Women's Health Action Selections from Women's Health Watch June 1998

Women's Health Watch

edited by Sandra Coney

Selected articles from Women's Health Watch newsletters in June 1998

Contents

Issue 45 June/July 1998

Editorial - Who's been looking at my file?
Privacy Commissioner scrutinises medical record databases
Cancer link to biotech cow hormone
Government-run consumer groups - a contradiction in terms (critique of National Health Committee plan to train consumer representatives)
Suicide & Roaccutane
Breast cancer & flight attendants
Burned in the quest for beauty
Hormones and hip fracture: benefits only for current users

Who's been looking at my file? Medical records and centralised databases

Women's Health Action welcomes the report by the Privacy Commissioner's office on health databases. For some months we have been worried about plans for various government agencies, including the former North Health and the New Zealand Health Information Service, to collect patient information that was formerly held only by doctors providing individuals' care.

We heard about North Health giving discs to GPs to remove unspecified information from their computer systems. Some GPs were given CD Roms containing the names of people along with their National Health Index numbers. The NHI is a unique identifier for users of health services. GPs were being required through contracts to attach the NHI number to all claims they sent on to funders.

Most New Zealanders are totally oblivious to these developments. The NHI number has been around for a long time (it was formerly called the National Master Patient Index or NMPI number), but it was not consistently applied to all individuals being mainly used as a hospital number.

The new plans involve attaching the NHI number to all health transactions, enabling a 'virtual patient record' to be built up. An individual's contacts with a number of providers GPs, Family Planning, midwife, sexual health clinic, mental health services, chemist, labs and hospitals - could be amalgamated into one chronological record which would be available to people involved in that person's care and to funders.

There was, of course, more to it than this. The system also underlay moves towards capitation, integrated care and ultimately managed care, where an individual would enrol in a particular health care plan. The NHI number enabled people to be tracked, to see that they were only enrolled with one plan. Centralised databases potentially enabled a person's use of health services to be monitored, could be used to constrain their use of services outside the plan in which they were enrolled.

Over 1996 and 1997 Women's Health Action raised its concerns with North Health and the NZHIS. We even organised a consultation with the NZHIS which was attended by many groups and individuals. The consistent message was that people were happy for their records to be held at the level of provider but they did not want their records to be passed on.

We met a wall or resistance and perplexity with this position. Health agencies simply tried to convince us that what they planned would be good for people.

Firstly we were told that electronic records were more private than paper files. There would be passwords and access protocols etc. We countered that this claim is not necessarily true. While paper files can be left carelessly sitting around, the number of individuals who could lay their eyes on a file is far less than the access provided when medical records are on-line to the nation.

Then we were told that the NHI had been used for years without people knowing or being harmed. This was a scarcely believable argument in that the public didn't know about the NHI so couldn't be expected to object. Furthermore, the current proposal greatly extends the use of the unique identifier, in particular to allow data-matching. Besides which we now have a Privacy Act which places various requirements on providers which didn't apply in the past.

We were told that health care would be enhanced by providers being able to have a chronological record of a person's medical history before them on the computer screen. They would be less likely to miss something important or misdiagnose. When we asked for proof of this a few irrelevant papers were produced. There is actually no hard evidence that electronic record keeping improves patient care or health outcomes.

Our concerns actually go way beyond privacy. These are the issues we raised.

Studies have shown that medical records are often incomplete and inaccurate. What is the effect on medical care of greater reliance on records?

Will doctors rely more on what is on the screen and neglect history-taking and examinations which are the fundamentals of diagnosis and medical care?

Will personal information, previous illnesses or diagnoses (which may be right or wrong) jeopardise future health care? For example, health records may contain information about psychological illnesses, sexuality, relationship and family problems, and employment difficulties, which may cause a provider to prejudge a person or wrongly interpret symptoms.

For young people experiencing depressive, sexuality or reproductive problems, anxiety about confidentiality could prevent them seeking help.

Initially we were told that patients would be able to authorise which providers saw what. We argued that patients would find it difficult to tell the doctor in front of them that some records were being withheld from them. In the very act of doing so their privacy would be breached (For example, I don't want you to look at my Lake Alice records), and in any case, most patients have no idea what is in their records.

In its response the NZHIS relied heavily on cases from the Medical Misadventure Unit of ACC which it stated 'have arisen from not having the right information in the right place at the right time.' The few case studies related to failure to diagnose meningococcal meningitis, lost lab specimens and use of antibiotics the patient was allergic to. There was no evidence that electronic records would be able to prevent such bad medical practices. You simply can't make good doctors out of bad doctors by using computers.

This over-selling of the benefits of computers is a major factor in the promotion of databases. The people promoting them, by and large, do not have a health background and have become enamoured of the technology itself.

They argue that through such things as 'firewalls', passwords and encryption, they can ensure privacy. As the Privacy Commissioner's report makes clear, all these systems are eminently fallible. Added to that, unique identifiers make individuals more, rather than less, vulnerable than they were when records used names, as there can be many people with the same name, but only one person to each number.

When we felt we were getting nowhere through meetings and letter-writing over a considerable period, in mid-1997 we asked the Privacy Commissioner to investigate.

Since the Commissioner's report was released the response from the government has not been reassuring. Essentially it consists of restating the protections that the Privacy Commissioner has already found to be inadequate.

Hopefully, the report has impressed on agencies the need to adhere to the Privacy Code, especially by telling people what information is being passed on and to whom. Such essentials were being neglected in the rush to get patients 'on-line'. The report can also empower GPs and IPAs who have doubts about HFA and NZHIS requirements. At the recent HFA General Practice Strategy meeting consumer representatives, such as myself and Judi Strid from WHA, were able to put the case for greater disclosure to clients and for more consultation about what should be held by whom.

There is still a need for the public at large to be fully informed and consulted about such schemes and whether they agree with them. Concerned consumers can ask providers, such as GPs, what they are doing with information about them.

Sandra Coney

Privacy Commissioner scrutinises medical record databases

A centralised patient database is being introduced into New Zealand by stealth and coercion, according to a report written by an Auckland barrister for the Privacy Commission.

