Schwitzer health news blog

Before we throw away the June page of the 2009 calendar, I want to thank readers for their interest in this blog and in HealthNewsReview.org. June traffic to both sites hit all-time highs for average daily unique visitors in a month. And when I say all-time, that means more than 3 years on HealthNewsReview.org and more than 4.5 years on this blog.

Andrew Alexander writes:

"For a storied newspaper that cherishes its reputation for ethical purity, this comes pretty close to a public relations disaster."

The Politico.com story about the Washington Post "pay for access" proposal isn't astonishing to Merrill Goozner, who writes:

It's a long standing practice by one of the few sections of the news business that remains profitable -- the newsletter and trade journal business. There's also a vibrant conference sponsorship industry that sells exclusive access to top government officials.

For instance, a Texas-based outfit called Pharma Education Concepts, Ltd. is running one of its trademarked "Pharma Conferences" in Cambridge, Maryland in late-August. Dubbed "GMP By The Sea," the meeting brings top drug industry executives together with Food and Drug Administration officials to hear the latest thinking on globalization and the regulation of drug and biologic manufacturing processes. Featured speaker this year is Murray Lumpkin, deputy FDA commissioner for international and special programs. Pricetag: $1,495 a ticket.

In mid-June, a scrappy industry newsletter called FDAWebview filed a citizens petition with the FDA demanding journalistic access to this and any private meetings where FDA officials appear. Its editor couldn't afford the $1,495 needed to send a reporter to cover the GMP By The Sea meeting where Lumpkin, a public official, might say something newsworthy.

The real issue is what will be the ground rules for these Post-sponsored conferences. The public has the right to know what gets said in these meetings with its elected representatives and civil servants. I stand with FDAWebview. Any session where a top government official appears should be open to the news media, right on down to the lowliest blogger.

As always, thanks for the perspective, Gooz.

I think I got Susan Perry of MinnPost.com turned on to the controversy surrounding the bill co-sponsored by Sen. Amy Klobuchar and Rep. Debbie Wasserman-Schultz

Regardless of how she got inspired, Perry is now all over the story, adding a new posting today. She adds the fact that noted breast cancer author Dr. Susan Love opposes the legislation, adding her name to a long list of critics. Excerpt from the new posting:

One of the most contentious issues of the bill is its emphasis on breast self-exams for women under 40, despite research from large randomized trials that have shown such exams have no effect on either detecting breast cancer or influencing survival rates in women of any age.

And Christine Norton of the Minnesota Breast Cancer Coalition says in the new article:

"It's upsetting to me that the preponderance of evidence was not persuasive to stop the introduction of this legislation that would call for $45 million over a five-year period," says Norton. "I understand that that amount is 'decimal dust,' but to a taxpayer, it's significant, especially at this time when we're supposed to be focusing on health-care reform."

Politico.com has posted the response it got from the Washington Post.

The new posting reads:

The Washington Post has now responded to POLITICO's report this morning that the paper is arranging salons for lobbyists at the home of publisher Katharine Weymouth, events that would include Obama administration officials, members of Congress, and the staffers.

The solicitation -- with costs between $25,000 to $250,000 -- was listed on a flier that circulated to a lobbyist, who later passed it along to POLITICO.

Post spokesperson Kris Coratti has now sent the following statement to POLITICO:

The flier circulated this morning came out of a business division for conferences and events, and the newsroom was unaware of such communication. It went out before it was properly vetted, and this draft does not represent what the company's vision for these dinners are, which is meant to be an independent, policy-oriented event for newsmakers.

As written, the newsroom could not participate in an event like this.

We do believe there is an opportunity to have a conferences and events business, and that The Post should be leading these conversations in Washington, big or small, while maintaining journalistic integrity. The newsroom will participate where appropriate.

Wow. More assaults on the firewall between bean-counters and editorial. What would have happened if Politico.com hadn't reported this?

Mike Allen reports:

For $25,000 to $250,000, The Washington Post is offering lobbyists and association executives off-the-record, nonconfrontational access to "those powerful few" -- Obama administration officials, members of Congress, and the paper's own reporters and editors.

