The Internet's Impact on Pharmaceutical Science

The explosion of the Internet within the last decade has impacted many man existence. It has changed the way people communicate, earch, shop, and pay their bills. The transformation has been dramatic in the realm of health care - and, some say, not the better.

While the Internet has made valuable medical information easily accessible to patients and allowed them, to some extent, to take control of their own health care, it's also become a channel for false or misleading data that can endanger lives. The online sale of pharmaceuticals in particular is a persistent point of contention between regulators and manufacturers.

But how has the emergence of the Internet affected the way pharmaceutical scientists themselves do business? And how will it impact the pharmaceutical sciences in the years ahead? Sessions at the recent AAPS Annual Meeting in Indianapolis addressed these questions, from a variety of perspectives, and offered clues to what the future may hold.

Moderator Jon Schommer, Ph.D., guided a panel of experts through an Internet symposia, entitled "The Roles of the Internet and Electronic Commerce in Drug Development and Marketing." Schommer is an assistant professor at the University of Minnesota and chair of the EMMS Section.

Stuart Speedie, Ph.D., discussed the "Next Generation Internet (NGI)," a new program sponsored by government agencies like the Department of Energy and NASA that will lead the push to create the next iteration of the 'Net. Speedic is Director of Information Technology Education and Professor of Healih Informaties in the medical school at the University of Minnesota.

At the outset, Speedie explained why today's Internet is becoming outdated. The Internet's original message-based design has become obsolete, he said, as we become more reliant on the Internet to transfer larger files containing graphics and streaming video. The Internet, in its current state, also doesn't offer sufficient security, and access is too restricted.

The mission of NGI, Speedie said, is to be fast, ubiquitous, trustworthy, and to offer high capacity transmission. NGI will bring web users personal video conferencing, virtual reality, real-time collaborations, digital libraries, and distributed learning. "Digital convergence will accelerate," Speedic said.

Paul Bleicher discussed clinical trials on the Internet. Bleicher, founder and chairman of Phase Forward, Inc., a web-based clinical trial management company in Waltham, MA, touted the benefits of centralized online databases for scientific collaboration. Using the Internet to conduct clinical trials allows for bulk data transmission, online data entry, and real-time viewing of the data from multiple locations.

"People have to change the way they think about doing clinical trials," Bleicher said, "The mandates [for web-based trials] are quality, timeliness, safety, regulatory alignment, and quality decision-making."

Bleicher's case for web-based clinical trials centered on the notion that a centralized database, monitored via the web from different geographical locations, offers global connectivity and the opportunity for scientists to collaborate from institutions around the world.

The FDA!s Melissa Moneavage, M.Ph., talked about regulating drug promotion on the Internet. Moncavage, who works in FDXs Division of Drug Marketing, Advertising, and Communications, gave an insider's view of how the FDA views drug promotion on the Internet and what the agency does to regulate online promotion.

Moneavage first outlined the required product information for drug promotion. The FDXs charge to drug manufacturers is that they must present a fair balance of the benefits and risks associated with any product. Moncavage gave examples of companies that had met - and failed to meet - this requirement in Internet promotion. Companies cited for violations by the FDA had included unsubstantiated claims, misleading statements, or information on unapproved uses of their products.

Moncavage suggested that drug manufacturers who promote their products on the Internet consider the following questions. Does the site meet the basic requirements under FDA:s 21 CFR? Could you hand out the information on your website if it were written in a brochure? Is all the information current, fair, and balanced?

In Indianapolis, Internet consultant Allan Jenkins presented a seminar on the topic, "How the Internet Affects Health Care." Jenkins noted that 54 percent of web users are now going online in search of medical or health information. And with 300,000,000 health-related sites on the web, the sudden availability of information is essentially altering the nature of health care.

"This is changing relationships between doctors and patients," Jenkins said. "People can now manage their own health care, educate themselves, and select their doctor based on informed choices."

Patients these days expect their doctors to be more proactive in their care, Jenkins said. They want to receive email updates and have access to e-communities where they can share medical information and receive support.

Ironically, Jenkins said, doctors rarely take advantage of the Internet as a resource. The fact that traditional medical record-keeping is done on paper, combined with the lack of online security, keeps doctors from relying heavily on the Internet for professional matters. As a result, some doctors are losing patients or taking on diminished roles in the lives of their patients, who are turning to the Internet and online medical communities for health care support.

Pharmaceutical companies, on the other hand, have an opportunity to fill the void left by doctors, Jenkins said. The corn build relationships with customers becoming involved in patient educ a health management.