Cancer Drug

NEW YORK - Two friends of Samuel D. Waksal, the imprisoned founder and head of ImClone Systems Inc., were charged with insider trading yesterday after he testified against them before a grand jury. Dr. Zvi Fuks, 68, chairman of the radiation oncology department at Memorial Sloan-Kettering hospital in New York, and Sabina Ben-Yehuda, 51, who worked at an investment fund founded by Waksal, were charged in a federal criminal complaint in U.S. District Court in New York. Prosecutors said Fuks was on the scientific advisory board of ImClone, which makes the colon cancer drug Erbitux, when he received the inside information.

On Feb. 3, Joyce Elkins filled a prescription for a two-week supply of nitrogen mustard, a decades-old cancer drug used to treat a rare form of lymphoma. The cost was $77.50. On Feb. 17, Elkins, a 64-year-old retiree who lives in Georgetown, Texas, returned to her pharmacy for a refill. This time, after a huge increase in the wholesale price of the drug, the cost was $548.01. Elkins' insurance does not cover nitrogen mustard, which she must take for at least the next six months, at a cost that will now total nearly $7,000.

THE pharmaceutical industry in the United States is getting away with extortion.The latest example of how drug companies rip off the public is the Upjohn Co.'s decision to jack up the price of Depo-Provera.Depo-Provera has been on the market for some time as a cancer drug. It cost $12 a dose. Last October the Food and Drug Administration cleared Depo-Provera for use as an injectable contraceptive. Upjohn quickly raised the price to $34 a dose.Since a woman using Depo-Provera as a method of contraception needs to get an injection about once every three months, that works out to a yearly cost of about $134.

Biotechnology stocks, down sharply since late last year because of a raft of bad news, appeared to begin a comeback last week as clinical trials results were leaked in advance of a major scientific meeting. The Amex Biotechnology Index, which measures the performance of a cross-section of biotech stocks traded on various exchanges, rose nearly 5 percent after hitting a six-month low of 450.14 Tuesday. One impetus for biotech's comeback: a Robertson Stephens research note, released Friday, that said leaked clinical trial results for a Millennium Pharmaceuticals Inc. drug showed "a powerful response rate" against myeloma, or bone marrow tumors.

Hospitals nationwide are experiencing shortages of critical generic intravenous drugs. We believe a fundamental reason for this national shortage is government price controls. With these limits, there is little incentive to invest in new facilities and technologies, leading to equipment failures. Manufacturers have little economic incentive to prepare for the quality assurance issues that routinely arise in the manufacturing of a sterile injectable compound. To reincentivize this process, the market needs to be free, spurring more manufacturers to produce these drugs, and encouraging reinvestment in facilities and the stockpiling of reserves.

A host of prescription drugs have been in low supply around the United States for some time, but doctors have been warning about a particularly acute shortage of a set of life-saving cancer drugs. Now the U.S. Food and Drug Administration said today that it has taken steps to boost the supply of those cancer drugs -- Doxil, or doxorubicin hydrochloride liposome injection, and methotrexate. On Doxil , the FDA plans to import temporarily a replacement drug called Lipodox to meet patient needs in coming weeks.

WASHINGTON - Physicians who want to prescribe anti-anemia drugs for cancer patients will have to register and undergo training or risk losing access to the drugs, under a long-awaited risk-management plan unveiled Tuesday by the Food and Drug Administration. The company also will require physicians to collect signed statements from patients attesting that they have been informed about the dangers of the drugs, which can cause tumors to grow faster and have shortened the lives of some cancer patients.

A combination of two potent anti-cancer drugs appears to halt the progression of the most serious cases of breast cancer in elderly women, according to a government study.Women over age 64 with advanced breast cancer who received the combination treatment lived about seven months longer than women receiving only one of the drugs, reported Dr. James N. Ingle of the Mayo Clinic in Rochester, Minn.The American Cancer Society projects 175,000 new cases of breast cancer in the United States this year and 44,800 deaths from the disease.

Cel-Sci Corp., a biotechnology company with research and development offices in Baltimore, said that three more medical institutions have agreed to participate in clinical testing of Multikine, an anti-cancer drug developed by the company.The new institutions are Wayne State University in Detroit; Sir Mortimer B. Davis Jewish General Hospital/Lady Davis Institute for Medical Research in Montreal; and Hamilton Regional Cancer Centre, in Hamilton, Canada.Those institutions join Hotel Dieu de Montreal Hospital in Montreal, which was the first to agree to participate in the study.

WASHINGTON -- Women's health advocates expressed grave concern yesterday that a new study aimed at preventing breast cancer is failing to warn participants about the serious side effects of their drug therapy, including the possible development of blood clots and liver tumors.Testimony about risks of the drug tamoxifen and inadequate warnings came as a congressional panel examined the first large-scale breast cancer prevention study, which was announced earlier this year by the National Cancer Institute.