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Women's Health Watch

edited by Sandra Coney

 

Selected articles from Women's Health Watch newsletters in Sepember 2001

Contents

Issue 58 September 2001

Softly, softly on drug ads to the public

Sandra Coney looks at the very tame outcome of the Ministry of Health's consultation on direct-to-consumer pharmaceutical advertising.
Minister of Health, Annette King, has decided not to ban director-to-consumer advertising (DTCA) of prescription drugs. New Zealand is one of only two countries (USA is the other) that allows DTCA and local media have been flooded with ads in the last couple of years. As well, advertising has appeared on buses, cars, and billboards and in sponsorship of high profile events. The Minister's failure to impose a ban was signalled in the Ministry's discussion paper last year. At that time, it was clear that the Ministry didn't want a ban because of the regulatory cost and a lingering market approach to health.

The submission process was heavily dominated by pharmaceutical industry players and media/advertising interests who have benefited greatly from New Zealand's permissive environment. Very few consumer groups commented.

Currently, there is a voluntary code of practice, but a significant proportion of advertising does not comply with the Medicines Act or the code.

Mrs King says that while industry self-regulation will continue, there may be more restraints on advertisers. Changes could be made via an amendment to the Medicines Act 1981 (under review since 1994) or by a new Therapeutic Products Act. She says over the next year she will look at a number of options:

  • Strengthen legislation governing advertising to provide more balanced information
  • Only allow advertising in broadcast and print media (Currently drug companies are writing directly to individual patients, running competitions, giving free offers and paying for doctors' visits)
  • Banning brand-name drugs on vehicles
  • Ban sponsorship of events using drug names
  • Lengthen the time risk information is shown on television as well as the font size
  • Require voice-over of risk information - required in the US.

Women and HIV/AIDs in New Zealand

  • A total of 45 women in New Zealand have been diagnosed with AIDS since 1986 (6 per cent of total cases)
  • Of these, 24 were European, 3 Maori, 4 Pacific, and 14 other ethnicities
  • 202 females (10 girls and 192 women) have been diagnosed with HIV infection since 1986 (14 per cent of total cases)
  • Of the 113 new cases of HIV in females since 1996, 19 were in European women, 5 Maori, 7 Pacific, and 70 other ethnicities
  • 70 per cent of females with new HIV infections were members of ethnic groups other than European, Maori and Pacific
  • Of the new HIV cases in women, 80 percent arose from heterosexual transmission, 4 were acquired before birth, 1 case arose from intravenous drug use, 1 from blood transfusion
  • 93 of the new cases of HIV infections in females were thought to be have been acquired overseas, with 51 acquired in Africa and 22 acquired in Asia
  • Of the 20 females whose infections occurred in NZ, 19 were infected by heterosexual means and 1 was infected perinatally
  • Seven of the women infected heterosexually in NZ had partners from high prevalence countries, while 7 had partners with other HIV risk factors
  • There is an increase in HIV among women with 32 per cent of HIV cases being in women in 2000.

These statistics are from AIDS- New Zealand Issue 48 August 2001

Medical abortion pill approved for NZ, but will it be used?

Sandra Coney discusses the approval of RU486 and problems about its use in the New Zealand setting

RU486 (Mifegyne (registered trademark) has been given the go-ahead by the Ministry of Health's Medsafe. A group of doctors formed a not-for-profit company called Istar to apply for the approval and after two-and-a-half years' negotiations, the drug will now be available for medical abortions. It is being hailed as another choice for women. But it is not that simple.

The drug works best early in the pregnancy and is not recommended after nine weeks LMP. It is also used for later pregnancies where there is a foetal abnormality or the foetus is dead. If Mifegyne is given before prostaglandins, it considerably shortens the length of labour.

For abortions, Mifegyne is most effective when used in combination with prostaglandins, which are given 36-48 hours after the administration of the Mifegyne.

Medsafe's Dr Stewart Jessamine says strict controls have been placed on its use. It can only be used by clinicians on premises licensed under the Contraception, Sterilisation and Abortion Act.

Dr Jessamine says that Medsafe had legal opinions that said that while women could leave the clinic after taking the Mifegyne after taking the prostaglandin, they cannot go until the abortion is complete. This is because the CS&A Act says that in New Zealand abortions can only be performed on licensed premises. As a small percentage of women abort after taking the first-stage Mifegyne, and this will take place outside the clinic, this requirement seems a contradiction, but Dr Jessamine says the legal opinion was that this met the criteria in the Act.

Is it practical?
The condition to stay on the premises after the prostaglandin makes it arguable whether RU486 can practicably be used in New Zealand. Overseas studies show that about 60 percent of women abort within 4-6 hours. This means that about 40 percent of women will not have aborted within a working day. Overseas studies show that some women take up to two weeks to abort.

Most New Zealand clinics are day-stay facilities, although all must have back-up arrangements in place when women need to be monitored overnight. To meet Medsafe's requirement, clinics would have to be able provide in-patient facilities. They would presumably only be able to transfer women to a hospital if it was licensed for abortions, and even then, it would be a very costly exercise to keep women in hospital while waiting to abort.

Another possible option would be to carry out a surgical abortion if women did not abort within 4-6 hours, but women would still have to be monitored for a couple of hours after the surgery. If a significant number of women ended up having to go through both medical and surgical abortions, this would destroy the argument of choice. The supposed non-surgical advantage of using medical abortion is undermined if a follow-up surgical procedure must be performed within a short timeframe.

Istar director, Dr Margaret Sparrow, says that it is doubtful that under this regime there will be much use of RU486.

'There are too many ³ifs², ³ands² and ³buts²,' she says.ŒIt won't be impossible to offer it to early cases, but everyone is well aware how difficult it will be under the present law. The clinics won't have the beds, or the funding for the beds. It will be used for second trimester abortions, as they are geared up for women staying now.'

But the Ministry's Sexual Health Strategy senior analyst, Stuart Bruce, does not see a problem. He says that as abortion clinics must have access to in-patient services, this would cover the legal requirement that women given RU486 must abort on licensed premises. He says it is'the clinicians' call as to whether they offer it or not.'

He also predicts that Parliament may have to revisit the CS&A Act'to make sure the legislative environment is up to speed. We need to consider the approval as a step in a process.'

How good was the safety assessment?
Stewart Jessamine says that how RU486 would be used in a New Zealand setting was not a question Medsafe needed to look at. It was only concerned about safety and efficacy. This raises a query of how Medsafe could have decided RU486 was safe and effective when the data on which it would have based its decision used a protocol that cannot be followed in New Zealand because of the law.

