Life

Longtime AIDS activist takes up a new fight: defending the FDA

In this July 21, 1992 photo, Gregg Gonsalves, center, poses with fellow AIDS activists David Barr, Mark Harrington, Peter Staley, and Derek Hodel during the 8th International AIDS Conference in Amsterdam, Netherlands.
In this July 21, 1992 photo, Gregg Gonsalves, center, poses with fellow AIDS activists David Barr, Mark Harrington, Peter Staley, and Derek Hodel during the 8th International AIDS Conference in Amsterdam, Netherlands.
Courtesy Gregg Gonsalves

Mark Harrington, executive director of the Treatment Action Group, which spun off from Act Up in the 1990s, says AIDS activists have long tried to distance themselves from such anti-Washington efforts.

By the mid-1990s, Harrington and Gonsalves were actually pushing for longer, larger studies of HIV drugs. That’s because the first drugs approved by the FDA were linked to dangerous side effects, including anemia and nerve damage.

Harrington says the Goldwater-backed state laws are political theater that will not help desperate patients. “They’re providing false hope and really pushing quack cures and medicines that could be unsafe and ineffective,” he says.

Federal law makes clear that patients do not have a right to experimental drugs and the Supreme Court has refused to hear challenges to FDA’s authority over the matter. For its part, the FDA already gives dying patients access to unapproved medicines if drugmakers are willing to provide them.

“The agency stands ready to work with companies that are interested in providing access to experimental drugs,” said FDA spokesman Stephanie Yao, in a statement.

But there’s nothing in the state laws that require companies to grant early access.

While the FDA faces pushback from conservative activists at the state level, it is also faces industry pressure at the federal level.

House lawmakers have held half-dozen hearings this year on “accelerating the pace of cures in America.” The push is part of a pharmaceutical industry-backed initiative dubbed “21st Century Cures,” designed to streamline the drug approval process.

“There is no doubt that our antiquated, patch-work clinical trial system makes developing new treatments a cumbersome, expensive and protracted process,” said the Friends of Cancer Research group in recent congressional testimony. The group receives funding from Pfizer Inc., GlaxoSmithKline and many other drugmakers.

Some FDA watchers say it’s too early to worry about a major overhaul of the agency. Congress is gridlocked and no major health legislation expected to pass until after the next presidential election.

But Gonsalves isn’t wasting time. In closing his talk on Capitol Hill last month, Gonsalves warned Senate staffers that a political shift to the right in coming elections could “change the game” for drug safety and effectiveness.

“We will have a different FDA than we have had for the last 30 years.”

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