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Health Watch May 2005
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Women's Health Watch

edited by Jo Fitzpatrick

 

Selected articles from Women's Health Watch newsletter in May 2005

Contents

Breast Implants: a travesty of technology

It is almost 14 years since the American Food and Drug Administration (FDA) introduced a regulation requiring manufacturers of silicone gel-filled breast implants to submit evidence of their safety and effectiveness in order for the devices to remain on the market, and then followed that up with a call for a voluntary moratorium on the use of these implants until their safety could be thoroughly reviewed. In April 1992 the FDA decided that the data that had been submitted to them did not contain sufficient evidence of their safety and declined approval. Access to silicone gel-filled implants was restricted to women enrolled in clinical studies.
This series of events lifted the lid of this particular Pandora’s box and resulted in the filing of lawsuits by thousands of women against the manufacturers of these devices. Women who had experienced serious problems with their silicone implants had finally found a way to expose the propaganda they had been fed about the devices and the medical cover-up that had followed their complaints.
In New Zealand, as in many other countries where breast implants had been heavily marketed, women came together to share their stories and support each other and found the courage to publicly speak out about the adverse effects that these devices had had on their health.
Tanya Brennan-Hodgson, a founding member of WIINNZ (Women’s Implant Information Network NZ), the New Zealand support group, reports further on the history of the breast implants saga. She describes herself as someone who has ‘experienced implants for a period of 23 years, during which time I came to realise what a dreadful mistake I had made. After having them explanted in 1992 (they are now languishing in my freezer as evidence’), I resolved to try to educate other women in the same predicament, and for those contemplating breast implants, help them to make an
informed decision.’ She reports:
Of all cosmetic surgery procedures, silicone breast implants have perhaps caused the most controversy. Silicone found its way into the breasts of women as early as the mid 1940’s. In the aftermath of World War 2, transformer coolant made of silicone was suddenly disappearing from the docks of Yokohama Harbour in Japan. The silicone fluid was used to enlarge the small breasts of Japanese prostitutes, who knew a more Western appearance would enhance their appeal to American servicemen. Large doses of the doctored industrial fluids were injected directly into their breasts. To prevent silicone from migrating in the body, the Japanese added cottonseed or olive oil to cause immediate scarring as a way of containing the silicone at the site of the injection.
In the US this method of breast augmentation was used first on topless dancers and Las Vegas showgirls. Strippers had a pint of silicone injected into each breast on a weekly basis. This method produced disastrous results as the silicone migrated, turning up in lymph nodes and other parts of the body. In extreme cases such silicone injections resulted in amputation. All recipients were expected to have pendulous breasts by the time they were 40.
When silicone-gel filled breast implants were first introduced in the western world in the early 1960’s they were hailed as every small-breasted woman’s dream. Women were promised that this relatively simple surgical procedure would transform them within hours and take them from a tiny size AA cup to a generous DD should they so wish. There would be a few minor discomforts, and even some pain in the process, but this would be incidental compared to the boost in self esteem, looking more attractive, and feeling a lot sexier. Women were assured that the implants were perfectly safe, were non reactive in the body, were virtually indestructible, and would last forever. Women were also told the presence of the implants would not impede the detection of cancer.
It was not long before the dreams dissolved, as increasing numbers of women reported health problems to their doctors, many of whom were reluctant to accept or document the evidence of what was to be another great medical cover up.
It is now known that silicone breast implants can be hazardous to the health of the recipient and that the real cost of cosmetic breast enhancement may not be the dollars paid in surgical fees to implant them, but a host of autoimmune symptoms and strange illnesses that can crop up, typically within about seven years of implantation. Silicone is in actual fact a biologically active and toxic substance, not the biologically inert and non toxic product that the Dow Chemical Company repeatedly claimed it to be.
The Dow Chemical Company’s original claim in the 1940s was based on a single one-week study of rats and guineas pigs. It was to be constantly repeated as the complaints about silicone gel implants began to surface. According to research gathered by attorney Richard Alexander, of the
Alexander Law Firm in San Jose, California, Dow Chemical and Dow Corning have been aware of the toxic effects of silicone and silica since the 1950s. The company had done further studies which revealed that these substances were bio-active, immunotoxic, and inflammatory when introduced into the human body, but the data was never published.
Autoimmune Disease
It is now accepted that breast implants can have a significant effect on the autoimmune system. The immune system is a complex network of cells that normally work to defend the body against bacteria, viruses and other invaders. However, with autoimmune diseases, the body attacks itself by targeting the carrier’s own tissues and organs. In layperson’s terms when silicone leaks into the body the immune system can go a bit crazy when it is unable to rid itself of the alien substance.
Physicians who are aware of the toxicological and immunological effects on the body of silicone, have a variety of names for silicone-induced disease: siliconosis, undifferentiated or atypical connective tissue disease, silicone related disease, silicone reactive disorder, silicone disease syndrome, and silicone implant disease (SID).
Typical symptoms include cognitive dysfunction, short-term memory loss, Sjögren’s syndrome (dryness in glands, such as the mouth, kidneys, eyes, and lungs), scleroderma, rheumatoid arthritis, dermatomyositis, severe joint and muscle pain, incapacitating fatigue, swollen lymph glands, skin problems, peripheral numbness, multiple allergies, headaches, hair loss, sunlight sensitivity, central nervous system disorders (similar to multiple sclerosis), etc.
Doctor recognition of problems
When the problems associated with the use of breast implants began to emerge many doctors shrugged off or denied there were problems with them. Of course some of them had been making a lot of money out of them. Rising above the backlash of the unfolding saga were a few reputable doctors who supported the women’s claims and were prepared to back them with research. By being prepared to speak out despite the untold pressure put on them they put their reputations on the line. The implant manufacturers responded with character assassinations and tried to hound these doctors out of their careers or make them look like fools. Some were personally threatened and their families were also threatened.
