Purdue Pharma is a drug company that thinks nothing of spending millions of dollars promoting their legal heroin product---OxyContin---even though it continues to kill people every day and daily ruins the lives of tens of thousands.  However, there are some individuals who will stand up to this company that pled guilty to a felony for lying to doctors about the addictive qualities of OxyContin.

Our country and our civilization have been built by ordinary people who did extraordinary things.  Pete Jackson is one of these people.  He is well known to the FDA.  He is a private citizen who pays his own expenses to attend and testify at FDA hearings.  His name is also a name that the admitted criminal drug company, Purdue Pharma, wishes it had never heard. 

Pete Jackson never asked to be a leader in the movement to ban OxyContin.  He is a biologist with the Environmental Protection Agency in Chicago.  He and his wife were raising two great children and looking forward to being grandparents.  Then it all changed.    The following is the statement Pete sent to the FDA.  At the end of Pete's statement is a picture of Emily, his daughter.

Statement of Peter W. Jackson

Docket No.  FDA-2009-N-0664
Joint Meeting of the Anesthetic Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee
September 24, 2009

My name is Peter W. Jackson.  I am a biologist with the U.S. Environmental Protection Agency in Chicago.  My wife and I reside in Arlington Heights, Illinois where we have raised two children.  The smiling girl on the screen is my daughter Emily, a friendly, compassionate and high-spirited eighteen year-old girl who died from an overdose of OxyContin in August 2006 after she had taken one OxyContin pill offered to her by her cousin.  This was her only encounter with OxyContin.  She was just a normal 18 ½ year-old kid.  She died three days before her first day of college.  We used the money saved for her college education to bury her. 

Tragically, when Emily accepted this drug from a trusted relative, she was not told that it was as dangerous as heroin.  She was blindsided.  One pill, swallowed whole.  What other drug can kill you with one pill?   

For some of you, Emily might look familiar.  I have appeared before your committees several times since Emily left us, as has my wife.  We have begged FDA to help stem the tide of death and addiction from the nonselective, widespread use of OxyContin approved for a wide variety of moderate pain indications.  We are still waiting.  I speak for many thousands of American families who, like us, are still waiting. 

I am also here to represent Advocates for Prescription Opioid Drug Reform (APODR), a national group of bereaved parents and spouses, and parents of children fighting opioid addictions.  Our families have been all but destroyed by opioid narcotics, primarily OxyContin.  We are also doctors, pharmacists, addiction treatment specialists and support groups, united in our determination to raise awareness of the silent epidemic of prescription opioid drug abuse, addiction and death that is gripping our country. 

OxyContin – Killer, Catalyst

The FDA’s approval of OxyContin in 1995 was the catalyst behind the dramatic increase in the production and sale of prescription opioids in this country.  Over a nine year period ending in 2006, oxycodone prescribing increased by 732% (ARCOS).  80% of the world’s prescription opioid supply is now consumed in the U.S. [1,2].  Statistics indicate that the increase in the prescription of opioids is behind the rising mortality trend with prescription drugs, which are now the second largest cause of unintentional deaths in the U.S. behind motor vehicle crashes.  Opioids now cause more deaths than cocaine and heroin combined [3].  From 1992 to 2003 new abuse of all prescription opioids among teens was up an astounding 542 percent, and ten percent of teens have abused OxyContin [4].  A recent study found that even children under the age of six are being harmed and in some cases killed by exposure to prescription opioids (in press).

According to new data from CDC, in 2006 an estimated 26,389 people died from drug overdoses in the U.S. [5]  A total of 10, 986 of these deaths were attributed to opioid analgesics as compared with 6,726 involving cocaine, and 1,869 involving heroin.  While the exact percentage attributable to OxyContin is unavailable for the nation as a whole, in 2008 oxycodone caused 941 deaths in Florida and was involved in 633 more deaths, more than any other drug [6].  Oxycodone is the single most commonly reported suspect drug in mortality reports to the FDA [7]. 

FDA Has Not Dealt with the OxyContin Problem

The existence of this well-documented explosion of prescription opioid drug abuse since the introduction of OxyContin is proof that the drug control policies in this country have been an utter failure.  FDA has taken a hands-off approach to the problem.  Regarding OxyContin, despite a variety of drug education programs, despite a risk management plan implemented by Purdue, despite FDA having issued warning letters and labeling changes, and incredibly, despite Purdue Pharma’s guilty plea to a felony charge of illegally misbranding OxyContin “in an effort to mislead and defraud physicians and consumers”[8], FDA nonetheless allows Purdue to continue to market OxyContin for a wide variety of moderate pain indications as if everything is fine.  As a result, oxycodone production levels continue to rise, OxyContin pills continue to flood our Nation’s medicine cabinets and school lockers, and people continue to die in increasing numbers.  Meanwhile, a number of prominent reviews and studies have cited a lack of evidence on the long-term efficacy and safety of opioid therapy for chronic noncancer pain, and have drawn attention to diminished pain relief, increasing tolerance, and increasing abuse and addiction rates resulting from long-term administration of opioids [9, 10, 11, 12, 13, 14]. 

