A Wall Street Journal story today looks at an important question in science, in policy-making, and in journalism: "What do the results of animal studies really tell us about humans? That question still puzzles researchers even though guinea pigs, lab rats and their brethren have long been part of experiments."
Two examples from the story:
Many times, however, subtle results in animals are unclear and scientists just don't know what to make of them. In the case of the new Novartis drug Galvus, James Shannon, the company's global head of pharmaceutical development, told investors that Novartis researchers "do not understand -- do not know -- the mechanism of the skin findings" in monkeys. They do know that "humans appear to react to Galvus in a very different way."Another example of the confusing disparities that can arise in testing is the case of the popular sleep drug Lunesta. It won FDA approval despite the fact that tumors appeared when rats and mice took huge doses of a closely related chemical cousin of the medication. Some FDA reviewers were concerned enough initially to recommend rejection of Lunesta. After further analyses, however, agency officials concluded the data from human testing didn't suggest a signal for cancer in people. But you won't see the issue highlighted in the company's ubiquitous green-moth commercials for the drug.
Journalists who report on preliminary findings from animal research without strongly emphasizing the inherent weaknesses in trying to interpret such findings are not serving the public.
Earlier this week, I pointed out how - on one day - the Wall Street Journal appeared to favor positive drug news out of the American College of Cardiology meeting more than negative drug news. But day in and day out, the WSJ is one of the few news organizations to put negative drug news on page one. And today they should be praised for the spot they gave the story headlined, " 'Miracle' Obesity Pill Looks Less Miraculous." It begins:
"When Sanofi-Aventis SA reported data on a new obesity pill at a medical conference in March 2004, it generated instant buzz.Hundreds of newspaper and television reports around the world the next day referred to the drug, Acomplia, as a "super pill" and a "miracle drug." With a new approach to obesity, Acomplia promised not only to help people shed pounds but also to raise good cholesterol and cut diabetes risk. It even showed signs of working as an antismoking aid.
"That is amazing. People are going to want this drug today, I'm sure," effused an anchor on ABC's "Good Morning America."
Three years later, Acomplia is looking less like a miracle. The drug still hasn't hit the market in the U.S. The Food and Drug Administration has asked for more data and repeatedly put off approval for the drug as an obesity treatment, while rejecting it for smoking cessation. Side effects associated with Acomplia -- including depression and anxiety -- are likely giving the FDA particular cause for concern, analysts and doctors say."
This episode is repeated many times each year: journalists trumpeting preliminary unproven claims made by drug companies or pharma-funded researchers without exercising appropriate skepticism and caution.
Thanks to the WSJ for not only pointing this out, for doing so in its prominent page one position.
The Associated Press reports that two 14-year old high school science students proved that drug company powerhouse GlaxoSmithKline was making unsubstantianted claims about one of its products. And the drug giant will be fined - although not much - for the misleading advertising.
This took place in New Zealand, where two science students found that Glaxo's black currant drink Ribena contained no detectable vitamin C. AP reports:
The multinational company admitted to 15 charges of misleading advertising between 2002 and 2006 in a suit filed by the Commerce Commission, a consumer watchdog, after a 2004 school science project exposed the false claims.
Ribena has long been sold as a healthy drink based on advertisements that black currant juice has more vitamin C than orange juice. Its New Zealand advertisements claimed Ready to Drink Ribena had 7 milligrams of vitamin C per 100 milliliters (0.25 ounce per 3.4 fluid ounces).
But high school students Anna Devathasan and Jenny Suo, then 14, found it contained almost no trace of vitamin C after testing the children's syrup-based drink as part of a science project in 2004. ...
The girls were in court to hear the verdict.
"We feel quite proud ... blown away," (one said.) "If we hadn't done that science test three years ago, Ribena could have been promoted as vitamin C full forever."
It was "remarkable nobody had even picked it up ... and we just stumbled on it by chance," she said, adding that she thought the fine should have been more because GlaxoSmithKline was a multibillion dollar company.
AP says the company was fined $156,000 in U.S. dollars.
