mp - Terence Young's testimony
Terence Young's testimony Terence Young, Member of Parliament for Oakville and founder of Drug Safety Canada
I thank you for inviting me here today. This subject is close to my heart. I have worked on these issues for 12 years, long before I got here. I think you will be interested in a number of things I have to say.
Terence Young speaks at 55 min I will be reading the first two pages, and then I will jump to the numbered items just to read the titles. I will stick to about seven minutes, which is your agenda.
The post-market monitoring of prescription drugs in Canada essentially relies on the major pharmaceutical companies marketing the drugs, known as big pharma, to monitor their own safety. These companies are treated by society at large with the utmost deference and respect because of their carefully crafted corporate images as great corporate citizens, creating jobs and investing their massive revenues in a struggle to save lives. These claims and their actions go largely unchallenged.
The reality is much different. The big pharma companies are, in fact, the most sophisticated marketing machines in history, selling billions of dollars in products that often do not work to tens of millions of people who do not need them, leading to millions of hospitalizations in North America every year and the fourth leading cause of death in North America.
The companies that call themselves research-based companies in truth spend more on administration and marketing than they do on R&D. This includes billions of dollars every year in gifts to our doctors, the gatekeepers of medicine, to influence their prescription-buying decisions, a practice that is illegal in virtually every other business in the civilized world.
Ironically, with regard to the post-market monitoring of prescription drugs, what is thought to be the most important way we protect patients who take prescription drugs and make sure they are taking them only when they are safe has been completely perverted by big pharma and instead does the exact opposite, making sure doctors and patients have no way to know when a drug is safe and when it is not. This is because post-market monitoring has been left primarily in the hands of the big pharma companies themselves, whose primary goal is to market blockbuster drugs — lifestyle drugs and those that treat chronic conditions that sell over a billion dollars a year — and keep them on the market even as a growing number of injuries and deaths are reported related to their use. This is how Merck's Vioxx was allowed to kill 55,000 to 65,000 patients due to heart attacks.
How did we get so far off track? In the late 1990s, under former Minister of Health Alan Rock, Health Canada was directed to close their testing labs, relying on drug companies to test their own drugs and partner with the pharmaceutical industry. How have patients fared since that time? Since 1997, 27 drugs that the big pharma companies told us were safe for our families have been yanked off the market in Canada for killing and injuring patients. Hundreds more have had to have their labels changed repeatedly, ostensibly to reduce the serious adverse drug reactions that injured and killed patients, while their sales continued to grow.
What is the scope of the problem? All drugs cause adverse reactions — not some, all. It is only a matter of how serious and frequent the adverse reactions are. All drugs are poisons. The only difference between a drug and a poison is dosage. Many drugs have what is called a narrow therapeutic index, which means the difference between the dosage that can help the patient and the dosage that can hurt the patient is small.
Prescription drugs are the fourth leading cause of death in North America today, 70 per cent of which are preventable. Since Vanessa Young died on March 19, 2000, the situation has not improved; it has become worse.
Since all drugs cause adverse reactions, every decision to prescribe a drug should be based on the answer to one question: Will the benefits of this drug outweigh the potential risks for me?
The big pharma companies do everything they can to make sure doctors and patients have no way to answer that question properly, or even recognize its importance. They do this by making sure doctors hear only positive things about their drugs and by covering up the true number and severity of adverse drug reactions, which are both corrupt practices.
How does post-approval monitoring in Canada fail patients and help big pharma companies cover up adverse reactions? I will just do the top lines.
Safety warnings are designed to fail. Drug labels are rarely read by doctors, and everyone involved knows this. They are written to ensure doctors have no way of knowing if a drug is safe enough. They are written by lawyers, for lawyers. If they end up in court, they can go to page 19 and say, “You see, Your Honour? Here it is, right here. There is the safety warning.” The labels are up to 60 pages long. The print is only eight points. They are full of language that even doctors sometimes cannot understand. It is called label clutter.
Health Canada-approved “Dear Doctor” letters are also rarely read by doctors. In fact, many doctors get up to 100 pages a day faxed to them. At the end, after seeing many patients in their office, at 7:00 in the evening they do not go to their machine and read all these faxes. The problem is this: Doctors believe that if a drug is dangerous, Health Canada would order it off the market. The reality is Health Canada's position is that the doctors must judge for themselves.
Health Canada has no effective process for public notice when drugs are given new contraindications or pulled off the market.
Patient information leaflets, the ones you get in a drug store, create a false sense of security and, as a result, are dangerous for patients. They talk about the common side effects, like headache or diarrhea, but not the most important ones, the rare and dangerous ones.
Adverse drug reaction reporting has been a facade. Adverse drug reactions reported to Health Canada by doctors and health care professionals are about 1 per cent of the true number. That means that if you go to Health Canada's website and look at the number for any drug, you can usually multiply it by a hundred to get the true safety picture.
Health Canada officials do not analyze adverse drug reaction reports or do anything useful with them.
Recently, The Toronto Star did a series on ADHD drugs. This is a report from David Bruser, the author of the article:
While the reports accumulate, the Canadian regulator says on its website it does not have the expertise to analyze the information for trends and is relying on the U.S. Food and Drug Administration . . . .
Adverse drug reactions are reported by the big pharma companies only after months and months of analysis. That delays regulatory action and delays early warnings for drugs that are harming patients. Inevitably, the drug company reports blame the patient in some way. The patient must have taken too much. The patient must have mixed it with some other drug.
Incredibly, big pharma companies often only report the deaths and injuries that occur in the jurisdiction. They might report the deaths in Canada and the injuries, but they do not report the ones happening in a hundred other countries. This gives regulators a skewed safety picture.
Gag orders are placed on researchers and also patients who are offered out-of-court settlements for their injuries or loss of life. That covers up the harm drugs cause and keeps blockbusters on the market.
Corrupt practices by big pharma companies go unchallenged. They never ever admit their drug harmed or hurt a patient, even after they paid billions of dollars in damages. That is because they buy insurance against their drug crashing off the market, and if they ever admit their drug caused harm, their insurance is no good. They might have a settlement, like what Merck did with Vioxx and then could not collect their insurance.
