Schwitzer health news blog

McCain, market-based solutions, and the money CEOs make

Senator John McCain announced more details of his health care plan yesterday. In a nutshell, it's all about competition and a market-based solution.

Competition and the market also today gives us the news that the new CEO of UnitedHealth Group, Inc. received total compensation of more than $5 million last year. (He's gotta go some to catch the compensation total of his predecessor, Bill McGuire.)

Ah, the American way, with 16% of the gross domestic product spent on health care, and, ironically, 16% of the population without health insurance.

You gotta love how that market works.

The Healthy Skeptic - written by one who is

Here's a book you should buy and read. University of California Press has published "The Healthy Skeptic: Çutting Through The Hype About Your Health," by Robert Davis, PhD.

Disclosure: Robert is my friend and trusted colleague. I hired him at CNN longer ago than either of us wants to remember.

Just to give you a taste of his book, here are some of the chapter titles:

1. Says Who? How We Know What (We Think) We Know
2. The News Media: Eat This!
3. Diet Books: Don't Eat That!
4. Advertisements: Take a Supplement!
5. Government Campaigns: Watch Your Cholesterol!
6. Celebrities: Get Tested!
7. Health Groups: Wear Sunscreen!
8. Consumer Activists: Beware of Chemicals!
9. Anti-Aging Doctors: Don't Get Sick, Don't Get Old, Don't Die!
10. Guaranteed! Overpromising on Prevention

We need more journalists like him, and more informational/educational efforts like his book.

Congratulations, Robert. Hope you sell a bunch of them.

Shearlings plowed - or Plough shares in blogosphere

In the hyper-specialization of the blogosphere, now we even have a blog tracking an individual drug company.

Shearlings Got Plowed is the name of a blog covering recent problems at drugmaker Schering-Plough

Re-design & new features on HealthNewsReview.org

Visit HealthNewsReview.org to see its entirely new design and new "Join the Discussion" forum, allowing for better dialogue among journalists, health care consumers, news consumers and others.

The site is now two years old and has reviewed more than 540 stories.

Why are Mommy's boobies bigger suddenly?

Newsweek's website tells us about a new book coming out in time for Mother's Day, entitled, "My Beautiful Mommy." It's supposed to help mothers explain their plastic surgery to their kids. As Newsweek explains, "Naturally, it has a happy ending: mommy winds up "even more" beautiful than before, and her daughter is thrilled."

Now that's role modeling.

Drug companies' 1,044 broken promises

Bloomberg News reports:

Drugmakers haven't made progress in starting studies that they promised to conduct after their products were approved by U.S. regulators, according to data released today.

The Food and Drug Administration determined that 1,044, or 62 percent, of incomplete studies for conventional drugs and biotechnology medications had yet to be started as of Sept. 30. At the same time in 2006, 1,026, or 63 percent, of the unfinished studies hadn't begun, according to the FDA.

To receive FDA approval, drugmakers often agree to perform additional studies of safety, dosing and other matters after medications come to market. The research is usually voluntary, and lawmakers have repeatedly complained it isn't completed. President George W. Bush signed legislation in September that allows the FDA to require certain post-approval studies.

``Drugs often come on the market with an expectation that studies will be conducted,'' said Peter Lurie, deputy director of the Health Research Group at Washington-based Public Citizen, an advocacy organization, in an interview. ``In fact, many of these studies begin late or do not begin at all.''

Doctors say post-approval studies may be needed to fully assess the risks of medications because some dangers don't emerge until products are in widespread use.

Some research has been pending for years. Of the 1,044 studies that hadn't begun, drugmakers committed before Oct. 1, 2004, to undertake 444 of them, according to the FDA.

So don't be surprised when you hear the next news about a "blockbuster" drug that is found to have "surprise" side effects months or years after it's been on the market.

Dingell buries von Eschenbach: "I didn't fall off the cabbage wagon yesterday."

The RPM Report states:

There’s no love lost between Rep. John Dingell and FDA Commissioner Andrew von Eschenbach. That tenuous relationship—and a little congressional theatrics—were on display during the Energy & Commerce hearing into FDA’s overseas drug inspections process....

