Hide this

Story at-a-glance -

  • “Institutional corruption” does not refer to any violation of existing rules or laws. Rather it refers to “a certain kind of influence, within an economy of influence, that has a certain effect”
  • An activity is considered institutional corruption if it weakens the effectiveness of an institution, and/or weakens public trust in that institution. Institutional corruption is rife within the pharmaceutical industry and its regulatory agencies
  • The consequences of institutional corruption include millions of adverse reactions each year, and at least 128,000 deaths as a direct result of adverse drug reactions within the hospital setting alone
  • When deaths related to diagnostic errors, errors of omission, and failure to follow guidelines are included, the number skyrockets to an estimated 440,000 preventable hospital deaths each year
  • That makes preventable medical errors the third-leading cause of death in the US, right after heart disease and cancer, and hospital-based lethal adverse drug reactions are the fourth leading cause of death
 

Institutional Corruption of Pharmaceuticals and the Drug Safety Myth

November 30, 2013 | 204,914 views

By Dr. Mercola

I've highlighted the fact that the pharmaceutical industry is responsible for nearly 20 percent of corporate crime in a number of previous articles.

Here, I want to draw your attention to an excellent article1, 2 on the institutional corruption of pharmaceuticals, published in the Journal of Law, Medicine and Ethics. It's well worth reading in its entirety if you have an interest in this topic.

This term, "institutional corruption," does not refer to any violation of existing rules or laws. Rather it refers to "a certain kind of influence, within an economy of influence, that has a certain effect," as explained the Cambridge lecture above. As presented in the video, an activity is considered institutional corruption if it:

  • Weakens the effectiveness of an institution, and/or
  • Weakens public trust in that institution

The lecture series was sponsored by the Edmond J. Safra Foundation Center for Ethics at Harvard, which also published the featured article on this topic, written by Donald W. Light, Joel Lexchin, and Jonathan J. Darrow. They write:3

"Institutional corruption is a normative concept of growing importance that embodies the systemic dependencies and informal practices that distort an institution's societal mission.

An extensive range of studies and lawsuits already documents strategies by which pharmaceutical companies hide, ignore, or misrepresent evidence about new drugs; distort the medical literature; and misrepresent products to prescribing physicians.

We focus on the consequences for patients: millions of adverse reactions. After defining institutional corruption, we focus on evidence that it lies behind the epidemic of harms and the paucity of benefits...

If "corruption" is defined as an impairment of integrity or moral principle, then institutional corruption is an institution's deviation from a baseline of integrity."

Lack of integrity is indeed different from outright violation of law, which is a punishable crime. Avoidance of "moral principle," while not illegal per se, is still a very serious concern—if nothing else for the very real harm it produces. This is true in most situations, but it's particularly heinous when it is the modus operandi of those who wield the greatest power over your health care.

The Three Levels of Institutional Corruption

The authors assert that, within the pharmaceutical industry, institutional corruption occurs at three different levels:

  1. Lobbying efforts and political contributions. This way, the pharmaceutical industry has influenced the US Congress to enact legislation that has severely undermined the stated mission and function of the Food and Drug Administration (FDA).
  2. Through the application of industry pressure, "Congress has underfunded FDA enforcement capacities since 1906, and turning to industry-paid "user fees" since 1992 has biased funding to limit the FDA's ability to protect the public from serious adverse reactions to drugs that have few offsetting advantages," according to the authors.
  3. Commercializing the role of doctors, undermining their position as "independent, trusted advisers to patients."

As stated in the featured article, the health care system is founded on the moral principle that a doctor, first, will do no harm. The principle of not harming the patient is explicit in the Hippocratic Oath,4 one of the oldest binding documents in history. Under that moral edict, the duty of any health care worker is, first and foremost, to treat illness using the best medical knowledge and science available, and to carefully assess the risks of harm.

"The institutional corruption of health care consists of deviations from these principles," the featured article states.

Unfortunately, the system in operation today has strayed quite far from this high moral ground. In fact, it has strayed so far that, today, the medical establishment as a whole is one of the leading causes of death!

According to the most recent research5 into the cost of medical mistakes in terms of lives lost, 210,000 Americans are killed by preventable hospital errors each year. When deaths related to diagnostic errors, errors of omission, and failure to follow guidelines are included, the number skyrockets to an estimated 440,000 preventable hospital deaths each year. That makes medical errors the third-leading cause of death in the US, right after heart disease and cancer. 

