Professor Gotche: “Big Pharma Behavior” Meets the Criterion “Organized Crime” ”
(translation of the online article “Daily Mail” dated February 23, 2016)
Sir Richard Thompson, the former president of the Royal College of Physicians of the former 21 years as the personal doctor of the Queen of Great Britain, warned today that many drugs are less effective than they think. He is one of six well-known doctors who are now warning about the impact of pharmaceutical companies on unwarranted prescription drugs.
Experts, led by the cardiologist of the national health care system, Dr. Asim Malhotra, argue that patients are too often prescribed useless and even harmful medicines and procedures that they do not need. They accuse the public health system of failing to confront pharmaceutical giants who promote drugs only for the purpose of benefiting from them, and not with the goal of benefiting.
')
Sir Richard said: “The time has come for a full and open public review of evidence of the efficacy of drugs. There is a real danger that some modern medical treatments are much less effective than previously thought. ”
The opinion of Sir Richard Thompson and Dr. A. Malhotra was supported by the following well-known and respected doctors:
* John Ashton, a professor at London Medical School at Southampton and the University of Liverpool, who served 6 years as director of public health in the UK, awarded the Order of the British Empire;
* Psychiatrist Dr. Yash Bamrach, Chairman of the British Association of Doctors of Indian Origin;
* cardiologist Rita Redberg, a professor at the University of California, member of the FDA advisory committee, editor of the Journal of Internal Medicine published by the American Medical Association (jama);
* James McCormack, Professor of Pharmaceutical Sciences at the University of British Columbia and the Medical University of South Carolina.
Dr. Malhotra, who initiated this campaign, is a trustee of the Royal Health Foundation, a member of the Academy of Royal Medical Colleges and an adviser to the National Forum on Obesity.
Sir Richard Thompson (left) and Dr. Asim Malhotra (right)
The group called on the Public Audit Committee of the Parliament to conduct an independent review of drug safety. Sir Thompson, Malhotra, and their like-minded people argue that public funds are often allocated for medical research, since it may be beneficial to the "big pharma", and not because it will be beneficial to the patients.
Dr. Malhotra said: “There is no doubt that the principle“ the more medicine, the better ”is at the core of our health care system. Financial incentives push the system to prescribe more drugs and carry out more procedures. But, there is an even more ominous obstacle in achieving progress that should worry us - this is the information that is provided to doctors and patients in the decision-making process about treatment. ” He accused pharmaceutical companies of “systemic deception” because they spend twice as much on marketing than on reliable research.
Dr. Malhotra says that prescription drugs often do more harm than good, and older people are especially at risk: “One of three hospitalizations in a group over 75 years old is the result of an adverse drug effect.”
In response to these allegations, a spokesman for the British Pharmaceutical Industry Association said: “All drugs undergo rigorous testing by global regulators for quality, safety and efficacy. However, we recognize that the discussion on the evaluation of medicines is timely, and we would be happy to contribute, together with many other interested parties, to the “assessment of evidence”. This dialogue is very important for the constructive evaluation of medicines. ” A spokesman for the public health system in England declined to comment on this.
Malhotra highlighted the situation with statins. The National Institute for the Advancement of Medicine (NICE), which regulates the use of drugs in the UK, reduced the statin prescription threshold in 2014, thereby encouraging physicians to prescribe drugs to more people. But later it turned out that 8 people from 12 experts who had made such an opinion received funding directly from drug manufacturers, or through the funding of their research. Malhotra argues that the full data on the effectiveness of statins and their side effects have not yet been disclosed.
He also pointed out the problem of the ineffectiveness of the drug for the flu Tamiflu, for which the state health system spent 473 million pounds sterling (in 2014, a group of prominent scientists concluded that Tamiflu is no more effective than Paracetamol).
Dr. Malhotra also refers to an investigation conducted by the British Medical Journal (bmj), which earlier this month suggested that the main blood thinner, Rivaroxaban, is not as safe as its public data indicates.
