Generic drugs not all equal and sometimes dangerous
March 11, 2020
As insurance companies push doctors to save money by switching their patients to generic drugs, complaints about those generics appear to be on the upswing. That’s the observation of journalist Katherine Eban, who has written a book, “Bottle of Lies,” that tells a very dark tale about the generic drug industry and the safety of generic drugs Americans are increasingly taking.
“My inbox is full of communications from patients who were on a drug that worked but were switched to a generic that didn’t work,” she told me. “Patients find themselves on a medical odyssey.”
She illustrated her point with a case from a major U.S. hospital transplant center where transplant patients who were switched to an immunosuppressant drug made in India suffered organ rejection. One died, and the other had a “tough stay in the ICU,” she said. Eban also noted the plight of one woman whose depression was stabilized on a brand drug but whose condition worsened when the pharmacist switched her to a generic.
In these cases, the pharmacy made the switch because it could. Many states allow pharmacists to make generic substitutions unless a doctor indicates the prescription must be dispensed as written. Many patients are not aware of those laws, which have been on the books in some states for many years. “If you are taking a maintenance medication, you may not know you’ve been switched,” Eban says.
Hundreds of patients have told Eban that they don’t do well on some of the generics and have no clue why.
But whether you are unknowingly switched to a generic or your physician, under pressure from an insurer to save money, decides to switch you, it’s important to understand the rules of the new pharmaceutical game you’re being asked to play.
That game is increasingly focused on the ingredients that go into generic drugs, which are mainly coming from India and China where Eban’s book shows that good manufacturing practices are often ignored in the name of profits.
Eban described the generic drug industry abroad as a “maze of global deception.”
One company, for example, deceived regulators around the world by submitting fraudulent data that made its drugs appear bioequivalent to brand name drugs. “We are dependent on distant drug manufacturers,” Eban wrote, “yet have little visibility into their methods.”
Eban also found that Americans can’t rely on the FDA to assure that generics made abroad are safe. Although the agency reviewed data from foreign generic drug makers and inspected their plants, it was not systematically testing the drugs. Yet, she pointed out that some 40 percent of the U.S. generic drugs are made in India. Eighty percent of the active ingredients in all of our drugs, whether brand or generic, are made in India or China. We all have a stake in safe and good manufacturing practices from companies abroad.
What Eban uncovered helps explain why that generic drug a doctor prescribed doesn’t work as well as a brand drug. Maybe it has been adulterated to save money and increase profits for the manufacturer.
“The FDA has presented generics as a bargain with no downsides,” Eban said. “But there are hidden costs that are not being examined.” Those costs come when people end up in the ER or in the ICU because a generic has not worked properly. “No one has studied those costs,” she added, noting that such incidents are “very frequent” based on the feedback she’s received.
So how do patients protect themselves if the generic drugs that insurers push us to buy or those given in hospital settings are unsafe? I asked Eban for advice.
She suggests learning more about the manufacturer of your drug. The drug maker is typically listed on the dispensing label. Find out if the manufacturer has been in trouble with the FDA by looking at the inspections, compliance, and enforcement sections of the agency’s website. If the company has received a warning, that’s a red flag.
It’s not possible, however, to find out where your drug was made. No law requires a drug maker to disclose the country of origin for either the ingredients or the manufacturing of the drug itself.
You can also find out if others are complaining about a particular generic that is not working properly. If they are, that helps build the case to get your doctor to switch you to a different brand.