Like other pharmacies, Valisure is in operation to turn a profit. It purchases medications from wholesale operations, adds a modest markup, then resells them to retail outlets and health care institutions. There is one major difference that sets Valisure apart: they test every product that comes through their lab. As a result, Americans have been alerted to the presence of potentially cancer-causing chemicals in common prescription meds.
Company co-founder Adam Clark-Joseph, whose primary background is in economics, says he got the idea when he was in college. He had been prescribed a medication that caused him to suffer serious side effects. His physician informed him that he likely wound up with a bad batch and should try a different pharmacy. After he had a few similar experiences, Adam attempted to find a lab that could analyze prescriptions in order to verify their ingredients. There were none. So he and David Light, a classmate with training in biochemistry, decided to start a lab of their own that would test and inspect prescription drugs for safety and efficacy.
Today, Clark-Joseph, Light, and a staff of 15 scientists and researchers work in a small, two-room laboratory located in what was once an arms manufacturing plant. There, they run numerous tests to ensure the medications dissolve in the stomach properly, confirm the amount and nature of inactive ingredients, and determine whether or not there are contaminants. Each time they expand their investigations, they find new problems and potential dangers.
In some cases, the problems discovered are minor – for example, drugs that take longer to dissolve in the stomach than manufacturers claim. Last year, the Valisure team published a paper in the journal Advances in Investigational Pharmacology and Therapeutic Medicine in which they reported the results of tests performed on Tylenol “Rapid Release” gel caps. It turned out that contrary to the manufacturer’s claim, the gel caps actually took longer to dissolve than generic capsules selling for nearly 25 percent less.
Earlier this year, Valisure began testing for carcinogens. Clark-Joseph’s young daughter had been prescribed Zantac (ranitidine) for acid reflux, so it was decided to test it. When NDMA, a carcinogenic industrial chemical, was discovered and verified by an independent lab, they reported the results to the FDA.
It begs the question of why a small start-up company is having to do the job that the FDA is supposed to be doing. In 2016, the Government Accountability Office issued a report finding that nearly 1,000 of the 3,000 foreign FDA-licensed pharmaceutical manufacturers had not been inspected – although Jeremy Kahn, a spokesperson for the FDA, told the Washington Post that the agency thoroughly tests all drugs for safety and efficacy prior to approving them. The process includes on-site inspections and checks to assure compliance with all regulations.
A large part of the problem is that in their rush to reduce costs and maximize profits, U.S. drugmakers have been moving production to countries such as China and India. According to recent testimony before the House Subcommittee on Health by Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, this trend has been “…driven by the pharmaceutical industry’s desire for cost savings and less stringent environmental regulations.” Companies in these countries are regularly cited for accidents and errors as well as failures in quality control, as was recently the case for India-based Hetero Labs.
Now, even Republican Senator Chuck Grassley of Iowa is questioning whether or not the FDA’s inspection program is adequate.
Valisure’s Chief Medical Officer, David Gortler, worked for the FDA before signing on with the company. He says that simply inspecting foreign manufacturing facilities isn’t enough – the FDA should be testing every shipment of pharmaceuticals that enter the U.S. “It’s really becoming a national health crisis, and eventually it’s going to become a national security crisis” he says.
At least the employees at Valisure are on top of it, doing what they can to alert Americans to possible dangers lurking in their medications that FDA inspections miss.