The following is Part 1 of Lee Smith’s story about her struggle for the approval of Herceptin in Canada. Go to Part 2. Go to Part 3.

In March of 1999 I could see a pink area of skin just below my mastectomy scar and my ribs felt like the invisible man had punched me.

The skin just felt weird and sometimes there were stinging sensations but no itching. Scans and tests were done and all came back clear. The end of April little white nodules the size of the letter “o” began to appear above and below my scar line. This was confirmed as skin metastasis. Immediately, chemotherapy using Taxotere was begun.

It had been ascertained previously that I was an overexpressor of the Her2/Neu oncogene so my oncologist applied through a compassionate use program to obtain Herceptin to add to my treatment. Herceptin was in use in the United States but had not been approved yet for use in Canada. I was assured that I was a good candidate and fit all of the criteria for access to the drug.

Early June brought the news that the drug company had closed it’s compassionate use program on May 31st 1999. The consensus of opinion was that they had done this to force desperate patients, their doctors and caregivers to put political pressure on Health Canada to speed up the approval process. Health Canada had this drug on what they call “fast track” for approval and were over their projected date for completion. My oncologist began to try to find a way to obtain Provincial funding to send me to the USA for treatment.

I called Health Canada and was put through to the Drug Directorate where I left a message on their voice mail. Three hours later the doctor who was in charge of the approval process for Herceptin called me and spoke to me for nearly an hour. In a caring and compassionate way he explained the problems with staffing and priorities of approvals which had begun prior to Herceptin coming in for review. “Soon” was the answer as to when the drug would be OK’d. I explained that “soon” was not an option for me.

Devastated, and envisioning the cancer cells sending out for travel brochures to figure out how to get to the Riviera on my liver, I searched the internet for the drug company Hoffman La Roche Canada and sent them the following e-mail:

June 15th 1999 Herceptin:
I understand the compassionate use program was ended by your company. I have contacted Health Canada. They say approval soon. Soon is not an option for me. Can your company help me? This is my life. I have a recurrence of Inflammatory Breast Cancer (rare and aggressive). Strong overproducer of HER2/neu onco gene.. I have also contacted my Member of Parliament and the Federal Health Minister. My type of cancer moves QUICKLY. Pretend I’m your mom or wife or sister. Please, someone help me. Lee Humble …

That same day I e-mailed the Federal Minister of Health, called my Member of Parliament and posted my despair to the ibc Research Foundation of which I had been a member since early June. Immediately hope reared it’s head as Owen Johnson and a group of twenty or so members launched themselves into battle mode for me. I was a cyber stranger but we were all struggling in a common cause.

June 16th Owen Johnson wrote to the National Breast Cancer Coalition in Washington D.C. asking for help. I had been unsuccessful in locating a similar organization in Canada.

June 17th there began a steady flow of offers of help and encouragement from members of the IBC on line support list.

June 18th I received the following from the drug company:

This is in response to your e-mail letter of June 15th concerning the availability of ‘Herceptin’ in Canada and the current status of our Special Access Program.

The drug trastuzumab, known under the tradesman Herceptin, is not yet commercially available in Canada. A New Drug Submission has been submitted to Health Canada to obtain approval to market this drug in Canada. Health Canada has granted priority review for this medication, and regulatory approval is pending.

Compassionate programs or special access programs fall under a special regulation from Health Canada and provide a means of access to medications not yet approved for use.

The choice to release product through a special access program rests entirely with the manufacturer of licensee of that drug. Not all drugs are released through special access programs prior to their approval. Products can be made available to patients provided that adequate supply is available and that Health Canada has approved the release. Access to products prior to their approval is always determined on a patient by patient basis. All special access programs have strict eligibility criteria to ensure that the right patients receive the medication. Usually, this includes the stipulation that the patient must have failed all other current therapies.

‘Roche’ Canada was provided with a limited supply of clinical trial stock from Genentech (the manufacturers of Herceptin) in late December 1998. With this limited supply of clinical trial stock, ‘Roche’ Canada chose to implement a Special Access Program for Herceptin in January 1999. This program was initiated to provide a necessary drug treatment to metastatic
breast cancer patients who met> the eligibility criteria and were without options. The Special Access Program was implemented with the strong belief that our limited supply of stock would be sufficient to last through the review process until the time of approval. Unfortunately, Health Canada has missed its priority review target, and it appears that approval will be delayed. Due to this delay by Health Canada, and the fact that demand for the SAP has been high, our limited supply of clinical trial stock is depleting. To ensure that there is sufficient supply to treat those patients currently enrolled in the program, the Special Access Program will be closed to all new applicants effective May 31, 1999. This measure has been taken to ensure that treatment for those patients currently enrolled is not compromised prior to receiving approval.