Robert Stevens prepared the report Medical Record Databases Just What You Need? after continuing complaints by GPs, consumers and MPs about plans by government agencies to compile or interconnect the health records of identifiable patients. In particular major concerns surround Ministry of Health plans for a ÒHealth IntranetÓ which aims to launch a common, secure inter-connection system for health records and a transmission system for health information. In his report Mr Stevens outlines a wide range of concerns about privacy issues, the lack of opportunity for public debate, coercion of health professionals and lack of co-ordination between the agencies planning data bases.

So why are Government agencies, particularly North Health and New Zealand Health Information Service (division of Ministry of Health) suddenly interested in centralising information about our health? In part the developments in this area stem from technological advances such as the development of specialised medical record software and computer networking tools. However Stevens' report points out another major reason is the move towards capitation and 'integrated health care'.

'Talk of integrated care has become common and the concepts behind those (often loosely-used) terms suggest the need for more flow of information between different bodies involved in the health care of an individual.'

He points out a unique identifier for each health care customer is the most obvious means of operating capitation systems where health management organisations are 'bulk-funded' to provide services. Individual 'customers' are enrolled with a health management organisation and they are then identified each time they're treated so costs can be referred back to the responsible organisation.

Interconnection and collation of health information may be useful for the planning and co-ordination of health care, and may even benefit individuals, but this is not something which should be simply assumed without investigation and informed debate, according to the report by Robert Stevens.

'The substantial changes to existing medical record systems will place a vast amount of additional information about the health care of identifiable individuals in the hands of various agencies which have not previously had such information in any useable form.'

Stevens notes that in the past it was not thought necessary for the state, through agencies such as the Ministry of Health, to see individual patient records in any but the most exceptional cases.

What particularly concerns Stevens is that many doctors don't know exactly what information about their individual patients is going to be collated and kept by the HFA and other bodies and where that information may ultimately end up. In these circumstances it's not surprising patients have even less information, says Stevens.

'Privacy legislation and perhaps medical ethics too, requires doctors take whatever steps are reasonable to ensure their patients are made aware of such matters, but this cannot be done unless and until those uses of the information are finalised, clarified and publicised. This has not happened.'

This lack of communication has resulted in mistrust and some downright hostility between North Health and some GPs, says Stevens. There's been a lot of speculation because North Health has never articulated its real purposes for collecting data in any detail.

'The truth may be North Health has never worked them out but has proceeded with moves to gather as much information as possible short of "frightening the horses".'

This approach is anathema to the Privacy Act, which requires and relies upon an agency only collecting personal information when it has formed a specific intention on how and for what purposes the information is to be used, says Stevens.

He believes health sector agencies are very conscious of record security but show a much lower level of appreciation about the broader privacy concerns and the privacy expectations of individuals.

To explain its patient database North Health produced a glossy colour-printed leaflet entitled Your Health Number Equals Your Health but Stevens notes the leaflet does not explain what information is going to be collected by North Health, what North Health will do with the information it gets and who will have access to this data.

Although the HFA has not appointed a Privacy Officer, it told Stevens that Bruce Rogan from North Health was responsible for privacy issues. In fact Mr Rogan has been the leading light in planning and directing the collection of personal information for North Health and is reported as saying providers have no legal obligation to tell consumers about information collected for payment and audit purposes, although informed consent may be mandatory and even desirable if more information is exchanged.

'If this report is correct, the statement suggests the person designated to look after the protection of individual privacy within the HFA has little understanding of the Privacy Act and even less sympathy with its intentions.'

In the past the four RHAs had designated Privacy Officers and Stevens says it seems these people have carried on with this job in the HFA's regional offices. However Stevens points out the HFA didn't volunteer any of these officers to help with his report.

'It's difficult to imagine any of them has been substantially involved in the HFA's data collection plans.'

Although there has been little public explanation by the HFA, North Health has put forward several explanations for its planned database, including better monitoring of claiming by health providers, better information for planning and funding services and improved access to patient information during medical emergencies.

Stevens notes a GP has never needed an NHI number to get medical records from other health care providers where the patient has authorised that collection.

'The main effect of interconnection through a common unique identifier will presumably be to facilitate collection of information which the patient has not authorised.'

Stevens points out he was unable to find any reported research linking better patient health outcomes with centralised medical records.

'These points should simply serve to warn against the assumption that a full and accessible patient health record is necessarily good for the patient.'

North Health's assumptions that it is not doing anything dramatically new by collecting data through the NHI are also not true, according to Stevens. He argues in the past the 'purchaser' did not really collect and retain information about individual patients. On the other hand, using the NHI number will allow the Funding Authority to collate and track the individual's attendances with different doctors, specialists, pharmacies, hospitals and other clinics over their entire lifetime.

Government agencies such as HZHIS claim its system is a virtual private network based on Internet technology and will be secure. However Stevens says the United States Department of Health and Human Services has stated there are no acceptable encryption mechanisms available on the Internet to ensure privacy. The Department's banned transmission of individually identifiable information through the Internet or other insecure environments.

'The American qualms about the effectiveness of encryption should give New Zealand pause. Any system involving medical records being available for on-line access through other than secure and dedicated lines must be considered vulnerable, not just to existing hacker techniques but also the copying of records and transmissions which can be kept to await future development of decryption.'

To be secure the NZHIS Intranet would need to use dedicated telephone lines and have what appoints to an actual air gap between its connections and the internet, says Stevens.

North Health plans to use encryption to preserve privacy also come in for criticism. Stevens says it is generally accepted any encryption system can be broken and in time probably will. He points out health data that is 50 years old is quite rightly regarded as highly sensitive.

Stevens also takes exception to North Health plans to set up an independent committee to act as the gatekeeper for access to individual encrypted NHI numbers. While health providers will have automatic access to information, an individual patient who wants to see what information is stored about her would have to go through the committee. This means release of the full record may not be freely given to a patient but the patient may not have the right to keep parts of her patient record confidential.

The report also raises concerns about the future security of the Medical Warnings Systems database. This database is accessible by a large number of people and protection against misuse has relied mainly on the fact the link between name and the NHI number was difficult to access.

Stevens questions why the issue surrounding patient confidentiality and databases have not been debated in Parliament. He argues public scrutiny is being bypassed because the HFA has the power to impose contracts on GPs which mean they have to give the State information in exchange for continued patient subsidies.

Cancer link to biotech cow hormone

Camille Guy reports on a possible link between breast cancer and milk from hormone-boosted cows

It is a food adulteration double whammy - much of the US milk supply is drawn from cows injected with a hormone to boost milk production, and that growth hormone is genetically engineered. Restrictions on labelling mean that consumers are unable to tell which milk or dairy products are from treated cows.

