In this article we provide series of articles from the British Medical Journal (Online) and other news coverage pieces that explore the issue of the pharmaceutical industry and its influence over doctors, and the nature of the relationship that exists between them by necessity of the health care (disease management) structure that is found in most nations. A relevant quote from Pharmaware:
"Large pharmaceutical companies spend about one-third of their revenue on sales and marketing, much of it aimed at doctors. The resulting entanglements between the companies and doctors have become widespread. Studies cited in the British Medical Journal have found that the relationships influence doctors' prescribing behaviour." Andrea Gerlin, Bloomberg News 2007
The vast majority of physicians and doctors sincerely seek to improve the situation of the patient and do their best to make evaluations and judgements they believe to be most correct in light of whatever information, research or education they have access to. Despite this, the system-wide bias that exists due to the nature of the domination of the pharmaceuticals over all arenas of medicine and disease management (and this includes the very education that doctors receive) means that there is a large degree of influence (on top of systemic bias) that passes by unnoticed. This problem is readily acknowledged in many journals.
In other articles we will explore the marketing of pharmacological agents based upon data and studies which by Islamic standards of legal evidence would be dismissed as outright fraud. We are speaking here of the bias in the selection of results and hiding of unfavourable data, then making use of statistical manipulations to portray a wholly positive picture of any observed effect. Also, paying doctors or researchers merely for putting their names on to studies that are ghostwritten by marketing firms. This is besides the fact that the studies are actually designed, in a very thought out, systemised and calculated way, to engineer a positive result in the first place. We will leave this subject for other articles.
For now, a read of the resources below (only a small selection) will allow a good overview of the nature of what we are dealing with in the "disease-management" industry. This industry merely manages disease, it does not deal in actual cure nor health. Remember that.
First an article in the British Medical Journal:
Ray Moynihan. Who pays for the pizza? Redefining the relationships between doctors and drug companies. 1: Entanglement. BMJ 2003;326:1189-1192 (31 May).
Twisted together like the snake and the staff, doctors and drug companies have become entangled in a web of interactions as controversial as they are ubiquitous (box). As national drug bills rise at rates that vastly exceed those of inflation (fig 1), this entanglement and the subsequent flows of money and influence are attracting increasing public and academic scrutiny. Studies from several countries show that 80-95% of doctors regularly see drug company representatives despite evidence that their information is overly positive and prescribing habits are less appropriate as a result. Many doctors receive multiple gifts from drug companies every year, and most doctors deny their influence despite considerable evidence to the contrary...
Another paper highlighting the problem:
Mark R. Tonelli, MD, MA, FCCP. Conflict of Interest in Clinical Practice. Chest. 2007 Aug;132(2):664-70.
Conflicts of interest, ubiquitous in medicine, occur when the interests of clinicians do not align with the interests of their patients. When systemic and institutionalized, such conflicts become particularly problematic, not only creating risks for individual patients but also undermining the integrity of the medical profession. Financial conflicts of interest arise when the reimbursement of clinicians appears to encourage decisions and actions that are unlikely to be in the best interest of individual patients. More insidiously, the influence of the pharmaceutical and medical device industry on clinicians, whether through gift giving, support of continuing medical education, or guideline development, creates conflicts of interest that may go unrecognized. Recognition and acknowledgment are the first steps in ameliorating conflicts of interest, which can then be disclosed and potentially eliminated.
A BBC news article covering the subject:
Doctors 'influenced by drug companies'
Some doctors may be prescribing unsuitable drugs Experts have called for new rules governing the relationship between the medical profession and the pharmaceutical industry.
It follows claims that some drug companies may have undue influence over what medicines doctors prescribe to patients.
Several studies published in this week's British Medical Journal (BMJ) suggest that this influence may cause some doctors to prescribe unsuitable and unnecessary drugs.
One of the studies in this week's BMJ suggests this may encourage some doctors to prescribe unsuitable drugs to patients.
Doctors must not be, or be seen to be, influenced in prescribing matters by any incentives from the pharmaceutical industry Dr Vivienne Nathanson, BMA
Researchers carried out a survey of 1,000 GPs across England. They found that doctors who see company reps at least once a week are more likely to consider prescribing new drugs and to agree to patients' requests for medication even if they don't need it.
They suggested that in some cases reps may even target those doctors who are most likely to prescribe their products.
Doctors are expected to only prescribe new drugs if there is medical evidence to show they are effective.
The researchers said doctors should be given better guidelines to ensure they only prescribe such medicines.
A separate study, by researchers in Sweden, suggests that even doctors who rely on research to decide which drugs to prescribe may also be unwittingly colluding with the pharmaceutical industry.
The researchers said this was because studies into new drugs were sometimes biased. They suggested that industry-funded trials were in some cases only published if they included favourable results.