Professor Ashton adds: “Public health must be based on a comprehensive, accurate, and cost-effective evidence base. We need to ensure that we make decisions based on the best available research, based on the priority of achieving the best result for patients. ”
Dr. Malhotra's exclusive interview for “Mailonline”:
“A few weeks ago I was a speaker at the annual conference of the British Association of Indian Physicians in Birmingham. In my presentation, I reported on the problems of modern medicine that are of deep concern:
* biased funding for medical research (they finance only what will be beneficial to the "big pharma" and not to the patients);
* biased coverage of issues in medical journals;
* the presence of a commercial conflict of interest of doctors and patients;
* the inability of doctors and patients to understand the real effectiveness and the risks of using drugs.
The problems listed above contribute to the growing epidemic of misinforming doctors and patients in the UK and abroad. The cost of this epidemic is a desperate situation with tens of thousands of lives around the world. Moreover, because of this, national economies are losing millions and billions of dollars.
A few months ago, the director of the national health care system in England, Sir Bruce Keog, admitted that every seventh medical procedure performed, including surgery, is in fact not necessary for patients. In the USA, according to experts, 1/3 of all medical activity does not bring any benefit to patients.
This is reinforced by the thought expressed by the ex-editor of the New England Journal of Medicine, Dr. Marcia Angel. In her report to the University of Montana back in 2009, she showed that out of 667 new drugs approved by the FDA from 2000 to 2007, only 11% were innovative or improved existing drugs. Three-quarters of them were just copies of old ones. Given the fact that pharmaceutical companies are primarily responsible for the profits of their shareholders, and not for the health of patients, this is not surprising.
At the same time, the Government Food and Drug Administration (FDA) reports that the undesirable effects of prescribed medicines have increased in the United States over the last decade more than three times. In 2014, this led to more than 123,000 deaths and 800,000 serious complications in the treatment process, including emergency hospitalization and disabilities. But, most likely, these data do not reflect the real magnitude of the problem.
Another expert who has long and decisively expressed the dangers of modern medicine is Peter Gotche, a professor at the University of Copenhagen, one of the founders of the Cochrane community. He estimates that prescription drugs are the third most common cause of death after cardiovascular diseases and cancer. In particular, he is seriously concerned about the effects of psychiatric drugs (antidepressants and drugs for dementia). In his letter to the British Medical Journal (bmj), he indicated that they are responsible for more than 1.5 million deaths of people over the age of 65 in the United States and the European Union.
Professor Peter Gotche
We are talking about older people who are most at risk of so-called "polypragmasy" when a patient takes several drugs. The problem with polypragmasy is that the more medications you take, the more you are likely to experience side effects, which are then incorrectly interpreted by doctors as symptoms of a disease that needs treatment with additional medications. Every third hospitalization after 65 years is the result of an adverse drug reaction.
Many of these patients are prone to falling and have fractures of the femoral neck due to the side effects of the drugs, and 25% of them die from this.
But what worries Professor Gotche most of all is the behavior of the pharmaceutical industry, which fully complies with the criterion “organized crime” defined in US law.
From 2007 to 2012, almost all pharmaceutical companies in the top ten were attracted to pay significant fines for various misconducts (for marketing their drugs for unauthorized use by regulators, for distorting the results of clinical studies, and for hiding data on the harm detected). But these penalties do not work as a deterrent. For example, in 2012, GSK was awarded a $ 3 billion fine for the largest public health fraud in US history — for illegally marketing a number of drugs (antidepressants, diabetes drugs, and drugs for treating epilepsy). But over the period of time when these violations occurred, GSK received a profit in excess of $ 25 billion from sales of these drugs.
Medical journals and the media also manipulate public opinion, not only marketing big-farm products, but also becoming their accomplices as they try to silence those who call for more transparency and independent verification of drug efficacy data.
Here, for example, is an article published in the “Medical Journal of Australia” (MJA) in June 2015. It argued that a documentary film (which went on the air in 2013 and wondered about the advisability of administering statins to people with a low risk of heart disease) could result in many people having a heart attack or dying due to refusing this medication.
