A friend sent me a notice found on the Bulldog Reporter website, which is designed to help public relations people pitch their stories to journalists.
The item was entitled, "AP Radio Welcomes News and Information Related to Healthcare, Eldercare." It appears to be a clear invitation to PR people to send audio clips along with news releases because that might improve their chances of getting their message on the air.
The notice read: "Include audio in your release. New technology allows AP Radio to put more natural sound into news reports, and this allows for new PR opportunities. "Provide bits and pieces of your news release in audio," AP Radio news general manager Thomas Callahan suggests. "Everyone sends printed releases, but attaching an MP3 with excerpts might attract attention."
It is surprising to see such an open invitation from a journalism organization to PR people, especially given the myriad concerns raised in recent months about the dissemination of video news releases in TV news. How will listeners know which audio clips and which stories came from the work of independent journalism, and which came from a source hawking a product or some other vested interest?
By the way, the notice bragged that AP's radio division serves more than 4,300 stations with text, audio and/or web content, reaching more than 1 billion people around the world who see or hear an AP story every day. And now that may be more than 1 billion people every day who hear unfiltered PR hype.
A Vermont court should order the state’s attorney general to allow public access to all records disclosed by pharmaceutical companies under the Vermont Pharmaceutical Marketing Act, a law intended to allow the public to learn the amount of money doctors receive from drug manufacturers, Public Citizen said in a lawsuit filed Friday against the Vermont attorney general. The lawsuit, which calls for the release of records being withheld at the request of drug companies, was filed in Vermont’s Washington County Superior Court.
The Reuters wire service reports that "the world's top two diabetes organizations have questioned the existence of a medical condition widely cited by drug firms, in a move that could hamper prospects for Sanofi-Aventis's new drug Acomplia. The American Diabetes Association and European Association for the Study of Diabetes said in a joint statement on Thursday that 'metabolic syndrome' -- which has come to be seen as a predictor of cardiovascular disease -- was poorly defined, inconsistently used and in need of further research. Doctors should not diagnose people with the 'syndrome' or treat it as a separate condition until the science behind it is clear, according to a paper to be published in the September issue of Diabetes Care and Diabetologia."
Reuters reports that the " strongly worded warning was a setback for Sanofi, which is keen to position its anti-obesity drug Acomplia as a medicine to treat 'metabolic syndrome.' "
"Metabolic syndrome" has been defined as applying to anyone with three or more of the following conditions -- a large waist circumference, high triglyceride levels, high blood pressure, low levels of HDL "good" cholesterol and high blood glucose.
The naming of new diseases and new syndromes to help sell drugs is well documented in books by Moynihan, Goozner, Avorn, Angell and others. It is refreshing to see scientists put up a STOP sign in at least one case.
On the same day the Vioxx verdict was announced last week in Texas, Merck placed an ad on an evening network newscast, with the theme of “putting patients first.” The evidence presented in that trial would suggest that mission has not always been practiced.
And GlaxoSmithKline has been placing ads in the network newscasts featuring a GSK researcher using the old line about drug development costing $800 million. To see the holes in that flawed claim, read Merrill Goozner’s excellent book, “The $800 Million Pill.”
Where's the truth squad on such ads?
"When Eli Lilly & Co. wanted to get the big California health-maintenance organization Kaiser Permanente to use its new antidepressant, it ran straight into Debbie Kubota." That's how the Wall Street Journal begins its piece on how insurers are scrutinizing drug studies and drug company claims.
The story continues: "Two studies published in psychiatry journals described the new drug, called Cymbalta, as 'superior' to the older antidepressants Prozac and Paxil. But Dr. Kubota, a Kaiser pharmacist here, observed that in both studies the patients who did the best on Cymbalta received a higher dose of it than recommended on the label. Although each article mentioned the superiority of Cymbalta in its abstract, or summary, both acknowledged lower down that the studies weren't designed to show whether one drug was better than another.
Dr. Kubota's conclusion: The claim of superiority was 'speculative.' She issued a negative report to Kaiser's physician committees, which agreed and ruled that Kaiser would bar Cymbalta from its list of favored drugs for its biggest regions, Northern and Southern California.