The UK-based pharmaceutical industry strives to maintain the highest possible ethical standards Dr Trevor Jones, ABPI
And they said a lack of access to negative studies meant some doctors were probably prescribing drugs on the basis of biased research.
Their findings were backed up experts in Canada. They reviewed 30 studies analysing research projects, which had been funded by a pharmaceutical company.
They found that these studies were more likely to come up with results that favoured the company compared with those that received funding from other sectors.
But they also found that these studies were less likely to be published in medical journals.
Richard Smith, editor of the BMJ, said the studies showed that the relationship between the medical profession and industry needed to change.
"Our central argument is that doctors, drug companies and most importantly patients would all benefit from greater distance between doctors and drug companies," he said.
Ray Moynihan, a medical journalist and guest editor of this week's BMJ, said the findings highlighted an unhealthy relationship between the medical profession and the drugs industry.
"We hope this will spark a broad debate about how to clean up the unhealthy aspects of the relationships between doctors and drug companies," he said.
The Association of the British pharmaceutical industry (ABPI) said companies were expected to adhere to strict guidelines when informing doctors about new products. It said the onus was on doctors to ensure they prescribed effective medicines.
Dr Trevor Jones, the association's director general, added: "The UK-based pharmaceutical industry strives to maintain the highest possible ethical standards in its dealing with healthcare professionals and other stakeholders."
The British Medical Association (BMA) said it hoped the studies would lead to a debate about the best way to prevent drug companies from inappropriately influencing doctors.
Dr Vivienne Nathanson, the BMA's head of science and ethics, added: "The guidelines in the UK put fairly strict limits on hospitality, gifts, sponsorship but should be constantly reviewed especially against any evidence of abuse or ineffectiveness.
"The individual needs of the patient are paramount when a doctor is prescribing medication.
"Doctors must not be, or be seen to be, influenced in prescribing matters by any incentives from the pharmaceutical industry."
Coverage from Science Daily:
Should Doctors Be 'Selling' Drugs For The pharmaceutical industry?
ScienceDaily (June 20, 2008) - Are senior doctors who help drug companies sell their drugs independent experts or just drug representatives in disguise, asks Ray Moynihan from the University of Newcastle in Australia, in the British Medical Journal. See also:
Moynihan exposes the reality behind the practice with some candid revelations from industry insiders.
Pharmaceutical companies regularly sponsor leading specialists with "generous fees to peddle influence" and promote drugs to the profession and the public, writes Moynihan.
Drug companies will pay influential doctors up to $400 an hour to act as key opinion leaders, and some doctors earn more than $25,000 a year in advisory fees.
Kimberly Elliot, a former award-winning drug company sales representative interviewed by Moynihan, reveals that drug companies desperately need key opinion leaders in order for doctors to believe what they are saying and prescribe their products, because drug representatives are often not believed. Essentially, she says, key opinion leaders are just salespeople.
So how independent are these doctors who have long term financial arrangements with drug companies?
According to Richard Tiner, medical director at the Association of the British pharmaceutical industry, although "the work might help to promote a particular medicine" it should be considered payment for work done, and not a bribe. The best antidote to concerns about independence would be more transparency--all company payments to speakers should be routinely disclosed at medical meetings, he adds.
But David Blumenthal, from Harvard University, believes that payments to key opinion leaders are not in the public interest or in the interests of the patients served by these doctors, and calls for a major cutback in industry influence over the medical profession and its education.
In an accompanying head to head, Charlie Buckwell, Chief Executive of the Complete Medical Group and Professor Giovannii Fava, from the University of Bologna, debate whether drug companies' use of medical experts is essential for medical advancement or whether it risks scientific integrity.
And another article highlighting the same concern:
Do Medical Schools Affect The Way Future Doctors Interact With Drug Companies?
ScienceDaily (Dec. 4, 2007) - Although more and more drug advertisements are appearing on television, the bulk of the approximately $21 billion dollars that pharmaceutical companies spend annually to market their products is targeted to physicians, doctors in training (residents) and medical students.
A literature review by researchers from the Indiana University School of medicine and the Regenstrief Institute, Inc. published in the December issue of the journal Pediatrics focuses on the interaction between drug companies, medical students and residents and concludes that well-designed seminars, role playing and focused curricula can affect medical student and resident attitudes and behavior toward drug companies.
The review, led by Aaron E. Carroll, M.D., M.S., assistant professor of pediatrics with the Children's health Services Research at the IU School of medicine and a Regenstrief Institute affiliated scientist, scrutinized the recent literature in the field. Dr. Carroll and colleagues found 12 studies since 1991 focusing on the efforts of academic medical centers to modify the relationship between pharmaceutical companies and medical students and residents.
"Not surprisingly, we found that the greatest impact medical schools had on the interaction of medical students and residents with drug companies was if the school banned all contact with company representatives. But even requiring medical students or residents to participate in one hour of training had an impact on the relationship," said Dr. Carroll, who is also with Riley Hospital for children, a Clarian health Partner.