For example, if under the New Zealand regime only 60 percent of women would successfully abort after the Mifegyne and prostaglandin, then this significantly lowers the efficacy rate for the method which in overseas studies has been 95 percent. And if we take a global view of'safety', there would be more risks to women if some 40 percent would have both surgical and medical abortions, and there would be risks around women's right to make informed choices. What would happen if a woman who did not abort after six hours wanted to leave it for a week or so rather than move to surgical abortion. Would she have to stay on licensed premises for all this time, or could she leave? She could not, after all, be detained. Or would she come under great pressure to accept surgical abortion, even though leaving it would be the safer option (both medically and psychologically) for her?

Ethical review
So far there has been no ethical review of the use of RU486 in the New Zealand setting. Dr Jessamine says that as the drug has had Medsafe's approval, there is no need for it to be taken to an ethics committee as an'innovative treatment'.

But Sharron Cole, Chair of Chairs of Ethics Committees, says that ethical review of the wider issues should occur.

'Ideally, this is the sort of issue that could go to the new national ethics committee, when it exists, as it is an issue of national importance.'

Footnote
In 2000 Women's Health Action hosted a seminar on RU486.The notes from this seminar are available here . See also a report on women's satisfaction with abortion methods including RU486.

Doctors punished for poor care of women during cosmetic procedures

Cosmetic surgery and so-called'appearance medicine' have been in the news with two high profile cases involving Dr Ian Little and Dr Warren Chan. Sandra Coney reports.

In the High Court, Dr Little was convicted of'failing to provide the necessaries of life thereby endangering [Leana Steven's] life or permanently injuring her health.' Mrs Steven died following a face peeling procedure. Dr Chan was found guilty of professional misconduct by the Medical Disciplinary Tribunal for failing to gain informed consent to a liposuction procedure, inadequate notes and providing inadequate care and follow-up. This is the fourth time Dr Chan has been found to have provided poor care in the course of his liposuction work and the Medical Council has circulated a warning to women and women's groups (see below).

The Little case
Dr Little of Christchurch was originally charged with manslaughter following the death of Mrs Steven but when he pleaded guilty to the lesser charge he was discharged on the manslaughter count. He still faces disciplinary charges.

Dr Little is a GP who set himself up as a practitioner in the newly created field of appearance medicine. He entered into an agreement with a Ms Bat-Zion Susskind to exclusively perform chemical face peeling using the Exoderm method. Their joint marketing exercise involved the use of a public relations firm.

Between late 1998 and early 1999 he performed the procedure 11 times, the last of these on Mrs Steven. The tenth was filmed and shown on the Holmes Show as a marketing exercise.

Dr Little approached a beautician Shelley Scott with an offer of a free Exoderm procedure as long as the woman agreed to be photographed for a feature in New Idea.

Ms Scott produced her 56-year-old mother, Mrs Steven, as the model for the marketing exercise.

It turned out that Mrs Steven was a regular smoker, her brother had had a heart attack and both he and their mother had suffered from angina. A post-mortem showed she had significant narrowing of the arteries, but when she met up with Dr Little she was fit and in apparently good health.

Plastic surgeons and dermatologists told the court they would not carry out the procedure without an anaesthetist, but Dr Little did not use one. He had some experience of anaesthesia but was not a specialist anaesthetist.

Marketing before safety
Prior to the procedure, Dr Little had ordered a pulse oximeter and resuscitation kit to monitor the patient's pulse and revive her should a complication occur. This was recommended for carrying out this procedure. Exoderm consisted of phenol or carbolic acid which burns off the top layers of skin, and it is known to be systemically absorbed. Phenol can cause cardiac arrhythmia and, on occasion, cardiac arrest.

However, on the day of Mrs Steven's appointment the pulse oximeter and resuscitation kit had not arrived. Despite this, Dr Little pressed on. Mrs Steven was prepared for surgery, although the judge noted her lipstick was not removed and he speculated whether this was to make her appear better for the New Idea photographer.

In the event, the lipstick hindered Dr Little's ability to detect any change in the colour of the lips that would have indicated that all was not well.

Mrs Steven was given sedatives through an intravenous line and instantly went into a deep sleep. She did not respond when talked to. The only time she reacted was about 30 minutes into the procedure when she flinched, gasped and squeezed the nurse's hand as the Exoderm was being applied to her eyelids. Dr Little gave her morphine.

Guidelines for the use of phenol were that when rational communication was lost with the patient, the procedure should have been stopped.

The emergency
Finally, as Mrs Steven's face was being taped up at the end of the face peel, she gave a load groan and it was realised that there was a serious problem. The nurse checked Mrs Steven's pulse and found none. Dr Little found she was not breathing. The photographer was asked to leave the room.

Dr Little and the nurse attempted resuscitation. An artificial airway was not available in the room as it was in the back of Little's car. There was no oxygen available, no suction device and no manual airbags.

The nurse had CPR training (Little didn't) and began resuscitation although this was criticised at the hearing. This continued when ambulance officers arrived but it was not until she was in the ambulance on the way to hospital that Mrs Steven was revived. By this stage she had suffered irretrievable brain damage. She died three weeks later as a direct result of the cardiac arrest she had suffered during the face peel.

Dr Little's crimes
Justice Young determined that Dr Little's criminal behaviour relating to the failure to provide the necessaries of life included:

  • The absence of the pulse monitor
  • The absence of oxygen and and other resuscitation equipment
  • The failure to continuously monitor her state of consciousness and cardio-respiratory function
  • The failure to stop the procedure once Mrs Steven became unconscious and attend to treating her.

Justice Young said that Little narrowly avoided being found culpable of manslaughter. He cautioned him against thinking that this case was simply bad luck, unfair or being a one-off error. He said that Dr Little allowed his good judgement to be clouded by the Exoderm marketing programme. There was no need to carry out the procedure on Mrs Steven before the safety equipment arrived except that he did not want to delay because he had the publicity arrangement with New Idea. The judge considered that Mrs Steven had lipstick on because it made sense in a marketing, not a medical, sense.

Justice Young concluded that when Mrs Steven lost consciousness, the pressure of the presence of the photographer persuaded Dr Little to continue instead of stopping.'The whole concept of performing a serious medical procedure as a publicity exercise was fundamentally flawed.'

