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Revised: 14 May 2013

Media Releases for 2006

9 Oct 2006 Guilty plea in medicines case - Ministry
18 Jul 2006 New licensing rules for industrial hemp take effect on August 1
22 Jun 2006 Medical products made from illegally-taken human body parts were not commercially imported into New Zealand.
9 Jun 2006 Man sentenced for retail sales of medicines without prescriptions
26 May 2006 Therapeutic Claims on Goji Juice
8 May 2006 Fines against companies found guilty of selling prescription medicines over the internet
23 Mar 2006 Herceptin (trastuzumab) provisionally approved

9 October 2006

Guilty plea in medicines case - Ministry

IT Pharmaceutical Supplies Ltd (ITP) has pleaded guilty to six charges under the Medicines Act in a case brought by the Ministry of Health's business unit Medsafe.

The case was heard this afternoon in the Manukau District Court, with the company fined a total of $9000, plus costs of $6000 and court costs of $780.

ITP came to Medsafe's attention after New Zealand Customs seized a consignment of medicines en route to Vanuatu. Following an investigation the Ministry concluded that ITP was sourcing medicines from overseas companies in Germany, Turkey and England and then selling them to purchasers in Vanuatu for on-sale over the internet.

The medicines involved were "new medicines" and had not been approved for sale in New Zealand by the Minister of Health, as required under the Medicines Act. The Ministry says that the sale of medicines without this consent from New Zealand is an offence.

Medsafe's Team Leader of Compliance Derek Fitzgerald has welcomed the guilty plea saying that the Medicines Act is designed to protect public health and safety by ensuring consumers receive medicines that are safe, effective and of acceptable quality.

ITP has agreed to no longer sell or distribute medicines, either in New Zealand or from New Zealand, unless those medicines have Ministerial consent.

"If a medicine distributed within or from New Zealand does not have Ministerial consent and has not been evaluated by Medsafe, there is no guarantee that the medicine is safe to use, or that the medicine actually contains what it says on the label".

Even though these medicines were unlikely to be sold to local consumers, Mr Fitzgerald said New Zealand was a responsible member of the international community, and should act to deter residents from selling medicines to overseas purchasers if these sales breached the Medicines Act.

"It appears the medicines concerned in this case were destined for supply to consumers around the world via internet sale," Mr Fitzgerald said.

Medsafe is concerned about the supply of prescription medicines without prescriptions via internet sale as it considers there are real dangers for consumers in this practice, he said.

"New Zealand has a good reputation when it comes to the international distribution of medicines. Companies who use New Zealand as a port of call before selling medicines over the internet are taking advantage of this reputation and are in danger of eroding it if this becomes an established practice," Mr Fitzgerald said.

ENDS


18 July 2006

New licensing rules for industrial hemp take effect on August 1

Commercial cultivation of hemp may become more common with a relaxing of the rules around its production from August 1.

The Ministry's medicine regulatory agency Medsafe will be implementing a new but less onerous regulatory regime for the cultivation, processing and distribution of industrial hemp as an agricultural crop. Those who wish to grow, trade in or process hemp will need to be licensed.

Spokesman Derek Fitzgerald said individuals and organisations would be allowed to grow hemp for industrial purposes and research under certain conditions.

"The new regulations --- the Misuse of Drugs (Industrial Hemp) Regulations 2006 and the Misuse of Drugs Amendment Regulations 2006 --- take into account the low drug content of hemp, which was previously subjected to the same strict controls as those placed on illicit cannabis," Mr Fitzgerald, Medsafe’s Team Leader for Compliance,explained.

"They seek to balance growers’ appeal for practical and reasonable requirements against the need to maintain adequate controls on hemp seed and plants," he added.

The new licensing system covers only industrial hemp, which refers to varieties of Cannabis sativa with low tetrahydrocannabinol (THC) - the psychoactive substance found in illicit marijuana crops – and primarily cultivated for their fibre or seed.

Other varieties of cannabis will continue to be regulated by the Misuse of Drugs Act 1975 and the Misuse of Drugs Regulations 1977.

