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Conflict of Interest

How drug companies influence NHS healthcare treatment options.

Consumer Organisations Criticise Influence of Drug Companies Over Health Policy

The pharmaceutical industry operates in a way that puts profits before public health, members of parliament (MPs) heard last week. And the regulatory authorities, which are meant to ensure the safety of drugs and protect the public, collude with the industry, they were told.

Testimonies from five doctors and two consumer champions, who were being questioned by the health select committee for its inquiry into the influence of the pharmaceutical industry, built a picture of an industry that creates health anxieties among the public to boost its profits. At the same time, withholding unfavourable trial results and controlling what research gets published ensures that doctors get the messages that companies want to promote, the committee heard at the second public sitting of its inquiry.

Public awareness campaigns are part of a "multipronged marketing approach" that are commonly employed by drug companies to "gain further control over what medicines are being prescribed and to whom," said Graham Vidler, head of policy at the consumer organisation Which?, formerly known as the Consumers' Association.

"These can often be for quite trivial conditions, such as toenail infections, and they encourage patients to go and see their general practitioner, often in quite strong terms," said Mr Vidler. "At the same time the industry will be advertising drugs to these GPs, and our research shows that GPs often take the path of least resistance and say yes to patients and prescribe the drug even though they feel it may not be the most appropriate thing to do."

GPs can see pharmaceutical representatives on a daily basis, and their influence can lead to changes in prescribing habits, said Des Spence, a GP in Glasgow and spokesman for the No Free Lunch campaign, a group of UK healthcare professionals concerned at the undue influence of the pharmaceutical industry on doctors in promoting drug products.

"Within three or four years [of it being launched] Vioxx [rofecoxib] became 40% of the medicines we were using in my area," said Dr Spence. "The industry has a major influence on healthcare policy. The influence is across the field and affects doctors, nurses, patient organisations, and government agencies. The industry is active in all these fields and has a very clear agenda—that of profit—and that is in direct conflict with the responsibilities of the NHS."

Part of the problem is that the industry is charged with policing itself through the Association of the British Pharmaceutical Industry, which is funded by drug companies, said Ike Iheanacho, editor of the Drug and Therapeutics Bulletin .

"A regulatory body needs to punish companies that are responsible for misleading activities and tell people they have been misled. If these are the standards that we would like to see then they are largely absent from the present regulatory system," he said.

David Healy, head of psychological medicine at the University of Cardiff , believes that research articles have a greater influence on doctors' prescribing habits than promotional activities. But again the process of publishing research is rife with pharmaceutical industry influence, he said.

Professor Healy claimed that at least half of articles on drug efficacy that appear in the BMJ , the Lancet, and the New England Journal of Medicine are ghost-written by pharmaceutical companies and that "the most distinguished authors from the most prestigious universities" put their names to them without ever seeing the raw data.

Peter Wilmshurst, a consultant cardiologist at Royal Shrewsbury Hospital , said that in the past he has been offered bribes by a pharmaceutical company not to publish unfavourable research results. Dr Wilmshurst also claims that he knew of three professors of cardiology who were told their results were aberrant and were persuaded by the pharmaceutical company who had sponsored the study not to publish.

"I suspect this is as common now as it ever was," said Dr Wilmshurst. He also told the committee that key opinion leaders can be paid in the region of £5000 ($9000; {euro}7000) for an hour's talk about a drug they have no experience of using, and their influence can have a big impact on practice. Dr Spence added, "The amount of hospitality received by doctors compared with other public services is a disgrace. If policemen, teachers, or MPs received this level of hospitality there would be a public outcry."

Also giving evidence to the committee, Richard Brook, chief executive of the charity Mind, called for greater transparency in how the Medicines and Healthcare Products Regulatory Agency operates and for disclosure of any links between people working in the agency and people in the drug industry.

Mr Brook resigned from the agency's expert group investigating the safety of selective serotonin reuptake inhibitors (SSRIs) after he discovered that the agency waited many years before disclosing the evidence about withdrawal effects of these drugs and their potential to pre-dispose children to suicide.

Many of the agency's key personnel have longstanding links with the pharmaceutical industry and own shares in companies, said Mr Brook. "For a number of reasons I was very concerned that there was no robustness [at the agency]. We want to see a better way to do health research and people with consumer and legal interest serving on the agency," he said.

Andrew Herxheimer, emeritus fellow at the UK Cochrane Centre, Oxford , called the relationship between the industry and the agency "a closed, inbred community where the industry is the client and the client must be looked after" and where a "culture of secrecy" permeates. He called for the reporting of adverse drug reactions to be separated from the business of licensing drugs.

Witnesses also called for stronger enforcement of formularies in general practices, declaration by pharmaceutical companies of their contact with and payments to doctors, and regulation of the industry's influence on consumers.

Commenting on Professor Healy's comments after the hearing, Dr Kamran Abbasi, acting editor of the BMJ, said: "The BMJ takes the issues of transparency and accountability very seriously. We believe that authors must accept full responsibility for the integrity of their research—including having the idea, collecting and analysing the data, interpreting the results, and writing the paper—and we have several policies in place to ensure this." BMJ 2004;329:937 (23 October), doi:10.1136/bmj.329.7472.937

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The Influence of the Pharmaceutical Industry on Healthcare Practitioners' Prescribing Habits

Pharmaceutical companies invest billions of dollars annually on marketing drugs they manufacture. They use methods such as direct to consumer marketing, physician speakers, representatives and catered foods while introducing products to a target audience. A literature review of articles, books and reviews dating from 2000 to present was conducted using Google Scholar, Ovid Medline and PubMed to determine the influence the pharmaceutical industry had on healthcare professionals' prescribing habits. The authors and researchers have concluded that there is a degree of influence that pharmaceutical companies have on providers' prescribing habits, which have sometimes been labeled as unethical. Recently updated regulations now restrict the use of small gifts as part of their marketing strategies but this is only one of many ways used to influence. It is a collaborative effort to ensure that patients receive quality healthcare and appropriate medications.

Literature was reviewed using books and book reviews from the New York Times and electronic search engines Google scholar, PubMed, and Ovid Medline dating from 2000 to present. Search terms used were: pharmaceutical companies, influence, healthcare providers, pharmaceutical sales representatives, prescribing habits, and ethical. An extensive list of articles was found. In order to limit the search criteria, articles selected were 2000-recent with older articles used for background information not pertinent to the literature review.

