Part 1 of Lee Smith’s story about her struggle for the approval of Herceptin in Canada.

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 its compassionate use program on May 31, 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 voicemail. 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 its 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 online 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 21, 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.

Part 2 of Lee Smith’s story about her struggle for the approval of Herceptin in Canada.

What follows are some of the e-mail messages sent over the next few days.

June 18th Owen sent the following e-mail to the research group:

How many of you have read Robert Bazell’s book, “Her 2, The Making of Herceptin, an evolutionary Treatment for Breast Cancer”? Robert Bazell is the chief science correspondent for NBC news. He lives in New York (city? I don’t know if that means the City, that’s just what the back flyleaf says).

page 54: “Soon after that, Genentech lost its innocence. On February 2, 1990, Roche Holding, Ltd., a Swiss company that owns Hoffmann-La Roche, agreed to pay $2.1 billion for 60 percent of Genentech’s stock and picked up an option to buy the remainder over several years. Economic necessity had forced the move. Like other biotechnology companies, Genentech was constantly starved for cash.

So the plot thickens: Roche CONTROLS Genentech. It won’t do any good to write to Genentech and copy Roche!!

There are some activist names in the book who arranged fax and phone zaps to Genentech and Roche, and at one time, led a funeral procession to and past Genentech to embarrass them.

Here are two names we have to locate. B– E—-, Chapter 8 of the book. He started a company in San Francisco called ******************; I don’t know if it is still there, but let’s locate —–. His wife died of breast cancer.

The second name is E—— P—, founder of San Francisco’s Breast Cancer Action in 1990
Finally, let’s get a phone number and e-mail and fax for Robert Bazell.

Would someone take on this effort to locate these three people? The first one to respond wins a gold star.

Thanks.
Owen.

Barbara, media person in WI, would you tell us how to get an investigative news reporter (paper and/or TV) involved in this Herceptin mess in Canada. Simply, here is the story as I see it now.

1. Roche-Switzerland controls Genentech
2. Roche-Canada had Herceptin supply and allowed compassionate use until May 31st
3. Roche-Canada said “we’ve run our of supply” so no more compassionate use

Since Roche-Switzerland owns Genentech, and Roche-Switzerland owns Hoffman-La Roche Ltd (what I’ve called Roche-Canada), then for Roche-Canada to point the finger at Genetech is like pointing their index finger at their sibling (Genentech) and their middle finger at the people of Canada who need Herceptin.

Barbara, can you help us get some media attention?

Owen.

June 19th 1999
Let’s get active!! Can this small group of about 20 people make a difference? We wanted to do something, so let’s “do it”.

Well, Owen certainly did something! He wrote the following also on June 19th.

Dear Mr. Bazell,

WE NEED YOUR HELP.

I represent a group of inflammatory breast cancer patients and their caregivers, several of whom are in Canada. Inflammatory breast cancer is a very aggressive, rare (1-4% of breast cancers) breast cancer.

Having read your book, we are aware of your knowledge and network of contacts in Genentech, Roche, and others involved in Herceptin development and marketing.

Based on that involvement you are certainly aware that Roche-Switzerland owns a controlling interest in Genentech. And Hoffmann-La Roche Limited (Canada) is a wholly-owned subsidiary of Roche-Switzerland.

Are you aware of what has happened in Canada? Here is a copy of an e-mail written today, June 18th, by Lee Humble in Ottawa, Ontario, Canada to a member of her government.

The Honourable Mr. Allan Rock (written June 18th 1999)

I have a very rare form of cancer called Inflammatory Breast Cancer which occurs in only in 1% to 4% of breast cancer patients. Presently I am coping with a recurrence to the chest wall. There is a drug called Herceptin which is not yet approved for use by Health Canada but was available through a compassionate program offered by Hoffman La Roche Canada. Health Canada was to have approved this drug by May 1999. They have not done so yet. Roche Canada has discontinued the compassionate use program (in my opinion) to use the patient as a pawn in it’s bid to get the gov’t under pressure to speed up the release. I believe that Roche Canada is playing with the lives of the 30% of breast cancer patients who are over expressors of the Her2/neu oncogene for which this Herceptin drug has been shown to increase the efficacy of standard chemotherapy by up to 65%. My type of cancer is very aggressive and fast moving. I have had every treatment possible since Jan 1998. All have failed me so far. The knowledge that this drug exists and is available in the USA, most of Europe and even some third world countries but not
in Canada is distressing to me. Health Canada assures me that the drug will approved soon. I spoke to Dr. Anthony Ridgeway of the Bio Theraputic’s division of Health Canada. I do not have the option for “soon”. Even after approval I am concerned that OHIP will not have this drug on it’s books for coverage for another period of time. Neither will my private health plan. What about initial supply problems via the drug
company? All this will mean more delay for me. I state again, I and others do not have time on our sides. Normal types of breast cancer move much more slowly than IBC (inflammatory Breast Cancer) but still these patients are deserving of access to the medication they need to live a bit longer.