Very preliminary findings from stem cell research got a lot of news coverage this week. Probably because there were local researchers involved, the Star Tribune put the story on the front page of Monday's paper. They reported:
An experimental treatment using adult stem cells was able to limit heart damage and improve the quality of life of patients suffering their first heart attack, according to a study of patients in Minneapolis and several other cities.
First, I balk at calling an experiment a treatment. It’s an experiment. Health lawyers have a term for this – “therapeutic misconception.” That means leading people to think there’s a certain therapeutic benefit from what is really an unknown undergoing experimentation.
The Star Tribune quoted four sources – which is usually good. But all four were connected with the research in some way, with a vested interest in reporting positive findings.
Especially since the work had only been presented at a scientific conference, which means that it had not yet been peer-reviewed, the story should have included independent perspectives.
Remember, questions have been raised about other stem cell research at the UMN – questions that are likely to come to the fore after peer review.
And ABC News recently reported on the drug Tykerb for metastatic breast cancer. But the story failed to mention that the drug is approved only for use with another drug (Xeloda) and that the combined cost of the drugs is $4,400 per month. It also failed to discuss potential harms of the two drugs.
It is hard to understand why/how such key components are so consistently left out of health news stories.
You're seeing lots of cardiovascular news this week because the annual meeting of the American College of Cardiology is going on in New Orleans.
I applaud the health news coverage of the Wall Street Journal, but even their coverage shows a bias toward the positive and against negative findings.
In today's WSJ, the front page of the "Marketplace" section, page B1, has a story on the "blockbuster drug plavix" and a pack of new rivals on the horizon.
But negative findings on two other drug studies are relegated to pages B6 and B7, deep in the paper and deeper in that section.
Stories headlined "Crestor Fails to Clear A Bar in Arterial Study" and "Two Heart-Failure Drugs Fail to Reduce Death, Admissions" were important, but got neither the quality nor quantity of space given to the generally positive Plavix (and rivals) story.
American consumers need to be reminded that not all drugs are blockbusters, and that hopes at the beginning of trials are often dashed at the end. Page 1 placement would drive that point home.
(But at least the WSJ reports on the negative findings somewhere - don't get me wrong.)
The Star Tribune today has more details from the reports filed with the Minnesota Pharmacy Board about drug company payments to physicians. Minnesota and Vermont are the only two states that require drug companies to publicly disclose such payments.
The paper's lede:
Dr. Inder Anand went to Paris. Dr. David Lowe went to Mankato. And Dr. Rex Haberman traveled across the United States.The three Minnesota doctors took the trips at the expense of pharmaceutical companies, which paid them tens of thousands of dollars in 2005 for their expertise and time.
The paper also reported:
Meanwhile, the reporting system that tracks payments in Minnesota was criticized in this week's journal article as flawed and incomplete.State officials confirmed that one drug maker, Pfizer, did not file a 2005 report with the pharmacy board, even though it reported $2.8 million in payments in 2004.
"I'll be sending them a letter," said Cody Wiberg, the board's executive director. A Pfizer attorney did not return a call for comment Thursday.
Because of the increased public interest in the filings, Wiberg said the board will post copies of the documents on the board's website.
Eventually, he wants to put all of the information in a database so the public can search by doctors' names.
The paper lists some of the big givers and some of the big receivers.
Gardiner Harris of the New York Times is all over issues about drug company influence on doctors and on the FDA this week. Today he writes:
Expert advisers to the government who receive money from a drug or device maker would be barred for the first time from voting on whether to approve that company’s products under new rules announced Wednesday for the F.D.A.’s powerful advisory committees.Indeed, such doctors who receive more than $50,000 from a company or a competitor whose product is being discussed would no longer be allowed to serve on the committees, though those who receive less than that amount in the prior year can join a committee and participate in its discussions.
A “significant number” of the agency’s present advisers would be affected by the new policy, said the F.D.A. acting deputy commissioner, Randall W. Lutter, though he would not say how many.
Yesterday, Harris' story on "Doctors' Ties to Drug Makers Are Put on Close View" simply blew away the competition - better by far than any other story I saw on the subject in many media across the country - including right here in Minneapolis. He and Janet Robert reported on records in Minnesota, where drug makers are required to disclose payments to doctors.