For example, in December 1993, Drs Britta Ostermeyer, Bernard Patten, and Dick Calkins, Department of Neurology, Baylor College of Medicine and Krug Life Science, Houston Texas, USA published an original research paper entitled:
‘Adjuvant Breast Disease: An Evaluation of 100 Symptomatic Women with Breast Implants or Silicone Fluid Injections.’ In a later interview Dr Ostermeyer admitted she had been subjected to death threats, harassment, and had been forced to quit her job. Dr Bernard Patten, also paid a high price in terms of personal safety. He had been subjected to death threats, arson attacks, and break-ins at his home.
Dr Patten, MD, FACP, FRSM wrote a condemning article: ‘Memoir of a Junk Scientist’ which lifted the lid on the deception and corruption within the breast implant industry. This compelling article was circulated word wide. (Copies are available from WIINNZ: phone (09) 479-4266; email: elvis.nz@internet.co.nz.)
Support Groups
A large number of research and support groups sprang up worldwide during the 1980’s and 1990’s as women stood up and spoke out publicly about the adverse effects of breast implants on their health. For many women, this was their first opportunity to talk together, and compare notes in a non judgmental and uninhibited climate of sisterhood. They united in their determination to make the breast implant manufacturers take responsibility for the suffering they had caused with a dysfunctional product and the subsequent cover up of evidence.
An Overview of the breast implant situation in New Zealand
The New Zealand support group WIINNZ (Womens Implant Information Network NZ) was established in 1992 as a sub group of Women’s Health Action. It gained momentum very quickly. In October 1994 its members voted for WIINNZ to became a separate identity and it has been functioning successfully ever since. In the early days, there were regular meetings with guest speakers, newsletters and information packages which were sent out to anyone who requested them. However, the advent of the internet and email has simplified the process as most people can now research and access their own information very quickly.
Following intensive lobbying by women’s health groups in New Zealand the Department of Health published a booklet in 1992 entitled Silicone Gel Breast Implants which provided basic information about implants, including the risks involved. Unlike the USA, silicone breast implants were still legal on the New Zealand market, as the Department of Health appeared to have little understanding of the adverse effects of breast implants.
Action Against Silicone - The Global Campaign
In April 1999, New Zealand had a voice in the Action Against Silicone - The Global Campaign conference held in Switzerland and timed to coincide with International Womens Day, for added impact. WIINNZ submitted a statement on behalf of the NZ women to the World Health Organisation, which was accepting and collating evidence from the many countries participating in the campaign. A letter was also sent to the Director General, Dr Gro Harlem Brundtland asking her to set up a research
programme into silicone and disease, and to have implants banned worldwide. WIINNZ worked closely at that time with two dedicated campaigners for healthcare and justice, Rose Irwin and Brenda Livsey, from Action Against Silicone Gel UK.
NZ Ministry of Health 2004
From 1 January 2004 new legislation has required sponsors to notify Medsafe of the devices they were importing into New Zealand via the use of an electronic database known as WAND. This includes companies importing breast implants. The legislation is a notification system only and does not restrict the importation and distribution in New Zealand of silicone breast implants.
The Australian and New Zealand Governments have agreed to form a joint agency to control therapeutic goods including medical devices and the information being collected on WAND will contribute to the move towards a joint agency. After an interim period all medical devices will be required to comply with the requirements of the Joint Agency.
At present the Australian Therapeutic Goods Administration has evaluated and accepted for marketing in Australia a limited number of silicone breast implants.
The Legal Situation
The subject of silicone breast implants is clouded and controversial, marked by denial, cover-up, stonewalling, suppressed research, bankruptcy, and class action lawsuits. The manufacturers and most plastic surgeons strenuously insist silicone breast implants pose no danger to the health and wellbeing of women.
Since 1991, thousands of women worldwide have filed claims in the U.S. Courts against Dow Corning and other implant manufacturers alleging injuries associated with implant use. Dow Corning turned to the U.S. Bankruptcy Court for protection from the deluge of claims by filing for bankruptcy reorganisation (Chapter 11) on 15th May 1995.
The Dow Corning Settlement Plan was approved on 30 November 1999 but because of outstanding appeals no claims could be paid until the ‘Effective Date’, which could not be set until all appeals against the Plan were rejected and all rights of appeal had expired. The Effective Date was set on 1 June 2004.
Some Australian and New Zealand women who were represented by Slater and Gordon, a firm of lawyers in Australia, did settle their claims against Dow Corning outside the Settlement Facility agreement. Most NZ claimants and thousands of others worldwide (including US women) were not part of that agreement and await settlement of their claims under the terms of the Settlement Plan.
All legal obstacles to the Settlement Plan have now been removed and the Settlement Facility for the Dow Corning Trust (SFDCT) is in the process of reviewing individual claims. They will first advise if a claimant’s proof of product i.d. is acceptable and if so, they will then review any other claims filed i.e. rupture, explant or disease claims. Eligible claims will receive compensation cheques. New Zealand women are still unclear as to when they can expect to receive any settlement cheques.
References
1Pauline Norris PhD, Research Fellow, Health Services Research Centre, Victoria University, Amanda Frost, Pharmacy Intern, School of Pharmacy, University of Otago, Kath Ryan PhD, Lecturer, School of Pharmacy, University of Otago, and Melissa Weenink PhD, Wellington. ‘Breast Implants: The New Zealand Situation.’ 1998.
Women’s Implant Information Network NZ (WIINNZ) To be added to the email network, contact: elvis.nz@internet.co.nz
Resources
The USA Food and Drug Administration’s website address for information on breast implants is www.fda.gov/breastimplants/
Medsafe published a booklet on breast implants and a copy of this is on the Medsafe website: www.medsafe.govt.nz
The TGA has also published information on this topic, see:http://www.tga.gov.au/docs/html/breasti.htm
The UK Medicines and Healthcare products Regulatory Agency recently released a Medical Device Alert on Trilucent Breast Implants and a copy of this article can be found on the following website:http://www.medical-devices.gov.uk

