One of the most successful drug treatments for AIDS thus far, Crixivan, may finally be available for dispensing through supermarket and other community retail pharmacies by April 1997, according to Merck & Co., its manufacturer.
The development follows protests by independent pharmacists and community pharmacy associations that pushed to get the drug, which is now being dispensed primarily through a Pittsburgh-based mail-order pharmacy, Stadtlanders, into broader retail distribution.
Retail pharmacists are eagerly awaiting the expanded distribution of Crixivan, one of a new class of drugs called protease inhibitors that have been highly effective in treating AIDS patients.
"Drugs for the treatment of HIV need to be made as easily accessible as possible," said Vern Shaffer, pharmacy manager for Bi-Lo Markets in DuBois, Pa.
"I think it should be sold by all pharmacies," said Scott Buchanan, pharmacy supervisor/manager, Dan's Foods, Salt Lake City.
"The drug is a life-saver," said Bob Marshall, the chief executive officer of the California Pharmacists Association, based in Sacramento. "Pharmacists have noticed remarkable changes in patients who have been on this drug."
Crixivan was approved by the FDA this March, six months ahead of schedule. "We had to build two new factories just to produce Crixivan," said Michael Seggev, a spokesman for Merck & Co., headquartered in Whitehouse Station, NJ. Merck decided to limit distribution to mail-order pharmacies because "there was not enough supply to fill the normal distribution pipeline."
Earlier this year, pharmacists in Los Angeles and San Francisco spearheaded protests against their exclusion from selling Crixivan. The National Community Pharmacists Association, formerly known as NARD, called for a Federal Trade Commission investigation of Merck's anticompetitive distribution plan. In the past few months, Alexandria, Va.-based NCPA representatives have held meetings with Merck representatives to call for a broader distribution of the drug.
While Merck initially estimated Crixivan would be sold through retail pharmacies by the end of this year, it has pushed the date back several times to next spring, Marshall said. "We heard Jan. 1, then we heard first quarter," he said.
"Our expanded distribution system could begin in April. Any pharmacy that wants to participate will be able to," Seggev said. But he cautioned that big international demand for the product might further delay retail distribution in the United States.
"We're concerned with the continued delay in opening up full distribution of this vitally important medicine, but at least this is a step in the right direction," said Calvin Anthony, NCPA executive vice president.
"Ultimately, we want it to be available through wholesalers and to all pharmacies," said Todd Dankmyer, a spokesperson for the NCPA. "We have not heard any assurances about when that will happen."
"We intend to go into normal distribution, but we don't know when that will happen exactly," Merck's Seggev said. "As soon as we build enough inventory, we are committed to doing that."
Currently, about 3,000 pharmacies distribute 80% of HIV medications, Seggev said. Most are concentrated in urban areas. "Not all pharmacies are in the AIDS business. The vast number of pharmacies have occasional distribution," Marshall said.
There are 67,000 people who take Crixivan now, Seggev said. The Center for Disease Control estimates there are as many as 900,000 AIDS-infected people in this country.
When protease inhibitors like Crixivan are taken in combination with other AIDS drugs like AZT and 3TC, the "cocktail" lowers the virus level in patients to undetectable levels. In addition to Crixivan, two other protease inhibitors, Invirase, from Roche Laboratories, Nutley, N.J., and Norvir, from Abbott Laboratories, Abbott Park, Ill., have been approved this year, and both are available through retail pharmacies.
Crixivan's list price is $12 per day, while Invirase costs $16 a day and Norvir costs $18, according to Seggev. Of the three protease inhibitors, Crixivan has the fewest side-effects, he said.
"There has been a lot of movement by the FDA to accelerate approval of drugs for treatment of HIV," Shaffer said.