(attn: Child bashing psychologist Mark Morin!- another one) FWD: conflicts between drug trials and $$$$
Question:
– Hide quoted text — Show quoted text – Usenet Advanced Search Usenet Help Search all groups Search the Web Click here for information about upcoming improvements to this beta version of Google’s Usenet search. Usenet search result 7 for PSYCHIATRIST group health Search Result 7 conflicts between drug trials and $$$$ Drug Trials Hide Conflicts for Doctors – Part I By KURT EICHENWALD and GINA KOLATA http://wwwlawyer.com/articles/article2321.cfm When Thomas Parham visited his doctor in the summer of 1995, he expected just another routine checkup. But his doctor had something else in mind. The doctor, Peter Arcan, suggested that Parham might want to join a study of a new drug to shrink enlarged prostates, according to records of the encounter. Parham was puzzled — his prostate was fine. But Arcan brushed aside the retired metal worker’s questions, saying the experimental drug might prevent future problems. Satisfied, Parham, a 64-year-old resident of La Habra, Calif., agreed to participate. There was one question Parham did not ask: What was in it for Arcan? The answer was money. The drug’s maker, SmithKline Beecham PLC, was paying $1,610 for each patient that doctors signed up — money that covered study expenses while allowing a portion to end up as profit for Arcan and his associates. Parham had no idea. "Nothing was mentioned about money," he said in an interview. "It’s a situation where you have faith in your doctor." Through his secretary, Arcan declined comment. With his decision, Parham had unwittingly joined hundreds of thousands of other patients recruited by their personal physicians into a booming venture: the business of testing experimental drugs on people. Once clinical research was a staid enterprise primarily administered by academic researchers driven by a desire for knowledge, fame or career advancement. Now, it is a multibillion-dollar industry, with hundreds of testing and drug companies working with thousands of private doctors. In this new industry, patients have become commodities, bought and traded by testing companies and doctors. Almost daily, the industry urges doctors to join the gold rush, bombarding them with faxes and letters blaring such come-ons as "Improve Your Cash Flow" and "Discover the Secret For Obtaining More Funded Studies." In an era of managed care, the pleas are seductive: The number of private doctors in research since 1990 has almost tripled, and top recruiters can earn as much as $500,000 to $1 million a year. This new system is a boon for drug companies because it reaches out to a vast pool of test subjects who have never before been available for experimentation. But it also injects the interests of a giant industry into the delicate doctor-patient relationship, usually without the patient realizing it. These changes have prompted little public debate, mostly because the full scope of what is happening is hidden. The industry treats research agreements as corporate secrets and contractually forbids doctors to disclose them. As a result, few people outside the industry, including government officials, have seen the contracts or know the magnitude of the money involved. But in a 10-month investigation, The New York Times obtained such contracts and thousands of other confidential documents that present a view of the research industry that has never before been available. These records, and interviews with participants, reveal a system fueling a pharmaceutical renaissance, but fraught with conflicts of interest; that places a premium on speed and meeting quotas; that relies on government and private monitoring that can be easily fooled and that some researchers said is inadequate; and that secretly offers a share of the cash to other health professionals who might influence patients to join a study. At bottom, the only thing separating a trusting patient from a study that could be inappropriate or potentially harmful is the judgment of a doctor torn by these unseen conflicts and pressures. The documents, including contracts, protocols or related financial records from more than 300 recent drug studies, were provided by a number of people in the industry concerned about its direction. The Times also conducted a computer analysis of more than 200,000 filings with the government and related data submitted by doctors who want to conduct research, and interviewed doctors, patients, ethicists, industry executives and government officials. These are among the specific findings of The Times’ investigation: — Drug companies and their contractors offer large payments to doctors, nurses and other medical staff to encourage them to recruit patients quickly. And doctors do not even have to conduct trials to get paid: There are finder’s fees for those who refer their patients to other doctors conducting research. — Doctors who recruit the most patients receive additional perquisites, such as the right to claim a coveted authorship of published papers about the studies — even though the true author is a ghostwriter using analysis from the drug company. Those who fail to meet the recruitment goals are usually dropped from future studies. — Testing companies often use doctors as clinical investigators regardless of their specialty, at times leaving patients in the care of doctors who know little about their condition. For example, psychiatrists have conducted Pap smears and asthma specialists have dispensed experimental psychiatric drugs. — A growing number of doctors conducting drug research have limited experience as clinical investigators, raising questions among some experts about the quality of their data. In interviews, industry officials and researchers said the emerging drug-approval system was dedicated to quality and offers significant benefits. Since patients are seeing their own doctors, researchers said, it adds a level of continuity and personal contact to the process — something unavailable from full-time researchers. Moreover, industry officials said, the new pool of test subjects is a resource of incalculable value