These Statements Have Not Been Evaluated By the FDA

Andrew Troxell is a second-year biological chemistry major at Grinnell College. In the future, Andrew hopes to attend medical school and become a surgeon. Andrew is fascinated by medicine, medical policy, and the underlying causes behind phenomena we observe in medicine both at the biological and cultural level. Andrew biggest hobby is trying to find new hobbies, and is in the progress of several knitting projects with no hope of finishing.

What do Echinacea, St. John’s wort, and Gingko biloba have in common? All three of them are sold as herbal supplements, and all three are not what they seem. A recent study found that in one third of herbal supplements tested, there was outright substitution; there was no trace of the plant being advertized on the bottle. Instead, researchers found plants like powdered rice, Alexandrian senna (a powerful laxative), and black walnut (dangerous for nut allergies).

The present issue is only one more link in a long chain of problems with food and drug safety in this country. The Pure Food and Drug act was passed in 1906 to solve the problem of corrupt food companies and their equally as corrupted products. By the 1980s, “the FDA was perceived as bumbling and inefficient” in the eyes of many Americans as a result of the rampant scandals at the time. [i]  Now, the problem of supplement mislabeling again calls for change in the agency that is supposed to protect us from what we consume.

One of the first names to mind in the crusade for the Pure Food and Drug Act, Upton Sinclair is most commonly recognized for his muckraking work The Jungle, and its influence on the American people. More than a century has passed since The Jungle was published, and in this time, the public perception of the book has changed. Now regarded as an important work that changed the way we trust and look at food, Sinclair’s work was actually intended to be a piece of Socialist propaganda. It was only the eight pages worth of description of Packingtown and the conditions that existed there that had much of an influence on the minds of its readers.[ii] This influence, along with the actions of numerous other individuals, led to the passage of the act, and a sense of security among the American people. [iii]

In 1984, the Drug Price Competition and Patent Extension Act (DPCPEA) was passed into law. An aging population requiring more drugs for less money, paired with aims of helping low income groups in American society, led to the formation of the bill.[iv] However, these efforts resulted in a major negative change in the FDA’s image. Herbert Burkholz, author and speechwriter for the FDA, wrote, “If there was a single series of events that… transformed the modern image of the agency, it was the generic drug scandals.” [v] Much like the developing problem of nutritional supplements, the DPCPEA was the result of companies producing products that did not meet standards by slipping through holes in the legislation. ‘Nutritional supplements’ are subject to less regulation than pharmaceuticals or food products, and as a result can be significantly less potent and far more dangerous than advertized. The DPCPEA, on the other hand, allowed for many new players to begin manufacturing generic drugs. These were often organizations without a qualified medical director, research and development department, or much of the discipline that the old-line companies possessed; they were “cooks following recipes,” nothing more and nothing less. [vi]  In 1988 an investigation by the House Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce uncovered corruption as a result of holes in the bill that led to mislabeling as extreme as a powerful psychotropic (mood and behavior altering) drug (haloperidol) being labeled as children’s cough syrup.

The year before the Investigative committee convened to address the issue of generic drugs, the FDA entered into yet another scandal with the approval of the antiviral drug azidothymidine (AZT). In a frenzy to find a drug with any hope of helping patients with AIDS, AZT was pushed through the approval processes at an alarming rate. After results were seen six months into the Phase II trial, the FDA deemed that Phase III studies weren’t needed for approval. Between June 1985 and March 1987, AZT went from being approved as an ‘Investigational New Drug’, to being approved for sale as a treatment for AIDS. Patenting of the drug caused great outcry in the AIDS community, and created precedent that led to drugs for rare diseases costing more than $300,000/year. James Todd, senior vice-president of the American Medical Association commented, “Penicillin couldn’t get through that fast.”[vii]

In the coming years, we may see reaction to the problems surrounding nutritional supplements as strong as those to DPCPEA, and impacts on the industry as startling as those from AZT. Compounds as seemingly harmless as St. John’s wort, Echinacea, and Gingko biloba, in the questions that they raise about regulation and the medical industry, remind us that we are not too far removed from the days of the jungle of Packingtown.

[i] Herbert Burkholz. The FDA Follies. New York: Basic, 1994.

[ii] Mark Sullivan. Our Times; the United States, 1900-1925. New York: C. Scribner’s Sons, 1926.

[iii] Lorine S. Goodwin. The Pure Food, Drink, and Drug Crusaders, 1879-1914. Jefferson, NC: McFarland &, 1999.

[iv] Andrew T. Ching, “A Dynamic Oligopoly Structural Model For The Prescription Drug Market After Patent Expiration*.” International Economic Review 51.4 (2010): 1175-207.

[v] Burkholz.

[vi] Ibid.

[vii] Ibid.