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Jocalyn Clark
A hot flush for Big Pharma
BMJ 2003; 327: 400 [Full text]
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[Read Rapid Response] Tempering with nature is not good medicine
Dr Nirmal K Bhattacharjee   (16 August 2003)
[Read Rapid Response] Where were the watchdogs?
GH Hall   (17 August 2003)
[Read Rapid Response] THE GREATEST EXPERIMENT EVER PERFORMED ON WOMEN
barbara seaman   (17 August 2003)
[Read Rapid Response] HRT Marketing
Ellen C G Grant   (23 August 2003)
[Read Rapid Response] Doctors forget they have a voice
Philip B Stowell   (25 August 2003)
[Read Rapid Response] Sometimes not enough marketing and advertising by manufacturers.
Geoff Crumplin   (26 November 2003)

Tempering with nature is not good medicine 16 August 2003
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Dr Nirmal K Bhattacharjee,
DGM(Medical)
AOD Hospital, Digboi, Assam, 786171

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Re: Tempering with nature is not good medicine

The adverse reports or to put it mildly, absence of positive reports about HRT is what we always believed. That we should not and never interfere with nature. The survival of human race never depended on 'sexing up' with human physiology and the intricate balance of hormones, minerals and chemicals in the milieu interior.The waning of sex hormones with age in both the sexes is entirely physiological - it is not a disease to be addressed to by creating a multi-billion industry. Anyone with a clear conscience and intelligence can understand that the Power that created us would have given us unlimited supply of those hormones to see us through the end of our life instead of reducing and stopping it in the middle of the life span, if it thought that the continuous supply is necessary for the survival. While a short course of the hormone replacement may be given where the ovarian function is abruptly stopped by surgery or radiotherapy,or temporarily to relieve the unbearable 'hot flushes',there can be no justification for indefinitely continuing the hormones, with the mistaken notion that those would keep the person forever young and feminine. Tempering with nature is never a good medical practice. Keeping oneself active in body and mind is what is needed to live long and age gracefully. Popping a hormone pill cannot be a solution for the problems at this phase in life. Hope this message percolates to the level of intended users and bring a balance in the approach to menopause, a perfectly normal phenomenon.

Competing interests:   None declared

Where were the watchdogs? 17 August 2003
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GH Hall,
Retired physician
EX1 2HW

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Re: Where were the watchdogs?

Fashionable and politically correct attacks on the pharmaceutical industry are all very well, but what do you expect? On other other hand, what can one reasonably expect is competent machinery for detection of adverse side effects of new (and existing) drugs. Clearly, the system failed with HRT, as it has with many other pharmaceuticals. What does the Committee on Safety of Medicines and the MCA have to say about the thousands of women who have developed breast cancer because their methods were faulty? Doubtless the excuse will be that long term studies are impractical. If that is the case, then the possibility of distant side effects should have been stressed to all concerned. The ethics of post marketing surveillance are very questionable. The secrecy surrounding safety testing results and methods (on the grounds of commercial sensitivity) has hamstrung attempts to open up this area to fair scrutiny, a deficiency adversely commented on by NICE and the Parliamentary select committee on health. Unfortunately the vested interests are so powerful that a conspiracy of silence on the part of the medical profession and pharmaceutical industry will reign as before. Only the press and the public will be able to prevent further damage.

Competing interests:   None declared

THE GREATEST EXPERIMENT EVER PERFORMED ON WOMEN 17 August 2003
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barbara seaman,
journalist and author
110 West End Ave NYC 10023

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Re: THE GREATEST EXPERIMENT EVER PERFORMED ON WOMEN

Thank you Jocalyn Clark for acknowledging my work, and thank you for noting the coming campaign to resuscitate HRT.. The theme, this autumn, will be "put the studies in perspective." Highly respected gynocologists will fan out over the United States to teach Continuing Medical Education courses, sponsored by the Coouncil on Hormone Education at the University of Wisconsin Medical School.I have heard these doctors speak.They are intelligent.They are eloquent, but they don't necessarily heed the words of Senator Daniel Patrick Moynihan:"You can have your own opinion but you can't have your own facts."

