Schwitzer health news blog

Americans ask "Why can't we get drugs from Canada?"

A Wall Street Journal online/Harris Interactive poll shows that two-thirds of Americans strongly believe a law prohibiting pharmaceutical imports from Canada and other countries is intended to protect drug-company profits. Only 9% feel strongly that it helps protect Americans from potentially harmful drugs.

Other poll results:

"80% of Americans favor allowing people to import prescription drugs from Canada and other countries if they are much less expensive there.

More than three-quarters of those polled said they believe confiscating drugs at the Canadian border jeopardizes the health of some Americans, compared with 15% who disagree. And 84% of those surveyed said they agree with making it legal to import drugs from Canada if they are approved and vetted by that country's drug regulatory agency, Health Canada, compared with 9% who disagree."

Record number without health benefits in '05?

Bloomberg News reports: "The number of Americans without health insurance probably rose to a record in 2005 as medical costs increased three times as fast as wages, according to forecasts for a Census Bureau report today.

'We've had absolutely no federal effort or interest in insuring the uninsured since 2000,'' said Thorpe, who was deputy assistant secretary for policy at the Department of Health and Human Services from 1993 to 1995. 'This has not been a priority of the Bush administration.' "

Journal conflicts of interest continue

The Wall Street Journal reports that the editor of the journal Neuropsychopharmacology, Charles Nemeroff, resigned after he wrote a favorable review of a new device for treating depression that didn't disclose his financial ties to the device's maker.

WSJ reports: "The journal, which carried the article, has published a correction citing Dr. Nemeroff's ties to the device maker and those of the article's other eight authors. In addition to Dr. Nemeroff, seven of the authors were academics who serve as consultants to the maker of the device, and one was an employee of the company, Cyberonics Inc., of Houston. The authors' relationships to Cyberonics were reported in The Wall Street Journal last month. Last month, the journal published a review in which it said the Cyberonics treatment, in which a small device is implanted in the chest to deliver mild electrical pulses to the vagus nerve in the neck, is 'a promising and well-tolerated intervention that is effective in a subset of patients with treatment-resistant depression.' "

As I teach students, I use the term "rampant" to describe the entanglement of conflicts of interest in the dissemination of health and medical news. Since many journalists live off what they get in medical journals, this is further evidence of how rampant the spoiling of the food chain is.

Drop in HMO enrollment

A story on the web by Minnesota Public Radio explains how Minnesotans' enrollment in HMOs dropped last year to its lowest point in 20 years. And this was the place that for years had the greatest penetration of HMO enrollment in the country.

But the key in the story is that this may not be a good thing, that it may be a sign of employer cost-cutting.

One observer in the story says, "They're trying to wring every dollar out of the health care expenditure that they can. And by moving to indemnity and self-funded plans, the employers have flexibility to design their own plans, where in the fully insured HMO model the coverage is really mandated in state law."

And a University of Minnesota economist says, "The risk with that is that if there is any major downturn in the economy as there was at the beginning of the 90s, you could see much less coverage from some of those employers."

It will never happen in this country

The Independent of London reports that the British health watchdog group with the ironic acronym of NICE (National Institute for Health and Clinical Excellence) has ruled that the goverment won't pay for Avastin (bevacizumab) and Erbitux (cetuximab) for treating advanced bowel cancer, saying the drugs were not cost-effective.

It will never happen in this country and I can already hear the great shouts of vested interests crying, "Hooray, and it never should happen."

But we don't have a NICE in this country. And past attempts in this country to discuss, weigh the evidence for, and perhaps even reject coverage for new technologies including drugs have often been ambushed by special interests.

Indeed, the British NICE decision is already being attacked by some.

But NICE ruled on the evidence, with a spokesperson concluding: "Although bevacizumab does show some increased benefit over standard treatment, the appraisal committee was not persuaded that it was cost- effective in the treatment of metastatic colorectal cancer. The evidence available on cetuximab does not compare it with current standard treatment and therefore we are not able to assess whether it is any better than existing treatments or whether the National Health Service could justify spending money on the drug."

With the U.S. outspending any other country in the world on health care, yet with some outcomes that are worse than those in much poorer countries, we don't have a cost-effectiveness watchdog like NICE.

Maybe it would be a nice idea.

Health care industry worried about Michael Moore's "Sicko"

AdAge.com is the latest publication to report that Michael Moore's pending documentary on the health care industry has industry execs rattled.

AdAge.com reports that drug company execs have told their employees not to talk with Moore. Quotes in the article:

"A review of America's health-care system should be balanced, thoughtful and well-researched to pin down what works and what needs to be improved," said Ken Johnson, senior VP for the Pharmaceutical Research and Manufacturers of America. "You won't get that from Michael Moore."

