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Double Blind Studies: Are They Still Valid Or Corrupted?

Dr. Paul Lynn

Paul Lynn, MD

Double Blind Studies were created to give  our modern medical culture a much needed source of unbiased conclusions about the effects of medical treatments. Early on, it provided clarity in areas which needed. it.  Questions common to medicine such as,”  Is this apparent improvement I see in a patient really  to treatment “ABC” or is there another factor I am not aware of  causing the improvement?  What is the  actual odds I can expect the same improvements with drug  ‘ABC” in other patients? In other words the double blind study was originally  designed to uncover the true benefits[ and risks]  of a treatment which is not obviously apparent upon simple observation. Great idea,  worked well at first. What about now?

Double blind studies are living off their positive impressions when they were conducted in an unbiased, objective way  to get after the truth. Sadly, my conclusion is that  double blind studies are now more likely than not to be well planned marketing devices. Most are now  designed and conducted in a focused  way to create data which will allow the product to pass the FDA, or enhance sales of a product already on the market. The intent is now about as  far from an unbiased search for truth [original intent] as you can get. This change of intent from an  unbiased search for the facts  represents a total corruption of a system which inially offered great service and gained  the respect of doctors and patients alike.

The purpose of this article is to alert and  remind  doctors and patients  alike to read the fine print carefully. Everyone has to adjust to to this new reality. What is described below is what is taking place now. I have noticed Doctors overall are perhaps slower than informed patients to make this adjustment. Understandably so, since we doctors have memories of  the good information a well done double blind study can offer.

There are 3 main avenues with which the original intent of the double blind study  has been corrupted  into a simple  search for data to use for selling a product.

1. First step in the corruption process began when a company that stands to profit from a positive outcome was given total control by the FDA of the studies to evaluate the effect and safety.   In other words,the Big Pharma company which  wants to  sell a new drug now  does  the double blind study and presents it  to  the FDA. Initially, a third party under the control of the FDA would do the studies. The potential for bias  in this change  is obvious.  Double blind studies are expensive to get done. The FDA approval system requires the company to fund their own research  on a new medication and bring it to them. Since the company only  exists as a business for profit making purposes, they must  find the most efficient  way to get the results they need from their expense or they will literally be out of business. Their need to have a bias is understandable and obvious, isn’t it?. Isn’t it unfair of us to ask such  a company to be unbiased when we all know it must be biased, completive to survive against their competitors? The more successful companies can and do find a way to keep up an image of an unbiased study while introducing bias into double blind studies. To corrupt the double blind model, they simply  find researchers in medical schools who need  the research grants provided by the company for this particular drug to support  all of their other  research. The company then has their own employed paid to be biased researchers  stay in  close contact with the ‘independent” medical  researchers hired to do the study. The researchers inside and ouside the companies are collegues after all. Often, the  researchers  working for the company were actually once ‘independent ” medical researchers themselves.  Obviously, those ‘independent ” researchers who most often come up data desired by the drug company are much more likely to receive furture profitable  contracts  for other drugs.

2. Method of corruption #2: The FDA now accepts the ability of a drug to create a positive change in a test result in a patients as the principal criteria to measure effectiveness instead of  changes in a  patient herself/himself. Certainly it is much cheaper for companies  to provide this kind of research.  But the enormous  greater medical costs and human suffering  from this change in policy  is difficult to grasp at first.  Real negative  side effects [disease produced] experienced by people taking a medication  is balanced against proven improvements in tests, not   real health benefits. This is a bad deal for us as medical consumers.

For instance, statins alone  in double blinded studies will reduce the LDL cholesterol levels in women. This is a conclusive fact.Thus the drug gets approved. Billions of dollars made selling statins to women. However, taking a more patient centered  approach,  study of research has never conclusively shown taking statins only will reduce  the health risks in women!. This is also a fact. The summary of the findings are that at the doses commonly given to women there” may be ‘a slight improvement  in risk of heart disease. Which of course means  there may not be. But if  you add in the risks of taking statins which are clearly established  facts, taking a statin is a proven  negative health activity for the vast majority of women.In simple terms, statins create   more disease than they prevent in women. Of course, all of these women will show a lower LDL. See the excellent research data analysis and links on the web site  of Beatrice Golomb MD, PhD for more information. She is one of the original developers of the statins and has decades of study of the medications.

3. The third and final  way the double blind studies have been corrupted is probably the least known but most  pernicious of the three. This is the proverbial ‘last straw” of corruption of what was  a wonderful method of getting at the truth about the  value of a treatment. If  modern physicians or patients do not know the term Contract Research Organization, commonly abbreviated CRO, and how this type of company is   used in a double blind  studies  we are  are ill informed.

Currently, 30% of  an average double blinded study is outsourced to a CRO. It is predicted that  this percentage will rapidly rise to 80% in 10 years. Shouldn’t doctors and patients know this? We should. Ironically, at the moment, it is mainly  the  patients and doctors who happen also to invest in the stocks of Big Phrma who know about this great  change taking place in medical research. This change is at least as significant or more than the change described in #1 above, the FDA giving the pharmaceutical companies. the right, duty and expense to do unbiased   research. The pharmaceutical companies, after failing to do unbiased research,  are passing this right, duty  and expense another step  further out.

CRO are companies formed overseas by entrepreneurs to make money by offering to serve to international drug companies.. Note they are not formed to serve patients or the FDA. They offer  Big Pgarma a contract to do all or part of a  double blind study at a far lower  cost than the Pharmaceutical company can do for themselves.The CRO can do the study for usually 10-15% of what it would cost the drug company to do the same work. Any pharmaceutical company  that does not quickly adapt to this method of outsourcing expensive work  will simply not be able to complete with the other companies  that do. If the slow adapting companies  profit margins erode, their stock price drops. Then they go out of business or are bought out by a company that did adapt to this method quicker. Some experts say the 80% quoted above is low. The “percentage” is really ‘all that can possibly be done at this lower cost. will be done as soon as possible”

The opportunity of  biases results are now greater. Here is how the new research system works:

Big Parma company, called A, has a new product, a medication called ‘xyz”.  Instead of paying researchers  as described in #1 above, they contact a dozen companies vying for there business .These companies  put in bids to do the work just as we would get several bids to get a remodeling job done. These companies, all in low wage locales, can  do the work for a fraction of what it would cost the drug company. The CRO  with the best reputation wins the contract. The best reputation is defined as 1.Its  ability  to  provide  data whose quality acceptable to the FDA 2.  Among the least costly  of the companies putting in bids 3.Has a good  track  record in the CRO marketplace  of coming in with data which will likely support the interest of the company employing them.

The conclusion is that the days of assuming double blind studies quoted in the media are not biased are over. A few studies are still being done by the FDA directly. These by far  have the least bias.  Other than these, the  results of double blind studies no longer can be automatically considered superior to patient and doctors doing critical vigorous observations on their own of the results of meds introduced into the marketplace. The results of double blind studies are not discarded at all, but nor are they placed automatically in a” defining the answer position” they once had in decisions on medical treatments.

Another point is to wait two years before taking any newly introduced medication. Once hundreds of thousands of people are taking a medication, it is hard to hide the side effects as they emerge in new age of  Internet blogs. If a physician suggests you take a newly marketed medication, often free samples are available. Let him or her know in a polite way you would like to review the information on the results posed on line in patient advocacy sites first.

Finally I will put a more historical perspective on how the concept of double blind studies were  derived in the first place on my clinic website.  With that info in hand, many of us  begin to become our own “unbiased investigators for truth” in medicine.

Wishing you the best in Life and Health,

Paul Lynn

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