So far New Zealanders can breathe easy. Our Dairy Board steered clear of engineered bovine growth hormone (Monsanto's rBGH or bST), because of 'consumer concerns about the product.' The product is also ruled out in the European Union until 1999 and is still not legal in Canada.

Given recent findings on the link between human growth hormone and cancer, we have reason to be grateful for what are patronisingly called 'consumer concerns'.The public may be scientifically naive, but in this case it seems that our wariness was wise. But if Monsanto does succeed in having BST marketed here, and if our government persists with its recent decision not to require labelling of most engineered foodstuffs (on the grounds they are 'substantially equivalent' to unmodified foods) then New Zealanders too may end up gulping milk and eating yoghurt that may raise the risk of cancer.

American consumer groups rallied strongly when Monsanto's bST product gained FDA approval in 1993. They fought hard to have bST-sourced milk and dairy products labelled. No go, said the US Food and Drug Administration.

'There is virtually no difference in milk from treated and untreated cows,' declared FDA Commissioner David Kessler. The FDA reckoned it lacked a basis to require special labelling. Also ruled out was labelling milk 'bST-free', since that could imply that milk from untreated cows is safer and better.

So is there any difference in the milks? Turns out there is. Quite apart from the undisputed fact that treated cows suffer more mastitis and receive more antibiotics, a detailed scientific report published by the US Consumers Union last September concludes that milk from treated cows contains higher levels of insulin-like growth factor-1 (IGF-1). This powerful, naturally occurring growth hormone, in illicit use by body builders, has two known hazards. It enhances the production of sex-steroids, which could increase tumour growth. It is also believed to interfere with the body's natural self destruction of damaged or mutated cells. Too much IGF-1 and damaged cells may survive, to develop into tumours.

Those concerns led a team from Harvard and McGill Universities to conduct the first prospective case-control study (using the Nurses Health Study cohort) to test whether high IGF-1 levels were associated with breast cancer. Their findings, reported in The Lancet on May 9, showed that women under 50 with high levels of IGH-1 (measured before any tumours were found) had a seven-fold increased risk of breast cancer.

These results were consistent with those reported in Science magazine, last January: men with high IGF-1 levels showed a four-fold increase in prostate cancer.

It is still not clear whether IGF-1 is actually causing the cancers, or whether high hormone levels are just a marker of some other causal factor. But 'there is substantial indirect evidence of a relation between IGF-1 and risk of breast cancer', the researchers note, including the finding that IGF-1 levels are reduced in tamoxifen users.

Two years ago Dr Samuel Epstein of the University of Illinois warned Americans that, with the complicity of the FDA, the entire nation was being subjected to an experiment involving large scale adulteration of milk by an unlabelled biotechnology product. Biotech crusaders dismissed his warning as scaremongering, but the newest research on the role IGFs play in the development and growth of many cancers (bone, lung, and gastrointestinal, as well as breast and prostate) suggests Epstein was right.

Monsanto continues to downplay the problems, insisting that they were mistaken in their earlier finding that IGF-1 levels are higher in milk from treated cows. But the Consumers Union review of all studies, including Monsanto's, concluded that the weight of the evidence showed that bST use increases IGF-1 levels in milk 'substantially'.

The chemical company also claims people do not absorb the IGF-1 in milk, since it does not survive digestion. Again, new data from animal studies shows that it does, and that it remains bioactive. The IGF-1 in cows' milk is chemically identical to IGF-1 in human, and casein in milk protects the hormone from digestion, which means it could pass into the bloodstream of milk drinkers.

Alliance MP Phillida Bunkle recently released information to the press about the issue of IGF-1 in milk and cancer, citing The Lancet study. Few, if any, media organisations reported her concerns - some were reassured by Monsanto that her fears were groundless.

Phillida suggested New Zealand dairy producers could grab a marketing advantage if we ensure our milking herds remain free of genetically engineered milk stimulants.

'All that is required to take advantage of this huge opportunity is for the Government to require labelling of genetically altered food,' she said.

'The New Zealand government is adopting the lax American standard for food labelling, including the flawed "substantial equivalence" test which doesn't allow consumers to avoid potentially killer products.'

Phillida has a bill before parliament on such labelling.

Suicide in users of a widely used acne drug

Packaging for the acne drug Roaccutane now contains warnings about depression in users. This follows

reports to Medwatch, the Food and Drug Administration's spontaneous warning system, of depressions and suicides of people on the drug. Since 1989 12 suicides in users of Roaccutane have been reported to the FDA. Patients reported that their depression lifted when they stopped taking the drug, but returned when they resumed use.

Although no cause and effect has been firmly established, the concerns made the FDA, the manufacturer of the drug, Hoffman-La Roche, and physicians, warn that Roaccutane should only be prescribed under specialist supervision.

The warning says:

'Psychiatric Disorders: Accutane [called Roaccunate in New Zealand] may cause depression, psychosis and rarely, suicidal ideation, suicide attempts and suicide. Discontinuation of Accutane therapy may be insufficient, further evaluation may be necessary. No mechanism of action has been established for these events.'

Roaccutane has been used since 1982 for the treatment of cystic acne that does not respond to standard antibiotic treatment.A report in the American Journal of Psychiatry showed that 6.1% of Roaccutane users aged 1524 years experienced a major depression in a 30-day period compared to 4.9% of the total population.

The relationship of Roaccutane to depression in users is complicated by the poor self-image and depression people with acne can suffer. Studies show that improvement in acne can decrease anxiety and depression and increase satisfaction with self-image (not just skin).

Roaccutane can clear or nearly clear severe acne in more than 75% of cases. For many patients a single course of therapy over 4 to 6 months can produce complete or prolonged remission of acne.

Within New Zealand, concerns were expressed in the early eighties about over-use of Ro-accutane, which had become fashionable among girls in some schools. Some doctors were suspected of freely prescribing the medication for even mild acne. Roaccutane has a number of other risks and there is a high a likelihood of damage to the foetus were it to be used during pregnancy. Sexually active users are advised to use two different methods of birth control while using Roaccutane.

