Questions of the Month
I've heard there is a shortage of crucial medicines in the US. What is the FDA doing and what are the answers?
When we pick up the phone, we expect a dial tone. When we go to the hospital--we expect to be able to get the medicines we need. Unfortunately, a disturbing trend may make that not to be the case. For many years we've taken medicines for granted, but a disturbing increase in drug shortages in the US started by setting a record in 2010 and so far in 2011, the situation has gotten worse.
This has and is continuing to influence hospitals and patients more than ever before. Surprisingly, the shortages cross into the most crucial medicines such as anesthetics and cancer treatments.
Visit www.fda.gov to view the current shortage list. The FDA will had a 30-minute webinar on September 30, 2011 at 11 AM. Captain Valerie Jensen, the associate director of CDER will talk about the extent of the shortage and the crucial importance of communication. The link is https://collaboration.fda.gov/drugshort/
For now, if you are scheduled to start a chemotherapy or other critical treatment with multiple cycles, be sure to ask your doctor if there is adequate supply of the medicine being selected. Many times there acceptable alternatives, yet stories are emerging of patients having interruptions in treatment. There is a weekly drug shortage update on the FDA site...once again, that is www.fda.gov.
What statins have been associated with diabetes and how large is the association???
It appears that roughly a 9% associated diabetes risk has been identified for one member of the statin family (rosuvastattin-Crestor). Many times, research involving a large number of patients helps decide how effective a medicine really is--and it can also identify possible side effects that have not been flushed out in smaller studies.
The JUPITOR trial (Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin) lowered the risk of heart attack by more than half in almost 18,000 people in the 2008 study.
When a closer look at this study and the great benefit in decreasing risk of death was examined further, it also looked like an association between taking this statin and about a 9% increased risk of diabetes. It's too early to say this drug caused diabetes, yet the association appeared clear.
It is important to remember that this means that if the data hold up, 91% of people who take this medicine (and perhaps any statin) will not have an associated diabetes. More clearly stated, the benefit outweighs the risk.
Still, this controversy is an important finding (personally important as Crestor is the statin that the author takes). For now, it seems reasonable for people taking a statin to talk to their doctor about having a baseline A1C (measure of sugar control in the prior three months) and perhaps every year while taking a statin. More information on statins is available in The Essential Guide to Prescription Drugs, Update on Statins, v 1.2 available from Amazon.
Where there any breakthroughs at the AHA meeting in Chicago
Yes, a novel Cholesterol treatment is a rising star called anacetrapib
<!-- article-content -->
Raising good cholesterol to a significant degree can presently only be accomplished with Niacin or exercise. HDL acts as a key dump truck in our body, taking cholesterol from the circulation to the liver where it can be made into useful products or removed.
A new era in cholesterol treatment may have dawned at the American Heart Association Meeting in Chicago. From the Late Breaking Clinical Trials session on the last day of the meeting, a Cholesteryl Ester Transfer Protein inhibitor known as anacetrapib was found to avoid the problems of a prior attempt in this family (torcetrapib) and the presenters resoundingly recommended that further studies commence!
I expect that the FDA will give this new drug fast track status (see www.fda.gov) and a brand new family of medicines will be born. The old target was bad cholesterol (LDL) and the new mantra will be LDL lowering and HDL raising combination therapy!
Q: What ever happened to that new weight loss drug at the FDA??? Was there a decision made???
A: What looked originally like smooth sailing for lorcaserin (Lorquess) became a huge discussion in the expert advisory panel. Questions revolved around AVERAGE weight loss (efficacy) and side effects in rats. It was surprising for me to hear usually unbiased FDA representatives adding descriptive language to ("marginal") effectiveness and a surprising lack of an oncology/oncogenic expert at the panel meeting itself. Turns out that when the drug is given in a huge dose to rats, it lead to tumors. The discussion from the committee members revolved around confusion about the relationship between tumors in rats and tumors in humans and no one seemed to know the answer.
In short, the FDA quoted safety concerns relative to benefits in rejecting the drug for now. Apparently the company (Arena Pharmaceutical) will meet with the FDA shortly to talk about the "more information/further studies" needed to clear up the present confusion.
What is coming up at the American Heart Association Meeting in Chicago?
SCIENCE/Research and outcomes. Some examples include: The 50th aniversary of CPR; Transforming Death into Life, late breaking science and research all organized into seven cardiovascular cores and nine clinical tracks. Phew. While it is an exhausting meeting (in Chicago, Nobember 13-17th), I will be there and will have the info as it breaks this year !!!