We are in dire need of transparency. Independent researchers are unable to properly study the safety record of drugs because Health Canada will not release what their big pharma partners claim is proprietary competitive information from clinical trials. Information on adverse drug reactions that patients have in clinical trials is not commercial information. It is life-saving information that is often hidden from researchers and the public.
I thank you for inviting me here today. This subject is close to my heart. I have worked on these issues for 12 years, long before I got here. I think you will be interested in a number of things I have to say.
Terence Young speaks at 55 min I will be reading the first two pages, and then I will jump to the numbered items just to read the titles. I will stick to about seven minutes, which is your agenda.
The post-market monitoring of prescription drugs in Canada essentially relies on the major pharmaceutical companies marketing the drugs, known as big pharma, to monitor their own safety. These companies are treated by society at large with the utmost deference and respect because of their carefully crafted corporate images as great corporate citizens, creating jobs and investing their massive revenues in a struggle to save lives. These claims and their actions go largely unchallenged.
The reality is much different. The big pharma companies are, in fact, the most sophisticated marketing machines in history, selling billions of dollars in products that often do not work to tens of millions of people who do not need them, leading to millions of hospitalizations in North America every year and the fourth leading cause of death in North America.
The companies that call themselves research-based companies in truth spend more on administration and marketing than they do on R&D. This includes billions of dollars every year in gifts to our doctors, the gatekeepers of medicine, to influence their prescription-buying decisions, a practice that is illegal in virtually every other business in the civilized world.
Ironically, with regard to the post-market monitoring of prescription drugs, what is thought to be the most important way we protect patients who take prescription drugs and make sure they are taking them only when they are safe has been completely perverted by big pharma and instead does the exact opposite, making sure doctors and patients have no way to know when a drug is safe and when it is not. This is because post-market monitoring has been left primarily in the hands of the big pharma companies themselves, whose primary goal is to market blockbuster drugs — lifestyle drugs and those that treat chronic conditions that sell over a billion dollars a year — and keep them on the market even as a growing number of injuries and deaths are reported related to their use. This is how Merck's Vioxx was allowed to kill 55,000 to 65,000 patients due to heart attacks.
How did we get so far off track? In the late 1990s, under former Minister of Health Alan Rock, Health Canada was directed to close their testing labs, relying on drug companies to test their own drugs and partner with the pharmaceutical industry. How have patients fared since that time? Since 1997, 27 drugs that the big pharma companies told us were safe for our families have been yanked off the market in Canada for killing and injuring patients. Hundreds more have had to have their labels changed repeatedly, ostensibly to reduce the serious adverse drug reactions that injured and killed patients, while their sales continued to grow.
What is the scope of the problem? All drugs cause adverse reactions — not some, all. It is only a matter of how serious and frequent the adverse reactions are. All drugs are poisons. The only difference between a drug and a poison is dosage. Many drugs have what is called a narrow therapeutic index, which means the difference between the dosage that can help the patient and the dosage that can hurt the patient is small.
Prescription drugs are the fourth leading cause of death in North America today, 70 per cent of which are preventable. Since Vanessa Young died on March 19, 2000, the situation has not improved; it has become worse.
Since all drugs cause adverse reactions, every decision to prescribe a drug should be based on the answer to one question: Will the benefits of this drug outweigh the potential risks for me?
The big pharma companies do everything they can to make sure doctors and patients have no way to answer that question properly, or even recognize its importance. They do this by making sure doctors hear only positive things about their drugs and by covering up the true number and severity of adverse drug reactions, which are both corrupt practices.
How does post-approval monitoring in Canada fail patients and help big pharma companies cover up adverse reactions? I will just do the top lines.
Safety warnings are designed to fail. Drug labels are rarely read by doctors, and everyone involved knows this. They are written to ensure doctors have no way of knowing if a drug is safe enough. They are written by lawyers, for lawyers. If they end up in court, they can go to page 19 and say, “You see, Your Honour? Here it is, right here. There is the safety warning.” The labels are up to 60 pages long. The print is only eight points. They are full of language that even doctors sometimes cannot understand. It is called label clutter.
Health Canada-approved “Dear Doctor” letters are also rarely read by doctors. In fact, many doctors get up to 100 pages a day faxed to them. At the end, after seeing many patients in their office, at 7:00 in the evening they do not go to their machine and read all these faxes. The problem is this: Doctors believe that if a drug is dangerous, Health Canada would order it off the market. The reality is Health Canada's position is that the doctors must judge for themselves.
Health Canada has no effective process for public notice when drugs are given new contraindications or pulled off the market.
Patient information leaflets, the ones you get in a drug store, create a false sense of security and, as a result, are dangerous for patients. They talk about the common side effects, like headache or diarrhea, but not the most important ones, the rare and dangerous ones.
Adverse drug reaction reporting has been a facade. Adverse drug reactions reported to Health Canada by doctors and health care professionals are about 1 per cent of the true number. That means that if you go to Health Canada's website and look at the number for any drug, you can usually multiply it by a hundred to get the true safety picture.
Health Canada officials do not analyze adverse drug reaction reports or do anything useful with them.
Recently, The Toronto Star did a series on ADHD drugs. This is a report from David Bruser, the author of the article:
While the reports accumulate, the Canadian regulator says on its website it does not have the expertise to analyze the information for trends and is relying on the U.S. Food and Drug Administration . . . .
Adverse drug reactions are reported by the big pharma companies only after months and months of analysis. That delays regulatory action and delays early warnings for drugs that are harming patients. Inevitably, the drug company reports blame the patient in some way. The patient must have taken too much. The patient must have mixed it with some other drug.
Incredibly, big pharma companies often only report the deaths and injuries that occur in the jurisdiction. They might report the deaths in Canada and the injuries, but they do not report the ones happening in a hundred other countries. This gives regulators a skewed safety picture.
Gag orders are placed on researchers and also patients who are offered out-of-court settlements for their injuries or loss of life. That covers up the harm drugs cause and keeps blockbusters on the market.