I was asked for an interview at ABC News in Australia to discuss this topic, but just 30 minutes before the start my interview was canceled. If I had the opportunity, I would share my point of view, which is that the article in MJA did not provide any evidence of the possibility of increasing the number of hospitalizations or deaths due to the refusal to take statins. Conversely, the documentary film about which I spoke was, in my opinion, one of the most brilliant results of medical journalism that I have seen recently. This opinion is also shared by Professor Simon Capwell, Vice-President of the Faculty of Public Health, who described it as “informative, transparent, and raising legitimate questions.”
Like Professor Capwell, in my article published two weeks ago in the medical journal BMC, I point out that research shows that 75% of those who were prescribed statins stop taking them within a year. At the same time, 62% cite serious side effects as the cause of such a failure. In the case, there is growing evidence that, at best, the benefits of statins have been greatly exaggerated, and the side effects are underestimated.
Recently, two unrelated research groups in Japan and France questioned the credibility of many earlier statin studies sponsored by pharmacists.
Japanese studies have gone so far as to suggest that statins may cause an increase in the burden of heart failure among the population. A well-known French cardiologist Michel de Lorgorel claims that all studies published after 2006 say "the absence of the use of statins for the prevention of cardiovascular diseases in all groups of patients." I fully support his call for a full reassessment of all statin research, and I agree that before completing such a reassessment, “physicians should be aware that statements about the efficacy and safety of statins are not based on evidence.”
In addition, we must require that the clinical trials unit at Oxford University provide the initial data of statins for independent verification. It was their pharmacy-sponsored research that led to the appointment of statins to millions of people around the world and increasing the profits of the multi-billion dollar industry.
But back to the bigger picture.
It has been more than 10 years since John Ioannidis, a professor of medicine and health research, and also a professor of statistics at Stanford University, published the landmark document "Why most of the published research results are false . " We are talking about the manipulation of statistical data. He went so far as to say: "The more financial interests are in a particular area, the less likely it is that the results of research in this area will be true."
Professor John Ioannidis
Here are just some facts confirming his rightness:
• Recently, several leading doctors, including Sir Richard Thompson, addressed the Secretary of the National Health Service, expressing their concerns about the impartiality of the NICE group that developed recommendations for the use of statins, since eight out of 12 of its members had financial ties with statin producing companies;
• In April 2014, independent scientists from the Cochrane Collaboration (whose opinion is considered the “gold standard” of medical research) concluded that
not counting other countries, only the UK lost about 500 million pounds on the purchase of the useless drug Tamiflu (see about this on geektimes) ;
• An investigation conducted by the British Medical Journal showed that the blood clotting control device used in the studies, which was published in the New England Medical Journal, was malfunctioning and gave false testimony during the research comparing Rivaroxaban with "Warfarin". This "casts doubt on the results that are used for marketing" the world's bestseller among oral anti-coagulants. Of course, NICE might not have known about the faulty device, but it was possible to question their decision to recommend the use of statins only because they accepted it on the basis of just one study, which was funded by a pharmaceutical company.
The fact that the number of prescriptions written annually in Britain exceeds 1 billion (twice as many as 10 years before) should be considered as a public health system crisis. Now, when the patient comes to me with any new symptom, my first thought becomes: “Could this be a side effect of the medicine?”.
Last week, speaking of recent scandals, Richard Smith, the former editor of the British Medical Journal, wrote: "Something has rotted in the state of British medicine and for a long time." The health care system is broken and cannot be fixed by simply pouring in even more money. Corporate greed and systematic failure put the public health system on its knees. Medical science has made a sharp turn towards darkness.
