[e-drug] NYT: Bayer sold unsafe blood products

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E-DRUG: NYT: Bayer sold unsafe blood products
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[Crossposted with thanks from Bayer CBG network; copied as fair use. WB]

An examination of internal Bayer company documents by The New York Times
reveals that the company was engaged in unsavory, probably criminal
marketing practices. The documents reveal that Bayer continued to sell
contaminated blood plasma causing thousands of hemophiliac patients to be
infected with AIDS. The company continued to sell the contaminated blood in
Asia for over a year when it had already introduced a safer, heated blood
plasma version in the US and Europe in February 1984.

The documents examined by the Times provide evidence of unrestrained corrupt
practices by a pharmaceutical industry giant. According to The Times,
records suggest that the reason for continuing to sell an AIDS infected
blood product, was to get rid of inventory and "the company hoped to
preserve the profit margin from 'several large fixed-price contracts.'"

This previously uninvestigated case demonstrates how this industry's lies
and crimes are shielded by officials at the Food and Drug Administration.
The Times reports that in 1985 FDA's Dr. Harry Meyer willingly helped Bayer
cover up "one of the worst drug-related medical disasters in history." Meyer
suggested that the issue should be "quietly solved without alerting the
Congress, the medical community and the public." This culture of
accommodation continues to prevail at the FDA.


2 Paths of Bayer Drug in 80's: Riskier Type Went Overseas

A division of the pharmaceutical company Bayer sold millions of dollars of
blood-clotting medicine for hemophiliacs ? medicine that carried a high risk
of transmitting AIDS ? to Asia and Latin America in the mid-1980's while
selling a new, safer product in the West, according to documents obtained by
The New York Times.

The Bayer unit, Cutter Biological, introduced its safer medicine in late
February 1984 as evidence mounted that the earlier version was infecting
hemophiliacs with H.I.V. Yet for over a year, the company continued to sell
the old medicine overseas, prompting a United States regulator to accuse
Cutter of breaking its promise to stop selling the product. By continuing to
sell the old version of the life-saving medicine, the records show, Cutter
officials were trying to avoid being stuck with large stores of a product
that was proving increasingly unmarketable in the United States and Europe.

Yet even after it began selling the new product, the company kept making the
old medicine for several months more. A telex from Cutter to a distributor
suggests one reason behind that decision, too: the company had several
fixed-price contracts and believed that the old product would be cheaper to
produce.

Nearly two decades later, the precise human toll of these marketing
decisions is difficult, if not impossible, to document. Many patient records
are now unavailable, and because an AIDS test was not developed until later
in the epidemic, it is difficult to pinpoint when foreign hemophiliacs were
infected with H.I.V. ? before Cutter began selling its safer medicine or
afterward.

But in Hong Kong and Taiwan alone, more than 100 hemophiliacs got H.I.V.
after using Cutter's old medicine, according to records and interviews. Many
have since died. Cutter also continued to sell the older product after
February 1984 in Malaysia, Singapore, Indonesia, Japan and Argentina,
records show. The Cutter documents, which were produced in connection with
lawsuits filed by American hemophiliacs, went largely unnoticed until The
Times began asking about them.

"These are the most incriminating internal pharmaceutical industry documents
I have ever seen," said Dr. Sidney M. Wolfe, who as director of the Public
Citizen Health Research Group has been investigating the industry's
practices for three decades. Bayer officials, responding on behalf of Cutter
and its president at the time, Jack Ryan, declined to be interviewed but did
answer written questions. In a statement, Bayer said that Cutter had
"behaved responsibly, ethically and humanely" in selling the old product
overseas. Cutter had continued to sell the old medicine, the statement said,
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. "Decisions made nearly two decades
ago were based on the best scientific information of the time and were
consistent with the regulations in place," the statement said.

The medicine, called Factor VIII concentrate, 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. It has
helped hemophiliacs lead normal lives.

But in the early years of the AIDS epidemic, it became a killer. The
medicine was made using pools of plasma from 10,000 or more donors, and
since there was still no screening test for the AIDS virus, it carried a
high risk of passing along the disease; even a tiny number of
H.I.V.-positive donors could contaminate an entire pool. In the United
States, AIDS was passed on to thousands of hemophiliacs, many
of whom died, in one of the worst drug-related medical disasters in history.
While admitting no wrongdoing, Bayer and three other companies that made the
concentrate have paid hemophiliacs about $600 million to settle more than 15
years of lawsuits accusing them of making a dangerous product. The Cutter
documents ? a few of them have surfaced in recent years in television and
newspaper reports about Cutter's marketing practices ? were gleaned from
that litigation. But because the documents did not relate directly to the
suits, most went uninvestigated. The documents ? internal memorandums,
minutes of company marketing meetings and telexes to foreign distributors ?
reveal and chronicle Cutter's decision to keep exporting the older product
after it began making the new one, which was heat-treated to kill H.I.V. The
heat treatment rendered the virus "undetectable" in the product, according
to a government study. (There are few available records documenting the
actions and decisions of the three other American-based companies that also
sold unheated concentrate after offering a heated product.)