Corrupt practices by big pharma companies go unchallenged. They never ever admit their drug harmed or hurt a patient, even after they paid billions of dollars in damages. That is because they buy insurance against their drug crashing off the market, and if they ever admit their drug caused harm, their insurance is no good. They might have a settlement, like what Merck did with Vioxx and then could not collect their insurance.
We are in dire need of transparency. Independent researchers are unable to properly study the safety record of drugs because Health Canada will not release what their big pharma partners claim is proprietary competitive information from clinical trials. Information on adverse drug reactions that patients have in clinical trials is not commercial information. It is life-saving information that is often hidden from researchers and the public.
Total corruption:drug companies bought their way onto fda advisory panels
(Natural News)
It is now an undeniable fact that the pharmaceutical industry weaseled its way onto key U.S. Food and Drug Administration (FDA) advisory panels, which were instrumental in shaping the way drugs are safety tested and approved. According to The Washington Post (WP), a recent public records request has revealed that drug companies purchased special access onto these panels, where they were given the keys to the kingdom in swaying decision-makers about official drug policy.
Based on critical information gathered from hundreds of leaked emails, pharmaceutical companies have doled out hundreds of thousands of dollars over the years to attend private meetings with the FDA, many of which were geared towards the regulation and approval of painkiller drugs. Drug companies would reportedly shell out upwards of $25,000 or more per meeting to have their voices heard, a small price to pay for direct access to the $9 billion American painkiller market.
According to the WP, officials from both the FDA and the U.S. National Institutes of Health (NIH) would regularly meet with pharmaceutical representatives in private to discuss regulatory protocols, co-write scientific papers and collaborate on various ways to help streamline the drug approval process. And the only parties who actually paid to attend such meetings were the drug companies, a fact that one official from the NIH expressed serious concerns about in an email, referring to the whole scheme as a "pay to play process."
Others who have since reviewed the emails agree, noting that, while the FDA did not necessarily benefit financially from these private meetings, many FDA officials went on to work as pharmaceutical consultants. In other words, FDA staff who agreed to grease the palms of the drug industry during these private meetings were later rewarded with high-paying positions in the drug industry. This is just one glaring example of how the line between the regulator (FDA) and the regulated (pharmaceutical companies) has been blurred beyond recognition.
"These e-mails help explain the disastrous decisions the FDA's analgesic division has made over the last 10 years," said Craig Mayton, the Columbus, Ohio, attorney who made the public records request to the University of Washington, to the WP. "Instead of protecting the public health, the FDA has been allowing the drug companies to pay for a seat at a small table where all the rules were written."
Big Pharma, FDA corruption runs deep It is no longer a conspiracy theory, then, that the drug industry owns the FDA. In this particular case, it was two academics by the names of Robert Dworkin, from the University of Rochester, and Dennis Turk, from the University of Washington, who allegedly orchestrated the painkiller plot. But there have been many other plots with the same ultimate end, a fact that NaturalNews and many others in the so-called "alternative" media have been shouting from the rooftops for years, but that the mainstream media has ignored, until now.
"Shame on the FDA and NIH for sending representatives to this panel, cooked up by two unethical professors and their drug company cronies," wrote one WP commenter about the scandal. It should be noted that FDA officials actively participated in the painkiller scheme, all the while knowing full well that the private meetings they attended were hatched by Big Pharma. "Congress should come down hard on both agencies for participating in what was clearly pay-to-play, with awful consequences for the health of many suffering Americans."
Such consequences include a flood of dangerous analgesic drugs to the market that were approved based on questionable or flawed safety studies. According to MedpageToday.com, the drug industry was successful during these meetings in convincing the FDA to adopt an "enriched enrollment" guidance for safety trials that eliminated patients who experienced adverse reactions. These and other modifications made it much easier for drugs to be declared safe and effective, and thus gain rapid approval.
Sources for this article include:
http://www.washingtonpost.com
http://www.medpagetoday.com
http://seattletimes.com
Learn more: http://www.naturalnews.com/042562_total_corruption_drug_companies_FDA_advisory_panels.html#ixzz2rgqBiEQ1
It is now an undeniable fact that the pharmaceutical industry weaseled its way onto key U.S. Food and Drug Administration (FDA) advisory panels, which were instrumental in shaping the way drugs are safety tested and approved. According to The Washington Post (WP), a recent public records request has revealed that drug companies purchased special access onto these panels, where they were given the keys to the kingdom in swaying decision-makers about official drug policy.
Based on critical information gathered from hundreds of leaked emails, pharmaceutical companies have doled out hundreds of thousands of dollars over the years to attend private meetings with the FDA, many of which were geared towards the regulation and approval of painkiller drugs. Drug companies would reportedly shell out upwards of $25,000 or more per meeting to have their voices heard, a small price to pay for direct access to the $9 billion American painkiller market.
According to the WP, officials from both the FDA and the U.S. National Institutes of Health (NIH) would regularly meet with pharmaceutical representatives in private to discuss regulatory protocols, co-write scientific papers and collaborate on various ways to help streamline the drug approval process. And the only parties who actually paid to attend such meetings were the drug companies, a fact that one official from the NIH expressed serious concerns about in an email, referring to the whole scheme as a "pay to play process."
Others who have since reviewed the emails agree, noting that, while the FDA did not necessarily benefit financially from these private meetings, many FDA officials went on to work as pharmaceutical consultants. In other words, FDA staff who agreed to grease the palms of the drug industry during these private meetings were later rewarded with high-paying positions in the drug industry. This is just one glaring example of how the line between the regulator (FDA) and the regulated (pharmaceutical companies) has been blurred beyond recognition.
"These e-mails help explain the disastrous decisions the FDA's analgesic division has made over the last 10 years," said Craig Mayton, the Columbus, Ohio, attorney who made the public records request to the University of Washington, to the WP. "Instead of protecting the public health, the FDA has been allowing the drug companies to pay for a seat at a small table where all the rules were written."
