Letter to the FDA

Letter to the FDA

This would be a wonderful thing. Daily we are seeing new revelations that doctors who have endorsed drugs were actually on the payroll of a company making the drug. Independent, scientific and non-biased research is essential if we are going to have confidence in any drug.

The excellent well-researched and documented letter below was written by Pete Jackson. Pete and his wife Ellen lost their daughter to an OxyContin overdose and have both been tireless advocates of stopping the abuses of this terrible drug. The letter is addressed to Dr. Woodcock. Dr. Woodcock has distinguished herself by being the advocate when drug industry interests conflict with consumer safety. She advocated and defended keeping Vioxx on the market even though the evidence was overwhelming that it was causing deaths and harm in huge numbers.

As reported in the January 9, 2008 WALL STREET JOURNAL, “On Nov. 14, 2004, she stated: 'There was more bleeding with naproxen, and more cardiovascular events with Vioxx. If you look at the numbers, it's a wash.' She said the FDA and its outside experts decided the balance of gastrointestinal benefit and heart risk justified keeping the drug on the market. Dr. Woodcock is among the agency's powerful administrative officers who tried to silence safety scientists--including David Graham, MD--who brought to light the lethal hazards of drugs such as Vioxx.”

Knowing this about Dr. Woodcock, it is hardly surprising that she did little to address Pete's concerns. Here is the letter that he sent.

November 22, 2007

Janet Woodcock, M.D.
Acting Director, Center for Drug Evaluation and Research
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

RE: OxyContin and Prescription Opioid Drug Abuse

Dear Dr. Woodcock,

In August of 2006 our 18 year-old daughter Emily died of an accidental overdose of OxyContin. Emily was a wonderful girl with a sweet disposition and her whole life ahead of her, but she made one simple mistake and now she is gone. Like many kids today, Emily apparently made an assumption that a prescription drug that is FDA-approved and prescribed by a doctor must be safe. Our best efforts to educate our kids as to the dangers of drug abuse were not enough to avert this tragic outcome. I am enclosing her picture so you can look into her eyes and see the innocence in her soul. I would like you to understand that if this can happen to someone like Emily, this can happen to anyone’s kid. We must do a better job of protecting our children and other family members. I am asking for your help.

In the time since Emily’s death, we have worked exhaustively with a team of bereaved parents and other family members, parents of children suffering from addictions, doctors, pharmacists and drug counselors, united in our determination to raise awareness of the silent epidemic of prescription opioid drug abuse, addiction and death that is gripping our country. We have written thousands of letters and made more phone calls. We have testified before Congress, and have spoken with our elected officials in Washington. We were present in Abingdon, Virginia last July when the three executives of Purdue Pharma were sentenced for misbranding OxyContin; 19 of us testified at the hearing that day. We have held public rallies, formed support groups, and we even started up a radio station to shed light on prescription drug abuse. On February 1, 2005 bereaved parent Barbara Van Rooyan and her husband submitted Citizen Petition # 2005P-0076 to the FDA requesting action on OxyContin. On March 29, 2007 Dr. Art Van Zee and I testified before the Anesthetic and Life Support Drugs Advisory Committee (ALSDAC) and requested that the FDA hold a public meeting to address the ongoing OxyContin tragedy and the broader prescription opioid epidemic.

Regarding OxyContin, despite all our hard work, despite a variety of drug education programs, despite a risk management plan implemented by Purdue, despite FDA warning letters and the addition of a black box warning to OxyContin’s label, 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” [1], Purdue continues to market OxyContin for a wide variety of indications with the blessing of the FDA, oxycodone production levels are even higher than last year, OxyContin pills continue to flood our Nation’s medicine cabinets and school lockers, and young people continue to die in increasing numbers. Other prescription opioids are also being widely abused, despite many of the same “safeguards” that are supposedly in place for OxyContin. 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 high abuse and addiction rates resulting from long-term administration of opioids [2].

I have assembled the attached summary of key statistics that document the prescription opioid drug abuse epidemic that is occurring in this country. As is made clear by the attached statement of facts, the prescription opioid problem is a national and growing crisis. Our family, like thousands of other families across the country, has personally suffered the tragic loss of our loved one because of this problem. In spite of the growing epidemic of prescription opioid abuse, the FDA has continued to approve new opioid preparations that have no proven efficacy or safety over drugs already available on the market, and has refused frequent pleas from the public to meaningfully address the severe and unanticipated problems that have resulted from allowing opioids already on the market, like OxyContin, to continue to be used for a wide spectrum of indications.

