“Pay-to-Play” Meetings Shed Light on FDA’s Role in Prescription Abuse Epidemic

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:

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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  1. You reduce your effectiveness when you mislabel Sen Joe Machin as (R-WV) in your letters and as from Virginia in your separating people into Virginia and non-Virginia.
    A strong message. Please correct errors so as to increase its effectiveness.

  2. The problem you ignore is the people with real pain. Not addicts. People hurting. You think this
    will help something and serve some nobel purpose. I use Vidcodin for pain. My life would be impossible without it. Thanks for trying to make it harder for me to get treatment. I was told by a
    very good doctor that marijuana would help me more and be much safer. But of course you and other make sure I cannot get it legally. I won’t break the law so I must use a more dangerous drug.
    Do you really feel more laws hampering doctors is the answer ? Addicts will get what they want
    another way. All the drug laws we have to put people in prison for using these illegal drugs hasn’t stopped anything. Drug companies don’t make much on Vicodin. It is cheap and generic and not worth these big companies time to try and fool anyone. If you want to do something useful try getting them to make drugs that cure something. They don’t want to cure you because you won’t be a customer anymore. Thanks

  3. I tried to take action by selecting the not a resident of Virginia button and your page briefly pops up and then is redirected by Yahoo and states this page is unavailable. I believe your being blocked by Yahoo.

  4. Big Pharma has played far too big a role in FDA drug approval processes–like having the fox watch the henhouse!

  5. Congress voted to allow for profit companies to provide funds to the FDA. Is the FDA going to bite the hand that feeds them? Bottom line is that the FDA does NOT have the best interest of the American people in mind when they have to support with actions their biggest money contributor – the pharmaceutical companies.

  6. The flip side of this is that patients with intractable chronic pain, the ones who have tried everything and need every possible option, are having tremendous new problems accessing opioids no matter how extreme their condition is. They are all being treated like addicts even when they are people who use medications carefully and as little as they can manage. Although in the past opioids were overprescribed, now there is a kind of Prohibition mentality that is no better, and patients of mine are among those being harmed. In this case FDA may have been correct (now there’s a phrase I don’t use often) because we really do not have safer painkillers available for the worst cases– the ones who haven’t responded to measures such as you listed in your “natural solutions for pain” article.
    ANH does very necessary work and puts out information that we all greatly need, but I get tired of your demonizing of whole classes of drugs. There is a place in health care for all types of approaches, including pharmaceuticals, and we often need to combine “alternative” and “mainstream” strategies. If you were working with extremely ill patients and trying to do everything you could to help them, you might have a different attitude. Let’s do what works best in each situation for each person, and keep our options open.

    1. This group is about promoting alternative non drug therapies because they profit off them and they are out to save their industry against the attack of the fda who is an arm of pharma, which have nearly destroyed the medical field. Sadly I see a similar trend in alternative doctors who are all about profit and gouge for natural therapies. The NASA pain reliever device they list for pain relief is listed at nearly 2k, when there are other non profit devices on the market for under 250.00 but they dont get pain on promoting them so you wont find those listed here. check out dr.bob c beck, he never patented anything but left us with the technology and a low cost source if you don’t want to build it yourself. His technology will break addiction, reverse effects of stress on the brain, which unravels a myriad of issues most drugs are used to quell. Pain is also one of the uses his device works on, but there is no profit margin for their sale, so there aren’t any promotions of it other than by people who’ve used them, of which I am one.
      I get sick of those positioning themselves as altruistic when they are in fact Profit motivated.

    2. Thank you so much Elene Gusch, DOM.
      Im a chronic pain patient myself. I am now prescribed less than half of the pain medications I was taking -but at times,if anything my pain is worse now. I’m taking so much less because especially in this.state..but in *msny* chronic pain patients are indeed treated like addicts! I’m not even given the same amount of Ultram I once was poo described. Many doctors either believe this prohibition like mentality, or, understandably-just don’t want to lose their licenses. However, I am sick and tired of being policed like this. A pain contract is oneting.
      However, I feel like I’ m facing incredible odds now and more all the time ingoddaughter in credibly, my granddaughter has an entirely different, but chronic pain issue..and faces this discrimination all the time. I’m so beat down by the judgement and demonizing that I wonder if I can go on like this. Thanks for the heath of fresh air.

  7. I’m sorry, but, this article grossly understates the dangers of FDA approved drugs. Adverse reactions (ADR’s), to FDA approved drugs causes over 100,000 deaths and over 2 million serious adverse reactions per year, and those numbers only account for ADR’s occurring in hospitals, not in the community, and do not include medical error of mis-dosing or mis-prescribing.
    This makes ADR’s to FDA approved drugs, the indicated drug, in the correct dose, in a hospital setting THE 4TH LEADING CAUSE OF DEATH IN THE U.S. behind only heart attack, cancer and stroke, and ahead of pulmonary disease, diabetes, AIDS, pneumonia, accidents, and automobile deaths. In other words, you’re in a hospital, you get the correct dose of an FDA approved drug, and it kills you, is the 4th leading cause of death. Community ADR’s are unknown.

  8. Finally, someone with intelligence, has spoken up for those of us that have no other choice but to use narcotic pain medications just to keep our pain levels down to the point that we are able to function in our everyday lives. I think it’s time someone went through the FDA, and any other group that is making a sham of drug regulation, and start kicking them out the door. Something has to be done about the incredibly large sum of money that is involved in this whole mess. Time to put some honest people into the program to get it in control. Thank GOD for those who are starting to speak up on behalf of us that have no other choice but to use these drugs. The process that my wife and I have to go through to get some relief from our everyday chronic pain is just outrageous and unnecessary. W are both elderly and just want to live out what is left of our lives without debilitating daily pain. Please, someone help us.

    1. I too am elderly living with chronic pain and need a painkiller sometimes once every day. Sometimes more, but I ration them with great care. Let us all hope that oxycodones and vicodins can remain available to those who truly need them..

    2. I have a nephew who got addicted to Oxycontin in high school. This drug is very dangerous. After years of not being able to shake the addiction he is now in a two year treatment program. This drug needs to be considered a class 1 narcotic and not a pain killer lightly prescribed by doctors so it winds up in the family medicine cabinet. No child should have access to this drug.

  9. I’ve tried several times to post a comment about this article but someone keeps censoring it. It looks like there may be someone here connected to the FDA that doesn’t like what I have to say. So much for our “Freedom of Speech”.

  10. This is where ANH is wrong. Prohibition is just wrong. ANH exists because Big Pharma is constantly trying to get safe & effective natural remedies prohibited. More prohibition is never the answer. Mentally sound adults should be able to obtain anything they want to buy, as long as it’s not harming anyone else. For Jiminy Cricket’s sake, people are allowed to buy & smoke cigarettes, which harms other people around them, in addition to themselves. Personally, I feel that things like this should be OTC through pharmacies, alcohol is regulated & available OTC. I have no desire to be on medications, OTC or otherwise, but it’s really none of my business if other people are.

  11. I too am concerned that it will be made harder for people truly in pain to find relief. Who knows why people are dying taking them; many also contain acetaminophen which can be very harmful to the liver if you combine it with alcohol, but I hardly ever see that mentioned.
    It seems obvious that an extended release opiod would be more habit forming because you don’t give it as much chance to really wear off. But on that note, I think everyone should be aware of this excellent article:

  12. Ozone works well for many causes, and can be injected directly into painful joints bringing often immediate relief.

  13. I make these posts in peices, because I have experienced NSA’s censorship before. Ozone works surprisingly well.

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