The Doctor Weighs In

Brian Klepper

This week TDWI is delighted to take our turn hosting Health Care Wonk Review, a collection that highlights some of health policy's best observers. The quality of these 14 posts is very high, and well worth your time.

As HWR has gained visibility and popularity, the number of submissions has risen. We couldn't publish them all, so chose the ones we thought were must-reads across industry sectors. (Apologies to those we didn't include this time.)

Before we begin, a quick announcement. Envision Solutions, LLC and Trusted.MD Network have launched the second annual global survey of healthcare bloggers.  The companies are producing this poll to shed additional light on why people blog about health-related subjects.  Click on the link to learn about and take the survey.  The study will close on October 15.

Now onto the show!

Physician Temper Tantrums. Over at Managed Care Matters, Joe Paduda picks a scab and elicits a (deliciously) minor furor. He argues that when payors use the results of claims data analysis to encourage patients to see better performing doctors, they are well within their rights as purchasers. He also notes (and I agree) that when doctors reject out-of-hand claims data as inherently flawed and inappropriate to provide quality analysis, they may not appreciate the progress in the available tools and methods, and may be simply defensive. Actually, he says "their actions look more childish than professional from here." A provocative piece.

No Docs in This Box. Retail medical clinics are popping up all over as an inexpensive alternative to a full-blown practice or the ER. Traditional providers are crying foul, but InsureBlog's Bob Vineyard suggests this is the pot calling the kettle black.

Abusing The Orphan Drug Law To Rip Off Customers. In a damning indictment of a drug company's business practices, David Williams at the Health Business Blog discusses Questcor Pharmaceuticals announcement about “a new strategy and business model for H.P. Acthar Gel(R).”

What Are The Real Savings In Medical Tourism. MedTripInfo's Michael Horowitz analyzes the probable total savings for a hip replacement obtained overseas. They're substantial.

Medical Justice League of America. The Sentinel Effect's Richard Eskow describes a new group that provides "gag order" forms to dissuade patients from reviewing their docs online, and also promises to "relentlessly" fight med mal lawsuits." The situation he relates would be hilarious if it weren't so lopsided and scary.

Make Sure Your Online SaaS Vendors Are Appliance Capable. The Healthcare IT Guy, Shahid Shah, provides sage advice on why you should not depend on "software in a cloud" without a backup plan. With big outages from Microsoft, Skype, eBay, and PayPal recently making headlines, it is wise to make sure you're protected. A fascinating and smart look at the pitfalls and realities of letting other companies be responsible for your mission-critical IT functions.

What The Lumenati Are Saying May Surprise You.  The ever-entertaining Matthew Holt is making the final dash toward hosting the Health 2.0 conference, where the discussion will focus on a significant portion of market-based reform, and the players will be none of the usual suspects. Meanwhile, back at The Health Care Blog, he ticks off some surprisingly lucid health care insights from the most unexpected sources.

Mitt Romney's Health Plan - A Foot In Each Canoe.  Over at Health Care Policy and Marketplace Review, Bob Laszewski wryly observes that conservative Presidential candidate Mitt Romney would like to have it both ways. He gloats over the Massachusetts reform he helped to engineer while assuring his political base that it wouldn't work elsewhere. (It's also not yet clear that it is going to work in Massachusetts.) It's a delightful bit of political dissonance, seen through the clarity of Bob's highly polished health policy lens.

BiPolar Diagnosis in Children: Another Epidemic? Here at The Doctor Weighs In, the erudite Dov Michaeli recounts a recent review article from the Archives of General Psychiatry. Between 1994-1995 and 2002-2003, an 8 year period, the rate of bi-polar diagnoses in children increased 40 fold! He lists a range of possible explanations for the epidemic, but settles, gloomily and cynically, on money. By explicating an immense but relatively obscure problem, he lays bare a pervasive trend that's corroding our health system. A must read!

Conflicted View on the Pitfalls of Government-Sponsored Comparative Effectiveness Research. In a withering analysis, Roy Poses at Healthcare Renewal rebuts a recent commentary by WSJ Editorial darling Scott Gottlieb. Dr. Gottlieb disparaged government-sponsored research as biased against costly drugs, while ignoring similar and more odious flaws in private sector research practices. AND Dr. Gottlieb conveniently neglects to disclose that he's associated with the biotechnology sector. Superb.

To Hell and Beyond: Dave Holland's Terrible Story. At Workers' Comp Insider, Julie Ferguson points to a particularly gruesome work-related accident by way of reminding us that these incidents are still all too common. Julie's perspective is particularly poignant, because it is also a reminder that what lies beneath the day-to-day work  of the people who write for and read this review is the vital goal of preventing and managing the suffering that is too often a part of life.

