Canada: Application for Medicinal Marijuana -- Dec. 17, 1997

Press Release

Ottawa Physician Applies for Legal Patient Access to Medical Marijuana

Ottawa (December 18, 1997): Using an existing Health Canada program, an Ottawa physician has applied to obtain access to marijuana for medical use in a single case. The application was made under Health Canada's Special Access Programme (commonly called the Emergency Drug Release Program), which allows physicians access to unmarketed drugs for treating seriously ill patients. This appears to be the first application relating to marijuana under this program.

The application was made by Dr. Don Kilby, an Ottawa physician with a large HIV/AIDS practice (a copy of the application is attached). The patient in question is Jean Charles Pariseau. Mr. Pariseau has advanced AIDS and uses marijuana to allay nausea and increase appetite. To date, Mr. Pariseau has not been able to obtain a legal source of supply, and has been criminally charged in relation to his use of marijuana.

Said Dr. Michèle Brill-Edwards, the second physician of the small group that planned the application, "We are using Canadian law for the intended purpose of this legislation -- to provide compassionate access to seriously ill patients whose needs are not met by available treatments". From 1988 to 1992, Dr. Brill-Edwards was responsible for administering the drug release program under which Dr. Kilby is now seeking to obtain marijuana.

Aubert Martins of Ottawa has offered to grow marijuana, if authorized under the program, for the medical treatment of Mr. Pariseau, a friend of Mr. Martins. Mr. Martins is prepared to meet any legal requirements imposed on the growing of this marijuana and to take measures to produce a quality product.

Other members of the group that planned the application are Glenn Gilmour and Eugene Oscapella, both lawyers and among the founding members of the Canadian Foundation for Drug Policy.

Regulations under the Food and Drugs Act provide authority for Health Canada to permit the provision of a quantity of an unmarketed new drug for the treatment of a patient on the request of a medical practitioner. Marijuana for medicinal use is a "new" drug under the Food and Drugs Act and is also a controlled substance under the Controlled Drugs and Substances Act.

For further information and research materials about medicinal marijuana, visit the Canadian Foundation for Drug Policy web site at: http://fox.nstn.ca/~eoscapel/cfdp/cfdp.html

Contact: Canadian Foundation for Drug Policy (613) 236-1027

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Following is the text of the application made by Dr. Kilby. The application was faxed on December 17, 1997, although it was dated December 18.

December 18, 1997

Special Access Programme Facsimile: 941-3194 Therapeutic Products Directorate Holland Cross, Tower "B" 1600 Scott Street, 3rd Floor Ottawa, Ontario K1A 1B6

Dear Sir or Madam:

I hereby apply for access to a new drug under the Health Canada Special Access Programme.

The following are the details of this application {details of addresses and contact numbers have been removed to protect the privacy of the individuals):

Name and telephone number of physician: Don Kilby, M.D., [Telephone numbers deleted ]

Address of physician's office where drug is to be delivered: University of Ottawa, Ottawa, Ontario

Drug name and dosage: cannabis sativa, in inhalable form

Manufacturer's name: Mr. Aubert Martins, [address, telephone and fax numbers deleted]

Total quantity requested: 60 grams

Intended dosage: 0.5 grams qid prn Patient's initials, date of birth, sex.: J.C.P., 67/08/22, male

Medical indication for use of drug: intractable nausea and anorexia associated with AIDS

I agree to report to the manufacturer and the Director on the results of the use of this drug, including information on any adverse reactions encountered. I also agree to account to the Director, on request, for all quantities of the drug that I receive. Please call me if you have any questions. Thank you for your assistance.

Yours truly,

Don Kilby, M.D.

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Ottawa Citizen Thursday 18 December 1997

Health Canada to rule on marijuana

Ottawa lawyers help doctors seek approval for drug to benefit AIDS patient

Jeremy Mercer The Ottawa Citizen

A group of doctors and lawyers has made a groundbreaking application to Health Canada to allow an area AIDS patient to legally use marijuana as medicine.

The application, if approved, will set a tremendous precedent in the battle to have marijuana legalized for the treatment of seriously ill patients.

The group -- Drs. Don Kilby and Michele Brill-Edwards, along with lawyers Eugene Oscapella and Glenn Gilmour -- made the application to Health Canada yesterday and will present their proposal at a news conference today on Parliament Hill.

"This obviously has broader implications than this one case," Mr. Oscapella said.

"We hope this will lead to legal and safe access to marijuana for (critically ill patients). Every journey starts with a single step."