that is allowing the development of an avalanche of new compounds. Drug tests "can get delayed if the patients aren’t out there and available," said Chris Kuebler, the chairman and chief executive at Covance Inc., a giant testing company. But some experts said patients were being pushed to participate in the studies because of the financial interests of their doctors. Doctors working as researchers "are enticing and cajoling patients who are in no position to resist their blandishments to enter clinical studies," said Dr. David Shimm, a member of the ethics committee at Porter Adventist Hospital in Denver who has written about research conflicts. "What the patients are not seeing is that the clinical investigator is really a dual agent with divided loyalties between the patient and the pharmaceutical company," he said. While patients must sign detailed consent forms to enroll in drug studies, they are often in no position to question their doctor’s suggestion that they join. "The physician has enormous power over you," said Uwe Reinhardt, a health care economist at Princeton University, who himself recently agreed to participate in a clinical trial run by his doctor — in part because he feared annoying him — and who had no idea that money might be involved. "You want to keep his favor. If you say no, you’ll worry that he may not like you." That is what happened with Parham and Arcan. In joining the study, Parham said: "I just followed his advice, just like if he said to take two aspirin instead of one. He’s a doctor and I’m not." In truth, Parham should never have been signed up for the prostate study. According to his medical records, he had been hospitalized the previous year with a chronic slow heart rate, a condition that specifically disqualified him for the study. But, saying that Parham’s heart rate was only mildly slow, an administrator handling the paperwork for Arcan sought an exemption from SmithKline. Based on those representations, the drug company granted the exemption; it was not told about Parham’s earlier hospitalization. Soon after joining, Parham complained of fatigue, a symptom of his slow heart rate. Arcan dismissed the complaints as emotional. Within weeks, Parham asked to be dropped from the study. Days later he was hospitalized and given a pacemaker; Parham never brought legal action and it is impossible to know whether his participation in the study affected his heart condition. His experience underscores a potential danger of the emerging drug- testing system: Doctors with money at stake may persuade patients to take drugs that are inappropriate or even unsafe. Under the current system of monitoring, such actions are almost impossible to catch and no statistics are collected on such events. Within the industry, most of the planning focuses on conducting studies quickly. Patient issues, some researchers said, are often lost in the rush. "You go to the trade meetings on clinical research; you go for two entire days, and patients are not mentioned," said Dr. Robert Califf, the director of the Duke Clinical Research Institute, an academic drug- testing center in Durham, N.C., affiliated with Duke University. "The patient is an object to make money. Having patients is just the dirty price for doing business." A letter sent out last July by
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What a fascinating article..probably the shape of things to come in Europe..I knew that doctors here receive free foreign holidays, childrens school fees and so on ..but the scale here is breathtaking..no wonder they are so keen to shut you up..
– Hide quoted text — Show quoted text – Usenet Advanced Search Usenet Help Search all groups Search the Web Click here for information about upcoming improvements to this beta version of Google’s Usenet search. Usenet search result 7 for PSYCHIATRIST group health Search Result 7 conflicts between drug trials and $$$$ Drug Trials Hide Conflicts for Doctors – Part I By KURT EICHENWALD and GINA KOLATA http://wwwlawyer.com/articles/article2321.cfm When Thomas Parham visited his doctor in the summer of 1995, he expected just another routine checkup. But his doctor had something else in mind. The doctor, Peter Arcan, suggested that Parham might want to join a study of a new drug to shrink enlarged prostates, according to records of the encounter. Parham was puzzled — his prostate was fine. But Arcan brushed aside the retired metal worker’s questions, saying the experimental drug might prevent future problems. Satisfied, Parham, a 64-year-old resident of La Habra, Calif., agreed to participate. There was one question Parham did not ask: What was in it for Arcan? The answer was money. The drug’s maker, SmithKline Beecham PLC, was paying $1,610 for each patient that doctors signed up — money that covered study expenses while allowing a portion to end up as profit for Arcan and his associates. Parham had no idea. "Nothing was mentioned about money," he said in an interview. "It’s a situation where you have faith in your doctor." Through his secretary, Arcan declined comment. With his decision, Parham had unwittingly joined hundreds of thousands of other patients recruited by their personal physicians into a booming venture: the business of testing experimental drugs on people. Once clinical research was a staid enterprise primarily administered by academic researchers driven by a desire for knowledge, fame or career advancement. Now, it is a multibillion-dollar industry, with hundreds of testing and drug companies working with thousands of private doctors. In this new industry, patients have become commodities, bought and traded by testing companies and doctors. Almost daily, the industry urges doctors to join the gold rush, bombarding them with faxes and letters blaring such come-ons as "Improve Your Cash Flow" and "Discover the Secret For Obtaining More Funded Studies." In an era of managed care, the pleas are seductive: The number of private doctors in research since 1990 has almost tripled, and top recruiters can earn as much as $500,000 to $1 million a year. This new system is a boon for drug companies because it reaches out to a