This article is dedicated to Anna Tomalis, a young girl who died of liver cancer on August 15, 2008. Anna’s parents desperately sought experimental treatment that might have saved her life, but were delayed for months by FDA bureaucracy. Anna finally received approval to obtain treatment through a clinical trial in July, but died after receiving just one round of treatment. She was thirteen years old.
Abigail Burroughs was not the typical cancer patient: She was just nineteen years old when she was diagnosed with squamous cell cancer that had spread to her neck and lungs. Her prognosis was poor, but a then-experimental drug, Erbitux, offered the hope of saving her life.
Abigail was denied that hope by the Food and Drug Administration. Because the drug was considered experimental, she could receive it only as part of a clinical trial—and Abigail was ineligible to participate in any trials at the time. Despite the best efforts of her family, friends, and doctor, Abigail was unable to receive the treatment that might have saved her life. At twenty-one years old, Abigail died of her disease.1
Abigail’s father, Frank Burroughs, thought other patients with life-threatening illnesses should not be denied the ability to try any treatment that might give them a chance. In his daughter’s name, he formed the Abigail Alliance for Better Access to Developmental Drugs, which sued the FDA in 2003. The group argued that the FDA’s restrictions on access to experimental treatments constitute a violation of the right to self-defense as well as of the Fifth Amendment right not to be deprived of life, liberty, or property without due process of law. In August 2007, the Appeals Court of the District of Columbia struck a blow against the Abigail Alliance, and against individual rights, when it ruled that patients, even the terminally ill, do not have the right to receive treatment that has not been approved by the FDA.2
Erbitux has since been approved by the FDA to treat cancer of the head and neck—too late, of course, for Abigail Burroughs. How has America come to a point where the government denies dying patients the right to try to save their own lives? To answer that question, let us begin with a brief history of the Food and Drug Administration.
A Brief History of the FDA
Prior to the 20th century, the government did not regulate pharmaceutical products in the United States. Although Congress had considered federal regulations on food and drug safety as early as 1879, it had refrained from passing any legislation in this regard. However, with the muckraking journalism of the early 1900s, and especially with the publication of Upton Sinclair’s novel The Jungle, which portrayed unsavory practices in the meatpacking industry, the American public clamored for laws to ensure the safe production of food and drugs. This public outcry pushed Congress to pass federal legislation in 1906. As the resulting Food and Drugs Act applied to drugs specifically, products were required to be sold only at certain levels of purity, strength, and quality; and ingredients considered dangerous (such as morphine or alcohol) had to be listed on the product’s label. Violators would be subject to seizure of goods, fines, or imprisonment. Thus, in order to enforce the Act, the Food and Drug Administration was born.3
In its early years, the agency focused primarily on food rather than on pharmaceuticals, but in 1937 it increased its focus on drugs after a new formulation of sulfanilamide, a drug that had previously been successfully used to treat certain bacterial infections, proved to be deadly. The drug’s manufacturer, S. E. Massengill Company, had dissolved an effective drug in a toxic solvent. More than one hundred people, babies and children among them, died as a result of taking Massengill’s product, known as Elixir Sulfanilamide.
Under the 1906 Food and Drugs Act, the FDA was not authorized to prosecute Massengill for selling an unsafe drug, and the agency had the power to recall Elixir Sulfanilamide only via a technicality. Because “elixir” was defined as a drug dissolved in alcohol, and because Massengill’s formulation used the nonalcoholic solvent ethylene glycol, the product was technically mislabeled, bringing it under FDA jurisdiction and enabling the agency to recall the product. The public and legislators wanted more: They wanted the FDA not only to recall mislabeled products, but to prevent the sale of unsafe drugs in the first place. Thus, popular demand gave rise to the Food, Drug, and Cosmetics Act of 1938, which greatly expanded the FDA’s authority.4
The most important change brought about by this Act was a shift in the burden of proof. Rather than prosecuting a drugmaker after the fact for having fraudulently marketed a product, the FDA would now require proof of safety before a drug could be marketed at all.5 (Note that this required manufacturers to prove a negative—i.e., that a given drug would not harm consumers.)
After World War II, pharmaceutical companies came under still more scrutiny. Then, as now, complaints about the cost of drugs reached Congress, and in 1961 Senator Estes Kefauver led the charge in an investigation not only of drug pricing, but of the relationship between the drug industry and the FDA. Kefauver sought to pass legislation that would increase the agency’s authority over drug production, distribution, and advertising. Whereas previously proof of safety alone was required to gain FDA approval, the proposed law would require drug manufacturers also to prove the efficacy of their products.
