Announcements

New Treatment Approved for ITP--Also Used for KS. The FDA has recently approved the marketing of a device for filtering the blood and removing unwanted antibodies in the treatment of ITP. The same treatment may also help for KS and possibly other AIDS-related conditions, but these uses have not been approved at this time.
The device, called the Prosorba Column, uses a disposable filter to treat the blood outside the body. Blood is removed, treated, and put back. In a study done by the manufacturer, persons with ITP received four to eight treatments over a four to six week period. 55 percent showed a significant rise in platelets; most maintained the benefit over an average followup period of eight months.
In addition, 17 patients with KS who were HIV positive were treated as part of a larger study of persons with cancer,
and their progress was rated in the standard categories used in evaluating cancer therapy. Six showed a "partial regression", meaning at least a fifty percent reduction of tumor size for at least 30 days. Two showed "less than partial regression", a 25 to 50 percent reduction. Eight showed "stabilization", meaning less than 25 percent increase or decrease. Only one continued with progressive disease. We do not know the condition of these patients before the therapy, nor what outcome would be expected in the absence of treatment.
About half those treated had some side effects, usually chills and fever--effects expected with any blood-handling
procedure.
Unfortunately the treatment is expensive, since each filter can only be used once and costs $650--meaning that the
complete course of treatment costs several thousand dollars. But since it is approved by the FDA, insurance may pay for it.
Unfortunately also, the approval of the Prosorba Column does not show that the FDA has streamlined its approval process for drugs for serious or life-threatening conditions. This treatment obtained approval as a device--much easier to get than approval for a new drug.
(Incidentally, we have learned that as of today, six months after the publication of the FDA's new "treatment IND"
rules which are supposed to allow easier access to experimental drugs before full approval for persons with serious or life- threatening illness, not a single person has received a single drug for any AIDS-related condition under these rules.)
For more information about the Prosorba Column, physicians or patients can call customer service at IMRE Corporation, Seattle, WA, (206) 448-1000. The company cannot refer patients to physicians, but it can refer physicians to other physicians who are experienced with this treatment.
The Wall Street Journal ran an informative article on December 28, 1987.

Ribavirin Available By Prescription? David Robison of Nutrico in Tulsa, Oklahoma (the group formerly called Oklahoma Project Inform), has researched legal loopholes which apparently permit physicians to prescribe ribavirin in the U.S. According to Robison, these prescriptions are filled through regular pharmaceutical supply channels, and can sometimes be reimbursed by insurance. They can be filled by mail.
Ribavirin is already approved in the U.S. for RSV (respiratory syncytial virus), a disease of children and infants. However, the ribavirin used for this condition is provided as an aerosol spray, not suitable for oral use for HIV. Robison learned that physicians can prescribe an approved drug for any patient, and can vary the route of administration
of the drug. He obtained documentation from the FDA on this matter.
On the strength of this research, several pharmacies are now filling prescriptions for ribavirin in the form used for
HIV. Some will do so by mail, so you can receive the drug from anywhere in the country.
For more information, call David Robison at (918) 234-0011.
Note: Ribavirin received much bad publicity in 1987 but seems to be returning to respectability. A new study using
larger doses of the drug should begin within several months at San Francisco General, New York University, Harvard Medical School, and University of California at San Diego. For more information see "FDA Okays Ribavirin Study" by Charlie Linebarger, SF Sentinel January 8, 1988, page 3. (To get a copy of this article, send a request and a self-addressed stamped envelope to: San Francisco Sentinel, attn. Keith Clark, 500 Hayes Street, San Francisco, CA 94102.)
Note: We ran the above announcement by Jay Lipner, an attorney in New York who has worked with Lambda Legal Defense on drug-regulation issues. He said that this is territory where the legal position of a physician or pharmacist is
unclear, and people should proceed with great caution. He pointed out that the FDA is intensely concerned about
commercialization of any drug outside of the normal process.
Lipner stressed that his comments are his personal opinion and not intended to convey legal advice to anyone.

Protest March on Burroughs-Wellcome, January 24 and 25. The AIDS Action Pledge, a new political group in San Francisco, will hold a protest march on January 24 from San Francisco to the Burroughs-Wellcome western regional office in Burlingame, a nearby suburb. On January 25 there will be a rally and civil disobedience at the Burroughs-Wellcome site.
According to a statement from the organization, "The AIDS Action Pledge is demanding accountability from Burroughs- Wellcome about the prohibitive cost of AZT, whether people have been misled about the drug's effectiveness, and evidence that some important research has been blocked into possible treatments that could compete with AZT."
For more information, contact the AIDS Action Pledge at (415) 821-9087.