The astonishing offer is detailed in a flier circulated Wednesday to a health care lobbyist, who provided it to a reporter because the lobbyist said he feels it's a conflict for the paper to charge for access to, as the flier says, its "health care reporting and editorial staff."

The offer -- which essentially turns a news organization into a facilitator for private lobbyist-official encounters -- is a new sign of the lengths to which news organizations will go to find revenue at a time when most newspapers are struggling for survival.

Allen wrote at 8:04 EDT that he is waiting for a response from the Post.

If true, this is a devastating story.

That's how psychiatrist Dan Carlat refers to the process of the revision of psychiatry's Diagnostic and Statistical Manual - or the DSM-V.

Carlat writes about criticism of the process coming from Dr. Allen Frances, the chairman of the committee that created the current DSM-IV. Bullet points of that criticism:

• The process of writing the manual is less transparent and less inclusive than in the past.


• The underlying science of psychiatry has not advanced enough to merit the kind of extreme makeover proposed by the DSM-V chairpeople.


• The main change being proposed--the official inclusion of a series of rating scales into the diagnostic criteria--is poorly conceived because busy clinicians will reject this extra paper-work.


• Other proposed changes in DSM-V will make it too easy to over-diagnose a range of conditions.

Specifically, Frances writes:

"The result would be a wholesale imperial medicalization of normality that will trivialize mental disorder and lead to a deluge of unneeded medication treatment--a bonanza for the pharmaceutical industry but at a huge cost to the new false positive "patients" caught in the excessively wide DSM-V net. They will pay a high price in side effects, dollars, and stigma, not to mentions the unpredictable impact on insurability, disability, and forensics."

Carlat writes that the American Psychiatric Association and DSM leadership responded by accusing Dr. Frances and his colleagues "of being greedy, deceptive, and dumb."

What fun to watch the sausage-making side of science.

The New York Times headline: "Bone-Growth Proteins Show Risk in New Study." Excerpt:

"Patients who received a bioengineered protein during spinal fusion procedures to correct neck pain had far more complications than patients who did not get it, according to a study released Tuesday.

The study, published Tuesday in The Journal of the American Medical Association, reinforces previous concerns about the use of the proteins in fusion procedures to treat upper spine, or cervical, pain. The substances studied, sold by either Medtronic or Stryker, are not federally approved for cervical procedures, although surgeons are free to use them for that purpose."

The Wall Street Journal headline: "Bone Proteins Costly In Surgery, Study Says." Excerpt:

"The findings contrast with previous studies, written by Medtronic consultants, in which authors concluded that cost savings over time could offset the initial cost of Infuse.

For instance, an article in 2002 by former Army surgeon David W. Polly Jr., now of the University of Minnesota, and colleagues said, "Preliminary results suggest that from a payer perspective, the upfront price of bone morphogenetic protein is likely to be entirely offset by reductions in the use of other medical resources. That is, bone morphogenetic protein appears to be cost neutral."

Dr. Polly, who last year received substantial consulting and speaking fees from Medtronic, didn't immediately respond to requests for comment."

The Star Tribune, serving the community where Medtronic and Dr. Polly are based, had what sounded like a local-business cheerleading headline, "Medtronic's Infuse a hit in growth of spine fusion."

But the story itself offered much more beef than the headline suggested.

Still, the Strib story seemed to swing back to what good news this could mean for Medtronic. Excerpt:

"JAMA's findings loom large for Medtronic, which sells the bioengineered product called Infuse used in spine fusion procedures. Since it was approved by the FDA in 2002, Infuse has proven to be a blockbuster device for the medical technology giant. Michigan-based Stryker Corp. makes a similar product, but Medtronic is by far the market leader.

While Medtronic doesn't break out figures for individual products, sales of biologics (including Infuse) have topped $3.6 billion in the past five years. Its spine division, which also markets devices used in spine surgery, is its second-largest with $3.4 billion in annual revenue."

And the Strib story never mentioned Dr. Polly right in their own backyard.

It's an important study and topic. Read all three stories if you get the chance.

