week, a commentary in the Journal of the American Medical Association addresses some of the stink. Excerpts:
The unusual release on January 14, 2008, in the news media and on a drug company Web site, of a portion of the Effect of Ezetimibe Plus Simvastatin Versus Simvastatin Alone on Atherosclerosis in the Carotid Artery (ENHANCE) trial data resulted in numerous articles and commentaries in the lay media. The availability of only fragmentary information created massive confusion and raised many more questions than answers for patients, physicians, pharmaceutical companies, and regulators. A full report of the ENHANCE trial in a peer-reviewed medical journal is not expected for months, and the first public presentation of the study's findings in a medical setting will not occur before late March 2008.Lesson 1: Drug Trials Should Not Be Done for Marketing Purposes Only
Lesson 2: The News Media Must Be Sure to Get the Facts Straight. Errors in Reporting Can Cause Serious Damage, and Patients May Be Harmed or Become Distressed From the Resulting Confusion
Lesson 3: Leading Scientific, Patient-Oriented, and Disease-Oriented Organizations Must Scrupulously Avoid Conflict of Interest
I get the Health Behavior News Digest from the Center for the Advancement of Health.
Two adjacent items in today's digest caught my eye.
An Associated Press story: Spending on Health to Rise Dramatically. "By 2017, total health care spending will double to more than $4 trillion a year, accounting for one of every $5 the nation spends, the federal government projects."
And then a Bloomberg story: Cosmetic Surgery Losing Stigma for U.S. Men, Rises 17% in 2007. "American men, favoring Botox injections and liposuction, underwent 17 percent more cosmetic procedures in 2007 to more than 1 million treatments, according to the American Society for Aesthetic Plastic Surgery."
Hmmm. Anybody else see a connection between the kinds of trends reflected in the Bloomberg story being a significant piece of the pie that's blowing up in the AP story? Not hard to find: there are connections like this every day in the news.
Pfizer's President of Worldwide Pharmaceutical Operations Ian Read said:
"...the way in which we presented Dr. Jarvik in these ads has, unfortunately, led to misimpressions and distractions from our primary goal of encouraging patient and physician dialogue on the leading cause of death in the world -- cardiovascular disease. We regret this. Going forward, we commit to ensuring there is greater clarity in our advertising regarding the presentation of spokespeople."
Hail the power of public opinion.
Probably the best example yet of a direct-to-consumer drug ad blowing up in the drug company's face.
Do you ever notice those newspaper ads for products touting "improved maximum sexual performance...increased libido...the best natural male potency ingredients"?
I don't anymore. It's just part of the daily newspaper race-through reading that I've learned to ignore.
But David Brauer of MinnPost.com noticed that last Tuesday, February 19, the Star Tribune's sports section had only two ads, both quarter page ads for such "satisfy her like never before" products. That's it - the only ads in the sports section - one whose entire last page was devoted to high school girls' hockey, by the way.
Brauer wrote:
"For the record, the Strib is not alone in taking solicitations for these capsules, or their close cousins, the "instructional" sex tapes. A Google search turned up newspaper ads in Memphis, San Jose and Philadelphia, among others. America is long past its plain-brown-wrapper days — and even if this stuff is quack patent medicine, it is legal (and largely unregulatable, thanks to Utah Sen. Orrin Hatch, who's spearheaded laws protecting the state's major herbal remedy industry).Newspapers do have advertising standards, but I'm hard-pressed to tell you what the Strib's currently are. My repeated queries were funneled to the paper's communications honcho, Ben Taylor, who remained incommunicado. (Stories like this won't exactly open that door.) In the past, the paper has had policies against nasty visuals in strip club ads, though the heavily made-up bimbos who pitch go juice and soft-core video porn are perhaps more high-minded. To a certain extent, they're no more salacious than the bra ads in the A section or the movie ads in Source, and a cut above the phone-sex ads in City Pages.
Back to those capsules: Just how loudly do they quack? The FDA won't comment, and a Google search turned up no stories of related deaths. The scary thing about Vazopren is that half the search-results pages are Russian; the Aspire36 search turned up hair-raising testimonials from bodybuilding sites where participants rave about their stamina yet add comments like "I've experienced a really bad headache lasting well over 14 hrs and redness in the face. Will try drinking more water next time, like someone suggested here."
Though this Associated Press story didn't mention either product, it's still a cautionary tale. "For men on common heart and blood-pressure drugs, popping one could lead to a stroke, or even death. 'All-natural' products with names like Stamina-RX and Vigor-25 promise an apothecary's delight of rare Asian ingredients, but many work because they contain unregulated versions of the very pharmaceuticals they are supposed to replace."
