Apropos of my post yesterday on Ambien, take a look at Lauren Slater’s Op-Ed piece in today’s New York Times (Jagged Little Pills). Ms. Slater gives an all-too-brief rundown of the history of psychotropic disasters, including iproniazid (introduced in 1955, yanked from the market in 1961 after causing 54 deaths), Miltown, and Prozac.
Ms. Slater suggests there is a twenty-year cycle on such drugs — twenty years between a drug’s introduction and the discovery of nasty side effects. I’m not sure where she gets this “twenty year” figure. Ambien hit the market in 1993. The bad news on Prozac, introduced in 1988, came out well before the twenty-year mark. We’ll take a closer look at Prozac in a moment. But first, what does Ms. Slater have to say about this delay?
Why the 20-year cycle? Perhaps it has something to do with the fact that a new drug has patent protection for about that length of time, after which it loses much of its profit power. Maybe drug companies are highly motivated to quash consumer complaints only until their patents expire. Or perhaps, more simply, 20 years is about how long it takes for nasty side effects to manifest. I like the idea that human hope has a half-life of about 10 years and is fully excreted in two decades, just as the chemical substrates of passion seem to last about four years, which is the point at which anthropologists have observed divorces begin to occur.
Ah, human hope has a half-life. Alliterative bliss, literary Prozac, Chicken Soup for the Pharmaceutically Challenged Soul. Excuse me, I have to puke.
Tell us, Ms. Slater, who is to blame?
One might be tempted to blame the pharmaceutical companies for our breathless approach to new drugs. Advertising sleep medications with butterflies alighting on upturned palms certainly gives the impression of safety, and more. But for how long can we rail against the predictable profit motive of advertisers?
It is time to say, buyer beware. Every questing singleton on Match.com understands that profiles are gussied up in the hope of sales. The nature of the game is such that no one writes “loveable, calm swm with occasional halitosis and some anger management issues.” And when these traits inevitably emerge, we don’t blame Match.com.
It is up to us, the consumers, to disregard the hype that too often infuses pharmacological findings — to know that the pill we cradle in our palm may ease our pain, but will just as surely take its toll.
So it takes twenty years for side effects to manifest. Hmm. And Big Pharma, which makes more than $2 billion per annum on Ambien and other sleep aids, isn’t to blame, but the emptor who fails to caveat. Someone please shove an enema tube in my ear and flush out all this bullshit. I spent two minutes on Google and found something Ms. Slater should have found, if she had bothered to do any research whatsoever on her op-ed piece. Guess when Eli Lilly, the manufacturer of Prozac — released in 1988, you’ll recall — first became aware of Prozac-related suicides and violence?
From Amanda Gardner, writing for Forbes:
Confidential company documents obtained by a leading medical journal suggest that drug giant Eli Lilly & Co. was aware that its antidepressant Prozac was linked to troubling side effects as far back as 1988, the same year the drug was introduced to the U.S. market.
But all meds have side effects, right? And Eli Lilly had to disclose those side effects to the FDA prior to Prozac’s release, right? Not so. Pharmaceutical companies are not required to release all of their research to the FDA. From Ms. Gardner’s 2004 article,
“The discovery of research, reportedly ‘missing’ for the past 10 years, that connects Prozac to increased suicidal tendencies and violence is one more tragic example of a greater problem: Unless we mandate that all research be disclosed to the FDA during the drug approval process, regulators have no choice but to make their decisions based on the best-case scenarios that drug companies report to them,” U.S. Rep. Maurice Hinchey (D-N.Y.), whose office is reviewing the documents, said in a statement. “These decisions affect the health and lives of millions of Americans. If Eli Lilly’s research indicated dangerous side effects of their product and they withheld that information, they knowingly jeopardized the public’s health. Their failure to disclose what they knew may have cost lives.”
Pharmaceutical companies don’t have to practice full disclosure to the FDA. The Bush administration argues that if the FDA has approved a drug, the company should be shielded from patient injury lawsuits. From the Seattle Times (2/19/06):
The Food and Drug Administration (FDA) last month issued a legal opinion asserting that FDA-approved labels should give pharmaceutical companies broad immunity from most lawsuits.
The Seattle Times article puts it all in context; the Administration would like to protect big business from lawsuits in general. What we’re seeing is an all-out attack on consumer protection legislation.
You know what? Ms. Slater is right. Caveat emptor. We need to look after our own asses. We certainly can’t count on Big Pharma, the FDA, and our government to do it for us.