Tag Archives: goozner

Potential changes in regulation of medical devices would likely impact health care costs

As the medical device industry ramps up its campaign against further government regulation, Merrill Goozner takes stock of the regulatory and business environment in that arena and explains what is at stake. The key battleground at present is possible modifications to the 1976 law which allows devices to bypass some rigorous testing as long as they’re similar to something that has already been approved for market. The problem? That similarity doesn’t always mean they’re safe, as Goozner points out.


Photo by AlishaV via Flickr

A study published earlier this year in Archives of Internal Medicine found that of 113 major product recalls between 2005 and 2009, only 19 percent had gone through the more rigorous clinical trial testing required for new products, while 71 percent had used the follow-on process. There had been only 49 major recalls in the prior five years.

Despite slipping onto market through the similarity provision, many of these new products claim to be improvements over their predecessors and thus come with commensurately higher price tags. According to Goozner and his sources, this little disconnect has done quite a bit to increase the cost of health care in America.

“Requiring evidence of benefit of effectiveness for patients before device approval would prevent billions of dollars from being spent on technologies that are not helpful for patients and are even harmful,” said Rita Redberg, editor of the Archives of Internal Medicine and a cardiologist at the University of California, San Francisco. “There are many examples, such as vertebroplasty and kyphoplasty for back pain [compression fractures], on which Medicare spends approximately $1 billion annually. After they were FDA-approved, randomized clinical trials showed they were no more effective than a sham procedure in relieving symptoms.”

The device industry, often cited for its red-hot growth rates in the past, now posts numbers that, while huge, still lag behind the health sector at large. That may be why the industry is stepping up political pressure to reduce its regulatory burden and to sidestep a 2.3 percent excise tax that was passed as part of recent health care reform efforts. For more on the money and politics involved, see Goozner’s full piece, which was also published in The Fiscal Times.


Everyone reacts to Avandia roller coaster

First, the background: Avandia, also known as rosiglitazone, is an anti-diabetes drug that helps patients control their blood sugar. It made billions of dollars for GlaxoSmithKline until it became associated with higher risks for cardiovascular issues. On Sept. 23, the FDA and European regulators issued their verdicts on the drug. In America, it will still be available, though with much stronger restrictions than before. In the European Union, regulators are looking to stop sales entirely and steer patients toward alternatives.

If you’re looking for the official lines and basic news, start with CardioBrief, where Larry Husten recapped a few of the highlights and then provided each agency’s press release, as well as the official take of Avandia maker GlaxoSmithKline.

Then, it’s time for the reactions. On the NPR health blog, Richard Knox examined the dueling story lines that have emerged since yesterday’s announcements. This larger framework makes all subsequent reactions a little easier to contextualize.

Speaking of other reactions, The Hill‘s health blogger, Julian Pecquet, rounded up the thoughts of some Washington heavy hitters involved in the Avandia debate, from the omnipresent Sen. Max Baucus to the consumer group Public Citizen. Another key player, cardiologist and Avandia critic Steven Nissen, spoke to The Wall Street Journal‘s Alicia Mundy.

In terms of the big regulatory picture, Avandia is the 30th drug which has been restricted under the FDA’s risk evaluation and mitigation strategy provisions since they began in 2007. Merril Goozner says that the FDA has created a new class of drugs. “They are not exactly safe, but not so dangerous that we would deny them to physicians or patients who really want to have them,” he wrote. Five years ago, he said, Avandia would have been pulled from the market. Now, it just gets restricted. It remains to be see how effective those restrictions really are.

Finally, Pharmalot’s Ed Silverman brings us the thoughts of cardiologist and Yale professor Harlan Krumholz, who you might remember from his recent star turn in Forbes. His take emphasized a principle well-known to health journalists: Marketing matters, and often it matters even more than regulation does.

“The company has announced it will no longer promote the drug,” Krumholz wrote, “and the practical result in Europe and the US may be a lot more similar than the decisions at first appear. Usage will stop in Europe and new use should virtually stop here.”

That said, Krumholz raises some interesting questions, any one of which could form the basis of a follow-up story or two. I’ll paraphrase:

  • A long series of fortunate coincidences lined up to produce the evidence that led to Avandia’s delayed near-demise, which begs the question: Why are we relying on luck when it comes to spotting danger in major pharmaceutical products?
  • “Why does the FDA believe that the barriers to prescription in new users should be stronger than those for current users? There are no studies that indicate that the excess risk dissipates over time.”
  • Will the FDA really be able to effectively implement the regulations and guide physician/patient behavior, especially when it comes to a blockbuster such as Avandia?
  • Have we done anything to prevent the next Avandia? How do we even go about doing that?

Update: The European Association for the Study of Diabetes weighs in

Medical groups voluntarily tighten ethics rules

Writing for NPR’s health blog, Maggie Mertens reports that while recently passed reform legislation includes the “Physician Payments Sunshine Act” (PDF) that will require companies to report any payments or gifts to physicians over $10 in value starting in 2012 (and reported and made available in a public database in 2013), some groups are getting a jump on the rules and voluntarily tightening their own conflict of interest policies.

