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Old 08-17-06, 12:52 PM   #5 (permalink)
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Re: Bayer knowingly sold AIDS infected drugs in the US and overseas!!!

Last half of the NY times article:

Quote:
For five months more, until August 1984, Cutter said it continued to make the old, unheated medicine. The records suggest that the company hoped to preserve the profit margin from ''several large fixed-price contracts.'' But in its statements to The Times, Bayer also said that some customers still wanted the old medicine, initially believing -- incorrectly, it turned out -- that heating the concentrate could leave it less effective and possibly dangerous.

The new product, meanwhile, was selling briskly, leaving Cutter with a problem: ''There is excess nonheated inventory,'' the company noted in minutes of a meeting on Nov. 15, 1984.

''They needed to get the return for what they invested,'' explained Michael Baum, a Los Angeles lawyer who has represented dozens of United States hemophiliacs in suits against blood-product companies. ''They paid the donors. They had processed the plasma, put it into vials, kept it in warehouses -- and all that expense had already been incurred.'' (One vial is roughly equivalent to a small dose, though more may be needed to stop severe bleeding.)

At the November meeting, the minutes show, Cutter said it planned to ''review international markets again to determine if more of this product can be sold.'' And in the months that followed, it had some success, exporting more than 5 million units (a typical vial might contain 250 units) in the first three months of 1985, documents show.

''Argentina has been sold 300,000 units and will possibly order more, and the Far East has ordered 400,000 units,'' according to a March 1985 Cutter report. Two months later, the company reported that ''in Taiwan, Singapore, Malaysia and Indonesia, doctors are primarily dispensing nonheated Cutter'' concentrate.

By then, while there were still a small number of buyers in the United States, nearly all of the unheated concentrate was being sold abroad, available records show. All told, Cutter appears to have exported more than 100,000 vials of unheated concentrate, worth more than $4 million, after it began selling its safer product.

Gary Mull, an international product manager for Cutter at the time, said no one at the company had ordered him to sell the unheated concentrate as a way of avoiding a write-off. ''If I had reason to personally believe, let alone the company'' that any of the material was highly infectious, ''we wouldn't have sent it out,'' he said.

Mr. Mull, who now works for another blood-product company, added, ''I wasn't the shipping person, but I would still be the person in charge of queueing it up.''

Bayer, which is based in Germany, said in its statement that an overall plasma shortage in 1985 had kept Cutter from making more heated medicine. But Cutter may actually have contributed to that shortage -- by using some its limited plasma supplies to continue making the old product.

Bayer's response also emphasized that some countries were slow to approve its new product. For example, Bayer said ''procedural requirements'' imposed by Taiwan had delayed its ''ability to apply for registration'' and had led to other delays as well.

But an official at Taiwan's health department, Hsu Chien-wen, said recently that Cutter had not applied for permission to sell the new, safer medicine until July 1985, about a year and a half after it began doing so in the United States.

In one case, records show, Cutter officials even discussed trying to delay Japan's approval of heated concentrate so the company could shed stocks of the older product. Bayer said Cutter did not act on that idea.

Officials from the three other American-based companies that continued to sell unheated concentrate -- Armour Pharmaceutical, Baxter International and Alpha Therapeutic -- either declined to be interviewed or denied wrongdoing, in some cases citing the same reasons Bayer did for its decisions.

Still, what is not in dispute is that by the spring of 1985, few researchers doubted the connection between AIDS and unheated concentrate. The previous October, the federal Centers for Disease Control, using a prototype H.I.V. test, had reported that 74 percent of hemophiliacs who used unheated concentrate had tested positive for H.I.V. In the same report, the agency said a study done with Cutter had shown that heat treatment rendered the virus ''undetectable.''

(Bayer said no one knew ''definitively'' that its heat treatment killed the AIDS virus until eight months later.)

By May 1985, as the AIDS scare reached hemophiliacs in Hong Kong, Cutter's distributor there placed an urgent call to Cutter headquarters, records show. Sounding distraught, he told of an impending medical emergency. Hemophiliacs were frightened. Children were being infected with H.I.V. Parents were hysterical. Couldn't the company send the new, safer product?

Cutter replied that most of the new medicine was going to the United States and Europe, and that there was not enough left for Hong Kong, though a small amount was available for the ''most vocal patients.''

Dr. Chan Tai-kwong, who treated hemophiliacs at Queen Mary Hospital in Hong Kong, said doctors asked Cutter's distributor for the heated concentrate but could not get it; 40 percent of his patients were H.I.V.- positive, Dr. Chan said.

Dr. Patrick Yuen, who worked at another hospital, gave a similar account. ''The local distributor asked us to keep using it,'' he said. ''They said not to be afraid.''

Even so, Cutter knew the market for the older medicine had all but dried up.

''It appears there are no longer any markets in the Far East where we can expect to sell substantial quantities of nonheat-treated,'' a Cutter official wrote in May 1985. Bayer said Cutter stopped shipping unheated concentrate in July 1985.

