- Passage of Federal Food and Drug Acts begins current era of the Food and Drug Administration [FDA] as a regulatory organization.
- NY doctor performs first transfusion using cross matching.
- A Chicago doctor coins the term “blood bank” for the blood collection and storage facility he establishes.
- Baxter introduces the first sterile, vacuum-type blood collection and storage unit, extending blood storage time to 21 days.
- Armour becomes largest provider of human albumin for U.S. military.
- Harvard biochemist, Dr. Edwin Cohn invents a method to separate proteins from blood plasma. This process came to be known as fractionation.
- The Journal of the American Medical Association reports evidence of transfusion-transmitted hepatitis.
- Centers for Disease Control [CDC] founded.
- Behringwerke is the first European company to fractionate plasma.
- American Association of Blood Banks, a national network of independent, community blood banks, is formed as an alternative to the American Red Cross [ARC] centers.
- National Hemophilia Foundation [NHF] founded.
- Blood shield laws provide an exception to the principle of strict product liability. For injury resulting from blood or blood product use the litigant must now prove negligence on the part of the hospital, blood bank, or blood product manufacturer.
- Baxter acquires Hyland Laboratories, the first U.S. company to make human plasma commercially available.
- Blood tests to identify hepatitis B are developed.
- Stanford physiologist Dr. Judith Graham Pool discovers cryoprecipitate, a plasma-derived therapy rich in Factor VIII.
- Physicians from the University of North Carolina and Hyland Laboratories, a division of Baxter, produce a concentrated form of Factor VIII by pooling and then concentrating large quantities of cryoprecipitate. The result is a powerful clotting agent in powder form, easily stored and self-injected.
- Baxter is licensed by the FDA to manufacture Factor VIII concentrates.
- Baxter’s Hyland division introduces the first commercially produced Factor VIII concentrate to treat hemophilia.
- Cutter Laboratories is licensed by the FDA to manufacture Factor VIII concentrates.
- Baxter joins Fortune’s listing of the 500 largest American corporations, as sales for the year reach $242 million. The Hyland division of Baxter manufactures Factor.
- Biologics regulation, including regulation of the U.S. blood supply, is transferred from the National Institute of Health [NIH] to the FDA.
- Blood tests to identify hepatitis A are developed.
- Comprehensive hemophilia care bill passes Congress appropriating funding to the creation of hemophilia treatment centers (HTCs) nationwide.
- The CDC goes on a campaign to immunize the American public against swine flu, a disease that never materializes. Millions were vaccinated and several people died. The episode reduces confidence in the CDC.
- FDA requires blood banks to label blood “paid” or “volunteer” based on donor compensation practices.
- Behringwerke announces the first heat-treated Factor VIII concentrate. They claim the product is free of hepatitis. Factor manufacturers, including Hyland Baxter led by David Castaldi, begin to prioritize viral inactivation research in their R&D programs.
- Dr. Edward Shanbrom patents detergent purification process for plasma protein products, including Factor concentrates. He claims the process will be effective in removing viruses like hepatitis from blood products.
- CDC publishes first report of 5 homosexual men with a new immune-deficiency disease. Fatality rate is 40%. They soon call the disease Gay Related Immune Deficiency or GRID.
- A new case of GRID is being diagnosed each day in the United States.
- Dr. Bruce Evatt of the CDC receives a report of a hemophiliac in Florida diagnosed with Pneumocystis Carinii Pneumonia, an opportunistic infection commonly associated with GRID.
- Jim Curran of the CDC testifies at the first Congressional probe into the epidemic, “With death rates soaring to 75% among people diagnosed with GRID for two years, the specter of 100 percent fatality from the syndrome looms ahead.” No major news networks cover the event.
- Two more cases of GRID appear in hemophiliacs.
- After a call from Bruce Evatt at the CDC, the NHF issues Patient Alert #1 to its chapters and treatment centers with news of GRID in patients with hemophilia. Risk is assessed as minimal and the alert states, “Patients should maintain the use of concentrate or cryoprecipitate as prescribed by their physicians. The life and health of hemophiliacs depends on the appropriate use of blood products.”
