The good, the bad & the ugly: the political economy of the blood products industry.

AIDS: Since 1998, the U.S. Surgeon General has recommended the use of recombinant factor concentrates for patients with hemophilia and other clotting disorders, rather than human derived factor concentrates. With the increased risk of HIV and HCV for these patients, studies show that using the recombinant factor gives them a greater degree of protection. Unfortunately, the recombinant factor is in short supply, and a recent report by the Government Accounting Office indicates that good manufacturing practices may not be in effect at many of the manufacturers of these concentrates. It is believed that the Federal government needs to take a more active role in regulating and monitoring the safety of plasma derivative products and the manufacturer's ability to supply them. It is also suggested that the four manufacturers of these products might be creating an environment of antitrust, by maintaining high prices and holding back information. In order to ensure the supply and safety of those who use these blood products, it is critical to adequately regulate the marketplace and focus consumer attention on this issue.^ieng

Settlement monies begin to flow.

AIDS: HIV-positive hemophiliacs are beginning to receive settlement payments from their class action lawsuits against pharmaceutical companies. The monies must be distributed to claimants by the end of February 1998 but there is concern that the deadline will not be met. A great deal of confusion and mistrust has also been associated with the content of the release form that each claimant is required to sign. Concerns about the expanded protection for the defendants, the inclusion of the government in the release terms, and the distinctions between Medicaid and private insurer liens are raised. Additional barriers to claim settlements are discussed.^ieng

Defendants challenge class action certification.

AIDS: The National Hemophilia Foundation (NHF) and the manufacturers of Anti-Hemophilia Factor Concentrates (AHF) are being sued in a class action case for ignoring and downplaying risks of HIV infection from AHF in order to enhance their financial gain. The defendants in the case, however, have challenged the class action certification. Their Petition for a Writ of Mandamus argues that a class action lawsuit is not an appropriate legal vehicle for this type of case because, among other reasons, it will place an entire industry's survival in the hands of a single jury decision. The two primary challenges to certification by the petition are that 1) it would complicate hemophilia/AIDS litigation and not simplify it, and 2) there is no common definition of negligence throughout state law. With certification in question, it is conceivable, according to attorney David Shrager, "that hundreds or even thousands of additional claims will now be filed in state and Federal courts throughout the country." Essentially, the defense against the Writ argues that the defendants knew in the 1960s of the high risk from known and new viruses in the plasma pools, that they had a duty to reduce such risk, and that they not only failed to withdraw their products from the market, they downplayed the harm done to persons who used contaminated AHF by making misleading statements. The class action trial is scheduled to begin October 2, 1995.^ieng

The good, the bad and the ugly, part II.

AIDS: The author provides a second installment to a previous column in which he wrote about the settlement proposal offered by Baxter and Armour and how it demonstrated industry's lack of respect for the hemophilia/HIV community. The author now argues that the courts have shown a less than exemplary track record in helping those who suffer as a result of government or multinational corporation actions, and this record continues. Despite feelings from some in the hemophiliac community that a concerted effort to obtain justice would backfire and harm the community, The Committee of Ten Thousand (COTT) persevered and has gotten a class action suit before the court.^ieng

Dallas, police surveillance and the NHF. National Hemophilia Foundation.

AIDS: In 1995, the National Hemophilia Foundation (NHF) held its annual meeting in Dallas amid ongoing controversies over AIDS and viral contamination of the U.S. blood supply. Principal topics were the class action lawsuit, delivering justice to those infected with HIV, and the legislative campaign for government compensation. The Dallas meeting was marked by controversy: the NHF failed to endorse the class action suit against blood supply producers; the NHF Board elections produced a leadership dominated by people without hemophilia and ignored persons who represented change; and a large number of police were present, authorized by the NHF, and seen by many to be a result of the NHF members' concern about potentially unruly demonstrations or possibly as a way of squashing dissent and diversity. The NHF has also discouraged those infected with HIV from taking legal action, and they have openly obstructed the pursuit of legal justice by disseminating misinformation regarding individuals' legal rights. It is felt that the NHF cannot be characterized as a consumer advocacy group and that the Dallas meeting served only to reinforce the view of NHF's role in obstructing the real empowerment of the hemophiliac community.^ieng

National Academy of Sciences convenes public hearing on HIV and the blood supply.

AIDS: On September 12th, the Institute of Medicine (IOM) convened a public meeting on HIV contamination of the nation's blood supply during the 1980s. A special IOM panel was created to prepare a report on how thousands of persons with hemophilia were infected with HIV through tainted blood products. Testimony was heard from persons with hemophilia and their families. The unconscionable behavior of the blood products industry, the blood banks, the doctors, and their Federal regulators, was the recurrent theme throughout the day. In the months following the meeting, the hemophiliac community has had a growing concern that the IOM report will be a whitewash and will not substantially impact those most responsible for the devastation. It is felt that the community must apply substantial pressure on the IOM to ensure that the final report is a correct reflection of how and why the hemophilia holocaust occurred.^ieng