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Medical News & Perspectives - December 3, 1997

WHO Considers Regulating Ads, Sale of Medical Products on Internet

The internet, like the air, is owned by no country and is being harmfully polluted by many. Health authorities in the United States and internationally have been growing concerned about the use of the Net to promote and sell fraudulent or illegal medical products across national borders.

In response to complaints from Belgium and other countries, the World Health Organization (WHO) convened an ad hoc working group to develop recommendations to help curb the escalating use of the Internet by promoters of health fraud and marketers of illegal drugs. The group met at WHO headquarters in Geneva, Switzerland, in September, and the director-general will report its findings and recommendations to WHO's executive board in January and to the World Health Assembly meeting in May.

The report, entitled Cross-Border Advertising, Promotion, and Sale of Medical Products Through the Internet, warns that the confidence and safety of the public are being undermined by the absence of assurance of efficacy, safety, or quality of the medical products being advertised or sold through the Net.

The marketing of unproven and dangerous health products has always been a problem, said Stuart L. Nightingale, MD, associate commissioner for Health Affairs at the Food and Drug Administration (FDA) in Rockville, Md, who served as rapporteur for the group. But in the past, the marketers usually advertised in publications that were not widely circulated. The Internet, with its global reach and easy-to-use, graphics-based component, the World Wide Web, is providing manufacturers and merchants with an unprecedented, inexpensive way to quickly reach millions of potential consumers worldwide. Because it is difficult to regulate, the Net has become a busy marketplace for promoters of fraudulent, illegal, and potentially harmful medical products.

The public has been turning to the Net at an accelerating pace to obtain medical information and purchase drugs and medical devices. According to the ad hoc group's report, many of these products have not been approved, authorized, or licensed for marketing by health authorities. And even if they were approved for marketing, the products being offered may not meet quality standards if they are not properly manufactured, packaged, and stored. There is no guarantee that the consumer will receive the actual product desired and not a fraudulent or adulterated substitute.

People also risk wasting money on ineffective, improper, or needless treatments. Even if the medical products are not harmful, buyers may compromise their health by not seeking proper advice and treatment from a medical professional. Furthermore, the distribution of products through illegal chains provides little or no opportunity to observe or report adverse drug reactions to appropriate authorities.

Daunting Challenge Ahead

Regulating the Net, however, may prove as daunting a challenge as drafting an international treaty to control air pollution. The global network of computers called the Internet is neither owned nor controllable by any country. Identifying those who are responsible for illegal activity on it can present challenging enforcement problems. It is often difficult to find the physical location of a person or organization responsible for information placed on the Net. Web sites are easy to shut down and move. But perhaps the greatest problem may come from the different attitudes countries have toward freedom of speech and the marketplace.

For example, the United States alone among developed nations allows pharmaceutical companies to advertise prescription drugs directly to consumers, the ad hoc group reports. And there are other differences that may make it difficult for member nations to agree on regulations for cross-border promotion and sales of medical products on the Net. While it is illegal to sell prescription drugs through the mail in most European countries, mail-order pharmacies are legal in the United States. What's more, US law does not provide for enforcement action against those who market products illegally in other countries when those products can be sold legally within the United States.

Also, many drugs that require a prescription in one country are available over the counter in another—or, as in the United States, are sold as unregulated "food supplements." An example is the adrenal hormone dehydroepiandrosterone (DHEA). Although substantial levels of this hormone are found only in primates and not in any food consumed by humans, it is widely available in US health food stores, advertised on the Internet, and sold by mail order as a food supplement. " This is as crazy as health food stores being allowed to sell cortisone supplements," said Arthur Schwartz, PhD, a professor of microbiology at Temple University School of Medicine, Philadelphia, Pa (JAMA. 1996;276:1365-1367).

Some Recommendations

Following are some of the ad hoc group's recommendations to the WHO's director-general:

  • Encourage the international community to formulate self-regulatory guidelines for use of the Internet that are consistent with the principles of the WHO Ethical Criteria for Medicinal Drug Promotion.
  • Collaborate with relevant international organizations and institutions on Internet issues related to marketing medical products.
  • Urge member nations to set up or strengthen mechanisms to monitor and survey cross-border advertising, promotion, and sale of medical products on the Internet.
  • Urge member nations to take regulatory action where appropriate for violations of their national laws.
  • Encourage member nations and concerned nongovernmental organizations to report problem cases of cross-border promotion and sale of medical products involving the Internet to the WHO.

The ad hoc group also recommends that member nations establish a Web site for dissemination of information about medical products promoted or sold through the Net and information on regulatory action; collaborate with other member nations and share information on problem cases through the WHO; and provide the public and health professionals with information to help them assess the health claims made and the products offered on the Net.

Fighting Fire With Fire

According to the group, the Internet can be not only a medium for disseminating, but also a potent weapon for fighting fraudulent or illegal promotion or sale of medical products. By exposing and highlighting national differences, the Net may lead to a growing harmonization of laws, regulations, and practices among countries regarding the sale and use of medical products. It can help member countries track and report abuses. It can help the WHO become a clearinghouse of information on the violation and enforcement of international laws regarding sale and promotion of medical products on the Internet. And it can be used to help health care professionals educate people about the risks and benefits of medical information on the Internet.

—by Andrew A. Skolnick

(JAMA. 1997;278:1723-1724)


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