- The CDC issues the Morbidity and Mortality Weekly Report (MMWR) stating, “The occurrence among the three hemophiliac cases suggests the possible transmission of an agent through the blood products.”
- The Public Health Services [PHS] renames the disease Acquired Immune Deficiency Syndrome or AIDS. At the same meeting, the PHS recommends laboratory testing of hemophiliacs nationwide to determine the scope of the problem. Testing is organized through the national hemophilia treatment center network.
- The epidemic of immune suppression had spread into twelve European nations, including Belgium, Czechoslovakia, Denmark, West Germany, Holland, Italy, Norway, Spain, Switzerland, Great Britain, and France.
- At the FDA’s Bureau of Biologics meeting it was noted that more than 90 percent of each group affected by AIDS had markers for hepatitis B. It was proposed testing for hepatitis B markers might prove effective as a surrogate test for AIDS.
- Asst. Secretary of Health Edward Brandt states the FDA position that no danger exists to the nation’s blood supply.
- A few hemophilia treatment centers, including Regina Butler’s in Philadelphia, offer their patients the option of returning to the older therapy, cryoprecipitate, in an effort to reduce the risk of AIDS transmission.
- Tylenol recalls pain relief tablets after seven people die from poisoning. In comparison, 634 Americans had been stricken with AIDS by October 1982. Of these, 260 were dead. The tampering story received widespread media coverage; AIDS had barely been mentioned in major media outlets.
- Alpha Therapeutics begins to close prison-based plasma collection sites used for the manufacture of blood products. Some manufacturers continue to operate prison-based plasma collection sites.
- Some Factor manufacturers institute questionnaires to exclude high-risk donors from the paid donor pool. NHF advocates screening out high-risk donors. Volunteer blood donor centers, including the Red Cross, refuse to institute questionnaires that screen for high-risk donors.
- FDA staff meets with Factor manufacturers to inquire what efforts are being undertaken to screen out high risk donors and to test whether AIDS is transmitted through Factor. An internal Cutter memo reporting on the meeting states, “[The FDA] requested that we send…some official notification of our plans so that [they] could use this as ammunition that voluntary efforts of the industry precluded the need for any further regulation or activities in the FDA compliance area.”
- Testing of hemophiliacs shows at least 30% have abnormal immunological tests. By now seven hemophiliacs, including two children, have been diagnosed with AIDS. There was no common lot of Factor concentrate shared by any of the patients leaving experts to deduce, if AIDS was in Factor it was widespread.
- A San Francisco infant is diagnosed with AIDS after receiving a blood transfusion from a donor who died of AIDS. CDC viewed this a definitive proof that AIDS was blood borne.
- The PHS study of hemophiliacs shows 1/3 to ½ of hemophiliacs showed altered immune function indicative of AIDS infection. AIDS was now the second leading cause of death in hemophiliacs.
- Though the blood supply and blood products are regulated by the FDA, the CDC calls a public meeting in Atlanta to identify opportunities to prevent AIDS transmission in the blood supply. The CDC makes two recommendations impacting blood policy:
- Institute surrogate testing for the hepatitis B core antibody which showed an 88% correlation with patients who had AIDS.
- Institute questionnaires identifying high-risk donors and exclude those donors from donating blood.
- Gay rights groups, supported by volunteer blood bankers, (ie: Red Cross and American Association of Blood Banks) resist questionnaires to identify high-risk donors claiming invasion of privacy and discrimination. One week after the CDC Atlanta meeting the AABB & the Red Cross issue a statement saying donor screening based on sexual preference is inappropriate.
- No changes to blood policy were instituted following the CDC meeting.
- PHS issues guidelines that compromise conflicting CDC and FDA blood safety recommendations. High risk donors would be asked to voluntarily exclude themselves, no questionnaires nor automatic exclusions would be instituted; surrogate testing for hepatitis B markers would not be implemented; no clear guidelines were issued regarding Factor concentrate use nor the inclusion of warning labels on Factor; no clear guidelines were issued about what to do with blood plasma donated by those presumed to be at high risk for transmitting AIDS.
