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Feature StoryHerceptin Heroines and the Judicial Review of PHARMACJudicial Review vindicates efforts of Herceptin Heroines, April 7th. Our Herceptin Heroines touch hearts as court battle with PHARMAC continues, Feb. 15th. Herceptin Heroines await outcome of the Review - read more ... The Judicial Review - What is it? The Review will examine the process by which PHARMAC arrived at their decision. The Judicial Review was officially launched on July 1st and this page will keep you up to date with developments on progress. The fund raising is now over and the Herceptin Heroines would like to thank all of those who contributed to the Herceptin Fighting Fund - please visit the Herceptin Fighting Fund page on our site. On this page: UPDATE 7 April "We are pretty happy with the outcome which effectively orders PHARMAC to revisit afresh the decision not to fund 12 months of Herceptin for women with early stage HER2 positive breast cancer." Justice Warwick Gendall found that PHARMAC had not consulted with parties likely to be affected by the decision not to fund 12 months Herceptin and indicated that the consultation about this should be undertaken "with speed." Chris says the women are now waiting to see how a government agency interprets the notion of "speed" and sees this as an opportunity for PHARMAC to get alongside the various stakeholders. "I have been amazed at the number of text messages, emails and phone calls myself and the other 7 women have had since the decision was released last Thursday (3 April). We are all very relieved that the Judicial Review is over but we know that there is still more to do if women are to get the 12 month regime." On behalf of the other 7 women, Chris would like to thank the public, friends, family, lawyer Alison Douglass, QC Helen Cull, BCAC and the oncology community for their support during this campaign. UPDATE 5 March Judge Warwick Gendall presided in the Wellington high court in Wellington. He commented on the cost of Herceptin being a major factor in the decision making, saying, “It’s abundantly clear if it was a cost of $50.00 it would have been fully funded.” Counsel for the women said PHARMAC fell short of its statutory obligations by failing to consult with consumers about its decision not to fund 12 months, arguing that a constant theme of blurred boundaries between PHARMAC’s clinical and economic evaluations resulted in the clinical risks and benefits of Herceptin being confused with cost constraints. The failure by PHARMAC to take into account relevant considerations, namely to receive objective advice from its committees, is also challenged by the plaintiffs. An Official Information Act request by the plaintiffs revealed that in June 2007 PHARMAC had applied to Medsafe to register the cheaper 9 week regimen, but this was declined because of insufficient evidence. Medsafe had registered the HERA-based 12 month treatment in March 2006. The women seek to quash PHARMAC’s decision to fund 9 weeks and not 12 months of treatment. Judge Warwick Gendall’s deliberations may take some time. The decision by PHARMAC to fund 9 weeks of Herceptin is closely linked to their decision not to fund 12 months. The plaintiffs claim that PTAC and CaTSoP were directed by PHARMAC to consider criteria beyond their statutory function. They were unable to provide objective advice to PHARMAC on pharmaceuticals and their benefits. By day six of the hearing Justice Gendall acknowledged the magnitude of the case and his expectation that it would take him some time to consider all the material and make his decision. He said he was grateful to the care, thoroughness and quality of both counsel presentations and observed that health funding is very often a matter of life and death. The eight Herceptin Heroines hosted a dinner and auction event in Auckland on February 23. MC Jools Topp and entertainers The Beat Girls headlined the evening, UPDATE 11 February Herceptin Heroines spokesperson, Chris Walsh, said, “The lives of thousands of New Zealanders depend on the decisions PHARMAC makes. We’re becoming increasingly concerned about the processes PHARMAC follows and the lack of clarity and transparency around its decision making. “We have undertaken a Judicial Review because we are concerned about how PHARMAC managed the advice it received about Herceptin, the