Is Implicit Trust in Big Pharma and Medical Doctors Deserving?






A guest post from one of our contributors, Gerald Bouthner

rp_images-4.jpgGerald Bouthner

Many people today still have an inherent trust of doctors. Most people are raised to respect the position and stature of a doctor and would still consider becoming a doctor as an esteemed, lofty and worthy goal.

One’s quest or path for medical advice and treatment will generally take them face to face with a doctor. As a result of these visits in 2011 doctors wrote out over 4.02 billion prescriptions for drugs in the U.S. alone. That averages out to about 13 prescriptions for every man, woman, and child in America.

No doubt some of these prescriptions were very helpful, life enhancing and even life saving. But were all of these prescriptions really necessary? Were all of these drugs taken by patients with full and accurate open disclosure as to the risk and benefit reward of them? The answer to both questions is unfortunately NO.

The truth of the matter is in some cases doctor’s prescribe pills unnecessarily or without having the true accurate risk reward information of the drug that they are prescribing. Although there is a process set up by the U.S. to properly regulate the safety and efficacy of drugs that are approved for the market this process has not always worked effectively.

The FDA is entrusted with the duty of ensuring drug safety and efficacy. The FDA does not actually test the drugs that it is responsible for approving or denying. The clinical trials used for determining approval or not are performed by the pharmaceutical companies and the data is then passed onto the FDA for approval. The problem with this process is that the Big Pharma companies have on many occasions fudged the results they are reporting about their drug(s) trials with the FDA.

Big Pharma has at times manipulated and misrepresented study results, they have over emphasized the positive results of their drug trial(s) and omitted some of the negative results. Big Pharma companies have actually rigged scientific information submitted to the FDA in their attempt for drug approval. Criminal acts?

Yes! And the FDA has been recently cracking down on such criminal and unethical actions on the part of Big Pharma. Here are some specific examples of the Big Pharma companies fraudulent acts and some resulting FDA fines:

  • GlaxoSmithKline $3 billion settlement will plead guilty and pay $3 billion to resolve federal criminal and civil inquiries arising from the company’s illegal promotion of some of its products, its failure to report safety data and alleged false price reporting. bribing doctors, and promoting medicines for uses for which they were not licensed. Including promoting Paxil for depression treatment in children although it had no FDA approval for under age 18 treatment. Read more here
  • Abbott Laboratories Inc. has pleaded guilty and agreed to pay $1.5 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of the prescription drug Depakote for uses not approved as safe and effective by the Food and Drug Administration (See FDA Report) 
  • Pfizer paid the government $2.3 billion in criminal and civil fines for improperly marketing 13 different drugs, including Viagra and cholesterol fighter Lipitor. Pfizer was accused of encouraging doctors to prescribe its drugs with free golf, massages, and junkets to posh resorts. It is illegal to promote uses for a drug that have not been approved by the FDA — a practice known as off-label marketing.
  • November 2011, Merck entered into a civil settlement agreement under which it will pay $628,364,000 to resolve additional allegations regarding off-label marketing of Vioxx® and false statements about the drug’s cardiovascular safety.

These fined Big Pharma companies noted above are just a few of the examples of the fraudulent acts that have been carried out by Big Pharma in pushing approval of their drug(s). When it comes to anti-psychotic drugs which generate upwards of 15 billion dollars annually, every major company that manufactures them has either settled health care fraud cases or are still currently under investigation, including Johnson & Johnson, Bristol-Meyers Squibb and AstraZeneca.

The Big Pharma companies have been found guilty of the following:

Payments to doctors and pharmacists to promote unapproved uses of their drugs.

  • Using incomplete even phony results to gain FDA approval for their drug.
  • Withholding for years from the FDA and public negative study results pertaining to risk of their drug while continuing to sell it.

FBI Special Agent Richard DesLauriers said concerning the GlaxoSmithKline case, “The completion of this investigation reflects law enforcement’s efforts to make companies like GlaxoSmithKline accountable for knowingly manufacturing and releasing defective products to millions of adults and children suffering from diabetes, depression, and skin infection. To avoid lost profits, GlaxoSmithKline intentionally disregarded the potential harmful effects of these defective drugs on consumers. The FBI will continue to work collaboratively with our law enforcement partners to identify individuals and companies who seek to line their pockets at the expense of the health care system and safety of each of us.” Read more here

Acting Associate Attorney General Tony West said concerning the Abbott case, “Not only did Abbott engage in off-label promotion, but it targeted elderly dementia patients and downplayed the risks apparent from its own clinical studies. As this criminal and civil resolution demonstrates, those who put profits ahead of patients will pay a hefty price.”

In the case against Pfizer the whistle blower in that case a former employee John Kopchinski a West Point Grad and Gulf War veteran stated “In the army, I was expected to protect people at all costs. At Pfizer I was expected to increase profits at all costs, even when sales meant endangering lives. I couldn’t do that.” Read more here

Despite the multi-billion fines Big Pharma companies thus far have failed to fully change their ways. Some people even have suggested that they view such fines as the cost of doing their business. The profits they obtained interim outweighed the risk of punishment. Really? What about the adverse effect these drugs have on people’s lives that you are illegally pushing Big Pharma? Maybe more imprisonment is in order here?

Don’t misinterpret that I am against pharmaceutical companies because I am not. I have written positive articles in the past about their successes and efforts. Such as this article on Mental illness treatment. I am not against the pharmaceutics industry I am against such wanton illegal selling of drugs to people that are distributed with false study results with seemingly no concern for those who will be taking them.

Advances in medicine has indeed achieved great results and helped vast amounts of people. Medicine has improved lives and saved many of them. But such acts by Big Pharma is manipulative, harmful, and breaks the trust one should be able to place when making decisions that effect their health.

Big Pharma’s hands are clearly dirty when it comes to putting profits over safety. However some doctor’s as well are not without blame when it comes to the issues associated with prescribing drugs. Some doctor’s have been inclined to prescribe particular drugs because of financial incentives that they carry from Big Pharma even though having incomplete safety and efficacy facts. Can such practices interfere with a doctor’s objective advice? Could this unduly influence the type and amount of prescriptions a doctor may write? Very possibly, maybe even very probably.

Even though a doctor accepting such incentives from Big Pharma is as of yet still legal, most medical policy makers view them as unethical. It is noteworthy to add that some medical institutions have banned this practice completely and others have required all such payments to be made public. Some doctor’s are also still too quick to prescribe a pill as treatment despite known potential long term side effects and addiction risks without even exploring other non-medicinal methods of treatment first.

Officials in government the FDA and elected officials as well as some medical institutions are making attempts and have made some changes to improve this major problem within the pharmaceutical industry. But at the same time the pharmaceutical companies have a large lobbying presence and spend hundreds of millions of dollars lobbying against certain bills that are presented for change.

Knowing such, despite any inherent trust we may have of doctor’s and the medicine they can prescribe it is in the best interest of our health to be cautious before accepting and taking medications. The least dangerous drugs would usually be those that have been around long enough to go through all post market side effects tests. Be cautious, do your research before putting a pill in your body. All pills have potential side effects, so don’t immediately discount any potential non-medicinal treatments as a viable option. Be an informed participant in all decisions related to your health.

About Author: Gerald Bouthner is a Mental Health Advocate, Blogger, and Guest Writer on Therapy Consumer Guide. Find out more about Gerald at The Challenges of Mental Illness or contact him via social media: Twitter  Google+  Facebook

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