Ray Moynihan reports in this week's BMJ on Australian scientists describing a new condition called "motivational deficiency disorder," for cases of extreme laziness.
The researchers claim the condition affects up to one in five Australians.
Of course, there's a drug attached to this research. They're studying indolebant in phase II studies, claiming that "one young man who could not leave his sofa is now working as an investment adviser in Sydney."
The researchers work in the University of Newcastle, where another professor, David Henry, is planning a conference this month on disease-mongering.
The conference agenda just got a bit longer.
I can't wait to see the ads for this one. I'm saving my spot on the sofa to watch them.
The Associated Press reports: "The maker of Ambien has begun a new ad campaign it hopes will reverse a sales slide triggered by reports that some patients couldn't recall driving or eating while sleepwalking when using the prescription sleep aid. The campaign Sanofi-Aventis SA launched Wednesday is likely the first salvo in what analysts predict will be a fierce advertising war in the market which has seen sales drop in the aftermath of the negative news. Sanofi's Ambien is expected to have a new competitor by this summer when Pfizer Inc. and partner Neurocrine Sciences Inc. are slated to debut a new pill."
"You are not going to be able to watch a television show without seeing a commercial for a sleeping pill," says one analyst.
Isn't it that way already?
This week you can expect to read and see countless news stories about "how sleep problems affect performance in nearly every aspect of teenage life – academically, psychologically and physically."
It's because of a promotional campaign called the 9th annual Sleep in America poll of the National Sleep Awareness Foundation.
They call it "National Sleep Awareness Week." I call it "National Sleeping Pill Advertising Week." The Foundation is run by drug companies that make sleeping pills, and by sleep lab operators and mattress makers. Not quite an unbiased source.
While the promotion will cite all sorts of statistics about sleep-deprived teens, they are not likely to brag about this: I read one estimate that the use of sleeping pills in kids ages 10 to 19 has skyrocketed 85 percent in recent years, with spending up 223 percent.
As a nation, we're spending billions on sleeping pills and drug companies are spending hundreds of millions to get us to use more.
That's what National Sleep Awareness Week means to me.
Last week, Dr. Peter Salgo had an op-ed piece in the New York Times entitled, "The Doctor Will See You For Exactly Seven Minutes."
"When politicians speak of America's health care needs," he writes, "they often miss an important point: the doctor-patient relationship has become frayed. Patients aren't unhappy just because health care costs too much (though they would certainly like it to be more affordable). Rather, people sense a malaise within the system that has eroded the respect they feel patients deserve."
Later in the piece he advises: "You, the patient, are the system's best hope. In the age of seven-minute health care, you need to realize that you employ doctors. That is, your doctor works for you. Although doctors shouldn't think of patients as customers, you can, and should, adopt a business mind-set when shopping for health care. Evaluate what it is you expect from your doctor, then ask for it. If you are unhappy with your doctor, fire him. If you cannot get more than a seven-minute face-to-face encounter with your doctor, he needs fewer patients. The true power in the health care economy rests not with the doctors and certainly not with the backroom business staff. It rests with you. If you insist on being treated with care and respect, you will be. And the system will improve as a result."
In case you were wondering, an FDA advisory panel rejected Cephalon's drug Sparlon for attention deficit hyperactivity disorder or ADHD. Sparlon contains modafinil, the same ingredient in Provigil, the company's sleep-disorders drug.
TheStreet.com reports "The advisory committee voted 12-to-1 against recommending Sparlon's approval, citing its concerns about Stevens-Johnson syndrome, a rare and vicious blistering of the skin that can be caused by certain drugs. The FDA isn't bound to follow its advisers' recommendations, but it usually does so."
Scandinavian researchers report in the BMJ this week on their study suggesting a 10% over-diagnosis of breast cancers from a mammography screening program.
"Over diagnosis" means finding early cancers or "pseudo-cancers" that would not have caused harm in the woman's lifetime.
Others reacting to the study think it underestimated the rate of overdiagnosis -- that it may be more like 24 - 30%.