evidence it reviewed, and how its actions stacked up against its obligations as a crown entity. “Internationally PHARMAC is out on a limb, on its own with this one. 24 other OECD countries now fund the proven and recommended Herceptin treatment regime of 12 months. We think it’s time PHARMAC was asked to explain why it won’t give us the same. “The odd thing is, PHARMAC is so uncomfortable about the decision, that it has taken the unusual step of funding a clinical trial to prove it was right. Our argument is that New Zealanders should be receiving 52 weeks treatment until 9 weeks is shown to be an effective alternative. “There are a large number of new, targeted therapies on the horizon and it is our belief that the issues, delays and inconsistencies seen with Herceptin simply can’t be allowed to happen again with a different treatment, or another group of patients.” Walsh said oncologists know the 12 month regime provides the best chance for women to beat this type of cancer. Sadly, they can only offer 9 weeks and advise women to take 12 months if they can afford it. Ms Walsh said many women are taking the 9 weeks offered and then fundraising to pay for as many extra treatments as they can. Others do not have resources to fundraise. “Unfortunately, taking a government agency to court isn’t cheap and we’re constantly trying to find funds to continue fighting on behalf of women with breast cancer, as well as New Zealanders who could find themselves in a similar position in the future.” UPDATE 30 January 2008 For further information please contact Chris Walsh on (06) 367 3930 or 021 0599553. UPDATE 1 November 2007
James is so outraged by the lack of government funding for Herceptin that he decided to put on a dinner to help the eight women with their Judicial Review proceedings against PHARMAC. James was blown away by the support from sponsors who donated goods and services towards the evening dinner and the staff who gave their time. Sponsors included Stop Banks, Peter Vaughn Transport, Randwick Meats Ltd, Fresh Foodservice, Nautilus Wines in Marlborough, Asian Food Specialist, Lake Chalice Wines, Devonport Chocolates, Dominion Breweries, Royal New Zealand Ballet, Rimu Grove Winery, Hiremaster, The Print Room, and Freixenet. The dinner raised $5,000 and Chris Walsh, spokesperson for the Herceptin Fighting Fund, was overwhelmed by the gesture. “For James to take on this and organise it shows that Herceptin is a ‘live’ issue that continues to impact on the lives of women every day in New Zealand. The generosity of sponsors is amazing and the willingness of people to help keeps us motivated to continue this campaign.”
Tickets for the dinner were pre-sold weeks ahead and about 70 people attended. The food was fabulous and the guests had a brilliant night out enjoying the ambience of the restaurant and the company of a wide range of people. The Herceptin Fighting Fund is still looking for more funds to pay for the legal costs which will see them in court on 11th February 2008. If you have any ideas for fund raising please contact Chris Walsh or Sue Ellis. UPDATE 18 October 2007 UPDATE 21 September 2007 The delay does give the women more time to fund raise to cover the legal costs. Planned fund raising includes a dinner at the Monsoon Poon in Wellington on 1st November organised by Linda Bennie's son James. Along with the donations that keep trickling in and the initiatives in Nelson (see below) Chris hopes that most of the money to cover legal costs will be raised before the court date. UPDATE 16 September 2007 The five fashion stores were joined by the local shoe shop, and hairdressers and pharmacies did the models' hair and make-up free of charge. 'The response to the show has be 'I would like to thank these wonderful people for their hospitality,' said Chris. 'It was also great to meet other women with HER2 positive breast cancers from the Nelson area. It is so important to connect and be able to support each other. The fashion show raised community awareness of the issues for these women and prompted alot of media interest. We are so grateful to have people like Debra who are willing and keen to promote the cause and to help women with their Herceptin funding.' 'We are a strong network and fighting for the greater good.
I am passionate and determined to do all that I can to help all the women
that need Herceptin.'
