Pubdate: Wed, 27 Feb 2008
Source: Wall Street Journal (US)
Page: A17
Copyright: 2008 Dow Jones & Company, Inc.
Author: Scott Gottlieb
Note: Dr. Gottlieb, a resident fellow at the American Enterprise 
Institute, was deputy commissioner of the Food and Drug 
Administration from 2005 to 2007.
Bookmark: (Chronic Pain)
Bookmark: (Methadone)
Bookmark: (Oxycontin/Oxycodone)


The death of actor Heath Ledger from an accidental overdose of six 
pain and anxiety medicines -- including the narcotics OxyContin and 
Vicodin -- has prompted warnings about misuse of prescription drugs, 
which ranks as one of the fastest growing segments of drug abuse. 
Nobody disputes the problem. But the strategies for tackling it 
aren't changing the trends, they are just hobbling doctors and 
patients, and may retard the development of new medications.

The Drug Enforcement Administration is, sensibly enough, targeting 
the small number of physicians who inappropriately prescribe drugs in 
violation of current laws, the "patients" who doctor shop for 
painkillers and hoard drugs to abuse or sell them, and the criminal 
diversion of these medications from pharmacies and distribution 
centers. But the DEA is also trying to influence clinical decisions 
about when these drugs are prescribed.

This is a mistake. Clinical issues are not the expertise of the DEA. 
Placing more restrictions on the legitimate prescribers can harm real 
patients and ethical physicians.

Innovative new drugs such as OxyContin that have been developed in 
the last two decades provide targeted relief for intractable pain. 
While they have helped innumerable patients, they have also been 
abused. The DEA response? One was to try and get the power (now 
exclusively vested in the FDA) to have a final say over whether new 
narcotic medications should come to the market. Legislation to do so 
was temporarily passed in 2004 and the DEA sought its reauthorization 
in 2005 -- as a "rider" attached to its appropriations bill, without 
Congressional debate. At one time, the DEA even sent out 
solicitations to hire clinicians to review new drug applications for 
narcotics, a role reserved for the FDA. The DEA has stepped back from 
that effort -- at least for now.

There have also been efforts to place additional restrictions on 
existing drugs. The DEA is carving out a role for itself in the 
creation of risk-management programs that manage how new narcotics 
are used. These programs often place burdens on doctors and patients 
that can discourage legitimate prescriptions, for example by 
requiring additional reporting by physicians who dispense these 
drugs, as well as certification that they received additional 
training in handling them.

The DEA is leading a campaign to "reschedule" drugs like Vicodin into 
a stricter classification -- placing them under the same restrictions 
as opium, methadone and morphine. It is widely believed that the DEA 
has also been quietly pressuring the FDA to reach a similar 
conclusion. The hope is that tighter controls will help control 
illegal diversion -- although medical studies show that determined 
abusers don't typically get their drugs through legal channels.

But there's a danger that the DEA will wade into areas that involve 
appropriate clinical practice. There will always be some trade-off 
between access and enforcement -- between the docs and the cops. The 
ensuing tension helps ensure the right balance between enabling 
legitimate prescribing, and maintaining restrictions that aid in 
reasonable enforcement efforts. The problem is when DEA activities 
end up influencing legitimate prescribing. For one thing, they prompt 
some law-abiding doctors to think twice before writing legitimate 
scripts. A 2001 study of California doctors found that 40% of 
primary-care physicians said fear of investigation affected how they 
treated chronic pain. A recent survey of physicians by the Center for 
Addiction and Substance Abuse found that one-third worry "a great 
deal" or "somewhat" about review of their own prescribing of 
controlled drugs by law enforcement agencies; and 44% report that 
this actually influences which medications they prescribe.

The expansion of DEA regulatory authority could slow development of 
improved medicines, by chasing away companies that fear added 
uncertainty about whether new products will get approved. This 
includes new generations of narcotics more resistant to abuse. It 
would actually be better for the public if the FDA made these 
abuse-resistant painkillers immediately eligible for priority review, 
which can shave time and cost off the development process.

The DEA for its part can take additional steps to curb the abuse of 
prescription drugs without intruding into legitimate medical 
practice. The agency could step up its work with individual states on 
prescription-monitoring programs that enable collection of 
information on dispensing of controlled drugs. This could help 
curtail doctor shopping and alert doctors to dangerous polypharmacy.

The National All Schedules Prescription Electronic Reporting Act -- 
which has passed but hasn't been implemented -- would create a grant 
program housed at the Department of Health and Human Services to fund 
state-run prescription drug monitoring programs. Currently 20 states 
have these programs, but information is not yet shared between them, 
so doctors can't view what other prescriptions a patient was given in 
another state. Part of the barrier to getting the system started has 
been maneuvering by DEA's parent, the Justice Department, to create 
its own rival scheme -- a law-enforcement tool geared more toward 
monitoring doctors as opposed to irregular purchases.

As prescription-drug abuse and criminal diversion escalates, there is 
a need for stepped-up law enforcement. But when it comes to managing 
legitimate medical practice issues, the cops should step aside. The 
risk is a return to an era when pain often went unrecognized, treated 
patients were commonly undermedicated, and doctors were reluctant to 
prescribe powerful narcotics -- sometimes out of fear of those 
looking over their shoulder.