We understand the FDA’s concern with ensuring that pain medications are available for the treatment of pain. What we don’t understand is why the FDA continues to ignore those who suffer the adverse consequences of OxyContin and other prescription opioid narcotics being so widely-distributed throughout our society like aspirin, as if to invite abuse. How many more young people need to die before the FDA will do something to stop this epidemic?

FDA plays a crucial role in the solution to this problem. After all, it was the FDA that approved these drugs. With OxyContin, FDA permitted Purdue Pharma to imply that this drug had a lower abuse potential than other opioid preparations, and it also approved the drug for moderate as well as severe pain indications. According to the GAO report on oversight of postmarket drug safety, the FDA has the authority to withdraw the approval of a drug for safety-related reasons and has done so at least ten times since 2000 [3]. FDA may also request that the manufacturer restrict the distribution of a drug to minimize risk. FDA can also negotiate labeling changes with the drug company [4].

As the rates of abuse, addiction and death from prescription opioid abuse continue to rise, two recent and significant events call for immediate FDA action. First, as referenced earlier, on May 10th of this year Purdue Pharma pleaded guilty to a felony charge of illegally misbranding OxyContin. Second, on September 27th of this year Public Law 110-85, the Food and Drug Administration Amendments Act of 2007, became law. We believe this new law strengthens FDA’s authority to address the prescription opioid epidemic. In particular, Title IX gives the FDA enhanced authority to regulate drugs already on the market through labeling changes, risk evaluation and minimization strategies (REMS), and if necessary, withdrawing the approval of a drug. REMS may require such measures as training and certification of health care providers and pharmacists, restrictions on how a dangerous drug may be dispensed, and monitoring and registry enrollment for patients for whom a drug has been prescribed. These provisions enhance FDA’s authority to address the prescription opioid epidemic in a comprehensive manner.

We believe our daughter’s death exemplifies our country’s prescription opioid problem. These drugs have become so commonplace that they are both readily accessible and widely assumed to be safe. There are those in the pharmaceutical industry who would argue that we should not let the actions of drug abusers affect policy related to prescribing and dispensing of prescription drugs. But good people sometimes make bad choices, especially as teenagers. In most cases these young people have no idea they are engaging in life-threatening behavior, despite what a drug’s label might say or what they were taught in a drug education program at school.

More importantly, while those in the pharmaceutical industry might wish to hold as sacred the broad application of opioids for the management of pain, thereby ensuring massive profits well into the future, these are, after all, narcotics. Oxycodone, the active ingredient in OxyContin, is a dangerous and addictive semi-synthetic narcotic derived from the opium plant, as is heroin; in fact, they are chemically similar and both contain the same chemical entity, morphinan. Our current reliance on opioid narcotics for treatment of a broad spectrum of pain ailments bears similarity to the one-time marketing of heroin as an over-the-counter cough suppressant by Bayer. We posit that drugs that are as inherently dangerous as heroin should be used much more selectively than is the current authorized practice in the U.S.

To turn our backs on our daughter’s tragedy because she made an error in judgment is not acceptable, nor is it protective of the public safety per FDA’s mission. That mission is to ensure the efficacy, security, and safety of the drugs that are approved for U.S. markets. It is time that the FDA paid more attention to the safety and security parts of its mission. Strong and meaningful safeguards need to be put into place on OxyContin and other life-threatening prescription opioids prone to high abuse rates, or we will continue to lose young people at an alarming rate. OxyContin and other opium-derived narcotics are the chemical equivalent of heroin, and it is time that our drug policies reflected this fact.

It is our understanding that the advisory committee charged with responsibility of reviewing the safety of prescription opioids, the ALSDAC, has not met to address this issue since September 9-10, 2003. We are writing you to once again request a special called meeting of the ALSDAC (and other advisory committees as appropriate) to address the OxyContin problem and prescription opioid abuse in general. Included in this meeting should be explicit consideration of the Van Rooyan citizen petition, which you indicated was still under review in a February 27, 2007 letter to Barbara Van Rooyan. We would also like to meet with you to discuss this meeting and identify strategies for addressing this issue.

We look forward to your response to the concerns that we have raised.

Peter W. Jackson Ellen A. Jackson

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