Double blind studies (and the politics of medical acceptance)

by Clark Zimmerman, LAc.

Western medicine is based on research.  It is a system that is always seeking the latest and greatest thing.  It is based on the idea that innovation is the solution to treating disease.  The cornerstone of modern medicine is the double blind study.  A double blind study is an experiment or clinical trial in which neither the subjects nor the researchers know which subjects are receiving the active medication or treatment.  It is meant to eliminate subjective bias from the test results.  These studies involve 3 groups.  The first is the control group that receives no treatment, the second is given a drug or treatment to be tested, and the third is given a placebo, which is an inert substance or treatment that shouldn’t have any effect on the patient.  The test is double blind if both the patient and the researcher doesn’t know who gets the drug and who gets the placebo.  It is considered to be the gold standard of western science in proving that a substance or treatment works.

While the double blind study can be helpful in providing useful information about a drug or procedure, it is not without its problems.  One of the big problems with the double blind study is that most studies are preformed by drug companies to prove to the FDA that their product is effective at addressing a certain disease, and that the drug is safe.  Since these studies cost a lot of money, only pharmaceutical companies that are attempting to develop a new drug are willing and able to fund the studies.  The studies are then presented as evidence by the drug companies to the FDA as proof of the safety and efficacy of their product.  This is like the proverbial fox guarding the hen house.  Since the drug companies develop the testing protocols and present the evidence to the FDA, there is an inherent conflict of interest with this setup.  There are cases where the studies are steered toward a particular result, or studies with results that are unfavorable towards a drug are unreported, or even buried.  After all, drug companies are big businesses that exist to make money.  So while certain drugs may be quite helpful, they are developed and tested with the goal of making a profit.  This is one reason why drugs that are developed for chronic conditions, such as statins used to treat high cholesterol, are a high priority for drug companies; while short use medication, such as antibiotics, are not.  The profit potential is much higher for a drug that someone will have to take daily for the remainder of their life.

The high cost of preforming experiments to prove the effect and safety of drug is one of the reasons that new drugs can cost so much.  You are not just paying for the cost of manufacturing, distribution and advertising; you are also paying for research and development, as well as potential liability claims.  Big pharmaceutical companies have the money to spend on such endeavors.  They know that with most new drugs that make it to the market place they will recoup their expenses, and make a profit.  Drugs then are protected by a patent to provide them with exclusive rights to that drug for a number of years.  Unlike drugs, natural substances such as herbs or nutritional supplements are not possible to patent.  This is good in that it prevents ownership of a plant by one or several companies, however it also is a disincentive to research plants and natural medicines, as the cost of this research cannot be easily recouped.  So, many herbs or nutrients go unstudied, which is not to say that they are not effective.  Maybe they haven’t been “proven” to be effective by modern science, but have used effectively for millennia in other cultures.  But modern medicine often says,  “show me the current research that proves the herb is effective.”  In many cases the herbs hasn’t been proven effective because the research costs so much, and there is little potential for a company or person to turn a profit as a result of positive test results.  So, many effective herbs go unstudied.  But given that many of the drugs that have been developed have been based on chemicals isolated from plants, it is evident that many plants can be quite effective at treating or even preventing disease.  They just haven’t been proven by double blind studies…yet.

Even the most well designed study is incomplete in relation to time and sample size.  A study that is done over the coarse of 10 years is looking at a relatively short amount of time.  Some side effects may not appear until someone is on a drug for a certain length of time.  This is one of the problems that occurred years ago with the estrogen controversy.  Estrogen given without other hormones, or unopposed estrogen such as Premarin, was used to treat the symptoms of menopause.  It helped moderate hot flashes, night sweats, irritability and dryness.  Many doctors prescribed it to their menopausal patients.  Years later it was correlated with a significant amount of female cancers, especially breast cancer.  It took years to really figure this out, but by that time many woman had been on estrogen drugs for a long time.  So suddenly this miracle drug became a harmful thing.  Many women quit the drug cold turkey, which caused a horrible spike in symptoms.  We later figured out that estrogen, given with progesterone carries less risk of cancer, and can be very helpful in women with severe symptoms associated with menopause, but many woman developed cancer before the problem was addressed.

Another issue with pharmaceutical medicines is that they are often used off label.  This means that though are tested and approved for a certain illness or disease, they are often prescribed by doctors to treat things that they weren’t originally designed and approved by the FDA to treat.  An example of this is the use of Lyrica to treat fibromyalgia.  While off label use can be safe and beneficial, it can also be problematic.  Given that the pharmaceutical industry often points to their rigorous testing standards as proof of a drug’s safety and efficacy, off label usage isn’t supported by the same research.

While research, and in particular the double blind study, have offered some wonderful things to the field of medical research, the strict adherence to it as an infallible system much be questioned.  Some medical traditions, or alternative treatments might not have the same types of science to back up their claims, but should not necessarily be entirely discounted because of lack of a specific type of evidence.  Though due diligence should be applied to any medical treatment, perhaps a wider criteria would create more acceptance of certain traditional medicines that have been proven over time to be very effective, even if they have not yet been proven by western science.