As the cost of drugs in the U.S. approaches $250 billion a year, pharmaceutical companies are running up against a growing breed of detective trained to see through marketing spin. Working for insurers, state Medicaid programs and nonprofit bodies, these detectives cast a wary eye on published studies in medical journals, once considered an unimpeachable source. They search for subtle aspects of clinical-trial design that might show the drugs are not all they're cracked up to be."
Rather than focusing on how money is raised to fund health care, government reformers should worry about how it is spent. That's the point of a column in The Economist.
It reviews struggles in Britain, France, Germany and the U.S. and concludes: "It is the job of governments to try to get more health care for the money that people pay. It is the job of providers to get more money for the health care services they offer and to avoid the unpleasant business of having to change their ways. They must be resisted."
The Mercury News of San Jose is the latest to look at issues of bias in drug studies - bias introduced by researchers' financial ties to industry.
The News writes: "Earlier this year, an herbal supplement called FertilityBlend got a glowing endorsement from a prominent Stanford researcher, an author of two small studies that showed it increased pregnancy rates in infertile women.
``I think my opinion of herbal supplementation has changed. I was a skeptic,'' says Dr. Mary Lake Polan, chairwoman of Stanford's department of obstetrics and gynecology, in a video on the Web site of the product's manufacturer. But after one-third of the women taking the pills in the study got pregnant, she became a believer, she says.
What many consumers may not realize is that Polan also has a financial interest in the Mountain View company that makes the product -- and that such relationships between academic scientists and industry are increasingly common."
The article continues: "Critics believe the growing number of monetary relationships between scientists and companies that make drugs, supplements and medical devices could be tainting research and compromising patient care, and some are pushing for tighter regulations on such financial ties."
What the FDA won't do, some physicians are doing. That is, to talk openly about the claims made by highly-advertised new sleeping pill Lunesta.
The Boston Globe reports on several physicians' criticisms of Lunesta ads. One says the ads don't mention how long the pills can safely be taken and he adds that more long-term studies of sleeping pill safety are needed. Another says "Patients who took this drug did not become normal sleepers." Another says behavioral therapy is preferable to pills for treating insomnia long-term.
The Globe says that a spokeswoman for the FDA said it would not discuss reviews of a particular company's advertising, such as why the manufacturer can claim Lunesta is ''approved for long-term use."
Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group, says that FDA denial of his group's petition to ban the weight loss drug Meridia is misguided.
In a statement on the Internet, Wolfe says: "For a drug such as Meridia to be approved or for it to stay on the market, there must be evidence that its benefits outweigh its risks. Evidence prior to its approval and more than 50 cardiovascular deaths, many in young people, since its approval confirm that its benefits do not outweigh its risks and that it should be removed from the market despite efforts by the FDA/Abbott duo to keep the drug alive."
The statement concludes: "Once again, the FDA is siding with a large drug company, much as the agency did several years ago with Merck concerning Vioxx, when it failed to demand a black box warning on that drug. How many more dangerously flawed decisions will the FDA make before the Congress repeals the Prescription Drug User Fee Act, which brings the agency ever closer to – and makes the agency less vigilant over – the companies that give it almost $200 million a year in funding?"
The Boston Globe offers a good look at how peer review of medical research by medical journals is not perfect.
In the Globe: "Now, after a study that sent reverberations through the medical profession by finding that almost one-third of top research articles have been either contradicted or seriously questioned, some specialists are calling for radical changes in the system."
The Globe says it is difficult to discover what goes wrong in peer review when it does go wrong, largey because "peer reviewers are unpaid, anonymous, and unaccountable. Moreover, their reviews are kept confidential, making it impossible to know the parameters of the reviews."
The take-home message for journalists and consumers is: if you're going to treat each journal article as gospel, you're putting your faith in a flawed process.
Unbelievable.
The Pittsburgh Post-Gazette reports that a KDKA-TV medical "reporter," who is a physician, was "peddling Joint Formula 88 joint pain relief cream ($21.90) on QVC." Worse, if it can get worse, is that the cream is his product.
Did anyone talk to this guy about journalism ethics before hiring him?