Will someone please explain to me why the FDA continues to ignore all of these deaths and those who suffer the adverse consequences of OxyContin being so widely-distributed like aspirin?  How many more people need to die before the FDA will do something to stop this epidemic?  I first asked this question at an FDA hearing early in 2007.  Since then 705 people died from oxycodone in Florida in 2007 and 941 people died from oxycodone in that state in 2008, yet still FDA does nothing.  And this is one state.  Imagine the number for the entire country if all states’ medical examiners filed reports as does Florida!  At the very least, FDA is complicit in the deaths of many people.

FDA plays a crucial role in the solution to this problem.  After all, it was the FDA that approved this drug.  FDA has the authority to withdraw the approval of a drug, restrict its distribution, or negotiate labeling changes [15], and passage of Public Law 110-85 last year significantly enhanced the agency’s authority to effectively regulate drug safety, including drugs already on the market.

A False Sense of Security

Of course, the official purpose of today’s meeting is to consider once again a new drug application for OxyContin that is purportedly tamper-resistant.  Can any committee members answer the question of how the FDA, an agency of the federal government, can even entertain an application from a company convicted of a felony by that same government when the company is still on probation for its crime?  It makes a mockery of our legal system.  And further, what is different from the last time Purdue brought this NDA in for review?  This formulation is presumably designed to preclude the release of the active ingredient upon crushing the drug as is possible with the current formulations of OxyContin.  However, our daughter did not crush the pill, she swallowed it whole.  In fact, most people I have spoken with whose child or spouse died from an OxyContin overdose said exactly the same thing – they took it like aspirin.  There was no tampering.  This is one of the big myths surrounding OxyContin – that it is only abused by crushing.  Is the new formulation somehow less risky for opioid-naïve users if taken whole?  And what about the effect of alcohol?  Has Purdue studied the effect of heating the drug? 

The FDA needs to be very leery of approving a new formulation that, upon approval, would be heavily marketed as “tamper-resistant”, or even as “safer”, by the same company that pleaded guilty to a felony charge of lying to doctors about the safety of the original formulation.  ANY formulation that is marketed by Purdue as a tamper-resistant or safer formulation of OxyContin will lead doctors to a false sense of security as physicians all across the country are once again duped by Purdue’s marketing propaganda to believe that the new formulation can do no harm, and the resulting surge in sales will lead to MORE deaths, not fewer.  Remember, Purdue is not claiming that this new formulation is tamper-proof; it is merely purported to be tamper-resistant or safer.   It defies logic and reason that Purdue, a convicted corporate felon, is still in business selling this same drug given this legacy of death and deceit.  I ask this joint committee to please recognize the false sense of security that will result if this new formulation of OxyContin is approved, and I urge you not to endorse approval of this NDA. 

Ban OxyContin

But today your joint committee has much more important business to conduct than to discuss the OxyContin NDA.  FDA’s mission is to promote and protect the public health.  FDA has failed to fulfill its mission insofar as OxyContin is concerned.  The problem with OxyContin has existed for some time, well before this NDA.  Committee members, as an impartial panel of experts you have an important opportunity to send the FDA a message that they must act boldly to stem the loss of life from this drug.   Because of this drug’s continued availability, the continuing deaths, the company’s long history of unethical and illegal marketing of the drug, and the company’s felony record for misbranding OxyContin, you must strongly recommend that the FDA remove OxyContin from all U.S. markets.

OxyContin must be removed for the following reasons:

1) The harm (to both patients and nonpatients) that has been wrought by this drug is far greater than any perceived benefits since OxyContin offers no efficacy or safety advantage over other previously available opioid medications [16-24].

2) OxyContin offers no benefit over previously-existing formulations other than convenience [16]; for this, we suffer thousands of deaths and addictions.

3) Perceived analgesic benefits of OxyContin are based on immediate, short-term effects of OxyContin on killing pain; longer-term benefits of opioids are unproven and extremely uncertain for most cases [10, 14].

4) Patients undergoing clinical detoxification from OxyContin often report lower pain after they are taken off OxyContin [25].

5) Rising demand for heroin is being driven by OxyContin use.  APODR has pages long lists of personal, documented accounts and there is increasing media coverage of this connection [26]; the true adverse impact of OxyContin is significantly underrepresented as it does not account for heroin deaths/addictions resulting from initial use of OxyContin.

