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I Heard The Owl Call My Name
There is a book entitled I Heard The Owl Call My Name by Margaret Craven, which is a beautiful celebration of life among an Indian tribe living in a remote area of British Columbia and the effect it has on a young vicar sent to minister to the tribe. The Indian tribe believes that you will live until you hear the owl call your name.
On Thursday, Larry Golbom, Ed Vanicky, Pete Jackson and I heard the owl call the name of many more people who will die or start on the path to addiction. The owl was speaking through an FDA Advisory Committee which recommended to the FDA the approval of the new formulation of OxyContin.
Purdue Pharma manufactures OxyContin. OxyContin is oxycodone—legal heroin, that is coated in such a way as to make it release the oxycodone over an extended period of time and not all at once. This is why a doctor will prescribe much higher doses of oxycodone in an OxyContin pill than they ever would of oxycodone alone because of the dangers of opioid overdose.
In practice, Purdue has ensured that the oxycodone in OxyContin can be immediately released. Since its release in 1995, addicts and people seeking a heroin-like high have simply crushed the OxyContin pills and snorted them, injected them or just swallowed them. Some have estimated that as much as 50% of the OxyContin sold by Purdue is crushed to release the oxycodone all at once. Purdue has publicly stated that this was a tragedy, but it is now 13 years since OxyContin was released and they still haven’t bothered to make the formulation more tamper-resistant.
Why? My opinion is that they don’t want to do anything that would affect the sales of their legal heroin product. As we discussed in last week’s newsletter, Purdue Admitted Lying But Wants Us To Trust Them Now, Purdue should be out of business, but they were able to convince the U.S. Justice Department to accept a plea agreement. Purdue Frederick, a subsidiary of Purdue Pharma, and the three top executives of Purdue Pharma did plead guilty to lying about the addictive quality of OxyContin but, in another miscarriage of justice, only paid fines and did no prison time.
However, Purdue is still making billions of dollars even though their product is killing people daily and ruining tens of thousands of lives. Other drug companies have actually taken steps to make abuse very difficult. Suboxone contains buprenorphine and naloxone. Since it was released in 2001, few addicts even attempt to separate the buprenorphine—an opioid like oxycodone—from naloxone, a drug that will put people into painful withdrawal. Embeda, an opioid drug that acts similar to OxyContin, contains a second drug that, if tampered with, will create painful withdrawal symptoms.
Not Purdue. Does it make any sense that in 14 years this company could not make their drug really tamper-proof if they wanted? Their medical director, who is now a convicted felon, promised the FDA in 2002 that they would incorporate another drug but still nothing—typical Purdue.
ADVISORY COMMITTEE DILEMMA
With all the clamor from the press and the government about the tragedies being caused by OxyContin, Purdue had to at least appear to be making their poison harder to abuse.
In May of 2008, Purdue submitted junk science to support their request for approval of a new formulation of OxyContin. The Advisory Committee ridiculed the proposal and Purdue slunk back to the sewers where people like this live.
The public pressure has grown even more and this time Purdue decided to place the Advisory Committee in a nearly impossible position. In essence, they said that their new formulation was not tamper-proof but would be harder to tamper with and this could save some lives. So you either approve our half-hearted effort or you are responsible for the deaths of at least some people who can easily abuse our form of legal heroin now.
Purdue’s new formulation primarily just adds polyethylene oxide (a chemical used in many other drugs) to OxyContin. Purdue’s experts say that it would be “more difficult” for anyone to separate out the oxycodone. They also stated that they weren’t asking to have the label changed. In a sick way, this was a brilliant approach.
Many of the Advisory Committee members expressed their frustration that they were being asked to approve a reformulation that really did not make OxyContin tamper-proof but less easy to tamper with. Many of the members voting to approve the new formulation said that they could not oppose Purdue’s proposal because the present formulation was so bad that anything that made it less bad was actually better and might save lives.
WHAT IS REALLY WRONG WITH APPROVING THIS REFORMULATION?
Yes, it is true that OxyContin is a deadly product but approving this reformulation is not the answer.
Larry Golbom, host of the Prescription Addiction Radio and a pharmacist, pointed out that none of the testimony from Purdue addressed two issues.
- The first was that the tablet appears to be highly susceptible to heat, maybe even as simple as putting it in an oven and this could release the oxycodone and make the tablet just like the current OxyContin–legal heroin. This technique would be on the internet the day the new formulation was issued.
- Someone attempting to heat the reformulated OxyContin in a pipe to smoke it might have deadly consequences. There is evidence that the polyethylene oxide will be converted to a poisonous gas.
- On the internet are ways of separating polyethylene oxide from other drugs so that the abuser can access the actual ingredients to get high.
Of course, we are asked to believe that Purdue somehow spent millions of dollars testing their new formulation, but they did not conduct tests on what happens if their reformulation is heated in the oven, or if someone attempted to smoke it, or if there were directions on how to separate out the polyethylene oxide. Right! That is really credible.
Pete Jackson and Ed Vanicky pointed out:
- The reformulation would have done nothing to save Pete’s daughter or Ed’s wife who died after taking OxyContin orally and did not tamper in any way with the drug.
- Most of the deaths caused by OxyContin happen after taking the pills intact and this will do nothing to prevent this.
- Purdue is a criminal company that will stop at nothing to make profits.
- Purdue will tell everyone that their deadly product is now safe, which will take thousands more lives.
The statement of Sandra Kessler who was ill and could not attend. In her statement, Sandra said:
- Sandra’s son Josh also overdosed while taking OxyContin intact.
- Purdue is only worried about increasing their blood money.
I made the following comments:
- Purdue was asking the FDA to trust them. As one of the Advisory Committee members skeptically pointed out, their scientific data supporting their reformulation was not very persuasive.
- Purdue is the same company that so misrepresented their patent application for OxyContin that a federal judge believed that terminating their actual patent was appropriate.
- Purdue is a company that pled guilty in 2007 to the felony of lying about the addictive nature of their product, legal heroin, to doctors, and caused the over-prescribing that led to tens of thousands of OxyContin-caused deaths.
- Except for the decision by the U.S. Attorney to apply a different form of justice to Purdue, this is a company that would have been out of business in 2007 and more thousands of lives would have been saved.
- How could the FDA trust that this criminal company would not have their sales representatives promoting that their new formulation was “safe”, which would likely result in more over-prescribing and more deaths and ruined lives, because this is what they will do.
- Since they are keeping the same name, there would be an unintended consequence if this new formulation of OxyContin was approved. People will think taking OxyContin, legal heroin, will give them a high, but when it doesn’t work immediately, they will take another and possibly even another. This will result in more people suffering from respiratory depression which will lead to more and more deaths.
- The deaths of these people will be the direct responsibility of the Advisory Committee members and the FDA if they approve this formulation.
Sadly, if the new formulation of OxyContin is approved, doctors will be told by Purdue sales representatives that their product is “safe.” In fact, many of the news stories talking about the Advisory Committee voting to approve the new formulation say that this is a “safe” version of OxyContin.
Sadly, we will hear the owl call the names of many who will be given this drug because of the false claim that it is now “safe” and who will die. Thousands more will become addicted or dependent.
Sadly, Purdue doesn’t care. The company has no shame and apparently has managed to find employees who have no conscience. To them it is only unethical or bad if somehow they don’t make a profit—regardless of the deaths and tragedies they create.
It is not the end of this story. The FDA still has to approve this and we will do everything that we can to help the FDA understand that this is another lie from Purdue and should not be approved.
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