I just spoke to a group of California journalists about the entanglement of conflicts of interest in the dissemination of health news and information. My recurrent message to them is what I would tell this "M.D.-reporter" -- YOU HAVE TO DECIDE WHETHER YOU'RE GOING TO BE A JOURNALIST OR A PR-ADVERTISING PERSON. You can't do both.
Add this egregious example to the long list of commercialism and conflict of interest incidents in journalism which I previously reported.
Often I criticize health news coverage in this blog. Today, I praise a reporter for nailing a story.
Andre Picard of the Toronto Globe and Mail hit a home run with his story, "Be Skeptical About the Herceptin Hype."
Herceptin is a drug intended for certain types of breast cancer. Picard writes:
"The most eye-popping claim is that, for this select group, the drug cuts the risk of recurrence by half. In clinical trials, women who took Herceptin along with a standard chemotherapy drug saw their risk of recurrence fall 52 per cent, compared to women who received chemo alone. That is an impressive relative risk reduction.
But what matters in the real world is absolute (not relative) risk reduction. Practically speaking, 15 per cent of women taking Herceptin and chemo had a recurrence of breast cancer within four years of diagnosis, compared to 33 per cent of women who took chemo alone. That is an absolute risk reduction of 18 per cent.
Nobody wants a recurrence, but what matters ultimately is survival. Herceptin, according to the studies, cut the death rate by one-third. That sounds impressive, but relative risk reductions always do. In reality, the difference in the death rate between the Herceptin and non-Herceptin groups was 2 per cent after three years, and 4 per cent after four years.
Based on those numbers, can we honestly say that Herceptin is an essential lifesaving drug?"
If more reporters knew the difference between relative and absolute risk, and reported the difference, we'd have a lot less hype in health news coverage.
A Star Tribune story shows how misleading it can be to hear that health care cost increases have slowed down.
That's happened in Minnesota, down to the lowest levels in seven years, according to a state study released this week.
But only health insurance companies seem to be getting relief, not consumers.
Because while expenses paid by Minnesota's health insurers rose 7.4 percent in 2004, consumer health care costs grew 15.3 percent last year.
"Out-of-pocket expenses for the average Minnesotan are becoming unaffordable," Julie Schnell, state council president of the Service Employees International Union, told the newspaper. "What we have is employers shifting the costs to employees," she said. "That is not the answer to reform, and that is not the answer to reducing costs in health care."
Suddenly lung cancer is a hot topic in newsrooms. Peter Jenning dies one day. The next day Christopher Reeve's widow announces she has lung cancer. So it is understandable that some well-intentioned "disease awareness" efforts would come forward.
But journalists should employ facts and full disclosure when giving attention to such disease awareness campaigns. (The "Selling Sickness" book by Moynihan and Cassels gives many reasons why.)
CNN gave several minutes of airtime yesterday to a founder of the group, Women Against Lung Cancer. The network never revealed that the group receives financial support from the drug industry -- from makers of lung cancer drugs. But CNN also allowed the guest to talk about "studies looking at special spiral CAT scans of the chest so that we can pick up tiny nodules, hopefully before they have a chance to get into the bloodstream and spread." What neither the guest nor CNN disclosed is that many scientists don't think there is proof that such scans prevent premature death. And many see risks in such screening, even the possibility that they do more harm than good when scans lead to unnecessary followup testing that carries its own risk. That's why they're doing the studies. It's not a slam dunk that benefits will outweigh risks.
Those would have been balanced facts to present. Not just the promise of early diagnosis discussed during the emotional reaction to two celebrities' diagnoses.
When you hear about "disease awareness" campaigns, always look for facts in context and full disclosure.
I just finished reading an important new book, "Selling Sickness: How The World's Biggest Pharmaceutical Companies Are Turning Us All Into Patients," by Ray Moynihan and Alan Cassels.
It documents disease-mongering, how drug companies foster the creation of medical conditions to create markets for their pills, the marketing of fear, the "medicalization" of normal states of health, the hidden agendas of "disease-awareness campaigns," problems with drug company relationships with celebrity spokespersons and patient advocacy groups, and other issues about which most consumers don't have a clue.
As one skeptic says in the book, "We're changing the experience of what it means to be human."
