Hemophiliacs in the United States are dying at the rate of one a day.
For years, they say, the National Hemophilia Foundation told them that contracting AIDS from blood-clotting medicines was an unavoidable tragedy, caused by the lack of early knowledge about the disease.
Now, a deposition and other documents related to a class-action lawsuit against the foundation and four drug companies show that foundation executives understood as early as 1982 that HIV, the virus that causes AIDS, likely was a blood-borne virus, that it could be transmitted to others through blood and that there was a potential for an epidemic.
Even so, documents obtained by the Inquirer from the lawsuit and from government files show that:
* In December 1982, Dr. Louis Aledort, the foundation's medical co-director, counseled a U.S. Food and Drug Administration advisory panel against requiring drug companies to kill viruses in clotting products, which are made from human blood. He said it might drive prices higher than hemophiliacs could afford.
* In July 1983, when an industry official estimated that up to 30 percent of blood-clotting products going on the market might be contaminated with HIV, Dr. Aledort told the FDA advisory panel that the foundation board wanted the government to order recalls but that his personal view was that "this is not the time for recall." The panel did not recommend a recall.
* In October 1985, the foundation board passed a resolution that said "it would not be in the best interests of persons with hemophilia" for a class-action suit to be filed against the drug manufacturers. The lawyer for one company attended the meeting, where he presented the board with his own suggested version of the resolution.
* In 1986, when the foundation was asked its position on lawsuits against the drug makers, its then-president wrote that he considered the companies to be foundation "constituents" and "family members."
* When people with hemophilia began to die from AIDS in the late 1980s, two former foundation medical directors and some doctors who served on the organization's medical advisory committee testified against patients who sued the drug companies. It wasn't until after "soul-searching and some serious reflection" that this practice was stopped, according to a deposition from Alan P. Brownstein, who was the foundation's executive director from 1981 until this year.
In the deposition, Mr. Brownstein said that three months after the July 1983 FDA meeting, Dr. Aledort was forced out as the foundation's medical director. Dr. Aledort's remarks to the FDA panel were contrary to foundation policy in that they opposed a recall, he said. "I cannot figure out why Dr. Aledort did that," Mr. Brownstein said.
Dr. Aledort and Mr. Brownstein could not be reached for comment last week.
A foundation spokeswoman said it should be remembered that the deposition was a one-sided event in which lawyers asked only the questions for which they wanted answers.
An FDA spokesman said his agency could not comment while the issues remained under investigation.
Representatives of the drug makers said last week that they had acted properly. The drug companies say they responded to the crisis as quickly as possible, given that so little was known about AIDS in the early years of the epidemic.
Beth Leahy, a spokeswoman for one of the drug companies, Rhone-Poulenc Rorer Inc. of Collegeville, Pa., noted that there had been 14 jury trials nationwide in which hemophilia patients or their survivors sued the companies. The companies have won 13 of those cases, and the 14th is being appealed. "That's an awfully good track record," she said.
Conduct in AIDS epidemic
As the foundation, formed in 1948, prepares for its annual meeting this week in Dallas, its conduct in the AIDS epidemic never has been more controversial. HIV-contaminated clotting drugs have infected more than half of those in the United States who suffer from hemophilia. About 3,000 have died. About 7,000 to 9,000 more have tested positive for the human immunodeficiency virus. Many of them are children.
Members of the foundation's hierarchy were among those to suffer. According to Mr. Brownstein, virtually all the board
members in the 1980s either had hemophilia or had family members with the disease. Some of them died from AIDS.
The class-action suit was filed last year in U.S. District Court in Chicago against the foundation and four clotting-drug manufacturers: Rhone-Poulenc Rorer and a subsidiary, Armour Pharmaceutical Co. Inc. of Collegeville; Miles Inc. of Pittsburgh; Baxter Healthcare Corp. of Deerfield, Ill.; and Alpha Therapeutic Corp. of Los Angeles. The lawsuit seeks unspecified financial relief for HIV-infected hemophiliacs.
It alleges that in the first half of the 1980s, the defendants sold and promoted HIV-tainted plasma proteins even after they knew, or should have known, of the risk.
According to the suit, most of the plasma came from paid donors who were inadequately screened for HIV even though they came from high-risk groups.
Throughout the early 1980s, before clotting drugs were treated to neutralize viruses or before a diagnostic test for HIV was developed, foundation newsletters consistently played down the risks of infection and urged people to keep taking their medicine.
Hemophilia is a hereditary disease, passed primarily from mothers to sons, in which the blood is missing a clotting protein. Without treatment, the most severe form can cause severe internal bleeding, crippled joints and death.
Thirty years ago, the only treatment was blood or plasma transfusions, done in a hospital.
In 1964, researchers developed a method to extract and produce the concentrated clotting protein from the blood of a single donor. The doctors called their discovery "cryoprecipitate." It allowed infusions at home.
In the 1970s, drug companies reduced the cryoprecipitate even more. Unlike cryoprecipitate, these new concentrates were not made from the blood of one person. They came from pools containing tens of thousands of plasma units, all mixed together. The blood was collected primarily from paid donors, many of them members of what later came to be called high-risk groups: intravenous drug users and gay men.