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Doctoring trials is the name of the game :
THE NEXT time your doctor prescribes some medicines, chances are that the choice of drugs has less to do with your ailment and more todo with the way pharmaceutical companies have managed to in- fluence him to prescribe their medicines. But how does it matter what the medicine is as long as you get cured? The question is simple; the answer is not. "There is growing evidence that doctors' prescribing habits are influenced by drug companies, either through discussions with medical representatives or through sales drives dressed up as medical education," wrote Kamran Abbasi and Richard Smith in the British Medical Journal (BMJ) in 2003.
Mr. Smith was the editor of BMJ then. "A British research group finds that doctors who are frequented by medical representatives are more willing to prescribe new drugs _ are more likely to agree to prescribing a drug that is not clinically indicated."
"_ information supplied to doctors by drug companies is systematically distorted," they noted while highlighting the ways by which companies tried to influence doctors' prescription patterns. "Sometimes they (the compies) bend the rules, but it is the doctors who are perhaps more to blame in coming to depend on drug company largesse." To put it succinctly, drug companies have managed to de-flect the moral compass of the doctors.
Marcia Angell, who was the editor in chief of the New England Journal of Medicinehas in her recent book `The truth about drug companies' highlighted how patients unwittingly become a part of phase IV trials _ to learn more about the long term effects of a drug that has already been launched. In reality, Phase IV trials have more to do with the way companies make doctors prescribe their drugs in lieu of even cheaper generic drugs.
Two chapters in her book have been dedicated to highlighting the ways in which companies market their products in the guise of education and research.
Many people have in the past brought out the compulsion for doctors to not bank on drug companies for information. Papers published in journals, peerreviewed journals in particular, are one of the best sources of unbiased information. But many doctors rarely use journals to update themselves. But in the first place, are journals truly unbiased and scientifically correct all the time?
Journals no saints
If drug companies can influence doctors, can journals be far behind? A plethora of studies has indicated the nexus between drug companies and journals and how journals knowingly or unwittingly become a part and parcel of the companies' propaganda machinery.
Drug companies know the high credibility enjoyed by papers published in peer-reviewed journals. And they have developed strategies to co-opt journals in marketing their products. It is a sad state that one of the last bastions of unbiased information has been successfully in- filtrated by drug companies.
"Journals have developed into information laundering operations for the pharmaceutical companies," wrote Richard Horton, editor of the journal Lancet last year. In oral evidence provided before the House of Commons select committee on health, Mr. Horton had said, "_ the problem we have at journals is that the great tools for marketing are the papers we publish." "(Journals) are little more than a marketing tool of the drug companies," Mr. Smith was recently quoted as saying in the Guardian.
How did journals, peer-reviewed journals in particular, kept on a high pedestal by the scientific community, stoop to this level and let themselves be used as a marketing tool by the pharmaceutical companies? Assured monetary benefits (to the journals) and some deft manipulations by the companies have made this possible.
Journals fighting back
"Journal editors are becoming increasingly aware of how they are being manipulated and are fighting back, but I must confess that it took me almost a quarter of a century editing for the BMJ( British Medical Journal) to wake up to what was happening," Mr. Smith had written recently in the Public Library of Science Medicine journal.
So how do drug companies manipulate that even the most respected and reputed journals, such as the British Medical Journal, the New England Journal of Medicineand the Lancet, were caught napping? Having spent millions of dollars in the clinical trials to test the drugs' safety and efficacy, drug companies make sure they load the dice in their favour by making the drugs look good. Only results that are favourable to their interests are ever published. And they go about doing this very meticulously.
Biased from the start
They build biases right from the beginning of the trials. For a true comparison, a new drug has to be tested against an existing drug to understand its safety and efficacy. Drug companies rarely follow this, though. The new drug is tested against a treatment well known to be inferior or against a placebo. Even if tested against a well known drug, it is done against too low a dose of a competitor drug.
Multicentric trials _ trials conducted in many places simultaneously _ are considered as one of the best ways to test the drugs' safety and efficacy. Journals tend to treat results obtained from such trials with greater respect. And it is precisely this sanctity that companies try to misuse.
Being multicentric in nature, many data sets are obtained. And only those that are favourable to the company are ever published. At times only those parts of the data that are favourable to the company get published. The favourable results are then published repeatedly in many journals by combining data from more than one centre.
