For people unwilling to pay retail prices, 36 tablets of 50-mg levamisole can be found for about $60 in Manhattan, just under $20 in Washington, D.C., and $13 in San Francisco from so-called "buyer's clubs." And no prescriptions are needed. But at pharmacies, which sell Janssen Pharmaceutica's Ergamisol, the Food and Drug Administration-approved form of levamisole, patients not only need a prescription—they also need a lot more money. A survey of several pharmacies in the Washington, D.C., area showed an average price of $230 for 36 tablets. Besides purchasing the low-cost version of the drug at buyer's clubs, people can also buy levamisole from veterinarians, who have used it as a dewormer since the late 1960s, or from veterinary or farming supply stores. James Letcher, D.V.M., of the Lincoln Park Zoological Park in Chicago, sells a 184mg pill for 18 cents; at this price, 36 tablets of 50-mg levamisole would cost about $1.75.
Ron Mealy, executive director of the Carl Vogel Foundation in Washington, said the foundation began selling levamisole about 6 months ago. He has heard many anecdotal reports from CVF patrons of increases in CD4 T-cell counts and "an overall good feeling— people just feel better after taking the drug." CVF and other non-profit buyer's clubs around the country assist HIVpositive people in obtaining vitamins, minerals, and experimental and imported drugs. Most buy the products wholesale or import them, adding a percentage to cover overhead. But even after the markup, their prices are far below pharmacy prices. Mealy said many patients who come to
Increased Demand Demand for levamisole has increased since two studies established that a bimonthly dose of 450 mg, coupled with intravenous 5-fluorouracil, is effective postsurgical adjuvant therapy for patients with Dukes' C colon cancer (see News, JNatl Cancer Inst, Nov. 1,1989). Each year, approximately 22,000 Americans are diagnosed with Dukes' C. AIDS patients have become interested in the drug for its immunomodulatory effects. And veterinarians still use levamisole to rid sheep, cows, and goats of intestinal parasites.
1128
CVF for levamisole have been referred by their physicians. Regarding purchasing the drug from veterinary or farming supply stores without a prescription, Letcher said, "It's certainly against regulations, but it probably happens." The drug's high price was questioned in a recent letter to the New England Journal of Medicine (see Correspondence, NEJM, March 7,1991) written by Arthur Rossof, M.D., of the MacNeal Cancer Center in Berwyn, 111., Letcher, and two colleagues.
Doctors: Pricing "Outrageous" Rossof and his co-authors calculated that, based on the cost to a veterinarian for the four available oral dosage forms, the cost of a 50-mg equivalent tablet for humans should be in the range of 3 to 6 cents. They found instead that pharmacies in the Chicago area were charging $180 for 36 tablets, or about $5 per tablet. The Washington area pharmacies, then, are charging anywhere from $5.56 to $8.33 per tablet. "I'm not opposed to pharmaceutical companies making money, and getting back their [research and development costs]," Rossof said in a telephone interview. "But we expected that [those costs] had already been covered," as levamisole has been on the market since the late 1960s.
Economics
Dr. Arthur Rossof
He believes the principles of economics pushed up the price. "In those two studies there was no doubt of favorable outcome in the patients receiving levamisole," he said. "[Janssen] can charge whatever it wants to charge and people are going to buy it." Rossof said several doctors have written or called him since the letter was published, expressing their irritation about the high pricing.
Journal of the National Cancer Institute
Downloaded from http://jnci.oxfordjournals.org/ at Florida Atlantic University on January 27, 2015
Promising Cancer Drug Has a Different Price for Every Use
News
Reasonable Return The company explained that a reasonable return on sales must be assured, "if compounds like Ergamisol are to be developed in the future." Factors affecting the price of drugs for humans, unlike veterinary drugs, include additional research, physician information and education, indigent and compassionate-use programs, and quality control. The Center for the Study of Drug Development estimated that the industry average for the cost of a drug's approval in the United States is now $231 million. Only 1 of 10,000 compounds studied ever proves to be useful, according to a survey by the Pharmaceutical Manufacturers Association. In a recent article in Science, P. Roy Vagelos, CEO of Merck and Co., stated that "7 of 10 marketed prescription medicines do not recoup the average cost of research and development."
According to Roger Aspeling, Janssen's director of professional relations, the drug's immunomodulatory effects were discovered in 1975, and extensive studies with levamisole began in breast, lung, and stomach cancers. Since then, 2,700 papers have been published on levamisole's immunomodulating properties, and eight Investigational New Drug indications researched. — By Nancy Volkers
searching the drug, scientists discovered that it not only dewormed animals but also boosted their immune systems, ridding them of infections and, in some cases, cancer. Janssen did not pursue further apporval of the drug for humans, because it already marketed Vermox (mebendazole), a human dewormer. But research into levamisole's other diseasefighting properties began soon after.
Stat Bite
NCI Annual Budget in Current and Real Dollars* Measured in "current dollars," it appears as if the NCI budget grew continuously from 1968 to 1991, with especially large increases in the 1980s. But in "real dollars," adjusted for inflation, the NCI budget reached its peak in 1976, declined somewhat in the late 1970s and early 1980s, and has been more or less constant since. Dollars in Billions 2.0
Free Supplies Janssen supplied Ergamisol free to more than 5,000 patients through NCI's Cancer Therapy and Evaluation Program before it was approved by the FDA, It continues to supply the drug to NCI for use in studies of patients with colon and rectal cancers. Janssen has also instituted the Oncology Program for Indigent Patients, in which low-income patients receive Ergamisol free through their physicians. Levainisole was developed as an animal dewormer in 1966. While re-
Vol. 83, No. 16, August 21, 1991
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1968
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1973
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i
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1983
1978
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I I
I
1988
I I I
1991
Year from current year dollars using the Research and Development Price Index.