Big Pharma, FDA corruption runs deep It is no longer a conspiracy theory, then, that the drug industry owns the FDA. In this particular case, it was two academics by the names of Robert Dworkin, from the University of Rochester, and Dennis Turk, from the University of Washington, who allegedly orchestrated the painkiller plot. But there have been many other plots with the same ultimate end, a fact that NaturalNews and many others in the so-called "alternative" media have been shouting from the rooftops for years, but that the mainstream media has ignored, until now.
"Shame on the FDA and NIH for sending representatives to this panel, cooked up by two unethical professors and their drug company cronies," wrote one WP commenter about the scandal. It should be noted that FDA officials actively participated in the painkiller scheme, all the while knowing full well that the private meetings they attended were hatched by Big Pharma. "Congress should come down hard on both agencies for participating in what was clearly pay-to-play, with awful consequences for the health of many suffering Americans."
Such consequences include a flood of dangerous analgesic drugs to the market that were approved based on questionable or flawed safety studies. According to MedpageToday.com, the drug industry was successful during these meetings in convincing the FDA to adopt an "enriched enrollment" guidance for safety trials that eliminated patients who experienced adverse reactions. These and other modifications made it much easier for drugs to be declared safe and effective, and thus gain rapid approval.
Sources for this article include:
http://www.washingtonpost.com
http://www.medpagetoday.com
http://seattletimes.com
Learn more: http://www.naturalnews.com/042562_total_corruption_drug_companies_FDA_advisory_panels.html#ixzz2rgqBiEQ1
How corrupted drug companies deceive & manipulate your doctor
Dr. Beatrice Golomb, Associate Professor of Medicine at University of California, San Diego, masterfully exposes the corruption that has metastasized like a tumor throughout the pharmaceutical and medical industries, in the video above.
If you have any doubt about drug companies being riddled with conflicts of interest, those doubts will be shattered after seeing the evidence she presents.
The corruption has become so prolific that it has literally debased medical science.
In the above linked Chicago Breaking News article, Dr. Paul Offit, an infectious disease specialist at the Children’s Hospital of Philadelphia, is quoted as saying:
“Science is not a democracy where people's votes decide what is right. Look at the data, look at science and make a decision based on science that has been published."
What he is really advocating is for you to blindly believe in “facts” that may have been produced in the midst of MASSIVE conflicts of interest.
Before you assume the science in medical journals is credible, let’s take a look at what is going on behind the scenes of editing and publishing in medical science.
Bias #1: Unwanted Results are Not Published In order for scientific studies to happen, someone has to pay for them.
The top funder for any drug trial is the pharmaceutical company that makes it, since the manufacturer is most invested in “proving” how spectacular its drug is. Dr. Golomb uses the case of statins as an example, stating that all of the major statin studies have been funded exclusively by the drug industry.
The second-highest funder of drug studies is the National Institute of Health (NIH), which is not the group of neutral government experts you may have assumed them to be. In fact, NIH accepts a great deal of money from Big Pharma and is deeply enmeshed with the industry.
But drug companies publish only a fraction of the studies they fund -- the ones that promote their drugs.
If a study does not have findings that are favorable to its product, it is unlikely it will ever make it into a journal for publication.
In contrast, studies that have favorable findings almost always make the cut.
There are simply thousands of scientific studies out there that have never been seen by you or your physician because they have been screened out by editors and reviewers who are being paid to uphold an industry agenda.
Published studies overwhelmingly favor the funding company’s drug. Whichever drug is manufactured by the study sponsor is the drug that comes out on top, 90 percent of the time!
Given this, how can medical journals be considered unbiased?
Bias #2: Bad Results are Submitted as Good When a scientific study has findings that cast doubt on the efficacy of a drug, oftentimes the negative findings are morphed into positive ones.
For example, in 2008, FDA officials analyzed a registry of 74 antidepressant trials, which included trials that were published and those that were not. The FDA’s findings were then written up in an article in the New England Journal of Medicine1.
This is what they found:
For statins, the odds that the funding company’s drug will come out on top are staggering1:
Selectively omitting negative trial results can be devastating to your health, as Merck & Co. proved when they concealed the fact that three patients suffered heart attacks from Vioxx during clinical trials. They conveniently omitted this data (along with other relevant findings) from the copy of the study they submitted to the New England Journal of Medicine for publication.
The omissions were uncovered years later during the 7,000 Vioxx lawsuit litigations.
Bias #3: A Favorable Study is Submitted Multiple Times When a study yields positive results, it is often submitted multiple times in a way that the reader doesn’t realize it’s the same study, obscured by different author lists and different details. Analyzers have had to look very carefully to determine which studies are actually duplicates because they are so cleverly disguised.
Not surprisingly, trials reporting greater treatment efficacy were significantly more likely to be duplicated, according to Dr. Golomb’s reporting.
In one analysis of the published reports about ondansetron (an anti-nausea drug), the same study was published 5 times. This duplication of data led to a 23 percent overestimation of ondansetron’s effectiveness when a meta-analysis was performed.2
Talk about good mileage!
Bias #4: Follow-Up Reviews Done by Biased Experts The editorials that follow from a study, submitted by so-called unbiased experts and then published in reputable journals, are often done by non-neutral parties who have a financial tie to the drug maker.
Dr. Golomb uses the case of calcium channel blockers (a type of heart medication) as an example. The connection between authors declaring their support for calcium channel blockers and those not in support of them was highly statistically tied to their affiliation with the drug manufacturer -- in fact, the odds that their opinion was NOT due to their affiliation was more than 1,000:1.
Bias #5: Ghostwriting Many of the articles that appear in medical journals purportedly written by well-known academics are actually written by unacknowledged ghostwriters on Big Pharma payroll.
Consider the example of Parke-Davis and their drug Neurontin.
Parke-Davis contracted with a “medical education communication company,” or MECC, which is a company paid almost exclusively by pharmaceutical companies to write articles, reviews, and letters to editors of medical journals to cast their products in a favorable light.
In this case, MECC was paid $13,000 to $18,000 per article. In turn, MECC paid $1,000 each to friendly physicians and pharmacists to sign off as authors of the articles, making the material appear independent.
This was also done by Pfizer as a strategy for marketing Zoloft. A document was written that included 81 different articles promoting Zoloft’s usefulness for everything from panic disorder to pedophilia.
