Monday, July 24, 1995
Trying to do the right thing can be a frustrating experience, particularly when the definition of what is right is strictly in the eye of the beholder.
MedImmune Inc. last week hoped to disclose findings of its PREVENT and Cardiac trials of RespiGam RSVIG-IV in preventing respiratory syncytial virus in at-risk infants and children. Instead, MEDI found itself caught between the competing demands of the FDA and the investment community.
Investors had been expecting to see the data. But the company, saying it was acting at the FDA's request, revealed only that the PREVENT trial reached statistical significance while the Cardiac trial did not.
Compounding the problem, the agency made statements after the data were released that apparently contradicted the message it had given the company. Laurie Harrison, a spokesperson for the Center for Biologics Evaluation and Research, told BioCentury that companies are completely free to publicize their data as they wish. Meanwhile, MEDI's CBER contact, William Purvis, the director of advertising and promotional labeling staff, was giving the company the opposite message.
In a conference call the day after MEDI's announcement, Harrison and Purvis tried to explain to BioCentury that their messages weren't contradictory. But even if this were true, the agency's restraints on MEDI's ability to explain itself made it look as if the company wasn't being candid with investors (see BioCentury Extra July 20).
After discussing the event both with the FDA and the company, one thing is clear: MEDI followed the agency's instructions to the letter and was being scrupulously honest when it told the investment community that the long-awaited data weren't being disclosed at the FDA's request.
"We are trying to work closely with FDA in the manner they deem appropriate," said Wayne Hockmeyer, chairman and CEO. "We're appreciative of their advice and guidance and are confident that they will, as always, complete a thorough and objective review of the application."
In choosing to please the FDA rather than investors, the company made what must have seemed like the only logical choice. After all, investors can shave points off a stock, but they can't approve or block a drug.