Background: The COVID-19 period highlights a huge problem that has been developing for decades, the control of science by industry. In the 1950s, the tobacco industry set the example, which the pharmaceutical industry followed. Since then, the latter has been regularly condemned for illegal marketing, misrepresentation of experimental results, dissimulation of information about the dangers of drugs, and considered as criminal. Therefore, this study was conducted to show that knowledge is powerfully manipulated by harmful corporations, whose goals are: 1/financial; 2/to suppress our ability to make choices to acquire global control of public health.
Methods: Pharmaceutical industry techniques for manipulating science and COVID-19 reporting were reviewed. Several sources of official documents were used: PubMed; National Institutes of Health resources; pharmaceutical companies; policy documents; national newspapers and news agencies; and books by prominent professionals (scientific and legal). A few studies have not been published in peer-reviewed journals; however, they have been conducted by reputable scientists in their respective fields.
Results: Since the beginning of COVID-19, we can list the following methods of information manipulation which have been used: falsified clinical trials and inaccessible data; fake or conflict-of-interest studies; concealment of vaccines’ short-term side effects and total lack of knowledge of the long-term effects of COVID-19 vaccination; doubtful composition of vaccines; inadequate testing methods; governments and international organizations under conflicts of interest; bribed physicians; the denigration of renowned scientists; the banning of all alternative effective treatments; unscientific and liberticidal social methods; government use of behavior modification and social engineering techniques to impose confinements, masks, and vaccine acceptance; scientific censorship by the media.
Conclusion: By supporting and selecting only the one side of science information while suppressing alternative viewpoints, and with obvious conflicts of interest revealed by this study, governments and the media constantly disinform the public. Consequently, the unscientifically validated vaccination laws, originating from industry-controlled medical science, led to the adoption of social measures for the supposed protection of the public but which became serious threats to the health and freedoms of the population.
Keywords: Behavior modification; COVID-19; Conflicts of interest; Scientific censorship; Side effects; Vaccination.
Pharmaceuticals: A market for producing ‘lemons’ and serious harm, analysis finds
Date:
August 17, 2010
Source:
American Sociological Association
The pharmaceutical industry is a “market for lemons,” a market in which the seller knows much more than the buyer about the product and can profit from selling products less effective and less safe than consumers are led to believe, according to an analysis that will be presented at the 105th Annual Meeting of the American Sociological Association.
“Sometimes drug companies hide or downplay information about serious side effects of new drugs and overstate the drugs’ benefits,” said Donald Light, the sociologist who authored the study and who is a professor of comparative health policy at the University of Medicine and Dentistry of New Jersey. “Then, they spend two to three times more on marketing than on research to persuade doctors to prescribe these new drugs. Doctors may get misleading information and then misinform patients about the risks of a new drug. It’s really a two-tier market for lemons.”
Three reasons why the pharmaceutical market produces “lemons” are: Having companies in charge of testing new drugs, providing firewalls of legal protection behind which information about harms or effectiveness can be hidden, and the relatively low bar set for drug efficacy in order for a new drug to be approved, Light said.
According to his study, independent reviewers found that about 85 percent of new drugs offer few if any new benefits. Yet, toxic side effects or misuse of prescription drugs now make prescription drugs a significant cause of death in the United States.
Light’s paper, “Pharmaceuticals: A Two-Tier Market for Producing ‘Lemons’ and Serious Harm,” is an institutional analysis of the pharmaceutical industry and how it works based on a range of independent sources and studies, including the Canadian Patented Medicine Prices Review Board, the Food and Drug Administration, and Prescrire International.
The foundation for the paper is the work Light did for a forthcoming book he edited, titled ‘The Risk of Prescription Drugs,” which is scheduled for publication this fall by Columbia University Press.
In both his paper and his book, Light describes the “Risk Proliferation Syndrome” that is maximizing the number of patients exposed to new drugs that have relatively low efficacy and effectiveness but have greater risk of adverse side effects. Building on clinical trials designed to minimize evidence of harm and published literature that emphasizes a drug’s advantages, companies launch massive campaigns to sell it, when a controlled, limited launch would allow evidence to be gathered about the drug’s effects. Companies recruit leading clinicians to try using the drug for conditions other than those for which it is approved and to promote such off-label or unapproved uses. Physicians inadvertently become “double agents” — promoters of the new drug, yet trusted stewards of patients’ well-being, said Light. When patients complain of adverse reactions, studies show their doctors are likely to discount or dismiss them, according to Light.
