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,