The Michigan Democrat took issue with FDA commissioner Andrew von Eschenbach’s broad plan to overhaul the agency’s overseas drug inspection structure to avoid another heparin situation during an E&C Oversight and Investigations Subcommittee hearing. Von Eschenbach was trying to explain that it’s not just the number and frequency of inspections by inspectors, but how the inspections are carried out that matter.

Dingell was having none of what he called the commissioner’s “toe dancing.” Dingell, during his allotted time for question-and-answer, asked von Eschenbach to answer “yes” or “no” to a series of questions. The commissioner started off obliging Dingell but then began getting off track with longer, more verbose answers. ...

Dingell: “I didn’t fall off the cabbage wagon yesterday. I’ve been talking to food and drug commissioners for 40 years. And you’re not the first fella I’ve had to skin for not doing his job and coming up here and defending an indefensible situation. I want to maintain my respect for you but I can’t maintain my respect for you if you keep toe dancing around the hard facts that curse you with the inability to do your job because you don’t have resources.”

Another screening controversy - another online debate

The BMJ has published a number of intriguing online debates recently. Last week they posted another: Will screening for aortic aneurysm be effective? An aortic aneurysm is a dilation (ballooning) of part of the aorta - the main artery carrying blood from the heart to the lower part of the body.

The YES argument is posted here. In a nutshell:

"Around 90% of people with a ruptured aortic aneurysm die. But if the aneurysm is discovered before it ruptures and is repaired by an experienced vascular surgeon, mortality is around 7.4%, the argument goes. Around 5% of men aged between 65 and 74 have abdominal aortic aneurysms, but they rarely cause symptoms, so screening in this age group would potentially ensure that most aortic aneurysms are diagnosed and repaired.

This side argues that a national screening program has the potential to save up to 2000 lives a year in England and Wales at a similar cost to other screening programs.

They point to a large body of scientific evidence that shows that aneurysm screening programs are effective. For example, an analysis by the Centre for Reviews and Dissemination at the University of York concludes that the likelihood of such a screening program being cost effective is greater than 95%.

Furthermore, recent data from four trials in the UK, Australia and Denmark showed that uptake of invitations to be screened ranged from 63% to 80%. And a review of the data from all four trials showed a highly significant reduction in aneurysm related mortality."

The NAYS have their say here. The stand:

The case for screening is not clear-cut. There are wide variations in the mortality for surgical repair between hospitals in England. In addition, many patients will not be fit enough to have a repair-aneurysm is a disease that rarely exists in isolation. Most patients will also have hypertension, or a history of myocardial infarction, stroke or diabetes. As a result, many patients will be left with the knowledge that they have a life threatening condition that is liable to cause sudden death and that nothing can be done about it.

Aneurysms of less than 5.5cm in diameter are unlikely to burst, and because the mortality from operating on them is greater than the likelihood of rupture, people with an aneurysm of less than this size will have to be monitored and sent for regular ultrasound examinations. Many of these patients will find it intolerable to have a "timebomb" inside them which might go off at any time and without notice, he says.

In addition, screening will show up much more than aortic aneurysms, and the cost of dealing with the comorbidity needs to be included in the cost-benefit analysis, he argues.

At the very least any person being tested will need intensive counselling about the possible consequences that screening might have for their future lives and psychological wellbeing.

What kicks this off is the fact that pilot screening programs for abdominal aortic aneurysms in men aged 65 are due to be launched in England this year.

In the US, the Society for Vascular Surgery has pushed for such screening in many people older than 55. But arguments similar to those raised against screening in the UK have been raised against the US recommendation.

Off-label promotion equals 19th Century medicine

Drs. Adriane Fugh-Berman and Douglas Melnick have written to the FDA:

"Loosening restrictions on the distribution of materials on off-label uses is an abdication of the FDA’s responsibility to protect the public. Off-label uses of pharmaceuticals have not been subject to the testing and review required for marketing approval. The scientific review of evidence of effectiveness and safety that drugs undergo prior to an approved, labeled indication for a drug protects patients. With off-label use, this protection does not exist.

While off-label use is sometimes necessary, it should be undertaken with the care and caution due the uncontrolled experiment to which a patient is being subjected. While some off-label uses are supported by randomized controlled trials, 73% of 150 million off-label prescriptions written in 2001 were for conditions that had little to no scientific support for efficacy.