It's probably logical that as legitimate advertisers drift away, bottom feeders will increasingly share the page with professional journalism. There's irony in that, though some media-haters might regard it as a perfectly natural coupling. In any case, buyer beware."
KevinMD.com is a very well-done blog, run by Dr. Kevin Pho, a New Hampshire primary care physician. I don't know how he runs such an active blog and sees patients. I've admired Kevin's work even before he named my blog one of his MedBlog Power 8 for my recent postings.
He writes: "The MedBlog Power 8 is a list of medical blogs that have had an exceptional week of blogging, based purely on my subjective measures. Factors I consider are how provocative the posts are, the amount of discussion it generates, and posting frequency."
Thanks, Kevin. I can't match the volume of your postings, but I try to make a daily quality or quirky contribution to our public discussion of health care and health policy and health journalism issues.
SNL did a hilarious parody of a commercial for their drug, named Annuale, to limit women's periods to once a year. The makers of the real drug Seasonale may not find it so funny.
The FDA overruled its expert advisory panel and approved the drug Avastin for breast cancer. On his Pharmalot.com blog, Ed Silverman writes that this could mark a major shift in FDA standards for evaluating cancer drugs. He writes:
"At issue was whether slowing tumor growth - known as progression-free survival - for an additional 5-1/2 months in metastatic breast cancer merits approval, even though Avastin wasn’t shown to extend life. The question, of course, resonates far beyond any one drug as the agency grapples with increasingly vocal cancer patients and their advocates, who insist any benefit is important.For drugmakers, the approval is an important signal, because it can be expensive to conduct the lengthy trials needed to prove a drug can extend life. The approval also bolsters an industry tactic called label expansion, which is used to squeeze additional revenue out of a medication. In the case of Avastin, which is already approved to treat colon and lung cancer, Genentech may reap an additional $1.3 billion a year in revenue.
The FDA’s decision may now open the door for other cancer meds to be approved if studies find the meds can shrink tumors, although some docs worry patients may not really benefit. “If FDA sets a precedent of approving a drug based on progression free survival, people are afraid they may stop looking at survival as the most important endpoint,” Kay Dickersin, director of the Center for Clinical Trials at Johns Hopkins University, tells the Associated Press.
“The FDA has lowered the bar on the approval of breast cancer therapies. At a time when many questions are being raised about how the FDA approves drugs for market, today’s decision is a victory for drug companies, but not for patients,” Breast Cancer Action executive director Barbara Brenner says in a statement headlined ‘Patients Lose, Genentech Wins.’ "
The Wall Street Journal reports that "Avastin costs about $7,700 a month, or $84,700 for an average 11-month course for breast cancer. However, with FDA approval, Genentech will enact a $55,000-a-year price cap." And the Journal further quotes Brenner about the debate over rising prices of biotech treatments. She said, "Where we're talking about the cost of health care, biologics are the elephant in the room."
A brief diversion from our usual discussion of health news on this site - but one that gives insight into how news is sometimes made.....
A friend in a news organization passed along this note received from a public relations person:
ABOUT THE MIAMI BEACH DANCE FESTIVALSpecial Note: The Greater Miami Convention & Visitors Bureau will cover airfare and hotel for journalists coming to Miami if they agree to do a tourism-oriented story. Anyone feel like warming up in Miami?
We all know this sometimes happens. But sometimes you have to see the sausage being made in order to make you think about what you're eating. Think about this the next time you see warm-weather location fluff pieces in the middle of winter. Always think about who paid the piper.
Dallas TV critic Ed Bark writes the latest chapter of an ever-thicker and ever-sicker story about TV stations selling "news" time to hospitals that want to look good on the air.
As I've asked before, when is the Radio-Television News Directors Association going to step up and address this situation, which is addressed in its own code of ethics but apparently almost universally ignored? Excerpts of that code:
Professional electronic journalists should:* Gather and report news without fear or favor, and vigorously resist undue influence from any outside forces, including advertisers, sources, story subjects, powerful individuals, and special interest groups.
* Resist those who would seek to buy or politically influence news content or who would seek to intimidate those who gather and disseminate the news.
* Determine news content solely through editorial judgment and not as the result of outside influence.
* Resist any self-interest or peer pressure that might erode journalistic duty and service to the public.
* Recognize that sponsorship of the news will not be used in any way to determine, restrict, or manipulate content.