The Minnesota records are a window on the widespread financial ties between pharmaceutical companies and the doctors who prescribe and recommend their products. Patient advocacy groups and many doctors themselves have long complained that drug companies exert undue influence on doctors, but the extent of such payments has been hard to quantify.The Minnesota records begin in 1997. From then through 2005, drug makers paid more than 5,500 doctors, nurses and other health care workers in the state at least $57 million. Another $40 million went to clinics, research centers and other organizations. More than 20 percent of the state’s licensed physicians received money. The median payment per consultant was $1,000; more than 100 people received more than $100,000.
The reporting on this latter story was complete and comprehensive, with many examples of Minnesota physicians receiving surprising amounts of money from drug companies; ten doctors and one dentist received more than $500,000. You should read the entire story. But be ready to take an anti-anxiety pill when you're done.
One of my students caught this: look at how two Twin Cities newspapers reported on Mayo Clinic’s latest financial report with quite different emphases in the headlines and ledes.
The Star Tribune:
Headline: Mayo revenue up 8% last year, clinic reportsLede:
The Mayo Clinic on Friday said total revenue in 2006 grew 8 percent, to nearly $6.3 billion.
The Pioneer Press:
Headline: Operating income slips again at MayoLede:
Operating income at the Mayo Clinic dropped for a second consecutive year in 2006, but overall income increased slightly because of a return of more than 18 percent on the clinic's investment portfolio.
Which angle is more important? Which story is more intriguing to you? Glass half-empty or half-full?
The Star Tribune reports that "The American Medical Association announced its opposition Monday to the pending merger between UnitedHealth Group Inc. and Sierra Health Services Inc. of Las Vegas.
In a letter to U.S. Attorney General Alberto Gonzales, the doctors' organization asked the U.S. Justice Department to block UnitedHealth's $2.6 billion purchase of Sierra on antitrust grounds.
'Federal authorities must not allow United's blatant grab for dominant market power,' wrote AMA board member Dr. J. James Rohack. 'Without threat of competition in Nevada, United will be free to raise premiums above market rates.' ...
The AMA has a history of opposing mergers in the health care industry out of concern that a small number of large insurers is not good for physicians and patients.
The AMA also raised antitrust concerns before UnitedHealth acquired California-based PacifiCare a year ago. In that case, the Justice Department made UnitedHealth divest portions of PacifiCare's commercial health insurance business."
Many serious health journalists struggle with how to handle research stories in animals. Last night, KSTP-TV in MInneapolis-St. Paul presented a story that showed little attempt to put mouse research findings into a meaningful context.
It was on Rett Syndrome, which KSTP reported was "a disorder similar to autism." They said, "Doctors, who are testing mice, were able to reverse the symptoms of Rett Syndrome, an advancement beyond what many had even hoped for. ... The discovery is so monumental because it could lead not only to a cure for Rett Syndrome, but it could also help doctors working to cure autism. This is still in the research stage, a cure is at least ten years out. In the meantime, the Evert family and thousands of others are excited about a Rett Syndrome clinic set to open at Gillett (sic) Childrens' Hospital in Saint Paul."
First, the finding is not new; it is more than a month old.
Second, the story made little of the leap required from mice to humans. How can one even discuss "cure" with something that has not yet been tried in humans? How good an animal model is the mouse for this syndrome? What are the hurdles that lie ahead? We heard none of this. Yet we heard "cure" three times within seconds.
Finally, the story seemed to fall prey to a news release from a local hospital creating a clinic for Rett Syndrome patients, without any regard for the fact that such patients may receive specialized treatment at other area hospitals as well.
But, as evidenced from a listing of stories on the research on the Rett Syndrome Research Foundation website, KSTP was not alone. Many other news organizations used the word "cure" in describing this perhaps promising but certainly preliminary finding.
I would not dissuade people from finding hope wherever they choose to invest it. But I would dissuade journalists from promoting what may be false hope laden with more emotion than evidence.
The magazine TV Week this week profiles my efforts with the HealthNewsReview.org website.
On Friday, I’ll present data at the Association of Health Care Journalists annual conference in Los Angeles on our findings from the reviews of the first 300 stories in our first 11 months of experience with the site. It’s not a pretty story.
Stay tuned.
