Science Equals Safety, Right?

FDA Approvedby Laurie Oakley

Most mainstream medical experts would have us believe that a lack of scientific testing makes it unethical for doctors to encourage or recommend the use of cannabis as medicine. Research studies, especially randomized controlled clinical trials, are the gold standard in pharmaceutical testing to establish whether medicines are safe and effective. Pharmaceutical study results are analyzed by the FDA before approval which, they say, ensures patient safety.

Most mainstream medical experts would have us believe that a lack of scientific testing makes it unethical for doctors to encourage or recommend the use of cannabis as medicine. Research studies, especially randomized controlled clinical trials, are the gold standard in pharmaceutical testing to establish whether medicines are safe and effective. Pharmaceutical study results are analyzed by the FDA before approval which, they say, ensures patient safety.

On the FDA's website we read:

“American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. The main consumer watchdog in this system is FDA's Center for Drug Evaluation and Research (CDER).”

That would be...fantasy.

In reality, things often begin to fall apart in the initial testing phase, which is done almost entirely by the pharmaceutical companies who are eager to make a profit. Their goal is always the same: to get drugs approved. Tests that do not confirm a drug's safety and efficacy will be thrown out. Experiments are then modified and/or repeated, and eventually the company gets the results they are looking for.

For a drug to be approved by the FDA, three studies to confirm safety and efficacy are required. The pharmaceutical company might do 12 studies, only two of which are successful. Company scientists continue tweaking their tests until a third study comes up successful. Then the three findings are submitted to the FDA. The number of failed studies are of no interest to the FDA.

Also on the FDA's website:

“The center's best-known job is to evaluate new drugs before they can be sold. CDER's evaluation not only prevents quackery, but also provides doctors and patients the information they need to use medicines wisely. The center ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks.”

Also fantasy.

Here is reality: when the FDA evaluates a new medication, it is almost always looking at drug industry data. In most cases, drug companies have withheld the tests which indicate a drug isn't effective. In too many cases, they also withhold evidence that the drug may cause harm.

Take Merck's arthritis drug, Vioxx, for example. Preliminary testing done by Merck scientists before Vioxx went to market in 1999 indicated that the drug might have a heart risk. Vioxx was approved by the FDA anyway. Post-approval testing continued to reveal this risk, yet Merck sold the FDA an unscientific explanation for the increased adverse cardiac events.* Merck went on to secretly cook their own study results before submitting them for publication in the New England Journal of Medicine. Doctors worldwide confidently prescribed Vioxx from 1999 to 2004, never connecting their patient's cardiac adverse events to the Vioxx they were prescribing.

It wasn't until outside scientists finally crunched the numbers and another Merck study revealed undeniable evidence, that the truth eventually came out. Only then was Vioxx “voluntarily” withdrawn from the market. Conservative estimates are that some 88,000 patients suffered heart attacks and strokes because of Vioxx, while an estimated 38,000 individuals died after being prescribed the drug. If you think Vioxx is an exception to the rule, you would be correct. In this case, the harm was statistically undeniable and Merck was forced to kill the drug. In many cases, harms that occur are difficult if not impossible to prove. Countless medicines are prescribed daily that cause problems that doctors will never link to the drug. And that is safe and very effective—for the pharmaceutical industry.

As for the missing scientific evidence concerning medical cannabis, the Ohio Rights Group has added a medical cannabis page to their website that lists over 200 studies. You can find these studies here.

Important Editor's Note: This article is not intended as a substitute for the medical advice of a physician. Before making any healthcare or treatment decisions you should consult with a qualified professional.


—Laurie Oakley is the author of the forthcoming book, CRAZY AND IT WAS—Surviving the Corporate Pharmaceutical Corruption of Western Medicine. You can find her on Twitter, or visit her website at www.laurieoaklely.com. She lives in Cincinnati, Ohio.

*The full Vioxx story can be found in Ms. Oakley's book, as well as in the following footnotes:

  1. “Dangerous Prescription: How Independent Is the FDA?” PBS Frontline. 13 Nov. 2003. Web. 23 July 2014.
  2. Reinberg, S. “Debate Builds Over Drug Companies' Fees to FDA.” ABC NEWS. 23 Mar. 2008. Web 23 July 2014.
  3. Brody, Howard. “Pradaxa: More Evidence of Drug Firms Manipulating Science.” Hooked: Ethics, Medicine, and Pharma. Blogger 23 Feb. 2014. Web 11 June 2014.
  4. Whitaker, Robert. “SAMHSA, Alternatives, and a Psychiatrist's Despair Over the State of American Science.” Psychology Today. 10 Oct. 2010. Web June 11 2014.
  5. Berensen, A., Harris, G., Meier, B., and Pollack, A. “Despite Warnings, Drug Giant Took Long Path to Vioxx Recall.” The New York Times. November 2004. Web. 20 July 2014.
  6. Prakash, S., Valentine, Vikki. “Timeline: The Rise and Fall of Vioxx.” NPR. 10 Nov. 2007. Web 22 July 2014.

  This blog post is sponsored by the Ohio Rights Group Education Fund.
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