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Big Pharma’s Dangerous Influence on the FDA Approval Process

Written by Ankin Law Office

For much of the past decade, OxyContin, a popular painkiller, was marketed as a safe prescription drug, approved by the FDA with a label indicating that the risks of addiction were “reported to be small,” and touted by such reputable medical journals as the New England Journal of Medicine as having “a minimal risk of addiction.”The nation’s ongoing painkiller addiction epidemic is highlighting the dangerous influence that the pharmaceutical industry has on the FDA approval process. According to statistics provided in a Washington Post article, prescription painkiller addiction is even more prevalent than cocaine or heroin use, with nearly 2 million people becoming victims of addiction – a fact that was denied for years by the pharmaceutical industry.

But in recent months and years, significant evidence has surfaced showing that not only is Oxycotin addictive, but that data indicating its addictive nature may have been disregarded for years.

OxyContin and other painkillers such as Vicodin and Percocet are in a class of drugs called opioids that are used to treat pain. Opioids include morphine and heroin, as well. For years, doctors had been hesitant to prescribe opioids to any patients other than those suffering from cancer or acute pain. But a growing body of data assembled by drug manufacturers helped reassure doctors that opioids were not addictive and soon the drugs were used to treat people with chronic pain conditions, such as back pain, arthritis, and sore knees.

Over the past 20 years, retail prescriptions for opioids have tripled and, upon closer look, it appears that the increased sales were due, in large part, to the medical opinions provided by pharmaceutical companies that stood to gain from the increased sales.

According to the Washington Post, the reports provided by the pharmaceutical companies reported minimal risks of addiction. As a result, the reports were used by the FDA, well-respected medical journals, and state medical boards in reaching decisions to approve and/or promote the drugs. The influential reports eventually made their way to physicians through Big Pharma’s marketing efforts. The doctors, in turn, relied on the data to prescribe the drugs more often and to more patients.

But the Washington Post is revealing that a closer examination of scientific papers, court documents, and FDA records shows that many of the claims that were made were developed in studies that were supported by Purdue Pharma, the maker of OxyContin, and other drug manufacturers, rather than independent research. The conclusions that the drug makers reached were sometimes unsupported by medical data.

A review of relevant data by the Washington Post revealed the following startling facts:

  • Of 16 key clinical trials, five were funded by Purdue Pharma and an OxyContin distributor, two were co-authored by Purdue Pharma employees, and two were sponsored by other drug companies making different opioids.
  • Internal company documents indicate that one of the key studies sponsored by Purdue Pharma, which was published and reprinted 10,000 times, omitted suspected cases of withdrawal symptoms.
  • To refine its policy on opioids, the FDA relied on the recommendations of a 10-person panel, five of whom had connections to Purdue Pharma and three of whom had connections with other pharmaceutical companies.

The low rate of addiction reported in the earlier studies contradicts more recent research showing that addiction is common in opioid patients. In fact, a study out of Yale School of Medicine found that diagnoses of addiction are “common” in patients given opioids for back pain, with as many as 24 percent engaging in “aberrant” or peculiar ways of taking the pills.

Phillip Prior, a board-certified addictionologist who has treated thousands of patients addicted to opioids, has expressed serious concerns about the role of pharmaceutical companies in the marketing and FDA approval process. “You could say these marketing tactics are merely concerning,” Prior said. “But I think of them as satanic. What the data are telling us is that these drugs are ruining people’s lives.”

The Chicago unsafe pharmaceutical attorneys at Ankin Law Offices, LLC are dedicated to protecting patients and consumers from harmful prescription drugs and medication errors. If you have been injured by a dangerous or defective pharmaceutical, contact our office at (312) 600-0000 to schedule a free consultation with one of our Chicago medical malpractice attorneys to discuss a possible legal claim.