CONFLICT OF INTEREST IN MEDICINE –
PERVASIVENESS AND FAR-REACHING CONSEQUENCES
Lidija GAJSKI, Croatia
Key words: Conflict of interest, medicine, medical science, medical education, medical experts
In the last few decades growth of biomedical research and new legislation has led to intensified collaboration between medicine and industry. Industrial financing creates divided loyalties within each of the main actors in medicine and health care. This is evident in various fields – science, education, clinical practice and regulation.
Individuals and institutions authorized to protect public interest, i.e. the health of the population, become advocates of manufacturers of medical products. Scientists paid by commercial entities produce scientific evidence in favor of the sponsor. Educators act as an extension of industrial marketing. Clinicians rewarded by pharmaceutical and medical equipment companies introduce expensive procedures. Politicians achieve and keep their positions by helping the medical industry.
Thanks to the financial ties of key protagonists in the medical system, new technologies are introduced without proper evaluation of their efficiency and safety. Modern pharmacotherapy is a good example. Medication is prescribed excessively – in cases where it is useless or has minimal effect, and causes more and more harm. Instead for being useful in curing disease, it is promoted for lifelong treatment. In the search for drug markets, definitions of disease are extended and new clinical entities are “invented”. Looking for individuals who are at health “risk” (screening), in order to make them eligible for pharmacological intervention, is a growing tendency.
Aided and abetted by medical professionals who experience the conflict of interest, modern medicine is treating more and more healthy people, diverting limited resources from those who really need medical care.
In the last few decades growth of biomedical research and new legislation has led to intensified collaboration between medicine and industry. Industrial financing creates divided loyalties within each of the main actors in medicine and health care. This paper deals with harmful effects and key protagonists of the conflict of interest in medicine. The phenomenon will be analyzed on the case of pharmacotherapy, which makes a big and important part of the medical science and practice.
- MODERN PHARMACOTHERAPY
In the past, medication has, no doubt, contributed to the improvement of human health and the prolongation of life. However, in the last few decades there has been no breakthrough in pharmacotherapy which can be compared to invention of penicillin or insulin. We have not seen a really new class of antibiotics for a long time; last significant advancements in cancer treatment happened 30 years ago; there is no evidence that new antidiabetics are any better than those we used in the eighties; new antihypertensives and antidepressants are equally effective as those we had 50 years ago.
Health indicators confirm it. In case of cardiovascular disease, reduction in morbidity and mortality is modest and only partly can be attributed to medication. Cancer rates stagnate – small progress is made mostly thanks to the early detection. Medicine has not succeeded in eradicating chronic conditions such as diabetes, asthma, allergies, rheumatism, Parkinson’s and Alzheimer’s disease. It still has no answer to the viral diseases – from AIDS to influenza. This is what Ivan Illich wrote in the seventies: “Medicine cannot cure cardiovascular diseases, most cancers, arthritis, advanced cirrhosis, or the common cold” (Illich 1974). It seems that nothing has changed since then. The most contemporary pharmacotherapy can do is to alleviate the symptoms of disease and postpone its complications, which often requires lifelong treatment.
It is so in spite of the fact that pharmacotherapy is being increasingly prescribed and more and more people are taking drugs. One fourth of the adult population or almost one half of those older than 55 are treated for chronic diseases in the European Union (European Commission 2007). The medicines that consume the majority of the ever growing drug budgets are antihypertensives (blood pressure lowering drugs) and hypocholesterolemics (cholesterol lowering drugs). Quite near the top are antidiabetics, antidepressants, antineoplastics and drugs for osteoporosis. What is the actual effectiveness of these most prescribed medicines?
Clinical trials show that in the group of older people and cardiovascular patients, antihypertensives and hypocholesterolemics reduce the rate of heart attack and stroke from approximately 4 % to 2.5-3 % per year, i.e. about 80 patients must be treated to prevent one cardiovascular event per year. In the younger and healthy population, reduction of unwanted events will be from about 0.8 % to 0.5 %, i.e. it will take a few hundreds of treated people per year to prevent one heart attack or stroke (Gajski 2009). As for antidiabetics, strict pharmacological regulation of blood sugar saves one complication of diabetes in 200 treated patients per year (UKPDS 1998). Antidepressants, except for the severe depression, are equally efficient as the placebo (Kirsch et al. 2008). Chemotherapy works for some relatively rare types of tumors, notably hematologic, while the most common cancers, such as the carcinoma of the lungs, stomach or intestine, are resistant to pharmacotherapy (Moss 1995). The effect of drugs for osteoporosis on the only really relevant bone fracture – the hip fracture, in clinical trials was below statistical significance (Cranney et al. 2002).
