HAI-Europe, December 1998, Vol 3 No 3
| In This Issue...
Cover story: Tamoxifen and the healthy woman: That ol' black medicalisation that we know so well |
Tamoxifen and the Healthy Woman:
That ol' black medicalisation that we know so well
by Sharon Batt
[Editor's note: On 29 October 1998, the US Food and Drug Administration approved the drug tamoxifen for use in reducing the short-term incidence of breast cancer in women deemed at high risk for the disease. This action broke new ground in prescribing potent medicines for the prevention of a possible, future illness. Below author Sharon Batt takes readers behind the scenes to the FDA committee that considered the evidence and explains how this drug with serious, known risks for women's health gained approval.]
On September 2, I witnessed a pivotal moment in the history of women's health. An expert panel advising the American drug regulatory agency, the Food and Drug Administration (FDA), reviewed a request to approve the drug tamoxifen as a safe, effective way to prevent breast cancer. The application was filed by Zeneca Pharmaceuticals, manufacturer of Nolvadex® and the sole company with the right to sell tamoxifen in the US.
After hearing some four hours of evidence, pro and con, the committee's eleven members wrestled with the fact that a clinical trial testing tamoxifen on healthy women had not proven the drug to be either a safe or an effective means of preventing breast cancer. Nonetheless, the members voted, in full view of the packed hearing room, to recommend FDA approval of the company's application (nine yeas, two abstentions). The main concession to reality was the recommendation that Zeneca only be allowed to promote the drug for "short-term risk reduction" of breast cancer, not for "prevention"--a subtle distinction which fell by the wayside even as accounts of the committee's decision surfaced in the next morning's news.
The hearing was the most recent plot twist in breast cancer's "chemoprevention" drama, that is, the effort to stop breast cancer with a pill. For a six-year period which ended last April, most of the activity has been offstage. If the sudden flurry of front-and-centre action caught you off guard, you're not alone. But keep your eye on this story. Tamoxifen is a women's health parable for the '90s.
Chemoprevention on trial
Seven years ago, the National Cancer Institute announced its plan to fund a North America-wide clinical trial involving 16,000 healthy women, defined as at higher-than-average risk for breast cancer. Half would be given tamoxifen, the other half a placebo. The budget was impressive: US$68 million, not counting the cost of the drug, which would be supplied by Zeneca. (Modifications to the trial later reduced the price-tag to US$60 million and recruitment eventually stopped at 13,388). Researchers in the UK, Italy and Australia-New Zealand mounted similar trials about the same time.
The National Women's Health Network (NWHN) intervened to try and stop the North American study. The Network was formed 25 years ago, in response to the reproductive issue crisis. Advocates of a science-based approach to women's health, its directors saw the plan to give a potent drug to healthy women as both scientifically questionable and a dangerous precedent in medicalising disease prevention.
Tamoxifen as treatment
Tamoxifen has been used in breast cancer treatment for twenty years, with some success. Women who have already had cancer in one breast are at high risk of developing cancer in their other breast. In post-menopausal women with estrogen-sensitive tumours, taking tamoxifen for up to five years reduces the risk of breast cancer in the opposite breast by 47%.
The drug's downside, which includes an increased risk of endometrial cancer, blood clots, cataracts, and a host of "minor" effects such as hot flashes, depression, weight gain and reduced libido, is par for the course in a cancer treatment. In fact, tamoxifen is one of the more user-friendly and effective breast cancer treatments. Doctors who treat breast cancer regard the drug highly.
Disease substitution vs. disease prevention
Physician Adriane Fugh-Berman of the NWHN's board agreed: "The risk/benefit ratio for women with a life-threatening cancer definitely favors tamoxifen." Where she parted company with the prevention trial's advocates was in giving the same drug to healthy women. "Acceptable risks for the sick are not acceptable risks for the well," she wrote in a 1991 critique of the trial. Cancer specialists tend to have a skewed perspective of safety, she noted, because they are so accustomed to slash-and-burn treatments. In preventive medicine the norms are entirely different: risks should be vanishingly small, as in vaccination or vitamin-D enriched milk. Trading a lowered risk of breast cancer against an increased risk of endometrial cancer, she argued, amounted to disease substitution not disease prevention.
The trial's proponents countered that the women being recruited were not actually healthy--they were at high risk of breast cancer. The verbal maneuver reminds one of President Clinton's attempts to redefine sex. Eligibility criteria for the North American trial defined "high risk" as that of an average sixty-year-old woman, specifically, a 1.66 percent chance of developing breast cancer during the next five years of her life. Younger women, from age 35 upwards, could enter if additional factors, such as a family history of breast cancer or a personal history of breast biopsies, elevated their statistical risk to the age-60 level.
The trial results
When the NWHN failed to rally enough support to stop the North American trial, public debate over tamoxifen as a preventive died down. For most of the last six years, trialists here and abroad have gone about the business of accruing subjects in relative quiet. (One notable exception was the trial's suspension, in 1994, to revise the consent forms because they failed to mention that tamoxifen carries a risk of potentially fatal endometrial cancers.)
Last April, in a bolt from on high, the North American researchers announced that they had halted their study more than a year before the scheduled date because the benefits of tamoxifen were so striking they could no longer justify denying the drug to the women in the placebo group. The announcement made banner headlines worldwide. After an average of about four years on tamoxifen, 85 women in the treatment group had developed breast cancer, compared to 154 women in the placebo group. Without a doubt, tamoxifen had reduced the number of breast cancer cases.
The results also confirmed the prediction of "disease substitution," however. Women who took tamoxifen had significantly more endometrial cancers, blood clots and cataracts. The tally in deaths from either breast cancer or a complication linked to tamoxifen was five to six: five women in the control group died of breast cancer, compared to three deaths from breast cancer and three from blood clots in the lung in the tamoxifen group. Among the less serious side effects, women on tamoxifen were more likely to suffer from uncomfortable hot flashes and vaginal discharge.
Whether the drug had actually prevented breast cancer was not clear. An equally plausible interpretation was that the onset of small, undetected cancers had been delayed. If this were the case, the women may have gained no greater advantage than if they were treated after a diagnosis. Or, if the tamoxifen does prevent cancers over the long haul, the survival benefit may be less striking than the reduction in incidence, because the tumours that respond to tamoxifen tend to be more readily treatable. Only long-term follow-up could answer these questions.
Get ready for STAR
This trial won't give us that long-term data, however. At the same time the researchers declared victory, they announced that they had offered women in the control group the choice of taking tamoxifen. Their rationale was that withholding the drug would be unethical, given the effect demonstrated. The trialists went further: they encouraged women in the control group to volunteer for another chemoprevention trial set for launch this fall.
