Press room ... 1996 archive

Consensus Statement on the Further Development of Protease Inhibitors and Human Growth Hormone

February 19, 1996

San Francisco, CA—A group of community AIDS treatment activists have been meeting in Washington DC, prior to the FDA hearings for the approval of the Abbot and Merck protease inhibitors as well as Serono’s recombinant human growth hormone, to treat HIV-related wasting syndrome. The purpose of the meeting was to develop an activist strategy and consensus prior to going into the hearings. The following is the consensus statement which was agreed upon after several days of discussion. Your organizations support for this statement would be extremely helpful to bring into the FDA on FRIDAY. While we understand this is very short notice, if your organization can endorse the attached statement, Please fax this page back to Dan Cusick at Project Inform at 415-558-0684.

Name of Organization (Please print clearly!): _____________________
[_] YES, our organization endorses the Consensus statement
Please print YOUR name: ________________________________
Phone number: (_______) _______–_______________

Consensus Statement on the Further Development of Protease Inhibitors and Human Growth Hormone
We, the undersigned individuals and organizations, represent hundreds of thousands of people with HIV infection in the United States. We are excited and hopeful that the therapies being reviewed for approval this week (two protease inhibitors and human growth hormone) can provide a substantial benefit for people with HIV. However, approval of these products is not the end of the process of drug development. In order to provide real access and information about how to use these drugs safely and effectively, we call on the Food and Drug Administration, the National Institutes of Health and the pharmaceutical industry and third-party payers to meet the demands outlined below. Failure to do so will seriously undermine the value that these therapies will offer to patients today and in the future.

Approve both indinavir and ritonavir for people with HIV infection for whom anti-viral treatment is indicated based on immunologic, clinical and biological markers. Approve human growth hormone for the treatment of wasting syndrome.

Whatever regulatory mechanism is used for approval, industry and government must agree to engage in post-marketing research to answer key unanswered questions about safety and efficacy. In order for this research to be effective, it will require a collaborative effort between industry, government, academia and community heretofore unseen in AIDS research. The commitment to engage in this effort quickly should be of paramount importance. We insist that a strategic plan be presented for achieving these goals by the time of the 11th International Conference on AIDS, to be held in Vancouver in June, 1996.

The following is a list of questions that we agree must be answered as soon as possible. The list is not meant to be exhaustive, but rather to highlight those issues we believe are of highest priority:

When in the course of HIV disease should anti-viral treatment generally be initiated?

Which treatment regimens should be used as initial therapy?
What are the best strategies for using combinations of anti-viral drugs, including protease inhibitors, for nucleoside-experienced patients?
When should people switch or stop anti-viral treatment regimens?
What is the pharmacokinetic and long-term safety profile on protease inhibitors?

To what level must viral load be reduced and sustained to successfully halt disease progression?

How will pediatric formulations of protease inhibitors be developed and studied?

What is the effect of protease inhibitors on perinatal transmission?
What is the optimal dose of human growth hormone, alone or in combinations?

Approve viral load test kits for clinical management now, not in six months. This is essential if we are going to be able to use these treatments effectively.

Provide protease drugs and growth hormone, at no cost, to all former and current clinical trial and expanded access program participants and collect long-term safety data from this group. This would provide the easiest and fastest way to get such information.
Promotional and educational materials must be developed and made available to doctors, patients, pharmacists and health educators immediately to inform them about safe and effective use of these products particularly around issues of compliance with treatment regimens and drug interaction problems. Community and consumer input into the development and distribution of such materials is essential.

Reimbursement decisions should be driven by clinical and/or surrogate data from controlled clinical studies.

Prices for these drugs must be fair, reasonable and sensitive to the current crisis in health care funding. Each company must guarantee treatments to those who have no other means of access or less than full coverage through patient assistance programs.
At minimum, pharmaceutical companies must agree to provide AIDS Drug Assistance Programs with similar rebates that are given to Medicaid programs.

Initial sign-on list, in formation:
ACT-UP Golden Gate
ACT-UP Philadelphia
AIDS Action Council
AIDS Research Alliance
American Foundation for AIDS Research
Critical Path AIDS Project
Gay Mens’ Health Crisis
National AIDS Treatment Advocacy Project
National Association of People With AIDS
New Mexico AIDS Services
Project Inform
PWA Health Group
San Francisco AIDS Foundation
Search for a Cure
The Living Well Project / Asian-Pacific Islanders AIDS Services
Treatment Action Group