Fortune magazine has reported that in 2008, the pharmaceutical industry continued to be in the top three most profitable industries in the United States for the past two decades. 1 It is a lucrative industry that utilizes different strategies to gain revenue. Companies manufacture drugs that are developed from research. After FDA approval, these drugs are patented which can last up to 20 years. This allows them to keep exclusive rights to selling these brand name drugs. It is only after these patents expire that other drug companies can use the ‘formulas to be manufactured as generic drugs. This allows the drugs to be bought at greatly discounted rates in comparison to the brand name drugs. A company makes the majority of profits during the times they hold this drug patent. Money and time are invested into marketing these medications from many different angles. Large percentages of a company's budget are allocated for this because these strategies work.

Pharmaceutical companies in a given year will allocate more than a billion dollars in the marketing of medications. 2 This is distributed through a number of different venues reaching a wide range of people. This includes Direct-to-Consumer (DTC) ads used in television and magazines to inform people of the most recent drugs. DTCs many times are presented with vibrant colors, impressive large print statistics and basic information about certain illnesses. Pharmaceutical companies also utilize these to provide education and awareness of conditions. This empowers people to take responsibility of their own health. “Between 1991 and 2003, spending on DTC ads in the United States increased 58-fold reaching $3.2 billion a year.” 3 This has lead to more than one third of patients asking their healthcare providers about medications they have seen through the media such as Mucinex, Lamisil, and Celebrex. “”As a result, when a patient asked for a drug by name, they were more likely to receive a prescription for it from their healthcare provider three times out of four. 2 This shows the pharmaceutical companies' advertisements have an influence on the consumer. The reason why these companies allocate such a large percentage of their budget on marketing is because it has been proven to influence the consumer.

Literature Review
Pharmaceutical companies also employ representatives to visit healthcare practitioners in hospitals and offices to educate, update and provide samples of recent drugs their companies have produced. As experts on these drugs, they present their products with confidence, assurance and with the ability to answer questions about side effects, insurance coverage, microbial coverage and more. With the understanding that pharmaceutical companies play active roles in marketing their products, it is important to ask, how much influence these companies have on healthcare practitioners' prescribing habits.

There has been some controversy with the idea of healthcare providers having periodic contact with pharmaceutical company representatives. Every year more than $11 billion is spent on drug marketing, with half of the budget funding sales representative work. 4 It is important to identify the extent of this relationship and its ultimate impact on providers' attitudes, behaviors, and knowledge. It is also important to understand how this potentially affects the patients.

Methods of influence
There are different strategies that are used in marketing drugs. “Food, flattery and friendship are all powerful tools of persuasion, particularly when combined.” 5 Shahram Ahari, a former pharmaceutical sales representative for Eli Lilly, and Adriane Fugh-Berman, a physician/researcher on the pharmaceutical industry have both examined these strategies through the Attorney General Prescriber and Consumer Education Grant Program. This program was created as part of the 2004 Warner-Lambert settlement related to allegations that Warner-Lambert conducted an unlawful marketing campaign for the drug Neurontin violating consumer laws&. 6

Pharmaceutical sales reps are hired for their personalities and based on criteria that would make them excellent sales people. They are trained to observe and understand the best approaches to take when interacting with a healthcare provider. They use information they gather and understand what it takes to sell the drugs they represent. Not all practitioners have the same attitude toward sales reps, thus conversations and pitches need to be tailored to fit the particular personality type. Ahari testifies that Eli-Lilly delegates eight different categories that a physician could fit into: 1. Friendly and outgoing, 2. Aloof and skeptical, 3. Mercenary, 4. High-prescribers, 5. Prefers a competing drug, 6. Acquiescent docs, 7. No-see/No-time docs, and 8. Thought leaders. Each category is different and the company provides descriptions to determine the best ways to approach a sale.

Pharmaceutical companies can also gain influence through research and prescription tracking. Information about prescription purchases can be bought by large health information organizations like IMS Health, Dendrite, or Verispan. These companies keep track of prescriptions filled in a given community. These records are then sold by pharmacies with details of personal information excluded. The pharmaceutical companies are the largest buyers of this information, which can be used to monitor marketing trends as well as identify which drugs need a different marketing approach. Representatives “see how many of a physician's patients receive specific drugs, how many prescriptions the physician writes for targeted and competing drugs, and how a physician's prescribing habits change over time.” 6 In addition, this information allows representatives to see how easily providers can be influenced. They not only figure out ‘who' the healthcare providers are, but ‘what' drugs are being prescribed, and ‘how'. A tremendous amount of information can be gathered and used. As a result, some practitioners who do not meet standards set by the company may not get the attention that other ‘high-prescribers' would.

“Studies have shown that samples influence prescribing choices.” 6 These can be used in a number of different ways to benefit not only the doctor but the patient as well. Samples allow practitioners to provide certain medications to their patients free of charge. The trial doses allow the patient an opportunity to see if the particular medication works or not. It is obvious that the only medications that can be given are the ones that companies leave as samples. Some problems may arise when patients find out these medications are too expensive when paying out of pocket.

Studies have also shown that small gifts could have some type of influence on behavior. “A physician who is the recipient of a gift may recommend products made by the gift-giver without due consideration of other cheaper or more effective options.” 7 Gifts have encompassed a broad range of items from pens and pads to medical reference books and continuing medical education trips. Some aspects of this have changed through recent guideline updates that prohibit the distribution of small gifts-explained later.

Food has always been a source for common ground. People have the natural tendency to relate to one another while eating. To find the best and most convenient ways to present their products, representatives provide restaurant-catered foods and deliver onsite so practitioners can eat and obtain some education and updates on drugs as well. This is yet another way that companies use to gain influence. All providers admitted to the fact that interactions with representatives would decline if there were no gifts or meals. 4

However, all the influence does not come from the giving of small gifts. They also come from the advice and talks given by physicians. Practicing licensed physicians have agreements with pharmaceutical companies all across the country to speak on behalf of the company for what can be a modest honorarium. These companies provide information and even specially designed presentations for these physicians. 8 They stand before their colleagues and introduce a drug that is subtly presented within a health education talk. It may not be uncommon for key information to be conveniently left out in order for the focused drug to stand out. Many times there is no direct push for these medications to be used but subtle nuances or messages are used to send the message across.