It also points to numerous instances of what the authors call "sycophantic media coverage" and an "indictment of the flaccid culture of much medical reporting."
I highly recommend the book.
This is becoming a recurring theme: journalists working in news rooms while also doing paid public relations work.
A Minneapolis-St. Paul TV anchor did it.
A Nashville TV reporter did it. (Although she called me yesterday to explain that she's not doing it anymore.)
And now Detroit Medical Center announced that it has named a former WDIV-TV anchorman to be its communication director, "providing guidance on media issues and serving as a principal spokesperson" for the medical center. That's fine. But in the next breath, it's revealed that the anchorman also has a long-term agreement with WDIV-TV to produce periodic in-depth documentaries for this Detroit-based NBC affiliate.
How does the audience know which hat the anchor/PR man is wearing at which times?
As critics said at the time of the Minneapolis incident cited above, journalists who cross these lines between journalism and public relations raise warning flags. Questions of credibility, conflict of interest (real or perceived), and truthfulness arise when you're being paid by someone to make them look good in the media -- at the same time you're supposedly being an independent, objective journalist in other venues.
A study in this week's New England Journal of Medicine claims that the drug modafinil, marketed as Provigil, can improve the wakefulness and performance of nighttime employees. But an editorial by another researcher in the same journal says the treatment is "little better than nothing."
The Wall Street Journal reports that last year, doctors wrote 1.9 million prescriptions for the drug, which generated $414 million in sales. The newspaper says, "The debate within the pages of the prestigious medical journal raises renewed questions over the reliability of research sponsored by drug companies. The study's lead author is Charles A. Czeisler, chief of the sleep medicine division at Harvard Medical School; his professorship is endowed by Cephalon for $2 million." Cephalon makes Provigil.
Syndicated columnist Judy Foreman has a good column on informed consent. In it, one ethicist says that too often "the ideals of informed consent get reduced to creating a paper trail for medico-legal and bureaucratic reasons." Another says that often, the informed consent process is geared to "protecting the doctor and hospital from malpractice," not empowering the patient.
Foreman includes good information on how and when the process should work, what informed consent should include, and on what consumers can do to protect themselves.
ABC World News Tonight broadcast a story last night, a portion of which is captured on their website, about patients' own stem cells used to build new blood vessels.
It is interesting clinical research, but the story offered only breathlessly optimistic projections -- no caveats, warnings, unknowns or uncertainties. An excerpt: "Results in more than 100 patients show that, within just three months after the stem cell injections, patients see a significant improvement in blood flow to the heart. The heart muscle itself actually doubles its ability to squeeze or contract.
The short-term results (3 months) send up one red flag. Another is the use of what are called surrogate endpoints. In other words, rather than reporting that people lived longer (which of course would be a pretty empty projection after only 3 months), they reported a different marker or endpoint to measure "success." That is, blood flow to the heart.
But the coup de grâce comes with the next line of the story: "Researchers say these adult stem cells might help tens of millions of heart patients each year."
Or, the story could be just as true to the facts and conclude, "Maybe not." The science behind this work holds great potential. It doesn't need hyping of short-term research measuring only surrogate endpoints that extrapolates these early findings to tens of millions of people.
The drug industry releases its voluntary code of conduct for direct-to-consumer drug ads today, an approach AdAge.com calls a "softball approach....falling well short of a mandate on the most serious issues."
AdAge reminds readers that this step may not stop Congress and/or the FDA from enforcing new rules. It quotes Senator Bill Frist: "Turn on your TV, and within 15 minutes you'll be bombarded by dreamy ads that suggestively over-promise and, even more likely, will make you and your children experts on erectile dysfunction. We must ask ourselves: 'Are these ads, which we know are costing billions, properly educating patients or just peddling expensive products?' "
A group of high blood pressure researchers is ending its 16-year relationship with a high blood pressure journal, and claims of improper drug company influence on doctors are at the root of the dispute.
The Wall Street Journal has details.
Dr. John Laragh, co-founder of the American Journal of Hypertension, complains that some doctors have become "heavily involved in pharma marketing for personal gain."
As the Journal appropriately frames the story, it is "a dispute reflecting heightened concerns about the control and credibility of medical information."