AIDS TREATMENT NEWS No. 057 - May 20, 1988
John S. James

ViRx Medical Group, Inc. aims to bring together patients seeking the latest AIDS research information and access to experimental treatments, with pharmaceutical companies which have promising drugs to test. ViRx differs from government and university research centers in that as a private company it has more flexibility and hopes to move faster in conducting trials. ViRx has also assembled top people in AIDS research, such as Dr. Luc Montagnier of the Pasteur Institute in Paris, who will serve as a consultant to keep ViRx informed on the most interesting treatment developments in Europe and elsewhere.

During its current start-up phase, however, ViRx is not yet conducting clinical trials, so patients will not have access to experimental treatments yet. Meanwhile they can benefit from the company's treatment expertise and its state-of-the-art research facilities. These facilities--the laboratory and an extensive in-house database of treatment information--are paid for by the investor, a major venture-capital company, and not out of patient fees, which are comparable to standard physician and laboratory charges.

Patients may also benefit because ViRx is spending considerable resources to inform itself of interesting treatments being tested anywhere; it will inform persons of such options even if ViRx itself cannot acquire them and must refer its patients elsewhere. Another advantage for patients now is that they can register to be informed immediately if any clinical trials for which they qualify do begin at ViRx.

ViRx will charge customary rates for its patient consulting and monitoring services, which should be covered by insurance. Any additional costs for sponsored clinical trials will usually be paid by the drug company. Later, ViRx may also sponsor its own trials, with the pharmaceutical company providing only the drug; then the cost of additional monitoring required might have to be paid by the patient, since insurance companies do not pay for experimental treatments. For nontoxic drugs, the routine monitoring being done anyway may be sufficient, meaning that the total additional cost to do the trial may be very small.

All this means that patients should usually be able to participate in most experimental trials through ViRx at little or no cost, beyond the cost of routine monitoring which is recommended anyway and covered by insurance.

Patients should be aware, however, that ViRx insists that it "is not a supermarket" for AIDS treatments. It will only use experimental treatments as part of scientific protocols. Therefore new treatments will seldom be available unless the company which owns a drug wants to run trials, and uses ViRx to do so.

Besides counseling and laboratory monitoring, ViRx would prefer not to provide primary care, handle hospitalizations, etc. Its clients will usually have their own physicians, and ViRx will be cooperating rather than competing with community physicians. But ViRx will expand patient services if its patients require them.

ViRx is seeking patients at all stages of HIV infection, from asymptomatic to persons with ARC or AIDS.

Personnel

The founder of ViRx, president Robert E. Anderson, M.D., has been Chief of the AIDS Section of the California Department of Health Services, and was the Public Health Medical Officer for AIDS in California. He also co-founded the San Francisco Men's Health Study. He is a specialist in laboratory testing procedures, and has authored or coauthored over a dozen papers or presentations on AIDS.

Other key consultants and personnel are:

* Dr. Dannie King, who was head of infectious diseases at Burroughs-Wellcome when AZT achieved its rapid licensing. "He knows how to make the FDA work."

* Peter Hutt, former general counsel of the FDA, and an expert on the history of drug regulatory law. He was involved in negotiating the treatment IND regulations.

* Gary Wilcox, a molecular biologist.

* William Lang, M.D., consultant and clinical supervisor.

* Bruce Decker, in business development.

ViRx is currently recruiting a full-time physician for both clinical and research work.

Facilities

ViRx has its own state of the art laboratory and can do T-cell subsets and P24 antigen testing on the premises. ViRx will use several quality-control checks not usually done in commercial labs to assure more accurate counts.

ViRx also has a computer network throughout the facility. Every examining room has a terminal. Patient records are coded with numbers to protect confidentiality; all identifying information is kept separately. The computer will also be used to monitor results of whatever treatments patients are already using.

Comment

ViRx hopes to conduct dozens if not hundreds of drug trials. It hopes to significantly speed FDA approval for the drugs it studies, by more quickly providing the data required by that agency. If it succeeds, the company could make a major contribution to AIDS treatment development.

What does ViRx offer to patients? Eventually it will provide access to experimental treatments which may be unavailable elsewhere. Already it has a top-quality laboratory, as well as an in-house database of treatment information, with staff who are informed about treatment options and have time to discuss them with patients.

ViRx can make an important contribution to AIDS drug development and to patient services. But since it is seeing patients for the first time this week, it is too early to know how successful this company will be in attracting patients and sponsored research.

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