If we limit it to adverse drug reactions alone, the featured article6 tells us that 2.7 million Americans experience a serious adverse drug reaction while hospitalized each year. Of those, an estimated 128,000 die as a direct result of the adverse reaction. According to those statistics, hospital-based adverse drug reactions alone are the fourth leading cause of death in the US.

Sadly, a majority of healthcare workers observe mistakes made by their peers yet rarely do anything to challenge them.  This too falls into the discussion in the featured video. In it, it is argued that if you have the ability to right a wrong, but do not, are you not also responsible for the outcome? In essence, part of the problem of institutional corruption is not simply "bad people doing bad things," but "good people looking the other way."

Do Pharmaceutical Companies Have a Moral Duty to Do No Harm?

According to the featured article:

"The major patent-based research pharmaceutical companies also nominally commit themselves to improving health and relieving suffering... But in fact, these companies are mostly developing drugs that are mostly little better than existing products but have the potential to cause widespread adverse reactions even when appropriately prescribed. This deviation from the principles of health care by institutions allegedly dedicated to health care is institutional corruption.

We present evidence that industry has a hidden business model to maximize profits on scores of drugs with clinically minor additional benefits. Physician commitment to better health is compromised as the industry spends billions to create what Lessig calls a "gift economy" of interdependent reciprocation."

Contrary to popular belief and corporate sob-stories bewailing the high cost of innovation, pharmaceutical companies devote a miniscule 1.3 percent of their revenues to research and development (R&D) of new drugs. Furthermore, pharmaceutical companies' revenues have climbed six times faster than their investment in R&D over the past 15 years. Meanwhile, an average of 25 percent of revenues is spent on advertising and promotion of "new" drugs that are no better than their predecessors. So much for the claim that R&D costs are becoming increasingly "unsustainable."

What's really unsustainable is the industry's blatant disregard for patients' health and well being... Most new drugs offer minor clinical advantages over preexisting drugs at best, and no advantage but greater risks, at worst. For the past 35 years, very few drugs created represent any true advancement in drug therapy. According to the three authors, multiple reviews conducted between the mid-1970's to the mid-1990's have found that only 11 to 15.6 percent of new molecular entities (NMEs) created provide any kind of "important therapeutic gain." According to the featured article:

"The independent drug bulletin, La revue Prescrire, analyzes the clinical value of every new drug product or new indication approved in France. From 1981 to 2001, it found that about 12 percent offered therapeutic advantages. But in the following decade, 2002-2011... only 8 percent offered some advantages and nearly twice that many—15.6 percent—were judged to be more harmful than beneficial. A mere 1.6 percent offered substantial advantages." [Emphasis mine]

They note that similar findings have also been made by the Canadian advisory panel to the Patented Medicine Prices Review Board, and by a Dutch general practice drug bulletin. Interestingly enough, the US has not conducted any such review. Remarkably, studies have revealed that one in every five new drugs ended up causing such serious harm that they eventually received a severe warning label or were withdrawn from the market.

"Of priority drugs that were reviewed in slightly more than half the normal time, at least one in three of them caused serious harm," the featured article states... [E]vidence suggests that commercial distortions of the review process and aggressive marketing contribute to both undermining beneficence as health care's raison d'être and to the epidemic of harm to patients."

Conflicts of Interest and Institutional Corruption Within the FDA

Just over two decades ago, in 1992, Congress passed the Prescription Drug User Fee Act (PDUFA), and from that moment on, the FDA was set squarely on the path toward doing more harm than good. The act authorizes the FDA to collect "user fees" from drug companies in order to increase the speed by which it can conduct drug reviews. A standard drug application must now be completed within 12 months of submission, compared to as much as 30 months prior to PDUFA. Priority applications must be completed within six months. Since the FDA began collecting user fees from the very industry it was intended to regulate, approved drugs have become increasingly dangerous. According to the featured article:

"Shortened review times led to substantial increases in serious harms. An in-depth analysis found that each 10-month reduction in review time—which could take up to 30 months—resulted in an 18.1-percent increase in serious adverse reactions, a 10.9-percent increase in hospitalizations, and a 7.2-percent increase in deaths." [Emphasis mine]

Can Institutional Integrity Be Restored to Produce Safer Drugs?