By Martin Brown, Ph.D.
NEWS 1129
Downloaded from http://jnci.oxfordjournals.org/ at Florida Atlantic University on January 27, 2015
Janssen responded that Ergamisol's price compared very favorably to other immunomodulators, the costs of which range from $6,000 to $8,000 per year of therapy. At Washington, D.C., pharmacy prices, Ergamisol costs an average of $1,400 per year.
Ron Mealy, executive director of the Carl Vogel Foundation in Washington, said the foundation began selling levamisole about 6 months ago. He has heard many anecdotal reports from CVF patrons of increases in CD4 T-cell counts and "an overall good feeling— people just feel better after taking the drug." CVF and other non-profit buyer's clubs around the country assist HIVpositive people in obtaining vitamins, minerals, and experimental and imported drugs. Most buy the products wholesale or import them, adding a percentage to cover overhead. But even after the markup, their prices are far below pharmacy prices. Mealy said many patients who come to
Increased Demand Demand for levamisole has increased since two studies established that a bimonthly dose of 450 mg, coupled with intravenous 5-fluorouracil, is effective postsurgical adjuvant therapy for patients with Dukes' C colon cancer (see News, JNatl Cancer Inst, Nov. 1,1989). Each year, approximately 22,000 Americans are diagnosed with Dukes' C. AIDS patients have become interested in the drug for its immunomodulatory effects. And veterinarians still use levamisole to rid sheep, cows, and goats of intestinal parasites.
1128
CVF for levamisole have been referred by their physicians. Regarding purchasing the drug from veterinary or farming supply stores without a prescription, Letcher said, "It's certainly against regulations, but it probably happens." The drug's high price was questioned in a recent letter to the New England Journal of Medicine (see Correspondence, NEJM, March 7,1991) written by Arthur Rossof, M.D., of the MacNeal Cancer Center in Berwyn, 111., Letcher, and two colleagues.
Doctors: Pricing "Outrageous" Rossof and his co-authors calculated that, based on the cost to a veterinarian for the four available oral dosage forms, the cost of a 50-mg equivalent tablet for humans should be in the range of 3 to 6 cents. They found instead that pharmacies in the Chicago area were charging $180 for 36 tablets, or about $5 per tablet. The Washington area pharmacies, then, are charging anywhere from $5.56 to $8.33 per tablet. "I'm not opposed to pharmaceutical companies making money, and getting back their [research and development costs]," Rossof said in a telephone interview. "But we expected that [those costs] had already been covered," as levamisole has been on the market since the late 1960s.
Economics
Dr. Arthur Rossof
He believes the principles of economics pushed up the price. "In those two studies there was no doubt of favorable outcome in the patients receiving levamisole," he said. "[Janssen] can charge whatever it wants to charge and people are going to buy it." Rossof said several doctors have written or called him since the letter was published, expressing their irritation about the high pricing.
Journal of the National Cancer Institute
Downloaded from http://jnci.oxfordjournals.org/ at Florida Atlantic University on January 27, 2015
Promising Cancer Drug Has a Different Price for Every Use
News
Reasonable Return The company explained that a reasonable return on sales must be assured, "if compounds like Ergamisol are to be developed in the future." Factors affecting the price of drugs for humans, unlike veterinary drugs, include additional research, physician information and education, indigent and compassionate-use programs, and quality control. The Center for the Study of Drug Development estimated that the industry average for the cost of a drug's approval in the United States is now $231 million. Only 1 of 10,000 compounds studied ever proves to be useful, according to a survey by the Pharmaceutical Manufacturers Association. In a recent article in Science, P. Roy Vagelos, CEO of Merck and Co., stated that "7 of 10 marketed prescription medicines do not recoup the average cost of research and development."
According to Roger Aspeling, Janssen's director of professional relations, the drug's immunomodulatory effects were discovered in 1975, and extensive studies with levamisole began in breast, lung, and stomach cancers. Since then, 2,700 papers have been published on levamisole's immunomodulating properties, and eight Investigational New Drug indications researched. — By Nancy Volkers
searching the drug, scientists discovered that it not only dewormed animals but also boosted their immune systems, ridding them of infections and, in some cases, cancer. Janssen did not pursue further apporval of the drug for humans, because it already marketed Vermox (mebendazole), a human dewormer. But research into levamisole's other diseasefighting properties began soon after.
Stat Bite
NCI Annual Budget in Current and Real Dollars* Measured in "current dollars," it appears as if the NCI budget grew continuously from 1968 to 1991, with especially large increases in the 1980s. But in "real dollars," adjusted for inflation, the NCI budget reached its peak in 1976, declined somewhat in the late 1970s and early 1980s, and has been more or less constant since. Dollars in Billions 2.0
Free Supplies Janssen supplied Ergamisol free to more than 5,000 patients through NCI's Cancer Therapy and Evaluation Program before it was approved by the FDA, It continues to supply the drug to NCI for use in studies of patients with colon and rectal cancers. Janssen has also instituted the Oncology Program for Indigent Patients, in which low-income patients receive Ergamisol free through their physicians. Levainisole was developed as an animal dewormer in 1966. While re-
Vol. 83, No. 16, August 21, 1991
I
1968
I
1973
I
i
i
•
i
•
i
i
i
I
l
1983
1978
I
I I
I
1988
I I I
1991
Year from current year dollars using the Research and Development Price Index.
By Martin Brown, Ph.D.
NEWS 1129
Downloaded from http://jnci.oxfordjournals.org/ at Florida Atlantic University on January 27, 2015
Janssen responded that Ergamisol's price compared very favorably to other immunomodulators, the costs of which range from $6,000 to $8,000 per year of therapy. At Washington, D.C., pharmacy prices, Ergamisol costs an average of $1,400 per year.
