Blue Jackie: Financial Review Debate — In Committee 
Blue Jackie: Financial Review Debate — In Committee 
[Volume:637;Page:7927] 
Dr JACKIE BLUE (National) 
: 
 I am disappointed that the Minister of Health is not in the Chamber this evening. 
The CHAIRPERSON (H V Ross Robertson) 
: The member cannot refer to the absence of another member. Each and every one of us at different times has other matters to attend to. 
Dr JACKIE BLUE 
: I apologise. The Minister has been strangely silent on the issue of Herceptin funding. The women of New Zealand want to hear from him. They want to know what he is thinking. The only voice we have heard to date is that of Pharmac and I wonder whether Pharmac speaks for the Minister of Health. I know that women with breast cancer want to know the answer to that question. 
To date Pharmac’s actions on whether it will fund Herceptin have been totally hypocritical. Midway through last year it stated that it wanted to consider only data that was peer reviewed and published in an international journal. That is fair enough we might say even though many countries did not feel the need to wait for published material. Indeed many countries started funding Herceptin from as early as a year ago on the back of earlier trials and of data that had been presented mid-year at a conference. Pharmac wanted to see that data published in peer-reviewed material and it got its wish—very recent data did appear in an internationally acclaimed journal. 
But what has happened? Pharmac has absolutely ignored the published data stating—unbelievably—that there is still insufficient evidence as to the frequency and timing of how Herceptin should be used. Rather Pharmac has done an about-face and has conveniently cherry-picked unpublished data to make the case for a short 9-week course of Herceptin rather than a proven 12-month course. I understand that Pharmac is going around doing a roadshow and showing a PowerPoint demonstration that presents its own in-house analysis of non-published short-course data in order to make its case. I have a bit of advice for the Minister of Health and that is to get independent expert advice on Pharmac’s in-house analysis. The Minister could be very surprised. 
My colleagues will be very interested to know that Pharmac’s recommendation for a short 9-week treatment is based on the FinHer trial which involved only 232 women. Half of those women received Herceptin and only 54 of those actually received the combination Herceptin regime that Pharmac is proposing in this clinical trial. On the back of a 12-month Herceptin trial in which over 12000 women participated with proven results to back it Pharmac has thrown science to the wind and now wants to back a regime that was used in only one trial that involved only 54 women—the results of which I might add were not statistically significant. I will say that again—it is an important point—Pharmac proposes to use the results of an unproven trial that involved only 54 women as opposed to the proven results from trials that involved 12000 women to back its case. It is a case of 12000 women versus 54. It is astonishing—I am sure members will agree on that. This proposal flies in the face of international opinion and is completely contradictory to Pharmac’s own original requirement that any funding for new medicine would be based on robust clinical evidence before being considered. 
Pharmac wants to throw desperate women with aggressive breast cancer a few crumbs in an unproven cut-price regime while women in Australia Finland the UK and Canada along with women in 19 other OECD countries are already gaining the benefits of a 12-month course. If the trial gets off the ground New Zealand women will be part of an experiment the results of which will not be available for at least 5 years. That will mean 5 years of women possibly taking an inferior regime before that was discovered. I wonder whether the Minister of Health has thought about the very serious ramifications of that scenario. 
There is a very interesting twist in all of this in that Pharmac is prepared to invest $3.2 million of what it calls “spare administration money” into this trial. Yes it has found some loose change to throw at Kiwi women. We should remember that this is an organisation that comes under budget regularly and last year it came under budget by over a staggering $19 million. Pharmac is an organisation that is more interested in not spending its budget and it is not at all interested in increasing New Zealanders’ access to medicines. Time and time again we have seen Kiwis’ lack of access to medicines and access to Herceptin is just another example. 
There is a question that troubles me and I hoped the Minister could take a call and answer it. The question is whether the $3.2 million of taxpayers’ money that Pharmac has found rattling around in its administration budget will be going to fund a clinical trial in New Zealand for New Zealand women or whether it will end up overseas and not be used for Kiwi women at all. I hope that question can be answered; it is one that has been bothering me. I do not think Kiwi taxpayers would be pleased to find out that their money was going to fund an international trial that did not involve Kiwi women. 
A clinical trial is designed to answer specific scientific questions and I do not have a problem with that if women are recruited freely and informed and if they give consent. But what is very unclear in all of this is what women who do not want to take part in the trial will be offered—that is what women who are off-trial will be offered. It seems to me from the noises that Pharmac is making that it is highly probable that women who are off-trial will be offered not the international best practice 12-month course but rather the short course. If that is the case we are in a very murky situation indeed. Women will not be entering the trial of their own free will. These women who are desperate to have Herceptin will be coerced in the hope that with the toss of a coin they will be lucky enough to get the long-arm 12-month treatment. Each and every woman will be hoping that Lady Luck is on her side. 
I have one word for a trial in the form I have just described—where women who are off trial receive the unproven short course—and that word is “unethical”. I would be very surprised if an ethics committee would approve a trial in that particular format. But who knows? Pharmac’s tactic so far seems to be one of bullying. It might yet get its own way. 
Members might ask what our own experts say about this situation and what our own oncologists advise. CaTSoP which is Pharmac’s cancer subcommittee reported in its November 2006 minutes that as a committee it had more confidence in the validity of the 12-month treatment. Its recommendation was for the 12-month regime. To read the CaTSoP minutes makes it clear that the experts were more comfortable with and preferred the 12-month Herceptin regime. 
Let us look at a scenario whereby this clinical trial gets ethics approval and begins in New Zealand and the off-trial option is the unproven short course. I know what I would do if I were one of those women. Yes I would feel absolutely railroaded. Yes I would feel very angry. But I would be desperate enough to go into the trial. I would of course be hoping that Lady Luck was on my side that the roll of the dice would be on my side and that I would get the proven long-arm 12-month treatment. If I were unlucky and did not get the 12-month course but drew the short straw by getting the short course I would do everything in my power after the course was completed to self-fund the remaining 9 months of Herceptin. And many other women would do the same thing. If in time there were a cheaper generic version of Herceptin available for women in this country to bring in themselves they would do it in droves. The results of any trial would make a farce of it. It would become a complete joke. The results of the trial would be contaminated by women who left the trial at its completion to self-fund and have the remaining 9-month course and any results would be laughed at by the scientific community. The trial would have no credibility. 
The Minister of Health Pete Hodgson in response to a question I posed to him in the House said he would take the views of our experts who are our oncology community. I seriously urge him to do that now. He needs to do it for women. He needs to start advocating for women in New Zealand with breast cancer.