FDA investigates liver injury claims from weight-loss medication users
NEW YORK This agency pulls no punches. The merest blip of a post-marketing serious adverse event report, and the agency is acting sooner than later. Because when you get right down to it, out of all the prescriptions for Xenical (approved for sale April 1999), out of all the people who have tried Alli when the ingredient orlistat was switched over the counter (in February 2007), there have been as many adverse events reported in the United States around orlistat and liver injury as there have been Boston Red Sox championships in the past 70 years: two.
That may be cause for concern. Because it taints the use of a product already approved for sale over-the-counter (and prescription-only in the case of Xenical) with a broad brush labeled “safety concern.” And with so few serious adverse event reports, that may be an unfair label causing some consumers who could benefit from the use of a product like alli not to try the product at all. And if these types of announcements become common, with so few serious adverse events to justify them, it could have the effect of making a public numb to any announced safety concerns.
Taking the other side, why might this be a good thing?
First, there is no actual recall here. Rather it’s a frank communication that a possible danger flag around the use of a product regulated by the FDA may be raised. And while this may certainly place the respective healthcare manufacturers on the defensive, it’s an indicator that the agency will aggressively live up to its mission statement — the protection of the American public.
There have been a host of criticisms around the agency’s ability to deliver on that promise leading up to this year. Contaminated prescription blood thinners and contaminated peanut butter are only the most recent examples of an agency with a somewhat tarnished safety reputation.
It’s good because actions such as these restore faith in the reputation of what is still considered the premier healthcare regulator in the world. And that’s important for all of the healthcare and food products around which there is no (or at least practically nonexistent) safety concern.
The challenge for those companies being called to the mat by FDA is educating the public around what the real issues are. In this case, it’s communicating to consumers that there has been no recall, and that the FDA is still recommending people use the products as directed. It’s communicating to consumers that safety concerns rank pretty high, with both the agency and the healthcare manufacturer. It’s communicating to consumers that those medicines available for sale over-the-counter are still real medicines, and that consumers need to follow usage directions.
Finally, it’s communicating to consumers that this is what they’ve asked for — the ability to make a healthcare decision with all the facts laid bare so that they and the healthcare professionals they look to for guidance can truly make a discerning decision about what’s right for them.
Report: Primary care physicians decreasing, giving way to retail clinic use
NEW YORK The shortage of primary care physicians is bound to escalate as long hours, lower pay, less prestige and more administrative headaches are turning doctors instead toward more lucrative subspecialties, according to a recent USA Today report.
With primary care losing its pull, retail-based health clinics will play an increasingly important role in the frontline for wellness and preventative-care programs.
The number of U.S. medical school students going into primary care has plummeted 51.8% since 1997, USA Today reported, citing data from the American Academy of Family Physicians. The AAFP, which represents more than 93,000 physicians, predicts a shortage of 40,000 family physicians in 2020, when demand is expected to spike.
The report also states that the U.S. healthcare system has roughly 100,000 family physicians and will need nearly 140,000 in 10 years. At the core of the demand: The 78 million Baby Boomers who begin to turn 65 in 2011 and will require increasing medical care.
Furthermore, the need for more doctors will rise if Congress passes healthcare legislation that extends insurance coverage to a significant portion of the 47 million Americans who lack insurance, USA Today reported.
Finding a physician will become more difficult, waits for appointments will grow longer and more people will turn to emergency rooms, which are already overflowing, Ted Epperly, president of the AAFP, told USA Today.
‘The Biggest Loser’ wellness coach launches weight-control supplement line
NEW YORK Jillian Michaels, renowned wellness coach from NBC’s “The Biggest Loser,” on Friday announced the launch of her line of weight-control supplements in partnership with ThinCare International.
“I have always been an advocate of supplements for boosting metabolic function and supporting weight loss,” stated Michaels, “My new QuickStart Rapid Weight Loss System is designed to help you overcome the two greatest obstacles to successful weight loss — appetite control and fat burning.”
“We are extremely happy to be working with Jillian Michaels,” said Gina Daines, spokesperson for ThinCare. “[Michaels] is a true icon and this product line is the biggest thing to hit the diet shelves in years.”
The entire Jillian Michaels supplement line includes: Maximum Strength Calorie Control, Maximum Strength Fat Burner, Triple Process Total Body Detox & Cleanse Plus Probiotic Replenishment and QuickStart Rapid Weight Loss System, which contains both the Fat Burner and the Calorie Control products.
The line launches Aug. 21 in GNC and will roll out nationwide over the next month.
Jillian Michaels’ products will be sold at GNC, Walmart, Walgreens, CVS, Rite-Aid Target and most chain grocery stores, the company stated.