A commentary in the current issue of JAMA uses that headline to open a discussion about how "it is time to address the possibility of net health harm by elucidating more fully aggregate health benefits and harms of current health care."

Excerpts and bullet points from the commentary:

• Unlike health, health care is not an unalloyed good.


• Determinants of well-being transcend health care.


• Harm may occur as a direct or indirect consequence of health care. Direct harm includes adverse physical and emotional effects, generally to individuals, as a by-product of health care delivery. Indirect harm is a collateral effect on individuals and communities not directly involved in care. Indirect harm is closely associated with excess health care costs, which may induce harm by competing with other health-producing services.


• Physical harm is a by-product of routine care processes. Some aspects of physical harm (eg, adverse drug effects and medical errors) are better known than others (eg, untoward effects of radiation from computed tomography). Although physical harm is an accepted risk of treatment with increasingly powerful medications and interventions, much consequent harm is avoidable when treatments are overused or used without sufficient evidence of effectiveness.


• Some overtreatment happens when physicians lack evidence about the ineffectiveness or risks of a treatment.


• Percutaneous coronary intervention (angioplasty, stents, etc.) is likely being overused in the Medicare population. Contrary to national guidelines, more than half of Medicare patients with stable coronary disease lack noninvasive documentation of ischemia before elective percutaneous coronary intervention.


• End-of-life care provides another example of medical excess. One study found that only 30% of hospitalized patients older than 80 years wanted care to prolong life, but 63% received life-prolonging care such as intensive care unit admissions, intubation, surgery, and dialysis. Wide variation exists in end-of-life care.


• Although the potential for harm is substantial, both physicians and patients generally embrace technology enthusiastically--implicitly trusting in its benefit before adequate assessment is made.


• Unnecessary care can also cause emotional harm, including anxiety from testing or treatment and from creating inappropriate expectations. Emotional harm, although less well studied than physical harm, has important effects on patient well-being.


• A diagnosis of hypertension made through screening resulted in more office visits and sick role behavior without improved medication adherence or blood pressure control. Spinal magnetic resonance imaging often reveals alarming but clinically irrelevant findings, and adults with back pain who receive magnetic resonance imaging results may experience worse dysfunction than those not given the results. Likewise, many unproven screenings, such as the prostate-specific antigen test, remain commonly used; although relatively inexpensive and often sought by patients, they are unlikely to help and may induce harm, including anxiety associated with false-positive results. Exaggerated fears and "medicalizing" normal phenomena are as harmful as unrealistic expectations and are fostered frequently by marketing hype and sometimes inadvertently by health care clinicians.


• Although health care's objective should be to improve health, its primary emphasis has been on producing services.


• The possibility that health care might cause net harm is increasingly important given the sheer magnitude of the modern health care enterprise.

It's a thoughtful commentary. Read the entire piece if you have the chance (although it requires a JAMA subscription).

Katie Hobson of US News & World Report tweeted, "RIP, CRP?"

See the Times story.

The Wall Street Journal added to the discussion about cost-effectiveness of cancer drugs reflecting on a commentary in the Journal of the National Cancer Institute estimating that "it would cost $440 billion to extend life by one year for the 550,000 Americans who die annually of cancer."

Important topic. I'm glad the WSJ addressed it.

But one line bothered me. It read:

"Some countries, like the United Kingdom, agree to pay for expensive drugs only if they meet a certain threshold of efficacy, but no such rationing exists in the U.S."

A news story that comes right out and labels a demand for proof of efficacy as rationing?

A semantics purist may say that the term applies in this discussion - like restricting or rationing consumption of meat or electricity during war.

But given that any newsroom must realize how the term is used as a heavy-handed piece of rhetoric by those who oppose evidence-based medicine and who oppose health care reform that calls for such evidence, this seems like editorializing.

Good story - but that one word in that one sentence left a bad taste for me. Semantics, word choice and framing matter if you care about public understanding of complex health policy issues.

Despite my red marks on that one section, read the rest of the article (if it's still available online), which was important enough to be on page one of at least the D section of the printed WSJ, not way back on D4.