Because Dr Little had ordered the safety equipment he had demonstrated he was aware of the risks, yet he chose to continue. This was the 11th time he had carried out the procedure without the equipment, so it was not a one-off error.

The were two ways in which Dr Little was criminally negligent ­ first, he should not have embarked on the face peeling procedure, secondly, he should have stopped when Mrs Steven lost consciousness. The judge said he was satisfied that had he stopped then, Mrs Steven would not have died.

Dr Little was fined $30,000, Justice Young noting that the publicity around the case would prevent any repetition of such behaviour.

Serial offender, Dr Warren Chan
The Medical Practitioners Disciplinary Tribunal has suspended Dr Warren Chan for a period of nine months, and fined him $12,500 (and $19,201 costs) after upholding a charge of professional misconduct against him. In addition, he must have a competence review.

This was the fourth such charge found against Dr Chan since 1995, but there had been concerns about Dr Chan and charges from the early 1990s. In the early 1990s Dr Chan began advertising liposuction widely but complaints from dissatisfied patients soon began to surface.

In 1991 Dr Chan told Maggie Barry he carried out over 1000 operations each year and claimed that liposuction was'the best operation ever developed'. He also inserted breast implants and later penile implants. Concerned at Dr Chan's activities ­ he had clinics in several cities - the Foundation of Cosmetic Plastic Surgeons began speaking out against him.

In 1993 six patients complained about Dr Chan to the then Medical Practitioners Disciplinary Committee and he was censured for serious deficiencies in advertising, inadequate care, shortfalls in hygiene, failure to keep records, failure to properly monitor patients in recovery, and inadequate post-operative care for patients who developed infections. In 1999 he was found guilty of professional conduct in the case of a patient on whom he carried out liposuction in May 1996. The charges were that he failed to obtain informed consent, that he failed to adequately assess the patient before the operation, and had poor records. Dr Chan was to be reviewed by the ethics committee of the Medical Association and be supervised. On appeal, this latter requirement was removed by the District Court which said it had proved impractical.

The case of Mrs A
The present case related to liposuction in July 1996. The charges were that there were serious deficiencies in his clinical practice:

  • that he failed to adequately inform the patient Mrs A of the anaesthetic process and the liposuction procedure she was to undergo,
  • that he failed to inform her of the risks associated with the procedure
  • that he failed to keep full and accurate records of his preoperative, intraoperative and post-operative care.

The decision does not contain full details of the case, but Mrs A said that she felt pressured into having liposuction, and the MPDT concluded that the methods used by Dr Chan and his staff to discuss the potential outcomes of liposuction fell far short of informed consent and'were effectively no more than a sales pitch'. The MPDT determined that Dr Chan took no steps to gain Mrs A's consent to the procedure, and that the information she was given that liposuction was'completely safe' was untrue. Research shows that the late 1990s mortality rate was 20 per 100,000 in the US. This compared with the fatality from car accidents of 16.4 deaths per100,000. in the US.

Dr Chan, who is a GP without specialist anaesthetic qualifications, did not carry out preoperative assessments or physical examination to see that Mrs A was a suitable candidate for anaesthesia and he used a high dose of the sedative/hypnotic Hypnovel. An expert anaesthetist said the dose given to Mrs A was'an excessively large dose to use on a patient who is lying in the prone position, who has an unprotected airway'. Hypnovel was used with Pethidine, Valium and Palfium. The expert said that the combination of drugs for a prone patient was'dangerous practice'. Guidelines said that the patient should be sedated but not unconscious, whereas it seemed that Mrs A had lost consciousness. When she woke during the procedure in considerable pain, she was given more sedation to make her go back to sleep. After the procedure she woke alone in the dark in Dr Chan's office. The MPDT concluded that Dr Chan was an'unsafe practitioner'.

A'reckless disregard'
The Tribunal, headed by barrister Wendy Brandon, accepted counsel Dr Rodney Harrison's submission that Dr Chan, having been disciplined by the Tribunal and its predecessor a number of times in similar circumstances to the present case, had demonstrated a pattern of'reckless disregard' for his professional duties and that he was indifferent to his profession and the Tribunal.

From 1 July this year changes in legislation mean that Dr Chan is unable to practice cosmetic surgery without oversight. It appears unlikely that any plastic surgeon in New Zealand will provide this oversight.

Notice to women's health organisations from the Medical Council of New Zealand

You may be aware of publicity in August about Dr Warren Chan who is a doctor in Auckland. Dr Chan undertakes cosmetic procedures such as liposuction and breast implants or reductions. Dr Chan is currently suspended from practising medicine until January 2002. He is not allowed to treat, prescribe medicine or operate on patients in any way. Dr Chan was suspended in April this year dur to continuing professional misconduct. The circumstances of Dr Chan's most recent offending before the Medical Practitioners' Disciplinary Tribunal were not informing a patient properly about a procedure, its risks, benefits or suitability, seriously deficient anaesthetic practice, and manifestly inadequate records kept before, during and after the operation. The Medical Council recommends that people considering invasive cosmetic surgery go to a vocationally registered plastic and reconstructive surgeon. If women have concerns or queries about this doctor, please call the Medical Council on 04 384 7635 and ask to speak to the Assistant Registrar. Sue Ineson Chief Executive/Registrar

Advocacy after five years

On the anniversary of the release of the Cartwright Report, Tania Thomas, Director of Advocacy in the Office of the Health Commissioner, spoke at a commemorative event. This is an edited version of her talk.

Director of Advocacy's background
I am the granddaughter of Myrtle and Tom on my Irish and Scot's side, the granddaughter of Tipene and Erana on my Maori side and the daughter of Nola McDermott and Herewini Tamati. I am a mother with three daughters and partner to Robert.

I mention my heritage and my family because in my role as the Director of Advocacy under the Health and Disability Commissioner Act I come face to face with the issues that I hope my family will never have to endure. Given that quality health care and disability support services are considered key determinants of wellness I want providers to do their very best when it comes to my family. I expect that you want the same for your families and that you want assurances that your rights and theirs are recognised and respected and if they are not that they will have some protection.

When considering my family and the services they may receive, I ask myself, have providers'got the message', are they doing the right thing and are they doing it right? Some have got the message, some haven't but more dangerous are those providers who are politically correct and well-trained.

I liken it to my experience as a Maori where people have a great deal of information about the Treaty of Waitangi and the aspirations of Maori however it doesn't always bring enlightenment and these people may continue to carry out racist practices. Some providers have not taken to heart the intent of the Code of Rights even though they know they have legal obligations under the Act.