Despite the extensive requirements for testing the efficacy and safety of each new drug, companies “swamp the regulator” with large numbers of incomplete, partial, substandard clinical trials, Light said. For example, in one study of 111 final applications for approval, 42% lacked adequately randomized trials, 40% had flawed testing of dosages, 39% lacked evidence of clinical efficacy, and 49% raised concerns about serious adverse side effects, said Light.
“Just recently, major reports have come out about biased, poor trials for Avandia and Avastin,” Light said, who noted that orphan drugs are tested even less well.
“The result is that drugs get approved without anyone being able to know how effective they really are or how much serious harm they will cause,” Light said. The companies control the making of scientific knowledge and then control which findings will go to the FDA or be published.
“A few basic changes could improve the quality of trials and evidence about the real risks and benefits of new drugs,” Light said. “We could also increase the percentage of new drugs that are really better for patients.”
The paper, “Pharmaceuticals: A Two-Tier Market for Producing ‘Lemons’ and Serious Harm,” was presented on Aug. 17 in Atlanta at the American Sociological Association’s 105th Annual Meeting.
American Sociological Association. “Pharmaceuticals: A market for producing ‘lemons’ and serious harm, analysis finds.” ScienceDaily. ScienceDaily, 17 August 2010. <www.sciencedaily.com/releases/2010/08/100817111825.htm>.
Over the past year, the U.S. Senate and TheNew York Times have been investigating the failure of the nation’s auto safety regulators to protect citizens from cars with occasionally dangerous faulty devices.
But neither august institution has paid attention to the Food and Drug Administration’s (FDA) failure to protect the 170 million Americans who take prescription drugs from adverse reactions that are killing more than 2,400 people every week. Annually, prescription drugs cause over 81 million adverse reactions and result in 2.7 million hospitalizations.
This epidemic of harm from medications makes our prescription drugs the fourth leading cause of death in the United States. Including hospitalizations and deaths from prescribing errors, overdosing, and self-medication, drugs move up to third place.
Below I describe the biases that appear throughout the drug development process, from initial research to FDA review and approval. I conclude with recommendations that would reduce drug development costs and ensure that drugs are only approved if they are safe and significantly more effective than already existing medications.
A Me-Too Business Model
Every drug has risks, so any drug considered for FDA approval should demonstrate clinical advantages that justify those risks. Yet public, independent advisory teams of physicians and pharmacists in several countries found over 90 percent of new drugs approved by the FDA and the European Medicines Agency (EMA) offer few or no advantages over existing drugs to offset their risks of serious harm.
Figure 1 shows the scorecard for 979 newly approved drugs over a 10-year span, based on detailed assessment of clinical benefits and risks by Prescrire, one of the world’s most distinguished, independent review bodies of physicians and pharmacists. (The exhibit focuses on France, a country whose consumer-oriented drug market features an array of products similar to the U.S.)
Figure 1. Few Clinical Advances in a Decade and Hundreds of Other Drugs Approved for Promotion
Only two were breakthrough advances and fewer than 10 percent offered substantial clinical advantages over existing drugs. Yet approved drugs have a 20 percent risk of producing enough harm for regulators to add a serious warning or have them withdrawn.
Flooding the market with hundreds of minor variations on existing drugs and technically innovative but clinically inconsequential new drugs, appears to be the de facto hidden business model of drug companies. In spite of its primary charge to protect the public, the FDA criteria for approval encourage that business model. The main products of pharmaceutical research are scores of clinically minor drugs that win patent protection for high prices, with only a few clinically important advances like Sovaldi or Gleevec.
This business model works. Despite producing drugs with few clinical advantages and significant health risks, industry sales and profits have grown substantially, at public expense. Companies spend 2-3 times less on research than on marketing to convince physicians to prescribe these minor variations.
Industry figures show the public pays companies about six times R&D costs through high prices on drugs. According to a study by Consumer Reports, high costs to patients lead them to postpone visits to physicians, avoid medical tests, and be able unable to afford other, effective drugs. For society as a whole, a leading health economist found that 80 percent of all new expenditures for drugs was spent on the minor variations, not the major advances.