My book,THE GREATEST EXPERIMENT EVER PERFORMED ON WOMEN, EXPLODING THE ESTROGEN MYTH. was published by Hyperion last month. I reveal how the estrogen industry was unintentionally jump- started in 1938 when London biochemist/physician. E. Charles Dodds, published his formula for diethylstillbestrol in NATURE Magazine, giving it away, in order to stop Hitler from cornering the world market in sex hormones.

Competing interests:   None declared

HRT Marketing 23 August 2003
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Ellen C G Grant,
Physician and medical gynaecologist
20 Coombe Ridings, kingston-upon-Thames, Surrey , KT2 7JU

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Re: HRT Marketing

Sir-

When Professor Sir Charles Dodds discovered that the non-steroidal compound diethylstilboestrol acted like an oestrogen in 1938, he warned of its power and cautioned against its use, predicting serious effects. Combined HRT, which it is now calculated to double the risk of breast cancer, is a combination of a progestogen and an oestrogen. Combined hormones formed the “Pincus” contraceptive Pill in the 1950s. My boss Dr Gerald Swyer and Dr Gregory Pincus were co-chairmen of the Oral Contraceptive Advisory group of the International Planned Parenthood Federation. They both believed that the Pill was the answer to the world’s population problems, it seemed to me, irrespective of the accumulation of serious side effects. By the time I wrote Today’s Drugs for the BMJ in 1969, I was doubtful if any changes in doses or type of oestrogens and progestogens could prevent thrombosis and other vascular and mental changes. Like Barbara Seaman, I have long been warning of the dangers of using hormones. My books The Bitter Pill (1885) and Sexual Chemistry (1994) detailed the dangers of hormone use and how to recover from the effects of hormone use, especially with regard to preconception care.

Who are the regulators? It is amazing that in spite of massive increases in premature illnesses, cancers and hysterectomies among women who have nearly all taken hormones as contraceptives or as HRT, epidemiological studies have been so flawed that they have managed to give an illusion of safety for over 30 years. The working group on HRT of the Committee on Safety of Medicine of the Medicines Control Agency is composed of three epidemiologists, two obstetrician gynaecologists, who are well known supporters of the use of HRT, a GP, a physician, and a paediatric haematologist. Where are the basic researchers who understand how hormones work and change cell chemistry and vasculature and cause cancers? When I took part in a drug company sponsored debate some years ago, I was the lead speaker against the use of HRT, while CSM working group gynaecologist, Professor David Purdie, led the pro HRT speakers. The vote of the UK’s leading consultant obstetricians and gynaecologists was 95% in favour of the unrestricted use of HRT. The marketing of HRT has been very successful in the UK in recent years and has been accompanied by sharp increases in breast cancer, which is the commonest cause of death in women of hormone-taking ages. This HRT promotion has been largely unhindered by restrictions from the regulatory authorities.

1. Changing oral contraceptives. BMJ 1969; 4:789-91 & also in Today's Drugs 1969. 2. Dr Ellen Grant. The Bitter Pill, Hamish Hamilton, London 1985 and Corgi, London 1986 and also published in Norway, Holland, Denmark, France and Japan. 3. Dr Ellen Grant. Sexual Chemistry, Cedar, Reed Books 1994.

Competing interests:   None declared

Doctors forget they have a voice 25 August 2003
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Philip B Stowell,
GP
Brisbane 4051

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Re: Doctors forget they have a voice

It is of no surprise, but sadly continuing disappointment to me that the medical profession as a whole (GPs as well as their specialist colleagues) have been surprisingly silent or stridently "prodrug" in this discussion. Often it seems to me that doctors suspend their critical faculties immediatley after qualification. (Please allow a little exaggeration to make this point !). We swallow drug company marketing information as though it were scientific fact and then when presented with the facts go on repeating what the drug companies said again and again, as though trying to reassure ourselves that all is well and that prescription drugs do not have serious unwanted effects.

