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.
Related
- Medical device investigation unearths conflicts, regulatory issues
- House Committee on Oversight and Government Reform hearing: FDA Medical Device Approval: Is There a Better Way?, June 2, 2011
Medical device investigation unearths conflicts, regulatory issues
Filed under: Health journalism, Hot Health Headline, Public health, Public records, Studies
The latest investigation from the Chicago Tribune’s Jason Grotto and Deborah L. Shelton focuses on a single medical device, yet still hits many of the health beat’s biggest narratives, primarily conflicts of interest and government regulation. In their centerpiece, they dig into the tale of a cardiologist who may or may not have tested a device he invented on patients without consent or regulatory approval. It’s in those gray areas that the story takes shape.
The device in question is an annuloplasty ring, which in 2001 was reclassified from class III to class II. In practical medical device terms, this means that new models don’t need clinical trials if they’re similar enough to devices that have already been approved. The reporters write that the rings earned this change of status in part because of the relatively low number of adverse events reported between 1991 and 1995 (465). Unfortunately, as their use has increased, so have the events.
Now that you have some idea of what they were up against, here’s a healthy excerpt from their “how we did it” sidebar, which is almost always Covering Health’s favorite part of a major investigative package.
The first hurdle in stories like these is understanding the medical science behind the device in question, which required us to gather up dozens of studies and reports on annuloplasty rings and the heart valve disease the device is intended to cure. We sifted through government documents and researched regulations as well as the history of the rings.
But writing about heart valve repair rings involves more than researching a disease and a device.
We also spent a lot of time with the patients in our stories because there is a level of trust that must be built up before people are willing to share personal information about their health. The same goes for Northwestern Memorial Hospital and surgeon, Dr. Patrick McCarthy.
We had to assure each of them that their viewpoint would be reflected in the stories. It’s a difficult balancing act that we tried to buttress with reams of documents, studies and interviews with independent sources.
For more on how Grotto and Shelton reported the story, watch for a “How we did it” article on the AHCJ website in the next couple of weeks.
If the issue sounds familiar, the storyline is similar to a 2005 investigation from The Wall Street Journal’s David Armstrong, which found a partnership between the Cleveland Clinic – and some prominent staff members – and companies manufacturing devices used in clinical trials there.
Skyrocketing drug price is chance to examine manufacturing, FDA approval process
St. Louis Post-Dispatch reporter (and Midwest Health Journalism Program Fellow) Jim Doyle has put together a series of stories on KV Pharmaceuticals that read like a primer on the confounding economics of drug manufacture and FDA approval. In the stories, especially the first and last installments, Doyle presents the big picture and helps readers understand why the systems work they way they do.
The first story shows how FDA approval could end up sending the price of a prenatal drug skyrocketing 16-fold and earn piles of money for a local pharmaceutical company. The second involves a U.S. District judge condemning a former head of that same company for “greed, abuse of power, recklessness.” Finally, he ends his tour of pharmaceutical avarice with a stern warning about the potential longterm costs, both monetary and medical, that could result from the fast-track approval of the drug whose approval formed the basis of the first story. For lots more about KV Pharmaceuticals, be sure to check the “Related Reading” box on this page.
Further reading
If you’re looking for more on KV Pharmaceuticals and the Orphan Drug Act, check out Ed Silverman’s post on Pharmalot. There, he interviews a nonprofit advocate who helps explain how KV’s manipulations were possible, how it could happen again and how the act should be modified.
Fauber: FDA to review data on jaw implants
Filed under: Government, Health journalism, Health policy, Hot Health Headline
The Milwaukee Journal Sentinel’s reporter John Fauber reports on the FDA’s order to review the long-term performance of certain joint implants. Fauber’s story on the agency’s failure to adequately test and regulate these products came out in late November.
Photo by Jacob Enos via Flickr
The implants in question treat certain ailments affecting the joint that connects jaw and head, a disorder Fauber says “affects more than 10 million Americans, including a small number who undergo radical surgery to implant an artificial jaw joint.” And those people, Fauber reported and the FDA now acknowledges, have had a rough time in the long term.
Among the medical device reports it has reviewed, 52% of the devices that had to be removed were taken out less than three years after they were implanted, the agency said in an e-mail to the Journal Sentinel.