There's been an interesting progression to the discussion in the BMJ recently. As editor Fiona Godlee points out, "Three weeks ago an editorial in the BMJ concluded that despite limitations, breast cancer screening does save lives. But in the same issue of the journal we published an analysis ... of the letters inviting women for screening. None of the letters mentioned the major harms of screening, and the authors concluded that organisers of screening programmes have a serious conflict of interest in wanting high uptake, which compromises their ability to provide balanced information about benefits and harms."
Dr. Marc Siegel, author of ''False Alarm: The Truth About the Epidemic of Fear," blasts bird flu expert Robert Webster of St. Jude's Children's Research Hospital in an editorial in the Boston Globe.
Siegel wrote that Webster “told ABC News this week that there were ''about even odds at this time for the virus to learn how to transmit human to human,’ and ''society just can't accept the idea that 50 percent of the population could die. . . . I'm sorry if I'm making people a little frightened, but I feel it's my role.’ “
Siegel disagrees with Webster, calling it “the latest Hitchcockian pronouncement” about the bird flu. He writes: “Why provoke the public to see a potential pandemic in end-of-the-world terms? A pandemic simply means people in several areas having a disease at the same time -- but it may be hundreds rather than millions. The last flu pandemic, in 1968, killed 33,800 Americans, which is about the flu's toll in an average year. We don't need to panic in advance for that kind of pandemic.
Cooking poultry kills any flu 100 percent of the time, yet the fear of H5N1 bird flu is already so out of control in Europe that 46 countries have banned French poultry exports after a single turkey was found to be infected. France, fourth in the world in poultry exports, is already hemorrhaging more than $40 million a month.
Imagine what would happen if a bird in the United States gets H5N1 bird flu. At the rate we are going, the fear of birds will be so great that our own poultry industry, number one in the world, is likely to be in shambles. We already have this problem with mad cow disease, where a single sick cow that is not even in the food chain makes people very nervous, despite the fact that it is almost impossible to get mad cow disease from eating beef.
Flu is worthy of our concern. But concern can lead to long term preparation whereas panic can be far more virulent and costly than the bird flu itself.”
Merrill Goozner asks this question on his blog. An excerpt: “With nearly a half million kids on six different mind-bending drugs, you’d think the psychiatric profession already had enough options for attention deficit hyperactivity disorder. But that’s not the way our drug approval system works. It’s a free market out there, open to all comers. So this Thursday the Food and Drug Administration’s Psychopharmacologic Drugs Advisory Committee will consider another drug for ADHD – Cephalon’s Sparlon, which is generically known as modafinil.
Late night truckers and shift workers are already familiar with this drug. In their sleep-disordered world, it is known as Provigil. It’s not an amphetamine. It’s mechanism of action, to use the mystifying argot of the drug scientists, is “poorly understood.” In layman’s language, that means they have no idea how or why it works.”
Read the rest of Goozner’s article, which discusses suicide risks, bribes, patent expiration and generic drug competition.
Goozner concludes: “I’m sure we’ll hear from plenty of testimony on Thursday from parents and physicians who swear by this new drug. But the jaded business reporter in me wonders if the kids are just pawns in the company’s patent game.”
Bristol-Myers Squibb and Sanofi-Aventis, makers of the anti-clotting drug Plavix, continue to run TV commercials that include statements refuted by scientific research.
One such ad says, "Plavix, in combination with aspirin and other heart medicines, helps provide better protection against heart attack and stroke than aspirin and other heart medicines alone.”
Compare with that with the lead in a Wall Street Journal story just last week: “In a setback for Bristol-Myers Squibb Co. and Sanofi-Aventis SA, a large study found that adding the blood thinner Plavix to aspirin wasn't significantly more effective than aspirin alone in preventing heart attacks, strokes or death from cardiovascular disease in a broad group of high-risk patients.The findings put a dent in the hopes of the companies, which co-market the medicine and funded the study, to widen the market for Plavix, which already is a blockbuster.”
The ad is also guilty of “disease-mongering,” scaring viewers by trying to make them think they are all vulnerable, with lines such as: “Janet is a formidable woman. But she was no match for something smaller than the tip of a pen.” In other words, a clot. In other words, something so small it could be lurking inside all of us. Why aren't we all on Plavix?
And where is the FDA's oversight of such an ad? Oftentimes by the time the FDA catches up to an erroneous claim in a drug ad, the ad has run its course and the company is on to the next campaign.