Belief is an unreliable gauge of efficacy. In the 19th century, physicians believed that mercury, arsenic, and bloodletting were effective for common ailments. More recently, physicians believed that oxygen therapy benefited premature babies when instead it caused blindness , and that menopausal hormone therapy benefited women’s health when the opposite was true . In these and many other cases, randomized controlled trials trumped prevailing medical opinion with truth. While “medically-recognized standards of care” may exist outside of a product’s approved product labeling, it is inappropriate for the manufacturers to create or promote these off-label uses without conducting the studies and applying for the new indication with the agency.

Industry has much to gain, and the public health much to lose, by the implementation of this guidance. Restrictions on off-label promotion of drugs should be strengthened, not gutted. The FDA should not jettison its responsibilities to protect consumers."

Drug-and-device-reps-free zone

Psychiatrist Daniel Carlat, whose blog is one of the smartest publications on the Web, recently
wrote:

I've had it. As of today, I am no longer allowing drug reps into my office.

Yes, until today, I was seeing reps a few times a month for 5 minute visits in order to keep up on trends in drug company marketing techniques. But today, an Astra Zeneca rep and his district manager came in to push Seroquel for bipolar depression. They came armed with the two studies that won Seroquel its FDA approval. The studies have their limitations, but somehow these reps didn't bring these up.

Instead, what I got was a ridiculous hard sell: "Dr. Carlat, given this data, would you choose Seroquel over the other atypical antipsychotics for bipolar depression?" I asked them if Astra Zeneca had done any head-to-head studies comparing Seroquel with the others. The rep adopted a pseudo-confused look, and said, "I'm not even sure that kind of study would be ethical--would the FDA even allow you to compare an approved drug with an unapproved drug?" I pointed out that the FDA, in fact, requires that drugs be compared with placebo, the ultimate in "unapproved" drugs, and that they deem this ethical enough.

He tried another tack. "What are the symptoms of bipolar depression that you have the hardest time treating?" I said that all the symptoms are hard to treat--that, in fact, bipolar depression is a very difficult illness to treat. Out came his computer, with a slide showing that Seroquel successfully treated every one of the depressive symptoms in one study. "Now doctor, if you had a patient come into your office with suicidal ideation, and you had an agent that would help those symptoms in a week, wouldn't you want to use that agent?"

Of course I would, and there are many other agents that will work better than placebo in a week. But my rep wasn't interested in talking about the alternatives. The focus, as always, was on his product, and on his bonus.

I've printed out the National Physicians Alliance's brochure, "Why Doesn't My Doctor See Drug Reps?" and will put it in my waiting room. I'll let you know how my patients respond. For now, I'm still accepting samples (making me the most despised of doctors among drug reps, a "sample-grabber") but that will be the next to go.

Meantime, my local Star Tribune newspaper today published a story cheerleading for a local device manufacturer.

With the story came the photo above, showing a device rep making his pitch to health care professionals. The story and the photo seem to come from a different planet - far away from any controversy or concerns about the coziness of such a reps-in-the-clinical-setting repertoire. Not a word about the kind of concerns that Dr. Carlat and so many others have raised. But as I've noted before, there appears to be an "anything goes" attitude with a different code of ethics for local business news on the business page.

Your job and your health insurance

On her blog, Maggie Mahar writes about "Just How Secure Is Your Employer-Based Health Insurance?"

Alcohol & breast cancer stories worthy of lining the bird cage

I should have mentioned Sandy Szwarc's blog, Junkfood Science, long ago. I am impressed by the depth and thoroughness of her analysis.

This week she jumped all over news coverage of a study linking alcohol intake to breast cancer.

You should read the entire post, but it begins:

Does a single drink a day really raise a woman’s risk for breast cancers? That’s what 403 media stories (and counting) have been reporting, based on a new study said to be “the largest of its kind.” But not all studies reported in the news are worth taking seriously or let worry us. Here’s why this one shouldn’t have even registered on our radar.

Since there’s actually no study to review (!), we’ll walk through the news. When would you have changed the television station or tossed the newspaper aside?

According to the news, the researchers reviewed data on 184,418 post menopausal women and found that women who drank even just one to two drinks a day were 32% more likely to develop breast cancers of a certain type (estrogen-receptor and progesterone-receptor positive, or ER+/PR+). This study was said to provide evidence that alcohol is positively associated with breast cancer.