Katrina: Two Years Later Are Health Systems Better Prepared?  On the second anniversary of Hurricane Katrina, NewsHour correspondent Tom Bearden asks a coastal area provider if the health systems are now better prepared. The short answer is "No," according to the  interview excerpted by Jane Hiebert-White on Health Affairs Blog.

Cookbook Medicine Saves Lives.   A pretty good cook (I can vouch for her!) as well as a physician, The Doctor Weighs In's Pat Salber relates the substance of a July 23 article in the Archives of Internal Medicine. She describes a new heart failure guideline that improves outcomes when followed by clinicians, and details the range and depths of those improvements. She concludes with a quote from  the lead author, telling us that if these protocols were followed in hospitals across the country, they would result in 40,000 fewer deaths and 1.4 million fewer hospital days annually. Keeping in mind that this is just one condition in the vast complex of health care, it is a deeply compelling point.

Reform's Tougher Problem. I've been a bedouin lately, wandering from oasis to oasis, grateful for the chance to publish on Pat Salber's The Doctor Weighs In, Bob Laszewski's Health Care Policy and Marketplace Review, and on Matthew Holt's Health Care Blog. This post, placed on Matt's site, summarizes what I've learned working for several years on the reform problem. I now believe that meaningful change can only occur through the leadership of the non-health care business community, the one group with more power and influence than the financially conflicted health care sector. Non-health care's business leaders will pursue this effort, not because they care about health care or social justice, but because health care's impending instability will threaten the stability of their own econonic environments.

Thanks again to Health Wonk Review for letting us host, and thank you for stopping by.

Medical science has always benefited from a healthy debate about the risks and benefits of various treatments. Doctors and other health professionals are trained to think critically about published data and to be cautious about recommending new (and old) treatments that have not met the highest standards of safety and efficacy.

GSK's Avandia (from the News&Observer)Then they leave the relatively protected environment of their training institutions and enter the real world of high pressure, big business that is medicine today. Squeezed by time pressures, struggles over reimbursement, marketeers pushing their products, and patients demanding stuff they see on TV, they start to prescribe products and recommend treatments that they may not have under different circumstances. I’ve been there myself…writing a prescription for an antibiotic for a cold because I didn’t have the time or energy to argue the point with a patient whose mind was firmly made up.

But that type of pressure is minor compared to what is going on in the high stakes world of big pharma. To wit, the sad tale of Avandia, a diabetes drug with the scientific name of rosiglitazone; GlaxoSmithKline, its manufacturer; the FDA; and a medical researcher at the University of North Carolina (UNC), John Buse, MD, PhD, soon to be president of medicine and science for the American Diabetes Association.

Dr. Buse, in written testimony June 6, 2007 before the House Committee on Oversight and Government Reform,
John Buse, MD, PhD, UNC researcher  reported that he was threatened by the manufacturer of Avandia, SmithKline Beecham which later combined with GlaxoWellcome to become GlaxoSmithKline or GSK. According to a report on Bloomberg.com, Dr. Buse testified that after he raised concerns about Avandia’s heart risks “company representatives said in phone calls that 'my actions were scurrilous enough to attempt to hold me liable for a loss in market capitalization.'"

The report goes on to say that “rather than pursuing his concerns, Buse agreed to work with the company on future studies and signed a statement drafted by the drugmaker that was to be used with investors.”   The NY Times reports that Dr. Buse sent a letter to the FDA a few months later, in March 2000, stating that “Avandia might raise patients’ risks of heart attacks, and he criticized the company’s marketing, saying it employed ‘blatant selective manipulation of data’ to overstate the drugs benefits and understate it’s risks.” Oh, oh, this is not good news for a publicly traded company earning billions on the sale of this product.

According to another news report in The News&Observer, the then chairman of Dr. Buse’s department at UNC also pressured him “out of respect for a longstanding academic colleague” who held a senior position in the company. This pharmaceutical company apparently left no stone unturned when it came to pressuring Dr. Buse.

Glaxo recently issued a statement saying, “We regret if, at any time, Dr. Buse felt the conduct of any employee was contrary to the spirit of open, scientific debate.” Well, I don’t know about Dr. Buse, but I think threatening an academic physician with being held liable for billion dollar losses IS contrary to the spirit of open, scientific debate.

The bullying tactics surrounding this drug don’t stop there. They also involve the FDA, the government agency that is supposed to protect us from unsafe drugs. According to Bloomberg.com, an FDA supervisor, Rosemary Johann-Liang, has said “she was rebuked after approving a recommendation for the strongest possible warning on Avandia and a competing drug, Takeda Pharmaceutical Co.’s Actos for swelling that could lead to heart failure.” She went on to say that “she was ordered to retract her approval of the warning and lost her authority to approve those assessments.” On June 6, 2007, under scrutiny by Henry Waxman and the Oversight Committee, the FDA announced that it would require just such a black box warning about the risk of heart failure on the labels of both Avandia and Actos.

