Healthy Skepticism International News

Newsletter Nov/Dec 1997

December 1997

Vol 15 Issue 11/12 Reports: An overview of promotion Part 3 Third of 3 parts expanding on a report titled Healthy Profits written by Melissa Sweet for the Sydney Morning Herald.

Healthy Profits: An overview of promotion in Australia Part 3

Introduction

This edition presents the third and final part of an article written by Melissa Sweet and published in the Sydney Morning Herald on 25 October 1997. It is mostly about the situation in Australia. However, we believe it is important reading for people around the world because similar things are happening in most countries. If it is not yet happening in your country be warned. It may happen soon.

Melissa Sweet’s article, as published, appears below in our usual Times New Roman font. We have added some comments, which appear in (brackets in Ariel font).

HEALTHY PROFITS (Part 3)

By Melissa Sweet

One of the biggest recent medical controversies relates to calcium antagonists, which have become widely used to treat high blood pressure. But it is not known whether they are better than older, cheaper drugs at reducing heart disease and strokes, and several recent studies have raised safety concerns.

The jury is still out, but the industry has gone to enormous efforts in damage control to defend the market, estimated to be worth $US8 billion internationally. The Lancet described how a press conference at the Congress of the European Society of Cardiology two years ago was manipulated to ensure that the best interpretation possible was put on what were fairly alarming results. “The European Society of Cardiology has been, until now, a creditable force in the cardiology community. Yet its pandering to the pressure exerted by a pharmaceutical company – coincidently, one of the conference’s major sponsors – is troubling,” the journal said.1

The drug bulletin Prescrire International said it was bewildering that calcium antagonists were amongst the world’s most widely used drugs. Yet their risk-benefit ratios were uncertain and better alternatives were available. “This inconsistency highlights the intricacy of the relationships between industry, prescribers, academics and health authorities, and the fact that ‘the patient’s best interest’ is not always the overriding factor which determines the choice of drug.“2

This is particularly alarming considering the unfortunate history of another class of heart drugs, introduced in the 1980s for treatment of abnormal heart rhythms. Pre-marketing studies showed they affected heart rhythm but had not examined their effect on death rates. Many thousands of Americans died before it was realised that they increased rather than reduced deaths. In the book Deadly Medicine by Thomas J. Moore, much of the blame for this tragedy is slated back to the close links between doctors, drug companies and regulators.

The Lancet recently criticised Bristol-Myers Squibb for putting pressure on researchers to finish early a trial of paclitaxel (Taxol) as a first-line treatment for ovarian cancer. The company argued that there was sufficient evidence of the drug’s benefits to stop the trial, although an independent monitoring committee concluded otherwise.3

Medical journals have also been spitting chips over a seven-year campaign by Boots Pharmaceuticals to discredit and block publications of a study showing that three competitor drugs had the same bioequivalence as its drug, Synthroid, a more expensive drug and one of Boots’ top-selling products. The study, which concluded that the four preparations are “interchangable without loss of therapeutic efficacy in the majority of patients for treatment of hypothyroidism”,4 was finally published this year, with an accompanying editorial in the Journal of the American Medical Association describing the company’s campaign.5 Knoll Pharmaceutical, which acquired some of Boots’s prescription pharmaceuticals in 1995, wrote that it had decided to allow publication “because we gained a better understanding of the importance of supporting academic freedom and the peer review process”.

It would be naive and unfair to portray the industry as an evil giant that profits from our misery. It is extremely important in developing drugs and funding research in times when other funding sources are shrinking. Marketing is integral to a profit driven industry that spends hundreds of millions of dollars to develop a new drug. And doctors do rely on it for information.

One study [published in 1988] showed that about 85 per cent of all prescriptions by physicians who graduated in medical school in 1960 were for drugs about which they had received no formal education.6

But there are legitimate grounds for concern, especially as the industry is steadily expanding its domain, becoming involved in divisions of general practice and, overseas, in running managed care and similar programs. This at a time when many universities and other groups that might be expected to provide some balance to the industry’s promotions are under great pressure, relying increasingly on funding from outside, such as drug companies.

