COPS AND DOCTORS

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.