* Refuse to allow the interests of ownership or management to influence news judgment and content inappropriately.
The Star Tribune newspaper has a feature story entitled, "How to be a screen queen."
Its primary focus is to remind women of all the screening tests they should have, but they also have a sidebar on men's screening test recommendations.
The problem is that many of the recommendations listed are controversial and are not supported by the
U.S. Preventive Services Task Force. (Even though the paper lists the USPSTF as one of its sources!)
I won't write anything more about this for now because I'm going to submit an op-ed piece to the paper. I'll let you know if it is published.
Two TV health segments that I'm sure were well-intentioned both caught my eye this week for how they might lead viewers to obsess about still another score, still another test result, still another number that they don't fully understand.
The CBS Early Show had a series entitled, "Early Intervention: Cardiac Arrest." Their reporter went around to food courts in shopping malls "seeking people eating unhealthy foods, or who were overweight, or who had other potentially problematic signs, and offered to check out their heart disease risk. They agreed to undergo CT scans to help assess their heart health. The doctors checked the images the scans produced for signs of calcium, which indicates the presence of artery-clogging plaque."
Before it was all over, the series made it sound like most of us should be running in for a CT scan and that we should certainly know our "calcium score" - a test result that was drummed into viewers over and over. Only briefly did I hear the caveat that these tests are only for people with risk factors including a family history of heart disease. But the caveat was rushed and unclear. CBS' website even states:
If you live in the Memphis area and want to have a scan to check on the calcium levels in your cardiac arteries, call (901) xxx-xxxx. (I have no intention of furthering the promotion by providing the phone number as CBS did.)
That sounds like an all-out invitation to all viewers, doesn't it?
Then CNN's Housecall program this weekend reported on one of the many tests being developed to screen for early Alzheimer's disease. The story said:
"Researchers are hoping to get the Detect system into doctor's offices as early as this fall. It will be used as an early screening tool starting around the ages of 45 to 50. The goal here would be to get a baseline of your cognitive skills early on, so doctors can act early if a drop in score is detected."
Well, sure they're hoping to get it into doctor's office this fall to start screening everyone around 45-50. What a huge new market. And let's get hundreds of thousands of more Americans worrying now about their baseline "cognitive skills score" or whatever it would be called. Meantime, there was no discussion of the sensitivity or specificity of the test. It was still another example of accepting claims about a new screening test without exploring any of the pitfalls, the downsides, the things that come from such screening that can have harmful effects on peoples' lives.
Calcium scores and cognitive skills scores: two more things to worry about, two more ways to promote fear in all of us and to "sell sickness." And two more examples of journalists not asking enough tough questions.
There's an old line that the only well person left in America is simply someone who hasn't been tested enough. Because the more you look, the more you'll find.
In a move that leaves you wondering about health policy in this country, the Food and Drug Administration is considering loosening regulations on "off-label" promotion of drugs. The Wall Street Journal reports:
The FDA's move already is raising objections from industry critics. Democratic Rep. Henry Waxman of California wrote to the agency urging it to hold off on issuing the guidelines, which he argued would create a "large loophole" in the laws against off-label promotion. "It's a conflict of interest for the company to be promoting sales when they haven't been able to establish that a drug is safe and effective through the rigorous FDA process," Mr. Waxman said.
On his blog, Merrill Goozner writes:
As the nation grapples with how to pay for skyrocketing health care costs and policy wonks grapple with how to get more physicians to follow evidence-based medical practices, the Bush administration's FDA... has proposed opening the floodgates to wider promotion and use of unproven drugs.There's a name for that kind of policy: Lack-of-Evidence-Based Medicine.
This is a head-scratcher. It raises anew the old questions about whom the FDA is protecting: citizens or industry.
Ten days ago, the New York Times posted Tara Parker-Pope's column, "No Answers for Men With Prostate Cancer." It discussed the federal agency report that concluded that nobody can tell men with prostate cancer what type of treatment is most likely to save their lives - or that any treatment is better than doing nothing.
Many news organizations, when they post such columns online, now offer readers the chance to comment online. As of this morning, 141 people have sent in comments in 10 days. They are all visible following the story posted online. Ms. Parker-Pope has responded to a few of the comments online, but other user comments raise assertions, make claims, ask questions - all unanswered or unchallenged.
That's disturbing for a number of reasons, the biggest one that it lends the credence of the New York Times' website to some spurious information posted on their site in an unchallenged manner.
I would suggest that if the Times is going to moderate some of the discussion, then it should moderate all of the discussion. And I realize what a tough task that would be, with 141 messages in 10 days.
