FDA in Bed with Bogus Non-Profit

Merrill Goozner, editor of GoozNews, broke this story first in Integrity in Science Watch, published by the Center for Science in the Public Interest, and then reported it on GoozNews.

The post deserves maximum exposure because it illustrates just how underhanded the FDA has become in recent years—while posing as a regulatory agency.

It seems that the Food and Drug Administration turned to “a non-profit run by a pharmaceutical industry advertising consultant to help design its new campaign to educate consumers about direct-to-consumer drug advertising. The FDA’s recently launched website, “Be Smart About Prescription Drug Advertising: A Guide for Consumers,” was developed by EthicAd, a non-profit run by Michael Shaw out of the offices of Atlanta-based Shaw Science Partners. Shaw’s firm claims credit for having helped launch over 25 pharmaceuticals, including Viagra, Celebrex, Zoloft, Cymbalta, and Rezulin, which was later withdrawn from the market because of safety concerns.”

Goozner points out that the site, “which claims DTC ads ‘can provide useful information to consumers,’ focuses its home page on examples of legally correct and incorrect ads—information more useful to ad designers who want to avoid running afoul of FDA regulations than to consumers. It does invite consumers to report violations of the law to the FDA’s division of Drug Marketing, Advertising and Communication.

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AHLTA: Textbook Bush Administration

In February 2007, William Winkenwerder Jr. announced he was stepping down from his post as assistant secretary of defense for health affairs following a press conference in which he downplayed the Walter Reed scandal as a mere "quality-of-life experience." In the months that followed, it seemed clear that Winkenwerder’s negligence may have been partly to blame for the deplorable conditions at the military hospital.

Now, more than a year and half after his departure, Winkenwerder’s legacy lives on in a multibillion-dollar Defense Department electronic medical-records (EMR) system that many military doctors believe is fatally flawed. One military physician, speaking anonymously, calls it "another Walter Reed-type scandal."

And now, as I noted in a piece that Mother Jones magazine posted this morning, it turns out that the Defense Department’s foray into the world of healthcare IT, a system dubbed AHLTA, is going to cost taxpayers somewhere in the realm of $20 billion—four times what the government had originally budgeted.

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Over the past few months I’ve twice posted about AHLTA, the poorly-designed, unreliable, and costly EMR system that the Department of Defense introduced in November 2005.  In my first post on the issue in June, I noted that one fundamental problem with AHLTA is that it shouldn’t exist: in contracting with an IT firm called Integic to develop the AHLTA software, the Defense Department has actively ignored the Veterans Administration’s successful VistA system as a promising option for building up the military’s EMR capacity.

Last month, my second post focused on the unhappy military clinicians who are forced to use AHLTA  to manage their patient records. Over the summer, the DoD held an online town hall to collect the comments and thoughts of military doctors on AHLTA, and the response was overwhelmingly negative. Participants said that they were “completely disappointed” with AHLTA, and that the system is “a debacle,” too slow and unreliable to be anything besides an “impediment to…seeing patients in an expeditious manner.” The message of the town hall was crystal clear: the Defense Department had spent over $5 billion in taxpayer money to develop an EMR system that its own doctors don’t want to use. 

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Barriers to Access: Medical School

At “Number Needed to Treat,” Josh, a public health expert and blogger, provides a welcome addition to my recent post on med school tuition http://numberneededtotreat.wordpress.com/2008/09/09/how-about-the-cost-of-applying-to-medical-school/

I wrote about how the cost of med school narrows the pool of applicants. Josh explains that even the copy of applying is well beyond what many students (and their families) can afford.

Josh writes:

“What struck me about Mahar’s discussion of the subject was a quote at the end of her article:

“According to the NEJM, a recent national survey of under-represented students reveals that the cost of attending medical school was the number-one reason they did not apply.

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Why Does It Cost So Much To Educate A Med Student?

       The post below,  "Free Tuition For Medical Students?"  (Sept. 9),  began a dicussion on the
"comments" thread about why med school education is so very expensive.

       Wouldn’t it be cheaper if students did more of their learning online?  Don’t they take a great many courses that ultimatley will be of little help in their chosen specialty?

       If you’re interested in my answer, see the reply I posted today, addressed to Barry and Red Baron at the top of the "comments" thread.

Palliative Care and Hospitals’ Bottom Line

If there are such things as universal truths, then one of them is almost certainly this: nobody likes to be in pain (okay, maybe masochists). This simple assumption is the key principle behind palliative care, which focuses on reducing the severity of pain and managing symptoms of patients with advanced illness—instead of relentlessly concentrating on trying to cure a condition. As many have put it before, palliative care is about caring, not curing—helping patients feel better, sometimes through medication and sometimes through communication and personal support.

Palliative care seems like a practice that would be somewhat at odds with American-style medicine, which centers on maxing out detection efforts and treatment interventions. The reasons for this tendency are two-fold: in our warped reimbursement system, doctors get paid more to do more procedures, and our medical culture is very much focused on ‘beating’ sickness instead of treating people.

Yet palliative care has been on the upswing in American medicine over the past few years. According to the American Hospital Association, as of 2005, 30 percent of U.S. hospitals and 70 percent of hospitals with more than 250 beds had a palliative care program—an increase of 96 percent from 2000. What’s behind this surge?

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Sarah Palin, The Free Market, and Certificate of Need Laws

A few days ago over at The Health Care Blog, Robert Laszewski posted a list of Sarah Palin’s health care priorities while serving  as governor of Alaska. Number one on her list was the repeal of certificate of need (CON) laws in the state. Such laws give state planning agencies the final say in approving the construction and development of a new hospital, nursing home, or medical service center. Simply put, in the 36 states currently regulated under CON laws, nobody can build a hospital or introduce a new hi-tech device such as magnetic resonance imaging (MRI) scanners without first getting government approval.