I am outraged, disappointed, sad and appalled when I read the complaints made by courageous consumers. I can't believe I am in the year 2001 when I read some of these complaints, things don't seem to have moved on from my days as a student nurse.

However I am not put off. These recent experiences and my induction into my new role has only served to spur me on to assist in making a positive and lasting difference in the lives of health and disability consumers with advocates I am proud to walk beside.

I believe and uphold the Commissioner's vision for HDC and have agreed to adopt it as the Advocacy vision.

Vision
The rights and responsibilities of consumers and providers are recognised, respected, and protected in the provision of health and dis-ability services in New Zealand.

Mission
Our mission is to promote the rights and responsibilities of consumers and providers and to resolve complaints by fair processes and credible decisions to achieve just outcomes.

Advocacy past, present and future
I have been in the role of Director of Advocacy since January this year. Nationwide advocacy services have been operating for five years now, under the Health and Disability Commissioner Act. I would like to share my thoughts on advocacy past, present and future.

ADVOCACY PAST
In the seven months I have been in the job I have copped a bit of flak from disability consumer groups, Maori organisations and women's health consumer groups including Women's Health Action Trust and the Auckland Women's Health Council.

I have the impression that advocacy services as they have been administered in the past are not seen as being a strong voice, they are seen as inflexible and that the empowerment model of advocacy assumes that the problem lies with the consumer not the health system. The empowerment model also seems to be seen as a convenient way of managing advocacy funding cuts by ensuring the onus is on the consumer to do it all themselves with minimal support from advocates.

It has been implied that advocates lack heart and if I am not careful will become robotic automatons slavishly complying with the rigid letter of the empowerment model without being human and approachable.

The service is under-funded and prioritisation of advocacy services is inevitable and unacceptable.

I have been accused of contracting services that don't offer long-term support where it is needed.

I have been told that low-level resolution is all well and good but what is the threshold for serious concerns around public safety, and do I understand that low-level resolution is not always appropriate.

There have been queries about the consistency of advocacy services and the adequacy of training for advocates. Advocates, I have been told, are ill-equipped to work with the diversity of consumers especially those who are Maori, consumers with multiple disabilities and consumers with severe hearing impairments.

I am in big trouble if I don't listen to you, the people on the ground closest to the action, closest to understanding how it is for women health consumers. I thank you for speaking up and giving me the information I need to better direct advocacy services.

I am aiming to direct an advocacy service that is well resourced, equipped to manage the complexity and diversity of complaints. I want to work alongside skilled and sensitive advocates who are responsive and innovative in working alongside consumers.

My main message today, despite the fact that I don't feel 100% assured that my family will have their rights respected when receiving a health or disability service, despite the fact that I see complaints on a daily basis that tell me some providers still haven't got the message or if they have and they are ignoring it, despite the fact that there are areas that need to be improved in the delivery of advocacy services, I do feel hopeful. The statistics I have from data collected about advocacy services is very positive. It tells me that advocacy works, it also tells me there are areas requiring work.

ADVOCACY PRESENT
Advocacy service statistics

  • Enquiries Closed 8,247
  • Complaints Managed 5,102
  • Presentations to Consumers and Providers 1,826
  • Contacts 3,402

Interesting complaints statistics

Ethnicity

  • 13% of all complaints managed by advocacy services were from Maori consumers.
  • 3% of all complaints managed by advocacy services were from Pacific Islands (including Samoa, Tongan, Nuiean and Cook Island) consumers.
  • 2% of all complaints managed by advocacy services were from Asian (including Indian and Chinese) consumers.
  • The majority of complaints are from New Zealand Europeans

Gender

  • 60% of complainants were female
  • 29% of complainants are male
  • 11% of complainants did not state their gender

Age

  • People over 25 made 48% of complaints managed by advocacy services.
  • The age groups 26-60 represent those who most frequently complain across all ethnic groups, both male and female.
  • New Zealand Maori, New Zealand European and Other European are the only ethnic groups that have complainants 61-99 years of age.

Ethnicity/Gender and Age

  • The highest number of complaints are made by New Zealand European females over the age of 25.
  • The second highest number of complaints are made by New Zealand males over the age of 60.

Frequent complaint issues

  • 74% of all complaints managed by advocacy services are around the following three issues:
    1. Appropriate standards - represents 51% of all complaints
    2. Fully Informed - represents 12% of all complaints
    3. Effective Communication - represents 11% of all complaints

Outcomes of complaints

  • 76% have been partly or fully resolved with the assistance of advocacy
  • 12% are unresolved at advocacy and have been referred to HDC
  • 12% have been withdrawn and consumers have decided not to proceed.

Referral methods of complaints
The majority of referrals are self-referrals through the regionally-based advocacy services. Health providers, followed by friends of consumers, other agencies and relatives make up the next most frequent referring agents.

Consumer satisfaction with advocacy services

  • 60% are satisfied

Low-level resolution
The advocacy service offered by advocates centres on achieving low-level resolution where appropriate. Advocates work with consumers to achieve constructive challenging that will ideally result in resolution between the parties concerned. This means that advocates have to simultaneously avoid complicit acceptance of the situation being faced by the consumer as well as avoiding conflict that is likely to be unproductive. This requires advocates to use high skill levels especially in an environment where complaints are becoming increasingly complex.

Empowerment advocacy
When advocates are practicing constructive challenging to achieve low-level resolution they are either assisting a consumer with self-advocacy or they are acting on the consumer's instruction. Advocates use what is called empowerment advocacy to assist or act on behalf of a consumer.

Empowerment is linked to advocacy. It is about choice, choosing one's own solutions to issues and concerns. The aims of empowerment are to assist consumers to see:

  • Themselves as causal agents in finding solutions to their problems
  • Themselves as having skills and strengths
  • Advocates as having knowledge and skills that consumers can use
  • Advocates as peers and partners in solving problems
  • That power structures are complex and partly open to influence

The advocate roles that work best in empowerment are as a:

  • Resources person - linking consumers to resources in ways which improve their self-esteem and problem-solving abilities
  • Sensitiser - assisting consumers to get self knowledge
  • Teacher/trainer - teaching processes and skills that enable the consumer to complete specific tasks

Advocates use a solution finding process with consumers that allows for a series of actions to:

  1. Define the issues
  2. Look for a range of options
  3. Identify resources and skills the consumer and his/her family and or friends can contribute
  4. Choose a solution
  5. Take action using the chosen solution
  6. Evaluate the result.