The first author of such papers is always different and no mention is made about the first time the data was published in a journal. This makes it very diffi- cult for journals to do the cross checking. These are but some of the strategies adopted by the pharmaceutical companies to hoodwink the journals.
Lure of money
But the journals are no saints either. Publicity and fame by publishing clinical data results of a large trial cannot be overlooked. It is not just that _ monetary gains are an implicit part of it. Companies tend to buy thousands of reprints _ exact copies of the papers as published in the journal along with the journal's name and other details.
The financial gain runs to thousands of dollars. If few thousands of dollars are suffi- cient to buy a doctor's loyalty, nearly a million dollars of revenue do the same with journals. These reprints are in turn used by companies as propaganda material to convince doctors of a drug's superiority. So what started as a biased study gets published and is used as a marketing tool!
* * *
Researcher as a pawn
One more player who is used as a pawn by companies is the researcher. With a `publish or perish' dictum being followed, researchers willingly part take in clinical trials. This sometimes becomes a necessity as clinical trials using public funds or others not connected with the industry are not many in number.
The flip side is that researchers who get involved in the trials have little say in what or how the paper sent for publication in journals has to be written; drug companies own the data and they call the shots.
Researchers being paid huge sums of money for just agreeing to be an author of papers already written up by companies are not uncommon.
Moving towards more transparency
The Bangalore based Biocon Limited has become the first company in the country and second in the world to make its clinical trial results (of human insulin Insugen) accessible on the Net since last year. This is a step in the right direction.
According to Dr. A.S. Arvind, Chief Operating Officer, Clinigene International which is a wholly owned subsidiary of Biocon, the aim, study design, conclusions, to name a few, of the trial have been put up for public access. Though significant, the details provide just the summary and corresponding results.
"We have provided the summary of the 120 patients who were tested for all the three insulin formations," he said.
While providing the summary will help users understand the drug's safety and efficacy, can the company not continue to exclude unfavourable results from a particular centre in the final summary?
And to be truly transparent, should not the number of (even if the names are not mentioned) centres where the trials are to be conducted and the number of patients to be enrolled be provided?
"(That) will lead to breach of confidence," he stressed. "It's an initial attempt. Giving as much information as possible is good."
--------------------------------------------------------------
Just read this article related to ur field...with absolutely no iontention to discourage u or anything like that ...
THE NEXT time your doctor prescribes some medicines, chances are that the choice of drugs has less to do with your ailment and more todo with the way pharmaceutical companies have managed to in- fluence him to prescribe their medicines. But how does it matter what the medicine is as long as you get cured? The question is simple; the answer is not. "There is growing evidence that doctors' prescribing habits are influenced by drug companies, either through discussions with medical representatives or through sales drives dressed up as medical education," wrote Kamran Abbasi and Richard Smith in the British Medical Journal (BMJ) in 2003.
Mr. Smith was the editor of BMJ then. "A British research group finds that doctors who are frequented by medical representatives are more willing to prescribe new drugs _ are more likely to agree to prescribing a drug that is not clinically indicated."
"_ information supplied to doctors by drug companies is systematically distorted," they noted while highlighting the ways by which companies tried to influence doctors' prescription patterns. "Sometimes they (the compies) bend the rules, but it is the doctors who are perhaps more to blame in coming to depend on drug company largesse." To put it succinctly, drug companies have managed to de-flect the moral compass of the doctors.
Marcia Angell, who was the editor in chief of the New England Journal of Medicinehas in her recent book `The truth about drug companies' highlighted how patients unwittingly become a part of phase IV trials _ to learn more about the long term effects of a drug that has already been launched. In reality, Phase IV trials have more to do with the way companies make doctors prescribe their drugs in lieu of even cheaper generic drugs.
Two chapters in her book have been dedicated to highlighting the ways in which companies market their products in the guise of education and research.
Many people have in the past brought out the compulsion for doctors to not bank on drug companies for information. Papers published in journals, peerreviewed journals in particular, are one of the best sources of unbiased information. But many doctors rarely use journals to update themselves. But in the first place, are journals truly unbiased and scientifically correct all the time?
Journals no saints
If drug companies can influence doctors, can journals be far behind? A plethora of studies has indicated the nexus between drug companies and journals and how journals knowingly or unwittingly become a part and parcel of the companies' propaganda machinery.
Drug companies know the high credibility enjoyed by papers published in peer-reviewed journals. And they have developed strategies to co-opt journals in marketing their products. It is a sad state that one of the last bastions of unbiased information has been successfully in- filtrated by drug companies.