This approval is based on “need” and “quality assurance.” Basically, the planning board asks whether a given community could benefit from a service or facility and if those services can be delivered effectively over time. In theory, the main goal of such a vetting of facilities is to reduce health care costs: by regulating the supply of health care in a given region, CON regulations are meant to limit the proliferation of expensive, medically unnecessary services. 

On paper, CON regulations sound exactly like the sort of policy that we at Health Beat have been advocating for a while now: one that realizes an all-you-can-eat buffet of health care options drives up costs without improving quality. Yet CON regulations haven’t been as successful as supporters hoped—not just by the ideological standards of free-marketeers, but also in terms of empirical impact. Why is this so?

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How Do You Help Critically Ill Children—and Their Parents?

Imagine being a pediatrician who treats only very, very sick children.  Many will live; and many will die. And as a physician you realize that, while you can help, you do not decide.  No matter how brilliant you are, your tools are limited.  Despite the arsenal of medical technology at your disposal, in many cases you are forced to recognize that medicine is still an infant science. Often, you must rely on intuition– barely articulate knowledge that comes with long experience.   And, even then, sometimes you won’t be able to save your patient –a child who hasn’t yet had a chance to live.

I can’t imagine a harder row to hoe—except to be the parent of a child in a Pediatric Intensive Care Unit (PICU).

In Your Critically Ill Child: Life and Death Choices Parents Must Face, Dr. Christopher Johnson, co-founder of the Mayo Clinic’s PICU  in Rochester, Minnesota manages to address both audiences: parents and physicians.

Ostensibly, the book is aimed at parents. But I would urge any doctor who treats seriously ill or injured children to read it.  Johnson, who has practiced pediatric intensive care for twenty-five years, offers a window on the parents’ world, and essential advice on how to collaborate with them.

The first tale focuses on Robert, a healthy five-year-old who suddenly and mysteriously lapses into a disoriented and ultimately hallucinatory state.  “By the time he arrived at the PICU he was agitated and combative. He could not recognize his mother. By that afternoon, he was developing all the signs of fast developing acute liver failure. “

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Free Tuition for Medical Students?

Always a trailblazer, The Mayo Clinic’s Medical School has had a generous scholarship program for the past 20 years that enables about 60 percent of its students to attend school tuition-free. The 50 students who started at Mayo last summer each received $25,000 to use towards tuition of $29,200. Students also are eligible to receive an additional $2,000 to $5,000 a year based on need, said David Dahlen, director of student financial aid at Mayo, based in Rochester, Minn.

Now, a few other schools are experimenting with much-needed financial relief for medical students. Most notably, the University of Central Florida’s brand new med school is offering four-year scholarships for tuition, fees and living expenses for every member of first-year class.  Students have until December to apply; already, the school has received 2,996 applications for its charter class of 40.

The Wall Street Journal reports that the $7 million needed to fund the charter class came from individuals and private philanthropies. There was no single donor who did most of the work; the two largest gifts were each a bit over $300,000. Perhaps other medical schools could follow this model.

The bad news is that this first class is the only one that will receive such a sweet deal. There will be some scholarships for students in subsequent classes, but essentially the University of Central Florida is using the financial packages to attract a top entering class, hoping that this will set the pace for the school’s future.

Mayo, of course, doesn’t need to offer financial enticements to draw the best students. It is simply part of the school’s “philosophy that your qualifications, motivation and commitment to service–rather than finances–should guide your decision to apply to medical school.” 

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Correction

Somehow, when describing the posts that Health Wonk Review highlighted as the best healthcare posts of the last two weeks, I managed to point to the wrong post on Roy Poses Health Care Renewal.


Poses is always on the news—and digging deeper. In this post he begins by giving you the background to the story: “in 1989, the U.S. Department of Justice tried but failed to prevent a merger between nonprofit Carilion Health System and the  former railroad town’s other hospital. The merger, it warned in an unsuccessful antitrust lawsuit, would create a monopoly over medical care in the area.

“After the 1989 merger, Carilion continued to operate Roanoke’s two hospitals separately,” Poses explains. “It later consolidated the hospital boards and in 2006, transferred most of Roanoke Community Hospital’s staff and services to a renovated and enlarged Roanoke Memorial Hospital.

“The moves eliminated any hospital competition in Roanoke proper….

“[Carilion CEO Dr Murphy] was convinced that the cost and quality of care in Roanoke could be improved if doctors worked in a more centralized system. In June 2006, he announced a seven-year, $100 million plan to transform Carilion into a multispecialty clinic, like the Mayo Clinic.

“Carilion began approaching private physician groups, offering to buy their practices and pay their salaries.”

Poses then goes on to look at what effect Dr. Murphy’s advocacy of more centralization had. See the full post here. 

Health Wonk Review Is Up

You’ll find Health Wonk Review, a compendium of some of the best healthcare posts of the past two weeks here.

Not surprisingly, some bloggers have taken on John Goodman, president of the National Center for Policy Analysis, for suggesting that the Census Bureau’s report on the number of uninsured this country is wrong. Goodman claims that anyone with access to an emergency room effectively has insurance, albeit the government acts as the payer of last resort.(Note: the National Center of Policy Analysis is a right-leaning think tank and Goodman helped craft Senator McCain’s health care policy.)

"So I have a solution. And it will cost not one thin dime," Mr. Goodman added: "The next president of the United States should sign an executive order requiring the Census Bureau to cease and desist from describing any American – even illegal aliens – as uninsured.

The Health Care Blog’s Matthew Holt suggests that Goodman must be joking. “Or,”Holt asks, “is he just mean?”

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