Hemp fibre is used in the manufacture of ropes, textiles, paper and plastics. Hemp seed oil is used in food, cosmetics and other bodycare products. Hemp derivatives are also used as replacement for petrochemical products or as a renewable energy source.

As a drug, cannabis usually comes in the form of dried leaves (marijuana), resin (hashish), or various extracts collectively referred to as hash oil.

"The new regulations still classify industrial hemp as a controlled drug and consider it an offence to advertise hemp for psychoactive purposes or to supply it to unauthorised persons," Mr Fitzgerald said.

A general licence costs $500 including GST and allows the cultivation, processing and dealing of cannabis varieties approved by the Director-General of Health. A research and breeding licence, on the other hand, costs an additional $150 and permits the cultivation and processing of non-approved varieties.

Under the new regulatory framework, only one general licence is required for multiple activities involving hemp on a single site.

Cultivation licences are granted initially for a year, and may be extended, on application, to three years. Licences solely for processing and distribution of hemp are granted for up to three years.

Mr Fitzgerald said licensees for any industrial hemp crops with THC levels higher than 0.5 per cent may be required to immediately harvest or destroy these crops.

Bare hemp stalks and processed hemp products are exempt from prohibitions in the Misuse of Drugs Act 1975 and the licensing requirements of the Misuse of Drugs (Industrial Hemp) Regulations 2006.

Licences for the import and export of industrial hemp will continue to be issued under the Misuse of Drugs Regulations 1977.

ENDS

To read the Misuse of Drugs (Industrial Hemp) Regulations 2006 and the Misuse of Drugs Amendment Regulations 2006 online, check the following websites after the new regulations come into force on August 1:

www.lexisnexis.co.nz

www.legislation.govt.nz

Questions and Answers:

1. Which varieties of Cannabis sativa are covered by the new regulatory regime?

The new licensing system covers only industrial hemp, which refers to varieties of Cannabis with a THC content generally below 0.35 per cent and not higher than 0.5 per cent.

In varieties grown for use as a drug, THC levels can reach as high as 20 to 30 per cent; these varieties will continue to be regulated under the Misuse of Drugs Act 1975 and the Misuse of Drugs Regulations 1977.

The Director-General of Health will decide on the varieties of hemp permitted to be grown in New Zealand. Growers may make an application for other varieties to be considered for cultivation.

2. Why were new licensing rules for industrial hemp developed?

In the mid-1990s, a review of security issues surrounding cannabis cultivation was conducted and resulted in a proposal for the trial cultivation and processing of industrial hemp.

In 2001, then Minister of Health Annette King approved a two-year trial cultivation of industrial hemp to determine its potential as a commercial crop and the level of control that would be appropriate for such cultivation. That scheme was extended to allow the continued cultivation of hemp while the new regulations were being developed.

In 2003, Cabinet approved the recommendation to develop a regulatory scheme to control activities relating to industrial hemp. In 2004, it approved the issue of drafting instructions for the regulations to govern this.

Government regulators including Medsafe believe that controls should recognise the low drug content of hemp, which was previously subjected to the same strict controls as those placed on illicit cannabis.

3. Will the new regulations – namely the Misuse of Drugs (Industrial Hemp) Regulations 2006 and the Misuse of Drugs Amendment Regulations 2006 – supersede the Misuse of Drugs Act 1975 and the Misuse of Drugs Regulations 1977?

The new regulations cover only industrial hemp. Other varieties of Cannabis sativa will continue to be regulated by the Misuse of Drugs Act 1975 and the Misuse of Drugs Regulations 1977.

The Misuse of Drugs Amendment Regulations 2006 amend the Misuse of Drugs Regulations 1977 and licences for the import and export of industrial hemp will continue to be issued under the latter regulation.

4. The psychoactive chemical tetrahydrocannabinol (THC) is present in all cannabis plant varieties. How will Medsafe ensure that industrial hemp is not used for illegal purposes, and that other forms of cannabis are not cultivated and distributed under the guise of industrial hemp?