Please help me. If your government can do anything, however small, please take action ASAP.

I request a reply.

Thank you for your speedy response.
Lee (Lillian) Humble

Owen also included a copy of the drug company response written on June 18th. Refer to that letter in the part of the story you have already read.

For Hoffmann-La Roche Limited (Roche-Canada) to blame Genentech for the lack of supply of Herceptin smacks of a con job, and “how dumb do they think we are?”. The only conclusion we can draw is that Roche-Switzerland wants to put the pressure on Health Canada to approve Herceptin, and has decided to halt the compassionate use program that was available until May 31st through Roche-Canada. Roche-Switzerland could just as easily have directed Genentech to send additional supply to Roche-Canada (if we believe that Roche-Canada was short of supply of Herceptin, which we don’t).

I am writing this message to you from Anchorage, Alaska. Our Canadian friends need our help.

WE NEED YOUR HELP.

PLEASE present a story on this on TV in the US and we hope it will play in Canada. We can put you in telephone contact with Lee Humble in Ottawa if you wish.

So Who’s in Control? Certainly not Genentech. Certainly not Roche-Canada. Is Roche-Switzerland? WE have to exert a voice and make it happen such that our friends in Canada are not pawns in this new “game”.

Please call me ASAP and I will get the message to our group. Call or e-mail anytime, but please make it SOON.

Owen Johnson

After seeing all this activity I was prompted to write the following to the Research Group:

I’m still new at this cancer stuff but am sure learning rapidly! Thank you all for caring. I hope this isn’t taking time and energy away from other pursuits. I didn’t join this group to become a focus of any kind … only to help out and I sort of feel bad to be the cause of such hard work. However, I feel good that maybe we can expose unfair practices and raise awareness of IBC in the process.

June 21st 1999

Dear Blaze and Owen

I really don’t mind being the centre of a cause if you want me to. Hell, I’ve always loved being the centre of attention ever since I figured out how to talk and say “Look Mommy! Look at me!”. I’m more than willing to shed a tear or two and be interviewed etc. I just want to be sure not to overstate the facts as they apply to me and I’m not on the verge of death like some are. I do have a contact in British Columbia who tried to get Herceptin for his wife (IBC patient) before the compassionate use programme even started … he was told by Health Canada about the special access program for drugs and the herceptin compassionate use thing in Dec 98 when it started up… by that time it was too late. She died Jan 99. Remember that all this time it was available next door in USA. There are two Canadian IBC list members presently on Herceptin that I know about and Joan in Alberta who’s onc says she’s a candidate at some future point. I’m sure we could scare up a really big list of people who need this drug ( maybe by asking the Cdn Oncology Assn .. if there is one … or asking Health Canada how many have been turned away). Sorry I’m saying too much again. I feel deep inside that my situation IS desperate but I am not yet out of options and am not at death’s door. I’m living a reasonably normal life. I intend to live to see my new grandchild at least get to kindergarten!
Lee

June 22nd
By this time many friends and supporters across Canada had taken the ball and begun to send letters to politicians. An example follows of a letter written by a friend (who is a well known figure in the business community) to the Federal Minister of Trade and Commerce.

John:

Nice to see you briefly at the picnic yesterday. I’m not sure I mentioned what a fine job I think you are doing. Keep up the good work.

This message concerns an urgent threat to the life of a dear friend of mine where I believe your office may be able to help.

When I opened my email this morning I found the following message from a long-standing, very dear friend of mine (I am godfather to one of her daughters). Lee Humble has a rare and very lethal form of breast cancer.

She is trying to obtain a new drug which, as I understand it, is a last resort but which has not yet been approved for use in Canada (“soon” according to Health Canada officials). The compassionate use program for this drug has been terminated on request of the drug company for reasons which, as the following message indicates, do not seem to be entirely reasonable if one is faced with a fast-moving threat to life.

