Contaminated haemophilia blood products

During the late 1970s and early 1980s, large numbers of hemophiliacs throughout the world became infected with HIV after receiving tainted clotting substances made by Armour Pharmaceutical Company, Bayer Corporation and its Cutter Biological division, Baxter International and its Hyland Pharmaceutical division and Alpha Therapeutic Corporation.^[1] Estimates range from 6,000 to 10,000 hemophiliacs in the United States becoming infected with H.I.V.^[1][2]

It is believed that three of these companies (Alpha, Baxter and Cutter) recruited and paid donors from high risk populations including former prisoners, needle-drug users, and donor centers with large numbers of homosexual donors, especially in cities with already large numbers of these persons to obtain blood plasma used for the production of Factor VIII and Factor IX.^[3] These companies allegedly failed to follow United States federal law mandates to exclude donors with a history of viral hepatitis.^[3] The medicine was made using pools of plasma from 10,000 or more donors, and since HIV at that time couldn't be screened out, the plasma carried a high risk of passing along the disease.^[4]

Factor VIII essentially provides the missing ingredient without which hemophiliacs' blood cannot clot. By injecting themselves with it, hemophiliacs can stop bleeding or prevent bleeds from starting; some use it as many as three times a week.^[4]

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Initial concerns

At its start, concern over AIDS always focused on homosexual men and intravenous drug users. On July 16, 1982, things changed, when the United States Centers for Disease Control and Prevention (CDC) reported that three hemophiliacs had acquired the disease.^[4] Epidemiologists started to believe that the disease was being spread through blood products, grave implications for hemophiliacs who routinely injected themselves with concentrate made from giant pools of donated plasma.^[4] Without an AIDS test, health officials had no idea how many plasma donors carried the disease.

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."^[4] By March 1983, the situation got so bad that the CDC warned that blood products "appear responsible for AIDS among hemophilia patients."^[4] By May 1983, a Cutter rival began making a heated concentrate and France decided to halt all clotting concentrate imports until it could figure out what to do.^[4]

Cutter feared losing customers, so according to an internal memo, Cutter "want to give the impression that [they were] continuously improving our product without telling them [they expected] soon to also have a heat-treated" concentrate.^[4] The heat-treatment rendered the virus "undetectable" in the product, according to a government study.^[4]

By June, 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 "This is of particular concern to us because of unsubstantiated speculations that this syndrome may be transmitted by certain blood products."^[4] France continued using unheated concentrate in August.^[4]

However, after stopping sales of the drugs in the United States in 1984, Bayer may have continued to sell the contaminated products overseas for at least another year.

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.^[4] Even after Cutter began selling the new product, for several months, until August 1984, the company continued making the old medicine.^[4] One reason was that the company had several fixed-price contracts and believed that the old product would be cheaper to produce.^[4]

Bayer officials (responding on behalf of Cutter) issued a statement, saying 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."^[4] Bayer officials also claim that an overall plasma shortage in 1985 kept Cutter from making more heated medicine; however, because Cutter was using some of its limited plasma to continue making the old product, they may have contributed to the shortage.^[4] While Bayer said that "procedural requirements" imposed by Taiwan slowed down their ability to sell the new product, according to 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.^[4] 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 which "It normally [takes] one week."^[4]

While the new product was selling well for Cutter, the minutes from a November 15, 1984 Cutter company meeting notes that "There is excess nonheated inventory", which the company deciding to "review international markets again to determine if more of this product can be sold."^[4] 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.^[4]

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.^[4] 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.^[4] 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."^[4] 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 possibly a small amount for the "most vocal patients."^[4]

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.^[4] 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"^[5] while another company noted that the FDA wanted the matter solved "quickly and quietly."^[4]

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.^[4]

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 hemophiliacs were infected with HIV - before Cutter began selling its safer medicine or afterward.^[4]

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.^[4] 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."^[4]

On August 22, 2003,^[6] MSNBC's Scarborough Country had Bayer on their "Rat of the Week" segment.^[5] 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."^[5] As of 2003, the United States Justice Department has yet to investigate any corporate executives.^[5]

Specifics by country

This scandal has led to a number of court cases worldwide.