Dubbed the "Study of Tamoxifen Against Raloxifene"or STAR, the new trial will compare tamoxifen with a pharmacological cousin, developed by Eli Lilly and currently approved for prevention of osteoporosis. If (as seems likely) many of the placebo-group women opt either to take tamoxifen or to enter the new trial, long-term data for the original trial will be useless.
Europe: a different story
To confuse the picture even more, researchers in Great Britain and Italy rushed early results of their own tamoxifen prevention trials to press this summer and neither study showed evidence of fewer cancers from tamoxifen. When carefully examined, the contradiction is not as baffling as appears at first blush. The North American study showed clearly that tamoxifen does not reduce the incidence of estrogen-negative tumours. Younger women are more apt to have estrogen-negative tumours and both European trials had more younger women than the North American trials.
Furthermore, all the women in the British study had a family history of breast cancer. Although family history was not rigorously defined, the British results raise a red flag about women with a genetic predisposition to breast cancer. With the advent of genetic testing, women with a mutated BRCA gene are a well-defined group that would be highly motivated to take a drug that could prevent breast cancer (many resort to prophylactic mastectomies); yet they are more apt to have estrogen-negative tumours and tamoxifen may not lower their risk of breast cancer.
In contrast to the other two studies, women in the Italian trial were not selected to be a high risk. About 26 % dropped out in the first year, weakening the power of the study and perhaps contributing to the negative result. On the positive side, the high drop-out rate suggests that women at low risk have a sensible aversion to tolerating unpleasant drug side effects in the hopes of preventing breast cancer.
A final difference which has been noted between the North American and European studies is the differential use of hormone-replacement [HRT] drugs, which could interact with tamoxifen. North American women were instructed not to take HRT during the trial. In the UK study, 41% of the women took HRT; in Italy 14% did so.
The message from Europe is that we still don't know enough to give women helpful advice about tamoxifen for chemoprevention. The British intend to continue their trial for many more years and, along with the Australians, may turn up some answers about long-term effects (the Italians stopped their trial because of the high drop-out rate). Researchers in the UK, still recruiting volunteers, made no secret of their chagrin when their North American colleagues declared the whole question history. The senior researcher from the British team, Trevor Powles, testified at the FDA hearing and was visibly frustrated that the Americans had so cheerfully closed the door on the long-term results of their own trial and thrown away the key.
The North American researchers, rather than worrying about tamoxifen's inadequacies, simply admit the drug is wanting. They defend the tamoxifen prevention trial as a necessary first step, not an end in itself, and describe tamoxifen as the precursor of better, smarter hormone pills.
The SERMs vision
Tamoxifen is gaining fame as the first of an emerging class of drugs known in the trade as Selective Estrogen-Receptor Modulators (SERMs). SERMs-enthusiasts envision a medical equivalent of hormonal smart-bombs, designer pills which will manipulate women's hormonal systems to put more estrogen here and less there, rolling together all the benefits of birth control, breast cancer prevention, and hormone replacement--with none of the nasty drawbacks. SERMs arose from the accidental discovery that tamoxifen blocks estrogen in certain parts of the body but stimulates the same hormone in other places.
Researchers realised that estrogen-receptors, the switches controlling whether or not estrogen enters a cell, are different at each of the many places in the body that use estrogen. Conceivably, estrogenic drugs could be designed to block estrogen's access to some sites, but enter cells in places that benefit from estrogen. The ultimate hormonal designer drug would inhibit cancers in the reproductive organs, strengthen aging bones and lend suppleness to arteries.
Enter Evista
Raloxifene, or Evista, Eli Lilly's entry in the breast cancer chemoprevention stakes, is a post-tamoxifen SERM. Currently being tested in clinical trials as a hormone-replacement therapy, the only results available are very preliminary. Lilly has nonetheless managed to create enough buzz about raloxifene to suggest the drug could trump both Premarin as a hormone replacement drug and tamoxifen as a chemopreventive for breast cancer. Raloxifene's promise is based largely on the two-year results of a study in which women on raloxifene had a 50 % reduced incidence of breast cancer compared to women taking the placebo. The company has highlighted this claim, based on a mere 35 cases of cancer in a trial of some 6,000 women, while downplaying the finding that raloxifene produced ovarian cancer in mice and rats.
In other words, raloxifene's claim to greatness as a breast cancer-preventive is as shaky as tamoxifen's. The so-called STAR trial (the acronym is more redolent of advertising hype than of scientific inquiry) will pit the ambitious rookie against the flawed veteran. Can we really believe women's health will be the winner?
The FDA hearing
At the FDA hearing, representatives from Zeneca and senior members of the research team presented their data, putting the results in the best possible light. Also arguing for approval of Zeneca's application was a woman from the Cancer Research Foundation of America, who acknowledged (as required the rules) that her organisation had received funding from Zeneca. Dr. Trevor Powles, from the British research project, answered questions about his own trial and made clear his distress about the North American trial. Fifteen years of follow-up would be needed to know if the effect was truly prevention, he said, pointedly. If the North American trial hadn't been unblinded, with all the trials together "we could have had useful data by 2005".
I was one of eight intervenants who urged that tamoxifen not be approved as a preventive for breast cancer. We echoed each others' concerns that the trial had shown short-term reduction in the risk of breast cancer, but hadn't demonstrated prevention. We reminded the committee of the risks (Ann Fonfa from New York opened her presentation with a taped voice from the grave saying, "Thank you for saving me from breast cancer, too bad I died of a pulmonary embolism.") We expressed our fears of exaggerated advertising claims targetting busy GPs eager to believe in a magic pill and frightened women eager to take one.
It's about advertising, not access
American advocates had briefed me on what approval of the company's application would mean. The issue was not, they explained, one of access to the drug for women at high risk of breast cancer. That right exists now. Because tamoxifen is already approved as a breast cancer treatment, any physician can prescribe the drug "off label" to a patient he or she believes might benefit from it. Given the results of the trial, such a prescription would not be an unreasonable decision for either patient or physician, provided that they both were aware of the drug's limitations and risks, and understood the need for monitoring.
Approving the drug for preventive use would mean that the drug company could advertise the product as proven effective for prevention, with a risk/benefit ratio favouring safety. Given the huge prospective market of healthy women (29 million Americans, if you restrict the numbers to those who meet the eligibility criteria of the trial), one could expect marketing to be intense. American law allows direct-to-consumer advertising, which is currently illegal in Canada, but high on the drug industry's wish list.