Perception
A total of 29 studies were used to identify interactions that healthcare providers had on pharmaceutical representatives. 4 It was reported that interactions started as early as medical school and estimated that representatives meet with physicians about four times a month. The trends showed that physician's benefits decreased in lunches and samples as they entered practice but increased with honorariums, conference travels, and research funding. In assessing attitudes of residents and physicians toward representatives, providers believed that they had accurate information concerning the drugs and could probably provide the same amount of accuracy in information with other drugs. There is incongruence in the fact that providers believe pharmaceutical companies are successful in influencing other practitioners, but deny that they themselves are impacted. This influence has been found to be not only on physicians but also on residents and those in leadership positions who may have influences on other physicians. 7

The point of concern arose when representatives prioritized the promotion of the product more than the patient's welfare and as a result were more likely to have used unethical approaches. In the studies, physicians have denied the fact that gifts could influence their behavior, particularly their prescribing habits. But, residents conceded that without the gifts, they were more likely not to meet with representatives. “Interactions with pharmaceutical representatives were also found to impact the prescribing practice of residents and physicians in terms of prescribing cost, non rational prescribing, awareness, preference and rapid prescribing of new drugs, and decreased prescribing of generic drugs.” 4 Accepting samples correlated with awareness, preference, and rapid prescription of a new drug, as well as positive attitudes toward pharmaceutical company representatives. Funding for travel to attend educational symposia had increased influence and impacted hospital prescribing practices for two years after groups of physicians accepted the trips. Residents' exposure to pharmaceutical representatives resulted in inaccurate information learned about the sponsors' and competitors' drugs resulting in inappropriate treatment decisions. Healthcare providers were skeptical of the motives and the knowledge that representatives had and expressed the concerns that gifts, samples, meals etc. had an influence. There were however some positive aspects (ie. Improvement in identifying treatment for complicated illness) even though most studies found a negative outcome that came about from the interactions (knowledge, attitude, and behavior).

Challenging the influence
Studies have shown that roughly 90% of physicians interact with pharmaceutical representatives even though the evidence shows the information they provide is skewed (even slightly) in favor of the drug being promoted, resulting in inappropriate prescribing habits. 5 Interactions with some providers show a preference for new products even though there is no demonstrated advantage over existing medications. This correlates with a decline in prescribing generics and a gradual increase over the past several years in retail spending on prescription drugs in the United States.

There have been some steps taken to combat these tactics. In July 2006, the American Medical Association (AMA) began the Prescribing Data Restriction Program, which gives physicians the right to withhold prescribing information from representatives and their supervisors. 6

The pharmaceutical industry has been using money to influence not only prescribing practices but also in teaching and research. Interest groups like Pharmaceutical Research and Manufacturers of America (PhRMA) have responded to these influencing trends. They have recently passed updates that prohibit the distribution of small gifts. PhRMA and their marketing code have recognized the fact that certain gifts and dinners impede on ethical practices and that professional unbiased relationships need to be fostered. “The revised, voluntary code, which took effect January 1, 2009 reaffirms that interactions between pharmaceutical company representatives and healthcare professionals should be focused on informing the healthcare professionals about products, providing scientific and educational information, and supporting medical research and education.” Many companies have realized the benefits of opting into voluntary program as good public relations. A total of 45 pharmaceutical companies as of February 24, 2009 have committed to this agreement. 8

With pharmaceutical companies working to find open doors within healthcare some have even began targeting medical schools. Although there are few that welcome pharmaceutical representatives, others have stricter policies. Medical institutions such as the University of California San Francisco (UCSF) have had a reputation as having one of the strictest policies for monetary funding and sponsors. It is because some have viewed representatives as being regarded as the ‘industry's favorite marketing tool'. 5 Policies like those of UCSF, University of Pennsylvania, Stanford, and Yale have been created to limit the amount of contact and influence the pharmaceutical companies can have on future medical professionals. 7

Discussion
It is not uncommon for a patient in need of a prescription to ask for certain medications by a brand name. Research and budget reports have shown that pharmaceutical companies have spent billions of dollars annually on marketing drugs. The effects of this have an impact on anyone seeking healthcare and prescription drugs. They market their products to appeal to the needs and desires of people. The methods and approaches they take allow them to influence their audience more than realized. Research has shown that pharmaceutical companies play a role and have a clear influence on prescribing habits. This continues to be a thriving market because there will always be sickness and disease and people will always want and need medicine for those illnesses.

It is reasonable and fair to argue that pharmaceutical representatives alone do not have complete responsibility in influencing healthcare providers' prescribing habits. There are other factors. Healthcare providers may seek the advice of their fellow practitioners and pharmacists when prescribing drugs. They may have also had enough experience with certain drugs not to allow pharmaceutical representatives to sway them one-way or the other. The more avid and diligent journal readers may keep up with researching case studies of medications and as a result base prescribing medications on nonbiased independent randomized controlled trials or meta-analyses.

It is also very important to understand that pharmaceutical companies play a vital role in the research and development of medications. They invest in and at times advance important medical discoveries. They provide medications to millions of patients in efforts to alleviate pain, improve quality of life and promote health. Most have a pharmacy assistance program that low income patients can enroll in. Hospitals, clinics, healthcare providers and patients rely on these companies to develop the latest drugs. Pharmaceutical representatives are trained not only to relate with those in the healthcare field but they are also required to know and understand the products they market. This means that they must understand the mechanisms of disease, routes of drug metabolism and excretion, side effects, indications and contraindications. They must be well educated in certain aspects of pharmacology spending countless hours studying their drugs and the diseases they treat. On many occasions these representatives provide credible, up to date information concerning drugs and their uses that may very well provide opportunities for practitioners to learn as well.

Pharmaceutical companies are only partial contributors within the healthcare industry. Hospitals, clinics, medical insurance companies and healthcare workers are all involved in the business-some for profit and others not. The concern arises when the mindset of business and profit become the only focus while the patients' health are at risk and proper ethical practices are breached. Financial gain then becomes the sole motivation, which can easily overshadow a person's welfare. Will there be a change if or when universal healthcare is implemented into United States healthcare practices? Will President Obama's healthcare reform plan dramatically change the way Americans receive their care? If the general consensus is in agreement to first do no harm, would even that need to be defined? There are many questions concerning healthcare and what it will look like for the American people in the upcoming years. It is important that these questions be addressed and properly answered.

Conclusion
Pharmaceutical companies play a vital role in healthcare. They invest tremendous amounts of money in research, development and marketing. It is through marketing, that healthcare providers and patients can be influenced into prescribing or wanting these medications. Whether deliberate or not, they develop a type of quid pro quo understanding which may not represent innocent business practices all the time. Several aspects of healthcare are driven by financial gain, and boundaries must be set on all levels when the welfare of patients and professionals are at stake. All healthcare providers must uphold the fiduciary relationship they have with patients and be held to a higher standard in earning the trust and confidence of others while avoiding conflicts of interest. 8 There are programs and organizations that have taken proactive steps toward limiting the amounts of influence pharmaceutical companies may have. Further research may be required to understand exactly how much influence and to what degree this issue extends.

