The pharmaceutical industry routinely complains about the length of time it takes the Food and Drug Administration (FDA) to secure approval for prescription drugs in the marketplace. They often point to rigorous clinical trials that are excessively long and drawn out – and often fail to point out how often those “rigorously tested” drugs still get pulled from the shelves because of terrible, often deadly side effects. The process, it seems, doesn’t work for anyone.
So what can be done? How can pharmaceutical companies ensure their products are safe for use without extending the length of time it takes to test them? How can doctors and patients ensure that they are giving, and being given, the best possible course of treatment?
Enter comparative effectiveness research
There are two key questions that federal regulators at the FDA and other parts of the government bureaucracy must answer in order to help consumers. These are:
- How do new drugs and treatments compare to existing ones in terms of effectiveness and safety?
- One of the pros and cons in any particular situation of a particular treatment or therapy for you, personally?
These important questions form the foundation of what is referred to as “comparative effectiveness research,” according to Aaron Carroll, doctor, researcher, and professor of pediatrics at Indiana University School of Medicine.
As a regular contributor to the New York Times column, “The Upshot,” Carol stresses the importance of patients obtaining evidence-based information to help them make informed choices about their medical options, including the cost and potential outcomes of those options. He also asserts that hospitals and doctors are often lacking clear information about the benefits of one course of treatment as opposed to another. This is important information patients need to make better decisions and avoid the use of potentially dangerous drugs and treatment options for their condition.
Example: Treating high blood pressure
Regarding treatments for high blood pressure, which some specialists assert affect almost 50 percent of American adults, Carroll discusses the uncertainty among doctors about the three main drugs used to treat hypertension. The study involving 33,000 patients over a four-year period in over 600 centers across the U.S. and Canada has evidently failed to establish the best course of care for patients afflicted with early and mild hypertension as well as uncontrolled and chronic high blood pressure.
The results of the study, which cost $100 million, indicate a particular therapy doctors should consider. However, as Carol reports, debate continues to flourish within the medical community about the best course of treatment.
One course of treatment with a prescribed drug may be dangerous for a particular individual as opposed to another option. However, only the results of proper comparative effectiveness research may answer these questions.
The two exclusive organizations attempting to perform the types of comparative studies that doctors, patients, hospitals need according to Carroll, are the National Institutes of Health and the Patient Centered Outcomes Institute. He argues that others also need to join the effort.
Traditional scientific research is necessary to produce breakthroughs in the understanding of how better treatments can be developed. This requires the inclusion of randomized controlled trials, pragmatic trials, and health services research. However, comparative effectiveness research is an essential component in order to find the answers to many of the unanswered questions patients currently have about the efficacy of their treatment options.
If you or a loved one has sustained an injury due to taking a drug with dangerous side effects, we are here to represent you and fight for any financial compensation you deserve for your losses. To schedule a free consultation with a dangerous drug lawyer from our team at Crandall & Pera Law, call us in Ohio or Kentucky at 877.686.8879. Or, complete our contact form to request an appointment.