Breast prosthesis or implants
A breast implant is an envelope containing a substance which has been developed in a laboratory to mimic the look and feel of the human breast as closely as possible. The envelope is usually made of silicone and the contents can be silicone, hydrogel, saline, soya oil, (trilucent) or the latest which is a cohesive gel, or even a combination of these substances.
The basic gel implant filler — DC 360 silicone fluid — was once considered worth following up for development by Dow Corning scientists as a potent insecticide, one of the few known substances capable of killing cockroaches! Silicone gel is actually not a single substance but a fluid comprised of numerous different versions of silicone, and is better termed a “silicone chemical soup.”
After silicone started to fall from grace, saline was considered to be a lot safer, but this too had problems with leakage, and fungi growing within the solution. Leroy Young then invented a catastrophic product called “Soy Oil” or “trilucent” breast implants which were introduced in 1995 and resulted in thousands of women in England and Europe needing to have his invention removed from their bodies within a few years. In some cases the implants ruptured, producing globules of an emulsified yoghurt-like substance causing swelling. In some instances they became rancid and smelt.

The Our Shattered Lives Quilt
In 1998 women worldwide were invited to participate in the making of a special quilt comprised of embroidered squares. Each square represented a country where women had been damaged by implants. WIINNZ sent a square representing New Zealand, which was included in this historic quilt. The quilt was named Our Shattered Lives, and was put together by a group of women in New Orleans. Once completed it was exhibited at meetings, seminars, courthouses, shopping malls, and media gatherings. The quilt is a very powerful and poignant visual statement of women’s suffering.