When hundreds of news outlets around the world report on a single study, out of the hundreds released each day, on exactly the same day and all saying exactly the same thing, you can be sure someone issued a press release. Sure enough, this paper came with a press release.

Please go to the link above to read the rest of her comments on this study and news coverage about it.

Blogs like hers give citizen journalism a good name.

Protesting off-label drug promotion

In his blog yesterday, Merrill Goozner wrote how "Patients Protest Promiscuous Promotion of Off-Label Prescribing."
Excerpt:

A coalition of consumer groups later today will send a scathing letter to the Food and Drug Administration protesting a proposal to give manufacturers a blank check to promote the off-label use of drugs and devices. The letter, signed by Consumers Union, the Center for Science in the Public Interest, the Government Accountability Project and a half dozen other patient and consumer groups, charges the lenient guidelines will undermine the FDA's authority to regulate off-label marketing and lower incentives for firms to conduct rigorous clinical trials or seek agency approval for the uses to which the drugs are being put.

The guidelines mark a "180-degree reversal of prior practice (by) eliminating Food and Drug Administration review of articles that manufacturers plan to distribute to physicians. As a weak and dangerous alternative, the draft guidance proposes a de minimus self-regulating standard," the letter asserts.

Tanning for dollars - researcher conflict of interest

The Wall Street Journal reports:

A Boston University researcher who authored an article in the New England Journal of Medicine last year recommending the moderate use of tanning beds as a way to treat or avoid vitamin-D deficiency has received research funding from an organization funded and controlled by the tanning-bed industry.

The link to researcher Michael Holick's work and the tanning industry wasn't made clear in the article. A note at the end of the article disclosed that Dr. Holick's research was funded, in part, by the UV Foundation. No information about the foundation was provided.

The nonprofit foundation, according to its Web site, is funded by the Indoor Tanning Association as well as the makers of tanning-bed equipment. The board of directors is composed entirely of tanning-bed-industry officials. Boston University was the top recipient of grants from the foundation from 2004 through 2006, the most recent three years of the group's Internal Revenue Service filings. In total, the university received $162,014 during that period.

On its Web site, the UV Foundation said it "has made a commitment of $150,000 over three years to Boston University, to continue the efforts of Dr. Michael Holick, a Vitamin D expert." The site said the foundation "is dedicated to exploring the positive effects of UV light and to increasing public awareness about those benefits."

Dr. Holick said in an interview that the money was an unrestricted grant that he used for vitamin-D research.

A report on the funding arrangement was to appear in Friday's edition of the Cancer Letter, a Washington-based trade publication. (See Cancer Letter story online.)

...

"I was surprised that the New England Journal, a very prestigious journal, would run the article this way," said Martin Weinstock, a Brown University dermatology professor. He said he was surprised the journal would run a piece by an industry-funded author.

60 Minutes piece on Kanzius cancer cure not worth 60 seconds

One of the worst stories by a major news organization on a health care topic was turned in by CBS' 60 Minutes last Sunday with a piece it entitled on its website, "The Kanzius Machine: A Cancer Cure?"

The story was reviewed on HealthNewsReview.org and given one of the lowest ratings possible. The review summary stated, in part:

If the report were to be done and broadcast on 60 Minutes, it would have benefited considerably from additional context provided by other credible researchers. Did CBS look for and fail to find anyone skeptical of this technique? None was interviewed.

The story has elements that make it appealing as an act of infotainment: a lone-wolf outsider who can cure cancer with pie pans and hot dogs, a man motivated by his desire to help "hollow-eyed kids" with cancer, and hopeful researchers with impressive institutional affiliations, including a Nobel laureate said to have turned from skeptic to believer by the time he died from cancer.

But good stories don't always make good journalism. This is such a case.

The segment is likely to raise hopes, clearly prematurely if not falsely, of millions of people affected by cancer, or even cancer risk. This is the opposite of public service.

The most disturbing aspect of the segment was its one-sidedness, its lack of context and independent perspective. And given that these segments run about 15 minutes, CBS can't hide behind the excuse that this is TV and we don't have enough airtime to go into great depth.

Ghostwriting: a scary practice

A case study in this week's Journal of the American Medical Association tells us more about the practice of ghostwriting.