On the listserv of the Association of Health Care Journalists, a journalist raises an important issue that we don't hear enough about. That journalist wrote:
"May I suggest that while Washington is obsessing about Walter Reed, the rest of us should be paying attention to what’s happening in our back yards in the run-up to the deadline for switching Medicare Advantage plans? In many areas, plans have contracted with independent brokers/agents to make a last push to persuade beneficiaries to switch plans. Many broker/agents who signed beneficiaries up for one plan in the fall (to begin Jan. 1) are now urging them to switch before the deadline; that way, they collect commissions twice. There’s a lot of misinformation being spread, a lot of dirty tricks. By the time we get around to reporting on it, the March 31 deadline will have passed and the misinformation campaigns will have been successful."
Have you heard anything about this from your news organizations in your market?
The headline above is the headline of an essay in the New York Times today by my former Dartmouth colleagues Gil Welch, Lisa Schwartz and Steve Woloshin. They address possible consumer confusion over how two studies - one in the New England Journal of Medicine last October and one in the Journal of the American Medical Association this month - could reach two such different conclusions on the possible benefits (and harms) of CT scan screening of smokers for lung cancer.
With their usual clarity, the three authors do a terrific job explaining how this could be - and I won't duplicate what they said here. But here's how they ended the essay:
"But neither study is definitive, because neither was a randomized trial. And both required assumptions. Given the potential benefit (so many people die from lung cancer) and the potential harms (some die from treatments), no one should have to assume anything.
Luckily, two randomized trials are under way — one a Dutch-Belgian collaboration, the other sponsored by the National Cancer Institute. Recent experience, notably with hormone replacement in postmenopausal women, has demonstrated how presuming benefits in the absence of randomized trials can cause real harm. To avoid repeating these mistakes, we should not screen for lung cancer unless the trials demonstrate a reduction in mortality."
Merrill Goozner suggests that the FDA announcement late last Friday afternoon, issuing an official warning against giving cancer patients erythropoietin drugs (Epogen, Procrit, Aranesp) for anemia, was timed to minimize bad news or embarrassment. Goozner writes:
"What struck me most about yesterday's announcement was its timing. It has long been a hallmark of White House public relations staff that the best time to release bad news was late on Friday afternoons. That way, the least number of people will hear about it through traditional news media sources. It's too late to make the Friday evening newscasts; and the print stories usually wind up inside the Saturday papers, which are the least read of the week. (The New York Times story, at least, got mentioned on the front page.)
Is this what the FDA wanted for this important warning? Is this the best way to counter the torrent of direct-to-consumer TV ads touting this drug by asking "if you're ready for chemotherapy"?
This late Friday afternoon release shows as much as anything how the culture of the agency has been transformed in recent years from industry watchdog to industry lapdog."
Dr. Sanjay Gupta’s HouseCall program on CNN today featured a story on anxiety disorders, and offered one of those handy self-assessments that allows you to diagnose yourself with almost anything under the sun.
Gupta said only one in five people with anxiety disorders get help. Then he offered a self-assessment from the Anxiety Disorders Association of America (ADAA). Gupta listed:
Do you have a (sic) anxiety problem?
• Excessive worry, occurring more days than not, for a least six months?
• Unreasonable worry about a number of events or activities, such as work or school and/or health?
• The inability to control the worry?
He said if you answered yes to any of these, you could seek help from your doctor or from ADAA.
He did not mention that the ADAA’s corporate advisory council is made up of drug companies Eli Lilly & Company, Forest Laboratories, Pfizer, Inc. and Wyeth.
I worry a lot about how commercial, how unquestioning, and how cheerleading much of CNN’s medical news is. It makes me very anxious and I am unable to control that worry. It only gets worse.
Sometimes my own critics have said that I am unfair to those who practice television health news. They imply that because I once worked in that field I am bitter in my criticisms.
Well, veteran journalist Trudy Lieberman never worked in TV news, but you must read her comprehensive indictment of current TV health news practices in the current issue of the Columbia Journalism Review.