Ref: JAMA 1998; 279: 1057

Breast cancer and flight attendants

A recent letter to the British Medical Journal reported a study which had found an increase in breast cancer among retired flight attendants from one US airline. The risk of breast cancer in this group was doubled. This findings adds to earlier studies which had found excess breast cancer among Finish and Danish airline attendants.

There has been speculation as to what might cause this increase in risk with radiation suggested as a cancer promoter. Other estimates suggest that radiation exposure could account for only a 10% increased risk.

The authors of this study, from the Environmental Health Division of the Environmental and Occupational Health Sciences Institute in New Jersey, suggests exposure to dicophane (DDT), an organochlorine pesticide, may be a cause. From the 1950s to the 1970s DDT was used to rid airplanes of insects. A hand operated aerosol dispenser was used by a flight attendant to spray the aircraft, while the doors were closed before takeoff when ventilation was minimal. This may have resulted in significant inhalation by the person spraying as well as exposure of the skin.

The researchers tested the hypotheses of radiation and DDT exposure by asking flight attendants the number of flights in their career (as a proxy for radiation exposure) and the number of times they sprayed pesticides. They found a strong association with spraying, but only a weak association with the number of flights.

The authors do not say whether the study was controlled for other risk factors for breast cancer, such as late childbearing or alcohol use, which may be more likely among flight attendants.

Ref: Wartenberg, D and Stapleton, C, BMJ 1998; 316: 1902

Burned in the quest for beauty

The US Food and Drug Administration warns users of skin peelers containing alpha hydroxy acids (fruit acids) that they can cause injuries such as skin burns. AHAs are used in cosmetics and by beauty therapists and dermatologists to 'rejuvenate' skin. The FDA said that some products penetrate the skin too deeply, causing severe skin damage. In several cases, people have been hospitalised for severe burns, swelling and pain. A Californian woman suffered a seizure, shock and second degree burns after a mixture of skin peel chemicals was applied to her legs by a beautician.

Skin peeling products can vary considerably as to their ingredients and strengths. Also, skin reactions vary among individuals.

Skin peelers contain different combinations of several different acids such as lactic acid, phenol, resorcinol, trichloroacetic acid, salicylic acid and glycolic acid. They are usually applied to the skin for a short time each day, usually for six to 12 days. The skin reddens, as if it is sunburned, then peels away revealing what manufacturers call 'new skin'. The treatments can be painful and leave permanent scars.

Skin peeling treatments used only to be carried out by plastic surgeons and dermatologists but they are increasingly being used by non-medical people such as beauticians, some using newly mark-eted products. Many have inadequate instructions and none has been approved by the FDA as effective or safe.

Cosmetics can also contain AHAs despite unanswered questions about their safety. Recently a study sponsored by the cosmetic industry indicated that such products may make skin more sensitive to sunlight especially W radiation which is implicated in the development of skin cancer. The FDA recommends that users of cosmetics containing AHAs should protect themselves with sunblocks, even if they have not used an AHA-containing cosmetic on the day they are going into the sun. The FDA has received about 100 reports of adverse effects from AHA cosmetics, ranging from mild irritation and stinging to blisters and burns. The FDA advises that women test the product on a small area of skin before using it further, and that use should be stopped if there is skin irritation or prolonged stinging.
Ref: US FDA Backgrounder: 'Alpha Hydroxy Acids in Cosmetics' and 'Skin Peelers'-

Hormones and hip fracture: benefits only for current users

A recent Swedish case-control study showed that women currently using hormone replacement therapy reduced their risk of hip fracture, but that within five years of ceasing therapy, women had lost most of the benefit.

Women aged 50-81 who had had hip fractures were compared with controls for their use or non-use of HRT. It was found that HRT reduced the risk of hip fracture but current or recent use was needed to obtain substantial protection. Current users reduced their risk of a hip fracture by about 70%. Women using combined therapy had a greater reduction in risk than those using oestrogen alone. The dose was also important: use of a low dose oestrogen (1 mg of oestradiol or 0.325 conjugated oestrogens or 25ug transdermal oestradiol) did not provide protection. Higher doses (equivalent to 2mg oestradiol or 0.625 conjugated oestrogen) did reduce the risk.

An interesting finding was that HRT did not need to be started immediately at the menopause to gain the benefits. Starting it nine or more years after the menopause gave equally strong risk reduction as starting it earlier.

This study was published in the British Medical Journal and an editorial by Kay-Tee Khaw, professor of clinical gerontology at Cambridge University, assessed current knowledge about HRT.

Professor Khaw sounds a warning note about the current enthusiasm for HRT, and its promotion to prevent disease in ageing women.

Prof Khaw points out that most of the trials showing cardioprotective effect have been far too small and short to give convincing results. Even the PEPI study (on which the New Zealand Ministry of Health based its decision to approve HRT for the prevention of heart disease) had fewer than 200 women in each arm of the trial. While HRT has been shown to have a favourable effect on lipids, selection bias was a real possibility. Most takers of HRT in the USA where most of the studies have been carried out tend to be thinner, healthier, more health conscious come from higher socio-economic groups and have different lifestyles than women who do not.

The effects on stroke risk are still not known. The WISDOM study in Europe and the Women's Health Initiative in America will eventually provide more answers but these are some years away.

Studies which show a cardioprotective effect of HRT or benefits in fracture reduction also show that the benefits rapidly diminish once women stop taking it. However, long-term use of HRT increases breast cancer risk and the risk of endometrial cancer is not eliminated by the addition of progestins.

Risk-benefit analyses show that the women most likely to benefit from HRT are women at high risk of heart disease, while women at low risk of heart disease or who have an increased risk of breast cancer may benefit less or even be worse off.

Risk-benefit estimates, warns Prof Khaw, cannot be universally generalised. Most studies have been done on US and British women who have high absolute rates of heart disease and fractures. Even then an estimated 2000 American women would have to take HRT for one year to prevent one coronary event. Most studies are based on conjugated oestrogens and the same effects cannot be assumed for different preparations and modes of administration.