- The FDA approves Hyland Baxter’s license for heat-treated Factor VIII product. This is the first heat pasteurized clotting Factor concentrate in the U.S. While not definitively proven for Factor VIII, heat-treatment is known to kill viruses in albumin. It is sold at twice the price of non-heated Factor. They continue to sell off their non-heated Factor stock in the U.S. and they continue to manufacture non-heated products for sale overseas.
- 11 additional confirmed cases of AIDS in hemophiliacs.
- France and England consider banning the import of American plasma.
- Health and Human Services Secretary Margaret Heckler told a House appropriations committee, “I have to say that, in the AIDS situation, I really don’t think there’s another dollar that would make a difference because the attempt is all out to find the answer.”
- Hyland Baxter recalls a lot of non-heated Factor VIII concentrated after a donor was identified who developed AIDS. The recall was voluntary and not mandated by the FDA.
- After Hyland’s recall the NHF issued a medical bulletin: “It is not the role of the NHF to judge the appropriateness of corporate decisions made by individual pharmaceutical companies. However, we urge that patients and treaters recognize the need for careful evaluation of blood products and note that such a recall action should not cause anxiety or changes in treatment programs….The NHF recommends that patients maintain use of concentrates or cryoprecipitates as prescribed by their physicians.”
- The French banned the import of American blood in mid-May.
- Cutter Laboratories employee circulates an internal memo in response to FDA’s approval of Hyland Baxter’s heat-treated (pasteurized) Factor. “On a short term we are facing a crisis. Our competitors have succeeded to come out first with a limited claim product.….We expect a total of six-nine months will be necessary to take us to approval by the OB.”
- The CDC investigates the first known transmission of HIV from a hemophiliac to his wife.
- French researcher, Luc Montagnier publishes an article in Science identifying the LAV virus though it was not yet directly linked to AIDS.
- The American Association of Blood Banks, the Council of Community Blood Centers and the American Red Cross issued a joint statement saying, “It appears at this time that the risk of possible transfusion associated AIDS is on the order of one case per million transfused.”
- Stanford University Hospital becomes the only major medical center in the United States to use surrogate testing for evidence of AIDS infection in blood.
- Secretary Heckler gives a press conference with D.C. American Red Cross and donates blood to the American Red Cross. “I want to assure the American people that he blood supply is 100 percent safe…The blood supply is safe both for the hemophiliacs who requires large transfusions and for the average citizen who might need it for surgery.”
- Given recalls are not mandated by the FDA, NHF issues recommendations, “The NHF Medical and Scientific Advisory Committee (MASAC) recommends to blood product manufacturers that any lot of concentrate be recalled it if includes material from an individual that has been identified as having AIDS, or from an individual that, in the best medical judgment of the manufacturers has characteristics strongly suggestive of AIDS.”
- FDA’s Blood Products Advisory Committee (BPAC) decides to withdraw Factor lots on a case‑by‑case basis rather than opt for automatic withdrawal upon discovering an AIDS contaminated donation.
- An internal memo issued by Cutter regarding the BPAC decision stated, “It was very clear that when confronted with this complex problem the Committee felt that a balance must be struck between theoretical risk of the product to recipients against the need for an uninterrupted supply of life-sustaining therapy.”
- An NHF publication states, “The Medical and Scientific Advisory Committee (MASAC) of NHF has recommended that cryoprecipitate be used instead of Factor VIII concentrate under certain circumstances. Although there is no evidence that this will reduce the risk, the exposure to fewer blood donors suggests that it is prudent to avoid concentrate, unless medically indicated, in patients under the age of 4, in newly diagnosed hemophiliacs, and in patients with mild hemophilia.”
- Hyland Therapeutics and American Red Cross announce recall of lots after donors were confirmed to have AIDS. The recalls are not required by the FDA.
- 26 hemophiliacs and 26 transfusion recipients have been diagnosed with AIDS.
- NHF issues an advisory: “It is not scientifically established that AIDS is transmitted through blood products.” NHF reaffirms its recommendation that patients maintain use of concentrate or cryoprecipitate as prescribed by their physician.