Device problems included the need for removal or replacement, loosening, difficulty removing, noise, fracture and breaking, the FDA said.
Patient problems included pain, surgical procedure or repeat surgical procedure, additional therapy and nonsurgical treatment or treatment with medication, infection, swelling, hospitalization and headache, it said.
At this point, the FDA isn’t talking about taking the devices off the market, but it is reviewing the existing data and beefing up its repeated requests that device makers supply long-term market data about the implants they’ve sold.
Beginning in 1999, the FDA approved four such devices made by three companies. At the time of approval it ordered the firms to collect the market data it now is reordering.
That data was inadequate, the agency said, noting that it did not show why or how soon the devices were being replaced. In addition, the companies had lost contact with many of the patients who had received the devices.
Without knowing that information, the agency cannot determine the true safety and effectiveness of the products or whether any of them should be removed from the market.
Diana Zuckerman, president of the National Research Center for Women & Families, credited Fauber’s reports in the Journal Sentinel and MedPage Today, a medical news website that partners with the newspaper, with prompting the FDA’s action.
Flawed approval process led to flawed jaw implants
Filed under: Conflicts of interest, Hot Health Headline
In the Milwaukee Journal Sentinel, reporter John Fauber proves that it’s possible to do cutting-edge reporting on conflicts of interest and tie those conflicts to clinical trials of devices that hit the market a few decades ago.
His targets? Jaw joint devices that were initially grandfathered in, and for which newer treatments were approved in the late ’90s and early 2000’s. These trials, Fauber found, were too small, too conflicted and too inconclusive to provide real data, yet the devices were approved anyway. Now, he has found, patients are paying the price.
I’ll just include the first sentence here, as I’m confident that nobody will be able to resist reading the rest of Fauber’s story.
Before implanting a third artificial jaw joint in Heidi Clark’s head, doctors had to remove particles of plastic from the second failed joint that had broken apart and become embedded in muscle.
FDA, device makers, patient advocates lock horns
Filed under: Government, Health data, Health policy
In MedPage Today, Joyce Frieden breaks down the FDA’s day-long town hall meeting that brought together device makers, federal officials and patient advocates last week. Frieden’s report points to more contention than consensus, with the debate crystallizing around a few key issues, most of them related to the FDA’s device approval process.
Predictably, the device makers’ griped about the FDA approval process, one which patient advocates say is lacking in clinical trials, especially long-term ones.
“The overall tone is that the predictability and certainty of our interactions with the FDA are worsening,” Paul LaViolette, venture partner at SV Life Sciences, said at the session, which was part of the Transcatheter Cardiovascular Therapeutics meeting. “Where is the problem? It’s at the review level.”
LaViolette, who is also a member of the board of directors of AdvaMed, a trade group for the medical device industry, said he had “a sense that turnover at the reviewer level is intensifying. Companies report that four out of every 10 submissions experience turnover at the reviewer level. So we have reviewers that are less confident in making a decision, and more meetings are required.”
The FDA blames the slowing approval process in part to the increased reliance on clinical trials conducted outside the U.S., which introduces a swarm of additional variables which regulators must take into account. The recession and an accompanying blow to the venture capital supply and investor confidence also helped reduce the number of devices approved, an industry representative said.
Other topics of discussion included the industry’s request that the FDA’s approval for use and CMS’ approval for Medicare reimbursement be “harmonized,” as well as the FDA’s request that industry look into ways to increase minority patient participation in clinical trials, which is disproportionately low at present.
FDA site tracks post-approval drug dangers
Thanks to new requirements, the FDA is now publishing updates on its safety evaluations of drugs that are already on the market. The evaluations get posted after the drug has been on the market for 18 months, or after 10,000 people have used it. It only includes drugs approved since Sept. 27, 2007.
The site also includes a full list of those drugs flagged by the FDA for various reasons, including ongoing safety alerts. Simply click on any drug in the list to find out what problems were identified and what action has been taken.
(Hat tip to The Plain Dealer’s Diane Suchetka)
FDA to regulate health information technology?
Fred Schulte and Emma Schwartz, the Huffington Post Investigative Fund duo who have made it their business to stay in front of all stories related to the federal push for the adoption of health information technology, now look at the possibility of federal regulation of health IT.