The new regulations provide safeguards from possible abuse. Firstly, the Director-General of Health will determine which varieties of cannabis can be cultivated. Applicants for cultivation licences must meet certain conditions with respect to background and suitability.

Licensees may also be required to have their crops tested for THC levels. Results of such tests must be provided to the Director-General of Health. If a test result showed that a crop has a THC level higher than 0.35 per cent or 0.5 per cent, the regulations prescribe different courses of action which may include further testing of, harvest of, or an order to destroy the crop altogether.

The regulations specify possible offences and prescribe penalties, including fines, suspension and/or revocation of licences, for these.

It must also be noted that the THC levels in hemp are generally below 0.35 per cent and not above 0.5 per cent.

5. The new regulations promise a less onerous regime for licensees than the Misuse of Drugs Regulations 1977. How will Medsafe balance the new regime against the interests of the wider community and ensure that hemp seed and plants are adequately controlled?

The new regime still classifies industrial hemp as a controlled drug, and provides adequate controls for the cultivation, processing and distribution of hemp.

First, a licence will apply only to a particular location and specify the activities and varieties licensed to be grown. The location for licensed activities must be safe and suitable for the relevant activity, and at least five kilometres from residential areas unless special permission is given.

Licence holders are also required to keep the hemp secure, maintain records, report on licensed activities to the Director-General of Health, and alert the police and the Director-General of unauthorised activities.

Applicants – either individuals or organisations – must meet certain conditions with respect to background and suitability before they are granted a licence. An applicant or a director or responsible person nominated by an organisation will be subjected to a background check by the New Zealand Police.


22 June 2006

Medical products made from illegally-taken human body parts were not commercially imported into New Zealand.

Initial checks by the Ministry of Health indicate that batches of medical products made from illegally-taken human body parts were not commercially imported into New Zealand.

The Ministry of Health monitors recalls conducted by the United States Food and Drug Administration (FDA) and investigates any issues that may involve New Zealand, says Chief Clinical Advisor Dr Sandy Dawson.

Four recalls were notified by the FDA but only one of these could have involved New Zealand. The recall currently affecting Australia was specific to Australia, the United States and Korea.

Follow-up action identified that the products were not imported into this country.

The Ministry is currently double-checking that products sent to Australia did not find their way to New Zealand.

"We believe the likelihood that any affected batches have been brought into this country is very low but we are double checking with doctors in New Zealand.

"We are not aware of any illegally-removed tissue having been exported to New Zealand."

The illegally-taken tissue exported to Australia was included in various batches of products including Alloderm, Graft Jacket and Repliform.

Links to the relevant FDA information will be made available on the Medsafe website.

These products are not formally approved for use in New Zealand and so they are not covered by the Medicines Act or regulated by Medsafe.

Doctors are able to import these products directly when they believe there is a clinical need.

When doctors import these products into New Zealand they are not currently required to inform any health authorities about this.

"When a doctor uses an unapproved material on a patient we have no way of knowing what was used, due to current regulatory requirements."

The Ministry of Health will be writing to District Health Boards, private hospitals and contacting doctors through their colleges and the Medical Council.

"We will be asking them to inform us urgently and contact their patients immediately if they have privately imported the particular batches of these products."

If any patients have been given tissue from the batches in question they will be advised to undergo blood tests for HIV/Aids, Hepatitis C and syphillis.

New regulations specifically covering tissue will be introduced under proposed new legislation for the first time in New Zealand with the establishment of the Australia New Zealand Therapeutic Products Authority.

The legislation will require such products to be registered before use and for clinicians to report the use of any unregistered medicines, medical devices, cells or tissues to the authority. The use of these products could be tracked if necessary.

Anyone who has had cosmetic or reconstructive surgery in Australia and believes they may have received one of these affected products should contact the surgeon or hospital where they were treated for more information.

If the Ministry of Health becomes aware the affected batches of product have been used in New Zealand we will provide further advice to patients through the specialists and hospitals involved.