She writes about news stations accepting pre-packaged new stories created by health care behemoths such as the Cleveland Clinic or the Mayo Clinic, creating stories that are "a hybrid of news and marketing, the likes of which has spread to local TV newsrooms all across the country in a variety of forms, almost like an epidemic. It’s the product of a marriage of the hospitals’ desperate need to compete for lucrative lines of business in our current health system and of TV’s hunger for cheap and easy stories. In some cases the hospitals pay for airtime, a sponsorship, and in others, they don’t but still provide expertise and story ideas. Either way, the result is that too often the hospitals control the story. Viewers who think they are getting news are really getting a form of advertising. And critical stories—hospital infection rates, for example, or medical mistakes or poor care—tend not to be covered in such a cozy atmosphere. The public, which could use real health reporting these days, gets something far less than quality, arms-length journalism."
Read the full story. Then you'll see that it's not just me who thinks that much of TV health news is in critical condition, possibly creating more harm than good.
The St. Paul Pioneer Press reports on a controversy surrounding University of Minnesota Medical School Dean Dr. Deborah Powell joining the board of PepsiAmericas, one of the world's largest sellers of Pepsi and Mountain Dew.
The paper reports:
“A recently completed internal review, standard for any U employee involved in outside work, found no conflict of interest in her service to PepsiAmericas, a publicly traded company that is the world's second-largest bottler of PepsiCo. brands.
That may not put the matter to rest. The appointment has wound itself into the national debate over how food and soft-drink makers do business. The basic questions: Can a doctor take money from a corporation but stay independent? Is joining a corporate board equal to endorsing its products?
‘If I didn't think I could make a difference on this board, I wouldn't stay on it, and I wouldn't go on it in the first place,’ Powell said Friday. ‘I'm trying the best I can to do something that I think will be valuable for the school and valuable for this company.
‘If it turns out it doesn't create value, then I won't stay on this board,’ she said.
Inside the U's health programs and departments, divisions remain over Powell's decision. Some have expressed hope that she can be a voice for children's health.
But Robert Jeffery, a nationally known researcher and a director of the Obesity Prevention Center in the U's school of public health, worries Powell's PepsiAmericas duty ultimately may hurt the university.
‘There is a level of 'ick' among quite a few faculty and students here,’ Jeffery said. ‘There definitely are some sour feelings. When you're talking about some of the most powerful people in the university backing it, it makes it distasteful.’
The U, he said, needs to have a ‘more serious conversation about where the ethical lines lie in corporate consulting. Whenever you get into a paid relationship with a commercial enterprise, there is an implied or maybe even explicit agreement that you're doing things for their benefit. I certainly would not have agreed to this.’ “
The screen-at-all-costs mentality takes an intellectual hit with the publication of a new study in the Journal of the American Medical Association. The conclusions of those authors: "Screening for lung cancer with low-dose CT may increase the rate of lung cancer diagnosis and treatment, but may not meaningfully reduce the risk of advanced lung cancer or death from lung cancer. Until more conclusive data are available, asymptomatic individuals should not be screened outside of clinical research studies that have a reasonable likelihood of further clarifying the potential benefits and risks."
Back in October, another study claimed quite the opposite, and many journalists failed to report with balance on those findings. (See summary on 8 stories on HealthNewsReview.org.) One journalist on the listserv of the Association of Health Care Journalists (AHCJ) has already pointed out this morning that some news organizations will have difficulty explaining the apparent flip-flopping findings today - if they did a naive job in October. Mike Taibbi of NBC News even went on the air in the fall reporting on his own CT scan after a life of smoking, and ended with a personal endorsement of the procedure. No spots on his lungs but now egg on his face.
One who wouldn't have a tough time explaining the latest study is former Miami Herald reporter Jacob Goldstein, who was recognized on HealthNewsReview.org for his excellent story in October. We've just learned that his excellence led the Wall Street Journal to lure him away as their first health news blogger.
Former New England Journal of Medicine editor Marcia Angell had an editorial in the Boston Globe last week that should not be missed. Excerpts:
"It's time to take the Food and Drug Administration back from the drug companies. … (I)n 1992, Congress put the fox in the chicken coop. It passed the Prescription Drug User Fee Act, which authorizes drug companies to pay "user fees" to the FDA for each brand-name drug considered for approval. Nearly all of the money generated by these fees has been earmarked to speed up the approval process.