Ghostwriting is the practice whereby academic researchers allow their names to be listed as publishers of research articles even though some, most or all of the writing may have been done by industry-hired medical writers. If there's any acknowledgement of the outside help at all, it's often euphemistically phrased "editorial assistance."

The JAMA case study is particularly interesting because it involves the case of research involving Vioxx (rofecoxib). The authors say their analysis "demonstrates that clinical trial manuscripts related to rofecoxib were authored by sponsor employees but often attributed first authorship to academically affiliated investigators who did not always disclose industry financial support. Review manuscripts were often prepared by unacknowledged authors and subsequently attributed authorship to academically affiliated investigators who often did not disclose industry financial support."

Another JAMA article contends that Merck, makers of Vioxx, tried to minimize deaths in two studies showing that the drug didn't work in treating or preventing Alzheimer's disease.

Merck calls the reports false and misleading.

Ghostwriting is misleading and deceptive, and the practice should be dragged into the light of day more often for more to see what impact it may have on the integrity of science.

US "system" compared to health care around the world

My friend Jon Palfreman's documentary, "Sick Around the World," airs on PBS Frontline tonight.

I watched an advance copy last night and urge you to watch tonight.

The film gives glimpses of health care systems in the UK, Germany, Switzerland, Japan and Taiwan. And it asks the question: "Other rich countries have universal health care. why don’t we?"

In the film, Swiss politicians from the political right and left enthusiastically support universal health care. Pascal Couchepin, the president of the Swiss Federation, argues: "Everybody has a right to health care. ... It is a profound need for people to be sure that if they are struck by destiny ... they can have a good health system."

Watch and learn. And think about how shallow the debate has been in this year's presidential campaign.

The myth of "the best health care in the world"

Monday morning catchup....

Newsweek, two weeks ago, published a column, "The Myth of 'Best in the World'."

Excerpt:

"Not to be heartless or anything, but let's leave aside the dead babies. In international comparisons of health care, the infant mortality rate is a crucial indicator of a nation's standing, and the United States' position at No. 28, with seven per 1,000 live births—worse than Portugal, Greece, the Czech Republic, Northern Ireland and 23 other nations not exactly known for cutting-edge medical science—is a tragedy and an embarrassment. Much of the blame for this abysmal showing, however, goes to socioeconomic factors: poor, uninsured women failing to get prenatal care or engaging in behaviors (smoking, using illegal drugs, becoming pregnant as a teen) that put fetuses' and babies' lives at risk. You can look at 28th place and say, yes, it's terrible, but it doesn't apply to my part of the health-care system—the one for the non-poor insured.

That, in a nutshell, is why support for health-care reform is fragile and shallow. Yes, many people of goodwill support extending coverage to the 47 million Americans who, according to the Census Bureau, had no insurance for all or part of 2006. An awful lot of the insured, though, worry that messing with the system to bring about universal coverage, even if it allows more newborns to survive, might also hurt the quality and availability of care that they themselves get ("If I have trouble getting my doctor to see me now, what will happen when 47 million more people want appointments?"). This is where you start getting the requisite genuflection to the United States' having "the best health care in the world." One problem: a spate of new research shows the United States well behind other developed countries on measures from cancer survival to diabetes care that cannot entirely be blamed on the rich-poor or insured-uninsured gulf. None of this implies a specific fix for the U.S. health-care system. It does, however, say that "the best in the world" is a myth that should not be an impediment to reform."

Drug ads should tell you the cost

A South Carolina physician states in a letter to the editor in this week's BMJ:

"Practising in the United States, I am well acquainted with direct to consumer advertising of prescription drugs. I suggest (and have suggested in the past to the Food and Drug Administration) that if such advertising is allowed, it should be mandatory for the manufacturer to state the typical cost of a course of treatment with the drug. My own experience of the $600 (£300; {euro}385) treatment for onychomycosis was that this information could save a great deal of time in explaining to the patient why the drug is not covered by their insurance. It could also prevent a whole unnecessary discussion in the first place as patients quite readily recognise that the cost is out of proportion to their problem."

Onychomycosis is toenail fungus. You know the ads.

WSJ Health Blog Flogs Vytorin Again

Scott Hensley of the Wall Street Journal Health Blog just posted this:

Merck and Schering-Plough attempted to recreate information from a crucial meeting about a major study on cholesterol blockbuster Vytorin after a Congressional panel began an investigation, according to documents obtained by a Congressional subcommittee, the WSJ reports.