NZ Research
Funding and resources for research on implants in NZ have been limited, but in 1996 a study was undertaken by the Health Services Research Centre which was a joint venture between the Wellington School of Medicine, the University of Otago, and the Institute of Policy Studies, Victoria University of Wellington.1 A paper ‘Breast Implants: The New Zealand Situation,’ by Pauline Norris PhD, Research Fellow, Health Services Research Centre, Victoria University, Amanda Frost, Pharmacy Intern, School of Pharmacy, University of Otago, Kath Ryan PhD, Lecturer, School of Pharmacy, University of Otago, and Melissa Weenink PhD, Wellington was subsequently published in April 1998 reviewing the development and controversy over breast implants. It looked at data on operations in NZ hospitals and sent a questionnaire to plastic surgeons to gather information about breast implantation in NZ. Both of these data sources had significant limitations, but suggested that around 3000 New Zealanders had had breast implant surgery at that time. A large number of operations were performed in the 1980’s but this declined sharply in the 1990’s perhaps due to a wider understanding of the side effects of implants. However in the past few years breast implants seem to have regained the popularity they once had, although there has been a move from silicone-gel filled to saline filled implants.
A follow up study entitled ‘How People Think About Risk: Breast Implants as a Case Study’, was researched by the same team, including Bridget Rowsell, Research Fellow, Health Services Research Centre, Victoria University, Wellington, and dated December 1999/January 2000. This study dealt more with the recipients of breast implants and how they coped with new information about medical devices particularly when there is a public debate about their safety.
There have been no other studies done in this country, due to a lack of funding which prevented other areas of interest from being explored.

Update on Breast Implant Settlement Claims
Legal claims were being processed so slowly for the 145,000 women alleging medical problems from Dow Corning breast implants that the federal court office overseeing the awards agreed to hire an outside consultant and more employees to speed up the process.
The claims office began issuing payments to claimants in June 2004. To date about one in ten women with Dow Corning implants who have filed a Proof of Claim in Dow Corning’s bankruptcy proceedings has received a cheque from the Settlement Facility-Dow Corning Trust. The Trust is a court-appointed agency which has been charged with dispensing $US2.35 billion set aside by the company to pay for medical care. Payments range from $US2,000 - $250,000.
Figures released by the settlement office to the Detroit Free Press show that most of the more than $US111.7million paid so far has been to women in three categories: those agreeing to receive smaller, so-called quick-release payments of $2,000; women with ruptured implants, and women who want or have had their implants taken out.
Attorneys representing women with more serious medical problems say most have not been paid and some are being subjected to follow-up questions that threaten to drag out the cases for months. Some have complained to US District Court Judge Denise Page Hood in Detroit, who is overseeing the case.
“If it’s taken this long to process the easiest of the claims, what is the future for women on more complex claims who are likely to be asked for more documentation?” asked J Douglas Peters, an attorney with Detroit’s Charfoos & Christensen law firm. He represents 187 breast implant litigants. Peters said he had received several dozen letters from the court office with trivial questions. One asked why a fax number was on one page of the claim and not on other pages.


Marketers, Ministries and consumers: The long struggle with the artificial baby milk industry

The breastfeeding community has waited two long years for the Ministry of Health to complete its review of New Zealand’s interpretation of the International Code of Marketing for Breastmilk Substitutes. Struggling with the task of making the artificial baby milk manufacturers and the breastfeeding fraternity happy, the Ministry took some time to produce a document which is wishy-washy and commits to nothing much. Louise James, WHA breastfeeding advocate reports
To understand the Code review it is best to go back to the beginning and the development of the original International Code. Through the fifties and sixties the manufacturing of artificial baby milk developed into a multi billion dollar industry, and was accompanied by declining health for babies all around the world, with some dying unnecessarily. The World Health Organisation (WHO) estimates 1.5 million babies die annually as a direct consequence of the reduction in breastfeeding.
The aggressive marketing of artificial baby milk, particularly to poor and vulnerable populations did not go unchallenged. The seventies saw the birth of the International Baby Food Action Network (IBFAN) with feminists, individuals and organisations mobilising to organise a boycott of Nestlé, the biggest producer of baby foods in the world. Today New Zealand’s Fonterra supplies Nestlé with milk powder for South American products worth millions annually. In 1981, WHO and UNICEF worked with the industry to develop and adopt the Code of Marketing of Breastmilk Substitutes. The Code was approved by 118 countries with only one country opposing – no points for guessing which country that was – USA!
In 1983, New Zealand adopted the Code in its entirety. This wasn’t a situation that was sustained, as opinions from industry lawyers and influential industry nutritionists saw the Code significantly weakened in New Zealand by 1997. Two documents were principally responsible - one from the Ministry for Health Workers and a watered down industry Code of Practice from the New Zealand Infant Formula Marketers for their members.
Objecting to the industry Code, breastfeeding advocates made continual requests for the Ministry of Health to review the Code in practice and assess its effectiveness at monitoring formula advertising. Eventually the Ministry responded with a Code Review in 2003 and sent out a lengthy questionnaire with a minimal three week turnaround time to complete. After another lengthy wait, the review was finally completed and published at the end of September 2004.
The consultation process for the review has been very frustrating with the Ministry of Health choosing to consult with self selected health professionals and formula manufacturers in preference to consumers or their advocates. The consumer meeting referred to in the Review happened only after consumer organisations demanded consultation. At that consultation a strong and united consumer voice requested a return to both the original International Code and subsequent World Health Organisation resolutions. This fact failed to make it into the Review report.
The report claims to balance the concerns of both the marketers of artificial baby milk and breastfeeding advocates. In failing to report the conclusions of the
consumer meeting, the report clearly favours the industry and pays lip service to breastfeeding. Outlined below are several reasons for this deduction:

