The FDA Attack On Free Speech
From the WSJ one of the many erosions of our civil liberties -- one that affects patient health -- has been dialed back:
On Monday a three-judge panel of the Second Circuit Court of Appeals said that Food and Drug Administration rules on the promotion of drugs violate the First Amendment's guarantee of free speech.Sales rep Alfred Caronia probably thought he was only doing his job when in 2005 he told a doctor that a drug called Xyrem that had been approved for narcolepsy might also be effective in treating chronic pain and fatigue. But it turned out the doctor he was talking to was a government informant with a wire, and he was convicted in 2008 of selling a "misbranded" drug.
Mr. Caronia was understandably puzzled why engaging in a conversation that would attract no legal attention had it occurred between two doctors, or between a doctor and patient, or indeed anyone besides a doctor and a pharmaceutical rep, should be considered a crime.
Also puzzled was the Second Circuit. "It only furthers the public interest to ensure that decisions about the use of prescription drugs, including off-label usage, are intelligent and well-informed," wrote Judge Denny Chin for the 2-1 majority. "The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good."
While the FDA tries to make "off-label" drug use seem sinister and criminal, it is often the state of the art in medicine. A great number of cancer medications are now first-line treatments for conditions different from the one for which they were originally approved.
In talking off-label uses, sales reps like Mr. Caronia are often trying to share the results of government-funded studies. By the FDA's logic, it should have stopped the promotion of aspirin to prevent stroke and heart attack as a crime. The decision guts the FDA's rationale for off-label speech regulation and could be a landmark that liberates companies and doctors to spread news about medical innovation.
A comment from the WSJ, from Michael Carter:
My father was a kidney dialysis patient. Following a dialysis session he was afflicted with itching sensations over most of his body that prevented sleeping.The kidney doctor prescribed Valium to help him sleep, but they discovered that it alleviated the itching. If given before dialysis no itching occurred at all. As one doctor described to me some of the greatest uses of medicines come from serendipitous side effects.
It is high time to remove the government from the doctor - drug representative and doctor - patient relationships. No good ever comes from government intrusion in personal decisions.
The first effective migraine relief therapy I had was from "off use" drugs. I had been through batteries of neuro tests, scans, you name it. As far as the doctor could tell, there was absolutely no reason for me to have crippling migraines that included decreased vision in my left eye.
Nothing I was given worked. I got the migraine 3-4 times a month, with an average duration of 3 days. In the end, the only treatment they could offer me were strong narcotics administered in the ER whenevery I had a headache that lasted for more that 48 hours.
Then one visit, the nurse was prepping my usual remedy and asked the new resident to sign off on the drug order. He wanted to know they were giving me something that strong and addictive. The nurse gave him a brief run-down of my history, ending with the narcotic after 24 hours being the standard treatment my neurologist recommended. The new resident said, "before we give her that, let's try giving her ___ and ___."
He came over to me, explained what he wanted to give me, clearly told me that it was off label use, told me that this usage was NOT recommended by the FDA, but that he, personally, had had experience with it working in several patients with chronic migraine. I consented, the drugs were administered to my IV and 10 minutes later I was sound asleep for the first time in 3 days, completely pain free.
If he had not been able to share what he knew and help me, I likely would have killed myself with either narcotic addiction or because of the debilitating pain. Now, the drug combination HAS been studied together and is authorised for this usage.
Keliandra at December 7, 2012 9:38 AM
Off-label use is common for drugs. There is a GI drug that increases milk production. Seizure meds work for anxiety attacks. The list goes on and on. If the pharm company is aware of side benefits, what's the harm in sharing that knowledge?
momof4 at December 7, 2012 10:45 AM
Wasn't viagra originally a medication for blood pressure that was used off-label for boner problems?
Elle at December 7, 2012 1:57 PM
I think the reasoning is that using a drug for its "off-label" effects amounts to illegal human testing. Like many a guideline/regulation/law it is susceptible to overzealous application.
And I am a bit amused that my blood medicine, Coumedin, may also be labelled Warfarin - developed {and still sold} as rat poison. OTOH, it was studied for effect on humans.
John A at December 7, 2012 5:13 PM
Don't miss that government rules for healthcare rule doctor discretion out.
If you haven't sent your Congressman a message about the Affordable Health Care Act, you should.
Radwaste at December 7, 2012 10:47 PM
I agree with this thought -- an example is Neurontin. Totally ineffective for peripheral neuropathy, but prescribed on the advice of drug reps. What needs to happen is that the doctors do a little research on their own like Keliandra described.
It was used as rat poison until they could synthesize it into a consistent formulation. But it is a natural product of hay rotting.
Jim P. at December 8, 2012 1:50 PM
Rogaine was, I believe, originally for blood pressure, but the clinical trials found a more lucrative effect.
I have eczema. Now that it's winter, I take a 24 hour allergy med in the morning, and benadryl at night (it knocks me out, so I can't take it during the day).
Then I got hives - seriously got hives while taking that.
Dermatologist put me on heart burn medicine. Zantac, used with the 24 hours stuff I've got, works better than the 24 hour stuff alone. I was surprised, but it worked.
Shannon M. Howell at December 10, 2012 4:24 AM
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