Added a spokesman for one of the top 10 pharma companies: "We expect it will be one-sided and
biased, just like his other documentaries."

Hmmm: one-sided and biased. Kinda like direct-to-consumer drug ads, in other words?

Moore has written, "I don't think the country needs a movie that tells you that HMOs and the pharmaceutical companies suck. Everybody knows that. I'd like to show you some things you don't know. So stay tuned for where this movie has led me. I think you might enjoy it."

The movie may not be released until early 2007.

Local TV news fails on Bush visit

I watched the 6 o’clock TV news on the 3 leading Twin Cities TV stations last night and I give them all an F on covering the President’s visit to the area.

Were issues covered? No.

He met with a health care panel and signed an executive order to make more health care cost and quality information available to consumers.

But the TV newscasts had more silly discussion about traffic jams caused by the Presidential motorcade and Air Force One than there was attention to issues. One station even offered live cut-ins of the president waving as he got back on the plane and then again as Air Force One began to roll on the runway. Wow, that's good and important TV.

Come on! This is the 14th largest broadcast market in the country. And this is the best we can get on substance? On issues?

If this was just a political fundraising trip, why not call it that? If there was no substance to the alleged policy announcements, why not report that?

What value was there in the President’s ideas and in the executive order? Where was the reporting? Was the biggest issue the traffic jam caused by his visit?

I think not, not given rising health care costs, problems of the uninsured, calls for universal national health insurance, questions about integrity in science at the federal level, etc., etc. etc.

Shame on the local media.

(AP Photo)

Seniors slamming into Medicare drug doughnut hole

The Minneapolis Star Tribune had an important story about seniors with Medicare drug coverage already hitting the "doughnut hole" in their coverage.

The paper reports: "Millions of Americans are nearing that gap. Nearly two-thirds of the 11.8 million beneficiaries who bought drug policies without gap coverage will hit the doughnut hole this year -- on average in the next few weeks -- according to the Kaiser Family Foundation. Simply put, the "doughnut hole" is the gap in the Part D benefit in which consumers must pay for all of their drug costs. In 2007, it will kick in after the first $2,400 in costs, with Part D coming back in to pay 95 percent of prescription costs beyond $5,451.25."

A state-sponsored senior help line reports calls from up to 450 seniors who have hit the hole and now need help paying for drugs. They report that many are shocked to hit the gap.

The paper portrays this as the second significant snafu in the program: the rocky start with much consumer confusion and now seniors worried and confused over hitting the hole so soon.

One woman, now paying $645 a month for her drugs and preparing to take a drug-buying bus trip to Canada, said in the story: "Congress was not thinking about people when it passed this law. It was thinking how they could make the drug companies and insurance companies even richer."

Ballooning rates of balloon procedure in one Ohio town

The New York Times published a story showing the questionable variation in health care, "Heart procedure is off the charts in an Ohio city."

Elyria, Ohio does coronary angioplasties (often including the use of drug-coated stents to keep arteries open) at four times the national average, three times the rate of Cleveland, just 30 miles away.

This was all found through the valuable Dartmouth Atlas project, which, according to the Times, "also shows that the Elyria doctors have a higher than average tendency to perform diagnostic coronary angiographies on patients — the primary test that is used to detect blockages in the first place. 'People are just geared to be looking at things, and they find them,' said Dr. John E. Wennberg, who pioneered the Dartmouth data analysis."

The Times story concludes: " In the absence of any real monitoring or oversight, doctors in most places, including Elyria, have few incentives not to favor the treatments that provide them the most reimbursement. (A) San Francisco cardiologist said that the way physicians are typically paid — more money for more procedures — results in too many decisions to give a patient a stent.

'You can’t be paying people large sums of money to do things without checks and balances,' he said."

Baseball and impotence

The National Football League had its lucrative promotional deal with Levitra.

But America's national pasttime turns to the tried and true Viagra for its sponsorship.

Yes, little boys and girls, this is what you've been waiting for. It came in my e-mail inbox yesterday.

"Major League Baseball® and Viagra (sildenafil citrate) have teamed up to recognize the greatest comeback players in the sport... and you can help select the winners!"

And just think: "NO PURCHASE NECESSARY TO ENTER OR WIN." So 9-year old Billy can vote for Nomar Garciaparra, and he doesn't even have to buy Viagra to qualify!

What a great country!