A subtle shift
As the eleven committee members began their deliberations, they seemed sobered by their responsibility. On the first question, whether the trial showed the drug was effective in preventing breast cancer, they voiced their concerns about the word "prevention", and finally settled on a rewording: the drug "reduced the short-term incidence of breast cancer." The next question, whether the trial showed a favourable risk-benefit ratio for the prevention of breast cancer, also caused the committee difficulty. Having jettisoned the word "prevention", the benefits were nebulous, and the risks, for some women, were obviously considerable. The vote was negative. By now the company reps were slumping glumly in their seats and the advocates were exchanging wide-eyed glances.
A subset to the risk/benefit question was whether the committee could identify a subpopulation with a favourable risk/benefit ratio. Again they had problems. The data don't point to any identifiable subset of women who would clearly benefit from taking the drug. As its members pondered this, the committee's mood changed, as if turning on an invisible pivot. One member said it would be a shame if the application was rejected and the researchers looked bad, because their trial was excellent and had yielded a wealth of data. Another member mentioned the 13,000 "courageous volunteers". The risk/benefit ratio was found to be favourable after all, and the committee voted to approve the application. The rest of the discussion slipped to damage control, via package inserts and working with the company to ensure "an extra educational effort".
Deceptive openness
The FDA has promised to rule on the tamoxifen-for-prevention application by November, and the agency usually accepts an advisory committee's recommendations. From where I sat, the committee members completely abdicated their responsibility to protect the public. No one I spoke to, however, expected anything different. This was strange, given that the procedure had all the appearance of a model exercise in democracy. Those of us arguing for a public safety decision were able to speak our minds, we were heard (committee members frequently quoted our arguments) but we lost all but a tiny corner of turf: the veto on the word "prevention". What happened?
In retrospect, the wide-open American hearing was deceptive. Behind the scenes, the drug company, the researchers and the regulators work in close contact (Zeneca's senior medical director opened his presentation by acknowledging his "colleagues" on the research team and at the National Cancer Institute). If the FDA blocked approval of a drug after the National Cancer Institute had invested US$60 million in a high-profile trial to test it, some career fur would certainly fly.
A milestone...on what road?
The media are complicit as well. Americans who sat down the next day with their morning coffee and their daily papers read an account of health policy moving smartly ahead. The Chicago Tribune stated that the panel had "urged the Food and Drug Administration to widen its war against breast cancer by approving a drug to prevent the disease...". The front page New York Times story said that if the FDA accepted the committee's recommendation, "...approval would be a milestone in efforts to prevent cancer."
A milestone, perhaps, but not for advocates of cancer prevention. As we head into a new millennium and the impending bombardment of hype about SERMs, I'll keep a bottle of old fashioned skepticism next to my bed.
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Sharon Batt is author of Patient No More: The Politics of Breast Cancer, published by Gynergy Books and A New Look at Breast Cancer--Beyond Early Detection, published by DES Action Canada. She is director of policy and research for Breast Cancer Action Montreal.
This article originally appeared in the DES Action Canada newsletter. It is reprinted with permission.
| WHO Revised Drug Strategy Watch
NGOs meet with WHO staff On 9 October, HAI coordinated the first NGO Pharmaceutical Roundtable between international health NGOs and WHO's Director General Gro Harlem Brundtland and senior staff members. At the meeting, the NGO representatives gave their views on key drug issues including equity and access, independent drug information, drug promotion and the impact of globalisation and trade agreements on health. (Presentations made by members of the NGO coalition as well as the briefing paper prepared for the meeting can be requested from the office or found on HAI's website (go to link). Its main outcomes included: - WHO acknowledged the need to strengthen its support for and collaboration with NGOs at the national level. - This meeting contributed to WHO's efforts to define and further develop processes for collaborating with NGOs and others. - No decision was made on the structure of future meetings, but Dr. Michael Scholtz, Executive Director for WHO's Health Technology and Drugs cluster, promised to devise a strategy for working with NGOs in the future. Both sides left the meeting in agreement that this had been an important step in repairing, redefining, and reinvigorating NGO contributions to and collaboration with WHO. Industry plans cooperation with WHO Later in October, members of the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) also met with Dr. Brundtland and WHO staff. They decided to set up a joint working group to analyse why one-third of the world's population still can't obtain the most essential drugs and vaccines and to look for ways to improve access. HAI reacted critically to this meeting as only members of the research-based industry were involved, excluding generic manufacturers who have a clear role in improving access to essential drugs. New RDS text In October, a special working group of the Executive Board (EB) also met to formulate a new draft text on the Revised Drug Strategy (as members had been unable to agree on a text at May's World Health Assembly). Zafar Mirza, coordinator of the Association for Rational Use of Medication in Pakistan (The Network), spoke on behalf of HAI at a technical briefing on access to essential drugs. In his remarks, he emphasised the need for public health interests to be placed above trade. He also recommended ways for national governments and the WHO to pursue public health goals in a globalised economy. A summary of Zafar's presentation can be obtained from the HAI-Europe office or from HAI's website at http://www.haiweb.org/news/globalization.html. At the end of the session, the EB's working group approved a new draft text on the Revised Drug Strategy. While the draft reflects compromise, it is quite promising. The text gives a broad mandate to WHO to advise Member States on the implications of international trade agreements and for the first time acknowledges that drug promotion causes problems in both developed and developing countries. (A line-by-line comparison of the new text and the previous version is available from the HAI-Europe office.) The special working group will present the draft text to the Executive Board in January 1999. |
Newer isn't necessarily better -- whether it's a new drug or new drug regulation
On 3 November, 1998, DES Action Canada hosted a public panel discussion in Toronto, "How safe are our medicines?", to take a critical look at the Canadian drug regulatory system and how it compares with regulation in the US and Europe.
The Health Protection Branch, Canada's regulatory agency, is currently reviewing the country's health protection legislation and just completed a series of public consultations in major Canadian cities at the end of October. Although the proposed legislative changes remain vague, DES Action and many other public interest and women's health organisations across the country are concerned that terms such as 'flexibility' and 'shared responsibilities' are being used to gloss a move towards deregulation. They are also concerned about the way these public consultations were carried out, with the food, drug, medical device and chemical industries more heavily represented than the public, and with some highly contentious issues--such as whether direct-to-consumer advertising should be allowed in Canada--hidden within a vague proposal to modernise the law.
At the public consultations, Mario Simard, the legal counsel for the Health Protection Branch, showed participants a photo of a 1953 car and told them that, "there's a point where you have to trade in an old car and we feel we've reached that point." He was referring to Canada's Food & Drug Act, also of 1953 vintage. However, he failed to mention the hundreds of pages of regulations passed since 1953 to continually update the Act, or the timelessness of some of its key principles--such as prohibiting fraud, deception and poisoning.
