While many people tolerate the differences between generic and brand-name formulations, some of us—as I learned the day I found myself bleeding in the driveway—do not. When I went looking into those differences, I found significant evidence to support this conclusion. Yet for the most part, western medicine insists it cannot be true.Ever since the 1984 Hatch-Waxman Act cleared the way for the wide-scale marketing of generic drugs in the U.S., the FDA has required that generic drugs have the same active ingredient, strength, and dosage form as brand names. “The generic manufacturer must prove its drug is the same (bioequivalent) as the brand-name drug,” said Sandy Walsh, an FDA press officer, in an email. Given that generics make up close to 90% of the U.S. drug supply, and that Americans spend around $300 billion a year on prescriptions, a lot is riding on this system working—about $117 billion a year.Most people think generic medications are identical to brand-name drugs; I certainly did. After all, that’s what pharmacists, insurance companies, and doctors tell us. But it’s not exactly true.
Richard Hansen, dean of Auburn University’s Harrison School of Pharmacy, points to another contributing factor: the nocebo effect. People expect generics to cause more side effects and be less effective, so that’s what they experience. Hansen calls this the public perception bias. “There’s actual clinical studies that show if you give 100 people the exact same thing but tell half of them that they received a generic, the half you told are going to have more adverse events and lower efficacy,” he said. His solution: education. Teach people that generics are just as good as brand-name drugs and their attitudes will change.The road to generic approval is a lot shorter.
“We’ve got a lot of companies that lie, that manipulate data,” said Joe Graedon, a pharmacologist and co-founder of the pharmaceutical watchdog site People’s Pharmacy. “There’s examples of fraud left and right. Quality control has been clearly a huge problem both in China and India but many other countries as well, and the FDA is probably not monitoring many of these countries as well as it should.”Pharmaceutical companies like Ranbaxy, a former Indian manufacturer, deliberately falsified data to fool regulators, lying to regulators about safety tests and results and then covering up those lies with more falsehoods.
Many psychiatric drugs fall into this category, which might explain why they’re among the most problematic. Studies of antidepressants like Effexor and Celexa, along with anti-psychotics like Risperdal, Clozaril, and Dogmatil, all highlight the fact that some patients do worse on the generic versions than on the brand-name medications. Research on other drugs with narrow therapeutic indexes, or NTIs, like cardiac drugs, immunosuppressants for transplant patients, and epilepsy drugs suggest similar discrepancies, though other studies on seizure medications showed no significant differences between brands and generics. “The narrow therapeutic index drug class, those are tricky,” agrees Jingjing Qian, an associate professor in health outcomes and research at Auburn University. “But in order to verify if that difference is perception or real difference—that needs more research. And there’s no incentive for industry to study generic drugs.”While many people tolerate those kinds of discrepancies, many don’t. And they might never realize that the problem is the generic version they’re taking rather than the medication itself.
Last September, the Trump administration approved a plan to let states import cheaper medications from Canada and elsewhere, though it is still unclear how exactly this will affect consumers. Several years ago AARP, whose more than 38 million members take an average of 4.5 medications apiece, announced an initiative called Stop Rx Greed, inviting people to “tell Congress to stop Rx greed and cut drug prices now!” Media coverage about profit-hungry pharmaceutical companies like Mylan, the makers of EpiPen that infamously jacked up its price 400 percent, make it politically untenable to do anything that makes the situation worse for consumers.“There’s no plan B for our drug supply,” Eban told me. “We’re facing critical drug shortages, we are reliant on these medications, and there is no meaningful price regulation for brand-name drugs. There is a tremendous amount of political pressure for these low-cost generics.” In a recent story about Eban’s book, published in a trade magazine for biopharma executives, a reviewer commented, “The entire U.S. pharma industry is under attack for its pricing policies, so who wants to question the quality of generics . . . that keep drug costs down?” Who indeed. We’d much rather believe that patients who report issues with generics are biased or victims of misperception because if they’re not, if they’re right about these problems, the whole system is screwed.So where does that leave people like Erica Smith, Charlynn Schmiedt, and the rest of us who have struggled with generics? Awareness is key, starting with awareness of our own perceptions and behaviors. While reporting this story I bought a pill dispenser so I could, as Michel Berg suggested, practice better medication hygiene. But we also need to be aware that there are major manufacturing and safety concerns with some generics. If you think something’s wrong with any medication, generic or not, report it on the FDA’s MedWatch site so the agency can track complaints about it and, ideally, investigate. There is clear scientific evidence that some drugs do affect some people differently, no matter what doctors and pharmacists and insurance companies say. LeClerc of the University of Quebec thinks people need to learn to advocate for themselves when things don’t feel right, and medical professionals need to listen. “When we listen carefully to patients, they say there is something wrong once they switch [from a brand to a generic],” she said. “It cannot only be in their heads.”Raising these kinds of questions about generics is deeply unpopular. And it’s understandable, in a way, because our healthcare system relies so heavily on generics.