For more information please contact:
Nikki Hooper
Media Advisor,
ph: 04-496-2689
or 021 542 467

Links to FDA enforcement reports

28 Dec 2005 FDA enforcement report recall by LifeCell Corp. http://www.fda.gov/bbs/topics/enforce/2005/ENF00932.html

18 Jan 2006 FDA enforcement report recall by Lost Mountain Tissue Bank. http://www.fda.gov/bbs/topics/enforce/2006/ENF00935.html

18 Jan 2006 FDA enforcement report recall by Tutogen Inc. http://www.fda.gov/bbs/topics/enforce/2006/ENF00935.html

12 April 2006 FDA enforcement report recall by Lost Mountain Tissue Bank. http://www.fda.gov/bbs/topics/enforce/2006/ENF00947.html


9 June 2006

Man sentenced for retail sales of medicines without prescriptions

The successful prosecution of an Onehunga man under the Medicines Act sends a strong message that supplying prescription medicines to the public without a valid prescription is illegal, the Ministry of Health says.

Graeme David Heard, 69, who last year pleaded guilty to 29 charges of selling prescription medicines without a prescription, has been sentenced to 200 hours community service in relation to the charges in the Auckland District Court today after a hearing on disputed facts.

Heard has previous convictions for similar offences under the Medicines Act. Financial gain appears to have motivated his scheme.

The scheme involved Heard accessing orders for prescription medicines from a Canadian website, which were forwarded on to a New Zealand pharmacy. The orders were supplemented by prescriptions bearing a forged New Zealand doctor's signature. The medicines were then collected from the pharmacy by Heard and couriered to consumers overseas.

The medicines included lipid-lowering drugs such as atorvastatin (Lipitor) which reduces blood fat levels; COX II inhibitor anti-inflammatory drugs including valdecoxib (Bextra), rofecoxib (Vioxx) and celecoxib (Celebrex); the rheumatoid arthritis drug leflunomide (Arava); and drugs for lowering blood pressure containing nifedipine (Adalat Oris), amlodipine (Norvasc) and quinapril (Accupril).

The Ministry of Health Medicines and Medical Devices Safety Authority, Medsafe, says increased risk of heart attack and stroke, as well as liver, bone marrow and muscle damage, are among the potential adverse reactions associated with some of the medicines.

Medsafe's spokesperson, Rob Allman, says the reason that medicines are classified as prescription only is because of the relatively high potential health risks associated with medicines in this classification. The prescription only classification serves to ensure that consumers get individual diagnosis and advice from a suitably qualified health professional about their health concerns. The risks and benefits of the use of a particular medicine for the consumer can then be properly assessed by the professional before the medicine is taken.

ENDS

Heard has previously been prosecuted and found guilty under the Medicines Act, Insolvency Act and the Crimes Act for offences involving the labeling, importation and sale of new medicines into New Zealand and carrying on business while he was bankrupt.


26 May 2006

Therapeutic Claims on Goji Juice

The Ministry of Health's medicines safety Authority, Medsafe, says therapeutic claims can only be made about products which are medicines and medicines must be assessed for safety, quality and effectiveness before they are placed on the market.

This legal requirement applies to all products including foods such as Goji Juice.

Medsafe is responsible for regulating medicines and other products used for therapeutic purposes. Therapeutic purposes are defined as the treatment, diagnosis and prevention of disease or the modification of a physiological function (such as digestion).

Complementary or herbal remedies that have, or claim to have, therapeutic properties require regulatory approval by Medsafe to comply with the Medicines Act 1981.

Medsafe's principal technical specialist, Dr Stewart Jessamine, says Medsafe routinely follows up complaints about products where therapeutic claims are made.

"Three complaints about the product Goji juice have previously been received. In one instance, advertising material was withdrawn, a further two instances were referred to the Food Safety Authority for investigation because the product was being sold as a food," Dr Jessamine says.

"Medsafe is particularly concerned that such extravagant therapeutic claims are being made about a product that has not been assessed as safe and effective.

"In particular, the sellers of this product appear to be targetting certain communities where health status is a matter of concern and use of such a product with or instead of conventional treatments may be detrimental."