6) Purdue, the manufacturer of OxyContin, engaged in unethical and illegal marketing behavior which resulted in the widespread distribution of OxyContin that ultimately caused the deaths of thousands of Americans and the addiction of thousands more.  As acknowledged by Purdue in a plea agreement in the U.S. District Court of Western Virginia, supervisors and employees of Purdue “marketed and promoted OxyContin as less addictive, less subject to abuse and diversion, and less likely to cause tolerance and withdrawal than other pain medications”, and thereby engaged in unethical and illegal marketing behavior “with the intent to defraud or mislead”, leading to a felony conviction for misbranding [27].

7) OxyContin has become the national symbol of prescription drug abuse in this country.  Purdue Pharma’s reckless and illegal marketing of this narcotic is also well-known throughout the pharmaceutical industry.  By banning OxyContin from U.S. markets, the FDA would be sending the industry a strong signal that this conduct will not be tolerated.

The risk-benefit ratio of OxyContin can no longer be evaluated without considering the felony record of this company.  This company should no longer be allowed to sell a drug that resulted in the deaths of thousands of Americans, all due to the overprescribing that resulted from Purdue’s acknowledged false claims to doctors.  I have included a copy of the U.S. Attorney’s summary of the crimes committed by Purdue that led to their felony conviction.  If you are not familiar with what this company did, you need to read the U.S. Attorney’s summary before you act.

Please remember, my daughter died from one OxyContin pill, made by a company that admitted lying to doctors about the risks, and the FDA has allowed that same pill to remain on the market.  It is too late to save my daughter Emily, but there are many other people whose lives can be saved with your voice, without sacrificing access to pain medication for those who truly need it. 

Stop the deaths.  BAN OXYCONTIN NOW.

References:
1. Manchikanti, L.  National drug control policy and prescription drug abuse: facts and fallacies.  Pain Physician 2007; 10: 399-424.
2. Volkow, N.D.  Director, National Institute on Drug Abuse, Testimony before the United States Senate Committee on the Judiciary, March 12, 2008. 
3. Paulozzi, L.J. Medical Epidemiologist, Centers for Disease Control and Prevention, Testimony before the United States Senate Committee on the Judiciary, March 12, 2008
4. National Center on Addiction and Substance Abuse (CASA).  Under the Counter: The Diversion and Abuse of Controlled Prescription Drugs in the U.S.  Columbia University, July 2005.
5. Paulozzi, L.J. Centers for Disease Control, pers. comm. May 2009.
6. Florida Department of Law Enforcement.  Drugs Identified in Deceased Persons by Florida Medical Examiners.  Medical Examiner’s Commission, June 2009.
7. Moore, T.J., Cohen, M.R. and C.D. Furberg.  2007.  Serious adverse drug events reported to the Food and Drug Administration, 1998-2005.  Arch Intern Med. 2007; (16): 1752-1759.
8. Brownlee, John.  Statement of United States Attorney John Brownlee on the Guilty Plea of the Purdue Frederick Company and Its Executives for Illegally Misbranding OxyContin.  U.S. Department of Justice, Abingdon, Virginia, May 10, 2007.
9. Ballantyne, J.C. Opioids for chronic pain: taking stock.  Pain 2006; 125: 3-4.
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20. Staumbaugh JE, Reder RF, Stambaough MD et al.  Double-blind, randomized comparison of the analgesic and pharmacokinetic profiles of controlled- and immediate-release oral oxycodone in cancer pain patients.  J Clin Pharmacol.  2001; 41: 500-506.
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25. Hayes S. Novus Medical Detox Center pers comm. 2009.
26. Peterson J.  Learn to Cope pers comm.. 2009.  Learn2cope.org. 
Siegal, H, et al.  Probable relationship between opioid abuse and heroin use. Letter to the editor, Am Fam Physician March 1 2003.      
Lewis, J and Lenton G.  “Teens follow ‘Oxy’ bridge to heroin”.  The Patriot – News, January 2005.    http://www.opiates.com/media/oxy-bridge-pat.html
Campbell, C.  “Highway to heroin: OxyContin users take the road to a cheaper high” Salt Lake City Weekly.Net, November 7, 2007.
http://www.cityweekly.net/utah/print-article-1889-print.html
Willis, M.  “OxyContin Users turning to heroin.”     
http://www.drug-rehabs.com/HeroinReplacesOxyContin.htm
27. Attachment F to Plea Agreement, United States vs. The Purdue Frederick Company, United States District Court for the Western District of Virginia, May 2007.
 

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