In a letter Friday, Rep. John Dingell (D-Mich.) and Rep. Bart Stupak (D-Mich.) asked why minutes of the companies’ ad hoc expert panel, which had met in mid-November, had been “created after the fact” in December. Spokesmen for Merck and Schering-Plough couldn’t be reached immediately by the WSJ for comment.

The minutes, circulated Dec. 19, a week after Dingell’s investigation began, suggest that the companies’ experts had agreed to move the goal post for the study, which would have made Vytorin and its sister drug Zetia look better. Internal company documents released by the House Commerce Committee, which Dingell chairs, include strong complaints from one of the study panel members. Click on image at right to see the documents.

“It was my understanding that there were no minutes or transcript of this meeting,” James Stein, a cardiac imaging expert at the University of Wisconsin, wrote in an email to Schering-Plough. (See his comment to the same effect in the margin of draft minutes that appears in the image above.) Some of the new minutes of the Nov. 16 meeting didn’t accurately represent his recollections or details of the debate during the meeting said Stein in an email to Schering-Plough.

“It was the decision of the company to change the endpoint,” Stein wrote in comments back to company about the minutes.

The companies had issued a press release on Nov. 19, shortly after the consultants’ meeting saying the outside experts recommended such a change, which is contrary to generally accepted scientific practice.

Earlier this month the Merck/Schering-Plough joint venture that sells Vytorin made public an email exchange with John Kastelein, the cardiologist who ran the study called Enhance, and who had objected to the proposed change in the endpoint for the study.

In March, Forbes’ Matt Herper laid out the challenge for Dingell’s panel posed by the creation of minutes from the meeting after the fact. The retrospective memo writing, he wrote, “could also make it more difficult for the companies to defend their own decision making with regard to the study.”

Two views about drugs from other countries

Amidst all the stink over the drug Vytorin in this country - including the barrage of two-sided full-page ads in US newspapers - Canadians are chucklingbecause they never got hooked on Vytorin like Americans did. And the story suggests that direct-to-consumer drug ads in the US (not allowed in Canada) may have a lot to do with the higher use here.

Then, from the UK comes a story that claims that cancer drug trials are being stopped too soon. An Italian research team says that the usefulness of some cancer drugs is being exaggerated because manufacturers are stopping trials the moment they find a benefit - but before all the evidence is in hand.

Minnesota proud to be at bottom of this list

In his newsletter last week, former US Senator David Durenberger wrote:

"WE ARE N0. 50
Usually Minnesotans don't brag about being 50th among the states. But when it's the number of us without health insurance we're pleased to be there. A new Minnesota Department of Health study shows 374,000, or 7.2%, of us were without insurance in 2007. The REAL news is that 200,464 of us are eligible for some form of government-subsidized health care but haven't signed up for it. That leaves only 173, 536 without insurance of whom 79,810 are above 300% of the federal poverty guidelines (meaning $51,510 income for a family of three). Mandates anyone?

LONE STAR EQUITY
Texas has the highest percentage of uninsured residents in the nation and among the lowest per capita rate of taxation. It has no income tax and Governor Rick Perry last month suspended the state's unemployment compensation tax which is required to match federal taxes on business to meet unemployment claims. The Governor says there is little unemployment in Texas and its job growth is twice the national average.

If you are conservative, you salute Texas for it's low/no tax policy. If you are liberal, you point to the problem we have as a nation in relying on state government to finance access to human services for all except through the job market. There is no demographic question but what jobs and economic growth, for-profit health care, retiree sales tax payers, and folks who can afford private schools and living without six months of snow and ice relish living in the south. The military bases have all been down south for a long time and the northern automobile and other large manufacturing jobs have adapted to this reality as well. Federal spending is disproportionately headed south rather than north to make low/no tax policies easier.

If you really care about insuring all kids or about universal coverage in health care or consumer choice in housing, health, education and public services you need to decide something right now. All states are not equal. But the Constitution and its Bill of Rights say all Americans are. A national income security policy, if we had one, would recognize the need to change our entitlement mentality and our entitlement programs. States are labs of change, but not of income security. Put the same rate of tax on income, sales, and property in two southern states like Texas and Mississippi, and you end up raising only half as much money for income security or public services in MS as you do in TX. Think about it. Before it's too late."