Kefauver’s bill might have languished in congressional debate but for the emergence at that time of data showing that thalidomide, which was then sold as a sleep aid and antinausea medication for pregnant women, caused severe birth defects in the children of women who took it. Thalidomide had not yet been approved for use in the United States at that time due to concerns of an FDA reviewer over a different side effect noted in the drug’s application for approval. The drug was widely used in other countries, however, and the babies of many women who used it were born with grotesquely deformed limbs. As their harrowing images flooded the media, Americans realized they had narrowly escaped inflicting these deformities on their own children. The resulting public outcry led to Kefauver’s bill being made law in 1962. This law served as the cornerstone for the wide powers that the FDA acquired thereafter, from requiring companies to include warnings in drug advertisements to dictating the way companies must investigate their own experimental compounds.6
Thus, although the scope and power of the FDA were modest at the agency’s inception, its scope widened and its power increased markedly in the decades that followed. Now, a century later, the agency’s purview includes foods and drugs for humans and animals, cosmetics, medical devices (including everything from breast implants to powered wheelchairs), blood and tissues, vaccines, and any products deemed to be radiation emitters (including cell phones and lasers). And the agency’s power is nothing short of enormous. Let us consider how the agency wields this power, specifically in regard to drugs. . . .
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1 Sue Kovach, “The Abigail Alliance: Motivated by Tragic Circumstances, Families Battle an Uncaring Bureaucracy,” Life Extension, September 2007, p. 26.
2 Andrew Pollack, “Court Rejects Patient Right To Use Drugs Being Tested,” New York Times, August 8, 2007. Accessed at http://query.nytimes.com/gst/fullpage.html?res=980CEEDA1230F93BA3575BC0A9619C8B63&st=cse&sq=abigail+alliance&scp=2.
3 Ira R. Berry, ed., The Pharmaceutical Regulatory Process (New York: Marcel Dekker, 2005), pp. 9–15.
4 Carol Ballentine, “Taste of Raspberries, Taste of Death: The 1937 Elixir Sulfanilamide Incident,” FDA Consumer, June 1981. Accessed at http://www.fda.gov/oc/history/elixir.html.
5 Berry, Pharmaceutical, p. 21.
6 Berry, Pharmaceutical, pp. 28–32.
7 Aaron Smith, “Generic Drug Flood Headed Our Way,” CNN/Money, August 3, 2005. Accessed at http://money.cnn.com/2005/08/03/news/fortune500/generic/index.htm.
8 Andrew C. von Eschenbach, Statement on Support of Science of the FDA before the House Subcommittee on Oversights and Investigations, January 29, 2008. Accessed at: http://www.hhs.gov/asl/testify/2008/01/t20080129c.html; U.S. Food and Drug Administration, “Summary of FDA’s FY 2009 Budget.” Accessed at: http://www.fda.gov/oc/factsheets/budget2009.html.
9 Andrew Pollack, “Despite Billions for Discoveries, Pipeline of Drugs Is Far From Full,” New York Times,April 19, 2002. Accessed at http://query.nytimes.com/gst/fullpage.html?res=9407E4DB153FF93AA25757C0A9649C8B63&st=cse&sq=%24800+million+drug+development&scp=3.
10 John Stossel, Give Me a Break: How I Exposed Hucksters, Cheats, and Scam Artists and Became the Scourge of the Liberal Media . . . (New York: HarperCollins, 2004), pp. 44–45.
11 Richard A. Epstein, Overdose: How Excessive Government Regulation Stifles Pharmaceutical Innovation (New Haven: Yale University Press, 2006), p. 117. “Tendency” reads “tendencies” in the original.
12 Ahmedin Jemal et al., “Cancer Statistics, 2008,” CA: A Cancer Journal for Clinicians, vol. 58, no. 2, March–April 2008, p. 76.
13 Stephanie Saul, “F.D.A. Plan on Medical Articles Takes More Heat,” New York Times, April 19, 2008. Accessed at http://www.nytimes.com/2008/04/19/business/19ghost.html?_r=1&oref=slogin.
14 Epstein, Overdose, pp. 121–2.
15 Pollack, “Billions.”
16 Aaron S. Kesselheim, “Intellectual Property Policy in the Pharmaceutical Sciences: The Effect of Inappropriate Patents and Market Exclusivity Extensions on the Health Care System,” The AAPS Journal, vol. 9, no. 3, pp. E306 and E309.
17 Matthew Herper, “Are Drug Patents Too Short?” Forbes,March 9, 2005. Accessed at http://www.forbes.com/sciencesandmedicine/2005/03/09/cx_mh_0309plavix.html.
18 Derek Lowe, “Aspirin: Not Approvable,” Medical Progress Today, November 17, 2005. Accessed at http://www.medicalprogresstoday.com/spotlight/spotlight_indarchive.php?id=1039.
19 Pollack, “Billions.”
20 Ehud Arbit et al., “Oral Heparin: Status Review,” Thrombosis Journal,vol. 4, no. 6, p. 1.
21 Elizabeth Weise and Julie Schmit, “Deaths Linked to Heparin Triple to 62,” USA Today,April 9, 2008. Accessed at http://www.usatoday.com/money/industries/health/2008-04-08-fda-heparin-deaths_N.htm?csp=34.
22 The iPLEDGE Program Patient Introductory Brochure, pp. 3–5.
23 Rebecca Webber, “Would You Risk Your Health for Clear Skin?” Glamour, September 2007. Accessed at http://www.glamour.com/fashionbeauty/articles/2007/08/accutane.
24 Saul, “Heat.”
25 Epstein, Overdose, p. 155.
26 Stossel, Break, pp. 45–46.