UPDATE 11 September 2007
UPDATE 29 August 2007 Spokesperson for the group, Chris Walsh, expressed disappointment at the decision saying, "We were hopeful that the judge would give some direction as to policies and procedures administered under the Cancer Exceptional Circumstances by PHARMAC which we feel are flawed and disadvantaged us." Much of the legal tenure of the case rested on whether or not the plaintiffs had a position to preserve under the law and the judge found that they didn't, given that 12 months of Herceptin was not publicly funded by PHARMAC. The decision to deny interim relief for the plaintiffs, while disappointing, is not the end of the matter. Justice Mackenzie suggested that the avenue of the plaintiff's applying for 9 weeks funding could be explored. Chris says the next steps will be to consider how the plaintiffs might follow up on the suggestion from the Judge to seek funding for 9 weeks but also progressing the substantive hearing where the decision not to fund 12 months would be examined. The Judge added thatother important issues would need to be addressed in the substantive hearing but it was not his place to comment on those. The substantive review will have implications for all NZ women diagnosed with HER2 positive breast cancer and Chris says. "This will take longer in court and requires more fundraising to meet the legal costs, so hopefully people will continue to support us to meet his huge challenge on behalf of all NZ women.” The 8 plaintiffs feel very strongly that the 9 weeks treatment of Herceptin should not be adopted now as the standard of care in NZ when it is an unproven regimen and 24 other OECD countries fund for 12 months. Timetabling for the substantive hearing will take place soon. UPDATE 9 August 2007 One of the most interesting criteria discussed in court that caused a circular argument was the issue of who would fund the Herceptin. The criteria state that the DHB must agree to fund the treatment, but the DHB cannot fund the treatment unless PHARMAC approves its inclusion in the schedule. The opposition say that the DHB have responsibility for funding under the Cancer Exceptional Circumstances (CaEC), not PHARMAC. It is submitted that PHARMAC has deliberately prescribed the criteria in such a way that it is circular, contrary and defeats its statutory function and discretion. Another issue was the appeal process the plaintiffs went through when seeking an appeal to the decision which is merely an in house series of reviews, decisions and discussions with no independent scrutiny or proper appeal or review procedures being exercised. The hearing lasted one and a half days and at the end, the Judge reserved his decision. Spokesperson Chris Walsh said that they expect the decision will be fairly soon and added that the group were keen to move things on and get to the substantive hearing where the 12 months of funding for all NZ women would be challenged. ' We are not expecting to gain much on the interim relief,' said Walsh. 'We had to go through the process to 'secure our position', and get this into court. The substantive hearing will challenge the decision not to fund 12 months and is very important for all NZ women because we cannot allow the 3 treatments to become the standard of care without challenging it. Dates are being negotiated at the moment for the substantive hearing which we expect will be this year.' UPDATE 2 August 2007 A week after the interim hearing, a timetable will be set for the hearing of the substantive Judicial Review. This review will deal with the wider implications of PHARMAC’s decision not to fund the 12 months of Herceptin treatment. Walsh adds, ‘This review will have implications for all NZ women who are diagnosed with HER2 positive breast cancer. At the moment women are being offered a sub standard treatment regimen of 3 treatments as opposed to the international standard of 17 treatments. We don't want the sub standard treatment to become the 'norm' and believe that NZ women deserve better.’ Meantime, it is one step at a time and Monday is the first hurdle to jump. Walsh says, ‘We are in a win-win situation because we will know that we are doing everything in our power to get a better deal for women with HER2 positive breast cancer. We are hopeful that with the legal scrutiny being applied to measure statutory obligations against decisions made by PHARMAC, there will be changes that will benefit all New Zealanders who are unfortunate enough to be diagnosed with cancer. ‘Thank you to all our supporters out there who have donated funds to help with our legal fees (still trying to reach our target) and to all women who are affected with breast cancer and their families and friends. We have a very dedicated and hard working legal team fighting hard for us and we feel blessed and very fortunate to have such support. In the words of Simon and Garfunkle ‘silence like a cancer spreads’. If we say and do nothing they think it’s ok. We can't remain silent. We can't let the cancer spread.’ UPDATE 19 July 2007 Several media contacted Chris on Monday wanting to know what was happening with the JR. They were reminded that the first day in court is 6th August. This week has been quiet as we recover from the activities of the past few weeks' fund raising. We have had several donations from members of the public and the word is spreading as indicated by the places people have been donating money from. From the deep south in Dunedin to the warmer climates of Motueka and Whangarei, people have donated what they are able to. One cheque received had a card saying 'thinking of you' and another a hand written note starting with "Dear people, This is a disgrace.Women shouldn't have to be doing this" and encouraging us with our fight. We are very grateful for the contributions and support and say a heartfelt 'thankyou' to all of you. We have about ten thousand dollars to go before we reach our first target. The fund raising continues for the Herceptin