Pepin’s Pharmaceutical Prattle for 12-06-2004

Quote of the day:  In the business world, the rearview mirror is always clearer than the windshield. ~ Warren Buffett

 Good morning ! 

 Effect vs side effect

You take a Benadryl to dry up your allergies and become drowsy. You take a Sleepinal or Snooze Fast as a sleep-aid and experience dry mouth. Same chemical with two effects. Each effect could be considered a "side effect" depending upon the reason you took the medication. We take the desired effects as "indications" and the undesired effects as "side effects". We sometimes anthropomorphize drugs… attributing thought to a chemical, The chemical has no desires, hidden agenda, or reason to do "good" or "bad". It is what it is… a chemical that can stimulate quite a number of receptors.

 When the FDA approves a drug for prescription use it is relying upon the physician/prescriber to weigh the desirable effects against the potential for adverse drug reactions (aka side-effects). The official labeling of the product is commonly know as the 'package insert". Most read like the New York City telephone book but the prescriber is responsible for knowing the facts before writing a prescription.  The FDA is also responsible for "post marketing surveillance" that is, to keep an eye out for an unusually high number or unusual or serious side effects that are not stated in the package insert. One way that the FDA monitors this is through a system of voluntary reporting by health professionals call MedWatch, http://www.fda.gov/medwatch/ . The other way is to monitor or conduct studies of drugs after they have received marketing approval. If someone is withholding information then the system falters.

 The latest round of demagoguery related to the grilling of the FDA over recalls and market withdrawals implies that the FDA must be "all knowing" and able to tell the future. The FDA does intense evaluation before a drug is approved and watches for problems. If the members of Congress want only those drugs that have no side effects approved then there will never be another one marketed. Society will suffer from the lack of medical progress.

I am not willing to say that the system is broken. Underfunded maybe but not basically sound. I'd hate to depend upon systems set up in ANY other country.

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ps. Best answer this week to the question "How are you?" was "Excited about my promotion to Senior Lending Specialist!" (my daughter at Affinity Mortgage)

 1) Avandia lowers something other than blood sugar…

The drug appears to lower the "good" cholesterol (HDL). This is not a happy finding because the HDL molecules act like "boxcars" to carry away the "bad" cholesterol. The "double whammy" is that patients with diabetes should be on lipid lowering therapy.

http://story.news.yahoo.com/news?tmpl=story&cid=594&ncid=594&e=12&u=/nm/20041126/hl_nm/avandia_lipid_dc

2) Stop the bloody antidepressants?

Not exactly new news but another paper suggesting that your chances of a bleed double with use of certain antidepressants.  It should be noted that your chances of recurring depression more than double if you stop the antidepressant. It is, once again, a risk-versus-benefit choice.

http://www.medscape.com/viewarticle/494691?src=mp

3) "Triple whammy?"

… and people with diabetes are more likely to develop depression!

Type 1 (insulin dependent or juvenile ) diabetes is more genetic. You can avoid acquiring type II diabetes (adult onset) by watching you weight… you may be a "diabetic waiting to happen". Hope this doesn't depress you.

http://www.foxnews.com/story/0,2933,139561,00.html

4) Bextra gets a black box.

Bextra, one of the two remaining COX II inhinitors with the demise of Vioxx, just received a change in the official labeling. A BLACK BOX waring is meant to alert prescribers to extra-ordinary dangers that must be considered before writing for the drug. In this case, physicians are alerted to a higher incidence of Stevens-Johnson's Syndrome in Bextra users. This is a rare, idiosyncratic reaction (like an allergy) that may occur within the first 2 weeks of therapy (or later in a few cases). It is serious problem if it occurs. Physicians have been sent 2 letters by the manufacturer warning about this potential side effect so there is nothing more to do at this time. It will get more press that it would have deserved except for the recent Vioxx press.

 http://www.pfizer.com/download/uspi_bextra.pdf

5) Botulism outbreak may be linked to Botox.

Four patients who were injected at the same clinic required ventilators due to paralysis. This could be due to a contaminiated or a super-potent vial of Botox… investigators will eventually find out. What price beauty?

http://www.cidrap.umn.edu/cidrap/content/bt/botulism/news/dec0104botox.html

6) If you want some dough you have to prove that Vioxx "did it".

Judge is requiring plaintiffs to show proof (read spend a lot of money on expert witnesses) in order to sue for Vioxx damages. If you are a 300 pound stressed out diabetic smoker with high blood pressure who doesn't take regular medications then you might as well not file. This should reduce the Merck liability below the projected $18 billion mark. Not out of the woods but the trees are thinning.

http://www.bloomberg.com/apps/news?pid=10000087&sid=avPzHKaNKvnE&refer=top_world_news#

7) New drug approved… Combunox

Not anything earth shattering but thought you would like to know about this new pain medication. It combines Ibuprofen with a narcotic.

http://yahoo.reuters.com/financeQuoteCompanyNewsArticle.jhtml?duid=mtfh88093_2004-11-26_21-31-07_wen0342_newsml

8) FDA unanimously rejects testosterone patch for increasing female libido.

More data is needed. This is probably a backlash to the Vioxx withdrawal and the Congressional grandstanding that is occurring now. Don't expect this one to go away folks but you will have to find another stocking stuffer for this Christmas.

http://www.newsday.com/news/health/sns-ap-female-sexual-dysfunction,0,2621944.story?coll=ny-top-headlines

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