POLITICS TRUMPS SCIENCE AT THE FDA

All Americans, whether or not they have any interest in medical
marijuana, should be concerned by the Food and Drug Administration's
recent statement claiming there is no evidence that marijuana is
medically beneficial. The FDA's pronouncement tells us little about
medical marijuana, but it says much about how politics appears to be
trumping science at the agency we all depend on to protect our health.

The FDA's missive, issued late in the day on April 20, proclaims that
"no sound scientific studies" support medical use of marijuana and
condemns state medical marijuana laws.

But why, one wonders, did the FDA issue this statement now? It cites
neither new scientific data, nor even any new analysis of old data.
The FDA did not, as it often does when addressing difficult issues,
convene an advisory committee of independent experts. Indeed, the
document appears to be nothing but a rehash of the federal
government's long-standing position.

And it's a selective rehash, to put it gently. Back in 1995, the
American Public Health Association cited nearly two dozen studies
reporting marijuana's safety and efficacy against pain, nausea,
vomiting, seizures and other serious symptoms. The APHA urged the
government to "expeditiously" make marijuana available to patients
through the Compassionate Investigational New Drug program that the
first Bush administration had closed to new applicants in 1991,
declaring, "Greater harm is caused by the legal consequences of
[marijuana's] prohibition than possible risks of medicinal use."

Four years later, in a massive review commissioned by the White
House, the Institute of Medicine (a branch of the National Academy of
Sciences) found significant evidence of therapeutic benefit, stating:
"Nausea, appetite loss, pain and anxiety are all afflictions of
wasting, and all can be mitigated by marijuana." While expressing
concern over the risks of smoking, it noted that for some patients -
particularly those with terminal conditions or not responding to
standard therapies - those risks would be "of little consequence."
The Institute of Medicine report added pointedly, "We acknowledge
that there is no clear alternative for people suffering from chronic
conditions that might be relieved by smoking marijuana, such as pain
or AIDS wasting."

The FDA simply ignored this mass of data. Indeed, the federal
government has long been hiding from such information. As Dr. John
Benson, one of three lead authors of the Institute of Medicine
report, told The New York Times last week, the government "loves to
ignore our report. ... They would rather it never happened."

It is true that the volume of research data on medical marijuana is
not as great as any of us would like. But the relative lack of large,
controlled trials of marijuana is almost entirely due to government
obstructionism.

The federal government has not only refused to fund medical marijuana
research, it has put in place a set of legal and bureaucratic
obstacles that have kept the flow of even privately funded medical
marijuana studies to a trickle. So with one hand, our government
tells us "there's no data," while with the other hand it works to
ensure there will never be enough data.

So why did the FDA issue this questionable document, containing no
new information whatever, at this particular moment? The only
apparent explanation is politics. Rep. Mark Souder, R-Ind., perhaps
the most vehement opponent of medical marijuana in the Congress, has
been hectoring the agency for months to issue a statement condemning
medical marijuana.

On Jan. 18, in a letter to acting FDA Commissioner Andrew C. von
Eschenbach, Souder wrote, "I am exasperated at FDA's failure to act
against the fraudulent claims of 'medical' marijuana." He renewed the
request two months later, in even more impatient terms. And Souder's
agenda fit perfectly with the administration's stand on the issue, so
all the political winds were blowing in the same direction. Science,
it appears, took a back seat.

For the FDA to do its job as protector of our nation's health, it
must be free from commercial or political pressure. When politics
trumps science at the FDA, we are all in danger.