Prescription for doubt
by Bill at 9/22/2004 04:26:00 PM
Yesterday at the office something interesting happened. I saw a patient whom I deemed as sick and in the need of antibiotics. In the interest of confidentiality I will leave out the details. He/She had the symptoms of a URI (upper respiratory infection) that meet the criteria for a probable bacterial infection, hence the need for antibiotics (most URIs are viral and you only need to treat the symptoms until they resolve). So, this patient looked pretty sick to me and I excused myself from the room to get a prescription pad. When I began writing I experienced a moment of self doubt (I believe that self doubt is a very good thing to have in medicine) and wondered if I should precribe the patient a "stronger' antibiotic; stronger can be construed to mean newer, more expensive and broader spectrum. I thought to myself, "wait, the severity of the patients supposed bacterial infection should guide me whether to use a antibiotic or not, not whether to use a newer one". I consulted the Sanford Guide for my choice. As the patient had no history of recent antibiotic use or treatment failures there was no indication to use a newer drug. But the act of doubting troubled me. Was it because I am working with colleagues that rarely use older generic drugs, was it because my patient base mistakenly demands the newest drugs, or am I the victim of too much pharmaceutical detailing? I am visted by drug reps at least three times a day, and ther constant quotation of industry sponsored studies must have some effect. Or perhaps I am just an average American that assumes that newer and more expensive must be better?
While I was visiting Wendy's folks, I read the following article on drugs in the AARP Bulletin, "The Dope on Drugmakers".
The highlights:
- marketing and admin cost at least twice as much as R&D
- 25-30% of cost is marketing
- 5 of the top 10 manufacturers are European where drug prices are regulated
- of the 78 new drugs approved by FDA in 2002, only 7 were "innovative", and not one of those 7 were from American drugmakers
- over the past 6 years, 78% of FDA approved drugs were classified as unlikely to be better than existing ones, and 60% didn’t even contain new active ingredients
There's more. It's interesting reading, and may explain why you are seeing so many pharma reps and why your patients might ask for newer drugs.
Of the 60% that didn't even have a new active ingredient; many are new sustained release formulas. Take prozac for example, you take one pill daily, and now it is generic (after many leagal battles), so Lilly decided to make a sustained release one pill weekely formula, and they push that extensively. Others are like Clarinex which has an isomer reversed from Claritin, which is now over the counter. No head to head study has ever showed Clarinex to be better than Claritin. Nor has any head to head study demnostrated any difference in the entire class of anti-depressant SSRIs (prozac, paxil, zoloft, celexa, lexapro). The list goes on and on.
I'm surprised that the Angell article did not mention the issue that likely costs the Big Pharma some of the most money: lengthy and exhaustive trials and the potential risks and costs associated with it of unforeseen dangerous side effects and very costly legal liability. What she fails to mention is that it is in the drug co's best interest to perform trials to ensure their drugs do what they claim they do and do not adversely harm people. Doctors and nurses are smart people. If the drugs do not do what you say they do, they'll stop being prescribed, no matter how much marketing you do. And if you create an unsafe drug, you risk serious legal ramifications.
I'm also surprised she suggested passing these very real costs onto taxpayers through this national institute. I guess we won't be sharing these drugs with other countries, too risky to the taxpayers since the drug co's are no longer culpable for their performance. The only way around that would be to restrict people's abilities to sue.
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