HEALTH

FDA investigates liver injury claims from weight-loss medication users

BY Michael Johnsen

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.

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Report: Primary care physicians decreasing, giving way to retail clinic use

BY Antoinette Alexander

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.

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Teva launches ‘Patient First’ project

BY Alaric DeArment

NEW YORK Most consumers may not know a lot about biosimilar equivalence, immunogenicity or what “monoclonal antibody” means, but they know that battling a chronic disease can be a frightening and financially devastating prospect. Teva’s new TV campaign is a very sobering reminder of what many already know at a time when all of America is focused on fixing health care.

 

On one end of the continuum of prescription drug prices lies generic drugs purchased under one of the growing number of generic discount programs offered by retailers for less than $50 a year. On the other end lies biotech drugs that can cost nearly half a million dollars a year.

 

 

This is a reminder to politicians and voters that for many patients, manageable diseases carry unmanageable costs. This especially is true for such diseases as cancer, multiple sclerosis and paroxysmal nocturnal hemoglobinuria. Rob Day, one of the patients profiled in the “Patient First” campaign — itself a part of the broader Year of Affordable Healthcare campaign — was diagnosed with PNH at age 19 and must pay $389,000 a year for biotech drugs to treat it.

 

 

While $389,000 is an extreme example, most biotech drugs remain incredibly expensive: A year’s supply of Genentech’s breast cancer drug Herceptin (trastuzumab) costs about $40,000, while a single vial of Elan Corp.’s multiple sclerosis drug Tysabri (natalizumab) costs more than $2,000. Setting up a regulatory environment that allows expensive biotech drugs to face competition from biosimilars would help to alleviate the fears and financial strain of some patients living with chronic illnesses.

 

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