In effect, the user fee act put the FDA on the payroll of the industry it regulates. Last year, the fees came to about $300 million, which the companies recoup many times over by getting their drugs to market faster.
But while it's a small investment for drug companies, it's a lot of money for the agency, and it has drastically changed the way it operates -- creating a disproportionate emphasis on approving brand-name drugs in a hurry. Consequently, the part of the agency that reviews new drugs gets more than half its money from user fees, and it has grown rapidly. Meanwhile, the parts that monitor safety, ensure manufacturing standards, and check ads for accuracy have languished or even shrunk. …
As part of the emphasis on speed, the FDA often approves brand-name drugs on the basis of less evidence than in the past. In these cases, approval may be contingent on companies conducting further safety studies after the drugs are on the market. But the companies usually don't honor that commitment. Of the roughly 1,200 such studies outstanding -- some for years -- over 70 percent haven't been started. …
The FDA now behaves as though the pharmaceutical industry is its user, not the public. Fortunately, the user fee law is subject to renewal every five years, and this is one of those years.
Congress should let the law die this time around and substitute its own support -- which ought to be increased. Other reforms recently proposed, such as administratively separating drug approval from safety surveillance, will not mean much as long as this law is in effect.
At $300 million to $400 million a year, the equivalent of about a day in Iraq, Congress can easily afford to buy this vital agency back for the public, and it should."
A story in the Washington Post last week is drawing a lot of attention as it reflects on the U.S. health care system.
It begins:
"Twelve-year-old Deamonte Driver died of a toothache Sunday.
A routine, $80 tooth extraction might have saved him.
If his mother had been insured.
If his family had not lost its Medicaid.
If Medicaid dentists weren't so hard to find.
If his mother hadn't been focused on getting a dentist for his brother, who had six rotted teeth.
By the time Deamonte's own aching tooth got any attention, the bacteria from the abscess had spread to his brain, doctors said. After two operations and more than six weeks of hospital care, the Prince George's County boy died.
Deamonte's death and the ultimate cost of his care, which could total more than $250,000, underscore an often-overlooked concern in the debate over universal health coverage: dental care.
Some poor children have no dental coverage at all. Others travel three hours to find a dentist willing to take Medicaid patients and accept the incumbent paperwork. And some, including Deamonte's brother, get in for a tooth cleaning but have trouble securing an oral surgeon to fix deeper problems."
Merrill Goozner writes: "The death of Deamonte Driver is a testimony to the moral bankruptcy of these piecemeal efforts to salvage a collapsing US health insurance system. Medicaid pays the least of all the nation's safety-net programs, and, as a result, doctors and dentists don't want to participate. Programs like CHIP, which rely on aggressive outreach to find uninsured kids, inevitably miss many of the needy - especially if they are tough-luck cases, like Deamonte.
These programs are part of the problem, not the solution. Let's get on with the business of reforming the entire system. As the Deamonte Driver case dramatically demonstrates, comprehensive reform wouldn't necessarily cost more money, since a health insurance plan that delivers timely, preventive care will avoid many monstrous catastrophic expenses. "
After shoveling more than two feet of snow in a couple of days, my motivational defiency disorder is kicking in.
I don't have the strength nor the clearheadedness to add anything new today.
What did the groundhog say?
In a followup story, the Minneapolis Star Tribune reports that "the Minnesota Medical Association on Wednesday asked regulators to pull the plug on Medica's controversial program to curb the use of high-tech diagnostic imaging.
The MMA asserts that HealthHelp, the company hired by Medica to give approval for tests such as MRIs and CT scans, is not licensed in Minnesota to perform "utilization review," as required by state law. ...
Medica began the preapproval process Jan. 2 on a voluntary basis. It becomes mandatory starting today, and Medica will not pay for scans not first submitted for review to HealthHelp, a Texas-based radiology management firm.
Medica, the state's second-largest health insurer, is the first to require reviews, saying the plan will save it $17 million a year. HealthPartners started a review process this month, and Blue Cross and Blue Shield of Minnesota is expected to do so in July.
Doctors say that consulting HealthHelp 'is a waste of energy, time and money,' and increases health care costs."
This cat-fight (or CAT scan-fight, along with MRI- and PET-scan fight) is worth following.