July #72 : Is That All There Is to Approval?

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Table of Contents

Splitting Image

Is That All There Is to Approval?

Combination Strategies

Gimme Shelter

Bells, Books and Candles

Quickies

Calling All Angels

It's Raining Meds

Demand Results

S.O.S.

Parody Killed The Prevention Ad

Genes In The Bunch

Deaths

Shop Till You Drop

Gyn and Bitters

The Untouchables

Mailbox

All Lit Up



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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July 2001

Is That All There Is to Approval?

Folks at the FDA say they know what's wrong with the fine print when they see it. This ad for DuPont's Sustiva (efavirenz) was yanked last year after officials declared that it violated the Federal Food, Drug and Cosmetics Act -- enforceable by law -- with numerous "misleading claims." A revamped version was approved after the following corrections were made.

"SO LIFE GOES ON"
The FDA editors asked DuPont for a rewrite because the ad's main tagline was misleading: It implied that Sustiva "improves survival in patients with HIV infection," which "has not been demonstrated by substantial evidence." That is, the cutie-pie might be celebrating the big 4-0 because of luck, not drug. The new ad traded in so ("in order that" -- Webster's) for because ("for the reason that"), softening the so alliterative Sustiva-sustenance association.

"LOWER VIRUS LEVELS -- LONGER"
Claims that Sustiva is "superior to protease inhibitor-containing regimens" were rejected because the drug had been compared to "only two of six in head-to-head trials," the FDA wrote. Version No. 2 names indinavir and nelfinavir specifically. Plus, the new copy spells out that Sustiva must be taken with two NRTIs to be effective.

"TAKE IT JUST ONCE A DAY"
DuPont added info specifying initial bedtime dosing and avoiding high-fat meals. "Failing to provide this context with your 'convenience' claims misleadingly implies that Sustiva can be taken without restrictions," the FDA wrote.

"GENERALLY TOLERABLE SIDE EFFECTS"
Sustiva's boast of "fewer gastrointestinal side effects" than Viracept was "an unsubstantiated superiority claim" -- diarrhea was more common among Viracept-takers, but rates of nausea and vomiting were about equal. New text: "Sustiva is generally well tolerated, with no long-term toxicities observed."

"SAFETY INFORMATION"
The ad "lacks fair balance because the risk information is inadequate," the FDA wrote. There was no mention of common side effects -- other than the famed Sustiva nightmares, dizziness and "a few reports of suicide, but Sustiva has not been established as the cause" -- or other meds with the potential for dangerous interactions. The revised version acknowledged "mild or moderate rash" and a number of drugs to avoid while on Sustiva.




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