by: Jeff S. Gibson, Attorney
What do you remember from your high school science class? You probably remember designing and conducting experiments. You might even remember the partner that was assigned to you (hopefully someone smart). In your science class you learned about how a well-designed experiment could answer a question. You learned the importance of creating a set of procedures that would give you reliable data across several points. The outcome of your experiment was measured against a control group that did not receive special treatment so you would have a good model of comparison.
The world of clinical drug trials shares some similarity with your high school science class. Experiments are designed to test the effectiveness and safety of drugs for the treatment of diseases and medical conditions. Health care researchers and scientists compile their findings to determine how well the subject of the experiment answered the question that they were asked.
Who is testing drugs?
You might wonder who these researchers and scientists are. For many years, these people worked at independent labs like the National Institutes of Health, which is an agency of the U.S. Department of Health & Human Services. Recently, many of the researchers and scientists that have been performing clinical trials for new drugs have been sponsored by the pharmaceutical manufacturers themselves. The level of funding from these drug makers varies from partial payment to full payment of the entire clinical trial.
If researchers and scientists get their funding from the maker of the drug that they are testing, are they giving unbiased answers to the questions of effectiveness and safety? The answer is ‘no’ according to research conducted by the Cochrane group, which is an industry leader in providing primary research for the health care industry. A recent analysis of clinical drug trials showed a strong bias in favor of drug makers when they funded clinical trials for their drugs in comparison to independent studies.
How well does the drug help?
Safety and effectiveness are two very important attributes for drugs. I previously discussed product safety and bias in drug trials using the example of Avandia. Bias can also appear in drug trials that seek the answer to a drug’s effectiveness in treating an ailment. Effectiveness means that the drug does what it is supposed to do for the patient.
The Cochrane group has reported that Tamiflu, manufactured by Roche, serves as a good example of a drug trial with biased effectiveness results. Researchers from the Cochrane group recently requested documentation from the clinical trial conducted for Tamiflu. Roche refused multiple requests to furnish this information, however, researchers were able to gather some information from regulatory bodies in Europe and the U.S. Assessments of these documents led the Cochrane group to state that there “were substantial problems with the design, conduct and availability of information from many of the trials”, which suggests that bias could certainly have played a part in the findings that were presented.
Forbes shared information about the Cochrane group’s assessment of the Tamiflu study. It highlighted 5 things you should know about Tamiflu including:
1. The drug trials for Tamiflu were sponsored by Roche and evidence of reporting bias was found.
2. Studies did not find that Tamiflu reduced the risk of hospitalization.
3. Studies were not able to determine the effect of Tamiflu on complications.
4. Studies were not able to determine if Tamiflu reduced transmission of the virus.
5. The use of Tamiflu did reduce the duration of symptoms by roughly one day.
The Tamiflu information becomes even more important as the CDC provides the public with information regarding the current flu outbreak. As I’ve said before, it is extremely important for consumers to be their own healthcare advocate. Protect yourself by asking questions to your medical provider as well as doing some research on your own.
People who have been injured by dangerous drugs or defective medical devices should contact a product liability/personal injury attorney to discuss their legal rights and options in obtaining compensation for their injuries. My practice is focused on these matters. I have helped people who have suffered serious personal injury litigate claims against drug and medical device manufacturers.
photo credit: William Brawley via photopin ccphoto credit: Tennessee Wesleyan College via photopin cc
Biased Drug Trials and the Effect on Patients
by: Jeff S. Gibson, Attorney