The Grade the News (GTN) website reports on the questionable medical “reporting” done by syndicated TV and radio celebrity Dr. Dean Edell, who calls himself “America’s Doctor.”
Edell appears on San Francisco’s KGO Channel 7 with introductions that often say, “Dr. Dean Edell reports.” But the story points out that Edell does no original reporting in many of the stories.
GTN reports: “Many of his TV stories, along with transcripts under his byline on the KGO Web site, were taken nearly verbatim from a low-profile news service in Florida that mails out prepackaged video reports to more than 100 TV stations across the country.
The company, Ivanhoe Broadcast News, allows local reporters to put their names on stories they didn't report, film or write -- without mentioning Ivanhoe. Stations also are permitted to omit geographical information, giving viewers the false impression that the stories were locally produced and the patients and doctors quoted in the stories could be their neighbors.”
Edell doesn’t practice what he has preached, according to GTN: “In his writing and in news stories on television, Dr. Edell has condemned the unattributed use of video news releases -- ready-to-run stories produced by companies or government agencies looking for publicity.
In an opinion piece he wrote for the Knight Ridder news service in 1997, ‘Beware the Television Report of 'Important Medical Breakthrough,' ‘ Dr. Edell scolded health journalists ‘faced with shrinking budgets and staffs, pressure to produce more segments, and shorter deadlines’ who succumb to self-interested parties pushing ‘pre-packaged video tape complete with ready-made scripts.’ “
It’s worth noting that the main product of Ivanhoe – the company from which Edell’s station buys ready-made news – is called “Medical Breakthroughs.” But he was correct in his 1997 warning: this kind of "just-add-water" TV health reporting is proliferating.
What’s happening at the Canadian Medical Association Journal should be of concern to anyone. Given how much news is determined by what is published in medical journals, this is a troubling story.
As an article in the New England Journal of Medicine states this week, “Canada is now the epicenter of the ongoing struggle over the scope and limits of editorial freedom at association-owned journals.”
Canadian journalists report that 14 members of the 19-member editorial board of the Journal quit yesterday, joining Dr. Jerome Kassirer, former editor of the New England Journal of Medicine who resigned earlier this week.
Those who quit did so in protest of last month's firings of the journal’s editor and senior deputy editor.
“We believe your recent actions and pronouncements regarding establishing editorial autonomy are largely cosmetic and unlikely to lead to an independent and free voice for health related issues in Canada,” they said.
The squabble has drawn international attention from the world’s leading medical journals: The Lancet, the British Medical Journal, PLoS Medicine, the Annals of Internal Medicine, the New England Journal of Medicine, and the Journal of the American Medical Association.
An editorial in The Globe and Mail of Toronto develops the issues more fully.
Katie Couric and the NBC Today Show are at it again, with a weeklong series entitled "Confronting Colon Cancer," and a subtheme of "The Fight For More Screening."
I heard today's segment and do not yet have access to a transcript. But what I heard was a confusing jumble of recommendations - some of which included references to recommendations for screening everyone - and how cost-effective that could be. The CDC's Julie Gerberding talked about "evidence-based" recommendations on the same segment.
The fact is that there is NO evidence-based recommendation for screening the entire population before age 50. Evidence-based guidelines state that high risk individuals may derive benefit from screening before age 50, but there is no such recommendation for the general public.
Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group, says that Dr. Andrew von Eschenbach is not qualified to lead the FDA. Here is Wolfe's statement:
"If confirmed by the U.S. Senate to be the next commissioner of the Food and Drug Administration (FDA), Dr. Andrew von Eschenbach will become yet another Bush appointee whose main reason for being selected is that he is a family friend, someone who has been warmly embraced by the regulated industries – especially the pharmaceutical industry – and someone who has been and will continue to be loyal to the White House agenda.
Von Eschenbach continues to exhibit extraordinarily bad judgment, a lack of being in touch with reality and insensitivity to the hopes and fears of other cancer patients and their friends and families, as evidenced by his oft-stated “plan” to eliminate the suffering and death from cancer by 2015. Eradicating cancer within 10 years is not realisitic, and by making this statement, von Eschenbach is cruelly raising people’s hopes.
He is a very poor choice to head this critical agency, and his nomination must be defeated. Otherwise, the FDA will be further weakened and the public health further damaged by someone who is so unqualified."