The short-term use of HRT for troublesome menopausal symptoms is not a problem, it is the long-term prophy-lactic use which raises the dilemmas. The international variations in experience of menopausal symptoms, and fracture and heart disease rates, show that these outcomes may be preventable through other strategies, such as diet and other measures, rather than simply taking pills.
Ref: Michaelsson, K et al, 'Hormone Replacement therapy and risk of hip fracture: population based case-control study' BMJ 1998; 316: 1858-63, and Khaw, Kay-Tee 'Hormone replacement therapy again' BMJ 1998; 316: 1842-44

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	Women's Health Watch edited by Sandra Coney Selected articles from Women's Health Watch newsletters in June 1998 Contents Issue 45 June/July 1998 Editorial - Who's been looking at my file? Privacy Commissioner scrutinises medical record databases Cancer link to biotech cow hormone Government-run consumer groups - a contradiction in terms (critique of National Health Committee plan to train consumer representatives) Suicide & Roaccutane Breast cancer & flight attendants Burned in the quest for beauty Hormones and hip fracture: benefits only for current users Who's been looking at my file? Medical records and centralised databases Women's Health Action welcomes the report by the Privacy Commissioner's office on health databases. For some months we have been worried about plans for various government agencies, including the former North Health and the New Zealand Health Information Service, to collect patient information that was formerly held only by doctors providing individuals' care. We heard about North Health giving discs to GPs to remove unspecified information from their computer systems. Some GPs were given CD Roms containing the names of people along with their National Health Index numbers. The NHI is a unique identifier for users of health services. GPs were being required through contracts to attach the NHI number to all claims they sent on to funders. Most New Zealanders are totally oblivious to these developments. The NHI number has been around for a long time (it was formerly called the National Master Patient Index or NMPI number), but it was not consistently applied to all individuals being mainly used as a hospital number. The new plans involve attaching the NHI number to all health transactions, enabling a 'virtual patient record' to be built up. An individual's contacts with a number of providers GPs, Family Planning, midwife, sexual health clinic, mental health services, chemist, labs and hospitals - could be amalgamated into one chronological record which would be available to people involved in that person's care and to funders. There was, of course, more to it than this. The system also underlay moves towards capitation, integrated care and ultimately managed care, where an individual would enrol in a particular health care plan. The NHI number enabled people to be tracked, to see that they were only enrolled with one plan. Centralised databases potentially enabled a person's use of health services to be monitored, could be used to constrain their use of services outside the plan in which they were enrolled. Over 1996 and 1997 Women's Health Action raised its concerns with North Health and the NZHIS. We even organised a consultation with the NZHIS which was attended by many groups and individuals. The consistent message was that people were happy for their records to be held at the level of provider but they did not want their records to be passed on. We met a wall or resistance and perplexity with this position. Health agencies simply tried to convince us that what they planned would be good for people. Firstly we were told that electronic records were more private than paper files. There would be passwords and access protocols etc. We countered that this claim is not necessarily true. While paper files can be left carelessly sitting around, the number of individuals who could lay their eyes on a file is far less than the access provided when medical records are on-line to the nation. Then we were told that the NHI had been used for years without people knowing or being harmed. This was a scarcely believable argument in that the public didn't know about the NHI so couldn't be expected to object. Furthermore, the current proposal greatly extends the use of the unique identifier, in particular to allow data-matching. Besides which we now have a Privacy Act which places various requirements on providers which didn't apply in the past. We were told that health care would be enhanced by providers being able to have a chronological record of a person's medical history before them on the computer screen. They would be less likely to miss something important or misdiagnose. When we asked for proof of this a few irrelevant papers were produced. There is actually no hard evidence that electronic record keeping improves patient care or health outcomes. Our concerns actually go way beyond privacy. These are the issues we raised. Studies have shown that medical records are often incomplete and inaccurate. What is the effect on medical care of greater reliance on records? Will doctors rely more on what is on the screen and neglect history-taking and examinations which are the fundamentals of diagnosis and medical care? Will personal information, previous illnesses or diagnoses (which may be right or wrong) jeopardise future health care? For example, health records may contain information about psychological illnesses, sexuality, relationship and family problems, and employment difficulties, which may cause a provider to prejudge a person or wrongly interpret symptoms. For young people experiencing depressive, sexuality or reproductive problems, anxiety about confidentiality could prevent them seeking help. Initially we were told that patients would be able to authorise which providers saw what. We argued that patients would find it difficult to tell the doctor in front of them that some records were being withheld from them. In the very act of doing so their privacy would be breached (For example, I don't want you to look at my Lake Alice records), and in any case, most patients have no idea what is in their records. In its response the NZHIS relied heavily on cases from the Medical Misadventure Unit of ACC which it stated 'have arisen from not having the right information in the right place at the right time.' The few case studies related to failure to diagnose meningococcal meningitis, lost lab specimens and use of antibiotics the patient was allergic to. There was no evidence that electronic records would be able to prevent such bad medical practices. You simply can't make good doctors out of bad doctors by using computers. This over-selling of the benefits of computers is a major factor in the promotion of databases. The people promoting them, by and large, do not have a health background and have become enamoured of the technology itself. They argue that through such things as 'firewalls', passwords and encryption, they can ensure privacy. As the Privacy Commissioner's report makes clear, all these systems are eminently fallible. Added to that, unique identifiers make individuals more, rather than less, vulnerable than they were when records used names, as there can be many people with the same name, but only one person to each number. When we felt we were getting nowhere through meetings and letter-writing over a considerable period, in mid-1997 we asked the Privacy Commissioner to investigate. Since the Commissioner's report was released the response from the government has not been reassuring. Essentially it consists of restating the protections that the Privacy Commissioner has already found to be inadequate. Hopefully, the report has impressed on agencies the need to adhere to the Privacy Code, especially by telling people what information is being passed on and to whom. Such essentials were being neglected in the rush to get patients 'on-line'. The report can also empower GPs and IPAs who have doubts about HFA and NZHIS requirements. At the recent HFA General Practice Strategy meeting consumer representatives, such as myself and Judi Strid from WHA, were able to put the case for greater disclosure to clients and for more consultation about what should be held by whom. There is still a need for the public at large to be fully informed and consulted about