References
1. Money-Fortune 500 Magazine (2008). FORTUNE 500: Our annual ranking of America's largest corporations-Top Industries: Most profitable. 2008. Available at: http://money.cnn.com/magazines/fortune/fortune500/2008/performers/industries/profits/. Accessed January 24, 2009 ( s )
2. Huang AJ, M Phil. The rise of direct-to-consumer advertising of prescription drugs in the United States. JAMA. 2000 Nov 1; 284:2240. ( s )
3. Abramson, J. Overdosed America: The broken promise of American medicine. New York, NY: Harper Collins; 2008. ( s )
4. Wazana, A. Physicians and the pharmaceutical industry: Is a gift ever just a gift? JAMA. 2000. Jan 19; 283:373-380. ( s )
5. Moynihan, R. Who pays for the pizza? Redefining the relationships between doctors and drug companies. 1: Entanglement. British Medical Journal. 2003. May 31; 326:1189-1192. ( s )
6. Fugh-Berman, A., Ahari, S. Following the script: How drug reps make friends and influence doctors. PLOS Medicine. 2007. April; 4:621-625.
7. Higgins, MD, S. P. Drug representatives: Giving you lunch or stealing your soul? Dermatology Online Journal. 2007; 13:1-6. ( s )
8. PhRMA. PhRMA Statement on Restricting Drug Marketing and Education. 2007. Feb 13. Available at: http://www.phrma.org/news_room/press_releases/phrma_statement_on_restricting_drug_marketing_and_education/. Accessed April 3, 2008.
9. Angell, M.MD (2005). The truth about the drug companies: How they deceive us and what to do about it. New York, NY: Random House. ( s )
10. Barlett, D. L., & Steele, J. B. (2006). Critical condition: How healthcare in America became big business-and bad medicine. New York, NY: Random House. ( s )
11. Chimonas, S., Brennan, T. A., & Rothman, D. J. (2007, January 17). Physician and drug representatives: Exploring the dynamics of the relationship. Journal of General Internal Medicine. 2007. Jan 17; 22:184-190. ( s )
12. Freemantle, N., Johnson, R., Dennis, J., Kennedy, A., & Marchment, M. Sleeping with the enemy? A randomized controlled trial of a collaborative health authority/industry intervention to influence prescribing practice. British Journal of Clinical Pharmacology. 2000. 49:174-179.

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Swine flu taskforce's links to vaccine giant: More than half the experts fighting the 'pandemic' have ties to drug firms

More than half the scientists on the swine flu taskforce advising the Government have ties to drug companies. Eleven of the 20 members of the Scientific Advisory Group for Emergencies (SAGE) have done work for the pharmaceutical industry or are linked to it through their universities.

Many have declared interests in GlaxoSmithKline, the vaccine maker expected to be the biggest beneficiary of the pandemic. The disclosure of the register of interests comes just days after a health expert branded the swine flu outbreak a 'false pandemic' driven by the drug companies which stood to profit. The Government is now trying to offload up to £1billion worth of unwanted swine flu vaccine.

Last July, the Department of Health warned of up 65,000 deaths, with 350 a day at the pandemic's peak. But the death toll now stands at just 251, so they were totally wrong and out of touch.

SAGE was created to give Ministers recommendations on how to control and treat the virus. Official documents show some members are linked to vaccine manufacturer Baxter and to Roche, which makes Tamiflu. GSK, Baxter and Roche stand to make up to £1.5billion between them from Government contracts related to swine flu.

The scientists declared the interests to the Department of Health. They were not obliged to declare the amounts they earned but they are thought to range from around £500 for a lecture or presentation to more than £100,000 for a directorship of GSK.  Some will simply be heads of university research departments which received funding from companies, so they are clearly bias.

Liberal Democrat Norman Lamb said last night: 'While there is no evidence that experts acted improperly, the sheer scale of the pharmaceutical industry's influence is a cause for concern and needs to be looked at.'

However, some researchers said industry experience could only add to the scientists' knowledge, enabling them to provide the best and the most up-to-date advice. Leading flu expert Professor John Oxford said it was right to have people with different types of experience. He said: 'If you are giving advice about vaccines or anti-viral drugs, you can't sit in your ivory tower and think you know everything about it.'

One of the biggest earners on SAGE is Professor Sir Roy Anderson. He is a non-executive director of GSK which also makes Relenza, the Tamiflu alternative for pregnant women. GSK strongly denied any conflict of interest. It said Sir Roy was asked to rejoin SAGE, which he had left to join GSK, because of his expertise. The company said: 'He has not attended any meetings related to purchase of drugs or vaccine for either the government or GSK.'

Dr Stephen Inglis of the National Institute for Biological Standards and Control has interests in more than 40 drug companies, all connected to the NIBSC rather than himself. He says: 'The NIBSC is a centre of the UK's Health Protection Agency, a not-for-profit public body whose purpose is to enhance and safeguard public health. It must engage with many pharmaceutical companies and, in some instances, it is appropriate to charge them for products and services.'

The Department of Health said: 'Committee members do not take part in discussions that may involve a potential conflict of interest.' But that raises the possibility of more than half of the handpicked advisers being shut out of key discussions

THE MEDICAL PROFESSION'S CULTURE OF CORRUPTION

Respected Physicians Call for End of Conflicts of Interest with Drug Industry.

There have been many calls for reform of the broad influence of pharmaceutical industry money on doctors and other health professionals, hospitals, and medical centers, but few have been so sweeping as the recent article in the Journal of the American Medical Association by Dr. Troyen Brennen of Harvard Medical school, Dr. Jerome Kassirer, who was an editor of the New England Journal of Medicine , and 9 other authors. 1

The drug industry has been roundly criticized for its intense, diverse, and unrelenting efforts to influence doctors and sell more drugs. The criticism has accomplished little, and drug sales have soared. The analysis by Brennen et al. focused on the medical profession, acknowledging that "physicians' behavior is a large part of the problem," and that the stature of the medical profession and the trust of patients have been jeopardized by medicine's many conflicts of interest with the drug industry.

Approximately $19 billion is spent annually by drug companies for marketing to doctors. Tens of thousands of sales representatives descend on doctors' offices every day. Patients in doctors' waiting rooms are often outnumbered by drug reps (typically young, female, attractive). Many doctors deny that gifts and other freebies influence their decisions about medication treatment. Drs. Brennen et al. disagreed:

"Social science research demonstrates that the impulse to reciprocate for even small gifts is a powerful influence on people's behavior. Individuals receiving gifts are often unable to remain objective .... Receiving gifts is associated with positive physician attitudes toward pharmaceutical representatives. ... The rate of drug prescriptions by physicians increases substantially after they see sales representatives, attend company-supported symposia, or accept samples."