Steve Nissen, MD, Chair Cardiovascular Medicine at the Cleveland ClinicAnd, if all of that is not enough, Dr. Steve Nissen, chairman of Cardiovascular Medicine at the Cleveland Clinic and author of a recent study, published in the May 21, 2007 New England Journal of Medicine that found that Avandia increased the risk of heart attacks by 43%. How did the FDA respond? According ABC News, Douglas Arbesfeld, a senior communications consultant to the FDA sent e-mails to journalists entitled: “What are St. Steven’s feet made of? Clay, perhaps?” The email included an anonymous blog accusing Nissen of playing favorites among drug companies. The blog posting, originally published in the Wall Street Journal, accuses Nissen of focusing his criticism on drug manufacturers that do not support drug trials at the Cleveland Clinic: 

Dr. Nissen responded by telling ABC News, “I’m a pretty tough guy, but I’ll tell you, having this kind of an e-mail that questions my motives, broadcast to the major journalists with whom I work and have established a reputation is – it’s an outrage.”

Yes, Dr. Nissen, you are right, it is an outrage. The FDA is supposed to be protecting the company from unsafe drugs, not wreaking havoc on the reputations of researchers who raise legitimate questions about a drug’s side effects. And Henry Waxman, you are right too to be shining a light on a governmental agency that seems to have abdicated its responsibility to protect patients in favor of a stance that appears to protect drug company profits.

Clinical trials must be performed and the results disseminated without coercion and intimidation – can anyone really argue with that? And, drug companies must be held accountable for completion of high quality post-marketing studies. Drug labels need to err on the side of caution so that doctors and their patients can fairly judge the risk-benefit equation for every medicine prescribed and taken.

The pharmaceutical industry has contributed greatly to the overall health the world. They have also been rewarded handsomely for their products. It is way past time to rebalance the whole pharma/pharma oversight system and move away from a strong “need to sell” and toward a industry-wide “need to be safe” stance.

*(PS:  while you are on the WSJ link, check out the obnoxious comment about Dr. Nissen written by someone who describes himself as "detail man"  -- as in "drug detail man"?  Here's a sample of what he says:  "Nissen is a world class boor, with an ego the size of an asteroid and a bug in his bonnet to screw the drug companies."   Civilized discussion, no?

Pat Salber, MD

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Medicine and profits:  An unholy alliance

Lot’s of funny (and not so funny) news to share:

Musician canned for focus on the wrong organ.

A Catholic priest has removed his church's organist and choir director from her duties saying her sale of sex toys was not "consistent with Church teachings." Linette Servais, 50, played the organ and sung with the choir for 35 years. Much of her work as choir director and organist was done without pay. When her parish priest asked to meet with her, she thought it was to say thank you. Instead, she was told to quit her sales job with company known as Pure Romance or she would lose her position in the church.

Doctor rails against attorneys on his blog, not a good strategy when it is your own malpractice trial you are writing about.

As Ivy League-educated pediatrician Robert P. Lindeman sat on the stand in Suffolk Superior Court this month,
Dr. Robert Lindeman, aka "Flea"defending himself in a malpractice suit involving the death of a 12-year-old patient, the opposing counsel startled him with a question. Was Lindeman Flea? Flea, jurors in the case didn't know, was the screen name for a blogger who had written often and at length about a trial remarkably similar to the one that was going on in the courtroom that day. In his blog, Flea had ridiculed the plaintiff's case and the plaintiff's lawyer. He had revealed the defense strategy. He had accused members of the jury of dozing. With the jury looking on in puzzlement, Lindeman admitted that he was, in fact, Flea.

In the Creation Museum, it is all by the Book.

The 60,000-square-foot Creation Museum, which opened this week on 49 acres of lush Kentucky countryside, is the work of Answers in Genesis, a leader in the "young Earth" creationist movement. Unlike proponents of intelligent design -- who question aspects of evolutionary theory but may accept that the universe is billions of years old -- members of "young Earth" groups insist that the Book of Genesis is an accurate historical record.

Evan O'Dorney, winner of the BeeAnd finally, did you watch the National Spelling Bee on television? Medical words were the “makers and breakers” of the contest. Nate Gartke, an eighth-grader from Edmonton, Alberta, misspelled coryza, a word for the common cold – he added an “h” at the end. Evan O'Dorney, a home-schooled 13 year old from Danville, California correctly spelled serrefine, small forceps for clamping a blood vessel.

Pat Salber, MD

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