Restlessness over restless leg syndrome drug promotion

The Sunday Times of Great Britain reports:

"The pharmaceutical giant Glaxo Smith Kline (GSK) has been reprimanded by an industry watchdog for promoting an unlicensed drug to treat the disputed condition of restless legs syndrome. ... Some doctors claim the condition ... has been concocted or at least exaggerated to help sell drugs. While patients had previously complained to doctors of leg cramp at night, few had heard of restless legs syndrome before drugs became available to treat the illness."

It's interesting to see how another country deals with drug ads. Of course, the U.S. is only of only two industrialized countries in the world to allow direct-to-consumer prescription drug ads. And, of course, restless drug ads have filled American media for a long time.

Dartmouth and VA Outcomes Group researchers Woloshin and Schwartz recently published "Giving Legs to Restless Legs: A Case Study of How the Media Helps Make People Sick" in PLoS Medicine. Their analysis of news coverage of "restless legs" led to this conclusion: "The news coverage of restless legs syndrome is disturbing. It exaggerated the prevalence of disease and the need for treatment, and failed to consider the problems of overdiagnosis. In essence, the media seemed to have been co-opted into the disease-mongering process. ... The stories are full of drama: a huge but unrecognized public health crisis, compelling personal anecdotes, uncaring or ignorant doctors, and miracle cures.

We think the media could report medical news without reinforcing disease promotion efforts by approaching stories like 'restless legs' with a greater degree of skepticism. After all, their job is to inform readers, not to make them sick."

Pfizer's "off-label" promotional shenanigans

An Annals of Internal Medicine article this week summarizes the authors' review of approximately 8000 pages of publicly available documents regarding the case of United States of America ex. rel David Franklin vs. Pfizer, Inc., and Parke-Davis, Division of Warner-Lambert Company. This is the lawsuit against Pfizer for illegal "off-label" promotion of the drug Neurontin - promoting it for a use for which it was not approved.

The authors write about Pfizer's recruitment of medical "thought leaders," "key influencers," and "movers and shakers. " "For example, in 2 documents Parke-Davis identified 40 potential thought leaders in the northeastern United States, including 26 current or future department chairs, vice chairs, and directors of academic clinical programs or divisions. Of these 40 leaders, 35 participated in at least 1 Parke-Davis–sponsored activity, including 14 who requested or were allocated $10 250 to $158 250 in honoraria, research grants, or educational grants between 1993 and 1997."

That is just one of many strategies outlined in this extensive review. Read it...and be ready to take an aspirin or your favorite upset stomach med.

Disease-mongering and female sexual dysfunction

How do you treat what you can't define? Never a question to stop drug companies.

Many have pursued a drug for so-called female sexual dysfunction or FSD. Pfizer recently announced that Viagra (the erectile dysfunction drug) increased vaginal blood flow in rats, so they're continuing to test it with hopes it could help women whose "female sexual dysfunction" is caused by that problem.

Not everyone buys into the FSD picture. In their book, "Selling Sickness," Ray Moynihan and Alan Cassels interview NYU psychologist Leonore Tiefer, who challanges the medicalization of women's sexual difficulties. She says, “Your body isn’t good enough. You aren’t good enough. You plus products…now maybe then you’re good enough." The authors write: "If there was no agreement on how to define or measure FSD, how on earth could a company show in a clinical trial that its drug had helped fix the dysfunction? If you can’t measure it, how can you market a pill to fix it?

One "probability sampling survey" published in the Journal of the American Medical Association 7 years ago estimated that 43% of U.S. women have sexual dysfunction. That authors of the "Selling Sickness" book say that estimate "will likely go down in history as one of the most abused medical statistics of our time."

But the estimate - weak though it may be - helps, if your goal is selling sickness.

For more on disease-mongering, see the website of this past year's Conference on Disease-Mongering in Australia.

And don't miss a special collection of articles on disease-mongering in PLoS Medicine.

Consumers can't figure out health care prices

The Chicago Tribune has a good story on how difficult it is for consumers to find out how much something in health care will cost before they agree to pursue it. And the story shows what a joke it is to discuss “consumer-driven health care” in the current environment.

“The market just isn’t ready to deliver on the promise of these new insurance products,” says the president of the Midwest Business Group on Health in the article.

The article told the story of several failed consumer attempts to find out pricing information. One was by a woman who is also an exec with the Wisconsin Hospital Association, who said “How are people supposed to make good decisions if you won’t give them information?”

“This is the only industry where people are buying services without any information,” said the executive director of the Business Health Care Group of Southeast Wisconsin in the article. “If we want people to become more engaged in thinking about what medical care costs, we have to change that.”

Health care conflict of interest down under

Two recent Australian news stories point to conflicts of interest in Australian health care.

