The Associated Press - Saturday, October 19, 1996
Lauran Neergaard, Associated Press Writer

Now the Food and Drug Administration is wading into the chaos, preparing to regulate promotion of drugs and medical devices in cyberspace. Critics fear such rules will block the free flow of information.

"We certainly recognize both the utility and the power of the Internet," FDA Deputy Commissioner William Schultz told 470 manufacturers, consumer advocates and Internet experts who spent two days last week debating FDA regulation.

"I don't think we need extra guidance," responded David Vance of the drug maker Glaxo Wellcome Inc. He ventured that everyone from highly informed laymen and physicians to more gullible novices use the Internet and said: "We can't protect the idiot."

Part of the Internet's appeal is that anybody can set up a home page and start publishing -- no expertise required. But doctors say that makes it hard for patients to separate science from quackery.

The FDA lacks the authority to sort out all the conflicts. The Federal Trade Commission already is working with 39 state attorneys general to determine broader regulation of Internet fraud, said Renardo Hicks, Pennsylvania's deputy attorney general.

By federal law, the FDA does regulate how manufacturers of drugs and medical devices promote their therapies to prevent having people misled about the value of medical. The FDA now is determining how to take its rules into cyberspace.

Take experimental drugs, which the FDA forbids companies to hype.

Consumer advocate Dr. Sidney Wolfe of Public Citizen cited a drug company president who told stock analysts that his experimental pain killer would turn competitors "into dinosaurs." The quote appeared on the Internet, but nobody knows if the company put it there to excite sick patients because the Internet is largely anonymous.

The question also remains open where the FDA will draw the line between hype and detailed information needed to decide whether to volunteer for clinical trials of experimental drugs.

"Any restrictions on us getting this information is going to cost lives," said Kiyoshi Kuromiya, whose Critical Path AIDS Project publishes Internet sites on experimental AIDS drugs.

Another group, Center Watch, said patients with numerous diseases visit its Internet sites more than 30,000 times a month seeking clinical trials.

Central to FDA's deliberations is how much disclosure to require. The Internet is rife with cleverly disguised infomercials.

"When you see an advertisement (in a magazine), it looks like an advertisement. When you click on the Internet, you don't know," said Louis Morris of FDA's marketing division.

The FDA already forbids companies from promoting unapproved uses of products. Again, that's more difficult on the Internet.

Say, for example, a drug maker helps consumers jump electronically from FDA-approved documents about its asthma drug to another Internet site where scientists say the drug also might fight heart disease. It's fine for scientists to promote new uses of drugs, but not companies standing to profit. But is a computer link a promotion?

Drug companies say they too can be hurt on the Internet. If a patient spreads erroneous information about a drug in a "chat room," can the manufacturer correct it? Washington attorney Peter Reichertz recalled one chat room that talked down a manufacturer's stock value.

And what is a company's responsibility if a patient reprints its Internet information out of context, such as by starting a new home page hyping a drug without mentioning dangerous side effects?

Ways exist to control Internet information. Glaxo's Internet site, for example, contains gastroenterology data just for physicians, who must register and obtain a password to read it. Center Watch prints notices of clinical trials only after hospital review boards clear the wording as fair.

Companies cautioned the FDA not to stifle the Internet's booming growth or the free exchange of information.

But Dr. Sarah Stein of Stanford University urged the government not to forget "the vulnerability of sick people, searching for information at a time they are overwhelmed."

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