There are ways to correct this fatally flawed system. Unfortunately, the pharmaceutical industry is at this point so enmeshed with our political structure, the US government may as well be viewed as a hybrid corporate-run entity, presenting a façade of concern toward the public but being none-too-confused about whom they're really serving, namely industry. The featured article presents five strategies that would "reduce conflicts of interest and improve the safety and effectiveness of drugs," should politicians and Americans at large decide that enough is enough:

  • Research companies should have no part in testing the drugs they've developed. What's called for is an independent institute to conduct drug studies.
  • The FDA must restore public trust by taking a renewed leadership role focused on drug safety. Part of this includes simply enforcing its currently existing rules, which are all-too-frequently ignored.
  • User fees must be eliminated. The FDA must be wholly funded by taxpayers-as-consumers, in order to clarify whom it serves and eliminate conflicts of interest with industry.
  • Approval criteria for new drugs should include evidence of superiority over existing drugs and be of relevance to the patient
  • Congress needs to create a National Drug Safety Board "with adequate powers, funds, and mandates to independently investigate and report on drug safety issues," and provide open access to all data. This would go a long way toward reestablishing the public's trust.

Proof That 'Science-Based' Medicine Is Disintegrating

If we continue allowing Big Pharma to live and operate on moral low ground, you really don't need supernatural powers to predict what the future will bring. History is full of examples of how far they will go to make a buck. Criminal corruption has reached pandemic levels within the industry already. In fact, it seems to be more of an unspoken rule than the exception.

Peter Gøtzsche, head of the Nordic Cochrane Centre (which is considered the gold standard in terms of independent research reviews), goes so far as to compare the pharmaceutical industry to an organized crime ring in his book, Deadly Medicines and Organized Crime: How Big Pharma Has Corrupted Healthcare.

"Besides peddling drugs known to be more dangerous than advertised, drug companies are also in large part responsible for the decimation of the very core of medical science, since they fund a great deal of the research. The source of funding has been shown to have a tremendous impact on the results of any study."

According to data from Thomson Reuters,7 the number of retractions of scientific studies have increased more than 15-fold since 2001, and a review8 published just last year showed that nearly 75 percent of all retracted drug studies were attributed to "scientific misconduct," which includes:

  • Data falsification or fabrication
  • Questionable veracity
  • Unethical author conduct
  • Plagiarism

Corruption of science is incredibly serious, as health care professionals rely on published studies to make treatment recommendations, and large numbers of patients can be harmed when false findings are published. The average lag time between publication of the study and the issuing of a retraction is 39 months. And that's if the misconduct is ever caught at all. What's worse, about 32 percent of retractions are never published,9 leaving the readers completely in the dark about the fallacies in those studies.

Poster Children for Corrupted Science

One clear example of how deadly corrupted science can be is the painkiller Vioxx. There were many indications that this would be a dangerous drug, despite Merck's claims, and I warned my readers to avoid it before its FDA approval in 1999. In 2008, four years after the drug was withdrawn from the market, an editorial10 published in the Journal of the American Medical Association (JAMA) suggested Merck might have deliberately manipulated dozens of academic documents published in the medical literature, in order to promote Vioxx under false pretenses.

The diabetes drug Avandia is another potent example. Between 1999 and 2007, Avandia is estimated to have caused over 80,000 unnecessary heart attacks,11 although the actual numbers of people harmed or killed by the drug is still largely unknown. Avandia is a poster child for the lethal paradigm of corrupted science as GlaxoSmithKline (GSK), the manufacturer of Avandia, hid damaging information about the drug for over 10 years, as they knew it would adversely affect sales!

Two years ago, GSK agreed to a $3 billion settlement over the sales and marketing practices of several of its drugs, including Avandia. This was the largest federal drug-company settlement in US history, surpassing the $2.3 billion paid by Pfizer in 2009 for illegally promoting off-label uses of four of its drugs. Most recently, GSK's crooked ways made international headlines yet again when Chinese authorities arrested four of the company's senior executives on charges of cash and sexual bribery.

The British Medical Journal's blog recently featured an article12 by former BMJ editor and director of the United Health Group's chronic disease initiative, Richard Smith. The piece is also the foreword to the book mentioned earlier, Deadly Medicines and Organized Crime. Smith writes:13

"The drug industry has systematically corrupted science to play up the benefits and play down the harms of their drugs... the industry has bought doctors, academics, journals, professional and patient organizations, university departments, journalists, regulators, and politicians. These are the methods of the mob.