Schulte and Schwartz write that “In the past two years, the agency has received reports of six patient deaths and several dozen injuries linked to malfunctions in the systems,” and officials say those voluntary reports represent just the tip of the iceberg. In case you’re interested, here are the transcripts from the relevant government hearing.
… digital medical systems are not risk-free. Over the past two years, the FDA’s voluntary notification system logged a total of 260 reports of “malfunctions with the potential for patient harm,” including 44 injuries and the six deaths. Among other things the systems have mixed up patients, put test results in the wrong person’s file and lost vital medical information.
Schulte and Scwartz summarize the three possible regulatory approaches outlined by officials:
- Option 1: FDA requires HIT makers to register, submit safety reports and correct problems.
- Option 2: FDA requires HIT makers to report safety concerns and sets minimum quality guidelines.
- Option 3: FDA makes HIT “subject to the broader regulatory actions that new medical products must face before they ever reach the market.”
Many manufacturers argue that such regulation could be counterproductive.
The manufacturers of the systems generally have opposed regulation by the FDA, arguing in part that imposing strict controls would slow down the government’s campaign to spur widespread adoption of the technology.
Regulation will not necessarily create a “safer” electronic medical record “and might actually limit innovation and responsiveness when it is needed most,” Carl Dvorak, executive vice president of Epic Systems Corporation, a Wisconsin-based company that builds the systems mainly for hospitals and large medical practices, said in his prepared testimony for Thursday’s hearing. The hearing is being held by an advisory group created by the stimulus law.
Government Health IT also is following the issue and points to some problems the Veterans Health Administration has run into and how it dealt with the lapses.
FDA warns against promoting unapproved drugs
Filed under: Health journalism, Hot Health Headline
The New York Times‘ Natasha Singer looked into the FDA’s recent warning of prominent cosmetic doctor Leslie Baumann (bio) for the promotion of an unapproved drug, based on comments she made about Botox-like Dysport (she was an investigator in a trial of the treatment) in outlets such as Allure, Elle and the Today Show. Singer also considered the chilling effect this warning might have on other clinical investigators upon which the media has traditionally relied.
Now, some industry experts say the F.D.A. warning may curb the media enthusiasm of certain cosmetic doctors who until now have provided scoops about coming medical products — or have talked up the latest unapproved cosmetic uses for drugs and devices that the agency had approved only for other purposes.
“It’s a wake-up call,” said Nancy Behrman, owner of Behrman Communications, a public relations firm in Manhattan. Her firm has represented cosmetic medical companies as well as doctors. “The whole business has spiraled out of control, and we need to step back and slow it down.”
FDA representatives say that there’s a line between scientific discussion and drug promotion, and that investigators are welcome to talk to the media as long as they don’t cross it.
Thomas W. Abrams, director of the agency’s Division of Drug Marketing, Advertising and Communications, said that investigators were free to have scientific conversations about investigational drugs with their peers and with journalists. But an investigator should not promote any unapproved prescription drug — or an unapproved use of an already approved drug — as being safe or effective if the agency has not yet deemed it to be so, he said.
Singer also talks to another of the media’s favorite doctors, dermatologist Fredric S. Brandt, who said that, in future discussions with media he would take care to offer only scientific facts on unapproved drugs, and leave his opinions and recommendations out of the discussion.
FDA approval causes drug price to skyrocket
In a collaboration between The Philadelphia Inquirer and Kaiser Health News, Harris Meyer looks at the case of colchicine, a drug used to treat gout that has been on the market so long that it predates the FDA approval process, and thus had never been approved. 
Like thousands of drugs it existed in a sort of grandfathered generic state. That ended in 2009 when URL Pharma earned FDA approval for a branded version of the drug, which it sells for 50 times more per pill than the generic.
The drug company convinced the FDA that its version was safer than the generic, a claim disputed by many physicians. Now, Meyer reports, it’s likely that the generic colchicine will be forced from the market over the coming months, driving customers of the centuries-old drug (a natural version was first mentioned by the ancient Greeks) into the arms of URL Pharma. According to Meyer, the case is just one of several that have resulted from post-2006 FDA efforts to gain control and approval over all those grandfathered-in unregulated drugs.
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