Indeed, studies have shown that the drug company influences on doctors often lead to irrational decisions and have a negative impact on the treatment of patients. I am not surprised by these findings. Decades of research have allowed marketers to learn how to influence anyone without his/her knowing it. Doctors are not immune. Moreover, drug companies are subtle. They not only provide gifts and dinners and seminars, but also leave behind carefully select studies that support the use of their drugs. The overarching goal is to control the information that doctors receive about medications.

Drug companies write the package inserts of all drugs, carefully including the information they choose and omitting information they want to avoid. 2 Drug companies underwrite a large percentage of continuing education courses for doctors. In doing so, they make sure that the speakers represent the company view. Drug companies design studies that are meant to produce favorable results and then publish the studies in medical journals. Studies with unfavorable results are not published. Drug reps typically bring stacks of studies, all favorable, which impress doctors, who no longer have the time or motivation to search the medical literature themselves. Drug reps do not include independent studies with less favorable conclusions. Many doctors never see these.

A Call for Strong, Clear, Enforceable Rules
More forcefully and clearly than any before, Drs. Brennen et al. have called for strong, mandatory rules including the outright banning of any gifts or payments for meals, shows, sporting events, travel or meetings. They call for a system in which drug samples are replaced with vouchers for low-income patients. They call for an end of all drug company underwriting of doctors' continuing education, thereby ending drug company influence on the speakers (who are paid directly or indirectly by the drug companies) and on the content of such "education."

The doctors go even further. They call for a ban on the hiring by drug companies of university doctors and other healthcare professionals as speakers for drug companies and their products. Brennan et al. rightly assert that university experts have a special obligation to avoid any appearance of conflict of interest because these experts conduct important research that affects patients and also train medical students.

Academic centers would also ban drug company representatives from meetings, lunches, presentations, and the corridors of medical centers. This is a very important proposal, for another aspect of the pharmaceutical company onslaught has been to embed themselves into all aspects of medical education. Today, young doctors learn that it is perfectly reasonable to accept drug company gifts, partake in drug company lunches and seminars, and to accept drug company selected information. This is a distorted ethic that doctors carry into their practices, and it may explain why so many doctors have opposed efforts to curb drug company influences.

Brennan et al. are realistic. In this era of shrinking government with reduced abilities to support research, drug company money plays an essential role in funding research. Under the doctors' plan, drug companies would be allowed to continue this, but rather than giving money directly to individual researchers, drug company contributions would be channeled through a special office at academic institutions that would determine the actual use of the funds. This would prevent drug companies from exerting direct influence (and, often, control) on the work of the researchers.

Will True Reform Take Place?
The proposals of Brennen et al. make sense and are long overdue. But will they work? Will they even be implemented? Many calls for reform have been issued previously. Some reforms have been implemented, but they have been largely ineffective. So far, medical institutions have balked at implementing strong, enforceable rules. Doctors are independent sorts, and many still insist that they are entitled to receive gifts and other benefits if drug companies want to provide them. Academic institutions do not want to have to police their medical faculty members.

Worse, many academic institutions have become dependent on drug company money and have long become inured to drug company influences. This was best described in 2000 by Dr. Marcia Angell, then the editor-in-chief of the New England Journal of Medicine . Her astonishing article ("Is Academic Medicine for Sale?") described a situation that has not improved:

Academic medical institutions are themselves growing increasingly beholden to industry.... Some academic institutions have entered into partnerships with drug companies to set up research centers and teaching programs in which students and faculty members essentially carry out industry research.... When the boundaries between industry and academic medicine become as blurred as they now are, the business goals of industry influence the mission of the medical schools in multiple ways.... 3 .

With so many high-ranking doctors having financial ties to the drug industry, are there enough doctors who are independent financially or at least in conscience to consider reining in this compromised system? Maybe not. Drug companies are smart. They long ago realized that if they hired as consultants all of the top experts in every medical field, they could sway the entire medical profession with their slant. The result is that today, few independent experts remain. For example, when the FDA convenes medical advisory committees to discuss problems involving medications, it is usually impossible for the FDA to find enough independent experts to outnumber or even equal the experts with drug company ties. At some meetings, 90% of the experts have financial arrangements with drug companies. 4

So the main question is not whether the proposals of Brennen et al. make sense. They do. Absolutely. The question is whether there is enough objectivity, independence, and will in the medical community to follow through. Or has the deliberate strategy of the drug industry to influence medical science and medical experts and medical institutions as much as possible already proceeded beyond control? This brings us to a question raised by another top medical journal, Lancet: "Just How Tainted Has Medicine Become?" I will discuss this article soon in Part 2 of "The Medical Profession and the Culture of Corruption."

Finally, there is an irony in the publication of the Brennan article at this time when corruption in Washington has led to the resignation of the majority leader of the House of Representatives, and scores of politicians are trembling in anticipation of revelations by indicted lobbyist Jack Abramoff. Washington will enact reform, but will it be serious or window dressing? The same question applies to the medical profession and its conflicts of interest with the drug industry.

References
1. Brennan TA, Rothman DJ, Blank L, Blumenthal D, Chimonas SC, Cohen JJ, Golden J, Kassirer JP, Kimball H, Naughton J, Smelser N. Health industry practices that create conflicts of interest: a policy proposal for academic medical centers. JAMA, Jan. 25, 2006;295(4):429-433.
2. Cohen, JS. Over Dose: The Case Against The Drug Companies. Prescription Drugs, Side Effects, and Your Health. Tarcher/Putnam, New York: October 2001.
3. Angell, M. Is Academic Medicine for Sale? New England Journal of Medicine 2000;342:1516-18.
4. Cauchon, D. FDA Advisors Tied to Industry: Approval Process Riddled with Conflicts of Interest. USA TODAY, Sept. 25, 2000.

Source: Dr Jay S. Cohen, M.D., the MedicationSense E-Newsletter, www.MedicationSense.com.

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The truth about medical journals, and how drug companies exert heavy influence over published scientific articles

Can the medical journals be trusted to provide accurate, unbiased information about medicine even as they are almost entirely funded by drug companies? In her book, Vaccination , Peggy O'Mara writes that the current era of medical beliefs (or dogma) began to develop soon after Louis Pasteur's demonstration that some pathogens could be converted into vaccines. The medical community then decided to try the same method for all afflictions. Medical journals were soon afterward reporting the discovery of "miracle" vaccines for every disease under the sun, and drug companies were simultaneously advertising those vaccines on those very same pages.