This message has already been sent to Minister Rock and the media, among others. If there is anything you can do to intervene either with the Minister of Health or with the Drug company, I for one will be extremely appreciative, not to mention Lee, her family and many friends.

June 27th … we had been trying to locate an e-mail address for Genentech but could only find one for their investors. Owen sent off the following

Hello,

Hoffman-LaRoche Ltd in Canada is blaming Genentech for insufficient supply of Herceptin to continue their Compassionate Use program prior to Health Canada’s approval of Herceptin. Please tell me, “what is the REAL” story.

That same day this suggestion was posted from Barbara.

Before everyone blasts off letters to Genentech I suggest we organize a stock purchase program so we can get a word in at the next shareholder’s meeting. As well, we can find out who is on the board of directors and bang on them.

The power with big business is NOT in compassion, it is in SHAREHOLDERS and making money for them … as such, a nice little block of stock would assure a platform for the meeting and a better sounding board. AND, of course, as shareholders, (even with only ONE share) they have to let us come to the meeting and we can make a HELL OF A LOT OF NOISE at that meeting..

Civil disobedience, through legal and shareholder channels might prove to be the fastest and easiest way to the top … who wants a bunch of us marching around with pictures of our loved ones and graphic posters of what IBC looks like during the shareholder meetings … or at the shareholder’s dinner for that matter .. Heck, we could sponsor a hole at the company golf outing … imagine the glorious HUGE posters we could put up to make them THINK about what this disease LOOKS like and FEELS like. All we need to do is buy ONE share each all of us and we have the right to be there and get someone to speak for us from the floor…

Anyone know what Genentech closed at on Friday? This could be FUN.

Barbara

June 29th Owen had located the Genentech Corporate list of Directors and sent off this:

Dear Mr. Cohen,

My name is Owen Johnson and I am a member of the inflammatory breast cancer support list and the inflammatory breast cancer research list. One of our list members in Ottawa, Canada who has inflammatory breast cancer, and medically qualifies for Herceptin is not able to receive it.

A review of the facts, as we know them now, are in the accompanying copy of a letter from Lee Humble to Hoffmann-LaRoche Ltd. in response to her first letter to them, and followed by their disingenuous response to her first message.

Our question to Genentech is simply, “Is Genentech purposely withholding supply from Hoffmann-LaRoche Ltd. for any reason or reasons which may include trying to put pressure on Health Canada to approve the use of Herceptin?”

We look forward to your response. A copy of this e-mail is being sent to the inflammatory breast cancer research group.

June 29th

Dear All,
I have been having trouble with high blood pressure these last few days and am very dizzy and weak. My onc called here last night to ck on me and we talked a bit about my fight to get Herceptin here in Canada. He is approaching OHIP (my provincial health provider) to get them to fully fund sending me to the USA for Treatment with Herceptin.In his opinion I am a prime candidate and he is worried that I will not be able to get the drug here until after I am finished taking the Taxotere. Of course the whole object here is to get the two drugs together so they work synergistically. OHIP has funded out of country care often for cases where time is of the essence and the recommended treatment is not available in Canada. He also will pressure his contact in the drug company to ask what happens with their reserved drugs for present members of the compassionate use program who die. Like … can his patient now get that supply? If not why not? If that works then I would not have to leave home for treatment and no cost would be incurred. I was taking Taxotere every three weeks but we noticed that 10 days after each chemo the skin mets started reddening and swelling in the skin appeared. We had a talk and the result is that starting last Thursday I am having Chemo every week. Instead of reducing the dose load to 33% which would be indicated by the change from three weeks to one, he is giving it at 40%. So we hope to accomplish two things here … zap the fast growing cells more often and with a slightly higher dose.

My daughter and granddaughter (3 months old yesterday) are visiting. It’s so great!!!

Lee in Ottawa Canada

Genentech responded to Owen’s e-mail and assured us that there was an adequate supply of Herceptin but that Roche Canada had not asked for extra supplies. They also gave us the name of the person to contact at the parent company in Switzerland.

Owen and Anne sent her about a zillion messages on this saga. She replied that the parent company did not control Compassionate Use programmes in individual countries but thanked us for making them aware of the Canadian situation. Somewhere in the messages that were sent was a suggestion I had made of the possibility of organizing a North American boycott of the non prescription products of this company. I said that no self respecting woman would ever again buy these products once they knew how Canadian breast cancer patients were being used. I like to believe that this hit a nerve. We were becoming a public relations nightmare for arms of the drug company in three countries.