- Cutter Laboratories recalls 13 lots of Factor VIII and one lot of Factor IX after a donor died of AIDS. The recall is voluntary and not required by the FDA.
- NHF issues Chapter Advisory #11: “It is not scientifically established that AIDS is transmitted through blood products….Only a fraction of 1% of all hemophiliacs have contracted AIDS and no common lots have been identified among those who have the disease. This strongly suggests that the great majority of people with hemophilia are not susceptible to AIDS.”
- Dr. Dennis Donohue, director of FDA’s Division of Blood and Blood Products recommends the use of a hepatitis B surrogate test for plasma screenings. However, the FDA’s Blood Product Advisory Committee [BPAC], whose members are largely industry and blood banking representatives, (not patient advocates) recommends against implementing a surrogate test because it would eliminate too many non-infected donors and would threaten the adequacy of the blood supply. They did however agree to create a task force to study the surrogate test. An internal Cutter Biological memo later released states, “[The proposal to convene a task force] was one that had been agreed upon by all the fractionators the previous evening” and that “the general thrust of the task force [was] to provide a delaying tactic for the implementation of further testing.”
- Nine European hemophiliacs had contracted AIDS from Factor VIII manufactured in the US, including 3 of the first 4 Spaniards to be stricken with the syndrome.
- The FDA licenses Armour Pharmaceutical and Miles, Inc. (formerly Cutter) to manufacture heat-treated Factor VIII product. Both companies continue to market both heat-treated and non‑heat treated products.
- Alpha Therapeutics recalls three lots of Factor after a donor is diagnosed with AIDS. Following the recall the NHF issues a statement, “NHF reaffirms its position that product withdrawal should not change the use of clotting Factor.”
- In just two years, AIDS emerged as the leading cause of death among hemophiliacs in the U.S. surpassing uncontrolled bleeding.
- Factor manufacturers have closed all of their prison-based plasma collection facilities.
- The FDA licenses Alpha Therapeutics to manufacture heat-treated Factor VIII product. They continue to distribute both heat-treated and non‑heat treated products.
- The BPAC Task Force created by the Factor manufacturers to study the utility of surrogate testing delivers its report. The majority opposes implementation of the surrogate test claiming expense and lack of specificity for AIDS.
- Secretary of Health Margaret Heckler hosts a press conference with Dr. Robert Gallo announcing the discovery of HTLV-III, the virus responsible for AIDS. At the press conference Heckler stated, “We have a blood test to detect the virus. The test will be available in 6 months.”
- Genentech announces the creation of the first synthetic Factor VIII.
- Using stored samples of hemophiliacs’ blood and a new HIV test, the CDC reports 72% of severe hemophiliacs show evidence of infection with HIV.
- NHF issues an advisory implicating the HTLV‑III/LAV virus as the causative agent for AIDS. “Testing positive for HTLV‑III/LAV does not suggest a diagnosis of AIDS.” NHF reaffirms its recommendation that patients maintain use of concentrate or cryoprecipitate as recommended by their physicians.
- Through a cooperative study by the CDC and Cutter Laboratories, it is determined that heat treatment is effective against viruses including HIV. The CDC announced, “The use of non‑heat‑treated AHF concentrate should be limited.” Manufacturers continue to market non‑heat‑treated AHF.
- NHF Medical and Scientific Advisory Committee revises its recommendations suggesting physicians strongly consider changing to heat-treated products and suggests cryoprecipitate should be used for newborns, children under age 4, and newly diagnosed patients.
- CDC reports 52 hemophiliacs in 22 states suffered from AIDS.
- The first cases of AIDS in both a wife and infant child of a hemophiliac are reported.
- NHF publishes an AIDS surveillance study confirming 58 cases among hemophiliacs. Of those, 31 had died.
- FDA licenses three manufacturers for heat‑treated Factor IX.
- FDA grants two licenses for commercial use of the HIV tests, and notifies all blood facilities of the availability of the tests and schedules a workshop on their use. Test use is voluntary at this point. The FDA does not require blood banks & Factor manufacturers to test all units of blood and plasma collected prior to the test. Untested units continue to be sold and distributed.