vast pool of test subjects who have never before been available for experimentation. But it also injects the interests of a giant industry into the delicate doctor-patient relationship, usually without the patient realizing it. These changes have prompted little public debate, mostly because the full scope of what is happening is hidden. The industry treats research agreements as corporate secrets and contractually forbids doctors to disclose them. As a result, few people outside the industry, including government officials, have seen the contracts or know the magnitude of the money involved. But in a 10-month investigation, The New York Times obtained such contracts and thousands of other confidential documents that present a view of the research industry that has never before been available. These records, and interviews with participants, reveal a system fueling a pharmaceutical renaissance, but fraught with conflicts of interest; that places a premium on speed and meeting quotas; that relies on government and private monitoring that can be easily fooled and that some researchers said is inadequate; and that secretly offers a share of the cash to other health professionals who might influence patients to join a study. At bottom, the only thing separating a trusting patient from a study that could be inappropriate or potentially harmful is the judgment of a doctor torn by these unseen conflicts and pressures. The documents, including contracts, protocols or related financial records from more than 300 recent drug studies, were provided by a number of people in the industry concerned about its direction. The Times also conducted a computer analysis of more than 200,000 filings with the government and related data submitted by doctors who want to conduct research, and interviewed doctors, patients, ethicists, industry executives and government officials. These are among the specific findings of The Times’ investigation: — Drug companies and their contractors offer large payments to doctors, nurses and other medical staff to encourage them to recruit patients quickly. And doctors do not even have to conduct trials to get paid: There are finder’s fees for those who refer their patients to other doctors conducting research. — Doctors who recruit the most patients receive additional perquisites, such as the right to claim a coveted authorship of published papers about the studies — even though the true author is a ghostwriter using analysis from the drug company. Those who fail to meet the recruitment goals are usually dropped from future studies. — Testing companies often use doctors as clinical investigators regardless of their specialty, at times leaving patients in the care of doctors who know little about their condition. For example, psychiatrists have conducted Pap smears and asthma specialists have dispensed experimental psychiatric drugs. — A growing number of doctors conducting drug research have limited experience as clinical investigators, raising questions among some experts about the quality of their data. In interviews, industry officials and researchers said the emerging drug-approval system was dedicated to quality and offers significant benefits. Since patients are seeing their own doctors, researchers said, it adds a level of continuity and personal contact to the process — something unavailable from full-time researchers. Moreover, industry officials said, the new pool of test subjects is a resource of incalculable value that is allowing the development of an avalanche of new compounds. Drug tests "can get delayed if the patients aren’t out there and available," said Chris Kuebler, the chairman and chief executive at Covance Inc., a giant testing company. But some experts said patients were being pushed to participate in the studies because of the financial interests of their doctors. Doctors working as researchers "are enticing and cajoling patients who are in no position to resist their blandishments to enter clinical studies," said Dr. David Shimm, a member of the ethics committee at Porter Adventist Hospital in Denver who has written about research conflicts. "What the patients are not seeing is that the clinical investigator is really a dual agent with divided loyalties between the patient and the pharmaceutical company," he said. While patients must sign detailed consent forms to enroll in drug studies, they are often in no position to question their doctor’s suggestion that they join. "The physician has enormous power over you," said Uwe Reinhardt, a health care economist at Princeton University, who himself recently agreed to participate in a clinical trial run by his doctor — in part because he feared annoying him — and who had no idea that money might be involved. "You want to keep his favor. If you say no, you’ll worry that he may not like you." That is what happened with Parham and Arcan. In joining the study, Parham said: "I just followed his advice, just like if he said to take two aspirin instead of one. He’s a doctor and I’m not." In truth, Parham should never have been signed up for the prostate study. According to his medical records, he had been hospitalized the previous year with a chronic slow heart rate, a condition that specifically disqualified him for the study. But, saying that Parham’s heart rate was only mildly slow, an administrator handling the paperwork for Arcan sought an exemption from SmithKline. Based on those representations, the drug company granted the exemption; it was not told about Parham’s earlier hospitalization. Soon after joining, Parham complained of fatigue, a symptom of his slow heart rate. Arcan dismissed the complaints as emotional. Within weeks, Parham asked to be dropped from the study. Days later he was hospitalized and given a pacemaker; Parham never brought legal action and it is impossible to know whether his participation in the study affected his heart condition. His experience underscores a potential danger of the emerging drug- testing system: Doctors with money at stake may persuade patients to take drugs that are inappropriate or even unsafe.
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