Friday June 30th 1999
Owen sent me mail saying “thanks for faxing the letter from the drug company.” I told him I had no idea what he was talking about. He faxed me the following letter addressed to me but sent to him by fax.

Dear Ms. Humble:

Thank you for your letter/e-mail dated June 21, 1999 regarding Hoffman-La Roche’s decision to no longer accept new patients into the Herceptin Special Access Program. Your concerns are noted and are being acted upon.

Let me assure you that Roche Canada takes the concerns of patients and physicians very seriously. The decision to no longer accept new patients into the Herceptin Special Access Program was made to ensure that treatment for those patients currently enrolled would not be compromised, given the quantities of Herceptin 150 mg in our Special Access Program inventory.

We are pleased to inform you that Herceptin has been made available for new Patients starting July 1st, 1999. Herceptin will be provided free of charge to all new patients enrolled in the program prior to Friday, August 13th, 1999. Please note, that all patients enrolled prior to August 13th, 1999 will continue to receive Herceptin free of charge until Notice of Compliance (NOC). As of NOC, the Herceptin Special Access Program will be discontinued, as patients will have access to commercial product.

As of August 16th, 1999 Herceptin will be made available to new patients by sale through a separate Special Access Program. These timelines are intended to satisfy the urgent needs of patients, and allow agencies sufficient time to set aside funding for Herceptin.

It is important to note that the responsibility of providing new therapies to patients is a shared one. There are three critical sectors, each with definitive accountabilities, responsible for bringing new therapies to Canadian patients.

* The pharmaceutical industry develops and manufactures new products
* Health Canada reviews the scientific evidence in support of new products and gives the manufacturer the authority to distribute new products in Canada.
* Provincial and other funding agencies ensure that adequate funds are set aside to cover the costs of new products introduced into the health care system.

Each of these sectors should be held accountable for delivering on their responsibilities. The pharmaceutical industry cannot make up for the deficiencies in Health Canada or the Provincial funding agencies.

At this time, we have received no formal indication from Health Canada as to when the review of Herceptin will be complete. It is important to know that as of July, Herceptin will be in it’s 10th month of review. In the US, Herceptin was approved in 5 months. Health Canada’s own performance target, which they aim to achieve 90% of the time is 6 months. In a recent communication from Health Canada we were informed that the department was satisfied with the progress of the Herceptin review. We believe the progress of the review has taken longer than necessary.

Should you wish to be treated with Herceptin, please contact your physician and ask him/her to contact Dr. N____ G____ (telephone ______). When we receive authorization from Health Canada to release Herceptin to your physician, we will expedite its shipment.

With this program we believe we are doing our part in ensuring that Canadian breast cancer patients are not denied this important new treatment.

Once again, thank you for your letter and best of luck with your continuing therapy.

Sincerely
Hoffman-La Roche Limited

and then signed by the medical director

We figure that the lady in Switzerland made a heated call to the Canadian company something to the effect of saying “WHAT ARE YOU GUYS DOING!!! Get these people off our backs!” Why else would they fax this letter to Owen? (I got the original delivered to my door by special courier on Monday morning.)

As soon as I read this letter on Friday I had my oncologist paged. He was amazed and phoned the Toronto number right away and then called me back to come into the clinic to sign papers that Toronto had faxed to him. I rushed over because it was closing time at the clinic. I had to read and sign 10 pages of consent forms which were then faxed back to the drug company doctor in Toronto.

My oncologist kept shaking my hand and hugging me. I wanted to scream my relief to the world. I don’t even remember the drive home.

With confidence that the Herceptin would prolong my life expectancy, I decided to get married! After thirteen years of togetherness Charles Smith and I got married in our backyard on July 4th, 1999. The bride wore a bandana over her baldness and carried flowers picked from the garden two minutes before the ceremony. The groom wore a clean golf shirt and a pair of walking shorts that he ironed himself. Our friends Peter and Judy were witnesses. There were no guests except for a few neighbours who peeked out their kitchen doors. We told our families about it after the fact. This is the reason you see me referred to as Lee Humble and then Lee Smith in this story!

July 13th 1999

I had my first Herceptin treatment.