Institutional Corruption
These startling results reflect studies from the Edmond J. Safra Center for Ethics at Harvard University, where research fellows have investigated “institutional corruption” in the pharmaceutical industry. “Institutional corruption” refers to systemic, legal ways that social institutions such as medical science, the medical profession, and the FDA become compromised by corporate and special-interest funding and influence.
Peer-reviewed studies already demonstrate how pharmaceutical companies manipulate FDA rules to generate evidence that their new drugs are more effective and less harmful than unbiased studies would show. The industry then recruits teams of medical writers, editors, and statisticians to select and repackage trial results into peer-reviewed articles that become accepted as reliable medical knowledge.
Based on his investigations, Marc Rodwin concludes, “Scholarly studies have revealed that drug firms design trials that skew the results and that they distort the evidence by selective reporting or biased interpretation.” This distorted evidence goes into clinical guidelines that become, Lisa Cosgrove and Emily Wheeler note, “essentially marketing tools for drug companies.”
Often Neither Safe Nor Effective
The Center for Drug Evaluation and Research (CDER – pronounced “C-DER”) is the FDA division responsible for determining whether new drugs should be approved. Its funding, however, now largely comes not from taxpayers but from the companies submitting their drugs to CDER for review.
This clear conflict of interest and approving so many new drugs with few clinical benefits serve corporate interests more than public interests, especially given the large risks of serious harm. Direct and indirect costs to society far exceed the cost of funding the FDA as a public, independent review body.
New FDA policies to get more drugs reviewed faster so that they can reach patients sooner result ironically in even more drugs being approved with less evidence that they are either safer or more effective. Faster reviews mean the chance that a drug will generate an FDA warning of serious harm jumps from one in five to one in three.
A systematic study of shortened reviews found that each 10-month reduction in review time produced an 18 percent increase of serious adverse reactions, an 11 percent increase of drug-related hospitalizations, and a 7.2 percent increase of drug-related deaths. Only 72 out of 1,300 CDER staff are charged with investigating drug safety, hard evidence that drug safety is a low priority at the FDA.
A recent review of FDA policies in Health Affairs describes how the FDA creates initiatives that ostensibly demonstrate its concern for safety from faster approvals. But the authors then describe how these initiatives frequently fail or backfire. They report no evidence of reduced harm or improved benefit to patients receiving these expedited drugs.
People imagine the FDA has stringent standards that take months or sometimes years for companies to meet. To a degree, that’s true. But the external independent evidence cited here of few new benefits and substantial risks of harm, calls into question what all this costly, lengthy review process is about.
An anthropologist might conclude it’s an elaborate ritual to make the FDA look like a tough watchdog against unsafe and ineffective drugs while it’s an industry-funded lapdog. Consider the easy ride that the FDA gives cancer drugs, requiring little evidence of improved patient outcomes.
For example, approving that new drugs are better than placebo is a low standard when other effective drugs already exist. Placebo trials are also unethical in these situations because they deny subjects in the control arm the use of an effective drug.
Another FDA standard, to prove that approved drugs are “non-inferior,” or not too much worse than an existing drug, does not allow patients to know if the new drug is better than the one they are taking. Using substitute measures for real benefits to patients makes approved drugs look more effective than they are. Allowing randomized trials to be drawn from biased populations that exclude many people who are likely to take the drug and experience an adverse reaction makes new drugs appear safer than they are.
Why does the FDA allow paymasters to design such trials?
Failure To Warn
The FDA is charged with providing physicians and the public with objective, scientific evidence showing that new drugs are safe and effective. Conveniently for drug companies, it carries out this responsibility narrowly by focusing on the label and not on alerting physicians or the public about biased evidence from those trials in leading medical journals that go into guidelines.
The FDA could alert the profession and public about how end points and other details get switched by industry ghost-writing teams, about unpublished negative results, and about positive results published twice; but it does not. Ghost writing and the ghost management of medical knowledge thrive.
To protect the public from unsafe and ineffective drugs and earn public trust, the FDA and Congress must acknowledge the biases described here that result from pharmaceutical corporations financing the public regulator. They should also require two changes: that new drugs demonstrate patient-based clinical advantages through comparative trials, and that these trials be based on the population that will actually take a drug.
These changes would reduce the flood of minor variations shown in Exhibit 1 and the subsequent billions spent on them.
