Shoulders To Stand On                                                                           EC Dec – Jan Issue 2016

The Long Road To Wellness (cont’d)

Prior to the approval of AZT by the FDA, in 1986 NIAID (National Institute of Allergy and Infectious Disease) established the Division of AIDS.  The Division of AIDS (DAIDS) was formed to develop and implement the national research agenda to address the HIV/AIDS epidemic. Toward that end, the division supports a global research portfolio to advance biological knowledge of HIV/AIDS, its related co-infections, and co-morbidities. With the ultimate goal of creating an “AIDS-Free Generation,” the division develops and supports the infrastructure and biomedical research needed to: 1) halt the spread of HIV through the development of an effective vaccine and biomedical prevention strategies that are safe and desirable; 2) develop novel approaches for the treatment and cure of HIV infection; 3) treat and/or prevent HIV co-infections and co-morbidities of greatest significance; and 4) partner with scientific and community stakeholders to efficiently implement effective interventions.   Well before 1986, the New York State Department of Health established the AIDS Institute.  The AIDS Institute, still in existence today, protects and promotes the health of New York State’s diverse population through disease surveillance and the provision of quality prevention, health care and support services for those impacted by HIV/AIDS, sexually transmitted diseases, viral hepatitis and related health concerns.  In addition, the Institute promotes the health of LGBT populations, substance users, and the sexual health of all New Yorkers.

In 1986 and 1987 a clinical research site for HIV treatment (ATCG) and vaccines (HVTN) was established at University of Rochester Medical Center (URMC).  In 1987 the first identified HIV clinic in Rochester was established at URMC by Bill Valenti.  By November, 1987 there were at least 40 products being researched by various companies hoping to find vaccines or therapeutic treatments for AIDS.  In 1988 URMC was among the first established Centers for AIDS Research by the NIH.  In 1988, URMC was identified as one of six university medical centers to conduct clinical trials of  the first experimental AIDS vaccine approved for testing in humans.  This new genetically engineered AIDS vaccine was made with the virus used to inoculate humans against smallpox.

In March, 1987 AZT was approved by the FDA as the first treatment for AIDS.  Burroughs Wellcome Co. changed the name to Retrovir so that it could be trademarked throughout the world.  A total of 4000 clinical trial patients received the drug at a cost of  $10 million to the developer/manufacturer.  The plan at the time of approval was to provide Retrovir to the most seriously ill and to trial patients already using it.  In May, 1988 Burroughs Wellcome Co. reported to the FDA that in human clinical trials of 144 persons with AIDS or ARC, nearly 85% are still alive after one year of treatment.  All patients in the trials given the placebo died.  In September, 1988 the British pharmaceutical corporation, Wellcome PLC offered a grant of $5 million to the US Congress for the provision of the anti-AIDS drug AZT to the medically indigent, provided Congress extend a program supplying the life-prolonging drug to low income AIDS patients.  The program extension was expected to cost $10 million.  A year’s treatment with AZT costs approximately $10,000.  The original congressional program, set to expire Sept. 30, was sponsored by Sen. Lowell Weicker (R-CT) in response to protests from advocates for AIDS patients over the high cost of AZT treatments.  The Senate approved a six-month extension of a program providing AZT to medically indigent AIDS patients.  On September 14, 1989 seven ACT UP members infiltrated the New York Stock Exchange and chained themselves to the VIP balcony to protest the high price of the only approved AIDS drug, AZT.  The group displayed a banner that said “SELL WELLCOME”  the pharmaceutical sponsor of AZT.  Several days following the demonstration Burroughs Wellcome lowered the price of AZT from $10,000  to $6,400 per patient per year.

In February of 1988, Anthony Fauci, NIAID Director, stated the final testing of any AIDS Vaccine may have to be done in Africa rather than is the US because the US AIDS infection rate is not high enough to determine whether a vaccine is working.  In March, Fauci reported that human clinical trials of  experimental AIDS drugs have been delayed due to insufficient staffing to direct the drugs through the clinical testing process.  In April, 1988 the Office of AIDS Research is created by the NIH in an effort to centralize and coordinate national AIDS research activities.

In May, 1988 AZT manufacturer Burroughs Wellcome Co. reported to the FDA that in human clinical trials of 144 persons with AIDS or ARC, nearly 85% are still alive after one year of treatment.  All patients in the trials given a placebo were dead.  In June, 1988 pharmaceutical manufacturer Ciba-Geigy Corp announced it would soon begin human tests on a vaccine against HIV.  Also in June NIH AIDS researchers announced at the Fourth International conference on AIDS the results of their tests with a genetically engineered vaccine developed from the AIDS causing virus HIV.  Dr. Jonas Salk, known for his work on the polio vaccine, suggested  that whole, dead HIV cells be used as a vaccine.  In July, 1988 federally sponsored human clinical trials of the anti-AIDS drug dextran sulfate began.

By 1988 frustration was growing over the length of time it had taken to approve AZT and the FDA’s slow progress in improving access to other experimental AIDS drugs. On 11th October 1988 more than a thousand ACT UP demonstrators descended on the FDA headquarters in Rockville, Maryland, demanding quicker and more efficient drug approval. Eight days later the FDA announced regulations to cut the time it took for drugs to be approved.

By the end of 1988 women were named the fastest growing group with AIDS.  The FDA did speed up the approval process for experimental drugs.  The First World AIDS Day was held in 1988 after health ministers from around the world met in London, England and agreed to such a day as a way of highlighting the enormity of the AIDS pandemic and nations’ responsibility to ensure universal treatment, care and support for people living with HIV and AIDS.  In December, 1988 a report in the journal, Proceedings of the Natioanl Academy of Sciences, a serum from healthy carriers of HIV was shown to remove the virus from the blood of patients with AIDS.  At the end of 1988 there were 89,864 cases of AIDS nationwide, and 46,134 people who had died.  There were 167 AIDS cases in Monroe County and 37 in eight rural counties.

Shoulders To Stand On recognizes the monumental work done by those early researchers who identified drugs and treatment for a disease that appeared to be unstoppable,  In 2017 we will continue the History of AIDS as we continue to walk The Long Road To Wellness.

 

Rochester AIDs History Chapter 21

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