Is That Newly Approved Drug Really Safe? Protect Yourself from Medical Reversal

Every year, many new drugs and other medical treatments are approved after rigorous research studies and get adopted into practice. Some of the new treatments are then hyped by the companies that produce them and become very popular. 

But here’s the problem: Many of these treatments will be found to be ineffective or even harmful when further testing is done years later—this is known as medical reversal. Among established practices tested in studies that were published in top journals, up to 40% have been reversed. 

Why medical reversals happen: Early research with a small number of participants may show that a new treatment or medication is better than existing treatment. The study seems sound, and the drug or therapy is widely adopted and heavily marketed to doctors and patients. But years later, when many patients are using the treatment, larger studies show that the therapy does not stand the test of time…and/or that the original results were misleading.

Case in point: In 2008, the FDA approved the drug bevacizumab (Avastin) as an add-on to standard chemotherapy for advanced breast cancer. Early studies found that it slowed the growth of breast cancer tumors by more than 20%, but follow-up studies found that the tumors eventually grew back and women did not live longer or better. After three years, bevacizumab was withdrawn by the FDA as a treatment for breast cancer.  

Other reversals: Sometimes a ­therapy is taken off the market, but there are plenty of treatments that have been reversed in studies yet continue to be used in practice. Examples…

Heart stents are commonly placed into the narrowed coronary arteries of people experiencing chronic stable angina, at a cost of at least $10,000, with the hope of preventing heart attacks, improving symptoms and lengthening life. However, since 2007, studies show that stents do not reduce the risk for heart attack or lengthen the lives of these individuals. These patients can avoid the risks of the procedure and do just as well with medications. Note: Stents have been shown to help patients who have had a heart attack.  

Arthroscopic knee surgery is one of the most common orthopedic procedures. Millions of these surgeries have been performed costing billions of dollars. The procedure repairs the cartilage that cushions and stabilizes the knee with the hope of reducing pain. Tears in this cartilage due to aging are very common in people over age 50. However, since 2013, studies have found that when the tear was not caused by an injury, this surgery is no better than physical therapy.

To learn about many other medical reversals, go to MedicalReversal.com, a site run by a team of researchers.

To protect yourself: For any proposed new treatment, ask your doctor probing questions. Examples…

• Is this treatment supported by a randomized clinical trial? The most reliable studies are randomized clinical trials (RCTs). RCTs randomly assign patients to the new treatment or the standard treatment and compare results.  
• Was the study sponsored by a drug company or performed by independent researchers? For more reliable results, look to studies done by reputable independent researchers such as the National Cancer Institute or the National Institutes of Health. 
• Will this treatment relieve my symptoms or help me live longer?
• How long have you been using this treatment?
• Are there follow-up studies that find that this treatment may not work?
• What did you recommend before this new treatment was available?
• Is there an older, less expensive treatment that is effective and has stood the test of time?
• Does the condition I have need to be treated now? Could a wait-and-see approach be an option?

If your doctor dismisses your questions, find a new doctor or get a second opinion. Also, you can research clinical studies on a specific treatment on your own online. A summary of the study (called the abstract) will be more readable than the full description. Helpful website: PubMed.gov.