Is advocacy the HDC way working?
As I have already said there has been criticism of the empowerment model of advocacy as used by advocates such as:

  • Advocates are ill-equipped to work with the diversity of consumers especially those who are Maori, consumers with multiple disabilities and consumers with severe hearing impairments.
  • The empowerment model of advocacy assumes that the problem lies with the consumer not the health system.
  • The empowerment model also seems to be seen as a convenient way of managing advocacy funding cuts by ensuring the onus is on the consumer to do it all themselves with minimal support from advocates.

It is true that advocacy resources are limited and that we cater for a very diverse group of health and disability service consumers. I do however reject the notion that empowerment advocacy is merely a means of abdicating our responsibilities as advocates or that our practice is not flexible enough to cater for the diverse needs of consumers. There is an issue around the low numbers of complaints we receive from Maori, Pacific Islands peoples and people with multiple disabilities this is however is another topic altogether.

ADVOCACY FUTURE
Patients' rights are on the map thanks to the Cartwright Inquiry. In the future I see that not only will they be on the map but people will be using the map, getting their bearings, they won't be lost, they will see other destinations and there will be pit stops with supplies and resources that they can make use of.

Advocacy model and philosophy
This will be reviewed to ensure it is consistent with what the Act requires and feedback from consumers that will enable us to be more responsive to their needs. There are a number of approaches being used in community organisations using a strengths-based approach and a technique called Appreciative Inquiry which aims to have people take a much more creative view of their situation and therefore offer more opportunities for resolution.

Advocates
Once we have confirmed the model and the philosophy we can look at what competencies are required for advocates to implement the model. A national induction process, core competency training and specialty training will be introduced this year. I aim to establish a national qualification for advocates in a few years and will establish a code of practice this year.

More comprehensive training and support for advocates will be provided so they can work at all levels along that continuum of advocacy, within a range of types of advocacy with confidence.

We have 27 full-time equivalents and that isn't enough. I will be seeking additional funding in the next budget round. Advocates need to work face-to-face with consumers as much as possible. They need to extend their services to support consumers once their complaint has gone to HDC for investigation and then continue supporting the consumer through the proceedings process. The referrals from HDC are increasing, this is a reflection of the increased complaints HDC are receiving.

Advocacy service
I do not support Robyn Stent's recommendation that advocates become permanent employees of the Commissioner reporting and responsible to the Director of Advocacy. I intend to continue contracting the advocacy services.

I want to ensure there are specific contracts for Maori, Pacific Islands consumers and consumers with disabilities, particularly people with disabilities who may experience high levels of vulnerability.

The processes for monitoring and evaluating advocacy services are about to be revamped. Evaluation of the efficacy of the HDC advocacy system is independently carried out. I know we are complying with the requirements of the Act. I do not know that consumers have felt empowered or whether they feel they will be able to advocate for themselves in the future. Meaningful performance measures will be developed including those required to cut the grade as an advocate. The measures need to be a mixture of qualitative and quantitative as well as output volumes we need to measure outcomes.

The data collected by advocacy service organisations is under review along with satisfaction survey formats.

A consumer advisory group will be established prior to the end of this year to work alongside the Commissioner, the Director of Proceedings and me. The purpose of this group will be to advise on a range of issues. This group will be important to me as the Director of Advocacy. It is important that all advocacy action taken by me is rooted in the needs and experiences of consumers. The establishment of this as a mechanism and a forum for issues to be frequently debated and proposals tested is essential, so that my lobbying at a National level and my direction of Advocacy Services is grounded in local experience.

Next steps
In an environment where health reforms continue and managers of health services state the services they operate are under funded, where fragmentation of health services and poor co-ordination of services is evident, where the Act and the Code are not implemented with any depth or in a meaningful way, advocacy is a must.

But despite the environment, I do feel hopeful. Nelson Mandela said' I have discovered the secret that after climbing a great hill one only finds that there are many more hills to climb. I have taken a moment here to rest, steal a view of the glorious vista that surrounds me to look back on the distance I have come. But I can rest only for a moment, for with freedom comes responsibilities, and I dare not linger, for my walk is not ended yet'.

This quote reminds me that we have climbed several hills already, the Cartwright Report, the Act, the Code of Rights, Advocacy Services and our journey has not ended. There are more hills to climb.

I have a backpack, pitons and ropes, I am fit and I am ready for the climb that is to be mine for the next few years. I hope I have you all in my team whether you are at base camp or a support climber. I will do my best to get us to the top of the next hill.

Setting the standard for health and disability

Standards New Zealand has developed a new health and disability standard for the Ministry of Health, with a surprising result. Sandra Coney takes a close look

'An important milestone in the goal to achieve a systematic approach in the delivery of health and disability services' and'the culmination of over two years extensive collaboration between the health and disability sector providers, consumers/kiritaki, the Ministry of Health, the Health Funding Authority and Standards New Zealand' is how Dr Karen Poutasi, Director-General of Health, described the new Health and Disability Sector Standards: Te Awarua o te Hauora.

Over 60 people actively took part in management and expert committees during the two-year process, and around 180 organisations made public comment. There was a nationwide roadshow in February 1999.

Women's Health Action was flabber-gasted that as an organisation with a key focus on health consumers' rights and the health service needs of women, this had all passed us by.

We could only find one women's group, from Hawkes' Bay, that had participated in the process. The groups that had participated were predominantly those concerned with disability groups, mental health services, and residential and institutional care, as well as a great number of DHBs, or CHEs or HHSs as they were variously called over the long period of the development of this standard.

Parent to Parent, Te Kete Hauora and the College of Midwives, were the only representatives of well person, primary health care, or health promotion services among the 60 members of the expert committees.

A few more groups made public comment, including Family Planning. But we wondered why the Building Industry Authority, Effective Business Technologies and Harbourside Investments Ltd, were invited to take part, when women's health groups and other community-based health NGOs were not.

The contents absolutely reflect the community of interest of those consulted. The standard is focused on consumers' rights, management, entry to services, service delivery, and safe and appropriate environments as they apply to those in residential and institutional care. Yet the Director-General's foreword and the Ministry's preface talk about these as standards for the health and disability sectors. If they had been named'Health and Disability Sector Standards for Residential and Long-stay Care' there would be less argument about the process or outcome.