But this should not just be a marketing move - that offering a sense of "online community" is good for business. Journalism principles should enter into this as well. But right now it looks like the New York Times has invited a conversation, got one, and now doesn't know what to do with it.
And this trend is only going to deepen. Witness CNN's I-Report feature that invites citizen journalism: "What's happening where you are? Is news happening in front of your eyes? Pull out your camera and I-Report it for CNN."
Democratization of news? Or abdication of journalistic oversight responsibility? Read the 141 messages (probably more by the time you get there) on the Times article above and make a judgment about whether the "community" discussion was worthwhile or not.
Headline: UNITEDHEALTH ACCUSED OF SHORTCHANGING PATIENTS. Read all about it.
Headline: PROBE TARGETS HEALTH INSURERS ON PAYMENTS. Read even more about it.
The Wall Street Journal published anecdotal reports that statins like Lipitor "make women stupid" - that the drug "dulls the minds of some patients."
The Journal reminds us that anecdotes don't equal data, but that:
Researchers at the University of California at San Diego are nearing completion of a randomized controlled trial examining the effects of statins on thinking, mood, behavior, and quality of life. Separately, the UCSD researchers are collecting anecdotal experiences of patients, good and bad, on statins; memory problems are the second most common side effect, after muscle aches, in about 5,000 reports to date."We have some compelling cases," says Beatrice Golomb, the study's lead researcher. In one of them, a San Diego woman, Jane Brunzie, was so forgetful that her daughter was investigating Alzheimer's care for her and refused to let her babysit for her 9-year-old granddaughter. Then the mother stopped taking a statin. "Literally, within eight days, I was back to normal -- it was that dramatic," says Mrs. Brunzie, 69 years old.
It's interesting to see the different interpretations, emphases, and headlines of different news organizations on the same story.
The New York Times uses a headline, "Most Breast Cancer Sites Get It Right" over a story that begins:
The Internet is filled with unreliable health information and bogus claims. But sites dedicated to breast cancer information appear to have a high level of accuracy, a new study shows.Texas researchers recently analyzed 343 Web pages, retrieved using search engines that consumers are likely to use when seeking information about breast cancer. The study, published online today in the medical journal Cancer, turned up 41 inaccurate statements on 18 of the Web sites, or an error rate of just 5.2 percent.
But that "just 5.2 percent" is the focus of the headline and the lead in a Reuters wire service story on the same study, but headlined, "Some breast cancer websites inaccurate." The story begins:
Five percent of breast cancer Web sites have mistakes, with those involving alternative or complementary medicine the most likely to be misleading, U.S. researchers reported on Monday.
So is an error rate of "only" 5% good - and worthy of headlines? Or is an error rate of 5% "bad" and worthy of the headline?
Probably the best judges are women with breast cancer.
The New York Times this week had a column on "a troubling new report from the Agency for Healthcare Research and Quality, which analyzed hundreds of studies in an effort to advise men about the best treatments for prostate cancer. The report compared the effectiveness and risks of eight prostate cancer treatments, ranging from prostate removal to radioactive implants to no treatment at all. None of the studies provided definitive answers. Surprisingly, no single treatment emerged as superior to doing nothing at all."
An AHRQ news release said, “Considerable overdetection and overtreatment may exist."
The New York Times provides even more questions and answers about the Lipitor ads starring artificial heart inventor Dr. Robert Jarvik.
The Times reports:
"...it has helped rekindle a smoldering debate over whether it is appropriate to aim ads for prescription drugs directly at consumers.A Congressional committee, concerned that the Lipitor ads could be misleading, has said it wants to interview Dr. Jarvik about his role as the drug’s pitchman.
Some of the questions may involve his credentials. Even though Dr. Jarvik holds a medical degree, for example, he is not a cardiologist and is not licensed to practice medicine. So what, critics ask, qualifies him to recommend Lipitor on television — even if, as he says in some of the ads, he takes the drug himself?
And, for that matter, what qualifies him to pose as a rowing enthusiast? As it turns out, Dr. Jarvik, 61, does not actually practice the sport. The ad agency hired a stunt double for the sculling scenes."
Meantime, the Los Angeles Times has a column on a new ad campaign for a sleep disorder pill:
You'd probably be interested in a drug that'll keep you peppy even when you're running on fumes.How about a drug that can cause depression, anxiety, hallucinations, psychosis, mania and suicidal thoughts? How about chest pain, sores or serious rashes?