  • The Code remains as one which is voluntary and self-regulated by the industry – something the industry is clearly happy about. The reason given for this is that it is consistent with New Zealand’s social and legislative environment. This ignores the fact that consumers have continually found industry regulated codes to serve consumers badly and asked for these to be changed. The major problem with them is they are complaints-based systems and sanctions generally occur after breaches of the Code have been complained about - the stable door closes after the horse has bolted.
  • The intention to combine the health workers code (based on the WHO international code) and the industry-based Code of Practice (based on manufacturers profit margins and what they can get away with) will inevitably lower the standards breastfeeding health professionals have been working under, and undermine Baby Friendly Hospital Initiative (BFHI) standards.
  • Expecting the manufacturers of teats and bottles to come up with their own industry Code, an approach which has failed in the past, demonstrates a lack of commitment to the WHO code and a lack of understanding of the multifaceted nature of breastfeeding failure.
  • The continuing debate and vacillation in the Ministry around breastfeeding and supplementary feeding recommendations water down and confuse WHO recommendations. The Ministry of Health supports breastfeeding for only one year rather than the two years and beyond recommended by WHO. This creates a loophole for the advertising of ‘toddler formula’. A product the industry aggressively markets to fill the possible loss of advertising for their ‘follow on formula’.
  • The persistent naïve belief that there is a shared intent and good will between marketers and breastfeeding advocates for encouraging breastfeeding. The industry has a bottom line which relates to selling formula, not breastfeeding. They are direct competitors and this belief allows the very wealthy industry wolf into the henhouse!

The Review highlights the weakness of the Ministry in relation to the industry and creates confusion and frustration for breastfeeding advocates. The attempt to keep
everyone happy is demonstrated by the cagey wording of the document. The conclusions demonstrate a lack of understanding of how the artificial baby milk industry increases their market share. The Ministry’s responsibility is to promote the health of the nation yet it appears to have a deficient knowledge of the health risks imposed on the children of NZ by the consumption of artificial baby milk. For breastfeeding advocates, who expect the Ministry to be their natural partner in protecting breastfeeding to promote health, the process has been deeply discouraging.
There is no need to advertise artificial baby milk on the market, whether for babies, crawlers or toddlers. It is a pharmaceutical product and should be classified and clearly labelled as such, with clear information on its attendant risks. The re-establishment of breast milk banks and the total enforcement of the WHO International Code of the Marketing of Breastmilk Substitutes and subsequent resolutions would promote and protect breastfeeding. The health of New Zealanders would benefit.
Breastfeeding in New Zealand needs protection, promotion and support with government and the Ministry leading the way.