The only problem was, for some articles, the name of the author was listed as "to be determined," even though the article was listed as already completed. They weren't helping out an existing team of scientists who happened to be talentless at writing -- Pfizer wrote the article, and then shopped around for scientists willing to claim authorship, to give it a veneer of credibility.
Wyeth-Ayerst employed a similar ghostwriting tactic to promote its “fen-phen” diet drug, Redux.
Bias #6: Journal Bias Medical journals are generally considered by medical practitioners to be a source of reliable information. But medical journals are also businesses.
Three editors, who agreed to discuss finances only if they remained anonymous, said a few journals that previously measured annual profits in the tens of thousands of dollars now make millions annually.
The truth is that Big Pharma has become quite adept at manipulating and brainwashing practitioners of conventional medicine. They influence the very heart and center of the most respected medical journals, creating dogma and beliefs that support the drug paradigm because it is blessed by the pinnacle of scientific integrity: the prestigious peer-reviewed medical journal.
Peer-reviewed medical journals contain advertisements that are almost exclusively for drugs, amidst articles that are biased toward promoting those drugs. If you have looked through a medical journal lately, you’ll see full-page Pharma glossies, cover to cover.
Pharmaceutical companies spend almost twice as much on marketing as they spend on research!
In 2003, drug companies spent $448 million dollars on advertising in medical journals2. It has been calculated that the return on investment on medical journal ads is between $2.22 and $6.86 for every dollar spent, with larger and older brands at the higher end.
Long-term returns may be even higher when you consider that one ad viewed by a physician could result in hundreds or even thousands of drug purchases, based on the prescriptions he or she writes.
The term “peer-review” has come to imply scientific credibility. But the fact is that many of the peer-reviewers are on the drug company’s payroll, and those who are not are unlikely to detect flawed research or outright fraud.
Medical journals are the number one source of medical information for physicians. In fact, nearly 80 percent of physicians use medical journals for their education, which exceeds information from any other source3.
Do you really want to blindly take the advise of a physician whose only source of medical information is a medical journal engaged in such profound conflicts of interest?
Advertisements for drugs focus the “latest and greatest” drugs to hit the market, drugs which may not be superior to existing, less expensive alternatives. So physicians are seduced into prescribing the newest, most expensive drugs, which drives up your healthcare costs.
An excellent article in PLoS Medicine regarding drug advertising in medical journals concludes4:
“The scholarly nature of journals confers credibility on both articles and advertisements within their pages. By exclusively featuring advertisements for drugs and devices, medical journals implicitly endorse corporate promotion of the most profitable products. Advertisements and other financial arrangements with pharmaceutical companies compromise the objectivity of journals.
The primary obligation of industry is to make money for its stockholders. The primary obligation of journals should be to physicians and their patients, who depend on the accuracy of information within these publications. Medical journals should not accept advertisements from pharmaceutical companies, medical device companies, or other industries ‘relevant to medicine.’"
In 2004, Dr. Richard Horton, editor of the Lancet, wrote, “Journals have devolved into information-laundering operations for the pharmaceutical industry.”5
Bias #7: Drug Companies Masquerading as Educators The education of medical students and residents also comes through the filter of the drug industry, which seeks to groom them before they even finish medical school.
According to Dr. Golomb’s data, Big Pharma now spends $18.5 billion per year promoting their drugs to physicians. That amounts to $30,000 per year for every physician in the U. S.!
And drug companies are allowed to develop their own education curriculum for medical students and residents, lavishing them with gifts, indirectly paying them to attend meetings and events where they promote the company’s products.
Why is the Accrediting Commission for Continuing Medical Education (ACCME) so permissive with industry involvement?
Almost half of the members are representatives of Big Pharma or are consultants for businesses that work directly with it to prepare these educational programs. Only a few represent academic CME institutions.
Any discussion of physician “seduction” would be incomplete without the mentioning of the 100,000 drug reps, who are groomed and trained to wine and dine and otherwise shower physicians in sweetness until they are handing out prescriptions like candy.
Reps are even taught tactics for manipulating doctors for industry benefit, as a standard part of their training.6
Hell Hath No Fury What happens if a physician or other person speaks up about these conflicts of interest? What happens to the proverbial whistle-blower?
Intimidating phone calls and direct threats, for starters.
In one case, Dr. Buse, an endocrinologist who is the incoming president of the American Diabetes Association, presented data in 1999 about his concerns about the risks of Avandia. Dr. Buse was intimidated with multiple phone calls by drug company officials. They suggested he could be financially liable to the company for $4 billion in lost revenues due to his “unscrupulous remarks.”
Other truth-tellers have had their reputations trashed or job offers rescinded for speaking the truths that Big Pharma works so hard to keep under wraps.
“Too Big to Nail” An individual truth-teller might be vulnerable to the wrath of an angry drug company, but drug companies are unlikely to suffer much of a consequence for their crimes.
A CNN report from April 2, 2010 reveals the truth about how shielded these huge drug companies really are.
Pfizer, the world’s largest pharmaceutical company, engaged in illegally promoting their drug Bextra for off-label use, despite their knowledge that it was associated with an increased risk of stroke and heart attack.
Bextra was pulled from the market in 2005, but not before many people were damaged by its use. When Federal prosecutors realized that convicting Pfizer would likely be a corporate death sentence (as any company convicted of major health care fraud is excluded from Medicare and Medicaid), they cut Pfizer a deal. Just as the big banks on Wall Street were deemed “too big to fail,” Pfizer was deemed “too big to nail.”
Why?
Prosecutors claimed to be concerned about the loss of jobs by Pfizer employees and financial losses to Pfizer shareholders as a result of being excluded from the Medicaid/Medicare programs.
So the prosecutors charged a Pfizer subsidiary, Pharmacia & Upjohn Co., instead. In fact, this particular subsidiary company was created specifically for this purpose, as a sacrificial lamb, having been incorporated the very same day its lawyers filed a “guilty” plea in another case involving kick-backs, leaving Pfizer with the penalty equivalent of being sent to bed without supper.
In the end, all Pfizer lost was about three month’s profit, but all contracts, including those with Medicaid and Medicare, were spared.
