Firstly, I would like to begin by welcoming Chairman Candice Miller to the 9^th Congressional District here in Boston, I thank you for your willingness to travel here to Boston and agreeing to hold this important field hearing.

 

The focus of this hearing has been described as "OxyContin and Beyond:  Examining the Role of the Food and Drug Administration (FDA) and the Drug Enforcement Agency (DEA) in Regulating Prescription Painkillers.” 

 

I think it is important to clarify that this hearing is not just about any particular piece of legislation.

 

Rather we are here to examine the recently amended and accelerated FDA drug-approval process that has somehow allowed a series of drugs to come onto the market, make their way into our pharmacies, only to be removed by the force of litigation and government pressure after fatalities and widespread injury to individual consumers.

 

Unfortunately, we have many examples:  Vioxx, the cox-2 inhibitor, with 27,000 heart attacks and sudden cardiac deaths before it was eventually pulled from the market; Ephedra, an appetite suppressant with 1,000 reports of serious health complications from its use and at least 100 Ephedra-related deaths; OxyContin, produced by Purdue-Pharma with hundreds dead from overdose and thousands hopelessy addicted—and this is 2002 data; and most recently Palladone, a potent narcotic painkiller twice as powerful as OxyContin and also produced by Purdue-Pharma, pulled from the market nine months after initial FDA approval.

 

These developments in and of themselves would be serious but it’s important to note that in the case of Purdue-Pharma a federal appeals court has recently ruled that their patent rights are invalid because Purdue-Pharma had lied to the united states patent and trademark office on its original application.

 

The revocation of exclusive patent rights will now allow other pharmaceutical companies to produce generic versions of OxyContin which will result in wider availability and therefore greater potential for abuse.

 

This issue came to my attention through our own experience with OxyContin.  We are here today because too many people in our communities and neighborhoods are struggling with the problem of prescription painkiller abuse, as well as the misprescription of these drugs, most notably OxyContin. 

 

According to a recent survey, OxyContin abuse was second only to heroin as the drug of abuse among patients in non-methadone treatment programs in Boston. 

 

However, this problem is not just confined to Boston and it is not just a problem impacting the inner cities of our nation.  Rural communities such as Maine, West Virginia and Kentucky as well as suburban communities from arizona to ohio are all grappling with the problem of OxyContin abuse and diversion.  In 2003, an estimated 2.8 million americans had, at some point in their lives, used OxyContin for non-medical purposes, a significant increase from the 1.9 million in 2002.

 

We are also very much aware that narcotic painkillers, such as OxyContin, can be used successfully by chronic pain sufferers, including cancer patients, to relieve pain.  In fact, Purdue-Pharma originally presented the drug as being specifically for cancer patients and severe and chronic pain sufferers.  

 

I find it remarkable that this drug was put on the market without any study pointing to its addictive properties.  Which leads to the underlying question we have for FDA and DEA—knowing the power of these drugs, knowing the pervasiveness of modern marketing techniques and also taking into consideration the astounding profit motive for drugs that create "customers for life”— how addictive will we allow these drugs to become and still be legally marketed? 

 

Also, there is compounding difficulty here in the fact that absent a significant number of drug-related deaths such as we have seen with Vioxx, Ephedra, and I’d argue OxyContin, once a drug receives FDA approval it is virtually impossible to require further research to improve its safety.  That condition leaves legislators in a position where the only option we have is to recommend the banning of that pharmaceutical.