We cannot make any recommendations regarding your treatment or make suggestions that would influence your health care. Only your physician should do so because he/she was involved in your diagnosis and decisions on your treatment course. Because of the relationship between physician and patient, which we respect, it is our policy to recommend you direct your questions to your physician or perhaps your pharmacist who is aware of your medication history.

Thank you for your interest in this product.

Yours very truly,

HOFFMANN-LA ROCHE LIMITED

By the end of the day there were over 30 emails to my inbox giving hard hitting advice as to what my next steps should be. Owen Johnson and the research group had located an email address for Genentech in San Francisco. They had also ascertained that both Genentech and Roche Canada were controlled by Roche Switzerland. The hunt was on to locate activists who had waged the fight to get the FDA to approve Herceptin in the USA a year or so before. Through “computerland” I met Barb, Blaze and Anne who advised and encouraged me to an unbelievable degree. In a fit of anger I send off the following email to the drug company on June 21st 1999:

Dear Sirs,

Thank you for your response of June 18.

(A) I understand that in December 1998 Health Canada put the approval of Herceptin on “fast track” to target approval by May 1999.

(B) I understand that Genentech in the USA manufactures and supplies the drug to you for Canada.

(C) I understand that the choice to release the drug under the compassionate programs “rests entirely with the manufacturer of licensee”.

What I do not understand is the following and I request your response as soon as possible.

(A) Since your company knew that Health Canada was trying to approve by May 1999, was there not a process in place to have an adequate supply of Herceptin ready for this promised release date? If not, why not? Bad planning on the part of marketing department? If a supply was pending for the proposed release date, why can not this supply be used temporarily to extend the compassionate use program?

(B) Roche Switzerland appearing to be the controlling parent, is not Genentech your sister company? Your letter to me seemed to hint strongly that the manufacturer was a completely different entity. It appears that they are churning out Herceptin just fine at their US plant and I see no reason for “limited supply” especially if under good business practice your company had foreseen to order supplies for the assumed release date.

(C) Health Canada assures me that the approval will be “soon”. Your letter to me shows that your company does understand that demand is high for Herceptin and that the people needing it are those for whom all other options have failed. The 30% of breast cancer patients who can benefit from Herceptin being those who are overexpressors of the Her2/neu oncogene are those who have very aggressive fast moving cancer. This leads me to assume that your company or your parent company made the decision to cancel the compassionate use program as a tactic to get the patient and their caregivers to pressure the Canadian Government about the approval process because people like me have such fast growing cancer that we can not wait another month or two. What, if any, plan does your company have in place to be in a position to provide the drug in a timely fashion if, say, approval happens in the next weeks or month? I dislike the idea that I and others with their lives at stake
are perhaps being used as pawns in a game or being held hostage in a bid to pressure government.

(D) All the above provided true, it remains that your company is to be commended for ensuring that those currently in the programme are adequately provided for. This shows compassion. What still bothers me however is that your company chose to be compassionate when you thought the 180 day fast track approval would go through from Health Canada but abruptly lost compassion for metastatic breast cancer patients such as myself on May 31 1999 when the target approval date was not met.

I need this drug. I do not have time to play games. I want to live to see my new grandchild at least to kindergarten age. I am prepared to be reasonable or unreasonable about my quest for life.

Please respond ASAP. Inflammatory Breast Cancer waits for no one. If I have to travel to the USA and incur great financial burden to get this drug I will do so but the world will know about it. If I die before I can obtain this drug the world will know about it. So will your god.

Yours sincerely,
Lee Humble

This same day I called the local TV affiliate of the Canadian Broadcasting Corporation (CBC) and left a message for the Health Beat Reporter telling her that I wanted to talk about a new angle on a story she had done about a young woman who was selected in the Herceptin lottery held in the USA the year before. The following morning a TV crew was at my home! The story was aired June 24th on the local 6 o’clock news. I believe this all came about due to the media tips compiled and sent to me by Barb B. of the ibc Research Foundation who is a broadcast columnist in her “other life”. Barb had also contacted 36 major radio and TV stations across Canada to alert them of the Herceptin story.

Go to Part 2. Go to Part 3.