When Libby Roughhead worked in a Melbourne pharmacy, she was annoyed that customers would take more notice of drug advertisements than what she said. As part of postgraduate studies at La Trobe University, she analysed audio tapes of 16 encounters between drug reps and GPs. Roughead, now a PhD student in the department of pharmacy and medical science at the University of South Australia, says the reps tended to give little information about side effects or drug interactions. They made many inaccurate statements, including recommending their products for unapproved uses. The doctors’ responses did not suggest they were critically evaluating the information.7

The APMA emphasises that training for medical reps has improved greatly since that study was done in 1992-94 and that they are now required to learn about the code.

(Defenders of lower standards frequently use the “but that was yesterday” argument. There is no evidence of increased compliance with the APMA Code by reps. A French study has found that even after “improved training” reps failed to mention side effects, contraindications and interactions during 71 to 82% of visits. This was not a significant change from the situation before “improved training”.8

It is also worth noting that Roughead’s findings are supported by a similar but less detailed study done in the USA. Ziegler et al studied audio-tapes of 13 presentations by reps at meetings of hospital doctors and concluded that: “Eleven percent of the statements made by pharmaceutical representatives about drugs contradicted information readily available to them. Physicians generally failed to recognise the inaccurate statements.“9)

Dr Ken Harvey, a senior lecturer in public health at La Trobe University, believes much marketing is still inappropriate. “They put their hand on their heart and say they want to do the right thing,” he says, “but if you really look at what is happening in PR campaigns, advertisements and consulting rooms, they are not providing balanced, fair, objective information about their products.”

Peter Mansfield’s group (MaLAM) has documented many instances of inappropriate or misleading marketing. “The problem will continue as long as the drug companies continue to reward reps according to sales volumes,” he says.

(As long as the industry is rewarded only according to sales volumes it is inevitable that industry staff will use the most effective techniques they can for increasing drug use. Teaching staff about the AMPA Code is not likely to have any impact. This is because the AMPA code system provides a low probability of disincentives, which are too little and too late to influence companies’ behaviour. By contrast misleading promotion has a high probability of “earning” large amounts of money quickly.)

Some senior medicos believe that drug marketing is contributing to the many thousands of hospital admissions and illnesses due to inappropriate use of drugs, although many other factors are also involved.

Ken Harvey says: “We’re a country that overconsumes drugs by international standards and we’re reaping the consequences of that in terms of increased adverse events.” He adds: “We teach medical students never to be the first to use a new drug, never be the last to use old drugs. That’s precisely because side effects are less known with new drugs.” He cites the case of benoxaprofen (Opren) which was introduced in the UK in the mid ‘80s and aggressively promoted for arthritic conditions, but withdrawn two years later after 100 UK deaths were blamed on it, and nearly 4,000 patients suffered severe side effects.10,11

Industry marketing has a profound impact on how much we pay for our health care and in distorting the health system’s priorities. Many argue that its success in persuading doctors to switch from cheaper, older drugs to new, more expensive brands has been a big contributor to the ballooning costs of the Federal Government’s pharmaceutical benefits scheme (PBS).

(Caudill et al mailed a questionnaire to 1603 doctors practicing adult primary care in Kentucky, USA. Only 446 returns were suitable for analysis. The questionnaire asked doctors to rate how frequently they used information provided by reps. Cost of prescribing was measured using clinical scenarios (acute bronchitis, hypertension, uncomplicated UTI). For each scenario doctors were asked to choose between 4 treatments that were very similar except for cost. The study found that the frequency of use of information provided by reps significantly correlated with the choice of more expensive therapies.12 It would be very useful to do a similar study in Australia using better measures.)