Canada

In Canada, by the time blood tests began in late 1985, about 2,000 people were infected with HIV and up to 60,000 with Hepatitis C.^[7] Three suits were brought against the Canadian Red Cross by people who had received tainted blood, two of whom subsequently died of AIDS and the third HIV positive.^[7] In April 2001, the Supreme Court of Canada found the Canadian Red Cross guilty of negligence for failing to screen blood donors effectively for HIV infection.^[7]

France

In France, an estimated 4,000 people, many haemophiliacs, were given blood infected with HIV.^[7]

A former Health Minister was convicted for failing to adequately screen the blood, leading to the deaths of five people from AIDS, and the contamination of two others during a key period in 1985.^[7] Two other government officials that continued to use the old unheated stock in 1985, when a heated product was available, were sent to prison.^[4][5] Allegedly, all three politicians delayed the introduction of United States blood-screening test in France until a rival French product was ready to be sold on the market.^[7]

Iran

In Iran, as of 2001, the former head of Iran's blood transfusion center went on trial (a Dr. Farhadi along with two other doctors) facing several charges including negligence for importing HIV-tainted supplies from France after patients contracted HIV. The case followed complaints by families of some 170 people, many of them children, suffering from haemophilia and the blood disease thalassemia.^[7]

Iraq

In 1986, officials from Saddam Hussein's Health Ministry had determined that at least 115 Iraqi hemophilacs had contracted AIDS from clotting agents imported from France and Austria.^[8] According to Dr. Said I. Hakki, the director of the Iraqi Red Crescent Society, 189 hemophiliacs, from 6 months to 18 years old, contracted HIV from blood products that Institut Mérieux and Immuno sold to Iraq from 1982 to 1986; undetected, the virus later spread to at least another 50 more Iraqis, through sexual intercourse, childbirth or breast-feeding.^[8]

In August 2005, the 35 or so survivors, along with the families of the ones who died, and the Iraqi Red Crescent Society have sued the Health Ministry and Institut Mérieux of France and Immuno AG of Austria, two corporations who either acquired or succeeded the companies that sold tainted blood products to Iraq.^[8] Institut Mérieux is now part of Sanofi-Aventis, while Immuno AG was acquired by Baxter International in 1996.

Several of the infected hemophiliacs spoke with the New York Times in 2006 about life under Hussein's rule. They were forced to "sign a pledge vowing not to work, marry, attend school, use public swimming pools or barbershops, visit a doctor’s office or tell anyone about their condition", punishable by death.^[8] The families' homes had warnings painted on them, telling neighbors to stay away because the house was contaminated with HIV and uninfected siblings were not even allowed to marry.^[8] As of 2006, the infected hemophiliacs receive about $35 a month in government assistance, but no HIV medication.^[8]

Italy

Angelo Magrini, the head of a haemophiliacs' association, said that as of 2001, 1,300 people, including almost 150 children, had died in Italy from infected blood infusions since 1985.^[7]

An Italian court in Rome ordered the Health Ministry to pay damages to 351 people who contracted HIV and Hepatitis C through blood transfusions; the court said that the ministry was too slow to introduce measures to prevent the virus being spread by donated blood, and did not establish proper checks on plasma.^[7] Although almost 100 of the victims had already died, the court ruled that their families were still entitled compensation.^[7]

Japan

In Japan, the Health Ministry did not ban unheated products until December 1985, despite knowing that they were contaminated.^[7] As a result, over 1,400 Japanese haemophiliacs were exposed to HIV, and more than 500 were believed to have died by 2001.^[7]

In November 1995, a case involving Japanese hemophiliacs settled, resulting in $420,000 for each victim, with $235,000 coming from industry and the rest from the Japanese government.^[1] This was much higher than the results being discussed in the United States cases.^[1]

In February 2000, three former drug company executives accused of selling blood products tainted with HIV were given prison terms.^[7]

However, in March 2001, a Tokyo court cleared the former top AIDS expert of professional negligence over the scandal.^[7]

Portugal

In Portugal, more than 100 Portuguese haemophiliacs were infected with the AIDS virus after receiving transfusions of contaminated plasma that had been imported and distributed by the public health service.^[7] In 2001, a court indicted Leonor Beleza, a former health minister, for propagating a contagious disease during her time in office during the 1980s.^[7]

