Will the FDA Finally Get Out of Bed With Big Pharma?

A test case for the new government will be how it deals with the
pharmaceutical industry, which rivals the gun manufacturers and tobacco
companies for the position of most amoral industry in America.

Democrats have long been promising to
stand up to Big Pharma on issues like Medicare drug pricing and
importing drugs from Canada, but they've accomplished little since they
won Congressional majorities in 2006. If they truly want to reign in
the drugmakers now that they have the clout, they'll need to not only
move forward on these hot-button issues, but also completely overhaul
the Food and Drug Administration, which stands as one of the most
corrupt and compromised bodies in the federal government today.

Last week offered a glimmer of hope, with a bipartisan bill aimed at
one of the many scurrilous practices employed by drug companies to win
swift approval for their products and push them on the public. Called
the Physician Payments Sunshine Act of 2009, the legislation was
introduced last Thursday by Senators Herb Kohl (D-WI), Chair of the
Senate Special Committee on the Aging, and Charles Grassley (R-IA), in
the past a rare Republican voice opposing some of Big Pharma's
outrages. They are calling for establishment
of "a nationwide standard requiring drug, device and biologic makers to
report payments to doctors to the Department of Health and Human
Services and for those payments to be posted online in a user friendly
way for public consumption."

Let's be clear: The proposed legislation doesn't say that doctors
can't receive money (or expensive dinners, or luxury junkets) while
they are testing or endorsing new drugs; it merely says the payments
have to be made public. Even this, however, has apparently proven too
much for the Food and Drug Administration: A report released earlier
this month found that the FDA had been sorely lax in demanding full
disclosure of these relationships. As reported by Bloomberg News:

Drug regulators haven't done enough to force disclosure of
financial conflicts of interest among the researchers who conduct
clinical trials of medications and medical devices, according to a U.S.
government investigation. A total of 42 percent of marketing
applications approved by the U.S. Food and Drug Administration were
missing financial information that was supposed to be submitted by drug
and device makers, according to a report today by the Health and Human
Services Department's inspector general. The FDA didn't act against the
companies, the report said.

Financial connections between companies that make drugs and devices
and the doctors and other researchers who test them on humans may
compromise the safety of patients in studies and the integrity of the
results, according to the inspector general's report. Lawmakers, led by
Senator Charles Grassley, a Republican from Iowa, have raised concern
that financial conflicts of interest among doctors and manufacturers
may influence prescribing decisions.

The FDA has fallen a long way since 1962, when legendary Senator Estes
Kefauver championed its expansion, insisting that it was the federal
government's responsibility to protect the public by ensuring that
prescription drugs were both safe and efficacious. The FDA has for
decades been playing footsy with the drug industry, and it reached new
lows under George W. Bush, as fundamentalist Christianity became yet
another force undermining the agency's work. Bush's appointments to the
FDA leadership included a veterinarian who presided over the Vioxx scandal and stalled the Plan B pill, and a faith-based gynecologist who refused to prescribe contraceptives to married women and advised prayer as a treatment for many female ailments.

In a 2006 survey of FDA employees,
more than 40 percent said they knew of cases in which political
appointees had interfered with agency decisions. At that time, more
than 100 whistleblower cases were also pending at the agency. Some
things will now surely change at the FDA--but how much, and how soon?

Obama has yet to announce his nominee for FDA commissioner, but HHS Secretary Tom Daschle talked about the agency at
confirmation hearings earlier this month, promising "to ensure that
trust in FDA is restored as the leading science-based regulatory agency
in the world. ...I will send a clear message from the top that the
President and I expect key decisions at the FDA to be made on the basis
of science--period."

It's true that we're unlikely to see prayer meetings in Tom
Daschle's HHS. But independence from Big Pharma is another story. Since
leaving Congress, Daschle has been working as an "adviser" to health
care industry clients, including at the law and lobbying firm Alston
& Bird. As the New York Times reported at the time his nomination:

Although not a registered lobbyist, Mr. Daschle, a South
Dakota Democrat who was party leader in the Senate, provides strategic
advice to the firm's clients about how to influence government policy
or actions....As examples of the firm's achievements the Web site lists
matters involving Medicare and Medicaid reimbursements, approvals of
federally regulated drugs and medical products, fraud investigations,
medical waste disposal, privacy and other compliance issues.

On the day Tom Daschle was nominated, the Washington Post's "The Ticker" blog reported:

According to Wall Street, Tom Daschle is a good choice to
be the new secretary of the Department of Health and Human Services.
Shares of the big drugmakers--Pfizer, Eli LIlly, Merck, GlaxoSmithKline
and AstraZeneca--are all trading up from their opening this morning.