Sorry I've been a little slow with posts in the past few days.
First, there's digging out from under a foot of new snow in the Twin Cities.
Second, there's digging out from under an avalanche of cardiology-related news coming out of the American College of Cardiology meeting.
It reminds me of the excellent paper by Woloshin and Schwartz in JAMA a few years ago, "Media Coverage of Scientific Meetings: Too Much, Too Soon?". Their conclusion: "Abstracts at scientific meetings receive substantial attention in the high-profile media. A substantial number of the studies remain unpublished, precluding evaluation in the scientific community."
Good story under this headline in the Los Angeles Times. Another cautionary tale of false hope, premature PR hype, and people who get hurt as a result.
The story begins: "When Hwang Mi Soon rose from her wheelchair and shuffled forward with the aid of a metal walker, her small steps were trumpeted around the world. 'Stem-Cell Gal's Miracle Steps,' crowed the New York Post in November 2004, while a New Zealand newspaper proclaimed, 'Miracle Cure for Paralysis.' The breathless pronouncements were accompanied by photographs of the 37-year-old South Korean woman who, just as in the cliche, was smiling through her tears.
Today there are only the tears.
Hwang is back in the wheelchair, where she has largely been since falling off a bridge as a teenager. She said the purported miracle treatment — which entailed injecting umbilical stem cells into her damaged spine — had only fleeting benefits that wore off after a few weeks. A second procedure in March 2005 caused an infection and left her in constant pain.
'I was like an animal they used for testing,' a bitter Hwang said."
One neurosurgeon says in the story: "The problem in Korea is that these therapeutic tests were conducted as much for public relations as for the patients," Jeong said. "There should have been more clinical testing on animals before they tried these procedures on people."
A study in this month's American Journal of Managed Care (not to be published online until next week) confirms some of what I've reported in earlier studies: local TV health news is troublesome. (The Milwaukee Journal Sentinel has a story on the study.)
Researchers from the University of Michigan and the University of Wisconsin-Madison analyzed one month of news coverage on 122 stations in the nation's top 50 media markets.
A Michigan news release states that: "The average story was 33 seconds long, and most did not give specifics about the source of the information presented. Items about specific diseases tended not to contain recommendations for viewers, or information about how common the disease was - which could help put the news into perspective with other health issues. But most disturbing, the study's authors say, were the egregious errors contained in a small minority of studies - errors that could have led to serious consequences."
One author said, "The fact that one of the most-covered stories in the study was about the removal of warts using duct tape, a topic which has questionable public health value, and that the story originated in a press release from a renowned medical journal, shows that we in the health community have work to do."
A majority of U.S. adults lack confidence in the Bush administration's ability to reform the nation's health-care system, a new Wall Street Journal Online/Harris Interactive health care poll shows.
The Center for Science in the Public Interest reports that "five of the eleven scientists so far selected to judge the safety of the new multiple sclerosis drug Tysabri have financial ties to either the drug's sponsors, Biogen and Elan Pharmaceuticals, or their competitors."
An advisory committee of the FDA meets today to reconsider Tysabri, which was pulled from the market last year after a handful of patients developed a rare brain disorder. Two permanent committee members disclosed they earned between $10,000 and $50,000 from either Biogen and Elan by serving on their speakers bureaus or consulting. Three other committee members consulted for or sat on the speaker bureaus of direct competitors. The FDA claims it cannot find experts without conflicts of interest to serve on advisory panels, whose advice it usually follows.
As part of the deal when the FDA approves new drugs, sometimes it requires drug companies to promise to do followup studies of safety and effectiveness - post-marketing surveillance. Sometimes the promise is made in return for speedier FDA approval. But the New York Times reports that two-thirds of the studies had not even been started.
Dr. Alastair Wood, associate dean of Vanderbilt medical school, told the Times that the F.D.A. needed to get tougher on drug makers. "Who would turn in their homework if they didn't have to?" Dr. Wood asked.
CJRDaily.org features an interview with Wall Street Journal health columnist Tara Parker-Pope. The interview focuses on her opinion that "a flawed communications effort led to widespread misinterpretation of results by the news media and the public" regarding the Women's Health Initiative (WHI) and its findings on how low-fat diets, consumption of calcium and vitamin D, and hormone replacement therapy affect women's health.
