Biotechnology has made it to prime time TV. Tonight, a CBS News48 Hours broadcast follows three patients in an HIV clinical trail of agene therapy product.

The show, at 10 p.m. EST/PST, was more than a year in the making.It focuses on Viagene Inc.'s HIV-IT (V) product in a Phase I trial;Jeffrey Galpin, chief investigator for the trial; and three HIV-positivepatients being treated by Galpin.

Up to 10 million people with limited understandings ofbiotechnology, clinical trials and the intricacies of drug developmentwill be getting a more detailed look at the industry.

Robert Abbott, Viagene's president and CEO, and Galpin, aninfectious disease specialist, both agreed to do the project, in part, tohelp enlighten people about the process. Abbott said 48 HOURScontacted Viagene, of San Diego, seeking help in detailing the plightof those developing drugs, and those participating in trials.

"Their [48 HOURS] impression was that the average American has avery poor understanding of what goes on in clinical trials, of what ittakes to document the safety and effectiveness of a drug," Abbotttold BioWorld. "We thought they had a very valid point andtherefore agreed. We thought it would be an educational program,and giving a little cooperation from the biotech side would be quitehelpful to our industry."

Galpin, chairman of the Shared Medical Research Foundation, saidhe grew tired of watching television shows dealing withexperimental drugs or treatments whose protagonists promised quickcures and raised hopes inappropriately. "I considered it a farce," hetold BioWorld. "Yes, people are dying, and we need answers, but westill must follow a clinical research model. I agreed to do it because Iwanted them to see there is a right way to do research."

The right way, he said, does not involve hyping, but ratherexplaining to patients and the public the risks, and the highlikelihood that drugs in research won't result in cures. "It's a risk,"he said, "and anyone who says any different about clinical trials isnot being honest. I don't want to see a stampede believing we have acure."

Mary Murphy, who produced the 48 HOURS broadcast, said thoseinvolved in the show "have always been interested in chroniclingwhat it takes to bring a drug to market. While there have been a lotof promising treatments for AIDS, this show is much more about thehuman contribution to these drug studies," she told BioWorld. "Wefocus very thoroughly on the three [patients] involved.

"When you walk away from this show you'll understand how thedrug works, but you'll really understand what's at stake for thepeople who make it," such as whether it will work and what side-effects it may have, Murphy said. "It's a very chancy enterprise."

The 48 Hours crew, for more than a year, followed the trial at theResearch Foundation in Tarzana, Calif., which is part of a nationalnetwork that conducts trials. The three patients are a 34-year-oldwoman raising two children, a 29-year old man and a 52-year-oldhemophiliac and father of three.

Each was injected with Viagene's HIV product, and followedthrough treatment courses. HIV-IT (V) is a non-replicating murine retrovector engineered to deliver the env and revgenes of HIV-1 to non-infected cells, where the respective proteinsare expressed. The goal is to induce cytotoxic T-lymphocyte activity.

In December, Viagene started a Phase II trial of HIV-IT (V) that'sexpected to enroll 190 patients by the end of the first quarter, Abbottsaid. At least 27 people already have been accrued. Galpin is aninvestigator in that trial, too, and 48 HOURS may be there.

Phase II: The Sequel

"We hope to follow a person into Phase II who's due to receive hisinjection in March," Murphy said. "We're gearing up to chroniclePhase II."

Neither Galpin nor Abbott previewed the broadcast, so they're notquite sure what to expect. But both came away from the experiencepleased with the TV crew's professionalism, and both hope for afavorable portrayal.

"Potentially, it can be positive in that it illustrates the possible rolefor biotechnology in the development of pharmaceutical products,"Abbott said. "The general public, because of the focus of the media,is more likely to get exposed to dramatic negative issues when itcomes to science.

"So when you hear about genetically altered tomatoes taking overNew York City, people remember that. If the program ends up beingconstructively positive, it would be helpful to the industry."

Galpin, too, would like to see the industry benefit from the program."I hope people understand that a tremendous amount of money isinvested in developing a new technology platform. They need tounderstand that the future is going to be built around newtechnologies, many of which aren't going to work. It will be veryinteresting to see how the public perceives what we do." n

-- Jim Shrine

(c) 1997 American Health Consultants. All rights reserved.