- The American Red Cross reported that 1 in 500 U.S. donors tested positive for the AIDS virus. Retrospective screening later showed that in the final weeks before the HTLV-III tests went into use, 150 infected donors had given blood to 200 recipients.
- The number of nation’s AIDS cases surpassed 9,000. Of these, more than 4,300 had died.
- At the first International AIDS Conference in Atlanta, GA James Curran of the CDC announced, “AIDS has already arrived in every major city in the developed world. Between 500,000 and 1 million Americans were infected with the HIV virus.”
- Edward Brandt also appeared at the conference. He endorsed voluntary testing and said, “I don’t think we were as effective as we should have been in the early stages of the epidemic. There must be a mechanism for emergency procedures to deal with epidemics such as AIDS without sacrificing scientific standards…”
- The FDA requests the recall and destruction of all untreated units of Factor. Compliance by companies is voluntary. An internal Cutter memo details Harry Meyer, head of the Bureau of Biologics at FDA stating, “This action is long overdue.”
- Ryan White, an AIDS infected hemophiliac, is banned from school in Kokomo, Indiana.
- Rock Hudson is reported to have AIDS prompting a media frenzy about AIDS.
- One of several internal Cutter memos is circulated regarding the use of unscreened plasma.
- Put unscreened material into finished inventory as soon as possible provided it does not constitute more than 6 months of inventory, as the FDA could require all material to be screened at some time in the future.
- Requests from the field for screened versus unscreened material will be referred to sales and marketing management. As a general rule, we will not distinguish between screened and unscreened.
- Get word to distribution to move existing unscreened finished goods inventory before screened material.
- If a foreign government wants only screened finished goods, we will comply, or if it is legally required.”
- Ryan White is permitted to return to school after a lengthy legal battle.
- In Arcadia, Florida three hemophiliac brothers, Ricky, Robert, and Randy Ray, are banned from school when officials learn they are HIV positive. When a federal judge ruled they could not be expelled they return to school. Less than one week later their family home is burned to the ground in a suspicious fire.
- The CDC reported that of an estimated 15,500 hemophiliacs in the United States, approximately 10,000 were infected with HIV.
- Armour Pharmaceuticals’ heat-treated Factor products are recalled after traces of HIV are found. Some of the product had been exported to Canada where six patients tested positive for HIV. A criminal investigation is pursued by the Royal Canadian Mounted Police and charges filed. All of those brought up on criminal charges are exonerated in 2002.
- Three years after the test is available, the FDA legally requires donated blood to be tested for HIV antibodies. Until then, use of the test — though widespread — was optional.
- Hyland becomes the first manufacturer in the U.S. to use a solvent detergent cleaning process in manufacturing Factor VIII. The process proves more effective against hepatitis C.
- The FDA finally requires the recall and destruction of all non-heated units of Factor.
- The Committee of Ten Thousand (COTT), founded by Jonathan Wadleigh in Boston and the Hemophilia/HIV Peer Association founded by Michael Rosenberg, become a more militant group in the hemophilia community demanding investigation and compensation. A rift begins to form within the hemophilia community dividing the National Hemophilia Foundation and those who believe the organization and the patients’ best interests were compromised.
- Non-A Non-B hepatitis virus is discovered. It is re-named hepatitis C.
- Blood banks begin screening blood for hepatitis C.
- Ryan White, the Kokomo, Indiana teen banned from school for AIDS infection, dies from complications of AIDS at the age of 18.
- A lookback program to identify and notify persons who may have received contaminated blood and blood products is implemented.
- Quintana vs. United Blood Services: Mrs. Quintana was infected with AIDS as a result of a transfusion given during surgery. The court initially rules in favor of United Blood Supply. On appeal the decision is reversed in favor of Quintana and the blood bank is held responsible for the product they sent. It is the first time in recent history blood shield laws do not protect the blood industry.
- FDA approves Interferon-Alpha to treat hepatitis C.
- The American Red Cross votes for a sweeping reorganization of the way it collects and handles blood.