Fighting Fund. On Sunday 26th August, come and try out Café Bastille's new degustation menu, 5 courses with wine match. The cost is $100 per person and the majority of this goes to help the Fund. Café Bastille is located at 16 Marjoribanks St, Wellington – if you want to know some more about the restaurant and their menus see www.bastille.co.nz Details about purchasing tickets for the fund raising dinner will be available on this website soon. UPDATE 10 July 2007 Auction items were donated by local businesses with some donors as distant as Otago. Two tickets for the upcoming WOW (World of Wearable Arts) in Wellington fetched the top bid of $360.00. This was closely followed by an original painting from Helen Jury which drew much attention and went for $340.00. A beautiful hand painted porcelain doll fetched $70.00 and a signed copy of Pinky's readings for weddings went for $70.00. A case of Olssens chardonnay from Bannockburn fetched $180.00 and hot bidding ensued for dinner vouchers at Wellington restaurants Citron and Dockside. Toops wholesalers put together a basket and other local businesses like Michael Hill Jeweler, Taita Pharmacy, Kooky fashions and Rodney Wayne hairstylists donated goods. Pack N Save stores in Lower Hutt and Petone have been very supportive and donated all the nibbles for the night. Hutt News, News Talk ZB, and the Breeze all advertised details of the event. The Herceptin Heroines wish to express their sincere thanks to all those who donated items for auction and to Pinky for her generosity and hard work encouraging the punters to bid heartily for auction items. An estimated $10,000 was raised from ticket, auction sales and donations. The Heroines have another $10,000 to raise to reach their target. Heroines spokesperson Chris Walsh would like to acknowledge and thank all those who have donated to the Herceptin Fighting Fund. ‘Public donations are coming in and we want to thank people for their generosity and support. The Mandy Carter petition requesting that Government fund 12 months of Herceptin is currently in circulation. It is raising public awareness about the issue and is getting lots of support too. Our little village here at Waitarere Beach has so far collected over 250 signatures and that's just through one outlet at the 4 Square. The staff ask everyone who comes in if they would like to sign and people are very willing to support it.’ Ms Walsh said that a full day on 6 August has been set aside in the Wellington High Court to hear the case. UPDATE 5 July 2007 'John Banks has put our details for donating to the fund on the Radio Pacific web site. This is a very serious undertaking for all the women concerned and not, as one radio interviewer questioned, a 'publicity stunt'. 'There is no backing from any drug company as another interviewer questioned and all the money raised so far has been by fund raising and donations from the public. We are still well short of the money for legal fees and hope the public, or a kind benefactor, will support us. This Judicial Review seeks to get 12 months as the standard of care for all NZ women with HER 2 positive breast cancer who need Herceptin.' Background to the Judicial Review New Zealand government pharmceutical funding agency PHARMAC has decided to fund only 9 weeks of Herceptin (as of July 1 2007) for our women with early stage HER2 positive breast cancer. ‘9 weeks of Herceptin treatment has not been proven to be effective,’ said Libby Burgess, Chair of BCAC. ’Women will still be told by their cancer specialists that 12 months’ Herceptin is the recommended course of treatment for early HER2 positive breast cancer. The safest response to PHARMAC’s 9 weeks of funded Herceptin is to view it as a partial subsidy. It is certainly not a substitute for the international standard of 12 months’ treatment. 'New Zealand women will continue to wonder why their lives are valued less than those of women in the 24 OECD countries now funding 12 months.’ Press Release July 1 2007 Spokesperson for the group of eight plaintiffs, Chris Walsh says “this is a significant legal milestone in New Zealand history. Never before has the Government’s drug funding agency been challenged at this level about how they make their funding decisions. Let alone by a group of women”. The filing of documents coincides with the commencement of funding for Herceptin on 1st July for women who meet the criteria to receive 3 treatments of the life-saving drug. Pharmac have agreed to fund a shortened course of Herceptin but Walsh claims the regimen of nine weeks is unproven and “sets a standard that is below what 23 other OECD countries have adopted”. Walsh adds, “The review can’t come soon enough. NZ women’s lives have been put at risk through poor decision making and stalling tactics on the part of Pharmac who seem more concerned with saving more money than optimal health outcomes for women with breast cancer”. Walsh says that about 320 women a year would benefit from having Herceptin and the 12 month regimen is the world-wide standard of treatment. “We have one of the worst records in the world for deaths from breast cancer and new treatments should be made available to improve our chances of beating this aggressive form of breast cancer.” The women involved in the Judicial Review are all funding their own Herceptin as well as fund raising to pay for the legal costs for this review. “This is not a level playing field. We have sausage sizzles and rely on our family and friends to help raise the money. Pharmac have extensive resources at their fingertips to mobilize against this court action”. Walsh says that the motivation for the eight women is largely driven by a sense of unfairness and a desire to see NZ women given the same opportunity as other women to live longer. The date for the hearing is set for 16th July. Further information can be accessed by contacting Chris at 06 367 3930 or 021 0599553 and by email.
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