BOSTON HERALD
by Michael Lasalandra
Monday, November 17, 2003
American cancer patients using an alternative drug made in Canada say they are having trouble getting the medication since U.S. Customs started seizing shipments over the past few months.
``I had been getting it for the past six months and then, in September, it just didn't show up,'' said Cathy Maguire of Braintree, who has been taking 714X for treatment of non-Hodgkin's lymphoma.
The drug, made by Cerbe Distribution of Quebec, is not approved by the FDA for prescription in the United States but is allowed in Canada under a limited ``compassionate use'' program.
Maguire and other U.S. patients say they recently received letters from U.S. Customs and Border Protection saying their FedEx shipments had been seized.
``This has most definitely interrupted my treatments,'' said Maguire, a mother of two in remission. ``I was getting it for so long and then it stopped. There was no reason for it. It's concerning.''
Maguire, who said she is taking 714X in addition to chemotherapy and other approved treatments, said she has managed to get the drug another way, although she wouldn't say how.
Some patients, however, say they have driven to Canada to get it, while the company says it is now sending shipments by mail rather than FedEx and they are getting through.
The drug drew extensive attention in 1995 when 16-year-old Billy Best, then of Norwell, ran away from home to avoid chemotherapy treatments for his Hodgkin's disease. He later started taking 714X and apparently was cured.
Best has continued to use the immune-boosting drug intermittently over the years but had a shipment seized last month, said his mother, Sue Best.
``We're very upset,'' she said.
Jacinte Naessens, wife of biologist Gaston Naessens, the drug's developer, said the seizures began in July soon after the National Cancer Institute held a hearing to decide whether to fund a study. No decision has yet been announced.
``We didn't know what was happening,'' she said. ``The first confiscation was three days after the hearing. Maybe it's a coincidence. But it is very, very curious this happened right after our presentation to the NCI.''
The drug, which is injected directly into the lymphatic system, contains mineral salts, camphor and a variety of trace elements. It is said to boost the body's immune system and repair damaged cells.
Customs officials referred calls from the Herald to the FDA, which said the drug has been under an ``import alert'' since 1996. An FDA official said she was unaware of any change in policy since then.
A spokeswoman for HealthCanada, which has allowed the drug to be prescribed since 1990 under a compassionate use program, said the agency has made it more difficult for doctors to prescribe the drug since the NCI hearing in July.
``In light of the review by NCI, access to 714X is limited at this point,'' said Krista Apse. ``We're asking for more information from the doctors (who want to prescribe it). We want a more detailed justification.''
She said the agency will review its policy after learning what the NCI intends to do.
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