As a profession we are witnessing an epidemic of breast and other hormone related cancers. The occurence or approx 10,000 new cases of breast cancer each year in Australia and increasing DEMANDS public comment by the profession. We know now that HRT has epidemiological relevance to breast cancer and we also know we have been prescribing estradiol which is clearly defined as a carcinogen by the FDA for over 40 years at a time when the planet is also being systematically polluted by the toxic products of numerous multi- national companies in their pursuit of profit ( often at the expense of common sense and the environment ) with little effective regulation by our political representatives. Scientists know of the xeno-oestrogen links to cancer,one oncologist in particular is telling my patients "It is OK and 'normal' for there to be 10,000 new cases of breast cancer in this small nation each year".

I, for one, do not think it is OK nor normal.

I believe that "there is little done in medicine that is NOT political" and I call on doctors to express their concern about this epidemic and join the aware-public in the fight for a cleaner environment and for better regulation of the occasionally very toxic drugs we prescribe.

yours

Philip Stowell

Competing interests:   None declared

Sometimes not enough marketing and advertising by manufacturers. 26 November 2003
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Geoff Crumplin,
Resource Co-ordinator
Inter Care (medical charity), LE7 1LD

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Re: Sometimes not enough marketing and advertising by manufacturers.

Medical professionals routinely complain of the levels of intrusive and agressive marketing directed at them by the pharmaceutical manufacturers. Whilst this marketing may be an irritant to the medical professionals in the UK, an absence of such marketing is far more of a threat to good medical practice than a surfeit.

There are specific groups of medical professionals who are being denied access to absolutely essential pharmaceuticals because they are excluded from marketing and advertising campaigns.

Medical professionals serving patients in the world's poorest communities are not able to offer essential diagnosis, treatment and/or prophylaxis even when the crucial pharmaceuticals are available at zero cost and appropriate to the available skills and resources. This is a direct conseqence of the absence of essential information on the availability of donations and how to access them – a consequence of the absence of targeted and agressive marketing.

A striking example is the availability of free supplies of nevirapine for the Prevention of Mother-to-Child Transmission of HIV (PMTCT), and of HIV-test kits for the screening of pregnant patients where PMTCT is available. Recent surveys of rural medical facilities in Africa reveal that a significant proportion of the medical staff do not know that the pharmaceutical agents are available at zero cost, and a far larger proportion do not know how to obtain the donations. This is not surprising when, on November 21 2003, a BBC World Service broadcast on the value of the nevirapine regime (by definition directed at the countries with the highest HIV incidence), did not mention that supplies are available without cost. Even more striking was the explicit comment that even when the drug might be available, it was not used because of the lack of appropriate diagnostic tools for screening pregnant patients.

Any reasonably competent marketing department would have known of the range of broadcasts planned by the BBC in the run- up to World AIDS Day, and would have made sure that the broadcasts included information on the availability of free supplies of potentially life-saving screening and prophylactic intervention.

It is a sad reflection of the apparent inability of "professionals" managing and delivering ethical and well-intentioned donation programmes to use corporate marketing professionalism and competence in such philanthropy programmes. A commercial agent is actually being paid a fee to manage and deliver the PMTCT donation programmes (as well as a donation programme for flucanazole for treating fungal infections in HIV/AIDS patients), the fee does not appear to cover effective marketing and advertising.

We have no way of knowing whether the lack of information provision represents a lack of commitment to philanthropy, or a simple oversight because "gifts" are not traditionally marketed and advertised. With over 8 million pregnant mothers probably needing access to PMTCT, there is no benefit to be gained from accusations – there is only benefit to be gained from competent marketing, advertising and delivery of valuable donations.

The absence of marketing does not threaten the clinical and finacial independence of the medical professionals, it actively prevents them from saving the lives of their patients. For once we should be demanding that the manufacturers indulge themselves in appropriate and agressive marketing.

Competing interests: None declared