Grassley Knocks Doc Taking Pharma Funds

The Wall Street Journal health blog reports:

"A University of Cincinnati psychiatrist who was the lead author of a 2002 study that concluded kids did well on AstraZeneca’s antipsychotic Seroquel has received hundreds of thousands of dollars from the company since then, according to Sen. Charles Grassley (R-Iowa).

Grassley raised the issue in a floor statement last week in support of a bill he’s co-sponsoring that would require drug and device makers with annual revenues of more than $100 million to disclose to the federal government on a quarterly basis anything of value given to physicians, such as payments, gifts, or travel expenses.

“Today, I am going to report on the actions of one physician to explain how industry payments to medical experts can affect medical practice,” Grassley said by way of introducing his remarks. Grassley then reviewed the funding for Melissa DelBello, who had reported to the University of Cincinnati that she had received $100,000 from AstraZeneca in 2003, the year after the study’s publication in the Journal of the American Academy of Child & Adolescent Psychiatry. She reported another $80,000 in 2004. The payments covered lectures, consulting fees, service on advisory boards and reimbursements for travel-related costs, Grassley said.

“The fact that a physician can promote a drug to other doctors and receive NIH funding, while hiding a very clear conflict of interest, is disturbing,” Grassley concluded."

New Dartmouth Atlas of Health Care released

Medicare rewards the inefficient and gets worse results for paying more. That's one of the conclusions you could draw from the new edition of the Dartmouth Atlas of Health Care: Tracking the Care of Patients with Severe Chronic Illness.

The new Atlas report shows that institutions that give better care can do it at a lower cost because they don’t over-treat patients. However, the Atlas documents that Medicare and most other payers encourage the over-use of acute-care hospital services and the proliferation of medical specialists thanks to misplaced financial incentives, especially for treating chronically ill people.

Examples from the new Atlas:
An elderly person spent an average 10.6 days in the hospital during the last two years of life in Bend, Ore., but 34.9 days in Manhattan.

The variation is even more striking in the last six months of life, when chronically ill patients visited the doctor an average of 14.5 times in Ogden, Utah, compared to 59.2 times in Los Angeles, Calif.

That creates wild variations in how much Medicare spends on these patients. The U.S. average was $46,412. The highest spending was in New Jersey at $59,379 per patient, or a quarter more than the average. The lowest was in North Dakota at $32,523 per patient, or a quarter less than the average.

The Atlas is one of the most important documents in U.S. health policy. It paints a picture of the "non-system" we have built. And it has direct implications for health care consumers, who must realize the variations in practice reflect uncertainties about what is the "right" care or the "best" care for them.

Our own work on HealthNewsReview.org - grading health news coverage of new treatments, tests, products and procedures - is based on the same theme. Journalists must do a better job of conveying the uncertainties that exist in health care - the tradeoffs that come with any health care decision. They must scrutinize the quality of the evidence, quantify harms and benefits, and discuss costs. Or else they're conveying a "kid-in-the-candy-store" picture of U.S. health care that contributes to the picture described above.

Nonprofit hospitals as profit machines

The Wall Street Journal story, "Nonprofit hospitals, once for the poor, strike it rich," should be required reading for anyone who wants to understand the current hospital industry.

Excerpts from the story:
• one nonprofit hospital system has a treasure chest of $7.4 billion - more than many large, publicly traded companies;
• the CEO of Northwestern Memorial Hospital in Chicago recently received a $16.4 million payout while the hospital spent $20.8 million on charity care - less than 2% of its revenues and a fraction of what it received in tax breaks;
• one nonprofit hospital system counts the salaries of its employees as a "community benefit" - including the $1.8 million in CEO compensation;
•"Nonprofit is a misnomer - it's nontaxable," says the president of a small for-profit hospital in a poor neighborhood on Chicago's west side. "When you're making hundred of millions of dollars a year, how can you call yourself a not-for-profit?"

Disease mongering by Women's Health magazine

Add Women's Health magazine to my list of publications guilty of disease-mongering by advocating tests that are not supported by evidence - recommendations that run counter to those of the U.S. Preventive Services Task Force.

