re: #667 reason0911

Bologna. And Arthur Robinson offers a poor excuse in that it was “15 years ago.” By 1995 a great deal was known about AIDs and HIV. HIV was discovered in 1984. The time line for 1995 alone includes:

* On February 8, FDA approved Mepron (atovaquone) for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in patients who are intolerant to trimethoprim-sulfamethoxazole (TMP-SMX).
* On February 23, FDA revised the guidance for Home Specimen Collection Kit Systems Intended for Human Immunodeficiency Virus (HIV-1 and/or HIV-2) Antibody Testing.
* On March 24, FDA cleared for marketing the first blood test to measure latex antibodies in the blood. The test can be used to help identify people who are allergic to latex and as such assist people in the use of barrier products to prevent HIV transmission.
* On April 14, FDA approved Chartex International plc. London, U.K. premarket approval application for the Femidom Female Condom. The product is an intravaginal barrier device and is indicated for use to help prevent pregnancy, which will be used as an indicator of the device’s performance in preventing STDs.
* In June 1995, FDA published “An FDA Guide To Choosing Medical Treatments,” FDA Consumer.
* In June 1995, FDA allowed the initiation of an open label study for saquinavir for the treatment of HIV infection and AIDS. Saquinavir, manufactured by Hoffmann-La Roche, is the first protease inhibitor made available outside of ongoing clinical trials.
* On June 6, FDA revised the blood donor criteria to exclude prisoners from donating blood, blood components and plasma for 12 months from the last date of incarceration.
* On June 11, FDA issued a Dear Healthcare Professional letter describing post marketing reports of new onset diabetes mellitus, hyperglycemia or exacerbation of existing diabetes mellitus occurring in HIV-infected patients receiving protease inhibitor therapy, summarizing the reports, and encouraging health care providers to report such cases, or other serious toxicity associated with the use of protease inhibitors, to the FDA’s MedWatch program.
* On June 16, FDA approved Foscavir (foscarnet) for the treatment of acyclovir-resistant herpes simplex virus.
* August 1995, FDA recommended that blood establishments should implement donor screening for HIV-1 antigen using licensed test kits. Although, currently there are no tests for HIV-1 antigen(s) approved for donor screening, FDA issued the recommendation on HIV-1 in advance of the availability of such test in order to provide blood and plasma establishments with maximum time to prepare for this testing.
* On September 1, FDA authorized pre-approval distribution of intravenous cidofovir (Vistide) under a treatment IND protocol for HIV-infected persons relapsing cytomegalovirus (CMV) retinitis that has progressed despite treatment.
* On September 8, FDA published in the Federal Register a proposed rule to amend its regulations pertaining to investigational new drug applications (INDs) and new drug applications (NDAs). The proposed rule is responsive to one of the recommendations made by the National Task Force on AIDS Drug Development. The proposed rule would clearly define in the NDA format and content requirements the need to present effectiveness and safety data for important demographic subgroups, specifically gender, age, and racial subgroups.
* On October 12, FDA approved Biaxin (clarithromycin) for the prevention of Mycobacterium avium complex (MAC).
* On October 27, FDA granted marketing approval for Cytovene capsules (oral ganciclovir) as a prophylactic treatment for the prevention of HIV-related cytomegalovirus (CMV) disease.

Continues.