A l i s s a C h e r r y THE EMERGENCY DRUG RELEASE PROGRAM (Globe and Mail) Electa Taylor developed asthma in her early seventies. She tried a respirator; that wouldn't help. She tried several asthma drugs; those didn't help either. Eventually, she hooked on to a pilot study for a drug not approved for sale in Canada. The drug proved to be great for her. "It was a god-send," says Taylor, now eighty. "They got it from Swtizerland or Sweden. At one point when they had problems getting it, I even offered to go there to get it myself!" But when the pilot study ended, so did the drug's availability. Josip Gabre developed cancer of the bladder. After his bladder was removed in surgery, the cancer metastasized to his rectum and prostate. The oncologist wanted to treat him with radiation, although she admitted it would only give him one year left to live; disillusioned with the medical system, Gabre decided to search for natural alternatives as well. Mrs. Taylor was lucky--when she asked her physician to continue her medication, he did so via Health Canada's Emergency Drug Release Program (EDRP). According to Mr. Gabre, he wasn't so lucky. He wasn't told about the EDRP; his oncologist didn't feel it necessary to recommend alternatives when conventional therapy may work, and his urologist, whom Gabre saw regularly, didn't offer the program, as he didn't know it existed. What is the Emergency Drug Release Program? And why doesn't the average healthy or non-healthy person know about this federal program? Some people are wondering. The EDRP is a Health Canada program which allows physicians to request investigational drugs (those not yet approved for the Canadian market), to treat terminally ill patients for whom marketed therapies have failed or to treat other patients for whom these drugs yield serious side effects. Patients such as Mrs. Taylor therefore fit the requirements of the program; patients, such as Mr. Gabre don't; if patients like Gabre request drugs not on the Canadian market, they still have a close to zero percent chance that their specialist will inform them about or help them attain these drugs through the EDRP. Literally, any non-approved substance thought to have medicinal properties may be requested by a physician, from manufacturers worldwide, regardless of the length of clinical testing already performed by the manufacturer. The investigational drugs include both conventional, orthodox drugs as well as alternative, more natural therapies such as Lorenzo's Oil, Essiac, Laetril, 714X, and even certain amino acids. Sometimes, the manufacturer or a province's health insurance program even covers the drug's cost. Since its inception, the 28-year old program has allowed physicians legal access to more than 600 investigational drugs. The Bureau of Human Prescription Drugs receives approximately 15,000 requests per year, with 900 physicians placing requests each month, yet most of these calls are for refills. If Health Canada does not note serious side effects in the available medical literature, they may request the drug from the manufacturer who has the last say in authorizing the physician be 3. granted the drug for their patient. Some doctors argue that all patients should know about the EDRP, either through a standard practice whereby physicians inform patients about the program or else via educational pamphlets available in doctors' offices. Dr. Philip Berger, Chief of the Department of Family and Community Medicine at Toronto's Wellesley Hospital, treats many AIDS patients. He goes as far as saying that all patients--not just those with AIDS--should be informed of the EDRP so that they know alternatives are available to them. But he senses a fear in the medical community that public information about the EDRP will inevitably lead to all patients demanding the right to choose their own medications. "It's up to the patient what risks they take, and they should be able to decide for themselves," Berger says. "I think the EDRP should be available to anybody who wants these unapproved medications, for whatever purpose, even if the person is not seriously ill. "If the non-approved drug or alternative therapy has no major side effects, their doctor should try to attain the treatment at the patient's request." Specialists, rather than general practitioners, usually know about the EDRP, and they learn about new drugs through the medical literature, medical conferences in other countries where the drug may already be approved, their hospital formulary or--in 4. extremely rare cases--through a patient. The only way the average person would accidently learn about the EDRP is through means which most lay people wouldn't employ--reading the Compendium of Pharmaceuticals and Specialties (page B110), a hospital formulary or, the odd time, the Canadian Medical Association Journal--literature available to physicians. Health Canada says the program should remain this way--that there is no need for patients to be informed about it as a routine practice. The EDRP exists to provide help in compassionate cases, not for patients to act as their own physicians, they say. "The point is, do we ask the patient to be treated by himself or do we ask the physician to treat the patient," asks Dr. Tomasz Uscinowicz, Acting Chief of the EDRP. "The program is not the option for the patient. Nothing has changed, and nothing will be changed. That is not important for the patient." Uscinowicz says there is no secrecy about the EDRP. His concern for patient safety is understandable, but that is no consolation for patients such as Gabre or Ruth Perricone. Perricone was recommended chemotherapy and radiation after she had surgery for liver cancer, but given no guarantee how long she would live, she took a costly trip to Mexico in search of alternatives. Ten years later, free of cancer, she credits the non-approved Essiac, Taheebo tea, and Laetrile as part of a herbal and drug program which saved her life. Josip Gabre also went his own way and tried Taheebo tea. His early recovery from prostate cancer, albeit with radiation initially, so surpassed his oncologist's and urologist's expectations that his urologist, Dr. Andrew Bruce, asked him how he could acquire the Taheebo tea for his own friend dying from cancer. Bruce emphatically believes that "lay people should know about this program," but ironically adds that he is "not sure if they have the right to demand (investigational drugs)." Perricone thinks otherwise. "It was quite costly doing it my way because I had to go to another country for things that I thought should have been available to me in my own country," she says. "Our tax dollars are paying for hospitals and health care, and if there are other alternatives out there that we can try, I think that we should certainly be made aware of what they are. "It's our right as taxpayers, and it's our decision if we want to use (alternatives) or not." Most specialists interviewed for this article seemed fearful--as Berger sensed--that routine public education about the EDRP, and a pandering to patients' rights, would result in droves of patients receiving non-approved remedies unsuitable for their case. "If you knew there was something new out there that may be better, and if you had a choice to pick it or not pick it, you would pick it," says Dr. Ronald Grossman, a respirologist who treated Electa Taylor at Mount Sinai Hospital. "If your doctor wouldn't request it, you would go to another doctor." If only the public education program is enacted, however, physicians must still be willing to request the drug from Health Canada; if patients are also granted the right to choose their own medications, the manufacturer must still be willing to release the drug, perhaps with increased risk of liability. Marilyn Nelson, president of the patient advocacy group, Freedom of Choice in Health Care, believes it's important that the public at least knows about the EDRP, especially for those interested in alternative therapies. "One of the needs that we find is there's people calling up all the time, saying, 'where can I get such and such as a natural remedy'," says Nelson, "so these alternative have become extremely important now in our society, and there's not enough information being put out there." As more people turn toward alternative therapies, as more people demand a choice in their health care, and as less hospital beds are available, Health Canada may need to take a second look at public education--and at the drug release mandate of the EDRP, much the same since l966. "I think there's an apathy, there's a fear, there's an inhibition to engage systems which exist but are not traditionally used," says Berger. "The EDRP is a mainstream, legal, normal legitimate process to use to get people medications they might want."
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