Pharmaceutical Outsourcing

Most U.S. citizens would be surprised to learn that the side effects and warnings for their prescription drugs (called Patient Insert leaflets) are only a brief summary of the drug manufacturer’s complete label. In addition the pharmaceutical companies don’t design the Patient Inserts, nor are they regulated or tested for accuracy by the FDA. Instead, pharmacies pay third-party corporations known as electronic drug information (EDI) companies to summarize the side effects.


Surprised? Welcome to the freakish world of our nation’s health-care bureaucracy influenced by powerful lobbies, a world I discovered the hard way. I took the antidepressant drug Zoloft (prescribed by our family doctor) for five months in 2003. During that time I experienced a drastic loss of inhibitions, boundless energy, speaking constantly, a head full of wild ideas, etc.


But what goes up must come down, and down I crashed once I tapered off Zoloft. I had a nervous meltdown, blew thousands of hard earned dollars, slept 16 to 18 hours a day, hallucinated in Salvador Dali fashion, and became obsessed with suicide. That fall I had to drop out of college and since then I’ve been trying to put together some semblance of a life.


I finally went to a psychiatrist a year after I quit Zoloft and got a devastating assessment: Zoloft had caused hypomania, which “triggered” a bipolar disorder and worsened it with every dose. My grandfather had bipolar disorder and shot himself because of it. Had I known Zoloft could induce mania, I would never have taken the drug. I knew that there was a genetic component to the disease and I was at risk of developing it.


Nobody had warned me of this potential nightmare, not even the pharmacy’s Patient Insert leaflets, designed by a company named First Databank. I discovered the hypomania/mania side effect was listed on and had been recognized by Pfizer and the FDA since October 1996. Pfizer representatives told me they are not responsible for the information given out by pharmacies, that this information comes from electronic drug information companies.  


EDI companies arose thanks to a bit of twisted history going back to the Reagan years. In 1979, during the Carter administration, the FDA pushed for mandatory Patient Inserts prepared by the drug companies with FDA oversight (as is currently done in several European countries). The pilot program was scrapped by an executive order issued by Reagan in 1981 and backed by the aggressive activities of vice president George Bush, head of the Administration’s regulatory reform council. The pharmaceutical industry had complained about costs and liability, pharmacists complained about storage space for the pre-printed Patient Inserts, and doctors complained that the warning sheets would infringe on the doctor-patient relationship.


The Reagan administration suggested the private sector design Patient Inserts, but it was never clear how that was to happen. Obviously the drug makers did not want to be involved and they got their wish. It was not mandatory for pharmacies to give Patient Inserts and ten years later it became clear the free market initiative was failing as people complained about injuries and of being ill informed. The head of the FDA during the Clinton era, David Kessler, pushed for mandatory Medication Guides to be designed by drug manufacturers. However, as in the early 1980s, a conservative Congress, backed by intense lobbying by the pharmaceutical industry and organizations like the AMA, declared the proposal dead on arrival.


Today the FDA has no power to regulate the drug information provided by pharmacies and we play drug roulette every time we have a prescription filled. What insanity is this? The drug manufacturer has more knowledge of their product’s side effects and risks than any party, including the FDA. Big pharma is playing pass the buck when it comes to the “duty to warn,” while their advertising generates record profits off the psyches of unknowing consumers. Shouldn’t pharmaceutical companies be forced to bear the cost of injuries associated with their product’s use, and not the pharmacies?


Pharmaceutical outsourcing is another chronic symptom of the U.S. government’s continual kowtowing to well-funded lobbying practices. Lives ruined, friends and family lost, innocent victims financially bankrupt­–these are the real side effects.


Frazer Merritt is 23-years old and unemployed. He was a 4.0 student before his Zoloft “accident” and he had to drop out of the University of Sheffield.