This is just one more example of your federal government failing to protect you, and opting to protect big business’ interests instead.
The bottom line is, the drug companies aren’t going to protect you.
The government won’t protect you.
The AMA won’t protect you.7
And it is unlikely that your physician can protect you either -- even a well-meaning one -- when he or she is operating within a system that has become RIGGED for Big Pharma profit.
Only you can protect yourself.
So, until real systemic change takes place, your best health strategy is quite simply to employ and maintain a naturally healthy lifestyle that will optimize your body’s innate healing abilities and minimize your need for the drug companies’ latest concoctions.
If you have any doubt about drug companies being riddled with conflicts of interest, those doubts will be shattered after seeing the evidence she presents.
The corruption has become so prolific that it has literally debased medical science.
In the above linked Chicago Breaking News article, Dr. Paul Offit, an infectious disease specialist at the Children’s Hospital of Philadelphia, is quoted as saying:
“Science is not a democracy where people's votes decide what is right. Look at the data, look at science and make a decision based on science that has been published."
What he is really advocating is for you to blindly believe in “facts” that may have been produced in the midst of MASSIVE conflicts of interest.
Before you assume the science in medical journals is credible, let’s take a look at what is going on behind the scenes of editing and publishing in medical science.
Bias #1: Unwanted Results are Not Published In order for scientific studies to happen, someone has to pay for them.
The top funder for any drug trial is the pharmaceutical company that makes it, since the manufacturer is most invested in “proving” how spectacular its drug is. Dr. Golomb uses the case of statins as an example, stating that all of the major statin studies have been funded exclusively by the drug industry.
The second-highest funder of drug studies is the National Institute of Health (NIH), which is not the group of neutral government experts you may have assumed them to be. In fact, NIH accepts a great deal of money from Big Pharma and is deeply enmeshed with the industry.
But drug companies publish only a fraction of the studies they fund -- the ones that promote their drugs.
If a study does not have findings that are favorable to its product, it is unlikely it will ever make it into a journal for publication.
In contrast, studies that have favorable findings almost always make the cut.
There are simply thousands of scientific studies out there that have never been seen by you or your physician because they have been screened out by editors and reviewers who are being paid to uphold an industry agenda.
Published studies overwhelmingly favor the funding company’s drug. Whichever drug is manufactured by the study sponsor is the drug that comes out on top, 90 percent of the time!
Given this, how can medical journals be considered unbiased?
Bias #2: Bad Results are Submitted as Good When a scientific study has findings that cast doubt on the efficacy of a drug, oftentimes the negative findings are morphed into positive ones.
For example, in 2008, FDA officials analyzed a registry of 74 antidepressant trials, which included trials that were published and those that were not. The FDA’s findings were then written up in an article in the New England Journal of Medicine1.
This is what they found:
- 38 of the trials reported positive results, and 37 of the 38 were published.
- 36 trials had negative or questionable findings. Of the 36, 22 were not published at all, and 11 were published in a way that conveyed the results as though they were positive.
For statins, the odds that the funding company’s drug will come out on top are staggering1:
- The odds that the funding company’s statin drug will come out looking better than anyone else’s statin in the “results” section of the article are 20:1.
- The odds that the funding company’s statin will come out on top in the “conclusions” part of the article are 35:1.
Selectively omitting negative trial results can be devastating to your health, as Merck & Co. proved when they concealed the fact that three patients suffered heart attacks from Vioxx during clinical trials. They conveniently omitted this data (along with other relevant findings) from the copy of the study they submitted to the New England Journal of Medicine for publication.
The omissions were uncovered years later during the 7,000 Vioxx lawsuit litigations.
Bias #3: A Favorable Study is Submitted Multiple Times When a study yields positive results, it is often submitted multiple times in a way that the reader doesn’t realize it’s the same study, obscured by different author lists and different details. Analyzers have had to look very carefully to determine which studies are actually duplicates because they are so cleverly disguised.
Not surprisingly, trials reporting greater treatment efficacy were significantly more likely to be duplicated, according to Dr. Golomb’s reporting.
In one analysis of the published reports about ondansetron (an anti-nausea drug), the same study was published 5 times. This duplication of data led to a 23 percent overestimation of ondansetron’s effectiveness when a meta-analysis was performed.2
Talk about good mileage!
Bias #4: Follow-Up Reviews Done by Biased Experts The editorials that follow from a study, submitted by so-called unbiased experts and then published in reputable journals, are often done by non-neutral parties who have a financial tie to the drug maker.
Dr. Golomb uses the case of calcium channel blockers (a type of heart medication) as an example. The connection between authors declaring their support for calcium channel blockers and those not in support of them was highly statistically tied to their affiliation with the drug manufacturer -- in fact, the odds that their opinion was NOT due to their affiliation was more than 1,000:1.
Bias #5: Ghostwriting Many of the articles that appear in medical journals purportedly written by well-known academics are actually written by unacknowledged ghostwriters on Big Pharma payroll.
Consider the example of Parke-Davis and their drug Neurontin.
Parke-Davis contracted with a “medical education communication company,” or MECC, which is a company paid almost exclusively by pharmaceutical companies to write articles, reviews, and letters to editors of medical journals to cast their products in a favorable light.
In this case, MECC was paid $13,000 to $18,000 per article. In turn, MECC paid $1,000 each to friendly physicians and pharmacists to sign off as authors of the articles, making the material appear independent.
This was also done by Pfizer as a strategy for marketing Zoloft. A document was written that included 81 different articles promoting Zoloft’s usefulness for everything from panic disorder to pedophilia.
The only problem was, for some articles, the name of the author was listed as "to be determined," even though the article was listed as already completed. They weren't helping out an existing team of scientists who happened to be talentless at writing -- Pfizer wrote the article, and then shopped around for scientists willing to claim authorship, to give it a veneer of credibility.
Wyeth-Ayerst employed a similar ghostwriting tactic to promote its “fen-phen” diet drug, Redux.
Bias #6: Journal Bias Medical journals are generally considered by medical practitioners to be a source of reliable information. But medical journals are also businesses.