Michèle Brill-Edwards, one of the three speakers at DES Action's panel discussion, does not believe the Food & Drug Act should be scrapped. She would just like to see it enforced more rigorously. Dr Brill-Edwards was a senior drug reviewer for the Health Protection Branch when she resigned in 1996 over concerns about the safety of nifedipine, a heart medication. She spoke of a gradual process of "deregulation by stealth", with increasing pressure for faster drug approvals at the same time as large-scale cuts to the regulatory agency's funding. A current scandal involves the veterinary drug bureau. Scientists who reviewed Monsanto's application for bovine growth hormone (rBST) have filed a complaint that they were pressured to approve the drug in spite of concerns about its safety and gaps in the information submitted to the agency.
The US FDA is often praised as a model regulatory agency, because of the openness and transparency of its regulatory procedures, structures for public participation and stringent safety standards. Dr Sidney Wolfe, of the Public Citizen Health Research Group in the U.S. spoke both about the positive sides of the US model, for example the ability of members of the public to sue the government when it fails to take appropriate measures to fulfill its own obligations to protect public safety, and more negative sides--especially a recent weakening of FDA standards. The FDA approved a record number of drugs during 1996-1997. However, the other startling record is the number of recently introduced drugs that had to be withdrawn because they were found to be unsafe, three drugs in the last 12 months.
Sidney Wolfe also spoke of the US "plague" of direct-to-consumer advertising within the "epidemic" of drug promotion, with US$1.5 billion spent in the US in 1998 advertising prescription drugs to doctors and patients. The combination of "misled patients and misled doctors" leads to unnecessary and frequently harmful prescriptions.
Ellen 't Hoen, who works with La Revue Prescrire and the International Society of Drug Bulletins (ISDB), spoke of the work the European independent drug bulletins have been doing to advocate improved access to information and accountability in drug regulation. Currently, the European Medicines Evaluation Agency provides better access to information on regulatory decisions and on safety and efficacy of new drugs than Canada's Health Protection Branch, although it lags far behind the US FDA. Europe also has mandatory patient package inserts accompanying all prescription drugs, which Canada lacks. However, patient package inserts are not always accurate because representatives of all countries in the European Union must agree on common wording. In the case of a drug to treat breast cancer, the word 'cancer' did not end up in the patient leaflet because of the worries of countries with conservative medical traditions that this would unduly alarm patients. As a result, the patient leaflet's information on indications was inaccurate. Ellen 't Hoen warned about the risks of this sort of "lowest common denominator" approach to joint regulatory decisions.
ISDB and HAI's work to improve access to information on regulatory decisions is very relevant to Canada, which has a secretive regulatory system. Recent safety scandals have highlighted the need for greater openness and public accountability.
DES Action Canada hosted this panel discussion both to help support better drug regulation and to celebrate the organisation's 15th anniversary. People exposed to DES (diethylstilbestrol) are still suffering from the results of an unnecessary and harmful drug exposure. "The only way Canada can prevent a tragedy like DES from happening again is through proper safety standards and wide public accountability in drug regulation," says Shirley Simand, president of DES Action Canada. For more information on Canada's regulatory review or the work of a newly formed coalition of women's health and public interest groups who are working together to put public safety first, contact DES Action Canada, 5890 Monkland Ave, Suite 203, Montreal, Quebec, Canada H4A 1G2, tel: (+1514) 482 3204, fax: (+1-514) 482 1445 or E-mail: desact@web.net .
EU drug policy echoes beyond its borders
Graham Dukes has produced a short paper tracing the effects of EU drug policy on non-EU countries in Europe. Originally presented at a European Public Health Alliance seminar on drug policy, Dukes emphasises that EU drug policy concerns itself with drug efficacy, safety, quality and truthful promotion, but takes no consideration of value for money and a particular national situation or need.
Potential differences in pharmaceutical situations raise questions about the appropriateness of the European rules. Dukes describes why many governments now feel extreme pressure to simply adopting policy as made in Brussels. This course of action is difficult to resist considering they are extraordinarily comprehensive, have become an international standard, and many countries aspire to joining the EU or trading with it. For example, when it joined the European Economic Area, Norway has had to give up its well-known "need" criterion for registration and as a result the number of drugs registered and marketed there is beginning to rise.
Some European countries, such as Macedonia have taken another approach. Determined to design its own law to address the country's specific situation, it adopted many elements of EU law but left out other parts completely. For example, it was able to incorporate rational use as a basic aim and included measures to record public drug utilisation figures and to strengthen training for students about proper use. Dukes concludes "In this sense, it is more a law about drug therapy than about drug products; a drug product law made sense for a Community seeking to ensure the free movement of goods, but today a drug policy law, of which drug product law is only a part, makes much more sense for a country thinking primarily of health and less of trade."
To receive a full copy of Dukes' paper, contact the HAI-Europe office.
| Dutch group awarded for work on generics
The European Generics Association (EGA) has honoured the work done by the Dutch Institute for the Effective Use of Medication (DGV) for its role in supporting the use of generic drugs. The institute received the prize for its success in increasing cooperation between doctors and pharmacists through a network of 800 pharmacotherapy teams in The Netherlands. These teams, comprised of five to twelve general practitioners (GPs) and one to three pharmacists, allow an informal exchange of information between the two groups that has led to an increase in the use of generics. The DGV estimates that generic substitution saves US$45 million a year. The DGV was started in 1994 by the Royal Dutch Association for Pharmacy (KNMP) and the National General Practitioners'Association (LHV). It is funded by the Dutch Ministry of Health. To learn more about its work, contact: Geert Kocken, Stichting DGV, Churchill-laan 11, 3527 GV Utrecht, The Netherlands, tel: (+31-30) 2916 216, fax: (+31-30) 2962 912 or E-mail: post@stichtingdgv.nl. (Managed Care Europe) |
Dutch promotion schemes exposed
Drug company MSD has recently been criticised for paying some Dutch general practitioners NLG 150 (US$75) for completing questionnaires about side effects related to the company's migraine treatment. According to a spokesperson from the Dutch GP's Society (NHG), there are currently no rules stopping doctors from taking part in this type of "survey" and getting paid for it. However, he added, GPs are supposed to prescribe drugs as cheaply as possible. Receiving a financial reimbursement turns this idea upside down.