such schemes and whether they agree with them. Concerned consumers can ask providers, such as GPs, what they are doing with information about them. Sandra Coney Privacy Commissioner scrutinises medical record databases A centralised patient database is being introduced into New Zealand by stealth and coercion, according to a report written by an Auckland barrister for the Privacy Commission. Robert Stevens prepared the report Medical Record Databases Just What You Need? after continuing complaints by GPs, consumers and MPs about plans by government agencies to compile or interconnect the health records of identifiable patients. In particular major concerns surround Ministry of Health plans for a ÒHealth IntranetÓ which aims to launch a common, secure inter-connection system for health records and a transmission system for health information. In his report Mr Stevens outlines a wide range of concerns about privacy issues, the lack of opportunity for public debate, coercion of health professionals and lack of co-ordination between the agencies planning data bases. So why are Government agencies, particularly North Health and New Zealand Health Information Service (division of Ministry of Health) suddenly interested in centralising information about our health? In part the developments in this area stem from technological advances such as the development of specialised medical record software and computer networking tools. However Stevens' report points out another major reason is the move towards capitation and 'integrated health care'. 'Talk of integrated care has become common and the concepts behind those (often loosely-used) terms suggest the need for more flow of information between different bodies involved in the health care of an individual.' He points out a unique identifier for each health care customer is the most obvious means of operating capitation systems where health management organisations are 'bulk-funded' to provide services. Individual 'customers' are enrolled with a health management organisation and they are then identified each time they're treated so costs can be referred back to the responsible organisation. Interconnection and collation of health information may be useful for the planning and co-ordination of health care, and may even benefit individuals, but this is not something which should be simply assumed without investigation and informed debate, according to the report by Robert Stevens. 'The substantial changes to existing medical record systems will place a vast amount of additional information about the health care of identifiable individuals in the hands of various agencies which have not previously had such information in any useable form.' Stevens notes that in the past it was not thought necessary for the state, through agencies such as the Ministry of Health, to see individual patient records in any but the most exceptional cases. What particularly concerns Stevens is that many doctors don't know exactly what information about their individual patients is going to be collated and kept by the HFA and other bodies and where that information may ultimately end up. In these circumstances it's not surprising patients have even less information, says Stevens. 'Privacy legislation and perhaps medical ethics too, requires doctors take whatever steps are reasonable to ensure their patients are made aware of such matters, but this cannot be done unless and until those uses of the information are finalised, clarified and publicised. This has not happened.' This lack of communication has resulted in mistrust and some downright hostility between North Health and some GPs, says Stevens. There's been a lot of speculation because North Health has never articulated its real purposes for collecting data in any detail. 'The truth may be North Health has never worked them out but has proceeded with moves to gather as much information as possible short of "frightening the horses".' This approach is anathema to the Privacy Act, which requires and relies upon an agency only collecting personal information when it has formed a specific intention on how and for what purposes the information is to be used, says Stevens. He believes health sector agencies are very conscious of record security but show a much lower level of appreciation about the broader privacy concerns and the privacy expectations of individuals. To explain its patient database North Health produced a glossy colour-printed leaflet entitled Your Health Number Equals Your Health but Stevens notes the leaflet does not explain what information is going to be collected by North Health, what North Health will do with the information it gets and who will have access to this data. Although the HFA has not appointed a Privacy Officer, it told Stevens that Bruce Rogan from North Health was responsible for privacy issues. In fact Mr Rogan has been the leading light in planning and directing the collection of personal information for North Health and is reported as saying providers have no legal obligation to tell consumers about information collected for payment and audit purposes, although informed consent may be mandatory and even desirable if more information is exchanged. 'If this report is correct, the statement suggests the person designated to look after the protection of individual privacy within the HFA has little understanding of the Privacy Act and even less sympathy with its intentions.' In the past the four RHAs had designated Privacy Officers and Stevens says it seems these people have carried on with this job in the HFA's regional offices. However Stevens points out the HFA didn't volunteer any of these officers to help with his report. 'It's difficult to imagine any of them has been substantially involved in the HFA's data collection plans.' Although there has been little public explanation by the HFA, North Health has put forward several explanations for its planned database, including better monitoring of claiming by health providers, better information for planning and funding services and improved access to patient information during medical emergencies. Stevens notes a GP has never needed an NHI number to get medical records from other health care providers where the patient has authorised that collection. 'The main effect of interconnection through a common unique identifier will presumably be to facilitate collection of information which the patient has not authorised.' Stevens points out he was unable to find any reported research linking better patient health outcomes with centralised medical records. 'These points should simply serve to warn against the assumption that a full and accessible patient health record is necessarily good for the patient.' North Health's assumptions that it is not doing anything dramatically new by collecting data through the NHI are also not true, according to Stevens. He argues in the past the 'purchaser' did not really collect and retain information about individual patients. On the other hand, using the NHI number will allow the Funding Authority to collate and track the individual's attendances with different doctors, specialists, pharmacies, hospitals and other clinics over their entire lifetime. Government agencies such as HZHIS claim its system is a virtual private network based on Internet technology and will be secure. However Stevens says the United States Department of Health and Human Services has stated there are no acceptable encryption mechanisms available on the Internet to ensure privacy. The Department's banned transmission of individually identifiable information through the Internet or other insecure environments. 