The application was made under the Health Canada special access program. This program allows doctors to request immediate approval of drugs not authorized under the Food and Drug Act if the patient is in an emergency situation.

Drs. Kilby and Brill-Edwards say such applications are common and generally approved as long as there is medical evidence proving the drug helps the patient.

"We have proof that it works," Dr. Kilby said. "I've made (applications for other non-approved drugs) before, and in typical cases, the medicines can be approved within 24 hours in an emergency situation or two or three days."

In this case, the application was made on behalf of Jean Charles Pariseau, a 30-year-old Vanier man who has AIDS and is a patient of Dr. Kilby's.

When Dr. Kilby began treating Mr. Pariseau, the man weighed only 82 pounds and had a prognosis of three months to live. Doctors had prescribed dozens of different appetite stimulants and nausea-fighters to try to help Mr. Pariseau keep down the 30-odd pills he takes each day to control his AIDS and help him eat food.

None of the them worked.

On the advice of a friend, Mr. Pariseau tried marijuana. To the astonishment of Dr. Kilby, Mr. Pariseau's weight shot up to 100 pounds and he changed his prognosis from three months to live to three years to live.

With this evidence, Dr. Kilby is asking Health Canada to approve marijuana as a medicine for Mr. Pariseau.

It was under the same Health Canada program that drugs such as cocaine, heroin and morphine were first approved for medical use.

If the group's application on behalf of Mr. Pariseau is approved, a precedent will be set for any chronically ill person who has the support of a doctor and someone who will grow marijuana for them.

It can take as long as a decade to get a drug approved for use under usual Health Canada procedures.

The group began working on a way to provide legal marijuana for patients six weeks ago after an article outlining Mr. Pariseau's plight appeared in the Citizen.

Mr. Pariseau had been arrested by the RCMP for possession of marijuana, despite the evidence that the drug was helping him survive.

He and Dr. Kilby came forward and spoke t0 the Citizen about how important the marijuana treatment was for Mr. Pariseau.

Afterwards, Dr. Brill-Edwards, one of Canada's leading drug-regulation experts, contacted Dr. Kilby and told him there was a route by which Mr. Pariseau could get legal marijuana. A former Health Canada doctor who oversaw the Health Canada Special Access Program, Dr. Brill-Edwards was confident Mr. Pariseau's case would qualify.

Mr. Oscapella and Mr. Gilmour, both founding members of the Canadian Foundation on Drug Policy, also contacted Dr. Kilby and offered their legal expertise on the criminal aspects of marijuana. The group is assisted by Jennifer Jermyn, a communications consultant.

But the key to the application was Aubert Martin, an Ottawa man with 20 years' experience growing marijuana.

Under the Health Canada program, each application for a new drug must include a "manufacturer" -- someone who is willing to provide the drug to the patient.

Mr. Martin has been involved in Ottawa's underground marijuana network and has been distributing free or discount marijuana to cancer and AIDS patients, including Mr. Pariseau, across the region.

When he agreed to become the "manufacturer" of Mr. Pariseau's marijuana, it allowed the group to go forward with their application to Health Canada.

The group expects a decision from Health Canada by next week.

The group of lawyers and doctors made their application to Health Canada on the same day the Crown Attorney's office announced it would be appealing a lower court ruling that allowed a Toronto man to keep smoking marijuana to control his epilepsy.

Terry Parker, 42, had been charged with possession of marijuana, but Judge Patrick Sheppard stayed all charges against him and ordered police to return 71 marijuana plants to Mr. Parker based on the his belief that marijuana was a medical necessity for Mr. Parker.

That Crown's appeal of Judge Sheppard's decision will likely be heard in the spring.

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Ottawa Citizen Friday 19 December 1997

'We'll approve marijuana prescriptions'

Marijuana 'no different than Aspirin,' Health Canada official says

Jeremy Mercer The Ottawa Citizen

Health Canada is prepared to approve the use of marijuana as a legal medicine in emergency situations.

Yesterday, the department turned down a request by an Ottawa doctor to provide an area AIDS patient with marijuana because of two technical flaws in the application.

But Dann Michols, the man in charge of regulating all drugs and medical devices in Canada, says Health Canada is ready to approve the use of marijuana on a case-by-case basis as long as these flaws are corrected.

"Yes, it would be approved if the changes are made," Mr. Michols said.

"There is no problem, basically, with marijuana as a medicine.