Even then there are gaps. One of the most vexed areas in residential and institutional care is the relationships of providers with the families of people in such care, especially if the person is not fully competent or when competence varies.There is little here to guide families, caregivers or providers in how these relationships can be established and maintained. For example, there is nothing in the informed consent section about the involvement of families.

There is also a failure to include a gender perspective in the standard. The needs of men and women in residential and long-stay care differ with regard to such things as sexuality, reproductive control, repro-ductive rights, safe sex practices, menstrual hygiene, urinary control, and so on. Girls and women are more vulnerable to sexual abuse, violence, and sexual harassment from both other residents and staff. For instance, what is the standard around other residents' possession or display of pornographic material, or women's rights to contraceptive choices, to managing menstruation without recourse to drugs?

Sexual orientation is not covered and lesbian and gay groups and the AIDs Foundation did not take part. But then sex in any form is simply absent.

There is a lot about floor surfaces and tap fittings, but nothing in the standard that acknowledges that men's and women's needs differ, that sexuality is an issue, and that women may need protection.

The Draft Operational Standard for Health and Disability Ethics Committees - the view of regional ethics committees

Recently the Ministry of Health released a draft new standard for ethics committees for comment. Sharron Cole, chairperson of the Wellington Ethics Committee and chair of the Regional Ethics Committees Chairs' Group, outlines the concerns of regional ethics committees and why they have rejected the standard.

The first National Standard for Ethics Committees was published in 1988 and since that time, the document has been revised a number of times as the experience and knowledge of regional ethics com-mittees broadened. The current national standard, published in 1996, was developed by the short-lived National Advisory Committee on Health and Disability Services Ethics (NACHDSE), together with the Health Research Council Ethics Committee and representatives from regional ethics committees.

The 1996 standard set out guidelines on the constitution, operation and account-ability of ethics committees. In its introduction, it noted that its focus was on'the review of research and innovative treatment but some advice is given in the area of ethical advice on services while recognising that this is an area where further work is needed'. It was intended that a review of the standard would be carried out in 1998.

The intended 1998 review in fact got under way in 1999 and by 2001, for various reasons, is still not completed.The unsatis-factory nature of this delay was highlighted by the Report of the Ministerial Inquiry into the Under-reporting of Cervical Smear Abnormalities in the Gisborne Region. Some of the recommendations of the inquiry were based on its perceptions of the ethical review process in New Zealand and while the accuracy of the perceptions can and have been debated, they nevertheless raised issues which a revised standard could either address or clarify.

The Ministry of Health believes that the National Advisory Committee on Health and Disability Support Service Ethics (the National Ethics Committee), to be established under the NZ Public Health and Disability Act 2000, will address the Gisborne Inquiry recommendations as part of its oversight role of ethical matters in the health and disability sector. Because this may take some time, the ministry decided to proceed with the review of the 1996 standard and therefore circulated the Draft Operational Standard for comment.

What's wrong with the new draft standard
In late August, there was a meeting attended by chairs of all the regional ethics committees, the chair of the Health Research Council Ethics Committee, the chairs of the accredited institutional ethics committees and also the chair of the New Zealand Polytechnic Research Group. It was the unanimous recommendation of all the chairs representing their various ethics committees that the Draft Operational Standard was neither workable nor acceptable and it should not replace the current National Standard for Ethics Committees 1996.

The reasons for this are:

  1. Contravenes international statements and guidelines
    The draft contravenes international statements and guidelines on the ethics of research involving human participants. While New Zealand has a uniqueness that must be reflected in any national standard, New Zealand cannot and must not depart from internationally accepted standards for ethical review. Any departure would be unacceptable for reasons of principle but also has further implications. Sponsors of internationally conducted research have very specific requirements with respect to ethical review and the departure of any country from internationally accepted ethical principles means that they would not permit research to be carried out in that country. Further, international reputable journals do not accept for publication research that is not carried out in accordance with the principles of the Declaration of Helsinki.
  2. Multi-centre review process
    There is no mention of the multi-centre review process in the document. This may well be because it is envisaged as a future role of the National Ethics Committee in any function it undertakes with respect to reviews on'priority issues of national significance' as requested by the Minister of Health. Any review of health research, be it single or multi-centre, must comply with the requirements of international regulatory and licensing bodies and failure to do so could jeopardise multi-centre research, most of which is currently multinational. One of those requirements is that ethical review must be undertaken free from all political interference. The issue of independence and possible conflict of interest must arise where the review committee is appointed by the minister.
  3. Regionally-based health services
    Ethical review by a single, centralised committee would run counter to the current emphasis on regionally-based health services. It would also take New Zealand out-of-step with current international practice, which encourages the carrying out of ethical review as close as possible to the population of research participants. It would make consultation with local iwi extremely difficult.
  4. Right to appeal to the National Ethics Committee
    The draft standard refers to the right to appeal to the National Ethics Committee about ethics committee decisions. Ethical review is based on a consideration and application of ethical principles. While one can debate principles and their relative merits and weighting, it is not possible to appeal principles. The right of review of decisions of regional ethics committees by way of a second opinion is more appropriate.
  5. Appeal process
    There are grave concerns about the proposed appeal process as this puts in place the possibility that ethical decisions by an ethics committee properly constituted and operating in accordance with internationally accepted principles can potentially be set aside by a body which does not comply with those requirements. It is not appropriate that the National Ethics Committee should be a final appeal body as this could jeopardise the independence of the current ethical review process. Any appeals process would take New Zealand out-of-step with accepted international ethical conduct.
  6. Treaty of Waitangi
    The place of the Treaty of Waitangi as New Zealand's founding document is not adequately acknowledged in the draft standard. The provisions of the Treaty require that the crown and its agents respect its principles and any national standard must reflect what this means for ethical review in New Zealand.
  7. Legal approach
    There is an over-emphasis on a legal approach in what is an ethical and principled document and consequently, the draft is too prescriptive and too legalistic. The general tenor appears to be that if something is legal, it is therefore ethical, a premise rejected by ethicists.
  8. Language used
    At times, the language used in the draft standard is vague and it is also inconsistent. It is important that any national standard for ethical review is clear on its understanding of the basic principles of ethical review and that the key terminology is also unambiguous and consistent. There is also inconsistency in the standard whether the process of ethical review is open or confidential
  9. The decision-making process
    The national standard and the decision making process that it defines for ethical review in New Zealand again must be consistent with internationally accepted guidelines. This must be by consensus decision-making, not by majority vote. This would also have implications for the National Ethics Committee with the present proposal in the terms of reference for a majority vote where the committee is unable to research a decision by consensus. It is not clear whether the National Ethics Committee would operate under the national standard and it would certainly be inconsistent with its role if it did not.
  10. A generic standard
    The 1996 standard is not relevant to most of the work done by institutional ethics committees and the new draft is even less relevant. The regional chairs, institutional chairs and HRC Ethics Committee were of the view that a generic standard for the ethical review of research involving human subjects is highly desirable to ensure that any such research is both consistent and conducted on internationally accepted ethical review principles.
  11. Definitions
    The draft operational standard does not have satisfactory definitions for important ethical terms such as serious adverse events, innovative practice and audit.