For the sake of our health and the viability of public health, the time has come for urgent collective action against the principle “the more medicine, the better.” This can begin with a full-scale independent investigation of the efficacy and safety of medicines by the public counting committee of parliament. Without complete transparency and accountability, no doctor can provide what we, the doctors, went to medical school for and what our hearts and souls are dedicated to - providing better services to our patients. ”
Sir Richard Thompson, the former president of the Royal College of Physicians of the former 21 years as the personal doctor of the Queen of Great Britain, warned today that many drugs are less effective than they think. He is one of six well-known doctors who are now warning about the impact of pharmaceutical companies on unwarranted prescription drugs.
Experts, led by the cardiologist of the national health care system, Dr. Asim Malhotra, argue that patients are too often prescribed useless and even harmful medicines and procedures that they do not need. They accuse the public health system of failing to confront pharmaceutical giants who promote drugs only for the purpose of benefiting from them, and not with the goal of benefiting.
')
Sir Richard said: “The time has come for a full and open public review of evidence of the efficacy of drugs. There is a real danger that some modern medical treatments are much less effective than previously thought. ”
The opinion of Sir Richard Thompson and Dr. A. Malhotra was supported by the following well-known and respected doctors:
* John Ashton, a professor at London Medical School at Southampton and the University of Liverpool, who served 6 years as director of public health in the UK, awarded the Order of the British Empire;
* Psychiatrist Dr. Yash Bamrach, Chairman of the British Association of Doctors of Indian Origin;
* cardiologist Rita Redberg, a professor at the University of California, member of the FDA advisory committee, editor of the Journal of Internal Medicine published by the American Medical Association (jama);
* James McCormack, Professor of Pharmaceutical Sciences at the University of British Columbia and the Medical University of South Carolina.
Dr. Malhotra, who initiated this campaign, is a trustee of the Royal Health Foundation, a member of the Academy of Royal Medical Colleges and an adviser to the National Forum on Obesity.
Sir Richard Thompson (left) and Dr. Asim Malhotra (right)
The group called on the Public Audit Committee of the Parliament to conduct an independent review of drug safety. Sir Thompson, Malhotra, and their like-minded people argue that public funds are often allocated for medical research, since it may be beneficial to the "big pharma", and not because it will be beneficial to the patients.
Dr. Malhotra said: “There is no doubt that the principle“ the more medicine, the better ”is at the core of our health care system. Financial incentives push the system to prescribe more drugs and carry out more procedures. But, there is an even more ominous obstacle in achieving progress that should worry us - this is the information that is provided to doctors and patients in the decision-making process about treatment. ” He accused pharmaceutical companies of “systemic deception” because they spend twice as much on marketing than on reliable research.
Dr. Malhotra says that prescription drugs often do more harm than good, and older people are especially at risk: “One of three hospitalizations in a group over 75 years old is the result of an adverse drug effect.”
In response to these allegations, a spokesman for the British Pharmaceutical Industry Association said: “All drugs undergo rigorous testing by global regulators for quality, safety and efficacy. However, we recognize that the discussion on the evaluation of medicines is timely, and we would be happy to contribute, together with many other interested parties, to the “assessment of evidence”. This dialogue is very important for the constructive evaluation of medicines. ” A spokesman for the public health system in England declined to comment on this.
Malhotra highlighted the situation with statins. The National Institute for the Advancement of Medicine (NICE), which regulates the use of drugs in the UK, reduced the statin prescription threshold in 2014, thereby encouraging physicians to prescribe drugs to more people. But later it turned out that 8 people from 12 experts who had made such an opinion received funding directly from drug manufacturers, or through the funding of their research. Malhotra argues that the full data on the effectiveness of statins and their side effects have not yet been disclosed.
He also pointed out the problem of the ineffectiveness of the drug for the flu Tamiflu, for which the state health system spent 473 million pounds sterling (in 2014, a group of prominent scientists concluded that Tamiflu is no more effective than Paracetamol).
Dr. Malhotra also refers to an investigation conducted by the British Medical Journal (bmj), which earlier this month suggested that the main blood thinner, Rivaroxaban, is not as safe as its public data indicates.
