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Wednesday, April 29, 2020

Small Pharmacy Takes Down Big Drugmaker

I had a fairly dim view of drug quality in the United States going into this, but we’ve discovered tons of problems I never even thought of—and they’re all over the place. —Adam Clark-Joseph, one of Valisure’s founders

A tiny startup in New Haven, Connecticut has thrown a stone into the waters of drug formulation. The splash caused a global recall of heartburn pill Zantac, and the ripples continue to affect the drug-making industry. Online pharmacy Valisure bills its mission in part as bringing “transparency and increased quality to the pharmaceutical industry.” Last November, its scientists told regulators that Zantac and the generic form, ranitidine, contained a cancer-causing chemical.

The Food and Drug Administration confirmed unacceptable levels of the chemical, N-nitrosodimethylamine (NDMA) in some ranitidine products for sale in the U.S., including a syrup made for babies. The agency warned people against panicking and noted that many products made to alleviate heartburn did not contain the chemical.

“We know impurities in medicines are of great concern to patients and consumers who rely on safe and effective medicines approved by the FDA, and we are working with manufacturers and global regulators to provide clear and actionable information,” says Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “These investigations take time and do not provide instantaneous answers.”

Valisure’s Beginnings

The company started the way many do: one of its founders was a guy with a problem. Adam Clark-Joseph refilled a prescription for a supposedly identical drug but it didn’t work. An economist and grad-school student, he’d had some training in chemistry and was shocked when his doctor told him he’d probably just gotten a bad batch and to try another pharmacy. Was this really possible in America?

It turns out it was, and is. Together with business partner David Light, the two put their own money into a pharmacy that would verify the content of prescription drugs, many of which are made overseas. The results have been eye-opening.

Valisure makes its money by buying drugs wholesale and reselling them at a higher price, the way all pharmacies do. But what’s different is that they test every batch coming through their doors, on the assumption that there’s no other way to be sure of what clients are putting in their bathroom cabinets.

One of their first ventures was testing lamotrigine, an anticonvulsant. The lab has artificial stomach acid that can reveal how long extended release pills take to dissolve. In this case, some batches took more than 24 hours, and one took over 48 hours, in spite of labelling saying the medication would dissolve in 12 to 15 hours. Finally, they found one maker that met their standards so they could dispense the drug.

Another discovery featured rapid-release Tylenol that wasn’t so rapid. It dissolved slower than tablets with the same dose that cost a lot less. Not a health problem, perhaps, but seemingly misleading all the same. A spokesman for Tylenol maker Johnson & Johnson noted that the gelcaps were “rapid release” compared to conventional tablets, not uncoated ones. But how can consumers keep track of such minutia?

Drug Production

A lot of the hue and cry over drug production has occurred as it has moved offshore, driven by cost savings and lax environmental regulations, according to testimony submitted to Congress by Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. Although the FDA evaluates drugs for effectiveness and safety prior to approval, a 2016 Government Accountability Office report found that nearly a third of foreign drug establishments licensed by the FDA had not undergone inspection. The FDA says it has now caught up.

However, many think these inspections are inadequate and too infrequent. David Gortler is a former FDA official who is now employed by Valisure as chief medical officer. He feels that every batch of a drug, especially those produced in foreign factories, should undergo testing.

“It’s really becoming a national health crisis,” Gortler says, “and eventually it’s going to become a national security crisis.”

If You Want Pills Tested

As of January 8, 2020 the recall on products containing ranitidine was still in effect. Check here for updates. If you’d like to use Valisure to check your own prescriptions, you can learn more about the company and contact them here or by calling 833-825-4787. Currently, it is the only U.S. pharmacy testing every batch of medicine it dispenses. It will also test pills that you have received from other sources. However, it cannot test medications paid for by government programs including Medicare and Medicaid, nor accept controlled substances, nor analyze biological drugs such as insulin. 

Click below for the other articles in the April 2020 Senior Spirit


Blog posting provided by Society of Certified Senior Advisors