Draft standard rejected
It is the view of regional chairs therefore that the 1996 National Standard for Ethics Committees should remain in operation until the merits of a shared set of principles covering all research involving human participants are explored. The combined August meeting recommended to the respective ministers that there be collaboration amongst the Ministry of Health (including regional ethics committees and the Health Research Council), the Ministry of Research Science and Technology, the Vice Chancellors' Committee and Associate Polytechnics of New Zealand to explore the merits of a generic standard.

Deficiencies in 1996 Standard
There is however valid concern with certain aspects or deficiencies in the current standard. These have been identified and the following suggestions made for remedying the deficiencies:

  1. The HRC paper on innovative treatment is comprehensive, thoughtful and can be included as an appendix.
  2. There is difficulty with the definition of lay and health professional members, both for regional ethics committees and for institutional committees. This needs addressing urgently.
  3. The definition of audit currently appears in two places in the standard, neither of which fit neatly together. This problem with defining what constitutes audits needs immediate attention.
  4. Research on children is absent from the current standard but the work done by Nicola Peart and David Holdaway can be inserted as an appendix.
  5. Research on incompetent persons has been an issue addressed by regional ethics committees and an almost completed paper could be included as an appendix.
  6. The HRC Ethics Committee has further refined the multi-centre process. There is currently very little dissatisfaction with the multi-centre process and the new updated version could be included as an appendix.
  7. The HRC paper on the ethical considerations relating to research in human genetics could be included as an appendix.
  8. Clarify what is an open and what is a closed meeting.
  9. Clarify what must be provided under an Official Information Act request.

Regional ethics committees welcome a National Ethics Committee that has the power to strengthen and enhance the present structure of accredited ethics committees. It also welcomes a review of the National Standard. However, any changes to the process of ethical review must keep New Zealand within internationally accepted standards and always keep as the first and most important principle, the protection from harm of individuals who participate in health and disability research.

The Draft Operational Standard for Health & Disability Ethics Committees can be found at www.moh.govt.nz. Submissions are now closed.

Some progress on National Women's

The Health Service Delivery Plan team that is master-minding the transfer of National Women's Hospital in Auckland into the new Acute Services Building (ASB) on the Grafton site has come up with some potential solutions to concerns about the shift.

NWH will be spread across the new ASB and the old Tower Block (existing Auckland Hospital). It is now planned to remove the ramp that currently takes people to the front entrance of Auckland Hospital and to create a NWH entrance at one level lower that the present front door.This is separate from the ASB entrance and would have NWH signage.

This would enable women to be dropped at the main door, or park briefly if urgent access is required.

A lift would take people directly to the NWH floors in the Tower Block and an airbridge at the same level would connect to the NWH floors of ASB.

Planning has also started on the Greenlane site which will contain an ambulatory centre, rehabilitation centre and short stay surgical. The current plan gives a completion date for these of late 2003. Outpatients' women's services and day-surgery for women will be located at the Greenlane site.

Ex-psych patients get big payout

Former Lake Alice patients have accepted a $6.5 million government compensation offer. In April 1999, almost 100 former patients lodged a claim in the High Court saying that they been tortured and sexually abused at the hospital's child and adolescent unit between January 1972 and December 1977. They said they were given the drug paraldehyde which causes extreme pain and electric shock treatment as forms of punishment. Former High Court judge Sir Rodney Gallen is meeting claimants to determine how the money should be split. If split evenly, each claimant would receive about $60,000 before costs which could be as much as 40 percent of the settlement. A report from Sir Rodney is expected in October.

New warnings about third generation oral contraceptives

A new Dutch study confirms women taking third generation oral contraceptives face an increased risk of venous thrombosis.

The study, published in the British Medical Journal looked at all the published studies assessing risk of venous thromboembolism among women using oral contraceptives before October 1995. It found a 1.7-fold increased risk among women taking third generation oral contraceptives compared to women using second generation pills. The risk was highest among first-time users of oral contraceptives.

However, an accompanying editorial in the British Medical Journal notes that prescribers still await a consensus on risk factors for thromboemolism. The editorial by Professor Drife from the General Infirmary in Leeds says editorials and reviews written over the past year have advised that second generation pills should be used as the first choice. However Professor Drife points out official advice is less specific, with the British Department of Health saying third generation pills may be offered as first choice provided the slightly increased risk is explained to the woman. According to the British National Formulary, women with a body mass index above 39 should avoid the pill but another review states obesity is not a problem for pill users.

Professor Drife questions how doctors can explain the conflicting information to women wanting oral contraception. He says doctors and women are getting used to commentators'talking up' or'talking down' the pill's risks. Doctors would be helped ­and lives might by saved- by clear guidance on asking about a family history or history of thromboembolism with a view to screening, he says.
Refs: BMJ 2001; 323:119-20; BMJ 2001: 323:1-9

Women should have choice of abortion method

Women should be given a choice between surgical or medical abortion, according to the authors of a United States study. The research, published in Contraception, found surgical and medical abortion procedures were equally effective and surgical abortion cost only marginally more than a medical abortion.

However the authors found women who had medical abortion were less happy with the procedure. 92 percent of the women who had surgery were satisfied with the procedure whereas only 63 percent of women who underwent medical abortion said they would select this approach again.

The authors say their research demonstrates the two procedures are similar in terms of cost and effectiveness but the study also demonstrates the importance of thorough counselling. They say women have different preferences and should have a choice of procedure.
Ref Contraception 2000; 62:117-24

Women may self-select for breast screening

Women who take part in breast screening programmes probably have a higher risk of breast cancer and are self-selecting for screening because they are worried about their risk of developing cancer. That is the conclusion of researchers at the University of Manchester who looked at the incidence of breast cancer in women who declined to participate in the British National Health Service breast screening programmes. After looking at the records of more than 44,000 women, the authors found women who chose not to take part in the screening programmes had a significantly lower rate of breast cancers than the general population targeted for screening.