Thank you Owen and all those of the IBC Research Foundation who helped me and numerous other Canadian metastatic breast cancer patients. I may owe my life to you.

In fact many others thank you as well. I received this comment in a letter from a fellow IBC Warrior in Canada on October 7th 1999:

“Health wise I’m on Herceptin weekly, thanks to you and the window that was opened from July 1st to Aug. 13th.”

I do believe that I will stop my story here. Perhaps another volume could be written on the push to get the Provincial Health Ministers to approve funding in a timely fashion. Suffice it to say that political mumbo jumbo and bungling is the same the world over! Interim funding was supplied so that no patient was left in limbo land without the drug.

October 8th 1999

I am considered NED (no evidence of disease) but continue to receive Herceptin each Tuesday. This will be my weekly routine until such time as the disease is seen to progress.

I am slowly recovering from the side effects of the Taxotere and the Decadron which were stopped September 7th. I still think I look like “Pig Woman from the planet Zenon” but am getting some definition back in my face and can actually see that I do have a neck again! I am hopeful.

Someone told me that NED should stand for “no expiry date”.

Part 3 of Lee Smith’s story about her struggle for the approval of Herceptin in Canada.

February 24, 2000

Is it at all possible that we have made a difference? Could it be that the fight for approval of Herceptin in the summer of 1999 had anything to do with the Science Advisory Board having recently “conducted a special ‘mini-inquiry’ into the branch’s drug-review process”? Might this have been prompted by the opposition party health critic enquiring as to why the Feds were being so slow?

Maybe our mini-war last summer was a tiny straw on the camel’s back.
Lee

Drug approval system under fire
Process needs overhaul to give Canadians more input, health minister told

Monday Feb 21, 2000
Mark Kennedy
The Ottawa Citizen

The federal government should dramatically overhaul its drug regulatory system so that Canadians have more say in whether proposed products are approved for sale, says a report prepared for Health Minister Allan Rock.

It notes the reforms could even include a provision to require pharmaceutical companies seeking regulatory approval for their drugs to defend the products as safe and effective at public hearings. Currently, drug companies submit their applications to the federal Health Protection Branch (HPB) in confidence and their request is reviewed privately by regulators.

That process has led to controversy and a decline in public confidence over whether the approved drugs are safe. Critics have complained consumers have no say in the process. Even some of the regulators have publicly claimed that they faced surreptitious industry pressure to approve drugs without sufficient scientific review.

Now, Mr. Rock is being urged by the Science Advisory Board to shine a light on the approval process. The board, led by astronaut Roberta Bondar, is a special committee of independent experts Mr. Rock created more than two years ago to review the operations of the beleaguered health-protection branch. In the last few months, the board conducted a special “mini-inquiry” into the branch’s drug-review process.

The thrust of the board’s observations are contained in an interim report completed four months ago and obtained by the Citizen. The document concludes the “transparency” of the drug approval process is responsible for much of the “friction and controversy surrounding the work of the HPB, and the consequent decline in public confidence.”

“Unless the scientific work of the HPB can be seen to be comprehensive, rigorous, adequately funded, and free from external influences, the current low level of confidence might dip even lower.”

The board is completing its final report, which will be presented to Mr. Rock.

In addition to calling for more openness, the board will urge the government to revisit its contentious “cost-recovery” policy in which pharmaceutical companies pay user fees every time they submit a new drug for approval. Critics have alleged this policy has prompted the drug companies to assume they should get faster service from regulators, even if it means a less rigorous review of safety considerations. Drug firms deny that charge.

Still, the firms complain it often takes too long to get their products approved, and some patients awaiting new drugs already sold in other countries have similar complaints. Thus, the board has concluded Mr. Rock’s department should increase government funds for the regulatory branch, so it can clear its backlog and review drug applications more quickly.

The board examined how the U.S. approves drug applications and discovered the Food and Drug Administration adopts a much more transparent process. There, each new drug application is potentially subject to a review in public. “In Canada, in contrast, the review process is internal to HPB, with high levels of confidentiality attached to the information supplied in support of the application.”

The board notes that in Canada, while the industry has indicated it is open to making the process more transparent, it also “seeks to protect its commercial intellectual property rights.”

“No observer can fail to be struck by the fact that the same companies that insist on secrecy when it comes to their applications in Canada are perfectly prepared to send senior scientific and management representatives to public hearings in Washington … to present details of their research and to answer detailed questions on the science supporting their applications to the FDA.”