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 2014 better known as PCLOB 2014canceled 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 Disclosure2014FDA Enforcement Activities,” held on Wednesday afternoon, and featuring Galvin and for 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 e-mail 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.