What about the cost-effectiveness of drugs? Due to high prices and excessive prescribing, in the typical case cardiovascular events are, according to the calculations made in Great Britain, prevented at the cost of approximately 120 000 £ (Marshall 2003). As for the oncology, in the final year of life of the cancer patient 38 000 USD is spent on chemotherapy, which is more or less useless (Gottlieb 2001). The main problem in this context is that older drugs are being replaced with the new ones, equally effective, but much more expensive.
How safe is a modern pharmaceutical product? Here are some of the agents withdrawn from the market mostly for lethal complications – terphenadine (antiallergic), troglitazone (antidiabetic), phenfluramine (weight reduction), astemizole (antiallergic), grepafloxacin (antibiotic), bromfenac (antirheumatic), mibefradil (antihypertensive), alosetron (antidiarrhoic), cisapride (stomach and bowel motility regulator), cerivastatin (hypocholesterolemic), rofecoxib (antirheumatic), sibutramine (weight reduction), rosiglitazone (antidiabetic). The real insight into the harm produced by the medication does not exist. Health statistics data do not reflect the real situation, because only a fraction of the side effects of drugs is reported. The scientists who were actively researching this issue came up with the number of 106 000 hospital deaths from drug toxicity per year in the USA, which makes drugs one of the leading causes of death in this country (Lazarou et al. 1998).
Considering all this, we might conclude that a modern drug is characterized by modest effectiveness, high prize and considerable toxicity. What is the reason we do not have better medicinal products? How come they possess the image of the excellent quality good and what is the secret of their ever increasing sale and market success?
The answer is in the conflict of interest.
- CONFLICT OF INTEREST AND ITS KEY PROTAGONISTS
Conflict of interest is defined as a conflict between the professional responsibility and the personal interest, of the individual in the position of confidence. It is the situation in which two duties, i.e. values are confronted – the primary, professional duty (in medicine the one to the patient and the society), and the secondary, personal interest (mostly financial, but also academic promotion, scientific rewards etc.). In such a setting, a person may act according to his/her personal, and not the public interest, and this is too often a case. What goes for the individual conflict of interest, applies to the institutions as well.
The conflict of interest in medicine has been actualized in the last few decades, with the increasing interaction and cooperation between medical professionals and the industry. Starting in the eighties with the specific legislation passed during Reagan era in the USA, private enterprise has quickly penetrated and spread within the vital segments of medicine. Through the partnership with companies which produce drugs and other diagnostic and therapeutic equipment, key protagonists of the medical system found themselves in the position of divided loyalties.
Let’s start with the driving force of the phenomenon – the pharmaceutical industry.
3.1. PHARMACEUTICAL INDUSTRY
What is the interest in drug business? Enormous. Estimations are that the global pharmaceutical market is worth almost seven hundred billion USD a year. The revenue of today’s ten top corporations amounts more than 280 billion USD (Consumers International 2007). World’s company No. I, Pfizer, is financially more powerful than Sweden, and Glaxo-Smith-Kline can compare to Croatia. The most successful drugs, the blockbusters, bring in several billion USD per year. Although the rise of the profit has slowed down a bit in the last few years, since the beginning of the last century the investment in the pharmaceutical sector has been steadily increasing. So is the value of shares and the salaries of the management. Chief executives of bigger companies earn around 70 million USD a year (Angell 2004). In order to keep their lucrative positions, the corporation managers must fulfill the expectations of the shareholders and investors. For the sales to keep going up, new products and new markets are needed. A good and useful commodity sells easily by itself. In order to sell the product of the characteristics earlier described, much more effort is needed. The manufacturer has to engage in the scientific research, medical education, health politics, media and the patients’ groups.