One, "Doctors have unhealthy desire for gifts," discussed a survey of 823 medical specialists about what companies gave them and what they asked for. The lead author concluded, "Doctors are sometimes seen as the innocent victims, and the villains in the piece are the pharmaceutical industry. In reality, it is a two-way relationship."

The other story, "Mental health takes industry pills," reports that Australia's "most influential mental illness advocacy group signed a deal that financially tied it to some of the world's biggest pharmaceutical companies." A spokesman for the group called Healthy Skepticism reacted: "The strategy is all about growing markets and increasing sales."

These are two important stories that may only give you the twisted satisfaction that we're not alone in our entanglement of conflicts of interest in U.S. health care.

Drugmaker wants LESS risk information in drug ads

AdAge.com reported a while back that drugmaker AstraZeneca wants to limit the number of risks mentioned in a TV drug ad. They say consumers are overloaded and overwhelmed by multiple warnings. An AstraZeneca study supposedly found that listing three risks is optimal; more than five is too many.

Maybe AstraZeneca should do another study of how overloaded and overwhelmed American consumers are by the onslaught of drug ads. We see prime-time TV ads for three impotence drugs and for what seems like 18 new sleeping pills. What's optimal in that picture? What's overload?

Meantime, this proposal comes, according to AdAge.com, when "The Food and Drug Administration has repeatedly asked for more risk information, and in remarks earlier this year the director of its drug marketing, advertising and communications division, Thomas Abrams, noted that 82% of pharmaceutical company violations in the past year were related to inadequate presentations of risk information."

Of course AstraZeneca makes the cholesterol-lowering drug Crestor. And AstraZeneca is in an intense battle with other drugmakers for market share in this sector, fighting to get many more Americans taking their drug. Because of the potential benefits. And forget those nagging side effect warnings (e.g.: rhabdomyolysis, a rare but serious side effect of all statins, pharyngitis, headache, diarrhea, dyspepsia, nausea, myalgia, asthenia, back pain, flu syndrome, urinary tract infection, rhinitis, sinusitis.....oops, I violated the optimal 3-side effect limit!)

Apple-eating mice: rejoice!

"An apple (or two) a day may help keep Alzheimer's away -- and fight the effects of aging on the brain," according to a story posted on WebMD.

The story should have said clearly, boldly and early: "IF YOU ARE A MOUSE."

But the story, reporting on a study funded by the U.S. Apple Association and the Apple Products Research & Education Council, didn't mention mice until seven paragraphs deep in the story. No important caveats appeared in the story.

In fact one quote was the exact same quote in a U.S. Apple Association news release.

Here's a caveat for news and health care consumers: Yesterday CBS News announced it was partnering with WebMD in an effort to "expand its medical and health coverage." Let's hope the partnership doesn't result in more mouse breakthroughs on the network newscasts.

Debate over stopping menstrual periods

An interesting column in the Chicago Tribune claims there is a lack of good information for women about new options to stop or limit menstrual periods.

The columnist blames journalists for biased coverage, doctors for failing to know enough about the risks and benefits of menstrual suppression, researchers who are "more interested in fighting for their point of view in a medical journal than provided balanced information to the public," and drugmakers "who are adept at promoting only the data that will help them sell their products."

The focal point of the current debate is the pending FDA approval of an oral contraceptive, Lybrel, the latest drug proposed to suppress menstruation.

The debate raises issues of what is "natural" for women, and whether there are elements of disease-mongering in treating menstruation as a disease - promoting prescription drugs to treat or surpress what some emphasize is a natural condition.

But that also raises issues of women's freedom to avoid bleeding if they can.

Still, safety questions hang over the entire discussion.

As it is, the column suggests that "American women are likely no closer to making an informed decision about whether to halt a function so seemingly integral to their bodies."

Politicizing the FDA

Was the FDA's surprise announcement that it would reconsider an effort to make the emergency contraceptive Plan B drug available without a prescription a political move on the eve of Senate hearings on the confirmation of Acting Food and Drug Administration Commissioner Andrew C. von Eschenbach?

The Washington Post reports that much of the hearing focused on the politicization of the agency.

The Post reported that Sen. Barbara Mikulski (D-Md.) said, "There is a crisis of confidence at FDA."

"More than 100 whistle-blower cases are pending at the agency, Mikulski noted -- an outgrowth, she said, of rock-bottom morale, much of it rooted in the perception that the Bush administration is imposing ideology over evidence.

Several senators cited a recent survey by the Union of Concerned Scientists in which more than 40 percent of nearly 1,000 FDA employees said they knew of cases in which political appointees had interfered with agency decisions."