"We have said this all along and our minister (Allan Rock) has said it all along: Marijuana as a medicine is not an outlandish proposition. Marijuana is no different than morphine, no different than codeine, no different than Aspirin. There just has to be a process where we are able to say they have undertaken the right experiments and produced a result that shows the benefit is greater than the risk for the individual patients."

Dr. Don Kilby, a physician at the University of Ottawa health clinic, had been seeking Health Canada's permission to prescribe marijuana to Jean Charles Pariseau, a Vanier man who has AIDS.

When Dr. Kilby began treating Mr. Pariseau, the man weighed only 82 pounds and had a prognosis of three months to live. Doctors had prescribed dozens of different appetite stimulants and nausea fighters to help Mr. Pariseau keep down the 30-odd pills he takes a day to control his AIDS and help him eat food.

None of the them worked, so on the advice of a friend, Mr. Pariseau tried marijuana.

To the astonishment of Dr. Kilby, Mr. Pariseau's weight shot up to 100 pounds and he changed his prognosis from three months to live to three years to live.

But Mr. Pariseau was arrested by the RCMP in October and charged with possession of marijuana. The police also seized his supply of drugs.

After a month of research, Dr. Kilby, aided by a team of lawyers and medical assistants, discovered a legal way to get Mr. Pariseau his marijuana.

Dr. Kilby applied to Health Canada's Emergency Drug Release Program to have marijuana approved for Mr. Pariseau's use. This program allows unauthorized medicines to be approved on a case-by-case basis, usually within 72 hours of the application being made.

All Dr. Kilby had to do was prove that the unapproved drug -- marijuana -- helped his patient.

Dr. Kilby filed an application to the Emergency Drug Release Program on Wednesday. Yesterday, Health Canada announced it would turn down the application because of two technicalities.

The first was that Dr. Kilby doesn't have a research licence under the Controlled Drug and Substance Act. He said yesterday he would apply for one and Mr. Michols said it is likely that application would be approved.

The second problem may be slightly more complicated.

Under the Emergency Drug Release Program, each time a doctor applies for a drug to be approved, he must list the name of the "manufacturer" of that drug. Dr. Kilby listed Aubert Martin, an Ottawa man with 20 years' experience growing marijuana who has agreed to provide the drug for Mr. Pariseau.

But according to Mr. Michols, Mr. Martin also has to have a research licence under the Controlled Drug and Substance Act before marijuana can be approved as a medicine for Mr. Pariseau.

"Our challenge is to make sure that the product that the physician wants access to is safe and of quality," Mr. Michols said.

Mr. Martin would have to prove that he has a secure, safe environment to grow the marijuana and has a background in medical research, a situation Mr. Michols deems unlikely.

So, if Dr. Kilby is successful in his application for a research licence, he must find a different source for marijuana, one that has a Controlled Drug and Substance Act research licence.

"It's not that major of a hurdle," says Mr. Michols.

Most research institutes, universities and pharmaceutical companies in Canada have this research licence. If Dr. Kirby finds just one that is willing to ask Health Canada for permission to experiment with marijuana and then promises to become a supplier, Health Canada should approve marijuana as a medicine for Mr. Pariseau.

"I don't feel that bad about (the application) being shot down," Dr. Kilby said yesterday. "We knew we would have some hurdles that we'd have to go through yet and I'm optimistic that we're going to meet their requirements. There's a way around this problem and we're going to get around it."

Other controlled substances, including heroin and cocaine, are approved for medical use in Canada.

In a poll of 1,515 Canadians conducted by Angus Reid earlier this year, 83 per cent of those asked supported the legalization of marijuana for medicinal purposes.

Aside from the Emergency Drug Release Program, which only applies to isolated case, marijuana could also be permanently approved for medical use in Canada if a strict set of tests are performed on the drug.

Mr. Michols says marijuana hasn't been granted permanent approval for medical use in Canada because it can cost millions of dollars and take up to ten years to put a drug through the Health Canada tests.

Commercial drug manufacturers, usually the only ones with the money to finance these tests, shy away from testing natural products such as marijuana because it is unlikely they will recover their money.

"I can only conjecture, but it probably has to do with the inability to ensure market exclusivity," says Mr. Michols. "You have millions and millions going into patented medicines because they can patent it and recoup their costs. (Marijuana) is not dissimilar to the situation with other herbal remedies: you go to all the trouble of proving a herb helps a common cold and then once you've spent the money, there's nothing to stop someone else from coming along and growing the same thing without the burden of the testing costs."