...[D]octors and academics are supposed to have a higher calling. Laws that are requiring companies to declare payments to doctors are showing that very high proportions of doctors are beholden to the drug industry and that many are being paid six figures sums for advising companies or giving talks on their behalf. It's hard to escape the conclusion that these 'key opinion leaders' are being bought. They are the 'hired guns' of the industry.

And, as with the mob, woe be to anybody who whistleblows or gives evidence against the industry. Peter tells several stories of whistleblowers being hounded, and John Le Carré's novel describing drug company ruthlessness became a bestseller and a successful Hollywood film."

Basic Tenets of Optimal Health

Any time your doctor suggests a drug for an ailment, I urge you to do your due diligence before taking it. That said, remember that leading a common-sense, healthy lifestyle is your best bet to achieve a healthy body and mind. And while conventional medical science may flip-flop back and forth in its recommendations, there are certain basic tenets of optimal health that remain unchanged. Following these healthy lifestyle guidelines can go a very long way toward keeping you well and prevent chronic disease of all kinds:

  1. Proper Food Choices: For a comprehensive guide on which foods to eat and which to avoid, see my nutrition plan. Generally speaking, you should be looking to focus your diet on whole, ideally organic, unprocessed foods. For the best nutrition and health benefits, you will want to eat a good portion of your food raw.
  2. Avoid sugar, and fructose in particular. All forms of sugar have toxic effects when consumed in excess, and drive multiple disease processes in your body, not the least of which is insulin resistance, a major cause of chronic disease and accelerated aging.

    I believe the two primary keys for successful weight management are severely restricting carbohydrates (sugars, fructose, and grains) in your diet, and increasing healthy fat consumption. This will optimize insulin and leptin levels, which is key for maintaining a healthy weight and optimal health.

  3. Regular exercise: Even if you're eating the healthiest diet in the world, you still need to exercise to reach the highest levels of health, and you need to be exercising effectively, which means including high-intensity activities into your rotation. High-intensity interval-type training boosts human growth hormone (HGH) production, which is essential for optimal health, strength and vigor. HGH also helps boost weight loss.
  4. So along with core-strengthening exercises, strength training, and stretching, I highly recommend that two to three times  a week you do Peak Fitness exercises, which raise your heart rate up to your anaerobic threshold for 20 to 30 seconds, followed by a 90-second recovery period.

  5. Stress Reduction: You cannot be optimally healthy if you avoid addressing the emotional component of your health and longevity, as your emotional state plays a role in nearly every physical disease -- from heart disease and depression, to arthritis and cancer.
  6. Meditation, prayer, social support and exercise are all viable options that can help you maintain emotional and mental equilibrium. I also strongly believe in using simple tools such as the Emotional Freedom Technique (EFT) to address deeper, oftentimes hidden, emotional problems.

  7. Drink plenty of clean water so that your urine is light yellow.
  8. Maintain a healthy gut: About 80 percent of your immune system resides in your gut, and research is stacking up showing that probiotics—beneficial bacteria—affect your health in a myriad of ways; it can even influence your ability to lose weight. A healthy diet is the ideal way to maintain a healthy gut, and regularly consuming traditionally fermented foods is the easiest, most cost effective way to ensure optimal gut flora.
  9. Optimize your vitamin D levels: Research has shown that increasing your vitamin D levels can reduce your risk of death from ALL causes. For practical guidelines on how to use natural sun exposure to optimize your vitamin D benefits, please see my previous article on how to determine if enough UVB is able to penetrate the atmosphere to allow for vitamin D production in your skin.
  10. Avoid as many chemicals, toxins, and pollutants as possible: This includes tossing out your toxic household cleaners, soaps, personal hygiene products, air fresheners, bug sprays, lawn pesticides, and insecticides, just to name a few, and replacing them with non-toxic alternatives.
  11. Get plenty of high-quality sleep: Regularly catching only a few hours of sleep can hinder metabolism and hormone production in a way that is similar to the effects of aging and the early stages of diabetes. Chronic sleep loss may speed the onset or increase the severity of age-related conditions such as type 2 diabetes, high blood pressure, obesity, and memory loss.

Thank you! Your purchases help us support these charities and organizations.