Scientific Integrity and the Commercial Speech Doctrine for Industry

An interesting article by Joanna K. Sax titled “Protecting Scientific Integrity: The Commercial Speech Doctrine Applied to Industry Publications,” appeared in the American Journal of Law and Medicine in 2011 (vol. 37, pages 203-224).

The article opens up by discussion how the economic reality of survival and profits may distort a company’s decision making process regarding full disclose on a particular drug. Dow Corning, which manufactured implants, withheld important data from long-term animal models which demonstrated adverse effects from breast implants and failed to conduct long-term studies. It was necessary for litigation in order to expose Dow’s failure to conduct the necessary studies. It was found that even though Dow denied liability they had evidence which demonstrated they had knowledge of the harmful effects of the breast implants and suppressed these findings.

The author later mentions how the tobacco industry used propaganda in the 1960s and 1970s to refute evidence of the harmful effects of second-hand smoke by flooding the scientific literature with studies which concluded that passive smoking was not harmful.

A discussion is made of a potential regulation called the Truth in Marketing (TIM) Act which would expand the Food and Drug Administration’s (FDA) role to penalize pharmaceutical companies for false or misleading direct-to-consumer advertising and allow them to regulate scientific journals.

The article then goes into a discussion of misleading industry publications which tend to have a bias in that they tend to report positive results of clinical trials. The author does point out though that this bias is not as extreme in publications by academic laboratories which receive public funding.

The author also points out how a variety of problems come about from the failure to report negative results. One issue is the widespread dissemination of these results which can be picked up by media reporters who are writing a story. A second issue is that the scientists may be lead on a dead-end chase of exploring the biochemical pathways of the drug even though the new drug is not better than the standard treatment already in place. A third issue is that misleading publications can influence policy decisions which can stifle scientific progress and erode the public’s trust in scientists.

The author mentions the Lanham Act which is designed to prohibit false advertising which states

“….in commercial advertising or promotion, misrepresents the nature, characteristics, qualities, or geographic origin of his or her or another person’s goods, services, or commercial activities, shall be liable in civil action by any person who believes that he or she is or is likely to be damaged by such act.”

One issue mentioned with the Lanham Act is that a publication in a medical or scientific journal may not meet the definition of commercial advertising or promotion.

The author states

” At present, no regulations exist that fully combat the problem of the dissemination of misleading or biased industry publications. The government has a substantial interest in protecting the health and welfare of its citizens. In addition, scientific integrity is called into question if the failure to report negative results from clinical trials is used to move science in the wrong direction.”

The author then goes into a discussion of a trial registry to ensure that information is publicly available. The author then mentions the Bad Ad Program by the FDA. A discussion is then made of the commercial speech doctrine applied to misleading or biased industry publications.

The author ends by concluding

“Policymakers can learn from publicized stories over the past few decades — such as the tobacco industry tactics and breast implant eases—to draft regulations to ensure that the scientific and medieal communities, policymakers, and the publie have accurate information in order to make the best healthcare decisions. In this way, scientific integrity—which beneflts the public—can be protected and continue to provide improved healthcare services to the public.”

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