Three editors, who agreed to discuss finances only if they remained anonymous, said a few journals that previously measured annual profits in the tens of thousands of dollars now make millions annually.
The truth is that Big Pharma has become quite adept at manipulating and brainwashing practitioners of conventional medicine. They influence the very heart and center of the most respected medical journals, creating dogma and beliefs that support the drug paradigm because it is blessed by the pinnacle of scientific integrity: the prestigious peer-reviewed medical journal.
Peer-reviewed medical journals contain advertisements that are almost exclusively for drugs, amidst articles that are biased toward promoting those drugs. If you have looked through a medical journal lately, you’ll see full-page Pharma glossies, cover to cover.
Pharmaceutical companies spend almost twice as much on marketing as they spend on research!
In 2003, drug companies spent $448 million dollars on advertising in medical journals2. It has been calculated that the return on investment on medical journal ads is between $2.22 and $6.86 for every dollar spent, with larger and older brands at the higher end.
Long-term returns may be even higher when you consider that one ad viewed by a physician could result in hundreds or even thousands of drug purchases, based on the prescriptions he or she writes.
The term “peer-review” has come to imply scientific credibility. But the fact is that many of the peer-reviewers are on the drug company’s payroll, and those who are not are unlikely to detect flawed research or outright fraud.
Medical journals are the number one source of medical information for physicians. In fact, nearly 80 percent of physicians use medical journals for their education, which exceeds information from any other source3.
Do you really want to blindly take the advise of a physician whose only source of medical information is a medical journal engaged in such profound conflicts of interest?
Advertisements for drugs focus the “latest and greatest” drugs to hit the market, drugs which may not be superior to existing, less expensive alternatives. So physicians are seduced into prescribing the newest, most expensive drugs, which drives up your healthcare costs.
An excellent article in PLoS Medicine regarding drug advertising in medical journals concludes4:
“The scholarly nature of journals confers credibility on both articles and advertisements within their pages. By exclusively featuring advertisements for drugs and devices, medical journals implicitly endorse corporate promotion of the most profitable products. Advertisements and other financial arrangements with pharmaceutical companies compromise the objectivity of journals.
The primary obligation of industry is to make money for its stockholders. The primary obligation of journals should be to physicians and their patients, who depend on the accuracy of information within these publications. Medical journals should not accept advertisements from pharmaceutical companies, medical device companies, or other industries ‘relevant to medicine.’"
In 2004, Dr. Richard Horton, editor of the Lancet, wrote, “Journals have devolved into information-laundering operations for the pharmaceutical industry.”5
Bias #7: Drug Companies Masquerading as Educators The education of medical students and residents also comes through the filter of the drug industry, which seeks to groom them before they even finish medical school.
According to Dr. Golomb’s data, Big Pharma now spends $18.5 billion per year promoting their drugs to physicians. That amounts to $30,000 per year for every physician in the U. S.!
And drug companies are allowed to develop their own education curriculum for medical students and residents, lavishing them with gifts, indirectly paying them to attend meetings and events where they promote the company’s products.
Why is the Accrediting Commission for Continuing Medical Education (ACCME) so permissive with industry involvement?
Almost half of the members are representatives of Big Pharma or are consultants for businesses that work directly with it to prepare these educational programs. Only a few represent academic CME institutions.
Any discussion of physician “seduction” would be incomplete without the mentioning of the 100,000 drug reps, who are groomed and trained to wine and dine and otherwise shower physicians in sweetness until they are handing out prescriptions like candy.
Reps are even taught tactics for manipulating doctors for industry benefit, as a standard part of their training.6
Hell Hath No Fury What happens if a physician or other person speaks up about these conflicts of interest? What happens to the proverbial whistle-blower?
Intimidating phone calls and direct threats, for starters.
In one case, Dr. Buse, an endocrinologist who is the incoming president of the American Diabetes Association, presented data in 1999 about his concerns about the risks of Avandia. Dr. Buse was intimidated with multiple phone calls by drug company officials. They suggested he could be financially liable to the company for $4 billion in lost revenues due to his “unscrupulous remarks.”
Other truth-tellers have had their reputations trashed or job offers rescinded for speaking the truths that Big Pharma works so hard to keep under wraps.
“Too Big to Nail” An individual truth-teller might be vulnerable to the wrath of an angry drug company, but drug companies are unlikely to suffer much of a consequence for their crimes.
A CNN report from April 2, 2010 reveals the truth about how shielded these huge drug companies really are.
Pfizer, the world’s largest pharmaceutical company, engaged in illegally promoting their drug Bextra for off-label use, despite their knowledge that it was associated with an increased risk of stroke and heart attack.
Bextra was pulled from the market in 2005, but not before many people were damaged by its use. When Federal prosecutors realized that convicting Pfizer would likely be a corporate death sentence (as any company convicted of major health care fraud is excluded from Medicare and Medicaid), they cut Pfizer a deal. Just as the big banks on Wall Street were deemed “too big to fail,” Pfizer was deemed “too big to nail.”
Why?
Prosecutors claimed to be concerned about the loss of jobs by Pfizer employees and financial losses to Pfizer shareholders as a result of being excluded from the Medicaid/Medicare programs.
So the prosecutors charged a Pfizer subsidiary, Pharmacia & Upjohn Co., instead. In fact, this particular subsidiary company was created specifically for this purpose, as a sacrificial lamb, having been incorporated the very same day its lawyers filed a “guilty” plea in another case involving kick-backs, leaving Pfizer with the penalty equivalent of being sent to bed without supper.
In the end, all Pfizer lost was about three month’s profit, but all contracts, including those with Medicaid and Medicare, were spared.
This is just one more example of your federal government failing to protect you, and opting to protect big business’ interests instead.
The bottom line is, the drug companies aren’t going to protect you.
The government won’t protect you.
The AMA won’t protect you.7
And it is unlikely that your physician can protect you either -- even a well-meaning one -- when he or she is operating within a system that has become RIGGED for Big Pharma profit.
Only you can protect yourself.