Funding health and social advocacy groups

A recent issue of the Health & Social Campaigners’ News (HSCNews) featured a fascinating review of the Annual Reports of 125 consumer, disability and health
advocacy organisations. The groups selected were mainly very large organisations based in Australia, Canada, the UK and the US. There were also 17 others who had their headquarters in Belgium, Denmark, France, Ireland, Sweden, Switzerland, Norway, Singapore and New Zealand. The one NZ organisation included was the National Heart Foundation. The geographical brief of the organisations studied ranged from global (18 groups), European (3), national (81) and local (23).
As well as forming a snapshot of the breadth and scale of the health and social campaigning movement worldwide, the Annual Reports illustrated the level of transparency and accessibility of the campaigners’ financial accounts and the sector’s source of funds, especially donations from medical suppliers and the rest of the healthcare industry. The latter is particularly important as the media, the medical profession and even some governments have begun to question whether pharmaceutical company ties with patient or consumer advocacy groups are bad for public health.
The HSCNews review found that 2003-2004 was a tough year for health advocates as governments around the world made across-the-board cutbacks in their grants to health campaigners. Some organisations suffered a setback in revenue growth because they had become overly dependent on legacies for their income. Others struggled as they waited for corporate donors to honour their pledges of cash. Many NGOs (non-government organisations) responded to the financial pressures by increasing their effort to obtain money from the corporate sector, especially from pharmaceutical companies.
The review also showed that pharmaceutical and medical device companies pick the NGOs to which they choose to donate on the basis of mutual interests, rather than on pure altruism alone. The table compiled by HSCNews revealed that in almost 100% of cases pharmaceutical companies seek associations with patient organisations that themselves specialise in one or more of the therapeutic areas in which the drug companies market or develop products.
The combined revenues of the 125 health and social advocacy groups studied totalled over $US8 billion. Almost half of this figure went into the bank accounts of only five huge, high-profile groups – World Vision, American Cancer Society, American Heart Association, Cancer Research UK, and Association des Paralyses de France. These five derived their money from a variety of sources, including the public, businesses, foundations and government. Smaller charities, whose areas of interest are confined to specific — sometimes uncommon — diseases, or which run parochial health campaigns, had a much more difficult time obtaining funding. A few groups seemed to be doing their best to hide the fact that they may well have been fighting the prospect of financial collapse.
All but two of the Annual Reports reviewed by HSCNews were available on the Internet. While public access to and the financial competency of the Annual Reports of health-based charities has improved over the past few years, the review stated that the ‘levels of opaqueness remain surprisingly high.’ HSCNews reported that only four of the 125 groups (the UK-based Epilepsy Action, the UK-based Help the Aged, the UK-based Men’s Health Forum, and the Swiss-based World Heart Federation) specified which pharmaceutical company was funding them, and by how much.
Given the mounting criticism from the media, from academics, from government and even from other NGOs, of organisations that get a large proportion of their funding from the pharmaceutical industry, the review noted that pharmaceutical companies and NGOs are currently looking more closely at their donor/sponsor relationship. However, some groups haven’t really got the message and have formed partnerships with pharmaceutical companies to develop advice on corporate giving. Others have unilaterally adopted policies to address the issues of corporate vested interests and ethical funding. The pharmaceutical industry, too, has been reviewing its practices on its funding of health-based charities and turning to areas in which the profit motive is less obvious, eg donations to the Tsunami appeal.
As part of their review HSCNews undertook a literature review of new policy statements on ethical giving by drug companies to health charities and the article provides website links to those of Breast Cancer Action, Diabetes UK, the Men’s Health Forum, and Muscular Dystrophy Canada. However, much work still needs to be done in this area. As the HSCNews article concludes:
‘Noticeably no single gold standard prevails – yet one has never been more needed. As the pharmaceutical industry’s financial involvement in the health campaigning sector becomes ever more influential, some people argue that the entire future of health campaigning could be at stake.’
Reference
HSCNews International, Issue 15 February

