Friday, January 06, 2006

F the FDA

A good number of bloggers are rightly unhappy with the Food and Drug Administration for their decision to take Cylert off the market. It's a drug that helps those suffering from narcolepsy, but because it has been implicated in liver problems in some people, the FDA has pulled the plug on it completely. The inherent problems in the whole FDA approval process is exposed very well by Eric Raymond, who notes that if we choose to live by government regulation, than we also choose to die by government regulation:

The Cylert ban isn’t an accidental failure of the system, it’s an essential one. It wasn’t perpetrated by villains, but by well-intentioned people working the levers of a system designed to elevate “public safety” above individual choice. That system functioned as designed; it’s the design that’s broken.

Julian at Reason also points out that we as individual consumers are better able to make a personal risk assessment than the government:

The FDA's reason is that it has determined "the overall risk of liver toxicity from Cylert and generic pemoline products outweighs the benefits of this drug." Except, of course, that Teresa Nielsen Hayden obviously thought the benefits outweighed the risk. And, of course, there isn't really such thing as the "benefit" or "risk" of a drug in itself, but only the benefit and risk to a particular patient—not just because of physiological variation between people, but because of how we differently value the same sets of positive and negative effects. A sane FDA would give us the information and let us decide for ourselves which way the balance came out.

As they say, Asprin would never get through the current FDA approval process.


At 12:27 AM, Blogger BloggingMolly27 said...

Asprin would never get through the current FDA process and neither would liquor and beer. Can you say scerosis of the liver?

At 2:00 AM, Blogger Christeen said...

I don't know. Unlike aspirin, tylenol and alcohol, pemoline was associated with acute onset fulminant (complete) liver failure at normal dosing whereas the former require massive overdoses or chronic ingestion (years) of higher than maximum daily dosages to cause liver damage. I agree with the FDA because pemoline was not a first line treatment for narcolepsy or ADHD (for which it was originally launched for) and has a track record of inferior efficacy as a stimulant at the price of increased risk of fatal liver failure. Not a great drug, and not widely prescribed in comparison to methylphenidate.

At 9:25 AM, Blogger Scott McC said...

Christine, what's your opinion as a pharmacist that patients should be given as much information as possible and then make their own decisions about risks associated with various drugs?

At 2:30 PM, Blogger Christeen said...

Well Scott, (tee hee sounding all serious), patients deserve the most education possible regarding drug therapy and should be included in the decision making process. Patient directed therapy is becoming a bit more common as an interview style employed by docs. But unfortunately a lot of the time patients will be at the counter and don't know much of anything or will say "I don't know what it's for. The doc just wrote something down" The internet unfortunately is a powerful source of info. I place a high importance on my counselling time because if I don't chances are the patient will research at unprofessional websites. Then you get all the phone calls at night "I read this about my that true?" I try to give people reputable website addresses while they're in the store. But most of the concern regarding safety lie in DMARDS (disease modifying antirheumatic drugs) like Methotrexate. i.e. very powerful, the gold standard at diminshing rheumatoid arthritis, but slightly increases your risk of destroying your immune system. But that's how most chemo-therapies work. You kill yourself just enough to kill the disease, but not enough to kill you. This is not the rational behind most drugs however. But these are important things to be aware of. I.e. Enbrel. Maybe you've seen happy arthritis free people dancing on beaches and gardening on the direct to consumer advertising for Enbrel. Did you notice in that horrific list of side effects at the end it mentions "increases risk of cancer". That's the thing. Most patients i've talked to on Enbrel (used for more end-stage disease than mild disease) are so happy they can get up and leave the house and walk that they don't care if there's a small increased risk of cancer. It's a quality of life issue at the heart of most risk benefit arguements. Yes, you could argue that pemoline for the patient that used it saved them from falling asleep at the wheel which was much better than death by way of car accident. BUT, chances are methylphenidate would provide that patient with the same benefits, as it is in almost all cases even better for narcolepsy than pemoline, without that liver risk. And the risk with pemoline was higher than slight. With Enbrel the risk is very low and there is no other drug like it with a better safety profile, as it is a biotechnology drug, so there's no substitute.

As time goes on I get nervous becaause in Canada more and more the government is unable to afford pharmaceutical R & D and clinical trials, so the research is becoming more and more industry-funded, meaning there is probably an increase of potential Vioxx situations because the studies produced by the industry are certainly not neutral. This scares me and I hate it. But anyway, it's always a good idea to talk to a doc about using an older drug vs a brand spanking new drug. Chances are the older drug is cheaper, and with 10 years of post marketing experience you can't go wrong becuase the medical community knows every possible known side effect and safety issue. Newer isn't always better. Think Vioxx again.

Except maybe in the case of antidepressants. People also get freaked out about antidepressants because they have heard you become addicted to them, and you can die of heart problems (associated with the very old ones and not any of the ones prescribed anymore)

I say this: if you were suicidal before you started them, and now you're not, it is still much better for your quality of life and mortality to take them for years and be able to live your life than the alternative.

I guess thats my stance. Weigh your quality of life against everything you know about the drug therapy, have a discussion with your doctor (and your pharmacist :-) about the alternatives, the long term safety, the side effects and the benefits and obtain reputable websites to look at for self-research, and then come up with a plan with your health care provider. Make regular appointments and continually evaluate your progress.

Wow I sound like some sort of manufactured documentary. Well anyway, I suppose I'm a product of my pharmacy enculturation. There you have it. A very long winded answer.

At 3:35 PM, Blogger Scott McC said...

Thanks for your views, I was very curious as to what you thought about this subject.


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