“Older, cheaper drugs may receive little promotion but, if used appropriately, can deliver equivalent health outcomes for a much lower price than newer drugs,” a recent editorial in The Medical Journal of Australia noted.13 The Federal Health Department says it often comes under political pressure to list expensive new drugs on the PBS after companies generate public demand for the products through the media. It also believes that industry promotion often encourages doctors to prescribe drugs for uses for which they are not meant to be reimbursed. (In Australia the PBS lists many drugs as available with a government subsidy (reimbursement) only if they are prescribed for specified diagnoses for which the drugs have been shown to be cost effective. It may be a common practice for doctors to untruthfully claim that patients have specified diagnoses so that they can have drugs cheaply when the doctors believe (rightly or wrongly) that the drugs may benefit patients with less severe or similar or even very different diagnoses.)

(In the context of relatively stable total national expenditure on health care, increased spending on drugs must be at the expense of other components of the health sector including health professional’s incomes.)

A serious concern is the contribution of enthusiastic marketing to antibiotic overuse. Much industry promotion has encouraged antibiotic use for respiratory infections. John Turnidge notes that three-quarters of all antibiotics prescribed outside hospitals are for these infections, 90 per cent of which are viral.

“We preach rational prescribing of antibiotics,” adds Dr Jock Harkness, director of microbiology at St Vincent’s Hospital in Sydney. “The companies pay lip-service to that; their priority is to sell their drug.” Richard Day emphasises that the health system simply does not have the resources or staff to counter the industry’s promotions. That many of the big teaching hospitals do not even have clinical pharmacologists has worrying implications for patient care and medical training, he says.

(The industry probably spends more than AUD$ 250 million on promotion of prescription only pharmaceuticals per year in Australia. That is much more than is available for medical education.

Clinical pharmacologists may be necessary but not sufficient for adequate medical education. There is a need for training in critical appraisal of misleading promotion for everyone in high school. Health professionals need higher level training in critical appraisal of health related promotion at both the undergraduate and post graduate levels so that patients can trust us for advice. MaLAM will soon receive funding from the World Health Organization’s Drug Action Program to produce teaching materials to help meet this need.)

There are also broader, opportunity costs to the industry’s influence, which lead to much medical research being designed to answer companies’ marketing concerns rather than the broader public interest. David Henry, professor of clinical pharmacology at the University of Newcastle, says much time and money is spent comparing competitor drugs, leaving more important questions unanswered – such as what is the best way of treating a particular disease.

Chris Silagy, professor of evidence-based care and general practice at Flinders University, notes that some of the big companies have formed a consortium to provide financial support to divisions of general practice. “Ultimately it will be used for projects that support their products,” he says. “The problem is that it leaves other questions not directly linked to pharmaceutical use, but which are incredibly important, out in the cold.” Peter Mansfield says the industry’s influence also means that medical research tends to be distorted towards finding long-term treatments for common chronic diseases of wealthy people rather than cures for some of the world’s most important health problems.

The bigger picture is that we have become a society that wants a tablet to cure our every ill. It is telling, perhaps, that many in the health industry describe doctors as “prescribers”, not “care givers”.

Just think how we have all heard so much more about depression in recent years. Much of this has been generated by the marketing campaigns for new antidepressants.

It’s probably fair to assume that many lives have been improved as a result of people being more willing to seek treatment. But many believe the pendulum has swung too far. Professor Beverley Raphael, the director of the NSW Centre for Mental Health in the NSW Health Department, says the issue is not clear-cut, but that on balance there may be too much focus on drug treatments and too little emphasis on psychological treatment.

(The tendency of optimistic health professionals, government agencies and drug companies to deny problems of low efficacy, dependence and withdrawal with anti-depressants deserves to be challenged.14)

Leonie Manns, executive officer of the Mental Health Coordinating Council, a coalition of consumers, carers and service providers, supports the role of drug therapies but believes they are being overemphasised, largely because of the industry’s influence on doctors. “People are starting to rely on drug treatments totally,” she says. “They are not being encouraged to make lifestyle changes. “

MELISSA SWEET

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