In the last few decades pharmaceutical industry has overtaken the most of the applied medical research. In 1980 it was sponsoring 32 % of biomedical research in the USA (the remainder was financed by academic institutions). By 2000, pharmaceutical participation had grown to 62 % (Bekelman et al. 2003). Similar trends are present in the rest of the world. Numerous evidence and affairs show that industry manipulates the results of the drug studies to make their products look better than they really are. Studies that have analyzed the relationship between outcomes of the studies and their sponsorship found that those financed by the pharmaceutical companies are four to five times more likely to produce results in favor of the sponsor, compared to studies financed by other sources (Bekelman et al. 2003, Lexchin et al. 2003, Als-Nielsen et al. 2003). By demonstrating “efficiency” of drugs, clinical trial, as well as observational and fundamental studies, increase indications for the medicines and enlarge boundaries of disease, which are spread into the areas of mild or temporary discomfort. In the same way new clinical entities which “require” medication are created, e.g. osteoporosis or menopause (Moynihan et al. 2002). With the help of the risk factor concept, millions of healthy people are turned into patients liable for lifelong treatment in order to prevent future disease (Gajski 2009).
In industrially sponsored research, scientists are technicians who receive partial access to data, hired solely to give legitimacy to the scientific product (Bekelman et al. 2003). The masters are marketing and PR experts. They decide not only how the study will be performed and presented, but what will be studied in the first place. And when marketing determines the subject of the research, it has little to do with the public interest and welfare. It only has to do with money (Angell 2004). Hence one more useless hypocholesterolemic and antidiabetic is “invented” rather than performing long-term and unpredictable research into the cause of the disease, natural remedies, non-pharmacological interventions, or truly effective pharmaceuticals including those for the diseases of the Third World .
Since physicians are their main “buyers”, in order to sell drugs pharmaceutical industry had to overtake the medical education as well. By means of continuing medical education and medical journals various topics are offered to clinicians, but the most consumed are those sponsored by drug companies. It is because such educational activities and literature are free; moreover, they come along with the lunch, gift or attractive trip (Consumers International 2007). When professional education is performed without defined curriculum enabling diverse and balanced offer of various topics relevant for clinical practice, which is the case today, the most energetic and aggressive distributor of the medical information prevails. Result – physicians supplied with mainly corporative information, unaware of the fact that it is biased and much closer to marketing than to education.
The same thing happens with the medical education of the patients and the public at large. By means of PR (public relations) and the media, pharmaceutical industry, as the main deliverer of medical information, aggressively promotes drugs and illnesses (Moynihan, Cassels 2005).
Politics is the place where the destiny of drugs is determined for the most part. That is why drug manufacturers have powerful lobbies influencing legislature. Law which enabled direct advertising of prescription drugs (USA) and laws which allowed drug patent extension are some of their successes (Angell 2004). Pharmaceutical industry has its advocates in the very top of the executive, for example Bush family, or former German chancellor Helmut Kohl (Levine 2004). It has penetrated drug agencies and other state regulatory institutions where its exponents have succeeded in loosening the standards of drugs’ safety and in the acceleration of the approval procedure (Abraham 2002). There is evidence that pharmaceutical companies corrupt judiciary as well. Today, drug industry business projects are carried out as political projects, implemented on the national and international level with the help of the political institutions; examples – introduction of preventive medication programs, vaccination programs, clinical practice guidelines which generally promote expensive pharmacotherapy, etc.
Chasing profit and growth, pharmaceutical industry has simply co-opted, devoured all the collaborative individuals and institutions, creating a gigantic complex in which at the end all from the scientists to the patients, consciously or unconsciously work for its benefit.
3.2. PATIENTS, JOURNALISTS, PHYSICIANS AND PHARMACISTS
The most unknowing and the least “guilty” assistants of the drug industry are the patients. By asking their doctor for a new medicine they have heard of in the media, by advocating for drugs to be included in the reimbursement list or by participating in the health awareness campaigns, they are convinced that they are doing good for themselves and for other people. The leaders of the patients’ organizations, yet, may not be so sure about it, since they know who pays for their activities and who designs them. Pharmaceutical industry is the main sponsor, sometimes even a founder of the patients’ organizations today. Its donations to a commercially attractive disease patients’ group can reach several million USD per year. In such a setting, patients’ organizations turn into prolonged arm of the industry, very successful tool for drug and disease marketing and for the lobbying against the restrictive health politics (Herxheimer 2003).
Journalists, no doubt, bear responsibility for the fact that medical industry abuses the media. Too often, reporting about medical issues is being used for drug marketing. However, journalists are not medical experts and they mainly only transmit the information they get from the medical professionals. Sometimes they do not even see articles, which come directly from the PR agency into the hands of the editor. There, in the editorial boards of the media and among the heads of the journalists’ associations, the conflict of interest really takes place. It is there that meeting corporate needs (corporations are often the hidden owners of the media) has replaced the professionalism and veracity.
