Study Indicates Clinical Trials for Drugs Don’t Include the Right People

As a fitting follow-up to my previous post in which I questioned whether the highly touted ending of a study on the anti-cholesterol drug Crestor because the results were too good was due to the fact that the people who were the “guinea pigs” (sorry, but that’s what they are) were too perfect to show a problem, the Washington Post reported on a study issued by Chronic Disease Prevention & Control Research Center at Baylor College of Medicine which indicates that testing on new drugs has excluded alot of important potential patient populations such as women, older people and minorities. Daniel Goldberg, the chief policy advisor for the report is quoted as saying “We’ve got a big problem, and it is extremely urgent that we fix it. Because we’re trying to figure out how to streamline health care and make people healthy, of course. And the fact that we have under-representation in clinical trials undermines both of these goals and undermines the quality of the evidence we come up with.”
This echoes the point I made in my previous post. These drugs, in the clinical trials the drug companies do to see if the drug works, must be tested on the type of population that it is expected will use the drug. Otherwise, in the clinical trials we will not see the REAL benefit of the drug and potentially what adverse reactions there might be when used in the population that will actually use the drug in the real world. As an example, if you are developing a drug to reduce cholesterol, you need to test it on people who have significant cholesterol issues. Additionally, you know that such drugs are more likely than not going to be used in the elderly and senior population, so you have to include seniors in your testing of the drug to see how they react. Unfortunately what you find when you read the details of many (not all) studies done by drug companies on drugs they are evaluating is that they try and pick the “perfect” patient with no significant medical issues other than maybe the one particular one which they are trying to address.
I understand that you need to exclude certain individuals because they may have a condition which may confuse your results i.e. you won’t know if its the drug that’s helping the individual or the other condition they may have, but there must be some consideration given to testing these drugs on the type of patient who will really be taking the drug once it gets out to the general population. In fact, part of the reason, in my view, that so many new drugs are running into problems once they get on the market is because of the failure to really evaluate the drug in the patient population which will actually be using the drug.
On a personal note, one thing I have learned after spending time learning about the pharmaceutical world and how it works is that I try not to take a drug the doctor prescribes for me unless its been on the market for at least 5-7 years. That way there has been time for the drug to be used in the “real” population and all the potential problems and issues addressed.