The researchers conclude the risk in women who attend screening must be higher, possibly because some of these women have a family history of breast cancer.
Ref: BMJ 2001;323:140

Caution over revolutionary infertility treatment

The use of the revolutionary new infertility treatment intracytoplasmic sperm injection (ICSI) should be limited to male-factor infertility, according to a review in The Lancet.

Professor Sergio Oehninger from Eastern Virginia Medical School writes that male factors are the commonest cause of infertility and ICSI has revolutionized the approach to treating infertility caused by sperm dysfunction. Professor Oehninger says ICSI is commonly used when the cause of sperm abnormalities cannot be determined but he warns that the technique bypasses natural sperm-selection barriers. This means there could be an increased risk of passing on chromosomal or genetic disease, resulting in malformation or cancer.

'The short-term and long-term effects of ICSI remain of concern so the results of the technique must be closely monitored..'

Professor Oehninger reports on one study just published in The Lancet which he describes as well-designed and case-controlled which did not find evidence of neurodevelopmental delay. This British study which looked at 208 children conceived by ICSI and a control group of 221 normally conceived children found no increased risk of congenital abnormalities, although it did find more abnormalities of the genitourinary tract in children born to fathers with less than the normal amount of spermatozoa in the semen. The authors conclude their study did not show any significant difference between children conceived after ICSI and their naturally conceived peers in terms of physical health and development. However Professor Oehninger warns that larger studies with longer follow-up periods, which take into account the various types of spermatozoal dysfunction, are needed.

He says other studies support the view that ICSI offers no clinical advantage over traditional IVF in cases of non-male factor infertility and unexplained fertility. The review says that on the current evidence ICSI should be restricted to male-factor infertility where it seems to be cost effective and relatively safe. However vigilance is needed to identify any negative effects on the long-term health of children conceived after ICSI, Professor Oehninger says.
Ref: The Lancet 2001; 357: 2080-84

Health effects of losing a spouse

The reaction of older people to the death of a spouse varies, depending on the stress levels caused by caring for dying relative. United States researchers investigated the reaction of caregivers to the death of a spouse because most deaths occur among older people with disabling conditions. This means family members have to care for their sick relative for an extended period.

Researchers studied about 130 people aged 66-96 whose spouse had died and looked for factors such as depression symptoms, antidepressant medication use, weight and health risk.

An interesting finding was that caregivers who were stressed while caring for their dying relative showed significant improvement in health-risk after the death of their spouse.

The authors say depression scores remained high but increased for spouses who were not caring for their dying relatives. Non care-givers also showed significant weight loss.

The authors conclude that the impact of losing one's spouse varies. For people who are stressed before the death, the death itself does not increase their level of distress. Instead they show a reduction in health risks.

However noncaregivers who lose a spouse show increased depression and weight loss.
Ref: JAMA 2001; 285: 3123-29

Powerful new method for detecting breast cancer

Testing of cells collected from breast ducts appears to provide a powerful method of detecting breast cancer, according to United States researchers.

Researchers from the Johns Hopkins University School of Medicine have found three genes in most tissue with invasive breast cancers and in ductal carcinomas in situ but these genes were not present in normal breast tissue. The genes were also found during routine operative breast endoscopy. Conventional cytology analysis of fluid was inconclusive and negative in the rest of these samples.

In women at high risk for developing breast cancer, the technique called methylation-specific polymerase chain reaction showed a 67 percent sensitivity and 89 percent specificity in detecting significant disease.

Dr Saraswati Sukumar says from Johns Hopkins says the technique will be especially useful for high risk patients. He says the test may be able to tell women if mammographic abnormalities are cancerous. The test may also pick up abnormalities in women with dense breasts before changes are detected by mammography.

Methylation-specific polymerase chain reaction can be used in an out-patient setting and is reported to be painless. Dr Sukumar says local anesthetic is rubbed on the nipple and a little anesthetic is added to the saline wash.
Ref: Lancet 2001; 357:1335-36

Tamoxifen after five years

Women who have had breast cancer gain no extra benefit from taking tamoxifen for more than five years, according to the results of a new study.

Researchers from the National Surgical Adjuvant Breast and Bowel Project at the University of Pittsburgh randomly assigned 1172 women who had already taken tamoxifen for five years and were disease free to continue taking either tamoxifen or a placebo.

After two years 82 percent of women taking the placebo were disease free, compared to 78 percent of women who continued on tamoxifen. There was no significant difference in relapse or overall survival.

However Dr John Bryant notes women in the trial had a good prognosis. He says there may be some benefit to extending treatment for patients with a worse prognosis, although there is no evidence for that at the moment.

Long-term use of tamoxifen is associated with uterine cancer.
Ref: J Natl Cancer Instit 2001:93:684-90

Incorrect medical care for menstrual problems

Many women may be receiving the wrong sort of care for menstrual problems, according to a new study carried out in Scotland.

Researchers set out to describe the menstrual experience of women referred for menstrual problems, especially heavy menstrual loss, and to look at the reasons why women were referred for hospital treatment.

They found that volume of bleeding was not a key symptom most women in the study but 76 percent of GPs gave it as a reason for referral to a hospital clinic. Only 38 percent of the 952 women studied reported excessive menstrual loss as a severe problem but doctors were unlikely to refer for pain or cycle changes.

The researchers say broad menstrual complaints tend to be reframed as excessive bleeding at referral and during management. This may result in women receiving inappropriate care, they say.

The authors believe many women are deterred from consulting by reticence about discussing menstrual problems, anxiety about investigations or lack of believe that medical help will be forthcoming.
Ref: BMJ 2001; 323: 24-28

Big babies are brainier

A startling new study suggests that IQ at age seven years is tied to birthweight. The US study, carried out in seven cities, studied a birth cohort of 3484 children born to 1683 mothers between 1959 and 1966. The sample was restricted to babies born beyond 37 weeks gestation and with normal birth weights (1500-3999 grams).

The researchers found that IQ increased with rising birth weight in both sexes. With same sex sibling pairs, differences in birthweight were directly associated with differences in IQ in boys but not girls. This suggests that weight creates a real difference as there would be no confounding from external socio-econcomic factors.
Ref: BMJ 2001; 323: 310-14