Contraception

Third Generation Pill Story
On 4th March 2011 the University of Otago’s department of Preventative & Social Medicine celebrated 125 years Public Health Teaching and Research by hosting a symposium in Dunedin in honour of Professor Sir David Skegg. Lynda Williams attended the symposium and reports on the presentation given by Lianne Parkin, a senior lecturer in Epidemiology in the Department of Preventative and Social Medicine at the University of Otago. Before undertaking training in public health medicine and epidemiology, Lianne worked for several years in general practice and in sexual and reproductive health clinics. She is currently involved in a project which aims to improve post-marketing surveillance of medicine safety in New Zealand.

Lianne Parkin’s presentation at the Dunedin symposium described the events surrounding the use of the third generation contraceptive pill in New Zealand.

In 1995 following the publication of three European studies showing that there was an increased risk of venous thromboembolism (blood clots) in women using third generation contraceptive pills, a warning was issued about the safety of four brands of these contraceptive pills – Minulet, Mercilon, Marvelon, and Femodene.

The risk of blood clots for third generation contraceptive pills which contain gestodene as well as oestrogen, was estimated to around twice that of second generation pills. Although the risks of blood clots for both are comparatively low, the sudden deaths of healthy young women created a great deal of publicity both in New Zealand and in other countries. In New Zealand in 1995 80% of oral contraceptive pill users were taking a third generation contraceptive pill, the highest percentage in the world. The Netherlands the figure was 63%, in the UK 50%, in both Canada and the USA 15%, and in Australia 5%.

Following the publication of the European studies, an urgent meeting was convened in Geneva in July 1995. A vast amount of reanalysis of the data was subsequently undertaken, mainly by the pharmaceutical industry and by pharmaceutical-industry sponsored groups. Eventually, independent research confirmed the original results.

When the story of the increased risk broke the Ministry of Health sent out a warning to doctors, but then withdrew it a week later. Once the results of the reanalysis were available, the MOH sent out new information that basically said that it was not necessary to alter prescribing advice if women are told of the risks in using third generation contraceptive pills. Not surprisingly, the Ministry’s prescribing advice had minimal impact on doctors' prescribing practice. The Medicines Adverse Reactions Committee (MARC) objected to such a low key approach, as did a number of women’s groups.

In May 2000 a letter from the Royal Australia and New Zealand College of Obstetricians and Gynaecologists was published in the NZ Medical Journal maintaining that there was no difference between the second generation and third generation pills. An article by Christine Roke from Family Planning and Paul Egermayer was also published in New Ethicals Journal in January 2000. The letter and article were criticised as being misleading and inaccurate as both misrepresented the research data. (1)

Professor David Skegg commented at the time: “The debate on third generation oral contraceptives has been acrimonious, partly because it has challenged both strong commercial interests and the natural reluctance of prescribers to accept that trusted products have potentially done harm.”

20 healthy young women died
The MOH subsequently released figures that showed in the decade between 1990 – 2001, 20 NZ women using combined contraceptive pills died of a blood clot in the lungs. Of those who died, 15 were using third generation pills. Five of those deaths occurred in the years 1997/1998. Many other women suffered a blood clot and survived, although with a vastly reduced quality of life. By 2001 the use of third generation pills in NZ had more than halved. 

Unfortunately the story doesn’t end there. A recent study published in the British Medical Journal in April 2011 showed that women using Yasmin, an oral contraceptive pill containing drospirenone (a new progestogen) were about three times more likely to develop blood clots. Concerns about this pill have been around for almost a decade. (2) But once again the pharmaceutical industry - in this instance, Bayer - has been reluctant to admit that their "new" oral contraceptive pill containing drospirenone carried almost three times the risk of blood clots than the second generation contraceptive pills containing the older form of progestogen. The much touted reduced side effects with Yasmin have also turned out to be little more than a marketing ploy. And once again healthy young women have paid with their lives.   
  
References
1. http://www.medsafe.govt.nz/profs/PUarticles/OCletter.htm
2. http://www.bmj.com/content/342/bmj.d2139.full.pdf



FREE ACCESS TO THE EMERGENCY CONTRACEPTIVE PILL
Pharmacists have joined the call for the emergency contraceptive pill (ECP) to be made freely available to young women after three DHBs found that subsidising the ECP resulted in a drop in both the number of abortions and in the teen pregnancy rate. 

Currently two DHBs are still funding free access to the ECP for women under the age of 25.

Waikato DHB
Waikato DHB has subsidised access to the ECP for almost four years, after pharmacists in the area reported that young women were coming into their pharmacy requesting the ECP and then leaving without it when told that it would cost $35. Around 400 women a month are accessing the ECP and the DHB has noted a reduction in the number of teen pregnancies and in the number of abortions. There is no restriction on the number of ECPs as Waikato DHB funds the service on a as needs basis.

Mid Central DHB
Mid Central DHB is reaching the end of a two-year trial of subsidising free access to the ECP and have reported a 7.5% drop in the number of abortions at the end of the first year. The current funding for the trial is due to end at the end of June 2011 and costs the DHB $98,000 a year. Around 170 women a month are provided with free access to the ECP. A Board spokesperson described the service as a fence at the top of the cliff instead of an ambulance at the bottom. 

Auckland DHB
The Auckland DHB ran a 5-month trial of providing free access to the ECP from October 2008 to March 2009 at a cost of $300,000. Pharmacists were reimbursed at a cost of $47+GST per ECP which included the cost of the drug, the dispensing fee, the cost of condoms, and the cost of the pamphlet detailing how the ECP should be taken. Around 1700 women per month were provided with free access to the ECP. A subsequent report to the Auckland DHB Community & Public Health Advisory Committee on 16 June 2010 stated that the busiest pharmacies were those situated in malls or in high pedestrian zones. There was a 13% drop in the abortion rate but this was regarded as not statistically significant because of the short period of the trial and the relatively low numbers.

It was noted that “the ‘other’ ethnic category utilised the service most (65%), followed by Asian (21%), Pacific (8%) and Maori (6%). This parallels with the ADHB population which consists of 59% ‘other’, 22% Asian, 12% Pacific and 7% Maori.”

The report pointed out that the price of a first trimester termination of pregnancy at Epsom Day Unit is $994, and that termination of pregnancy rates for Maori and Pacific women are considerably higher than for European and Asian women.

Despite that fact that one of the key findings was the clear downward trend in terminations rates in Asian and European ethnic groups, and that “the positive trend observed provides confidence that this type of service will be of benefit to ADHB financially and the population on a psychological and social level,” Auckland DHB has no plans to extend the ECP pilot at this stage. 

Women in the Auckland DHB area are still able to obtain the ECP free from family planning, and are able to purchase it over the counter from a pharmacy, or by visiting a GP and obtaining a prescription – and some funding is directed towards making this service free with Procare Network Auckland for under 18-year-olds.

West Coast DHB
The West Coast DHB provides access to the ECP to under 22-year-old young women at a cost of $3.

Other DHBs have different schemes in place regarding access to the ECP. 

Family Planning support
Jackie Edmond, the CEO of the Family Planning Association (FPA), appeared on Radio NZ Checkpoint on 3 February saying FPA would like to see the ECP subsidised across all pharmacies.

It would certainly be extremely beneficial for women. And for cash-strapped DHBs is makes good economic sense – a $35 pill compared to nearly $1,000 for an abortion is a no-brainer.

Sources
• Radio NZ Checkpoint. 3 Feb 2011
• ADHB CPHAC Agenda papers 16 June 2010