Professor Ashton adds: “Public health must be based on a comprehensive, accurate, and cost-effective evidence base. We need to ensure that we make decisions based on the best available research, based on the priority of achieving the best result for patients. ”
Dr. Malhotra's exclusive interview for “Mailonline”:
“A few weeks ago I was a speaker at the annual conference of the British Association of Indian Physicians in Birmingham. In my presentation, I reported on the problems of modern medicine that are of deep concern:
* biased funding for medical research (they finance only what will be beneficial to the "big pharma" and not to the patients);
* biased coverage of issues in medical journals;
* the presence of a commercial conflict of interest of doctors and patients;
* the inability of doctors and patients to understand the real effectiveness and the risks of using drugs.
The problems listed above contribute to the growing epidemic of misinforming doctors and patients in the UK and abroad. The cost of this epidemic is a desperate situation with tens of thousands of lives around the world. Moreover, because of this, national economies are losing millions and billions of dollars.
A few months ago, the director of the national health care system in England, Sir Bruce Keog, admitted that every seventh medical procedure performed, including surgery, is in fact not necessary for patients. In the USA, according to experts, 1/3 of all medical activity does not bring any benefit to patients.
This is reinforced by the thought expressed by the ex-editor of the New England Journal of Medicine, Dr. Marcia Angel. In her report to the University of Montana back in 2009, she showed that out of 667 new drugs approved by the FDA from 2000 to 2007, only 11% were innovative or improved existing drugs. Three-quarters of them were just copies of old ones. Given the fact that pharmaceutical companies are primarily responsible for the profits of their shareholders, and not for the health of patients, this is not surprising.
At the same time, the Government Food and Drug Administration (FDA) reports that the undesirable effects of prescribed medicines have increased in the United States over the last decade more than three times. In 2014, this led to more than 123,000 deaths and 800,000 serious complications in the treatment process, including emergency hospitalization and disabilities. But, most likely, these data do not reflect the real magnitude of the problem.
Another expert who has long and decisively expressed the dangers of modern medicine is Peter Gotche, a professor at the University of Copenhagen, one of the founders of the Cochrane community. He estimates that prescription drugs are the third most common cause of death after cardiovascular diseases and cancer. In particular, he is seriously concerned about the effects of psychiatric drugs (antidepressants and drugs for dementia). In his letter to the British Medical Journal (bmj), he indicated that they are responsible for more than 1.5 million deaths of people over the age of 65 in the United States and the European Union.
Professor Peter Gotche
We are talking about older people who are most at risk of so-called "polypragmasy" when a patient takes several drugs. The problem with polypragmasy is that the more medications you take, the more you are likely to experience side effects, which are then incorrectly interpreted by doctors as symptoms of a disease that needs treatment with additional medications. Every third hospitalization after 65 years is the result of an adverse drug reaction.
Many of these patients are prone to falling and have fractures of the femoral neck due to the side effects of the drugs, and 25% of them die from this.
But what worries Professor Gotche most of all is the behavior of the pharmaceutical industry, which fully complies with the criterion “organized crime” defined in US law.
From 2007 to 2012, almost all pharmaceutical companies in the top ten were attracted to pay significant fines for various misconducts (for marketing their drugs for unauthorized use by regulators, for distorting the results of clinical studies, and for hiding data on the harm detected). But these penalties do not work as a deterrent. For example, in 2012, GSK was awarded a $ 3 billion fine for the largest public health fraud in US history — for illegally marketing a number of drugs (antidepressants, diabetes drugs, and drugs for treating epilepsy). But over the period of time when these violations occurred, GSK received a profit in excess of $ 25 billion from sales of these drugs.
Medical journals and the media also manipulate public opinion, not only marketing big-farm products, but also becoming their accomplices as they try to silence those who call for more transparency and independent verification of drug efficacy data.
Here, for example, is an article published in the “Medical Journal of Australia” (MJA) in June 2015. It argued that a documentary film (which went on the air in 2013 and wondered about the advisability of administering statins to people with a low risk of heart disease) could result in many people having a heart attack or dying due to refusing this medication.