A month earlier, pharmaceutical company Glaxo was exposed for closing lucrative deals with hundreds of Dutch pharmacists. These contracts resulted in discounts and bonuses when they sent details about drug sales to the company. The country's Minister of Health, the Parliament, the GP Association and the Pharmacists Society have all publicly criticised the company's manner of working. The Health Inspection Service is now investigating the Glaxo contracts.
(Het Parool, 7 October 1998)
Advertising to consumers for health or profit?
In her article, "Direct-to-consumer advertising: For better profits or for better health?" Ellen 't Hoen raises strong objections to the FDA's decision to ease restrictions on direct-to-consumer (DTC) advertising on TV and radio. Under proposed guidelines, US companies can now make health claims and describe a drug's action as long as they also mention its biggest risks. In addition, advertisements no longer have to include the "brief summary" information that provides more detail about the drug (which is still required of printed advertisements). 't Hoen worries that public health may be damaged by these new rules considering the first violation came only two weeks after the guidelines were in place.
The idea that DTC advertising will lead to more rational drug use is questioned. The article cites a recent report by the WHO's Action Programme on Essential Drugs which states "Pharmaceutical marketing to prescribers, dispensers and consumers may contribute to irrational use" and goes on to express concern about the great imbalance between commercial and non-commercial sources of information. There is also worry that more DTC advertising will lead to increased consumption of newer, more expensive brand-name drugs instead of older, cheaper and often safer medicines.
The FDA's decision may have implications abroad. While DTC advertising is currently prohibited by the European Union and Canada, there are signs that the pharmaceutical industry in both regions is applying strong pressure to change current regulations.
To receive a copy of the full article, contact: Ellen 't Hoen, Prescrire International, P.O. Box 459, 75527 Paris Cedex 11, France, tel: (+33-1) 47 00 94 45, fax: (+33-1) 48 07 87 32 or E-mail: ethoen@csi.com.
Israel says no to sponsored trip
Two hundred public health doctors were banned from attending a conference in Turkey arranged and paid for by a drug company. The trip was organised to promote the new antihypertensive drug Cardura-XL which the company Teva promotes in Israel for Pfizer. Teva had personally invited 200 urologists, internists and hypertension specialists to attend the meeting when it was informed by the Ministry of Health that personal invitations were not permitted. The firm then issued invitations to public hospitals and asked them to select participants. After the health minister forbade the doctors from taking part, the company canceled the meeting and is now considering legal action against the Ministry. Said an official "We don't want doctors who are public employees going on holidays directly at the expense of commercial firms, even if they do attend a couple of lectures to justify it."
(British Medical Journal, Vol. 317, 8 August 1998)
German medical journals: too close to industry?
German journal editors have started discussions on the problems they face in retaining editorial independence. Today many of these journals are owned by private companies and have small readerships. Most of their funding comes from advertising although this source is decreasing as pharmaceutical companies turn to other more profitable, promotional means.
Scientists must accept some of the responsibility for this development, according to the protocol produced by the German society for internal medicine. "Scientists are by no means bystanders of this development. As opinion leaders they give the cues for the reports the industry wishes to be printed in the journals" and "the scientists who give the desired cues will be invited most frequently to the well paid press symposia as well as to the continuing medical education meetings for physicians." The document concludes "We observe a spiralling negative image as to the credibility of our medical journals. The publishers are obviously unable to escape the grip of dependence. This should be made known to marketing people in industry as well as to the medical scientific societies."
(British Medical Journal, Vol. 317, 10 Oct. 1998)
| IBFAN receives Right Livelihood Award
The International Baby Food Action Network (IBFAN) will join a number of groups receiving the "Alternative Nobel Prize" this year for its work in the global struggle to put limits on corporate power. The international jury which selected the winners praised the network "for its committed and effective campaigning over nearly twenty years for the rights of mothers to choose to breastfeed their babies, in the full knowledge of the health benefits of breastmilk, and free from the commercial pressure and misinformation with which companies promote breastmilk substitutes." The award, worth approximately US$230,000 was presented to IBFAN and the other recipients on 9 December in Stockholm, Sweden. The Right Livelihood Award was created by Jakob von Uexkull in order "to honour and support those offering practical and exemplary answers to the most urgent challenges facing us today." |
Consumers say DTC ads educate and confuse
A recent survey suggests US consumers believe DTC advertising informs them about products that could have possible benefits for them while it raises confusion about benefits and risks.
The study, carried out by the consumer health magazine, Prevention, interviewed 1,200 adults to gain their perceptions of DTC advertising. While 74% thought DTC advertising helped them become more involved in managing their health, many were concerned that such advertising trivialised drugs by making them seem like other consumer products. The survey's respondents found most advertisements below average in terms of usefulness and many did not know what condition the drugs were intended to treat, although they had good recall of brand names. The survey concluded that the inclusion of risk information may not be the cause of consumer confusion, but rather that it may increase public confidence in advertised drugs.
DTC advertising continues to grow in the US and there are predictions that the industry will exceed the US$1 billion budget forecast for this year.
(Scrip, No. 2358, 5 August 1998)
Celebrating success against "vaccines" research
Last month marked the fifth anniversary of the campaign to stop research on anti-fertility "vaccines"(immunological contraceptives). In October, members of the campaign voiced their concerns about this research at the Congress on Reproductive Immunology held in India. At the meeting they also released a statement outlining the hazards related to "vaccines" and this method's potential for abuse. Campaign representatives distributed the statement among scientists attending the meeting and discussed medical ethics and the social context of medical research with them. The report, Target practice: Anti-fertility vaccine research and women's health, produced by the Indian NGO Saheli was also released.
Since it started, the campaign's goals have been endorsed by almost 500 groups in 41 countries. In April this year, the International Development Research Centre (IDRC) in Canada decided to stop funding vaccines research in India and said it no longer plans to support any research on anti-fertility "vaccines". This announcement followed an earlier meeting between 30 women from the campaign and senior staff from the IDRC in 1995. Research on these "vaccines" taking place in India and Sweden has encountered problems with funding, adverse reactions and low efficacy and as a result has slowed. While there are certainly reasons to celebrate, the work is far from done. The campaign's coordinators recently reported that a new trial involving fertile men has started in Chile. To learn more about the campaign and its future plans, contact: Annette Will, Women's Global Network for Reproductive Rights, NZ Voorburgwal 32, 1012 RZ Amsterdam, The Netherlands, tel: (+31-20) 620 9672, fax: (+31-20) 622 2450 or E-mail: office@wgnrr.nl.