"Journals have developed into information laundering operations for the pharmaceutical companies," wrote Richard Horton, editor of the journal Lancet last year. In oral evidence provided before the House of Commons select committee on health, Mr. Horton had said, "_ the problem we have at journals is that the great tools for marketing are the papers we publish." "(Journals) are little more than a marketing tool of the drug companies," Mr. Smith was recently quoted as saying in the Guardian.
How did journals, peer-reviewed journals in particular, kept on a high pedestal by the scientific community, stoop to this level and let themselves be used as a marketing tool by the pharmaceutical companies? Assured monetary benefits (to the journals) and some deft manipulations by the companies have made this possible.
Journals fighting back
"Journal editors are becoming increasingly aware of how they are being manipulated and are fighting back, but I must confess that it took me almost a quarter of a century editing for the BMJ( British Medical Journal) to wake up to what was happening," Mr. Smith had written recently in the Public Library of Science Medicine journal.
So how do drug companies manipulate that even the most respected and reputed journals, such as the British Medical Journal, the New England Journal of Medicineand the Lancet, were caught napping? Having spent millions of dollars in the clinical trials to test the drugs' safety and efficacy, drug companies make sure they load the dice in their favour by making the drugs look good. Only results that are favourable to their interests are ever published. And they go about doing this very meticulously.
Biased from the start
They build biases right from the beginning of the trials. For a true comparison, a new drug has to be tested against an existing drug to understand its safety and efficacy. Drug companies rarely follow this, though. The new drug is tested against a treatment well known to be inferior or against a placebo. Even if tested against a well known drug, it is done against too low a dose of a competitor drug.
Multicentric trials _ trials conducted in many places simultaneously _ are considered as one of the best ways to test the drugs' safety and efficacy. Journals tend to treat results obtained from such trials with greater respect. And it is precisely this sanctity that companies try to misuse.
Being multicentric in nature, many data sets are obtained. And only those that are favourable to the company are ever published. At times only those parts of the data that are favourable to the company get published. The favourable results are then published repeatedly in many journals by combining data from more than one centre.
The first author of such papers is always different and no mention is made about the first time the data was published in a journal. This makes it very diffi- cult for journals to do the cross checking. These are but some of the strategies adopted by the pharmaceutical companies to hoodwink the journals.
Lure of money
But the journals are no saints either. Publicity and fame by publishing clinical data results of a large trial cannot be overlooked. It is not just that _ monetary gains are an implicit part of it. Companies tend to buy thousands of reprints _ exact copies of the papers as published in the journal along with the journal's name and other details.
The financial gain runs to thousands of dollars. If few thousands of dollars are suffi- cient to buy a doctor's loyalty, nearly a million dollars of revenue do the same with journals. These reprints are in turn used by companies as propaganda material to convince doctors of a drug's superiority. So what started as a biased study gets published and is used as a marketing tool!
* * *
Researcher as a pawn
One more player who is used as a pawn by companies is the researcher. With a `publish or perish' dictum being followed, researchers willingly part take in clinical trials. This sometimes becomes a necessity as clinical trials using public funds or others not connected with the industry are not many in number.
The flip side is that researchers who get involved in the trials have little say in what or how the paper sent for publication in journals has to be written; drug companies own the data and they call the shots.
Researchers being paid huge sums of money for just agreeing to be an author of papers already written up by companies are not uncommon.
Moving towards more transparency
The Bangalore based Biocon Limited has become the first company in the country and second in the world to make its clinical trial results (of human insulin Insugen) accessible on the Net since last year. This is a step in the right direction.
According to Dr. A.S. Arvind, Chief Operating Officer, Clinigene International which is a wholly owned subsidiary of Biocon, the aim, study design, conclusions, to name a few, of the trial have been put up for public access. Though significant, the details provide just the summary and corresponding results.
"We have provided the summary of the 120 patients who were tested for all the three insulin formations," he said.
While providing the summary will help users understand the drug's safety and efficacy, can the company not continue to exclude unfavourable results from a particular centre in the final summary?
And to be truly transparent, should not the number of (even if the names are not mentioned) centres where the trials are to be conducted and the number of patients to be enrolled be provided?
"(That) will lead to breach of confidence," he stressed. "It's an initial attempt. Giving as much information as possible is good."
--------------------------------------------------------------
Just read this article related to ur field...with absolutely no iontention to discourage u or anything like that ...