New information about therapeutic claims made as part of the advertising of this product is of interest to Medsafe and we will be following this up.

"For everyone's benefit and to avoid complaints, Medsafe encourages companies to talk to the Therapeutic Advertising Pre-vetting Service before placing any advertisements to ensure they comply with the law," Stewart Jessamine says.


8 May 2006

Fines against companies found guilty of selling prescription medicines over the internet

Three companies and an individual were fined approximately $33,000 in the Hamilton District Court today, after admitting to selling prescription and other medicines to overseas purchasers over the internet and to the advertising the medicines over the internet.

Medsafe's principal technical specialist Dr Stewart Jessamine stressed that buying medicines over the internet is not a victimless crime and can be very dangerous to the health of patients to use prescription medicines without medical advice or supervision.

"Today's sentencing sends a message to New Zealand suppliers that irrespective of where your website is situated, or where the medicines are ultimately supplied from, if the route of supply originates in a New Zealand entity and the sale takes place in New Zealand, you are committing an offence under New Zealand law and may be prosecuted. Medsafe will continue to prosecute those found to be committing similar offences." Dr Jessamine said.

Ink Media Ltd, Ink Electronic Media Ltd, Standard 304 Ltd and one of the companies' directors, Wallace Leslie Waugh, faced numerous charges at a hearing late last year and were found guilty of the charges in February this year.

At today's sentencing hearing Wallace Leslie Waugh and Ink Media Ltd were fined approximately $33,000 in total, with court costs still to be decided. In addition, Ink Electronic Media Ltd and Standard 304 Ltd were also convicted and ordered to pay court costs.

Ian Wallace Waugh, the remaining defendant at the centre of this case, and the son of Wallace Waugh, was absent overseas during the proceedings and a warrant has been issued by the Court for his arrest.

Ian Wallace Waugh was to be sentenced today but his sentencing has been adjourned in the Hamilton District Court to Friday 26th May. Judge MacLean will also consider prosecution costs at the same time.

The charges faced by the three companies and Wallace Leslie Waugh included selling a prescription medicine without a prescription, selling medicines by wholesale transaction without holding a wholesale licence, selling new medicines without Ministerial consent for distribution, unlawful possession of medicines and breaching advertising restrictions.

At the hearing late last year, the court heard the combined enterprise had a turnover of over $10 million from November 2001 to Autust 2003.

ENDS


Background Information

The companies had advertised prescription and other medicines without providing legally required information including potential adverse effects, warnings, precautions and notification of the classification of the medicine.

Through Ink Electronic Media Limited and Ink Media Limited and using a Fijian company, the defendants caused medicines, including prescription and restricted medicines, to be supplied to overseas consumers.


23 March 2006

Herceptin (trastuzumab) provisionally approved

The cancer medicine Herceptin has been provisionally approved for the treatment of some women with early stage breast cancer.

The announcement was made today by the Medicines and Medical Devices Safety Authority (Medsafe).

The provisional consent limits the use of Herceptin to treat women with early breast cancer who test positive for the HER2 gene once they have had surgery and completed their adjuvant (additional) chemotherapy.

Due to concerns that use of Herceptin may be associated with heart damage, the provisional consent also limits the treatment to those women who have a normal heart function before treatment starts and requires women using Herceptin to have their heart function checked by echocardiogram every three months during treatment.

Medsafe's principal technical specialist, Dr Stewart Jessamine, says Medsafe is the first medicines regulatory authority to assess and approve Herceptin as a treatment for primary breast cancer.

The decision to approve Herceptin follows a positive recommendation from the Medicines Assessment Advisory Committee.

"The decision to give provisional consent means that Medsafe and the committee are satisfied that the benefits of treatment outweigh the risks at this stage. This decision has been made on the basis of limited data, and further data examining the overall safety and effectiveness of Herceptin in the long term is required before Herceptin can be considered for full consent," Dr Jessamine says.

As part of the approval process, the Medicines Assessment Advisory Committee considered an interim analysis of clinical trial results including the pivotal HERA study, and other published data. It concluded that treatment with Herceptin significantly reduced the recurrence rate of breast cancer compared to women who received no additional treatment.