The study authors reported evidence that policy decisions to restrict contact between trainees and the pharmaceutical industry were associated with greater skepticism toward information given by drug company product representatives and altered behavior in future contact with drug company representatives.
"Doing nothing is no longer an acceptable option. Medical schools need to bring up the complex financial, medical and ethical issues involved in the interactions between doctors and drug companies. Fortunately doing almost anything seems to have at least a minimal impact," said Dr. Carroll.
Co-authors of the study are Rachel Vreeman, M.D. and Jennifer Buddenbaum, MHA, of the IU School of Medicine's Department of Pediatrics and Thomas Inui, M.D., president and CEO of Regenstrief Institute and Sam Regenstrief Professor of health Services Research; Professor of medicine and associate dean for health care research, IU School of medicine.
And another Associated Press report published on AZ Central showing that this matter is recognized by many in the medical industry. This report reveals the extent of the problem, despite the actual widespread recognition of it within medical circles.
TRENTON, N.J. - Just about every segment of the medical community is piling on the pharmaceutical industry, accusing drugmakers of deceiving the public, manipulating doctors and putting profits before patients...
Recent articles and editorials in medical journals blast the industry. Medical schools, teaching hospitals and physician groups are changing rules to limit the influence of pharmaceutical sales reps. And top editors of the New England Journal of medicine last month publicly sided against the drug industry in a U.S. Supreme Court case over whether patients harmed by government-approved medicines may still sue in state courts.
As more voices have called for change, new guidelines for how drugmakers and doctors should interact are coming from both industries, and doctors say some abuses of the past have ended. But the industries' dealings remain fraught with potential conflict because the sectors depend on each other so much.
"The influence that the pharmaceutical companies, the for-profits, are having on every aspect of medicine ... is so blatant now you'd have to be deaf, blind and dumb not to see it," said Journal of the American Medical Association editor Catherine DeAngelis, a longtime industry critic. "We have just allowed them to take over, and it's our fault, the whole medical community."
In an April editorial in her journal, DeAngelis noted two studies indicated that past reports about Merck & Co.'s withdrawn pain reliever Vioxx frequently were penned by ghostwriters and that reports on some Vioxx studies minimized the risk of death. Merck has denied the charges.
"Manipulation of studies and publications by the pharmaceutical and medical-device industries is either increasing or there has been more exposure of these practices," she wrote.
She said industry influence includes swaying doctors and medical students to their brands with gifts, funding research at top teaching hospitals but keeping control of the studies and results, failing to disclose study authors' conflicts of interest, even taking over the continuing medical education system for doctors by running courses on new treatments. Critics say such courses are taught by company-paid speakers who often promote expensive new drugs.
The next paragraph demonstrates the virtual control of the pharmaceutical industry over all areas of research:
Still, no one is suggesting anything as drastic as cutting off industry funding for academic research on new drugs. Those billions help pay lab and other expenses at virtually all U.S. teaching hospitals, medical schools and affiliated practices, while giving the drugs' developers the cachet of having big-name academic researchers running their studies.
Further in the report:
But pharmaceutical analyst Steve Brozak of WBB Securities said drugmakers will find ways to adapt to new rules.
"The earlier you can hook one of these doctors, the more loyal they are" to a brand, Brozak said.
Medical groups have been fighting industry influence harder since a 2006 JAMA editorial by 11 prominent doctors urged teaching hospitals to lead in cleaning up conflicts of interest between medicine and industry.
Finally we can quote from the Lancet (Student) a lengthy article showing firstly, the extent of the problem and secondly that the problem is readily acknowledged by students and professionals in the medical field.
The pharmaceutical industry and its influence on doctors and medical students
The pharmaceutical industry and the medical profession are uneasy bedfellows as Tom Jaconelli discusses
It would be hard to imagine a functioning healthcare system without medicines. Even outside the system many of us frequently take over-the-counter drugs for common ailments: in the USA 50 billion aspirin tablets are consumed each year. (1) Also, it is difficult to think of any kind of human experience that doesnt come with a health warning. (2) This medicalisation of society explains why pharmaceutical companies such as GlaxoSmithKline and AstraZeneca rank in the top 10 share prices in the UK economy. However, the nature of pharmaceutical companies as profit-driven businesses in contrast to their role as health providers heralds a seemingly intrinsic problem: is their priority health or wealth?
There are three focal points involved in this situation-the industry, the doctor and the patient. By regulating each of these it is possible to exercise some control over the situation. I wish to concentrate on the relationship between the clinician and the pharmaceutical industry, though I will also look briefly at the position of the industry and the patient.