In the interview Parker-Pope says, "I also think that as reporters, we should never take anything at face value. I think a mistake that a lot of people might make is to read the press release. I almost never read the press release. I read the study first, because I don't want to be swayed by what the press release says. That's what you have to do with any kind of scientific research -- ask what is really being asked here, and how much is really being answered?"
She also says that science doesn't work in soundbites. "But I also think just because we have 15 seconds or 800 words or whatever the amount of time we have to tell our story, we still have to get it right. It's challenging but it's also what's kind of fun about being a health writer -- taking this really technical, complicated stuff and distilling it down into something that people can understand and use to make decisions about their health."
I'm part of a team that has been working for months on a system to evaluate and grade U.S. health news coverage of clinical research. A website displaying these evaluations will be launched in about a month. It's meant to support excellence in health/medical journalism, but also to help people become smarter consumers of news and of health care. More details on this website in the weeks to come.
It may be difficult for people to understand how there could be any problem with having a screening test. We've been trained that "early detection leads to better chance of cure." Journalists often promote this theme without knowing there's much more to the story.
Articles in this week's BMJ push for more discussion about the negative side effects of screening for breast cancer. One study suggests that breast cancer screening could result in a 10% rate of over-diagnosis.
Researchers say that the information given to women needs to be more balanced to ensure women are adequately informed about the benefits and harms. Research has shown that women generally exaggerate the benefits and are unaware of the harms of screening such as overtreatment.
An excellent resource on this topic is Dr. Gil Welch's book, "Should I Be Tested for Cancer? Maybe Not and Here's Why."
Why must this Administration frame almost every issue in the context of terrorism?
Yesterday Surgeon General Richard Carmona said that America's obesity epidemic will dwarf the threat of terrorism if the nation does not reduce the number of people who are severely overweight.
Severe overstatement might be the way to describe Carmona’s following questions: "Where will our soldiers and sailors and airmen come from? Where will our policemen and firemen come from if the youngsters today are on a trajectory that says they will be obese, laden with cardiovascular disease, increased cancers and a host of other diseases when they reach adulthood?"
The Associated Press pointed out that “The surgeon general offered few specific solutions but said public policy reforms would not be helpful in curbing obesity, explaining that common-sense health decisions cannot be legislated.”
Public policy reform would not be helpful?
Policies on food labeling and food advertising wouldn’t be helpful?
Policies on foods available to kids in public schools wouldn’t be helpful?
This Surgeon General and this Administration have to come up with a better plan than just scaring people with a terrorism comparison, and then running from any policy-setting responsibility.
The wall that once existed between news and advertising has many gaping holes in it.
The Bulldog Reporter's Daily Dog website says that some readers of the Charlotte News & Observer were bothered by the paper's handling of two pieces on the GlaxoSmithKline drug company this past Sunday.
The website says: "Big pharma giant GlaxoSmithKline got a lot of attention in last Sunday's News & Observer in Charlotte. On the front page was a story headlined, "GSK scientist pursues Alzheimer's treatment," that featured the pharmaceutical company's efforts to produce a breakthrough drug to treat or prevent the disease, reports Ted Vaden, a staff writer for the daily.
On the front of the Classified section was another story titled, "It takes a vast team to introduce a new drug." The story focused on the GSK drug Valtrex, used to treat genital herpes and other afflictions.
Even though one GSK story was in the news section and the other in advertising, their conjunction caught the attention of some readers.
"I was just blown away, as a consumer advocate, by the GlaxoSmithKline one-two punch," said Adam Searing, a healthcare advocate with the N.C. Justice Center. "The first was the real puff piece about an Alzheimer's treatment that's two or three years away. Then I opened the Sunday Classified and it seems like Glaxo has bought half the classified section, and it's not even identified as advertising. I don't think it serves your high standards to allow someone like Glaxo to have such an influence on the newspaper."
The paper says the Classified story was not an ad. It just looked that way to some. They say it was actually a story written by a freelancer hired by the advertising department. (Doesn't that make it an ad?)
A North Carolina ethics prof said, "I don't think the line between advertising and editorial is as clear in your readers' minds as it is in your offices."