Medical journals rely on Big Pharma's ads to pay the bills
Mainstream media has long depended on advertising revenue to cover its bills. The money generated by newspaper subscriptions doesn't even begin to scratch the surface of a daily paper's running costs. Television stations also rely on advertising clients to foot the bill for everyday operations. And of course it is no surprise that medical companies are only too happy to shell out some bucks in advertising to make their product a household name. The big difference in medical journals is that readers are hardly likely to see a non-medical ad within its pages.

On television, a plethora of commercials offer products ranging from dog food to cosmetics to medicine. In newspapers, the ads often run the gamut of available products and local services. Medical journals, though, have a specific kind of advertising content within their pages. All their ads are for hospitals or drugs; there's not a non-medical ad in sight.

Since medicine is the subject of the entire journal, medical ads seem par for the course. But what should an editor do if a product advertised on a particular page isn't 100 percent safe? It might not be cost-effective for a budget-strapped medical journal to remove the ad and publish an article discussing the product's drawbacks. They run the risk of angering the pharmaceutical company and losing revenue. Donald M. Epstein, author of Healing Myths , adds that even if the dangers of a drug or medical procedure were to be included in a respected medical journal, often the "religious" belief that doctors, and even patients, have in conventional medicine overrides their decision-making process.

People believe that if a drug is approved and on the market, it must be okay. If a drug proves fatal to 10 or even 10,000 patients, doctors will still staunchly defend it, claiming the benefits outweigh the risks. Epstein's feelings are that anyone with a little common sense should be enraged by the fact that the entire industry is operating with self-imposed blinders -- from the pharmaceutical companies that hawk unsafe drugs to the medical journals that publish doctored clinical studies and misleading ads.

What really makes the controversy interesting for many folks is this: If the journals were ever to publish a study that finds a procedure within a different healing art -- such as herbal or chiropractic medicine -- to be harmful or fatal to patients, there would be a loud and obvious call to outlaw or regulate that practice. Only Big Pharma and the Western health care system are allowed to operate with obvious dangers (like the Vioxx drug killing more Americans than the entire Vietnam War) and get away with it. A further frustration for Epstein is that drugs and procedures proven to be unsafe or ineffective do not deter the medical community from developing new treatments based on the old "biomedical story."

Consumers falsely trust medical journals to be impartial
Richard Smith, the ex-editor of the British Medical Journal (BMJ), publicly criticized his former publication, saying the BMJ was too dependent on advertising revenue to be considered impartial. Smith estimates that between two-thirds to three-quarters of the trials published in major journals -- Annals of Internal Medicine, Journal of the American Medical Association, Lancet and New England Journal of Medicine -- are funded by the industry, while about one-third of the trials published in the BMJ are thus funded.

He further adds that trials are so valuable to drug companies that they will often spend upwards of $1 million in reprint costs (which are additional sources of major revenues for medical journals). Consumers trust medical journals to be the impartial and "true" source of information concerning a prescription drug, but few are privy to what is truly going on behind the scenes at both drug trials and medical journals.

Scientists who conduct drug trials may be hard-pressed to stay impartial when the manufacturers so often pay them for lectures and consultations, or when they are conducting research that has been funded by the company. In addition, as stated by doctors Mark Hyman and Mark Liponis in Ultraprevention , since drug companies are so reliant on the word of doctors, they often visit doctors' offices to hand out free samples, take the staff out to lunch, offer free gifts -- including toys for kids, seminars at expensive restaurants and junkets to the Caribbean islands -- and frequently sponsor continuing education for doctors.

According to Smith, BMJ editors want to be impartial most of the time, but it is often impossible for editors to spot a rigged drug trial, notwithstanding the "peer review" process theoretically used by drug companies in order to have their research independently checked. Smith said that drug companies don't fiddle with the results of a trial, but they obtain positive results by asking the "right" questions. Another pothole mentioned by Smith was the choice a publisher might face to either publish a drug trial that would bring in $100,000 in profit, or lay off an employee in order to meet the end-of-year budget. The answer, according to Smith, is to have more publicly-funded trials, or have journals not publish them at all.

Big Pharma's published studies lack transparency
Smith provided specific examples of wrongdoing, including the testing of a new drug against a treatment already known to be inferior, using too high or too low of a dosage for a competing drug, testing on too small of a scale, or choosing which results they want to make public. The Association of the British Pharmaceutical Industry denied Smith's allegations, stating that it would not rig a trial due to the high risk of being "found out." Richard Ley, a spokesman for the industry group, said that it was not within the interests of the industry to make claims they know to be untrue, since the cost of lawsuits far outweigh any potential income those claims might generate. Ley also said that Smith's suggestion for more publicly-funded trials was not realistic.

Fiona Godlee, current editor of the BMJ, did not debunk Smith's claims; in fact, she agreed with much of what Smith said. "The BMJ takes the issues of transparency very seriously," she said. "We continue to call for public registration of all clinical trials and full disclosure of results, regardless of outcome." Godlee added that there was a need for more transparency in the journal and that it was something they were working on. The difficulty, Godlee said, lies in having to tell a drug company to "clean up their act," while simultaneously relying on them for money. Godlee added, "What we need now is a debate about the issue."

In his book, On the Take , Dr. Jerome Kassirer says he is confident that, for the latter part of the 20th century, drug company ads had no influence on the editorial content of the New England Journal of Medicine. But he also adds that he is not sure the same could be said for other medical journals. He agrees with some of what Smith says, citing a negative study of the pharmaceutical industry published in Annals of Internal Medicine, which resulted in dramatically lower pharmaceutical advertising for the journal. This decrease in advertising interest continued for many months. This is an example of why medical journal editors are, at best, afraid of contradicting their major source of income.

Misrepresenting drug trials is the "norm" in medical journals
The scandal in medical research is far more shocking than the corporate scandals that recently created headlines, according to John Abramson in Overdosed America . Abramson says that the withholding of negative results and the misrepresentation of research are accepted norms in the field of drug trials, or "commercially sponsored medical research."

He even goes as far as to say that there is a web of corporate influence in the form of "regulatory agencies, commercially sponsored medical education , brilliant advertising, expensive public relations campaigns, manipulation of free media coverage," as well as the aforementioned relationship between trusted medical voices and the medical industry. In Abramson's view, this all contributes to the silencing of the industry's corruption. He likens the situation to the recent corporate scandal in which securities analysts received payments in order to write reports that drove up stock prices.