- A new blood test effectively eliminates hepatitis C from the nation’s blood supply.
- Hemophiliac activists including COTT and the HIV Peer Association protest the annual conference of the National Hemophilia Foundation.
- Ricky Ray, the Arcadia, Florida teen whose home was burned dies of AIDS.
- In the US, one person is dying each day from hemophilia associated AIDS.
- FDA Commissioner David Kessler obtains a Justice Department consent decree that requires the Red Cross to strengthen quality control and training and improve its ability to identify, investigate, and record problems.
- Senators Edward Kennedy (D‑MA), Robert Graham (D‑FL), Representative Porter J. Gross (R‑FL) requested Secretary of Health and Human Services Donna Shalala open an investigation into the events leading to the transmission of HIV to individuals with hemophilia from contaminated blood products.
- Secretary of Health Donna Shalala commissions a study and report from the Institute of Medicine, an arm of the National Academy of Sciences, on the contamination of the U.S. blood supply with HIV.
- Class action suit filed in federal court (Wadleigh, et al vs. Rhone Poulenc) was intended to consolidate the nearly 300 cases involving 400 hemophiliac plaintiffs. In those cases some doctors were testifying on behalf of the Factor manufacturers about the state of knowledge in the 1980s. NHF’s Medical and Scientific Advisory Board passes a resolution stating that physicians and NHF staff members should not testify against their patients.
- Hemophilia Federation of America is incorporated as an alternative to the National Hemophilia Foundation.
- Judge John Grady of Federal District Court in Chicago certifies the class action suit.
- The Ricky Ray Hemophilia Relief Fund Act is introduced in Congress by Rep. Porter Goss. It requests the establishment of a $1 billion dollar fund for hemophilia families affected by HIV. The bill dies in Congress.
- Class action suit is decertified by Court of Appeals Judge Posner writing, “One jury, consisting of six persons…will hold the fate of an industry in its hands.” He determines cases must proceed individually.
- The Institute of Medicine issues its findings in a report entitled HIV and the U.S. Blood Supply: An Analysis of Crisis Decisionmaking.
- Producers of blood-clotting medicine – Bayer, Alpha Therapeutics Corp., a unit of Japan’s Green Cross, Baxter International Inc., and Rhone-Poulenc Rorer Inc. – agreed to pay $100,000 to each U.S. hemophiliac infected with HIV to settle the lawsuits. In Japan, the Green Cross, had just awarded each infected individual $420,000.
- The Ricky Ray Relief Fund Act is re-introduced in Congress by Rep. Porter Goss.
- The first meeting of the Advisory Committee on Blood Safety and Availability convenes in response to the 1995 Institute of Medicine report. Patient advocates are now part of the committee making recommendations to the Secretary of Health on the safety of the U.S. blood supply.
- The Krever Commission Report investigating the contamination of the Canadian blood supply and blood products issues its report. The findings lead to a major overhaul in the regulation of Canada’s blood supply.
- In New York as in other states, hemophiliacs wanting to decline the drug company settlement to pursue individual litigation must fight to extend the statute of limitations. Infected with HIV from tainted blood products in the 1980s, but only ascertaining corporate wrongdoing in the 1990s, by the time they decide to take legal action, the statute of limitations has passed. In states around the country, hemophiliacs lobby to extend the statute of limitations permitting them to sue blood product companies for another two years. Their efforts are successful in some states.
- The Ricky Ray Relief Act is passed and funded by Congress. The U.S. government issues an additional $100,000 payment to each HIV-infected hemophiliac.
- The National Hemophilia Foundation appoints Val Bias Chief Executive Officer. For the first time in the organization’s history a hemophiliac co-infected with HIV and hepatitis C is named to the post. Val Bias lost his wife to AIDS-related complications after he unknowingly infected her with HIV and he was vocal advocate in the passage of the Ricky Ray Relief Act. Many believe his appointment brings a new chapter of healing to the hemophilia community.
- The Justice Department consent decree issued nearly two decades ago against the American Red Cross [ARC] remains in effect. Despite millions of dollars in fines ARC has not remedied problems identified by the FDA.