So, until real systemic change takes place, your best health strategy is quite simply to employ and maintain a naturally healthy lifestyle that will optimize your body’s innate healing abilities and minimize your need for the drug companies’ latest concoctions.
Institutional Corruption and the Pharmaceutical Industry: a special issue of the Journal of Law,
Medicine and Ethics
October 25, 2013
The systematic corruption of medical knowledge, ranging from clinical trials and new diagnostic categories through practice guidelines to physician prescribing practices, is highlighted in a special fall issue of the Journal of Law, Medicine & Ethics (JLME, 41:3). In the seventeen articles of this JLME symposium issue, "Institutional Corruption and the Pharmaceutical lndustry," lab fellows from the Edmond J. Safra Center for Ethics at Harvard University present findings from their in-depth, multi-disciplinary investigations of corruption in pharmaceutical policy, and propose methods to mitigate these critical problems. Their research shows that widespread practices in the medical and pharmaceutical industries can lead to doctors who are psychologically, financially, or intellectually dependent on drug companies, a phenomenon which has resulted in insufficiently tested drugs, many of which cause harmful side effects.
Their research also reveals how top medical researchers can be financially tied to drug firms. For example, researchers have been found to conduct clinical trials on medications while simultaneously calling for their consumption and guaranteeing that insurance companies will pay for them. Doctors who take such misleading information at face value prescribe drugs that are often unnecessary, harmful to patients, or more costly than equivalent medications. Fellows uncovered how pharmaceutical marketing also distorts medical practice, and how drug firms are even funding social network websites for doctors in order to quietly track their opinions on issues that affect their bottom lines.
Drawing on insights from law, medicine, behavioral psychology, economics and finance, business, sociology, political science, and philosophy, the Fellows' research also shows how lawmakers and patient advocacy organizations can bedependent on money from drug companies, resulting in representation that serves the interests of big pharma rather than the public. The pharmaceutical industry's own mission and purposes are often undermined, the investigation concluded.
ln his introduction to the JLME issue, Harvard Law School Professor Lawrence Lessig, director of the Edmond J. Safra Center for Ethics, wrote: "Every author in this collection writes from the perspective of institutional corruption. Not every author accepts the definition that l have offered here, or at least, not completely. But a field does not begin with a definition. lt begins with examples and with analysis of those examples. And the collection offered here is a rich and valuable intervention into a field that is increasingly the focus of regulators and the public. My hope is that this collection might inspire a similar examination elsewhere."
For more on this journal issue, including links to advance copies of the articles, go to http://www.ethics.harvard.edu/lab/featured/325-jlme-symposium
To download an article that summarizes the research, go to: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2298140
ln 2010, Lessig launched the Edmond J. Safra Research Lab, a major initiative designed to address fundamental problems of ethics in a way that is of practical benefit to institutions of government and society around the world. As its first undertaking, the Lab is tackling the problem of institutional corruption. Over a five-year period, the Edmond J. Safra Research Lab is studying a wide range of important institutions, with the ultimate goal of producing a set of practical tools that might be used both to understand the dynamic of institutional corruption and to respond to it. A structure of fellowships supports the project, and draws scholars and researchers from academia, industry, and government. Collaborative research that integrates the work of different fields is a strong component of the Edmond J. Safra Research Lab's efforts.
The systematic corruption of medical knowledge, ranging from clinical trials and new diagnostic categories through practice guidelines to physician prescribing practices, is highlighted in a special fall issue of the Journal of Law, Medicine & Ethics (JLME, 41:3). In the seventeen articles of this JLME symposium issue, "Institutional Corruption and the Pharmaceutical lndustry," lab fellows from the Edmond J. Safra Center for Ethics at Harvard University present findings from their in-depth, multi-disciplinary investigations of corruption in pharmaceutical policy, and propose methods to mitigate these critical problems. Their research shows that widespread practices in the medical and pharmaceutical industries can lead to doctors who are psychologically, financially, or intellectually dependent on drug companies, a phenomenon which has resulted in insufficiently tested drugs, many of which cause harmful side effects.
Their research also reveals how top medical researchers can be financially tied to drug firms. For example, researchers have been found to conduct clinical trials on medications while simultaneously calling for their consumption and guaranteeing that insurance companies will pay for them. Doctors who take such misleading information at face value prescribe drugs that are often unnecessary, harmful to patients, or more costly than equivalent medications. Fellows uncovered how pharmaceutical marketing also distorts medical practice, and how drug firms are even funding social network websites for doctors in order to quietly track their opinions on issues that affect their bottom lines.
Drawing on insights from law, medicine, behavioral psychology, economics and finance, business, sociology, political science, and philosophy, the Fellows' research also shows how lawmakers and patient advocacy organizations can bedependent on money from drug companies, resulting in representation that serves the interests of big pharma rather than the public. The pharmaceutical industry's own mission and purposes are often undermined, the investigation concluded.
ln his introduction to the JLME issue, Harvard Law School Professor Lawrence Lessig, director of the Edmond J. Safra Center for Ethics, wrote: "Every author in this collection writes from the perspective of institutional corruption. Not every author accepts the definition that l have offered here, or at least, not completely. But a field does not begin with a definition. lt begins with examples and with analysis of those examples. And the collection offered here is a rich and valuable intervention into a field that is increasingly the focus of regulators and the public. My hope is that this collection might inspire a similar examination elsewhere."
For more on this journal issue, including links to advance copies of the articles, go to http://www.ethics.harvard.edu/lab/featured/325-jlme-symposium
To download an article that summarizes the research, go to: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2298140
ln 2010, Lessig launched the Edmond J. Safra Research Lab, a major initiative designed to address fundamental problems of ethics in a way that is of practical benefit to institutions of government and society around the world. As its first undertaking, the Lab is tackling the problem of institutional corruption. Over a five-year period, the Edmond J. Safra Research Lab is studying a wide range of important institutions, with the ultimate goal of producing a set of practical tools that might be used both to understand the dynamic of institutional corruption and to respond to it. A structure of fellowships supports the project, and draws scholars and researchers from academia, industry, and government. Collaborative research that integrates the work of different fields is a strong component of the Edmond J. Safra Research Lab's efforts.
