What if the drugs you are dependent on for your health could maybe give you cancer? What would you choose? To take them, to try to find an alternative that might now work as well, to stop them…..no good choices there. The FDA works hard so that you do not need to make that choice however it is becoming more and more difficult to inspect the drugs we use when so much of what is being manufactured is made overseas. According to an NBC News special, 85% of the raw materials for popular drugs are made overseas, often India and China where production costs are lower but oversight is more difficult.
This is the alarming message ex-FDA inspector Massoud Motamed gave in an interview to NBC in which he detailed equipment difficulties, paperwork shredding and impurities found in the production plants of pharma giants that make drugs for American consumers. His take home message? The FDA is understaffed for an increasingly difficult job and that situation is dangerous. Since the summer of 2018 there have been a total of 45 recalls of generic blood pressure medications, drugs that save lives every day. This puts patients between a rock and a hard place because stopping blood pressure medications is extremely dangerous, and even switching brands can cause unexpected blood pressure fluctuations.
Doctors feel the dilemma. Bound by the Hippocratic oath to do no harm…how do they decide when the medications they usually turn to might turn against their patients? In 2016 1.6 million people purchased valsartan and 9.2 million purchased losartan, two of the recalled blood pressure medications. Finding alternatives for that many people is a challenge.
The FDA says the overall risk is small. For valsartan, the pills they tested contained between 3 and 210 times the agency’s acceptable level of NDMA, the probable carcinogen involved in the recall. The FDA’s statement to address this? “This is troubling to us and we know it’s troubling to the public. The concern is appropriate”
Motamed left the FDA in 2017 and believes that there is a “significant portion [of drugs]” that would not pass quality control if tested in the U.S. Where does that leave patients? Anxious, and for some, finding lawyers.