The HERA study found that after 12 months, the recurrence of HER2 breast cancer was reduced by 9% after treatment with Herceptin (86% disease-free on Herceptin + standard adjuvant chemotherapy vs. 77% disease-free following standard adjuvant chemotherapy).

Another study includes a small number of women who have been followed up for up to four years. This study has reported that treatment with Herceptin in addition to standard adjuvant chemotherapy reduced the recurrence of HER2 breast cancer by 18% (85% disease-free on Herceptin+standard adjuvant chemotherapy vs. 67% disease-free on standard adjuvant chemotherapy).

Answering the question about whether preventing breast cancer recurrence also prevents premature death is more difficult at this stage. One study found a 4% increase in survival rates at four years (91% survival of those treated with Herceptin at 4 years compared to 87% for those with standard treatment). However this study examined data at four years for less than 200 patients, which limits our confidence in the results. The range of survival rates from this study could be as low as 0.6% increase in survival or as high as 9%. However, the pivotal HERA study showed no significant difference in survival rates for those treated with Herceptin at 2 years follow-up.

In addition to demonstrating benefits, it was noted by the committee that research also demonstrated that use of Herceptin was associated with significant side effects. Of most concern was the finding that up to 3% of women developed severe heart failure while being treated with Herceptin.

"Due to these concerns the committee recommended that careful monitoring of heart function be undertaken as a condition of the provisional approval", Dr Jessamine says.

"Before the committee is able to consider an application for full approval of Herceptin the manufacturer has been asked to provide the committee with further safety and efficacy data as it becomes available, including data on long-term survival after treatment."

The Medicines Assessment Advisory Committee (MAAC) is a Ministerial advisory committee consisting of clinicians and experts in a range of specialties.

The members of the committee assess data on the safety and efficacy of medicines independently of Medsafe. Dr Jessamine wished to take this opportunity to publicly thank the committee for the professionalism they bring to the task, and the time they invest in evaluating medicines applications.

"I believe that the skills we apply when considering the safety and efficacy of medicines are up there with the rest of the world, and that it is good to see that a small regulator, such as Medsafe, can in the right circumstances be the first to assess and come to a conclusion about the safety of a new medicine, such as Herceptin."

ENDS

Lucy Taylor
Media Advisor
Ministry of Health
04 819 6882
027 207 1406


Questions and Answers

What is the Medicines Assessment Advisory Committee?

The Medicines Assessment Advisory Committee (MAAC) is an expert advisory committee established under the Medicines Act 1981 to provide advice to the Minister of Health. The Committee's role is to assess the safety, quality and efficacy of new medicines and advise whether the products meet the required standards. Medsafe provides secretarial services to the Committee. The Committee's members have a broad range of expertise including clinical pharmacology, psychiatry, oncology, general practice and biostatistics. The Committee uses both Medsafe and International guidelines as the basis for their assessment process.

What is the role of Medsafe in the medicines approval process?

Medsafe (the New Zealand Medicines and Medical Devices Safety Authority) is a regulatory arm of the Ministry of Health which is responsible for administering the Medicines Act 1981 (the Act). The Act sets out a pre-market evaluation and approval system for medicines that is designed to ensure that new medicines meet the required standards.

The evaluation of medicines is based on internationally agreed standards which cover all aspects of the medicine including:

The medicines assessment process involves:

How are medicines approved under the Medicines Act 1981?

Full consent: Medicines can be given full consent under Section 21 of the Act when all of the application requirements have been met.

Provisional consent: Medicines can be given a provisional consent under Section 23 of the Act. This occurs in situations where there is a clinical need for the medicine and when the data set available demonstrates that the risk: benefit profile of the medicine is acceptable.

Herceptin received provisional approval for the treatment of patients with metastatic breast cancer in 2001.

Approval under Section 23 is valid for two years, but can be renewed, or converted to a full consent provided that the sponsor provides additional data justifying this approach. It is also possible to place conditions or restrictions on the use or supply of a medicine that is given provisional consent.