Doctors and patients contacted overseas said they had not known of the
contents of the Cutter documents. Bayer and other blood-product companies,
though admitting no wrongdoing, have already made some payments to foreign
hemophiliacs. It is unclear if Bayer could now face legal liability
specifically for selling the older product after a safer one was available.
Federal regulators helped keep the overseas sales out of the public eye, the
documents indicate. In May of 1985, believing that the companies had broken
a voluntary agreement to withdraw the old medicine from the market, the Food
and Drug Administration's regulator of blood products, Dr. Harry M. Meyer
Jr., summoned officials of the companies to a meeting and ordered them to
comply. "It was unacceptable for them to ship that material overseas," he
said later in legal papers.

Even so, Dr. Meyer asked that the issue be "quietly solved without alerting
the Congress, the medical community and the public," according to Cutter's
account of the 1985 meeting. Dr. Meyer said later that he could not recall
making that statement, but another blood-product company's summary of the
meeting also noted that the F.D.A. wanted the matter settled "quickly and
quietly." Dr. Meyer died in 2001.

Whether Cutter was behaving ethically became an issue in internal company
discussions. "Can we in good faith continue to ship nonheat-treated
coagulation products to Japan?" a company task force asked in February 1985,
fearing that some of its plasma donors might be H.I.V. positive. The
decision, records show, was yes.

Taken together, the documents provide an inside view of Cutter's bottom-line
strategizing and efforts to manage the flow of information amid growing
public anxiety about the safety of its product.

When a Hong Kong distributor in late 1984 expressed an interest in the new
product, the records show, Cutter asked the distributor to "use up stocks"
of the old medicine before switching to its "safer, better" product. Several
months later, as hemophiliacs in Hong Kong began testing positive for
H.I.V., some local doctors questioned whether Cutter was dumping "AIDS
tainted" medicine into less-developed countries. Still, Cutter assured the
distributor that the unheated product posed "no severe hazard" and was the
"same fine product we have supplied for years." Li Wei-chun said her son,
who died in 1996 at the age of 23, was one of the hemophiliacs in Hong Kong
who got AIDS after using that product. "They did not care about the lives in
Asia," Ms. Li said in a recent interview. "It was racial discrimination."

How It Started

Discovery That Blood Spreads the Disease

At the beginning of the epidemic, more than two decades ago, fear over what
would later be known as AIDS was centered mostly among gays and intravenous
drug users. But that changed on July 16, 1982, when the federal Centers for
Disease Control reported that three hemophiliacs had acquired the disease.
This gave epidemiologists a strong reason to believe that the disease was
being spread through blood products. And that belief carried grave
implications for the many thousands of hemophiliacs who routinely injected
themselves with concentrate made from giant pools of donated plasma. Because
an AIDS test had not yet been developed, federal health officials had no
idea how many plasma donors carried the disease.

By March of 1983, the C.D.C. went so far as to warn that blood products
"appear responsible for AIDS among hemophilia patients." The unfolding story
had not gone unnoticed at Cutter headquarters. Back in January, Cutter's
manager of plasma procurement had acknowledged in a letter: "There is strong
evidence to suggest that AIDS is passed on to other people through . . .
plasma products."

With sales of concentrate beginning to slip, Cutter got more bad news in May
1983: after learning that a Cutter rival had begun to make heated
concentrate, France decided to halt all imports of clotting concentrate
until it could figure out what to do. Fearing a loss of customers, Cutter
conceived a marketing plan that stopped well short of full disclosure. "We
want to give the impression that we are continuously improving our product
without telling them we expect soon to also have a heat-treated"
concentrate, an internal memo said.

Several weeks later, Cutter tried to minimize the danger hemophiliacs faced
when using blood products. "AIDS has become the center of irrational
response in many countries," the company said in a June 1983 letter to
distributors in France and 20 other countries. "This is of particular
concern to us because of unsubstantiated speculations that this syndrome may
be transmitted by certain blood products." The French decided to keep using
unheated concentrate, and Cutter said it sold them more of the unheated
product in August 1983. Later, two French health officials were sent to
prison for continuing to use up old stocks of unheated concentrate in 1985,
when a heated product was available.

Cutter finally received United States approval to sell heated concentrate on
Feb. 29, 1984, the last of the four major blood product companies to do so.
Though some doctors and patients held out against the heated product, a
safer era had clearly begun for hemophiliacs in the United States.


Market Considerations

Bayer Says Some Wanted Old Product

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."

THE NEW YORK TIMES May 22, 2003 , by WALT BOGDANICH and ERIC KOLI

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