'The American qualms about the effectiveness of encryption should give New Zealand pause. Any system involving medical records being available for on-line access through other than secure and dedicated lines must be considered vulnerable, not just to existing hacker techniques but also the copying of records and transmissions which can be kept to await future development of decryption.' To be secure the NZHIS Intranet would need to use dedicated telephone lines and have what appoints to an actual air gap between its connections and the internet, says Stevens. North Health plans to use encryption to preserve privacy also come in for criticism. Stevens says it is generally accepted any encryption system can be broken and in time probably will. He points out health data that is 50 years old is quite rightly regarded as highly sensitive. Stevens also takes exception to North Health plans to set up an independent committee to act as the gatekeeper for access to individual encrypted NHI numbers. While health providers will have automatic access to information, an individual patient who wants to see what information is stored about her would have to go through the committee. This means release of the full record may not be freely given to a patient but the patient may not have the right to keep parts of her patient record confidential. The report also raises concerns about the future security of the Medical Warnings Systems database. This database is accessible by a large number of people and protection against misuse has relied mainly on the fact the link between name and the NHI number was difficult to access. Stevens questions why the issue surrounding patient confidentiality and databases have not been debated in Parliament. He argues public scrutiny is being bypassed because the HFA has the power to impose contracts on GPs which mean they have to give the State information in exchange for continued patient subsidies. Cancer link to biotech cow hormone Camille Guy reports on a possible link between breast cancer and milk from hormone-boosted cows It is a food adulteration double whammy - much of the US milk supply is drawn from cows injected with a hormone to boost milk production, and that growth hormone is genetically engineered. Restrictions on labelling mean that consumers are unable to tell which milk or dairy products are from treated cows. So far New Zealanders can breathe easy. Our Dairy Board steered clear of engineered bovine growth hormone (Monsanto's rBGH or bST), because of 'consumer concerns about the product.' The product is also ruled out in the European Union until 1999 and is still not legal in Canada. Given recent findings on the link between human growth hormone and cancer, we have reason to be grateful for what are patronisingly called 'consumer concerns'.The public may be scientifically naive, but in this case it seems that our wariness was wise. But if Monsanto does succeed in having BST marketed here, and if our government persists with its recent decision not to require labelling of most engineered foodstuffs (on the grounds they are 'substantially equivalent' to unmodified foods) then New Zealanders too may end up gulping milk and eating yoghurt that may raise the risk of cancer. American consumer groups rallied strongly when Monsanto's bST product gained FDA approval in 1993. They fought hard to have bST-sourced milk and dairy products labelled. No go, said the US Food and Drug Administration. 'There is virtually no difference in milk from treated and untreated cows,' declared FDA Commissioner David Kessler. The FDA reckoned it lacked a basis to require special labelling. Also ruled out was labelling milk 'bST-free', since that could imply that milk from untreated cows is safer and better. So is there any difference in the milks? Turns out there is. Quite apart from the undisputed fact that treated cows suffer more mastitis and receive more antibiotics, a detailed scientific report published by the US Consumers Union last September concludes that milk from treated cows contains higher levels of insulin-like growth factor-1 (IGF-1). This powerful, naturally occurring growth hormone, in illicit use by body builders, has two known hazards. It enhances the production of sex-steroids, which could increase tumour growth. It is also believed to interfere with the body's natural self destruction of damaged or mutated cells. Too much IGF-1 and damaged cells may survive, to develop into tumours. Those concerns led a team from Harvard and McGill Universities to conduct the first prospective case-control study (using the Nurses Health Study cohort) to test whether high IGF-1 levels were associated with breast cancer. Their findings, reported in The Lancet on May 9, showed that women under 50 with high levels of IGH-1 (measured before any tumours were found) had a seven-fold increased risk of breast cancer. These results were consistent with those reported in Science magazine, last January: men with high IGF-1 levels showed a four-fold increase in prostate cancer. It is still not clear whether IGF-1 is actually causing the cancers, or whether high hormone levels are just a marker of some other causal factor. But 'there is substantial indirect evidence of a relation between IGF-1 and risk of breast cancer', the researchers note, including the finding that IGF-1 levels are reduced in tamoxifen users. Two years ago Dr Samuel Epstein of the University of Illinois warned Americans that, with the complicity of the FDA, the entire nation was being subjected to an experiment involving large scale adulteration of milk by an unlabelled biotechnology product. Biotech crusaders dismissed his warning as scaremongering, but the newest research on the role IGFs play in the development and growth of many cancers (bone, lung, and gastrointestinal, as well as breast and prostate) suggests Epstein was right. Monsanto continues to downplay the problems, insisting that they were mistaken in their earlier finding that IGF-1 levels are higher in milk from treated cows. But the Consumers Union review of all studies, including Monsanto's, concluded that the weight of the evidence showed that bST use increases IGF-1 levels in milk 'substantially'. The chemical company also claims people do not absorb the IGF-1 in milk, since it does not survive digestion. Again, new data from animal studies shows that it does, and that it remains bioactive. The IGF-1 in cows' milk is chemically identical to IGF-1 in human, and casein in milk protects the hormone from digestion, which means it could pass into the bloodstream of milk drinkers. Alliance MP Phillida Bunkle recently released information to the press about the issue of IGF-1 in milk and cancer, citing The Lancet study. Few, if any, media organisations reported her concerns - some were reassured by Monsanto that her fears were groundless. Phillida suggested New Zealand dairy producers could grab a marketing advantage if we ensure our milking herds remain free of genetically engineered milk stimulants. 'All that is required to take advantage of this huge opportunity is for the Government to require labelling of genetically altered food,' she said. 'The New Zealand government is adopting the lax American standard for food labelling, including the flawed "substantial equivalence" test which doesn't allow consumers to avoid potentially killer products.' Phillida has a bill before parliament on such labelling. Suicide in users of a widely used acne drug Packaging for the acne drug Roaccutane now contains warnings about depression in users. This follows reports to Medwatch, the Food and Drug Administration's spontaneous warning system, of depressions and suicides of people on the drug. Since 1989 12 suicides in users of Roaccutane have been reported to the FDA. Patients reported that their depression lifted when they stopped taking the drug, but returned when they resumed use. Although no cause and effect has been firmly established, the concerns made the FDA, the manufacturer of the drug, Hoffman-La Roche, and physicians, warn that Roaccutane should only be prescribed under specialist supervision. The warning says: 'Psychiatric Disorders: Accutane [called Roaccunate in New Zealand] may cause depression, psychosis and rarely, suicidal ideation, suicide attempts and suicide. Discontinuation of Accutane therapy may be insufficient, further evaluation may be necessary. No mechanism of action has been established for these events.' Roaccutane has been used since 1982 for the treatment of cystic acne that does not respond to standard antibiotic treatment.A report in the American Journal of Psychiatry showed that 6.1% of Roaccutane users aged 1524 years experienced a major depression in a 30-day period compared to 4.9% of the total population. The relationship of Roaccutane to depression in users is complicated by the poor self-image and depression people with acne can suffer. Studies show that improvement in acne can decrease anxiety and depression and increase satisfaction with self-image (not just skin). Roaccutane can clear or nearly clear severe acne in more than 75% of cases. For many patients a single course of therapy over 4 to 6 months can produce complete