The article, "THE MEDICAL TESTS YOU SHOULD TAKE: Head-to-Toe Tune-Up" is not unlike those I've criticized on CNN, in the Minneapolis Star Tribune, and in a number of other news outlets.

No source is given for the recommendations.

Journalists: when you promote testing and screening in healthy populations in the absence of evidence of benefit and in the presence of known harms you may be causing harm yourselves. And you're certainly stirring up the "worried well" to seek medical attention when they may not need it. We're already devoting 16% of the gross domestic product to health care.

NEJM tries to clear up dirty lung study controversy

See the New England Journal of Medicine's correction, clarification and editorial over the controversial lung cancer CT screening study.

How drug companies wine & dine doctors

An Australian newspaper gives a glimpse of how much drug companies spend to wine and dine doctors at "educational events." Excerpt:

"A drug giant spent more than $514,000 on a weekend seminar that included just six hours of "education content".

The symposium by Australian-based AstraZeneca included gourmet meals, alcohol and two nights free accommodation.

A new report shows "Big Pharma" is prepared to spend millions showering doctors with hospitality in the hope they will prescribe their drugs.

It reveals drug companies spent $31 million on educational events in the second half of last year, including $16 million on meals, airfares and accommodation.

Drug companies funded 14,643 functions during the period, 52 of which are under investigation for possible breaches of new industry rules.

Critics attacked the spending as an "orgy of wining and dining designed to schmooze doctors and boost the sales of new medicines".

But doctors claimed the hospitality amounted to little more than "a glass of orange juice and a sandwich".

Industry body Medicines Australia said drug companies had to keep doctors informed about new medicines.

"No one knows more about pharmaceuticals than the people who make them," chief executive Ian Chalmers said.

Medicines Australia refused to disclose which companies hosted the suspect events until the cases are reviewed.

Companies that breach the rules face $200,000 fines.

More than 220 gastroenterologists attended the AstraZeneca event, which was one of the most expensive disclosed.

Another company, Roche Products, spent $511,791 on a weekend hepatitis symposium for 337 specialists at Melbourne's Grand Hyatt, including $415,000 on hospitality.

Pfizer spent $340,000 on a cardiovascular forum for 220 specialists in Sydney, and Wyeth spent $333,000 sending 178 psychiatrists to an $1800-a-head event on Sydney.

Australian Medical Association president Rosanna Capolingua said the events were necessary and spending was reasonable."

We should expect better from a medical journal

I've reported many times on news organizations hyping medical technologies. But this past week, a medical journal - BMJ - did the same thing in its "news" section, presenting only the fantastic potential of robotic surgery without any evidence - any quantification - of potential benefits and harms and without any discussion of costs.

The BMJ "news" story was entitled, "Robotic prostatectomy transmitted live to engineers to promote collaboration."

Read my letter and that of a British oncologist in response to that article. I wrote:

"...the story was completely devoid of any data.

We learn that robotic radical prostatectomies are much more common in the US than in the UK but we learn nothing about outcomes.

We learn that there are ethical issues but none is specified.

We learn that a urologist believes robotic surgery has several advantages. But those are not quantified. What does "better results" mean?

We learn that "patients recover more quickly" but we're not told how many patients. We learn of "better cancer control" without any definition of that term.

Ditto for reported claims of more precision, "less collateral damage, resulting in less blood loss, faster recovery, and fewer complications." No numbers.

I'm trying to teach my health journalism students, "No numbers? No story." I hope they weren't reading this week's BMJ "news" section."

Stop running scared

Shannon Brownlee on disease-mongering.

More suggestions of drug company deceit on Vytorin

The New York Times adds more questions to the Vytorin drug data delay story. Excerpt:

"The lead outside investigator on a crucial trial of two widely used heart drugs said in an e-mail message last July that Merck and Schering-Plough, the companies that make the drugs, were deliberately delaying the release of the trial results “to hide something.”

The companies did not release the preliminary results of the trial, called Enhance, until January, almost two years after the trial was finished. When they were finally released, the trial’s results showed that the drugs, Vytorin and Zetia, did not work to reduce plaque in arteries. The results led a panel of cardiologists to recommend on Sunday that the drugs be used only as a last resort. ... The drugs are used to lower cholesterol and are among the most widely prescribed medicines in the United States, with sales of $5 billion last year. Shares of Merck and Schering plunged on Monday."