Take, for instance, the recent decision by a bunch of medical specialty groups to stop taking industry money when coming up with guidelines for treatment. The Council of Medical Specialty Sciences, representing groups like the American College of Physicians, the American College of Cardiology and the American Society of Clinical Oncology, unveiled new rules on conflicts of interest last week. Thirteen of the member groups have adopted them so far, with the others saying they aren’t far behind. The rules also require that all funding from pharmaceutical and device-making companies to board members or groups will be publicly disclosed. Swag at medical conferences becomes a no-no, although big drugmakers had said a few years back they were going to stop the giveaways of medicine-branded pens, logoed tote bags and that sort of thing anyway.

For a discussion of the challenges reporters face when investigating conflicts of interest, read Elizabeth Bahm’s AHCJ article about a related panel at the recent Health Journalism 2010 conference, and this related article by John Fauber.

Deconstructing a NYT op-ed in three acts

On April 17, New York Times‘ op-ed columnist Thomas Friedman wrote a column about globalization, international competition and entrepreneurship. Here, as anyone who has even held a newspaper with his column in it will know, he’s on all too familiar territory. It’s not until he steps over into uncritical praise of a medical device maker that Friedman starts stepping on land mines.

He profiles EndoStim, a company working on an implant to treat acid reflux. Friedman admits that he has “no idea if the product will succeed in the marketplace,” then the cheerleading begins.

EndoStim was inspired by Cuban and Indian immigrants to America and funded by St. Louis venture capitalists. Its prototype is being manufactured in Uruguay, with the help of Israeli engineers and constant feedback from doctors in India and Chile. Oh, and the C.E.O. is a South African, who was educated at the Sorbonne, but lives in Missouri and California, and his head office is basically a BlackBerry. While rescuing General Motors will save some old jobs, only by spawning thousands of EndoStims — thousands — will we generate the kind of good new jobs to keep raising our standard of living.

Photo by Roadsidepictures via Flickr

Journalist Merrill Goozner, of GoozNews fame, picked up on the story the next day and asked the world “Why Is Tom Friedman Championing Higher Health Care Costs?” Goozner effortlessly chronicles the marketing-driven history of acid reflux treatments, from Pepto-Bismol to Zantac to Prilosec to Nexium, each conveniently emerging as the patent to their predecessor expired, then puts EndoStim in its place at the end of the chain.

… instead of finally being out from beneath the wasted billions now being spent on brand name acid indigestion pills like Nexium, the health care system will be lined up to move onto the next chapter in the lengthening medical text for treating what for most people is a relatively minor and passing phenomenon.

In his final paragraph, Goozner gets to the heart of what Friedman’s vision of “thousands of EndoStims” really means for the U.S. economy.

Friedman is right. Endostim’s success will create “the best jobs – top management, marketing, design” at company headquarters. But let’s not forget that to create those jobs, the entire society through its collective health care system will have to pay an unnecessary tax, which burdens every other industry and shifts scarce societal resources away from potentially more useful activities.

Finally, Trudy Lieberman, AHCJ immediate past president, catches Goozner’s post and wades into the fray in her own column on cjr.org, writing that Friedman’s column was “essentially a puff piece for EndoStim.” Lieberman ties Goozner’s observations on EndoStim into his previous writings as well as her own, writing “there’s nothing in the new law that limits the use of the device only to patients with chronic disease who don’t respond to other, less costly treatments.”

I can see hospitals advertising: “Hey acid reflux sufferers come to us. Our surgeons know how to get that thing down your gut. They are the best in the world, and by the way, insurance will pay.”

CSPI shuts down Integrity in Science Watch

The ongoing economic crunch has claimed yet another casualty – the Integrity in Science Watch program that was run by the Center for Science in the Public Interest. The nonprofit organization, which is based in Washington, D.C., last week closed the effort due to a lack of funding, according to a CSPI spokesman.

ISW was a valuable source of weekly information that spotlighted the various conflicts of interest in science and medicine that are found in government agencies, academia, hospitals and industry. The digest, which was overseen by AHCJ member Merrill Goozner, a former journalist for the Chicago Tribune, aimed to highlight examples that the media may have missed and regularly follow up pertinent examples that faded from public view.

The ISW project was launched nearly three years ago as a way of publicizing conflicts, highlighting attention to the issue, and “casting an investigative eye on stories that had not yet hit the public eye,” says Goozner, who is contemplating transferring the effort to his weekly blog about health topics called GoozNews. “I think the Integrity in Science project at CSPI helped raise the profile of the conflict of interest in science in general, and in medicine in particular.”

What was he proud of pursuing? Analyzing the prevalence of  failures to disclose conflicts in medical literature (2004); helping The New York Times unmask conflicts on the 2005 FDA advisory panel that evaluated Vioxx after the drug was withdrawn; lobbying for a ban on conflicts of interest on FDA advisory committees through the House (which failed in the Senate but obtaied greater disclosure of waivers and a two-week advance notice provision as a compromise – 2006); put that into law (2007).