Sex patches for women

Proctor & Gamble have come up with a testosterone patch (Intrinsa) for use in treating women’s ‘sexual dysfunction’ – ie women deemed to have a low sex drive. As part of the process of seeking FDA approval for their new product the company submitted the results of two studies involving almost 1100 women who had had their ovaries and uterus removed for medical reasons. The women were taking oestrogen and were experiencing a problem with lack of desire for sex. One study found that, compared to women on placebo, women using Intrinsa experienced a 56% rise in sexual desire and a 74% rise in satisfying sexual encounters – working out to about one additional sexual episode per woman per month.
Fortunately, the FDA panel voted unanimously against approval for Intrinsa citing concerns about the safety of long-term use and its use by groups of women not yet
adequately tested. One expert in female sexual health, Professor Lenore Tiefer from New York University’s department of psychiatry, addressed the FDA panel and warned of the dangers of long term use of hormones. Pointing to the checkered history of oestrogen supplementation where long-term use was linked to increased risk of heart disease and breast cancer, Professor Tiefer said. “We have a lot of scary history with long-term hormone use and whatever studies we have now on testosterone for women are short-term. It turns out that hormones have effects in the long term that they don’t have in the short term.”
The US National Women’s Health Network also urged the FDA panel not to recommend approval as long as there were still so many unanswered questions about the safety of testosterone use. It is clear that the drug is intended for long-term use, so women need to know about its long-term effects on their health. There is, however, no data on the safety of long-term testosterone in women.
It is therefore extremely alarming that there are currently lots of health websites and books advising women to use testosterone for the problems they face in their sex lives. Testosterone use by women in their reproductive years raises a whole new set of questions about the safety of this drug to which there are as yet no reliable answers. It is widely accepted that testosterone use during pregnancy is contraindicated but there is no information on how its use might affect future fertility.
Other experts [male] were much more enthusiastic about use of the drug. Dr Irwin Goldstein, a professor of urology and gynaecology at Boston University and director of its Institute for Sexual Medicine, said the FDA meeting “marks the first time that the government has acknowledged the existence of women’s sexual health issues and is thinking of pharmaceutical solutions to deal with it.” He claimed that ‘the data epidemiologically shows that 43% of American women have this problem at some point in their lives.’
Just what ‘this problem’ actually is deserves further scrutiny, as does the oft-quoted figure of 43% of women with it. One of a number of milestones in the making and marketing of this new ‘problem’ that women are experiencing was a JAMA article that appeared in February 1999 entitled ‘Sexual dysfunction in the United States: prevalence and predictors.’ The authors of the article, two of whom have close links to the drug company Pfizer, stated that for women aged 18 – 59 years, the ‘total prevalence of sexual dysfunction’ was 43%. This figure is now being widely cited in both the scientific and lay media.
So where exactly did this figure of 43% come from? It was unearthed when University of Chicago sociology professor Ed Laumann and colleagues reanalysed a slice of data from a 1992 survey. About 1500 women were asked to answer yes or no to whether they had experienced any of seven problems, for two months or more, during the previous year. The problems cited included a lack of desire for sex, anxiety about sexual performance, and difficulties with lubrication. If the women answered yes to just one of the seven questions, they were included in the group characterised as having sexual dysfunction. Given such a definition it’s rather remarkable the figure was so incredibly low!
However, it was apparently high enough for the pharmaceutical companies to put their noses to the grindstone in order to come up with a drug to deal with the millions of women who suffer from this very popular and potentially lucrative new disease. Apart from the fact that this can be seen as just another example of the medicalisation of perfectly healthy women (only this time it’s their sexuality that’s ‘dysfunctional’), it can also be argued that a lack of sexual desire and the symptoms that go along with it such as a lack of lubrication, is a healthy and natural response for women who are stressed, tired, or facing threatening patterns of behaviour from their partners.
Dr Tiefer contends that the medical model is far too limited to deal with problems of sexuality because of its mind-body split, focus on diseases rather than people, and its reliance on norms. It risks oversimplifying the sexual difficulties of both men and women because it ‘promotes genital function as the centerpiece of sexuality and ignores everything else.’
Of course it’s been much more difficult to measure female sexual responses compared to those of men (well, they only have one really). However, researchers and clinicians have beavered away and developed a host of new methods including measuring hormone profiles, vaginal pH, and genital vibratory perception thresholds, as well as using ultrasound to measure clitoral, labial, urethral, vaginal and uterine blood flow.
On the basis of studies of the genitalia of female New Zealand white rabbits, animal models of ‘vaginal engorgement insufficiency and clitoral erectile insufficiency’ have also been developed. Presumably this will result in the development of sex patches for rabbits.
This disturbing sequence of events has not gone completely unnoticed by the medical profession and an editorial in the BMJ referred to ‘the potential risk, in a process so heavily sponsored by drug companies, of the complex social, personal, and physical causes of sexual difficulties and the range of solutions to them being swept away in the rush to diagnose, label, and prescribe. Perhaps the greatest concern comes from the flip side of inflated estimates of disease prevalence and the ever-narrowing definitions of ‘normal’ which help turn the complaints of the healthy into the conditions of the sick.
These revelations about female sexual dysfunction should spark a more widespread and rigorous investigation into the role of drug companies in defining and promoting new diseases and disorders.
Reference
www.nwhn.org/content/index.php?pid=66
BMJ 2003; 326: 1-2

