Contaminated Haemophilia Blood Products - Sales To Asia and Latin America

Sales To Asia and Latin America

On February 29, 1984, Cutter became the last of the four major blood product companies to get US approval to sell heated concentrate. Even after Cutter began selling the new product, for several months, until August 1984, the company continued making the old medicine. One reason was that the company had several fixed-price contracts and believed that the old product would be cheaper to produce.

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." 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. 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. Dr. 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 in which "It normally one week."

While the new product was selling well for Cutter, a Cutter company meeting notes 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." Cutter decided to sell millions of dollars of the older medicine to Asia and Latin America while selling the new, safer product in the West, to avoid being stuck with large stores of a product that was proving increasingly unmarketable.

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. Several months later, once haemophiliacs 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. 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." 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."

The United States Food and Drug Administration helped to keep the news out of the public. In May 1985, the FDA's regulator of blood products, Dr. 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. Cutter's notes from the meeting indicate that Dr. 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."

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 " and stopped shipping unheated concentrate in July 1985.

According to The New York Times, doctors and patients contacted overseas said they had not known of the contents of the Cutter documents. The effects are close to impossible to calculate. Since many records are unavailable and because it was a while until an AIDS test was developed, one cannot know when foreign haemophiliacs were infected with HIV - before Cutter began selling its safer medicine or afterward.

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 haemophiliacs lawsuits described below. Dr. 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."

On August 22, 2003, 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 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 has yet to investigate any corporate executives.