WHO moves on global standards for raw materials
After more than 80 children died in Haiti in1995 as a result of taking contaminated, mislabelled cough syrup, the WHO has renewed efforts to adopt international standards for the trade in starting materials for pharmaceuticals. In May, national drug regulatory authorities, pharmacists, traders, chemical and pharmaceutical manufacturers, customs officials and NGOs (including HAI) met in Geneva and set out recommendations to avoid future tragedies.
The group's solutions focused on the fact that contamination most often occurs during manufacture of the starting material or during subsequent trading, transportation and distribution to the maker of the final medicinal product. They agreed that health authorities should authorise such practices and companies should follow Good Manufacturing Practice. Government inspectors should also be able to inspect materials at any time. To prevent the mislabelling of containers as starting materials change ownership during shipment, the group recommended that a system of Good Distribution Practice be developed.
WHO was asked to draw up a list of critical excipients (inactive starting materials). It was thought that this would help all of those involved in the trade to recognise and check the quality of pharmaceutical starting materials. Countries and individual manufacturers were also encouraged to maintain testing facilities able to analyse both starting materials and the quality of final products. The meeting experts advised countries lacking this capacity to use formulations in essential drugs with ingredients which they could test. In addition, the group agreed that while all of the actors involved in the international trade were each responsible for their own activities, the final responsibility rests with the manufacturer of the final product.
(WHO)
Amnesty for unregistered trials
Last year, 50-100 medical journal editors called for the investigators of unregistered trials to register them. Since then, only 165 trials have done so. Although this is a small number considering how many unregistered trials exist, the idea has won broad support. The editors agreed that withholding the data from such trials meant withholding information about treatment effectiveness, something that could lead to inappropriate decisions.
One pharmaceutical company has decided to work on its publication policy. Glaxo Wellcome said it would collaborate with Dr. Iain Chalmers of the UK Cochrane Centre to register its trials to make the results of those studies available until they are published in full. Surprisingly, the UK Medicines Control Agency sees no great need to make such information public. It claims clinical trial data is commercially valuable and therefore exempt from disclosure unless there is an overriding health or safety risk. This is a surprising view considering its mandate is safeguarding public health.
Ian Roberts, Director of the Institute of Child Health in London opposes such secrecy and says "Prospective registration of clinical trials promises to make publication bias a thing of the past. But in the meantime we must make the best use of the information at hand. Finding out about unpublished studies is a critically important aspect of this."
(British Medical Journal, Vol. 317, 19 September 1998)
Dutch groups publish guidelines for donations
"What isn't good enough for us, isn't good enough for people in developing countries" writes the Dutch Minister of Health in the foreword of a new publication promoting appropriate drug donations from The Netherlands. Guidelines for Drug Donations from The Netherlands [Richtlijnen voor geneesmiddelendonaties vanuit Nederland] is based on the inter-agency Guidelines for Drug Donations issued by WHO in 1996. The publication was developed by members of the Dutch Working Group on Drug Donations and has received the support of the Dutch government, the Dutch pharmaceutical industry, wholesalers and international NGOs such as the Red Cross. To date, it has already been distributed to 1,500 organisations and individuals interested in drug donations.
The complete guidelines can be accessed from the Internet at the following address: http://www.wemos.nl/donaties. For more information about the guidelines, contact: Mark Raijmakers, Wemos, Postbus 1693, 1000 BR, Amsterdam, The Netherlands, tel: (+31-20) 468 8388, fax: (+31-20) 468 6008 or e-mail: wemos@wemos.nl.
Are energetic children ill?
The growing use of stimulants to curb exuberant behaviour in children continues to cause concern. A recent editorial in the International Journal of Risk and Safety in Medicine describes the growing fashion of medicating school-aged children who display hyperactivity, impulsive behaviour and inattention. Admitting that this description fits a great number of healthy, well-adjusted children hasn't slowed the drugs' popularity. In fact, the International Narcotics Control Board (INCB) has already noted that "10-12% of all boys between the ages of 6 and 14 in the United States have been diagnosed as having ADD (Attention Deficient Disorder) and are being treated with methylphenidate." It has also found that 90% of the drug's consumption (best known by brand name Ritalin) takes place in the US, with Canada in second place. The journal's editor points out the dangerous side effects on the cardiovascular and central nervous systems and the risk of dependence. The INCB has also seen another disturbing trend, the skyrocketing rise in its abuse, especially by teenagers.
How has this situation developed? The journal's editorial suggests that part of the answer may stem from the uncoordinated roles that psychiatrists, teachers and parents have played in addressing the problem. It also questions the US psychiatric practice's strong dependence on the drug industry. It has found a number of situations where government advisory panels are filled with psychiatrists having direct links to companies. In fact, the parent-based group "Children and Adults with Attention Deficit Disorder" seems to obtain a high proportion of its income from drug companies and has many of its activities underwritten by Ciba-Geigy, which happens to produce methylphenidate.
(Those interested in learning more about the drug and its growing popularity are advised to read Peter Breggin's book Talking Back to Ritalin, which is highly recommended by the journal.)
(International Journal of Risk and Safety in Medicine, 11 (1998) 1-3)
Unethical trial tied to DES exposure
A group of women in Australia recently discovered they had been part of an experimental trial using large doses of the drugs diethylstilboestrol (DES), ethinyloestradiol and norethisterone. The trial was conducted between 1959-1975 among healthy, tall girls in an effort to stunt their growth. Most of the girls were approximately ten years old when the trial started (although some were as young as eight) and the experiment lasted up to four years.
None of the girls' parents were informed that this was an experimental trial. They were led to believe it was a recognised treatment with no long-term side effects. If this wasn't enough reassurance for parents to give consent, the researchers said that the girls would have to have pieces of bone removed removed later to correct the extreme height that would inevitably result.
The girls involved in the trial now suffer from a variety of reproductive health problems and infertility. Most of them had never made a connection between the treatment they received and DES's known side effects. Many were too young to remember the names of the drugs they were given and enquiries made to gynaecologists yielded little information. The group which calls itself "The Tall Girls Group" as the local media have named them, have developed a database of 135 women. Among them, one in three has experienced ovarian cysts, one in three has developed infertility problems, one in five has endometriosis, one in ten has fibroids, one in ten has had a hysterectomy and one in six, a miscarriage.
The group discovered that the researcher who carried out their experiment brought the idea back from the US. They have already had contact with US women who underwent similar treatment as girls and are concerned that there may be a large group of women in the US and possibly Europe who are at risk and wondering the cause of their reproductive health problems. Such women are at double risk if their mothers took DES while they were pregnant with them.
To find out more about this trial and the work of the Tall Girls network, contact: Tall Girls Inc., P.O. Box 7, Carnegie, Victoria 3163, Australia.
