Ask the doc: Are you prescribing the latest drugs?

Mar. 04, 2014 @ 11:56 PM

Doc: I heard of this new drug, Dangitol, that treats anxiety. Will you prescribe it? (OK, I stretched that a bit.)

Answer: Nope. Don’t drive a car that is in its first year of production and don’t be the first to try a new drug.

I call this my “Posicor Rule” as I learned a tough lesson with the drug Posicor in 1998. Roche Laboratories launched a new blood pressure pill names “Posicor” in 1997 with a lot of promotion and a lot of hype. It was a new branch in an old class of medicines, appeared safe, and really worked well.

Until it seemingly started killing people.

Unfortunately the studies had not thoroughly covered all of the drug interactions that could occur and a commonly used cholesterol medicine apparently didn’t get along with Posicor too well. The liver was the battle ground, and reportedly several patients died.

Roche, a responsible company, immediately pulled the drug from the market and braced for the lawyer commercials. Nevertheless, I was stuck with several patients I had placed on the medicine and didn’t have any way to know which ones to call. (This is a quickly resolved problem now with electronic medical records.)

So I waited. Waited for the refill requests to come from the pharmacy in order to know who to change medicines for, or for the patient to call in. Many people weren’t on the internet in 1998 so the information did not quickly spread. While I waited, I decided I would never write a drug that has not been on the market for at least 18 months.

That was a good decision, too.

The FDA has a very thorough process for evaluating drugs prior to release. Seeing the drug used for years in Europe and Asia usually helps approval, but not always. Some companies spend hundreds of millions of dollars on a drug and then have to abandon the research. That is why when one is released to the market, it now gets a lot of publicity.

One drug, which we will call “Poopease” for sake of discussion, came on the market in 1998 to help women, only women, with abdominal pain and constipation. I thought it was odd that a drug knew if it was in a male or female’s gut, but the drug rep persisted. She was plucked from some modeling agency or dance team, given some basic education of the drug, and sent out with her Brooklyn accent and attitude to promote this new drug to doctors in Georgia (where I lived at the time).

She was pushy. Lots of perfume. Even more smiles. The ladies in my office didn’t like her or what she wore. Or at least tried to wear. Her third time back she said, “Dr. Littleton, don’t you want to help you women patients with abdominal pain?” and that was when I asked her to not come back, partly for the Posicor Rule, and simply because she wasn’t professional.

She didn’t come back when the drug was recalled, either.

Or the diabetic drug when it was subtly implied I wasn’t on the cutting edge of caring for my patients if I didn’t write it. It killed patients with pancreatitis, an incredibly painful way to die. It, too, was pulled from the market. Posicor Rule, again.

Bextra and Vioxx, however, were a little different. Both were on the market for years, and I found they were very successful in treating arthritis and inflammation. The FDA determined the risk for cardiac complications (heart attack and congestive heart failure) were too great and both were pulled from the market. I literally had patients in tears when they learned they had to give up these meds as they truly worked well. A few offered to sign waivers hoping the company would supply them with the meds for their pain.

So when you see an ad on TV, during the news, showing happy people smiling and enjoying life while a soap opera voice talks about side effects that are worse than the disease, keep in mind those are usually newer medicines with potential unknown secrets.

Maybe it is a great drug that will extend life, reduce hospitalizations and keep a person functional. Or maybe it will be appearing in a lawyer commercial next year. (I’ve often thought they should show people at the pharmacy when they see the price of the new drug instead of sitting in bathtubs.)

The Posicor Rule isn’t perfect, but it has served well. No rule is perfect, but neither is the hype that often accompanies the launch of a new drug.

Eric J. Littleton, M.D. is a Family Physician in Sevierville, TN. His new office is located at 958 Dolly Parton Parkway. Topics covered are general in nature and should not be used to change medical treatments and/or plans without first discussing with your physician. Send questions to askdrlittleton@gmail.com.