Prescribers of the drugs are in the center of attention of the pharmaceutical industry. So are the pharmacists. Drug companies spend several dozen thousand USD a year on each physician (Gagnon, Lexchin 2008). Taking gifts from the industry has become normal, even expected part of their communication. Physicians do not ask themselves what the reason for the hospitality is and do not feel bribed because they are convinced they are doing the best for their patients. Because of the lack of the truthful information, they are not aware that they are prescribing worthless and overrated substances and have no insight into the fact that they are doing harm; by spending on useless, expensive medication, they are depriving sick people of the medical interventions that really help.
3.3. MEDICAL EXPERTS AND POLITICIANS
Not being aware is not the case with the experts. Academic clinicians and pharmacologists know, or should know exactly what sort of products they recommend and support. A leading medical specialist is the main authority and arbiter in all the matters concerning drugs. He embodies many different roles – he is the leader of the research project, reviewer of the scientific paper, member of the editorial board of the journal, graduate and postgraduate educator, creator of the clinical practice guidelines which affect global medical practice, author of the drug expertise for the regulatory agency and the health insurance, consultant for the health authorities, expert witness in court and the source of medical information for the media, i.e. public. As opinion makers, leading professionals are extremely valuable to drug industry. In all the areas mentioned, it establishes more or less visible ties with them. And for the experts, it really pays off. Main researchers make approximately
200 000 USD per clinical trial, 10 000 for a scientific paper and a few thousand per lecture (Elliot 2001). Who would resist such collaboration? That is why 90 % of authors who publish in medical journals are financially tied to the industry (Healy 2003). If the work is done according to the sponsor’s expectations, the expert is engaged for the future projects which not only bring more money, but also foster professional career, prestige and power. In such a setting, insisting on the research integrity and education credibility means letting someone else take the place. Academic clinicians are the hostages of the industry, not only because of the present and future ties. Their past binds them to the drug industry as well. Considering the lack of public money for research and education, the usual way to obtain the academic title in clinical medicine is by means of the industrial support. In the academic clinical medicine there are hardly any independent individuals who could research, teach and talk about illnesses and therapy in an unbiased, objective way. Today’s clinical professors are not only paid by the industry, they are made by the industry. And they cannot be anything but its servants (Gajski 2009).
However, above the profession, there is almighty politics which eventually governs all the segments and aspects of life. As for the conflict of interest, politics is its birthplace. Too often politicians prefer to meet the needs of the corporations who enable them to seize or keep political power, over the needs of the people. Pharmaceutical industry is one of the major sponsors of the political parties’ election campaigns (Brown 2006).
3.4. PRIMARY VS. SECONDARY INTEREST
The idea and the philosophy of the private enterprise is earning money. It is expected to do whatever it takes to make profit, even if it includes manipulation and corruption, which are quite common in the business world. Fifty years ago it was possible to cure disease and earn money at the same time. Meanwhile, thanks to the greed of the owners, i.e. shareholders and the passiveness of the medical profession and public institutions, pharmaceutical industry has grown to huge dimensions. On today’s level of expansion there are not enough sick people to be treated. In order to make profit, industry not only must not cure illnesses, but has to keep them and artificially produce new ones (Gajski 2009). And it is only logical and expected, because treating disease is not the prime duty of the drug industry. Its principal obligation is the one towards shareholders. Profit is the primary interest of the company as it is the synonym of its very existence. Split between treating people and its own survival it actually has no choice.
Because of its aggressive and corruptive methods many accuse drug industry of being the most selfish and arrogant of all industries; it was nicknamed “Big Pharma”, which is a synonym for greed and unscrupulousness. However, drug industry practice is almost legitimate; it could even be exculpated and amnestied. To blame it for what is happening is wrong and unproductive. It is the easiest to say: it is pharmaceutical industry’s responsibility. That way the source of the problem is placed beyond our reach, in the private enterprise domain, inaccessible both to the government and the citizens.
The real culprits are those without whom the industry could not function – its accomplices in the medicine and politics. And their duty and responsibility is very different from the one of the industry. We are talking about the civil servants paid by the public money, whose primary interest – the welfare of the patients and the society, is indisputable and unquestionable. However, dragged into the conflict of interest, they choose the secondary one, their own benefit. They let the private business buy and instrumentalize them for its purposes. It is about the witting abdication of the entrusted social role and joining those who pay more.
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