(E-Drug message)
Pharmacists must act as health professionals
Pharmacists play a crucial role in self-care and self-medication. The way consumers practice self-care and their understanding of the role of medicines depends on the health information available to them, explained Ellen 't Hoen, on behalf of HAI, in her address to the Fourth WHO Consultation on the Role of the Pharmacist in the Health Care System held in The Hague, The Netherlands in August.
Today there are enormous differences in who is allowed to sell medications in different countries as well as what kind of medications can be sold. More and more drugs are available as over-the-counter (OTC) medications, and the amount of promotional material about drugs far surpasses the available independent drug information. At the same time, research done in the US and several European countries has found that pharmacists often give poor quality information to consumers seeking advice about medicines and possible treatments for illness. Part of the problem is that pharmacists have a conflict of interest: their role as a health care professional and their need to make a profit. 't Hoen set out recommendations for pharmacists to take their role as a health care provider more seriously, including:
- Pharmacies should be set up in a way to reflect the pharmacist's role as a provider of information. There should be designated, private areas to discuss consumers'questions.
- Pharmacists should also play a role in preventing and reporting adverse drug reactions thought to be caused by OTC products.
- They should not sell inadequately tested and ineffective products.
- Pharmacists should take an independent view regarding the products they sell. Consumers should be able to rely on the fact that the pharmacist acquires knowledge from independent sources and that the pharmacist has skills in critical appraisal of evidence.
- They should become involved in their community and take on a role in drug education outside of the pharmacy too.
This meeting was the fourth in a series of collaborations between the WHO and the International Pharmaceutical Federation (FIP). The conferences have been held to follow up on resolutions on the Revised Drug Strategy of WHO which recognise the key role pharmacists play in the rational use of medicines. As part of the meeting's recommendations, the participants called on national pharmacy associations to use the WHO resolutions to promote national action on rational drug use.
To receive the complete text of "Self-care and self-medication in the prevention and treatment of diseases: A consumer's perspective" , contact Ellen 't Hoen, Prescrire International, P.O. Box 459, 75527 Paris Cedex 11, France, fax: (+33-1) 480 78732 or e-mail: ethoen@csi.com.
A link between regulation and poor prescribing
The outcome of the drug approval process plays a major role in determining how drugs will be prescribed, argues Joel Lexchin in an article describing how psychotropic drugs were marketed in Canada during the 1960s and '70s. Although much of the regulatory data used to assess the safety of these drugs is considered secret, Lexchin draws on indirect evidence to conclude that the regulatory system had serious deficiencies at that time and as a result, approval was probably granted on suboptimal studies, indications were approved for which no good data existed and key safety aspects were ignored. As a result, prescribers were given a misleading risk-benefit profile.
In addition, he says, the more a product is promoted, the more it is prescribed and studies have shown that the health professionals who depend most heavily on promotion are the least rational in their prescribing. Lexchin points out some of the specific ways these drugs were promoted using blatant sexism and the idea of medicalisation of daily problems. He asserts that the promotional excesses were possible because the regulatory system was so lax. If the drugs had not been approved for certain indications then the companies could not have advertised them for those uses.
The Canadian regulatory process has undergone continual evolution since then. However, Lexchin argues that many of the same features still exist which may contribute to misprescribing. These include a lack of accountability, secrecy and a failure to consult outside, interested parties. In conclusion, he calls on the agency to issue a "summary basis of approval" document which would explain the reasons why a drug is approved for marketing. For a full copy of the article "The relationship between pharmaceutical regulation and inappropriate prescribing: the case of psychotropic drugs in Canada during the 1960s and early 1970s", contact the HAI-Europe office.
(International Journal of Risk and Safety in Medicine 11 (1998) 49-59)
UK patients lack access to quality information
Patients are being denied access to reliable information about treatment options, says a report released by the UK King's Fund. Informing patients: An assessment of the quality of patient information materials suggests that health professionals either don't know the answers to questions, withhold information or simply fail to present all the benefits and risks to consumers.
The report describes a study in which 62 patients and 28 clinical experts reviewed a wide range of leaflets, videos and audiotapes from various sources including commercial publishers, pharmaceutical companies, patients groups and the National Health Service. They found the information they contained was often out-of-date and inaccurate and sometimes seriously misleading. It did not include full details of treatment options, information about outcomes and treatment effectiveness was omitted or was unreliable and patients' questions remained unanswered.
The study expressed concern about the way medicines were promoted in much of the material. While information produced by drug companies is not allowed to mention brand names (direct-to-consumer advertising is prohibited within the European Union) much of the material about medicines was biased towards drug treatments instead of non-drug treatments and said more about benefits than risks.
The patients involved in the study felt that the text of many leaflets was patronising and failed to recognise their right to be actively involved in decisions about their own care. Said one participant, "When they measured my cholesterol levels, I tried to find out what the numbers meant, what the safe levels were and the role of triglycerides. I also asked whether the tamoxifen I am taking for breast cancer would have an effect on my cholesterol and on my heart. I was completely brushed aside; they ignored the knowledge I had acquired from my own research and was told not to read too much! They also said no one else had complained about lack of information."
The released study recommends that information should start by answering the questions and concerns raised by patients. It should be presented in language that is easy to understand without being patronising. It should also be honest about the benefits and risks involved in treatment.
To order a copy of the publication, contact: The King's Fund Bookstore, 11-13 Cavendish Square, London W1M OAN, UK, tel: (+44-171) 307 2591 and fax: (+44-171) 307 2801.
(The King's Fund)
| Drug Information On-Line
More and more drug information is now available through the Internet. Keep these resources in mind the next time you need information quickly. Essential Drugs List WHO's Tenth Model List of Essential Drugs is now available on-line. To see the full text, visit: http://www.who.int/dmp/edl-10.htm An alphabetical listing of the drugs on the list can be obtained from: http://www.who.int/dmp/edlabclist.htm FDA-approved drugs If you've ever wondered just what drug products the US Food and Drug Administration (FDA) has approved, you can now find them all on-line at the FDA's website. An electronic version of the "Orange Book" is available which allows readers to search drug products by active ingredient, proprietary name, applicant holder and applicant number. The database includes prescription-only drugs, over-the-counter medicines, biological products and discontinued products. To find the Orange Book, visit: http://www.accessdata.fda.gov/ob/. To search for 1998 drug approvals, see http://www.fda.gov/cder/approval/index.htm. |
FDA calls for new warnings on popular OTCs
In late October, the US FDA announced that all over-the-counter pain relievers and fever reducers must now carry a warning label advising people who consume three or more alcoholic drinks a day to consult their doctor before using these drugs.