It's great to be first. But it's better to be complete, balanced, and helpful with your news.

CBS claimed an "exclusive" with a report on the "first person ever to get an infusion of his own heart stem cells" to try to avoid future problems after a heart attack.

OK, they had the exclusive report that the procedure was done.

But they didn't make clear that:

• There is currently nothing known about the benefits of this approach in people. That simply wasn't emphasized in the story.


• Instead, it was referred to as a "cutting edge" clinical trial. Are there non-cutting-edge clinical trials?


• It was called a "major advance."


• It was called a "trailblazing procedure."


• But the onscreen graphic continuously trumpeted it as a "CBS Evening News Exclusive."

The segment was clear that this treatment is experimental, but the failure to discuss potential risks, potential harms, costs involved, and current treatment options available to patients were huge omissions.

For anyone who really wants to learn about this area of research, the National Institutes of Health has a website describing the current state of the art. It contains questions we wish the CBS segment had explored, such as (excerpt follows):

"What are the implications for extending the research on differentiated growth of replacement tissues for damaged hearts? There are some practical aspects of producing a sufficient number of cells for clinical application. The repair of one damaged human heart would likely require millions of cells. The unique capacity for embryonic stem cells to replicate in culture may give them an advantage over adult stem cells by providing large numbers of replacement cells in tissue culture for transplantation purposes. Given the current state of the science, it is unclear how adult stem cells could be used to generate sufficient heart muscle outside the body to meet patients' demand.

Although there is much excitement because researchers now know that adult and embryonic stem cells can repair damaged heart tissue, many questions remain to be answered before clinical applications can be made. For example, how long will the replacement cells continue to function? Do the rodent research models accurately reflect human heart conditions and transplantation responses? Do these new replacement cardiomyocytes derived from stem cells have the electrical-signal-conducting capabilities of native cardiac muscle cells?"

An interesting story on a condition called FMD, or fibromuscular dysplasia, soon tumbled into an exercise in disease-mongering. Excerpts:

"I believe that a large number of Americans have FMD," says Jeffrey W. Olin, director of vascular medicine and a professor at the Mt. Sinai School of Medicine in New York City. "It's reasonable to say that many thousands could be saved from complications like heart attack, stroke, ruptured aneurysm and even death, by screening patients."

...Dr. Olin has prepared a top-10 list of doctors' misconceptions and missteps. They include, "Telling patients that the symptoms are all in their head. Telling patients that FMD is a rare disease. Telling patients with severe headaches with FMD that there is nothing that you can do for them."

..."Three to five percent would be a very reasonable estimate in the general population for FMD," says Thom W. Rooke, vascular medicine professor at the Mayo Clinic. That works out to there being possibly 10 million Americans who have FMD, he says. By comparison, an estimated 3 million Americans have epilepsy, 2.5 million have breast cancer, more than 2 million have schizophrenia and 725,000 have melanoma.

Dr. Rooke says many FMD patients might never have symptoms, and only a few are likely to experience severe problems. But, he says, many "vascular catastrophes," such as heart-rhythm deaths and strokes in young people, may stem from FMD.

The screening assertion is never clarified nor challenged. It is just left hanging out there: maybe 10 million Americans with this silent problem. If only we screened for it!

Whom would you screen?

When would you start?

What's the number needed to screen in order to prevent one event?

What evidence is there for effectivness of such screening?

The WSJ reporter in question has done this kind of story before - pro-vascular-screening advocacy without the perspectives of anyone who might challenge the prudence of such screening recommendations.

Dartmouth's Dr. Gil Welch, in response to that previous pro-screening story, wrote me: "Screen many, to find the few -- while many others get labeled at risk in the process. And thus many will be treated "wrong." "

Why isn't that important perspective included in this kind of story?

That quote comes from a Minnesota physician in a Pioneer Press article that includes many good elements:

• Info on disparities in Medicare spending;


• Dartmouth Atlas data and graphic;


• Local angle on Atul Gawande's New Yorker piece .

Kudos to reporter Jeremy Olson.