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FDA's Delay to Decide on Plan B for OTC Use

For the record, I was extremely disappointed in the FDA's decision to delay a decision on Plan B's approval for OTC use. This is old news from August, but after hearing an interview with Dr. Susan Wood on her decision to resign from the FDA's Office of Women's Health, I wanted to mention it. The FDA should operate independently of the nation's political quagmire, but after delaying a decision on Plan B after its own advisors gave the go ahead, I find the FDA's decision disturbing. Dr. Wood is a personal hero for having the guts to resign.

To hear Dr. Wood speak about her resignation, listen to the New England Journal of Medicine's podcast.

:: Bryan Travis :: 10/27/2005 @ 10:33 :: [link] ::
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Pargluva (muraglitazar) and Heart Disease

A news item from last Thursday that caught my attention:

Investigational Diabetes Drug Linked to Increased Risk of Death, Strokes and Heart Attacks

CLEVELAND, Oct. 20 - Researchers here said today that the use of the investigational diabetes drug Pargluva (muraglitazar) doubles the risk of death, heart attack and stroke, and they asked the FDA to delay approval of the drug.

In an analysis that was released online by the Journal of the American Medical Association, Steven E. Nissen, M.D., and colleagues at the Cleveland Clinic said the FDA should not approve Pargluva until its cardiovascular safety can be proven in "a dedicated cardiovascular events trial."

[...]

Last month an FDA advisory committee recommended approval of Pargluva by a vote of eight to one, and two days ago the FDA issued an "approvable letter" to Bristol-Myers Squibb and Merck & Co., which are jointly developing the drug. The FDA letter asked for more data about cardiovascular safety.

Muraglitazar's mechanism is similar to thiazolidinedione (TZD) drugs such as Avandia (rosiglitazone) and Actos (pioglitazone). These drugs for the treatment of type 2 diabetes activate the PPAR receptor to increase insulin sensitivity. PPAR receptors are present on adipocytes, which may be related to the drugs' effects on blood lipids. Hyperlipidemia is common in type 2 diabetics, so the TZDs' effects on blood lipids (lowered triglycerides, increased HDL and LDL) may influence their use. Pioglitazone has more favorable lipid effects (pioglitazone doesn't increase LDL as much as rosiglitazone), but also causes more weight gain. Finally, TZDs may also cause edema and should never be given to patients with severe CHF.

Using TZDs and muraglitazar for their positive effects on triglyceride and HDL levels must be carefully weighed against their negative effects on weight, edema (CHF), and LDL. Is the net effect on the patient positive or negative? It may be negative for muraglitazar, and it will be interesting to watch how the FDA proceeds with its approval. The recent delay on a decision to make Plan B available for OTC use shook my faith in the FDA a bit.

:: Bryan Travis :: 10/25/2005 @ 01:36 :: [link] ::
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Obligatory Post for October 2005

The second round of block exams is complete, and my stint with GE is complete. I have some time to write this month's post, even as I keep nodding off while sitting in front of the keyboard and monitor.

I'm taking an elective class in UK's MHA/MPA program track. I'm not in the MHA/MPA program, but I wanted to polish my MBA with some healthcare management classes. The class is HA-601, Introduction to the Healthcare Delivery System. What's so striking is that I scored 100% on the 8 essay question mid-term exam, but A's are few and far between in pharmacy school this year.

The lowest scores are always on the CAPP (Contemporary Aspects of Pharmacy Practice) exams (mean scores are in the 70s), but CAPP has low scores by design. While the other classes teach us technical knowledge of pharmacy, CAPP encompasses the duties and responsibilities of the pharmacist, the skills we need to actually do our job, such as clinical practice standards, legal issues, patient counseling, compounding, IV admixtures, prescription errors, math, and other stuff like that. CAPP strengthens our skills with countless impossible/unreasonable challenges. So we ignore CAPP because it's supposed to be hard, and there's always a curve.

CAPP aside, the killer test this round was immunology, and that's the class consensus. Our immunology professor says we don't laugh at his jokes. He must be taking our "tough crowd" response personally, because he's mentioned it to enough people that it's starting to come back around to us through the grapevine.

I honestly believe he doesn't like us. Both times on test day, before handing out the exam, the professor has told us that he's writing more challenging exams this year that "will make you think." While handing out the second test, he went so far as to say, "This is a challenging exam. If you didn't study, you're going to be really pissed off." Even though I had studied, I immediately knew that I was going to be pissed off, anyway. Sure enough, there were multiple instances during the exam when indiscretion got the best of me, and I had several stinging thoughts directed toward the man.

:: Bryan Travis :: 10/24/2005 @ 00:56 :: [link] ::
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