The decision means that manufacturers of these products must add this warning to their labelling within six months. The action came after recommendations from the Nonprescription Drugs Advisory Committee and the Arthritis Drugs Advisory Committee that chronic alcohol users should be warned about their possible increased risk of liver damage and stomach bleeding from using these drugs.
New OTC pain relievers and fever reducers approved for OTC, adult use since 1993 are already required to carry such warnings for heavy alcohol users. However, labelling that indicates the specific risk associated with each ingredient is a new requirement.
For the complete text of the announcement, see: http://www.fda.gov/bbs/topics/NEWS/NEW00659.html
(US Department of Health and Human Services, HHS News)
New studies offer first evidence of genetic effects from DES
Two scientific studies suggest that exposure to diethylstilbestrol (DES) may cause genetic changes.
Nature Genetics reported that scientists who exposed mice to a synthetic estrogen-like hormone (DES) during a critical gestational period found that it may have suppressed the gene Wnt-7a which controls reproductive tract development. This resulted in changes in the uterus and vagina that resemble those found in women exposed to the same drug before birth. Researcher David Sassoon said, "This work reveals that DES, and possibly other environmental agents, work by disturbing the delicate balance of factors that guide the development of the embryo. By merely disturbing the levels of Wnt-7a, and not mutating the gene, a precancerous state can be induced. As such, the study of DES is not merely an historical footnote but also provides for a new way to understand how cancer can be caused by environmental agents."
A second study published in September in the journal Carcinogenesis reported on a significant increase in reproductive cancer in the elderly female "grandchildren" of mice injected with DES.
DES daughters, women whose mothers took the drug while pregnant, are calling for more research as a result of these findings. They are concerned that grandchildren of DES-exposed women, the third generation, may be at risk for reproductive cancers and abnormalities resembling those found in DES daughters.
The first study mentioned can be found at Nature Genetics' website: http://www.genetics.nature.com. The second study is available at the website: http://www.oup.co.uk/carcin.
(E-mail message 27 October 1998 and DES Action US)
Detecting Adverse Drug Reactions: Pharmacovigilance in The Netherlands
by R.H.B. Meyboom
"The final test of the safety of a drug is in fact its release for general use," (L. Witts, 1964). With this opening quote, Ronald Meyboom sets the stage for his PhD thesis on pharmacovigilance in The Netherlands. As he states at the start, his thesis aims to increase understanding of the scientific basis of pharmacovigilance. In a series of articles, he describes the country's system of reporting adverse drug reactions, sets out good pharmacovigilance practice principles and highlights future trends such as confidentiality and transparency, rational use and information overload and questions whether pharmacovigilance can be "privatised". By examining the country's experience with reporting on drugs, (both its strong and weak sides) he believes more effective systems can be developed, better information can be made available to prescribers, pharmacists and consumers and ultimately, more rational and safer use of drugs can be promoted. For many years, Meyboom directed the Dutch pharmacovigilance centre and advised the Medicines Evaluation Board about adverse drug reaction reporting and has worked closely with WHO's Uppsala Monitoring Centre. HAI contacts interested in adverse drug reactions, drug regulation and secrecy will find this book to be required reading. (For ordering information, contact the HAI-Europe office.)
Dissemination of Climacteric and Post-Menopausal Hormone Therapy in Finland:
An Example of the Social Shaping of a Medical Technology
by Päivi Topo, STAKES, 1997, 276 pages plus annexes
ISBN no.: 951-33-0329-2
The use of hormone therapy has rapidly increased in Finland since the 1970s. While it was originally used by menopausal, well-educated, urban women, its popularity later spread to many other groups of women. In the same way, although it was originally prescribed only for women experiencing difficult menopausal symptoms, over time it has become accepted for treating all types of menopausal complaints and is now recommended to prevent some age-related health problems. In this thesis, Topo examines the reasons for the therapy's rising use in Finland and compares it with trends in other Nordic countries. She describes the key role physicians have played in shaping opinion about this treatment. According to a 1989 survey, one-fourth of post-menopausal respondents stated they wanted hormone therapy, but more than 40% have had it offered by a physician. She suggests that physicians own views about women's status and roles, the quality of life and fears about aging all played a significant role in increasing its popularity. The book also examines how the therapy's growing acceptance has changed women's own ideas about menopause and aging.
Copies of the publication can be obtained from: National Research and Development Centre for Welfare and Health (STAKES), P.O.B. 220/publications FIN-00531, Helsinki, Finland, tel: (+358-9) 39 671 or fax: (+358-9) 3967 2450.
Blaming the Brain: The truth about drugs and mental health
by Elliot S. Valenstein, Free Press, 1998, 292 pages (hardcover price US$25)
ISBN No. 0-684-84964-X
In the last fifty years, psychopharmacology has led to a revolution in how we think about depression and schizophrenia: the development of successful drug treatments has popularised the view that these diseases are due to biochemical abnormalities of the brain which can in principle and often in practice be corrected by drugs. But when the history of the science is carefully traced and the experimental and clinical evidence examined, as it is in this book, this view becomes untenable. The story grippingly illustrates how readily a seductive concept can be swallowed by vast numbers of doctors, including psychiatrists, and many of their patients - especially when pharmaceutical companies promote it heavily. Valenstein writes clearly, without being too technical. The title of the book aptly underlines what was going on: impersonal biochemistry got the blame for mental illness - it's nobody's fault. The result has been an over-reliance on psychotropic drugs, and unrealistic expectations from their use. The book brings us back to reality, and provides an excellent broad background for Charles Medawar's The antidepressant web.
(Review by Andrew Herxheimer)
Contributors to this issue: Sharon Batt, Babet Bonemeijer, DES Action Canada, DES Action US, Ruud Coolen, David Gilbert, Graham Dukes, Rose de Groot, Bas van der Heide, Andrew Herxheimer, Ellen 't Hoen, Beryl Leach, Joel Lexchin, Ronald Meyboom, Barbara Mintzes, Mark Raijmakers, Tall Girls Inc., Päivi Topo, and Annette Will.
Design: Marit van Vliet
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HAI-Lights is produced by the HAI-Europe office to support the work of Health Action International and participants in the HAI-Europe network. A subscription to this newsletter is included in the annual membership fee to the HAI-Europe Association. Other individuals and groups working for the rational use of drugs who wish to subscribe to HAI-Lights can do so by asking the HAI-Europe office for a subscription form. For more information about the publication and the cost of subscribing, contact the HAI-Europe office. |
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