This is a Very Bad Idea

I was stunned when I saw this headline in the New York Times last week: “Court sides against FDA in ‘off-label’ drug promotion case.” In case you missed it, here is the lede:

The maker of a prescription fish-oil pill won an early victory Friday against the Food and Drug Administration over its right to publicize unapproved uses of its drug.

The gist of the story is that the pharmaceutical company successfully claimed that restricting its ability to promote off-label use with (in the words of the court) “truthful and non-misleading information” violated its First Amendment right to free speech.

Let me be clear here. I am all for maintaining the longstanding prerogative that physicians and other licensed prescribers have to prescribe approved medications for unapproved indications.  That’s not what this is about.

This is about unleashing the marketing machines of pharmaceutical companies to push their products in a way that circumvents the safeguards built into the current FDA approval process. That process includes weighing all the available evidence – published and unpublished – to determine if a compound is “safe and effective” for the stated indication. An eloquent defense of that process by Jerry Avorn appears coincidentally in the current issue of the Annals of Internal Medicine.

Under the terms of the recent court ruling, it seems that a drug company could get approval of a new agent for one narrow indication, and then cherry pick limited data to market it for much broader use. This is a gigantic, dangerous loophole that does not serve the public interest.

Here’s something else that appeared in the New York Times the same day: the obituary of Frances Oldham Kelsey, who, in 1960, was a physician at the then newly established Food and Drug Administration. It was Dr. Kelsey who blocked the approval of thalidomide in the United States. That courageous and unprecedented step prevented untold tragedies and strengthened the precedent to regulate pharmaceuticals.

Sadly, I fear she is already spinning in her grave.

What do you think?

1 thought on “This is a Very Bad Idea

  1. I am a person that’s greatly frustrated with the FDA and medicare pharmacy formulary. I take Armour Thyroid hormone supplement. The FDA stopped the production about 2006 or around that time. I’ve tried synthroids several times, and I have terrible reactions to them, because my body can’t break the synthetic T4 down into T3. I had to have it compounded, and my TSH was all over the place. My doctor should have suggested that I take some compounded pills to a lab to be checked. My body was so stressed-and foggy mind that I didn’t think of it. Most thyroid sites, people complain that the first year of canadian pork wasn’t good for us. Then 2 years ago, I received a letter from medicare that it was illegal for me to take Armour, and it was illegal for a doctor to prescribe it. The VA and military really fought this, along with medical associations. I’ve been self-pay for Armour-you aren’t paying for it.

    Then I suffer from the long-term side effects of statin toxicity. I am fortunate that the prescribing PCP put seizures as a side effect of statin. The NIH, FDA, Medicare, etc. all recommend that wait a while, and restart a statin regime. I told her to look at my drug allergies on my EHR. Why couldn’t she believe that I had really black urine for a little ove 90 days, that I couldn’t walk without assistance, that I had to have PT by the care of a specialist that also is lucky that he can toddle around his office. He was a marathon runner before statin.

    Why is acetaphimen in almost every OTC med? Children are starting to have enlarged livers by the age of 10. I don’t think that their mothers put Jack Daniels in the formula. I’m allergic to acetaminophen-Surfer’s Ear- and doctors ask me how I ended up with a liver that’s not spongy, not enlarged, etc, No Tylenol Then do you want me to comment why many OTC meds are locked up? because they are Nazi meth- what the Third reich developed for the troops invading the Soviet union—and we wonder why so many get addicted or prone to addiction. FDA—F stands for Food- and the FDA hasn’t figured that one out yet. I was an adult during the thalidomide tragedy. I was pregnant and scared, but there is a difference between fish oil, turmeric, etc. and what you are pointing out.

    I’m terrified of new drugs, statin toxicity, synthroids, Tylenol, etc. I’m tired of being told to take poisons. PS. I kept going to different Urgent Cares-by different companies and independent doctors to get my diagnosis. I had to do that to get my PCP and Medicare HMO type advantage system to admit that I had it. Then my current PCP wanted to put me back on statin because of HMO pressure caused by Medicare pressure for compliance. Sir. I understand what you say—but leave fish oil, and other herbs alone-Leave my thyroid alone.

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