What One Human Test Subject's Experience Can Tell Us About Pharmaceutical Companies And The OxyContin Scandal

What One Human Test Subject's Experience Can Tell Us About Pharmaceutical Companies And The OxyContin Scandal

by from Medelita | Monday, May 09, 2016
tags: Medical News

Drugmaker Purdue Pharma has come under fire after an L.A. Times investigation published last week revealed that the effects of the company’s cash cow medication OxyContin wears off in patients far sooner than advertised, leading to aggressive withdrawal symptoms. Many experts believe the highly addictive drug - which is a chemical cousin of the cheaper street heroin - to be at the center of the nation’s current opioid epidemic, with over 7 million Americans reported to have abused the medication in the past two decades since its release.

This story comes as the latest headline adding fuel to the fire of public opinion regarding sketchy practices within the pharmaceutical industry, where officials have proven time and time again to be more concerned with profit margins than the well-being of patients. Purdue Pharma, the pharmaceutical company at the center of this startling discovery, reaped over $31 billion in revenue since introducing OxyContin to market by advertising the drug to relieve pain for 12 hours. But the uncovered documents tell a different story, indicating that Purdue was actually aware of the falsity of this claim since early clinical trials of the medication failed to relieve patient symptoms for a full 12 hours.

Entering the industry as a human guinea pig

The journey for a new drug to go from the lab to the medicine cabinet is a long one, and is unique for every drug, according to the FDA, but every drug must undergo a series of clinical trials. After being tested safely on animal subjects, a drug moves into phase 1 of clinical trials, where it is administered to a group of 20-80 healthy human subjects. With the public growing more and more distrustful of the pharmaceutical industry while the rate of new drugs being introduced to market continues to grow, who exactly are these people willing to volunteer as human guinea pigs?

Recently VICE reported an interview with Sam Spadino, a writer and filmmaker who funds his passion projects by working as a human lab rat in phase 1 clinical trials. During phase 1 of clinical trials, drug companies seek to test new medications on healthy patients to observe any side effects. Though this line of work is inherently risky, a full-time human test subject can make up to $28,000 by participating in these studies. 

At the time of the interview, Spadino was on day 71 of a 90-day thyroid medication study. He details the accommodations (a dorm-style clinic with bunk beds), the food (mediocre hospital-type food), and the compensation ($250 a day, which he says is pretty reasonable), and describes some of the weirder experiments he has been a part of. As an individual with limited access to regular healthcare services on his own, Spadino feels that he benefits from the regular check-ups with doctors that this line of work allows him.

Spadino believes that his non-traditional day job has given him an insider’s perspective of the pharmaceutical industry, which he says is “a really f**ked up system of legalized drug dealing...just a creative means to push products that don’t seem to cure anyone.” While he doesn’t deny the fact that there are drugs out there that do help people, he compares the relatively small number of cures discovered to the large number of sleeping pills or amphetamines that are produced regularly. Spadino says that he does not use pharmaceutical drugs himself outside of his participation in these sorts of studies.

As for the recent discovery of Purdue Pharma’s false claims, records from the clinical trials of OxyContin seem to confirm Spadino’s observations about the industry from which he admittedly benefits. Investigators found that in almost every clinical trial of the drug, “many patients given OxyContin every 12 hours would ask for more medication before their next scheduled dose,” at the same time as the company was pursuing FDA approval and a patent for “a medical breakthrough that controlled pain for 12 hours ‘in approximately 90% of patients.’”

Obtaining FDA Approval

FDA agency guidelines required Purdue to demonstrate that the medication was safe, effective, and would last for at least 12 hours in at least 50% of patients. To receive this approval, Purdue submitted an 1989 study of ninety women recuperating from surgery in Puerto Rico - though more than a third of the women given the drug complained of pain within the first eight hours, and almost half required more pain medication before 12 hours. Still within the range required by the FDA - but just barely. The FDA approved OxyContin in 1995.

The leader of the FDA’s medical review of the medication, Dr. Curtis Wright, left working at the agency not long after its approval. Less than two years later, he was working for Purdue Pharma in the new product development department. Dr. Wright declined to comment on the LA Times’ discovery. Current officials at the FDA also declined to comment.

Though drugs work differently on different individuals, it seems clear that the pharmaceutical industry has a tendency to obscure relevant truths to the public for financial gain. The industry has been facing pressure for greater transparency when it comes to prescription medications, echoing a desire from both patients and providers who are becoming increasingly frustrated over soaring drug prices and the questionable ethical practices of the companies behind it.