Later, in the early 1990's, two members of a Hong Kong government commission that concluded the tragedy could not have been avoided, expressed concern when told of the internal Cutter documents. Dr. Yuen, a member of the panel, said Cutter failed to warn doctors and hemophiliacs in Hong Kong about the dangers of unheated concentrate. ''It should tell the whole world, not just Europe and America,'' he said.

Bayer also said Cutter did fully inform foreign customers about the heated product. And Bayer said it took more than a year to get Hong Kong's approval to sell it. But Dr. Cindy Lai, assistant director of Hong Kong's health department, said that in the 1980's Cutter needed only to get an import license. ''It normally took one week,'' she said.

The delay harmed more than just the hemophiliacs, said Mrs. Li, the mother of the young hemophiliac who died of AIDS in 1993. Infected with a terrible and still mysterious disease, hemophiliacs were often shunned by family, friends and employers.

''It was the immoral drug company that caused some families to fall apart,'' she said. ''They blamed and tortured each other. It was better to die than to live.''

The Message Gap
Many Slow to Hear Of the Problems


Today, in the Internet age, vast amounts of the most up-to-the-minute medical information are available at the click of a mouse. News moved less efficiently in 1985.

In Taiwan, Dr. Shen Ming-ching, who ran the country's largest clinic for hemophiliacs, recalled in a recent interview that it was not until he traveled to the United States for a conference in July 1985 that he learned for certain that heat treatment killed H.I.V. Upon returning home, he said, he immediately insisted that Taiwan authorities stop importing the old concentrate.

For his efforts on behalf of the hemophiliacs in Taiwan, Dr. Shen said, the government gave him a certificate and ''a beautiful medal.'' As for the hemophiliacs themselves, 44 of Dr. Shen's patients got AIDS, including a 2-year-old. He said 23 had died.

None of the Taiwan patients interviewed by The Times said they knew that Cutter had begun selling the safer medicine in the United States in early 1984.

One Taiwan patient who received Cutter's old concentrate was Lee Ching-chang. Mr. Lee said he got his first concentrate in November 1983 at age 22, and continued receiving the unheated type into 1985.

Mr. Lee said he tested positive for H.I.V. in 1986. ''I am bitterly angry,'' he said. Mr. Lee said he was too sick to work.

Six other hemophiliacs with H.I.V. or their families spoke to The Times about despair, discrimination, job loss or in some cases thoughts of suicide. Mr. Lee was the only hemophiliac with H.I.V. willing to be photographed.

Tang Fu-kuo helps AIDS patients in Taiwan. ''I cannot tell myself that it's just history; let's forget it,'' Mr. Tang said. ''Nobody wants to acknowledge fault.''

Selling Medicine In Spite of Danger
According to internal company documents, Cutter, a division of Bayer that made a blood-clotting medicine called Factor VIII concentrate, continued to sell medicine overseas that carried a high risk of AIDS even after a safer product was available.

JULY 1982 -- Centers for Disease Control reports three hemophiliacs ill with what later became known as AIDS and warns that the disease may be transmitted through blood products including concentrate.

JANUARY 1983 -- A Cutter official warns in a letter that ''there is strong evidence to suggest that AIDS is passed on to other people through . . . plasma products.''

JUNE 1983 -- Cutter complains to overseas distributors about ''unsubstantiated speculations'' linking AIDS to concentrate.

FEBRUARY 1984 -- Cutter gets license in the United States to sell new concentrate that has been heated to kill H.I.V.

OCTOBER 1984 -- C.D.C. says a study with Cutter found that heat treatment kills the AIDS virus. Prototype H.I.V. test finds 74 percent of hemophiliacs who used unheated concentrate tested positive for H.I.V.

NOVEMBER 1984 -- Cutter notes excess inventory of unheated product. ''Will review international markets'' to see if more unheated product can be sold.

NOVEMBER 1984 -- The company tells its Hong Kong distributor ''we must use up stocks'' of unheated medicine before switching to ''safer, better'' heat-treated product.

FEBRUARY 1985 -- A Cutter task force asks in a memo, ''Can we in good faith continue to ship nonheat-treated coagulation products to Japan?''

APRIL 1985 -- Cutter considers trying ''to influence a delay in introduction of heattreated product'' in Japan. The company later says it did not act on that suggestion.

MAY 1985 -- Cutter tells its Hong Kong distributor that the unheated medicine poses no ''severe hazard.''

MAY 1985 -- Cutter says Hong Kong doctors question whether it is selling off ''excess stocks of old AIDS-tainted'' medicine.

MAY 1985 -- The Food and Drug Administration realizes that companies are still selling unheated concentrate overseas. F.D.A. official wants problem ''quietly solved without alerting the Congress, the medical community and the public,'' according to Cutter documents.

JULY 1985 -- Cutter says it started shipping only heated product.
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