Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Monday, August 24, 2015

Medical Implants are SEXY (and profitable)! FDA and Bad Ads.

By Sabriya Rice  | August 19, 2015
Since it launched in 2010, the U.S. Food and Drug Administration's “Bad Ad” campaign has received hundreds of complaints about potentially misleading or imbalanced drug advertisements.

Most recently it condemned a series of social media posts by reality TV star Kim Kardashian, in which she raved about relieving morning sickness with a pill she endorses.

But while drug marketing is subject to “Bad Ad” oversight, watchdog groups, clinicians and policy leaders say there's far less scrutiny for medical devices and other health services.

Modern Healthcare recently spotted an ad on the back of a bus in downtown Chicago that could be a good example.

“Diets don't work, get a lap band,” is the message from Dr. Fredrick Tiesenga, a surgeon with the Elmwood Park, Ill.-based weight-loss surgical center, New Hope.

Tiesenga supports the claims. Diets have about a 5% success rate for morbidly obese people, he said. “That's the same as the number of people who think Elvis is still alive. It's not really evidenced-based medicine to continue to send those people to dietitians.”

Though Tiesenga says the ad is intended for people with extremely high body mass indexes who have tried and failed multiple diets, others say the average observer wouldn't know that just by looking at the ad.

“It's misleading. He's making a definitive statement that diets don't work, which we know is not true. And it doesn't include any qualifiers,” said Dr. Bruce Lee, director of the Global Obesity Prevention Center in the Johns Hopkins School of Public Health.

Behavioral modifications, including dietary changes, are a major part of success after bariatric procedures, which cost, on average, between $20,000 and $25,000 in the U.S.

The worry is that those who are struggling with weight loss, upon seeing a message such as that might feel validated to ditch the diet, thinking they can eventually opt for surgery. “It's a very strong statement,” Lee said. “When I see an ad like that, I'm concerned about what the impact might be.”

Experts say misleading health information can be propagated as federal agencies continue to struggle with both the ability to monitor the deluge of ads and identify what counts as an advertisement.

The issue is not only complicated for federal regulators, but also for patients, said Dr. Yael Schenker, an assistant professor of medicine at the University of Pittsburgh. She coauthored a 2014 report in the American Journal of Bioethics that evaluated the ethics of advertising healthcare services.

“It's hard for people to figure out what is truthful,” she said. “It's very easy to mislead the public about something like healthcare where there is an imbalance in terms of access to information.”

To date, the FDA has received nearly 800 complaints through its Bad Ad campaign. It did not say specifically how many of those complaints ended in warning letters or corrective actions such as civil monetary penalties, injunctions and referrals for criminal investigation.

An FDA spokesperson said: "We don't track this metric, as the goal of the program is to raise awareness of misleading advertising and not to increase enforcement actions."

The FDA says complaints about medical devices are forwarded to the Center for Devices and Radiological Health, which enforces violations against federal ad regulations. The Federal Trade Commission may also take actions separately based upon its own jurisdiction.

But the article last year from Schenker and colleagues urged that without consistent oversight and standards, ads for general healthcare services continue to play on emotional, fear-evoking appeals that don't provide specific information about risks, benefits and costs.

Developing and enforcing new standards will not be easy, but the current health environment contributes to “an incoherent status quo,” they said, one where the industry is working to create high-quality medical systems while competing with marketing messages that might encourage patients to seek unnecessary care and dump clinicians who refuse to give it to them.

“We have to accept that advertisements are intended to be persuasive and are never going to present a complete or exhaustive list of risks or benefits,” Schenker said. “But there needs to be a unique set of criteria and oversight that is different from cars or cereal and other run-of-the-mill consumer products.”

For Michael Carome, director of the Health Research Group at the watchdog organization Public Citizen, the differences in advertising reflect a broader concern about pre-market FDA approvals, which are also different for drugs and devices. “The standards are much lower for devices than for drugs,” he said. “That dichotomy extends to advertising provisions.”

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