Getting a ‘Fair Go’ ? Do consumers really moan to the media

The perception that disgruntled patients take their complaints to the media at the drop of a hat is widespread amongst health professionals. At the Health & Disability Commissioner’s Media seminar held on 2 December 2004, Director of Advocacy, Judi Strid gave one of three presentations from a consumer’s perspective. She provided some thought-provoking insights into why consumers go to the media and what happens when they do. Lynda Williams reports.
Judi Strid has a wealth of experience in dealing with the health system and brings many years of listening to consumer’s stories of their struggles with the health system to her role as Director of Advocacy. At a seminar sparked by reactions to Commissioner Ron Paterson’s comments about ‘Trial by Media’ in his Annual Report last year, Judi outlined what drives some consumers to go to the media and described some of the intended and unintended consequences that result from media involvement in the process of achieving justice for the consumer. Her presentation highlighted issues that were subsequently echoed in the three presentations from the media at the end of the seminar.
It takes a lot for someone to approach the media with a complaint about their experience in the health care system. It’s an end of the road decision taken when all other avenues have been tried and failed. Consumers who go to the media are frustrated by what they regard as an inadequate response to their complaints and the lack of appropriate action. Some have been unable to get answers to the questions they have about what happened which leads to a belief there has been a cover-up. They usually go to the media in desperation, feeling that they have run out of places to go.
For most consumers, nothing happens. The media is uninterested and fails to respond. If and when their story goes public, consumers who take this step are often unprepared for what happens. There is no guarantee the reporter will present the story in the way the consumer or the family wants, or that he or she will understand and investigate the issues of concern to the consumer. Ms Strid described several media health stories which clearly demonstrated how families had little say in or lost control over both the initial story and the responses it generated.
Consumers whose approach to the media is successful often underestimate the media interest and the level of public involvement in their situation. They are unprepared for the response to the public exposure of their plight and the amount of support and criticism that often occurs in the wake of the initial blaze of publicity. If there is ongoing media interest many come to find being public property overwhelming and oppressive. If they are expecting ongoing coverage and don’t get it, they may be disappointed at how fast the story becomes old news and the passing interest of the media.
Most consumers go to the media primarily because they want changes made to ensure that others do not have to go through what they experienced. They want the system made safer for others. Some consumers go to the media in order to get publicity for a widespread problem in the health system – either past or present – or to encourage others who have been affected to come forward, eg abuse of patients in the mental health system, and the incidence of fires in hospital theatres during surgery.
Some are also motivated by a desire for a public acknowledgement of what happened, an apology, and some form of compensation for past wrongs.
For the lucky few who get their issues aired on TV programmes like Fair Go, 60 Minutes or the Holmes Show the result can sometimes be a speedy resolution for their particular complaint as well as a means of alerting others to potential problems. In such situations media attention can provide a way of short-circuiting what otherwise would have been a much longer process and is of tremendous benefit to those concerned. However, as Ms Strid pointed out, the use of the media is a two-edged sword which can also raise expectations which are not able to be fulfilled and leave consumers stressed out by the whole experience.
In commenting on the issue of public interest and public safety, Judi Strid observed of health professionals that ‘the more significant the role and responsibility, the greater the public interest and the focus on accountability. In effect it is part of the job and goes with the territory for anyone in public office or roles where public safety and wellbeing is at stake.’ Giving examples of the public scrutiny that politicians’ personal lives are often subjected to, Ms Strid asked why doctors believe they should be exempt from media attention, especially when the failure to disclose the name of the doctor at the centre of the story results in other doctors coming under suspicion or places other patients at risk, eg if a doctor has been accused of sexual impropriety.
In fact, doctors in New Zealand lead a very protected life when compared to the consequences in other countries when things go wrong. They do not face being sued for malpractice or being sent to jail should a patient die as a result of their negligent practice. The worst that can happen is that he or she will be struck off the medical register (with provision to reapply in the future), have practice conditions attached, or be given a fairly negligible fine and have their name made public.
Judi Strid concluded her presentation by reiterating the point that consumers’ use of the media is usually a last resort for those with a health care issue. It is a last resort which sometimes works well but equally can also make things worse. She pointed out that by far the best way of dealing with health care issues is to develop more effective processes so that consumers don’t feel they have to go to the media to get the matter sorted out. “It is my view that a complaint that is dealt with in an appropriate and timely manner, with a response that acknowledges what happened, provides an explanation that includes accountability matters and an apology where indicated plus the steps taken to avoid re-occurrences is unlikely to be raised in the media by the consumer or person complaining on their behalf,’ she said.
Contact:
Health and Disability Commissioner National Freephone:0800 11 22 33; E-mail: hdc@hdc.org.nz; website: www.hdc.org.nz Auckland Office:09 373 1060