I was asked for an interview at ABC News in Australia to discuss this topic, but just 30 minutes before the start my interview was canceled. If I had the opportunity, I would share my point of view, which is that the article in MJA did not provide any evidence of the possibility of increasing the number of hospitalizations or deaths due to the refusal to take statins. Conversely, the documentary film about which I spoke was, in my opinion, one of the most brilliant results of medical journalism that I have seen recently. This opinion is also shared by Professor Simon Capwell, Vice-President of the Faculty of Public Health, who described it as “informative, transparent, and raising legitimate questions.”
Like Professor Capwell, in my article published two weeks ago in the medical journal BMC, I point out that research shows that 75% of those who were prescribed statins stop taking them within a year. At the same time, 62% cite serious side effects as the cause of such a failure. In the case, there is growing evidence that, at best, the benefits of statins have been greatly exaggerated, and the side effects are underestimated.
Recently, two unrelated research groups in Japan and France questioned the credibility of many earlier statin studies sponsored by pharmacists.
Japanese studies have gone so far as to suggest that statins may cause an increase in the burden of heart failure among the population. A well-known French cardiologist Michel de Lorgorel claims that all studies published after 2006 say "the absence of the use of statins for the prevention of cardiovascular diseases in all groups of patients." I fully support his call for a full reassessment of all statin research, and I agree that before completing such a reassessment, “physicians should be aware that statements about the efficacy and safety of statins are not based on evidence.”
In addition, we must require that the clinical trials unit at Oxford University provide the initial data of statins for independent verification. It was their pharmacy-sponsored research that led to the appointment of statins to millions of people around the world and increasing the profits of the multi-billion dollar industry.
But back to the bigger picture.
It has been more than 10 years since John Ioannidis, a professor of medicine and health research, and also a professor of statistics at Stanford University, published the landmark document "Why most of the published research results are false . " We are talking about the manipulation of statistical data. He went so far as to say: "The more financial interests are in a particular area, the less likely it is that the results of research in this area will be true."
Professor John Ioannidis
Here are just some facts confirming his rightness:
• Recently, several leading doctors, including Sir Richard Thompson, addressed the Secretary of the National Health Service, expressing their concerns about the impartiality of the NICE group that developed recommendations for the use of statins, since eight out of 12 of its members had financial ties with statin producing companies;
• In April 2014, independent scientists from the Cochrane Collaboration (whose opinion is considered the “gold standard” of medical research) concluded that
not counting other countries, only the UK lost about 500 million pounds on the purchase of the useless drug Tamiflu (see about this on geektimes) ;
• An investigation conducted by the British Medical Journal showed that the blood clotting control device used in the studies, which was published in the New England Medical Journal, was malfunctioning and gave false testimony during the research comparing Rivaroxaban with "Warfarin". This "casts doubt on the results that are used for marketing" the world's bestseller among oral anti-coagulants. Of course, NICE might not have known about the faulty device, but it was possible to question their decision to recommend the use of statins only because they accepted it on the basis of just one study, which was funded by a pharmaceutical company.
The fact that the number of prescriptions written annually in Britain exceeds 1 billion (twice as many as 10 years before) should be considered as a public health system crisis. Now, when the patient comes to me with any new symptom, my first thought becomes: “Could this be a side effect of the medicine?”.
Last week, speaking of recent scandals, Richard Smith, the former editor of the British Medical Journal, wrote: "Something has rotted in the state of British medicine and for a long time." The health care system is broken and cannot be fixed by simply pouring in even more money. Corporate greed and systematic failure put the public health system on its knees. Medical science has made a sharp turn towards darkness.
For the sake of our health and the viability of public health, the time has come for urgent collective action against the principle “the more medicine, the better.” This can begin with a full-scale independent investigation of the efficacy and safety of medicines by the public counting committee of parliament. Without complete transparency and accountability, no doctor can provide what we, the doctors, went to medical school for and what our hearts and souls are dedicated to - providing better services to our patients. ”
Source: https://habr.com/ru/post/390899/
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