United States

In 1993, top executives of three companies - Baxter International, Rhône-Poulenc and Alpha Therapeutic - met with leaders of the hemophilia community to outline the terms of a $125 million offer.^[1] Rejecting the offer, the next day, David Shrager, a plaintiffs' lawyer filed a class action lawsuit with Jonathan Wadleigh as lead plaintiff, on behalf of American hemophiliacs.^[1] Shrager had previously negotiated a favorable settlement on behalf of Canadian hemophiliacs, and then established a panel of claimants, led by Wadleigh, to advise him and other lawyers.^[1] In early 1995, the United States Court of Appeals for the Seventh Circuit in Chicago decertified the lawsuit, saying it might bankrupt the industry.^[1]

There became a split between Wadleigh and Corey Dubin (another named plaintiff) favoring appealing the Seventh Circuit decision to the Supreme Court of the United States, to protect the rights of all affected hemophiliacs, not just those who had already sued, while Shrager wanted to shift gears and pursue the separate Federal proceeding that had consolidated hundreds of individual lawsuits that had been filed against the producers.^[1] By June 1996, the differing groups reconciled, looking for industry settlement proposals.^[1]

Meanwhile, the clotting producers were quietly settling many claims. Individual lawsuits continued to fail because most states had laws shielding blood products from traditional product liability claims.^[1] However, discovery was producing damaging documents contending that the companies had collected blood from high-risk donors like homosexuals and prisoners, intensifying informal settlement negotiations.^[1]

In 1997, Bayer and the other three makers agreed to pay $660 million to settle cases on behalf of more than 6,000 hemophiliacs infected in United States in the early 1980s, paying an estimated $100,000 to each infected hemophiliac.^[2][4][8][9]

Soon after the settlement, because the New York state statute of limitations required people to file a lawsuit within three years of discovering an illness, New York Governor George Pataki signed a bill allowing people infected by blood products, or their survivors, two years to bring product liability suits against the manufacturers.^[9] The settled class members are barred from filing suits against the companies, however the bill allowed an estimated additional 75 eligible to file suits.^[9]

The plaintiffs alleged that the companies manufactured and sold blood factor products as beneficial "medicines" that were, in fact, contaminated with HIV and/or HCV and resulted in the mass infection and/or deaths of thousands of haemophiliacs worldwide.^[3] The companies' failure to follow US federal law and conduct tests against viral hepatitis increased the risk of plasma containing HIV entering plasma pools.^[3]

References

1. ^ ^{a b c d e f g h i j k l} Meier, Barry. "Blood, Money and AIDS: Hemophiliacs Are Split; Liability Cases Bogged Down in Disputes", New York Times, 1996-06-11. Retrieved on 2006-09-13. 
2. ^ ^{a b} Zamora, Jim Herron. "Bad blood between hemophiliacs, Bayer: Patients sue over tainted transfusions spreading HIV, hep C", San Francisco Chronicle, 2003-06-03. Retrieved on 2006-09-20. 
3. ^ ^{a b c d} Introduction: Lawsuits by Persons with Haemophilia. Retrieved on 2006-09-13.
4. ^ ^{a b c d e f g h i j k l m n o p q r s t u v w x y z aa ab ac ad ae af} Bogdanich, Walt and Koli, Eric. "2 Paths of Bayer Drug in 80's: Riskier One Steered Overseas", New York Times, 2003-05-22. Retrieved on 2006-09-13. 
5. ^ ^{a b c d e} truemusix. AIDS HIV Bayer [YouTube video]. Retrieved on 2006-09-20.
6. ^ Templin, Chris. Transcript from SCARBOROUGH COUNTRY of MSNBC from 8-22-2003 about his rat of the week Bayer Corporation. Sunshine's Place. Retrieved on 2006-09-20.
7. ^ ^{a b c d e f g h i j k l m n o p} "Aids scandals around the world", BBC News, 2001-08-09. Retrieved on 2006-09-20. 
8. ^ ^{a b c d e f g} von Zielbauer, Paul. "Iraqis Infected by H.I.V.-Tainted Blood Try New Tool: A Lawsuit", New York Times, 2006-09-04. Retrieved on 2006-09-20. 
9. ^ ^{a b c} Dao, James. "Pataki Signs Bill Letting Hemophiliacs Sue Companies Over Blood-Clotting Products", 1997-12-02. Retrieved on 2006-09-20.