The industry is regulated in the UK by various bodies. The Association of the British pharmaceutical industry (ABPI) is the industrys trade association and annually publishes codes of practice on how companies should act. It is worth noting, however, that membership to the ABPI is voluntary. The Pharmaceutical Price Regulation Scheme (PPRS) which operates under the Department of health caps the profits companies can make. Again participation in the scheme is voluntary. The PPRS says that all scheme members will have a common Return on Capital target of 21%. (3) These policies should be made mandatory as they are effectively window dressing unless they are explicit and vigorously observed. (4) The National Institute for Clinical Evidence (NICE), as the governments rationing tool which assesses cost-effectiveness, has since its inception, made pharmaceutical companies more aware of their pricing methods in order to make any new drugs viable in the UK public market. However, it has its own limitations as not all clinical practice has changed in line with NICE guidance. (5) NICE needs to do more to increase compliance of its guidelines...
Despite the aforementioned regulatory procedures in place, there are still problems that exist with the direct relationship between the pharmaceutical industry and clinicians. These interactions are omnipresent and due to vast investment (greater than that spent on the production of medicines) in marketing and the generation, collation and dissemination of medical information. (6)
And in another part:
Since commencing my clinical training I have been surprised by the significant amount of contact my colleagues and I have had with the pharmaceutical industry. Contact includes being given free lunches and gifts such as pens and medical equipment with branded drug names clearly printed on them.
Pharmaceutical companies make themselves known to students in many other ways such as sponsoring medical facilities and lecture halls and subsidising travel to medical events (thereby instilling their names in the minds of students). Indeed the influence does not stop at undergraduate level. The widespread influence of drug manufacturers on postgraduate medical education activities makes more stringent regulation necessary. (7) The interesting factor is that many medical students, when asked, express the belief that pharmaceutical industry contact does not have any influence on them. However social science literature suggests that it would be surprising if doctors were not influenced by small and large services and tokens of appreciation. (8) Gifts create relationships: they create a subconscious indebtedness and the feeling of a need to reciprocate. (9) This reciprocation is well documented in the form of increased prescribing of the heavily marketed drugs, even if those drugs are no more efficacious than other generics in that particular therapeutic area and do not display cost-effectiveness.
Apart from the intensive marketing that pharmaceutical companies deliver, they often claim that their clinical trials are an important source of readily available information for the busy clinician. Indeed this is true to an extent but we must realise the flaws in their processes. Many new drugs are compared to a placebo drug or ineffective doses of established drugs rather than the gold-standard equivalent as a comparator. This results in the new drug being shown in a more favorable light. Studies sponsored by the industry are four times as likely to have outcomes favouring the sponsor than are studies funded by other sources. (10) There is also widespread evidence of negative results from trials being suppressed-a clear form of publication bias. Also, in the realm of clinical trials erroneous data result from insufficient documenting of adverse outcomes. This prejudices patients, as in the case of the revolutionary COX-2 selective inhibitor drugs which came on to the market a few years ago. On release they were heavily marketed as revolutionary anti-inflammatory drugs without the gastric side effects common in the COX inhibitor class of drugs. Yet they were later found to have detrimental effects by increasing the number of thrombotic events. These consequences were not revealed in trial findings.
Once a trial has been written up it is usually published in a major medical journal. However, 75% of clinical trials published in major journals are funded by the industry (11). An additional number of these have further bias from the professionals conducting the trials who have conflicts of interest (e.g. as shareholders). Even though they have to declare any interests, this is not always complied with. Richard Smith, former editor of the British Medical Journal, told BBC news that the journal was too dependent on pharmaceutical industry advertising revenue to be considered impartial. This means that industry-sponsored trials and the journals they are displayed in should be regarded with considerable scepticism.
The article continues:
How does this affect medical students?
The above entanglements between the industry and doctors apply even more so to medical students, as they have the longest prescribing life and so are key targets for pharmaceutical representatives. (12) With the advent of nurse and pharmacist prescribers this dimension can only increase. Medical students are also at their most naïve, as they are formulating views on the industry and rapidly expanding their drug knowledge. As such, medical students need to think actively about their relationship with the industry, in the same way that they consider the doctor-patient relationship. They need clear guidance on how to interact with the pharmaceutical industry from an early stage...
...I believe medical schools should take a more active role in ensuring medical students are educated about the pharmaceutical industry. In particular, they should publish polices to provide a point of reference for occasions when their students have dealings with the industry (e.g. sponsorship of sporting events). I contacted five UK medical schools at random and none had an active policy in place about how medical students should interact with pharmaceutical companies. Evidence suggests that these entanglements should be explicitly addressed at the level of policy and education. (13) This would enable standardisation in any dealings with the pharmaceutical industry and control the industry's influence over medical students.
At the end of this article website links are provided to numerous bodies that are attempting to change the current relationship between health professionals and the pharmaceutical industry. These are useful resources.
These are useful resources for anyone wanting more information on this and related subjects.