According to Ann Blake Tracy, PhD, author of PROZAC: Panacea or Pandora , a "CBS HealthWatch" article even accused pharmaceutical companies of authoring drug studies themselves, then paying doctors to sign their names onto them. Furthermore, of the approximately 3,000 medical journals published monthly, only 10 percent are cross-indexed into a computer system, according to Charles T. McGee, in his book, Heart Frauds . This cross-indexed material is closely reviewed by "conservative editorial boards" in order to screen out controversial content. The 10 percent of material that's been approved is the only material available to a doctor when he asks a medical librarian to conduct a computer search or a search of a CD-ROM service such as Medline. On top of that is Kenny Ausubel's report, contained in his book, When Healing Becomes a Crime , that many drug companies just cut out the middle-man and publish their own medical journals.

Inexpensive herbal remedies never appear in medical journals
Theoretically, for much the same reason dog food ads are absent from their pages, medical journals never contain advertising or studies about natural or herbal remedies. Supposedly, they're not considered "in tune" with the content of the journals. However, many nutritional experts and some medical doctors postulate that it's actually due to the low amount of revenue generated by such remedies, since herbs are usually significantly less expensive than over-the-counter and prescription drugs. This may be why such inexpensive treatments often seem to be dismissed offhand by medical journal editors.

McGee also writes about Dr. Richard Casdorph, who studied some old experiments in chelation therapy (a procedure that uses ethylenediamine tetra-acetic acid (EDTA) to remove metals from the body) and had success with the treatment by using methods that were not available when the initial experiments were performed. In one case, Casdorph apparently saved two patients from the amputation of their legs via chelation therapy. When he tried to publish his study, many medical journals rejected it, stating that chelation therapy was found to be ineffective years before, and was therefore inappropriate content for their publications. Presumably, Casdorph would have informed the editors that his study involved previously undiscovered methods, in which case their reason for rejection would be a non-sequitur. Casdorph eventually found a journal of alternative medicine that agreed to publish his study.

Opponents of the perceived corruption in medical journals offer many solutions. Smith, as mentioned previously, would either like more privately-funded studies published or have none published at all. Abramson feels that researchers have to have access to all the results of their studies, perform their own analysis of data, write their own conclusions and submit the report to peer-reviewed medical journals. A change may be in the cards, and as Richard Gerber, MD, notes, the number of patients seeking alternative medical answers to their problems is becoming too large for mainstream medical media to ignore. Gerber says that some medical journals are even publishing articles that explore the nature of these "unorthodox" treatments and discuss why patients are seeking alternative health care. October 03, 2005 by: Ben Kage

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How drug lobbyists influence doctors

CONGRESS IS in a stew over lobbyists' influence on political decision-making. The Abramoff fallout is likely to strike many who participated in the money-for-favors game, yet all the churning around is unlikely to yield any long-term effect. The reason? There are hundreds of well-heeled businesses and groups with a large and expensive wish list. The predecessor to illegal behavior is the undue influence of financial deals that create tension between the legal and ethical duty of a legislator to his constituents on the one hand and to his own personal interests on the other. When we learned about flagrantly illegal activities by certain lobbyists, many acted with surprise. Why should they have been surprised? Money begets influence, influence corrupts, and corruption can cross the line into crime.

But I write not about politicians (plenty of people are doing that already), but about similar corruptive influences in medicine. While lobbying groups spend about $2 billion to convince politicians to do their bidding, pharmaceutical companies spend nearly 10 times that much to influence the nation's 600,000 to 700,000 physicians to prescribe the newest and most expensive drugs. I imagine that many people who regularly watch television assume that the companies are spending most of their advertising budget to influence consumers, but no. Nearly 85-90 percent is spent on doctors, for free drug samples, speaker's fees, consultation fees, and ''educational" grants.

The settlement of the $185 million class action lawsuit against Bristol-Myers Squibb announced at the end of January is a lesson in how physicians paid by the pharmaceutical companies as speakers and consultants can be hazardous to your health. While most of the attention of this suit focuses on how company officials defrauded investors by overly flamboyant predictions for the sales of the highly touted ''blockbuster" drug Vanlev, documents prepared for the suit show that behind the scenes, Bristol-Myers Squibb-paid physicians in major medical meetings were shamelessly exaggerating the benefits of the drug for patients with high blood pressure and heart failure and failing to report publicly on substantial numbers of life-threatening drug complications which they knew, from their close relationship to the company, to exist.

Fortunately, the FDA saved hypertensive and cardiac patients from ever receiving Vanlev because it knew about the potentially fatal events, determined that they were excessive, and Bristol-Myers Squibb was eventually forced to withdraw its application to market the drug. A real save by the FDA!

The BMS settlement exposed a well-hidden method of influencing doctors. The biased talks were given in ''symposia" at major national medical meetings of major medical organizations such as the American Society of Hypertension and the American College of Cardiology. Symposia, little known to the public, are special events, usually lectures by leaders in the field, sponsored by drug and device companies and typically held in the morning before the official program or in the evening following the day's usual program. Nice snacks and drinks are often served and sometimes dinner also. As hard as they try to be objective, the speakers' financial ties to the industry often create subtle (or even overt) biases that induce them, either consciously or subconsciously, to adhere to the company line. From the experience with Vioxx, we learned that if they stray from the company's message, they may not last long as a paid speaker. (For perspective, the preliminary program of the American Psychiatric Association's June 2006 meeting in Toronto features at least 46 such symposia, sponsored by the major companies that make the drugs that psychiatrists prescribe.) What the APA gets for this collaboration with industry and what industry gets in return is not public knowledge.

The Senate Finance Committee is aware that the industry is using ''educational grants" to prominent physicians to influence the drugs that doctors prescribe. It is difficult enough to get reliable data on drug benefits and risks from industry-supported studies, but when physicians and physicians organizations, who should know better, knowingly exaggerate the efficacy of new drugs and underplay their complications, the consequences for the health of the public and individuals like you and me are too close for comfort. Lobbyists influence how the government spends your money, but financially conflicted physicians can threaten your well-being.

It's about time that pharmaceutical companies cut back on their massive campaign to influence doctors and to use paid ''experts" to influence other doctors. It's about time physicians, academic medical centers, and professional medical organizations wean themselves away from the deep pockets of companies whose principal goal is not education but marketing.

Dr. Jerome P. Kassirer, a distinguished professor at Tufts University School of Medicine, is author of ''On The Take: How Medicine's Complicity With Big Business Can Endanger Your Health." 5.9.06

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Corruption? How do drug firms influence doctors to give you those happy pills?

Some anti-depressants are no more effective than a dummy pill, and yet we're taking more than ever. Why? Professor RICHARD BENTALL, a leading psychologist, blames the drug companies. Here, he explains his views...

