Behind the headlines “FDA Panel Unanimously Rejects…” and “Arthritis Pill From Pfizer Wins Support…” was, for me, over 600 pages of reading and two days at the FDA as the Consumer Representative to the Arthritis Advisory Committee (AAC). These were my first meetings following an almost yearlong process that started with a nomination by Diane Aronson, the Consumer Representative whose term was ending, and culminated with my four year ...

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The FDA is deciding whether to allow patients to purchase prescription medications over the counter for many common ailments. This idea is controversial. On one hand, deregulation would remove one of the largest barriers to receiving treatment for some conditions – the doctor’s visit. If no doctor’s visit is necessary to receive necessary blood pressure medications or diabetes medications, then patients don’t have to wait for an appointment and the patient/government ...

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An excerpt from The Truth About Statins. Like all physicians, I’ve had interactions with pharmaceutical companies. Shortly after I went into private practice in Rhode Island in 1977, I received a telephone call from a drug company representative. He offered me an all-expense-paid weeklong trip to Germany to attend a medical conference. I was taken aback, knowing that the cost of such a trip would run to thousands of dollars. I ...

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In our world of 24/7 media, where we seem to hear about the next big cure, important dietary change or very dangerous drug virtually every day, it is hard to believe that the news people, tweeters and bloggers could miss anything that is going on in health care today.  However, it appears most everyone missed a big one. This might be one of the most important stories in health care today, that no one ...

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An excerpt from Born With a Junk Food Deficiency, (Prometheus Books, 2012).  Can anyone remember life before Direct-to-Consumer (DTC) advertising with its notorious “Ask Your Doctor” ads? The only thing laypeople knew about prescription drugs came from the ads they peeked at in the Journal of the American Medical Association (JAMA) in the doctor’s waiting room. The ads were full of vaguely ominous terms—nulligravida? hemodialysis?—as well as side effects ...

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As a treating physician who also serves as the Chairman of the Alliance for Safe Biologic Medicines (ASBM), I have been watching with great interest as the Food and Drug Administration (FDA) begins to unveil the approach it will take to bring “biosimilar” medications to the US.  Biosimilars are attempts to replicate brand name biologic medicines. But as the name indicates, they are similar to them but not identical.   ...

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Welcome to my day from hell.  It is 2 p.m. and I’ve just logged my fifth prior authorization denial of the day.  In simpler terms, five patients will either change their medications or pay for them out of pocket.  Personally, I’m sick of this crap. When it comes to prescribing medication, I am very judicious in my prescribing habits.  According to one of the largest insurers, my percent of generic prescriptions ...

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The latest supplement toxic alert thankfully involves only two young soldiers who died suddenly, both reported to have the unregulated amphetamine-like dimethylamylamine, DMAA, aka "Jack3d" and "OxyelitePro," as the suspected death-dealing toxicant. Who knows how many other unexplained deaths and near-deaths can be attributed to the vast experiment foisted upon an unwary American populace by such drugs -- I mean, "supplements"? Thanks to 1994's Hatch Act, the Dietary Supplement Health ...

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Confession: I have been watching the reality show The Real Housewives of Beverly Hills. Quite frankly, I don’t take shows like that seriously and often wonder if it is bordering on obscene to have such lavish lifestyles displayed on the televisions of homes across America (and around the world) during these hard economic times. But I was particularly disappointed in some of the footage that was shown on a recent episode. ...

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Recently, the world’s largest research-based drug company, Pfizer, announced that an automated packaging error led to a recall of the birth control medication, Lo/Ovral-28 and the generic counterpart, Norgestrel/Ethinyl Estradiol. The packaging issue had to do with the placebo pill being placed in the wrong order in the 28-day cycle and an inexact number of placebo (should be 7) or active forms (should be 21) of the medication. The placebo pill ...

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