December #66 : The Viral Lowdown: Pharma Flubs Phase IV

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Table of Contents

The Viral Lowdown: Can You Believe What She Says?

The Viral Lowdown: Say What

The Viral Lowdown: Word Is Out For New HIVers

The Viral Lowdown: Dishing Out the Denial

The Viral Lowdown: Pharma Flubs Phase IV

The Viral Lowdown: Lack of Leadership Leaves Latinos In Lethal Lurch

The Viral Lowdown: Mystery: Partially Positive

The Viral Lowdown: Prison Death Prompts Probe

The Viral Lowdown: African AIDS Under a TAC

The Viral Lowdown: All Dolled Up: Rx Abuse High Among Gay HIVers

THE VIRAL LOWDOWN: WORLD AIDS DAY 2000

The Viral Lowdown: If Not Now, When? If Not Us, Who?

The Viral Lowdown: News Flash: The Sky Isn't Falling!

The Viral Lowdown: HIVers in Hock to Homophobia

Tales of the (Safer Sex) City

Clean, Sober...and Medicated?

The Secret Plot to Destroy African Americans

Mailbox

The Art Of Living

Summit, Some More

Channel Surfing

Shout Out

Lights! Camera! Handcuffs?

Quick Picks

Life Is Sweet

Packing Meat, Just Barely

A Cell of One’s Own

Milestones

Doing AIDS Justice

Petal Pusher

Carry On, MP

Milk Got You?

Comfort Zone

Big Science Kicker

Herb Of The Month

Protease Progeny

It Takes Guts

Between A Recovery And A Hard Place



Most Popular Lessons

The HIV Life Cycle

Shingles

Herpes Simplex Virus

Syphilis & Neurosyphilis

Treatments for Opportunistic Infections (OIs)

What is AIDS & HIV?

Hepatitis & HIV


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December 2000

The Viral Lowdown: Pharma Flubs Phase IV

FDA to Activists: Be careful what you wish for

When the FDA finally yielded to years of activists yelling "Drugs into bodies!" and mandated accelerated approval of lifesaving meds, HIVers heaved a sigh of relief. Now, four years and many nasty drug side effects later, treatment troops are tooting this tune: "Where's the post-marketing data?"

A drug passes through three phases to get green-lighted; Phase IV, conducted once the product is on the shelf, investigates effects of its long-term use in real-life situations, such as in combination with other meds. AZT, the first AIDS drug, flew through clinical trials in 1987 to meet a desperate need -- and set a precedent for approval speed. But under the 1997 Modernization Act, post-marketing studies became FDA recommendations rather than requirements; as a result, few companies conduct adequate post-approval research.

"Industry has no incentive to carry out Phase IV studies," said Gregg Gonsalves, of the Treatment Action Group (TAG). Project Inform founder Martin Delaney agrees: "Companies want to coast along in the light of whatever short studies showed the drug worth licensure -- they aren't interested in searching for warts."

But in the wake of the FDA's recent banning of potential hazards such as Rezulin for diabetes and Fen-Phen for obesity, the need for post-marketing data has become clear. "Sadly, there is a gap between what activists call Phase IV and what drug companies call it," said Delaney. "Long-term studies should compare drugs, provide success and failure info and reveal side effects." Current studies, he said, are done by marketing teams "interested only in what will help them sell more drugs."

Yet Gonsalves said this void may soon be filled. He was part of a coalition that has pushed the NIH to launch Phase IV to test the best time to start and stop anti-HIV therapy. "We need this research," Gonsalves said, "because people are making decisions in the dark."




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