These products caused large numbers of hemophiliacs to become infected with HIV and hepatitis C.
The companies involved included Alpha Therapeutic Corporation, Institut Mrieux (which then became Rhone-Poulenc Rorer Inc., and is now part of Sanofi), Bayer Corporation and its Cutter Biological division, Baxter International and its Hyland Pharmaceutical division.[1] Estimates range from 6,000 to 10,000 hemophiliacs in the United States becoming infected with HIV.[1][2]Factor VIII is a protein that helps the clotting of blood, which hemophiliacs, due to the genetic nature of their condition, are unable to produce themselves. By injecting themselves with it, hemophiliacs can stop bleeding or prevent bleeding from starting; some use it as often as three times a week.[3]
In 1981 concern was growing over an unidentified infectious disease associated with immune system collapse that would later become known as AIDS. In the U.S. it was found mostly in homosexual men and intravenous drug users, while in France a more diverse group of patients was affected.[4] On July 16, 1982, the United States Centers for Disease Control and Prevention (CDC) reported that three hemophiliacs had acquired the disease.[3] Epidemiologists started to believe that the disease was being spread through blood products, with grave implications for hemophiliacs who had routinely been treated with concentrate made from large pools of donated plasma, much of which was collected by commercial paid-donor plasmapheresis prior to routine HIV testing, often in U.S. cities that had large numbers of homosexuals and intravenous drug users and in some U.S. prisons and underdeveloped countries during the four or five years of the late 1970s through early 1980s before AIDS was discovered and recognized as a public health concern.[3]
In January 1983, the manager of plasma procurement for Bayer's Cutter Biological division acknowledged in a letter that "There is strong evidence to suggest that AIDS is passed on to other people through ... plasma products."[3] In March 1983, the CDC warned that blood products "appear responsible for AIDS among hemophilia patients."[3] By May 1983, a Cutter rival began making a heat-treated concentrate and France decided to halt all imports of clotting factor concentrates.[3] Cutter feared losing customers, so according to an internal memo, Cutter "want[ed] to give the impression that [they were] continuously improving our product without telling them [they expected] soon to also have a heat-treated" concentrate.[3] The process rendered the virus "undetectable" in the product, according to a government study.[3]
By June 1983, a Cutter letter to distributors in France and 20 other countries said that "AIDS has become the center of irrational response in many countries" and that "This is of particular concern to us because of unsubstantiated speculations that this syndrome may be transmitted by certain blood products."[3] France continued using older style, untreated concentrate through August 1983.[3] Continued sales
On February 29, 1984, Cutter became the last of the four major blood product companies to get US approval to sell heated concentrate.[3] Even after Cutter began selling the new product, for several months, until August 1984, the company continued making the old medicine.[3] One reason was that the company had several fixed-price contracts and believed that the old product would be cheaper to produce.[3]
Bayer officials (responding on behalf of Cutter) issued a statement, stating that Cutter continued to sell the old medicine, "because some customers doubted the new drug's effectiveness", and because some countries were slow to approve its sale. The company also said that a shortage of plasma, used to make the medicine, had kept Cutter from manufacturing more of the new product."[3] Bayer officials also claimed that an overall plasma shortage in 1985 kept Cutter from making more heat treated medicine; however, because Cutter was using some of its limited plasma to continue making the old product, they may have contributed to the shortage.[3] While Bayer said that "procedural requirements" imposed by Taiwan slowed down their ability to sell the new product, according to The New York Times, Hsu Chien-wen, an official at Taiwan's health department, said in 2003 that Cutter had not applied for permission to sell the heated medicine until July 1985, a year and a half after doing so in the United States.[3] Cindy Lai, assistant director of Hong Kong's health department, said that Cutter needed only to get an import license in the 1980s to sell the newer product, and that the process would normally take one week.[3]
While the new product was selling well, a Cutter company meeting noted that "There is excess nonheated inventory", which resulted in the company deciding to "review international markets again to determine if more of this product can be sold."[3] Cutter decided to sell millions of dollars worth of the older medicine to Asia and Latin America while selling the new, safer product in the West, where the nonheated product was proving increasingly unmarketable.[3]
In late 1984, when a Hong Kong distributor asked Cutter about the newer product, records show that Cutter asked the distributor to "use up stocks" of the old medicine before switching to its "safer, better" product.[3] Several months later, once hemophiliacs in Hong Kong began testing positive for HIV, some local doctors began to question whether Cutter was dumping "AIDS tainted" medicine into less-developed countries.[3] Cutter denied the allegation, claiming that the unheated product posed "no severe hazard" and was in fact the "same fine product we have supplied for years."[3] By May 1985, when the Hong Kong distributor told of an impending medical emergency, asking for the newer product, Cutter replied that most of the new medicine was going to the US and Europe and there wasn't enough for Hong Kong, except for a small amount for the "most vocal patients."[3] The United States Food and Drug Administration (FDA) helped to keep the news out of the public eye. In May 1985, the FDA's regulator of blood products, Harry M. Meyer Jr., believing the companies had broken a voluntary agreement to withdraw the old medicine from the market, called together officials of the companies and ordered them to comply.[3] Cutter's notes from the meeting indicate that Meyer asked that the issue be "quietly solved without alerting the Congress, the medical community and the public" while another company noted that the FDA wanted the matter solved "quickly and quietly."[3]
At the same time, a Cutter official wrote that "It appears there are no longer any markets in the Far East where we can expect to sell substantial quantities of nonheat-treated [medicine]" and stopped shipping unheated concentrate in July 1985.[3]
According to The New York Times, doctors and patients contacted overseas said they had not known of the contents of the Cutter documents. The number of affected patients is unknown. Since many records are unavailable and because an HIV test was not available at the time, one cannot know whether foreign hemophiliacs were infected with HIV before Cutter began selling its safer medicine or afterward.[3] The New York Times found these largely unnoticed documents ("internal memorandums, minutes of company marketing meetings and telexes to foreign distributors") as part of the production in connection with the American hemophiliacs lawsuits described below.[3] Sidney M. Wolfe, director of the Public Citizen Health Research Group, which has been investigating the industry's practices for three decades, called them "the most incriminating internal pharmaceutical industry documents I have ever seen."[3] On August 22, 2003,[5] MSNBC's Scarborough Country had Bayer on their "Rat of the Week" segment. Speaking with Mike Papantonio, a legal advisor to the show, they discussed the 2003 The New York Times article referenced above, saying that the product (known by Bayer to bear the risk of contamination) was "dropped ... in Japan, Spain and France." As of 2003, the United States Justice Department had yet to investigate any corporate executives.[citation needed]