The
taped speech sounded almost like a confession, even a hostage plea.

“My
name is Chris Galvin,” the faceless voice said, blaring out over the
microphones in a conference room in the basement of the Hyatt Regency hotel in
Bethesda, Md., on Wednesday afternoon. “I’m an analyst with the Office of
Evaluation and Inspections for the Office of Inspector General for the
Department of Health and Human Services. If you are listening to this, I
apologize that I am unable to be there in person.”

Galvin,
of course, was shut
down, one of almost 800,000 federal employees deemed
non-essential and sent home until Congress agrees on a bill to fund the government.

He
had been slated to appear at a conference
sponsored by the Drug Information Association, a global nonprofit organization.
The conference had been scheduled for months, and was meant to wrestle with the
push for greater transparency in the world of clinical drug trials.

Almost 100 people showed up, mostly
from across the United States, but also from Canada, Denmark and Germany.
Most spent at least $595 to attend (except for the media, who graciously were
allowed in for free). There were top officials from pharmaceutical companies,
leading academics, consultants, patient advocates and two officials from the
Canadian government.

What
was missing: Their counterparts, the U.S. officials. Suffice it to say, it left
some major holes in certain sessions.

In
some ways, the conference, held on Tuesday and
Wednesday in the hotel’s Haverford suite, with a small stage, inconsistent
audio, a large screen backed by beige curtains, and round tables with
floor-dragging white tablecloths, is a microcosm of how the country has been MacGyvering its way through the government shutdown. Most people
have been finding workarounds, waiting for Congress to quit bickering, hoping
that the shutdown will be lifted before something really bad happens, like poor
children running out of food or, well, not getting enrolled in clinical trials
for new cancer drugs.

In
other ways, the conference shows how no stopgap really substitutes for the real
thing, even when the real thing is the notoriously cautious and circumspect
Food and Drug Administration or its parent agency, HHS.

A
pharmaceutical executive and a consultant ended up reading the slides from two U.S.
government officials who didn’t record their comments. PowerPoint fatigue set
in. And little useful clarity emerged about where the FDA actually stood on enforcing
requirements for greater and accurate disclosure of certain clinical trial
results.

The determination of the
conference to stay on schedule, and to hold sessions even without the government
speakers, ultimately came to seem like an odd, but kind of admirable, act of
defiance. Elsewhere, other meetings challenged by a distinct lack of government
participants just folded. For example, the Privacy and Civil Liberties
Oversight Board  — better
known as PCLOB —canceled its planned hearing on Friday, after being
notified “by a significant number of witnesses that they are unable to
testify.”

Galvin,
for sure, went beyond the call of duty. He could have just skipped the clinical
drug trial conference.

But
he prerecorded his speech, even saying “next slide” whenever the moderator was
supposed to click ahead in his PowerPoint presentation. (There was one moment
when what sounded like a guitar string interrupted the recording, inexplicably.
The audience laughed.)

Many
of the conference’s participants had been most interested in his final session,
“Clinical Trial Disclosure—FDA Enforcement Activities,” held on Wednesday
afternoon, and featuring Galvin and Jarilyn Dupont,
the director of regulatory policy for the Food and Drug Administration. In
fact, some participants mentioned that it was the main reason they traveled to
Bethesda, curious what the FDA would say, especially since FDA enforcement of
clinical trial disclosure rules so far seems to be just as quiet as their
offices this week.

The
final session’s moderator, Robert
Paarlberg, a pharmaceutical consultant who
specializes in global clinical trial disclosure strategy and regulations, did
his best. He launched into the enforcement session, using a picture of a
kayaker landing on a whale, saying that he didn’t want anyone in the audience
to be stuck in that position. Two of the three chairs for speakers, reserved
for Galvin and Dupont, sat empty.

First,
the lone speaker, Mark Barnes, a lawyer
and medical research expert with Ropes & Gray in Boston, spoke about
enforcement for about a half-hour. Then Paarlberg
turned on the tape of Galvin, while clicking through Galvin’s slides.

At
the end, Galvin said: “Once again, I am sorry I was unable to be there and
perhaps answer questions. Should you have any questions, feel free to contact
me.” Galvin then gave his email address.

There
was a pause, before a bit of confused clapping.

“But
he can’t answer the email until after this is over,” Paarlberg
reminded everyone.