You had to sift through the fine print of full-page newspaper ads that ran coast to coast last week to learn that these drugs are one and the same. The ads were for Provigil, which its maker, Cephalon Inc., is pitching to consumers as the solution for something many people might not even realize is a disorder: excessive sleepiness.
Provigil, the ads said, can help "fight the fog."
Next time I find the urge to go rowing through the fog on an early morning after a sleepless night, I hope I can find a stunt double.
A tip of the hat to KARE-11 TV (Minneapolis) reporter Rick Kupchella for the start of his ratings period series, "A Cure For Health Care?".
TV news across the country is a wasteland if you 're looking for serious health policy discussions. But in the past couple of years Kupchella has tackled some of the most complex health care reform issues and proved that local TV news can tackle these topics. He's once again proved that TV doesn't have to hide behind the excuses of "It's gotta be short" or "It's gotta be gee-whiz visually."
And he doesn't even cover health news fulltime.
Kudos to Kupchella for his personal commitment and for striving for excellence in serving local viewers.
An Advertising Age story appearing on PRWatch.org:
The pharmaceutical companies Merck and Schering-Plough, which co-market the cholesterol drug Vytorin, "have gone into damage-control mode, taking out newspaper ads." The PR campaign follows the companies' reluctant publication of a study showing that neither of the drugs present in Vytorin "reduced the buildup of fatty plaque in arteries." The study "was completed in 2006, but Merck and Schering said they didn't release it for nearly 21 months due to the complexity of the data and their own scientific concerns." The drug companies' ads, which ran in the New York Times and USA Today, refer to the damning study as "a single study that has generated a lot of confusion." The ads stress that the drugs "have been proven to lower LDL (bad) cholesterol," but what the study showed was that Vytorin is not "any better than generic Zocor in reducing the buildup of fatty plaque." Members of Congress have called for an investigation into why the "massive advertisement campaign for Vytorin was allowed to continue," after the study was belatedly made public. (The drug makers pulled their Vytorin TV -- but not print -- ads on January 22, reports Associated Press.) Class-action lawsuits are also being filed, alleging that the drug companies "misrepresented and withheld significant information" from the Food and Drug Administration and the public.
Last week the NBC Today Show presented a series it called “Mini Medical Miracles.”
Were you waiting for news on cancer? Heart disease? Diabetes? Infectious diseases?
Sorry. What you got was baldness, insomnia, dandruff and wrinkles.
But NBC called the approaches “miracles” and “breakthroughs.” Man, that’s what we need is a good miracle for dandruff and wrinkles.
Anchor Matt Lauer led into the wrinkles story by asking “Could having a new laser treatment in your forties or fifties prevent you from ever needing a facelift?”
Who says that anyone needs a facelift? Facelifts are a matter of want, not need.
47-million uninsured is a matter of need.
Lauer and NBC medical editor Dr. Nancy Snyderman could barely contain their enthusiasm for the laser “treatment.”
(Snyderman:) “This is going to be in your doctor’s office soon.”
(Lauer:) “It’s interesting. And anything that keeps people away from the knife. I mean, that’s major surgery.”
(Snyderman:) “I think you can say to people, this is a preemptive strike and it’s taking care of your skin and you can avoid a real operation. There will be a lot of people, men and women, who will be interested.”
There was no discussion of evidence, no quantification of benefits or harms, no discussion of how long the approach has been tested nor in how many people.
On HealthNewsReview.org the story is one of only 10 of the first 500 stories reviewed that got a score of 0.
Oh, for the good ol’ Today Show days of Dave Garroway and J. Fred Muggs, the chimp.
Don't miss an important story from the Wall Street Journal last week about things going wrong in clinical trials, questions about informed consent forms, and about liability - especially as companies speed up the pace of trials.
The New York Times reports on what would be the largest fine ever paid by a drug company for violating laws on how drug makers can promote their medicines. It involves Eli Lilly's marketing of the antipsychotic drug Zyprexa.
Excerpts:
"Zyprexa has serious side effects and is approved only to treat people with schizophrenia and severe bipolar disorder. But documents from Eli Lilly show that from 2000 to 2003 the company encouraged doctors to prescribe Zyprexa to people with age-related dementia, as well as people with mild bipolar disorder who had previously had a diagnosis of depression.Although doctors can prescribe drugs for any use once they are on the market, it is illegal for drug makers to promote their medicines for any uses not formally approved by the Food and Drug Administration. ...
Zyprexa is Lilly’s most profitable product and among the world’s best-selling medicines, with 2007 sales of $4.8 billion, about half in the United States."