Awesome Aussie Example of Pharma Largesse

Ray Moynihan gives us an inside look at one drug company's wining and dining of top doctors in The Australian. Excerpts:

"It was a glamorous Saturday night out in Sydney. The restaurant, the food, the wine and the calibre of guests were all first-class. The exclusive Guillaume at Bennelong restaurant sits atop the stairs at the Sydney Opera House, commanding one of the best views in the nation.

Roche has quite an interest in blood disorders and cancer. Its top-selling drug in the world is MabThera, a cancer treatment for non-Hodgkins lymphoma, which costs almost $10,000 a treatment."

Drug Makers Pay for Lunch As They Pitch

The headline above appeared in the New York Times last week, and the online version has photos and video of food being delivered to doctors' offices. Everyone knows drug companies throw gifts and lunches at doctors to influence prescribing, but the Times staked out one doctors' office building to see how often it happened. It happened almost every day, with great volumes of food.

An excerpt:

"Anyone who thinks there is no such thing as a free lunch has never visited 3003 New Hyde Park Road, a four-story medical building on Long Island, where they are delivered almost every day. On a recent Tuesday, they began arriving around noon. Steaming containers of Chinese food were destined for the 20 or so doctors and employees of Nassau Queens Pulmonary Associates. The drug maker Merck paid the $258 bill.

A deliveryman carrying trays of gourmet sandwiches sashayed past patients at Advanced Internal Medicine. The bill showed that Takeda Pharmaceuticals was picking up the bill. The doctors in the group must have liked the sandwiches. The next day, the exact same delivery came in, paid for by Cephalon.

Free lunches like those at the medical building in New Hyde Park, N.Y., occur regularly at doctors’ offices nationwide, where delivery people arrive with lunch for the whole office, ordered and paid for by drug makers to the tune of hundreds of millions of dollars a year.

Like the “free” vacation that comes with a time-share pitch attached, the lunches go down along with a pitch from pharmaceutical representatives hoping to bolster prescription sales. The cost of the lunches is ultimately factored in to drug company marketing expenses, working its way into the price of prescription drugs."

And, by the way, did you know that drug companies can deduct such marketing costs from their taxable income?

Some medical centers have now banned such free lunches, but they're in the minority.

One group fighting the practice is worthy of note for its goals and for its name: NoFreeLunch.org.

Star Trib deals double dip of premature health hype

Monday’s Minneapolis Star Tribune had two stories that wore the pom-poms of cheerleading better than the ink-stained wretchedness of good journalism.

Back in February, the Star Tribune was among the local Minneapolis-Saint Paul media that hyped an announcement of the reversal of diabetes in a few monkeys over a short term by transplanting insulin-producing cells from pigs.

Monday’s story, “From pigs, a cure for diabetes?” profiled “a Duluth businessman's vision: cells from pigs … will help U researchers.” The story said that “In February, a scientist at the U announced that he and other researchers had cured diabetes in monkeys by injecting cells from pigs.” I don’t recall the scientist ever using the word “cure,” nor did the University news release.

Even if he did, what does that term mean to readers? If you asked 100 people about a cure for diabetes, what would they say that means? A short-term reversal in some (but not all) animals on which it was tried? I doubt that would be the accepted definition.

The paper also wrote: “The Food and Drug Administration has yet to approve clinical trials of the pig islets' use in humans, but clearance is expected.” Better not bank on that one until it’s in hand. The trail of tears of expected FDA approvals that never happened is longer than you may think. But if you’re in cheerleading mode, you bet on the hometown team, right?

Then, in Monday’s business section, the Star Tribune had a story, Hypertension implant has promise,” “reporting that “ a Maple Grove firm's device to lower stubbornly high blood pressure is attracting attention -- and deep-pocket investors, as well.”

The story, also in cheerleading fashion, describes a photo taken during the first human implantation of the device, with a masked surgeon in an operating room holding up a piece of notebook paper on which he's scrawled, "It works."

Good science and good journalism demand more than a thumbs up after just one case.

Indeed, the story says the device “still is undergoing clinical trials and has a long way to go to win regulatory approval as being safe and effective.”

The paper quotes a company exec who says it's too soon to say how much the system might cost, but it's likely to be between $6,000 - $35,000, with an initial U.S. market of up to 2 million patients.

Hey, how’s that for letting the manufacturer use your newspaper to create demand while setting a narrow price range – only a $29,000 swing in price possibilities!

Couldn’t this story have waited until some more data and evidence were in hand?

Or is this not journalism? Is it cheerleading? You can’t do both.