Drug companies paid up to $25,000 to influence FDA policy—the latest in a decades-long FDA/Big Pharma scandal. Action Alert!
What class of drugs:
- causes more deaths a year than heroin and cocaine combined;
- accounts for two-thirds of drug overdose fatalities;
- killed 16,000 Americans in 2010 alone;
- adds $72.5 billion a year to the cost of US healthcare from misuse; and
- according to the CDC, has directly contributed to a sharp rise in our country’s suicide rate?
We’ll give you a hint: they’re FDA-approved.
Since the 1990s, there’s been an explosion in the use and abuse of highly addictive painkillers such as oxycodone (the main ingredient in OxyContin) and hydrocodone (found in drugs like Vicodin). Given the alarming social, health, and even economic costs of this epidemic of painkiller abuse, there has been considerable pressure from both inside and outside the FDA to improve the regulation of these drugs. In 2008, the DEA requested that FDA tighten controls on hydrocodone (a request the FDA denied), and in early 2013, the FDA’s own advisory panel of experts recommended that it toughen restrictions on highly addictive painkillers (FDA has yet to take the panel’s advice).
A recent “pay-to-play” scheme—exposed by the Washington Postearlier this month—hints at the FDA’s real priorities. The Post reports that companies paid as much as $25,000 to attend meetings with FDA officials to shape policy on how drug manufacturers can prove the “safety and effectiveness” of their painkillers. These are, of course, the magic words that lead to enormously lucrative drug approvals.
The FDA states that the fees paid to attend the meetings did not go directly to the Agency. If so, they presumably went to the organizers. This is believable—$25,000 is a pittance in the big drug game. Even so, the FDA cooperated. And it does not seem a coincidence that two of the FDA officials who participated thereafter went on to work as pharmaceutical consultants.
In a recent statement, Sen. Joe Manchin III of West Virginia—one of the states hardest hit by the painkiller epidemic—suggested a plausible connection between the pay-to-play meetings and the FDA’s rulings. They could “explain why it has taken the FDA almost a year to reach a decision to reschedule hydrocodone even after their own expert advisory panel recommended it.”
The senator is now calling for a full investigation of the FDA’s role in these meetings. In a letter to the FDA, he demanded the names of all companies that paid to attend meetings, how much they paid, and all emails between FDA officials and the meeting organizers. The senator deems this necessary in order to address “serious doubts about the FDA’s ability to make objective and scientifically based decisions regarding the proper treatment of prescription painkillers.” We agree.
All of this is just the latest chapter in a long saga of FDA foot dragging about acknowledging and addressing the prescription pain killer epidemic. So far there has been some talk but little action.
For example, in a September 2013 press release, the FDA issued labeling changes for long-acting opioids (like OxyContin), stating their “resolve to reduce the serious risks” of rampant painkiller abuse via responsible labeling. This is about eighteen years too late, and no one thinks that better labeling alone will solve the problem.
In 1995, the FDA approved the labeling claim “delayed absorption” because it was thought that this form of the drug would reduce the potential for abuse. The idea was that extended release would make the drug less addictive. It’s worth noting that Purdue, the drug company that produces Oxy, never submitted independent studies to support this special labeling claim, and the FDA didn’t ask for any.
Twelve years later, the FDA—instead of acknowledging its mistake—made moves to cover its tracks. In 2007, the FDA publicized its decision to fine Purdue $600 million for telling doctors that Oxy is less addictive than immediate-release opiates. This fine was a pinprick, a tiny sumcompared to the $26 billion worth of Oxy sold since approval. But more importantly, as we have seen, the FDA had themselves approved the extended claim in 1995 precisely because it was thought to render the drug less addictive. In effect, the agency was fining Purdue for “illegal” activities that they themselves had approved.None of this is too surprising—the parties in our crony capitalist drug system do not trust each other, and for good reason. Anyway, the agency has now completely reversed itself: as of 2013, it declares that extended-release drugs are more dangerous, the reverse of what they had earlier assumed to be true.
There are, of course, much safer and more natural approaches to pain relief. We discuss a number of them in this article in today’s newsletter.
Action Alert! The American people deserve to know the full story here. Please write to your senators and ask them to join Sen. Manchin’s call for a full investigation of FDA’s inappropriate relationship with painkiller producers and other drug companies.
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