or prolonged remission of acne. Within New Zealand, concerns were expressed in the early eighties about over-use of Ro-accutane, which had become fashionable among girls in some schools. Some doctors were suspected of freely prescribing the medication for even mild acne. Roaccutane has a number of other risks and there is a high a likelihood of damage to the foetus were it to be used during pregnancy. Sexually active users are advised to use two different methods of birth control while using Roaccutane. Ref: JAMA 1998; 279: 1057 Breast cancer and flight attendants A recent letter to the British Medical Journal reported a study which had found an increase in breast cancer among retired flight attendants from one US airline. The risk of breast cancer in this group was doubled. This findings adds to earlier studies which had found excess breast cancer among Finish and Danish airline attendants. There has been speculation as to what might cause this increase in risk with radiation suggested as a cancer promoter. Other estimates suggest that radiation exposure could account for only a 10% increased risk. The authors of this study, from the Environmental Health Division of the Environmental and Occupational Health Sciences Institute in New Jersey, suggests exposure to dicophane (DDT), an organochlorine pesticide, may be a cause. From the 1950s to the 1970s DDT was used to rid airplanes of insects. A hand operated aerosol dispenser was used by a flight attendant to spray the aircraft, while the doors were closed before takeoff when ventilation was minimal. This may have resulted in significant inhalation by the person spraying as well as exposure of the skin. The researchers tested the hypotheses of radiation and DDT exposure by asking flight attendants the number of flights in their career (as a proxy for radiation exposure) and the number of times they sprayed pesticides. They found a strong association with spraying, but only a weak association with the number of flights. The authors do not say whether the study was controlled for other risk factors for breast cancer, such as late childbearing or alcohol use, which may be more likely among flight attendants. Ref: Wartenberg, D and Stapleton, C, BMJ 1998; 316: 1902 Burned in the quest for beauty The US Food and Drug Administration warns users of skin peelers containing alpha hydroxy acids (fruit acids) that they can cause injuries such as skin burns. AHAs are used in cosmetics and by beauty therapists and dermatologists to 'rejuvenate' skin. The FDA said that some products penetrate the skin too deeply, causing severe skin damage. In several cases, people have been hospitalised for severe burns, swelling and pain. A Californian woman suffered a seizure, shock and second degree burns after a mixture of skin peel chemicals was applied to her legs by a beautician. Skin peeling products can vary considerably as to their ingredients and strengths. Also, skin reactions vary among individuals. Skin peelers contain different combinations of several different acids such as lactic acid, phenol, resorcinol, trichloroacetic acid, salicylic acid and glycolic acid. They are usually applied to the skin for a short time each day, usually for six to 12 days. The skin reddens, as if it is sunburned, then peels away revealing what manufacturers call 'new skin'. The treatments can be painful and leave permanent scars. Skin peeling treatments used only to be carried out by plastic surgeons and dermatologists but they are increasingly being used by non-medical people such as beauticians, some using newly mark-eted products. Many have inadequate instructions and none has been approved by the FDA as effective or safe. Cosmetics can also contain AHAs despite unanswered questions about their safety. Recently a study sponsored by the cosmetic industry indicated that such products may make skin more sensitive to sunlight especially W radiation which is implicated in the development of skin cancer. The FDA recommends that users of cosmetics containing AHAs should protect themselves with sunblocks, even if they have not used an AHA-containing cosmetic on the day they are going into the sun. The FDA has received about 100 reports of adverse effects from AHA cosmetics, ranging from mild irritation and stinging to blisters and burns. The FDA advises that women test the product on a small area of skin before using it further, and that use should be stopped if there is skin irritation or prolonged stinging. Ref: US FDA Backgrounder: 'Alpha Hydroxy Acids in Cosmetics' and 'Skin Peelers'- Hormones and hip fracture: benefits only for current users A recent Swedish case-control study showed that women currently using hormone replacement therapy reduced their risk of hip fracture, but that within five years of ceasing therapy, women had lost most of the benefit. Women aged 50-81 who had had hip fractures were compared with controls for their use or non-use of HRT. It was found that HRT reduced the risk of hip fracture but current or recent use was needed to obtain substantial protection. Current users reduced their risk of a hip fracture by about 70%. Women using combined therapy had a greater reduction in risk than those using oestrogen alone. The dose was also important: use of a low dose oestrogen (1 mg of oestradiol or 0.325 conjugated oestrogens or 25ug transdermal oestradiol) did not provide protection. Higher doses (equivalent to 2mg oestradiol or 0.625 conjugated oestrogen) did reduce the risk. An interesting finding was that HRT did not need to be started immediately at the menopause to gain the benefits. Starting it nine or more years after the menopause gave equally strong risk reduction as starting it earlier. This study was published in the British Medical Journal and an editorial by Kay-Tee Khaw, professor of clinical gerontology at Cambridge University, assessed current knowledge about HRT. Professor Khaw sounds a warning note about the current enthusiasm for HRT, and its promotion to prevent disease in ageing women. Prof Khaw points out that most of the trials showing cardioprotective effect have been far too small and short to give convincing results. Even the PEPI study (on which the New Zealand Ministry of Health based its decision to approve HRT for the prevention of heart disease) had fewer than 200 women in each arm of the trial. While HRT has been shown to have a favourable effect on lipids, selection bias was a real possibility. Most takers of HRT in the USA where most of the studies have been carried out tend to be thinner, healthier, more health conscious come from higher socio-economic groups and have different lifestyles than women who do not. The effects on stroke risk are still not known. The WISDOM study in Europe and the Women's Health Initiative in America will eventually provide more answers but these are some years away. Studies which show a cardioprotective effect of HRT or benefits in fracture reduction also show that the benefits rapidly diminish once women stop taking it. However, long-term use of HRT increases breast cancer risk and the risk of endometrial cancer is not eliminated by the addition of progestins. Risk-benefit analyses show that the women most likely to benefit from HRT are women at high risk of heart disease, while women at low risk of heart disease or who have an increased risk of breast cancer may benefit less or even be worse off. Risk-benefit estimates, warns Prof Khaw, cannot be universally generalised. Most studies have been done on US and British women who have high absolute rates of heart disease and fractures. Even then an estimated 2000 American women would have to take HRT for one year to prevent one coronary event. Most studies are based on conjugated oestrogens and the same effects cannot be assumed for different preparations and modes of administration. The short-term use of HRT for troublesome menopausal symptoms is not a problem, it is the long-term prophy-lactic use which raises the dilemmas. The international variations in experience of menopausal symptoms, and fracture and heart disease rates, show that these outcomes may be preventable through other strategies, such as diet and other measures, rather than simply taking pills. Ref: Michaelsson, K et al, 'Hormone Replacement therapy and risk of hip fracture: population based case-control study' BMJ 1998; 316: 1858-63, and Khaw, Kay-Tee 'Hormone replacement therapy again' BMJ 1998; 316: 1842-44