When considering approval under Section 23 of the Act, the risks and benefits of using the medicine are assessed against the risks and benefits of using available alternative products and the risks of denying access to the medicine. Approving a product under Section 23 allows a product to be used in the community at an earlier stage than would be possible if it was necessary to wait until further data were available to satisfy the data requirements for full consent. Section 23 is therefore a useful tool to allow early access to a treatment where other options are limited, or absent, such as a vaccine to manage an epidemic.

Medsafe considers applications for consent to market medicines independently of PHARMAC (who are responsible for making decisions about which medicines to fund). The data and criteria considered by Medsafe and PHARMAC often differ when performing an evaluation. Medsafe considers only the safety, quality and efficacy of a medicine, it does not consider product cost or cost-comparison with other medicines in its deliberations. PHARMAC examines cost-utility and cost effectiveness of a medicine compared to other medicines that produce the same or similar effect, to determine how treatment with a medicine might impact on the health of New Zealanders and the pharmaceutical and overall health budget before coming to a decision about funding.

What approval has been sought for Herceptin?

In November 2005 Medsafe received an application to licence Herceptin for the treatment of primary breast cancer. This application requested extension of the provisional approval for Herceptin granted by Medsafe in 2001 for the treatment of patients with metastatic breast cancer to include treatment of patients in women following surgery and who have completed chemotherapy.

Information about Herceptin, its currently approved uses and side effects is available on the Medsafe website: www.medsafe.govt.nz/profs/Datasheet/h/Herceptininf.pdf

What happened after the Medicines Assessment Advisory Committee made its recommendations to Medsafe?

Medsafe considered the Committee's recommendation and in the first instance contacted the medicine's manufacturer about the outcome. In addition, the minutes of the meeting were rapidly ratified by the committee and then sent to the Minister of Health delegate for consideration and decision making.

What is Herceptin and what is HER2 positive breast cancer?

Herceptin or Trastuzumab is a cancer treatment which targets the HER2 protein found on the cells of some breast cancers. HER2 positive cancers tend to be more aggressive than other cancers that are HER2 negative (or don't have the protein). Herceptin has been used in trials to treat some HER2 positive breast cancers following, and in addition to, completion of standard breast cancer treatments: surgery, radiotherapy and or chemotherapy.

What are the studies of Herceptin which have been used by the MAAC in its consideration?

Early results have been reported from three large trials. One of these trials is a large European and worldwide trial called HERA and two other trials are being run in America. The trials have all looked at giving Herceptin to women who have completed standard treatments of surgery, radiation and or chemotherapy. The trials have been looking at whether this combined treatment reduces the risk of breast cancer recurring compared to the use of surgery and chemotherapy on its own.

The pivotal HERA (HERceptin Adjuvant Trial) is a long-term randomised clinical trial which has been investigating the use of Herceptin for 1 or 2 years versus no treatment (observation) following a range of surgery, radiation and chemotherapies. An interim analysis comparing the first year of the trial was published in the New England Medical Journal last year (October).

Another American study, the National Surgical Adjuvant Breast and Bowel Project trial B-31, has also been looking into the use of Herceptin for up to 4 years in a small number of women compared to a group who has no treatment following standard treatments of surgery, radiotherapy and or chemotherapy. The most recent analysis of this study was also published in the New England Medical Journal last year (October).

These are very early trial results and new data and information will need to be considered as it comes to hand, including long-term survival data.

Further information is available at: http://content.nejm.org/

What does adjuvant mean?

Adjuvant means in addition to and in combination with a range of other treatments. For example the standard treatment for cancer includes a combination of surgery, and or adjuvant radiation and chemotherapy treatments.

What is an echocardiogram?

It is a test used to examine the heart by using ultrasound. It allows clear images of the heart to be seen in a two-dimensional view, including viewing the heart chambers, valves and major blood vessels and enables problems to be detected. It can be used to calculate the volume of blood pumped out of the heart with each heart beat, (Left Ventricular Ejection Fraction), and so measure heart function.

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