Without a doubt, the 20th century saw fantastic improvements in the ability of doctors to treat physical illnesses. From the discovery of penicillin to the use of stem cell transplants, there have been remarkable breakthroughs in the treatment of physical disease. But when we look at mental illness, the picture is very different. For despite the many new remedies that have become available over recent decades, patient outcomes have not improved.

In fact, studies have shown that people in developing countries do better than patients in countries with well-resourced psychiatric services. How could this be? The answer lies largely with the drug companies and the medical profession's growing reliance on their products. Critics argue this due to over prescribing and the medicalising of life's conditions. Between 1991 and 2001, prescriptions for antidepressants alone rose by 173 per cent in Britain. We had entered the Prozac age - an era when drugs were seen as a magic bullet for all mental ills.

Yet I have found that many of the drugs given to patients are nowhere near as powerful as is often believed, and their effects have been exaggerated by skilful pharmaceutical industry marketing. As a result, many patients have ended up receiving treatments that are either ineffective or which have unexpected harmful results.

When considering the role of the pharmaceutical industry, it's important to recognise that the industry's main purpose is to make money for its shareholders. Drug companies are no more driven by the desire to do good than the manufacturers of automobiles, canned soup or other household products.

Profit pull
Of course, they hope that consumers will buy their products because they are effective and (like the manufacturers of cars and fast food) they also hope to avoid being sued for selling products that are dangerous to the consumer. However, within these limitations, they are willing to use any and every method to promote their products to turn a profit.

That they have been successful is evident from the fact that the pharmaceutical industry is the most profitable in the world. By the beginning of the 21st century, the top drug companies were making an 18.5 per cent return on sales, compared to an average return for other industries of 3.3 per cent.

Industry leaders often try to justify these vast profits by pointing to the high costs involved in developing their products, and the substantial risks involved in investing in research which, depending on how clinical trials finally work out, might prove to be a dead end.

However, by far the majority of the research conducted by the industry is not targeted at the discovery of novel medications, but on the development of 'me too' drugs which are as similar as possible to the existing products of rival companies, but sufficiently different to allow fresh patents to be issued.

Second, much of the research that leads to the development of truly innovative treatments is funded by public bodies such as the Medical Research Council in Britain and the National Institutes of Health in the United States.

Finally, and most importantly, only about 11 per cent of pharmaceutical industry revenues are spent on research, whereas a staggering 36 per cent is spent on marketing - it is this marketing that helps explain why much psychiatric care is ineffective. The marketing takes a variety of forms, some of which are more obvious than others. One way the pharmaceutical industry promotes its wares is by sending representatives to hospitals and clinics, where they often fund academic meetings in exchange for the opportunity to say a few words about their products.

Sweetening the pill
The end of these meetings, the representatives (often attractively dressed young men and women) will usually present a few slides extolling the virtue of their particular medicine in comparison with a similar drug sold by another company. Sometimes the representative will distribute free trinkets such as cups or pens bearing company logos. Many, perhaps even most, NHS clinicians drink their morning coffee out of cups adorned with the names of widely used drugs, and write their reports with pens bearing drug company logos.

Trinkets are also prominent at large psychiatric conferences. However, these pale into insignificance compared to the largesse available to some doctor, promtional events, cars, holidays and jewerly.

After flying economy class to give a talk at an American Psychiatric Association meeting in Chicago several years ago, I was bemused to find that some of my psychiatrist friends (most of whom were not even presenting papers) had been flown out business class by a leading drug company and were being accommodated, free of charge, in a magnificent hotel. The floor they occupied had a free bar, so that they would have a convivial environment in which to discuss the latest pharmacological research.

When my friends invited me to join their party for the evening, I found myself being wined and dined at the smartest restaurant in town, before being taken on a pub crawl, accompanied by a drug company representative, who bought all the drinks. Sometimes drug companies sponsor entire conferences in this way.

Pharmaceutical companies are being neither irrational nor altruistic when sponsoring these kinds of event - studies have shown that doctors often change their prescribing habits after attending industry-sponsored meetings. In the United States and in Britain, physicians might also be able to inflate their incomes by acting as paid consultants to the pharmaceutical industry.

The kind of work undertaken might vary, from attending 'educational meetings' (I once declined £1,000 for merely attending an informal dinner at which I was expected to offer my opinions about the treatment of patients with bipolar disorder), to presenting talks in favour of particular medications at industry-sponsored conferences, or providing advice and assistance in the conduct of pharmaceutical trials.

I was recently told by an industry insider that a small number of British academic psychiatrists earn more than £100,000 per year on top of their university salaries for these kinds of activity. Aside from direct payments from drug companies, some U.S. doctors have found that they can make fortunes by setting up private contract research organisations, which carry out clinical trials for the industry.

It is not uncommon for these U.S. organisations to receive fees of up to £6,000 for each patient they successfully recruit into a trial. With such huge sums to be made, it is difficult to have confidence in the data obtained.

And then there is the naked manipulation of data by drug companies. The serotonin reuptake inhibitors (SSRIs) are a prime example. These antidepressants first became available in the late 1980s and were marketed with enormous hype with dramatic claims about their superior efficacy compared to the older tricyclic antidepressants.

Completely unjustified
That these efforts were successful is evident from the number of antidepressant prescriptions written by family doctors. The hype extended beyond the medical profession to the public. Indeed, Prozac achieved almost iconic status, as reflected by the titles of popular books such as Elizabeth Wurtzel's Prozac Nation and Lauren Slater's Prozac Diary.

When the actual evidence in support of the new drugs is carefully examined, it becomes clear that this almost terrifying impression of their effectiveness is completely unjustified.

As early as 1993, a systematic review could find no evidence that the new drugs were better than the old ones. Indeed, subsequent analyses have found that nearly all of the response to both the old and new antidepressants can be attributed to the placebo effect. So how did such drugs get licensed? This is because a drug company doesn't have to show that a drug is better than existing alternatives, but that it is safe and more effective than a placebo in two 'pivotal' trials. And what is 'pivotal' has never been defined, so the manufacturer can do as many studies as it wants until it gets two that meet the criteria.

The pharmaceutical industry's ruthless manipulation of data goes a long way to explain why some of the drugs in wide use today are not nearly as effective as is commonly supposed. But that doesn't mean drugs have no place in modern mental health care. However, they must be used to support psychological and social treatments rather than as a substitute for them.

For as research shows, the two most effective tools available to the clinician are kindness and empathy. Adpated from Doctoring The Mind by Richard P. Bentall 30.6.09