Most people assume that a drug is a drug – that Lipitor, for example, or a generic version, is the same anywhere in the world, so long as it’s made by a reputable drug company that has been inspected and approved by regulators
That, at least is what journalist Katherine Eban, in her new book says “ is the logic that has driven the global generic-drug revolution: that drug companies in countries like India and China can make low-cost, high-quality drugs for markets around the world.
The problem is the manufacturing standards are different depending on the country buying their drugs. Generic drugs are safe and effective as brand name drugs.”
While these generic drug manufacturers take their biggest swaps of high-quality to low-quality ingredients, Eban writes, the countries that receive the short-cut produced drugs are markets with very poor regulation such as sub-Saharan Africa, Southeast Asia, and areas of South America.
Often health insurance plans require patients to switch to generics as a way of controlling costs. Eban warns that some of these medications might not be as safe, or effective as we think.”
Most of the generic medications being sold in the U.S. are manufactured overseas, mostly in India and China. The U.S. Food and Drug Administration states that it holds foreign plants to the same standards as U.S. drug makers, but the FDA often announces its overseas inspections weeks in advance, which gives plants where generic drugs are made the chance to fabricate data end results. When I asked the FDA to confirm this, I did not receive a response.
CBS News in a broadcast this year began with: ”It is something we have heard before. Generic drugs are the same as brand name drugs. They contain the same active ingredients and the manufacturers are supposed to prove they work the same way as their brand name counterparts. Many of those generics come from abroad with 80 percent of active ingredients and 40 percent of finished drugs coming from outside the U.S.”
There is also a category of drugs known as “Narrow Therapeutic Index Drugs.” There are different definitions of these drugs, but put simply, it means those pharmaceuticals having a narrowly defined range between risk and benefits.
Different states have different rules and regulations concerning these drugs and how they act. The North Carolina Board of Pharmacy defines these drugs one way, again the narrowly defined range between risk and benefit. Canada defines Narrow Therapeutic Range drugs as having a ratio between the lowest concentration at which clinical toxicity occurs to the median concentration providing a therapeutic effect — less than or equal to two. This came from a report published in 2009 and written by Nathan D. Pope, PharmD. The latter was never a term I heard while I was practicing pharmacy.
Examples of drugs that are NTI drugs are Digoxin, Lithium, Phenytoin, Theophylline and Warfarin.
The U.S. drug supply is not immune to quality crises. Over the last 10 months, dozens of versions of the generic blood pressure drugs valsartan, losartan, and irbesartan have been subject to large recalls.
In Africa, for instance, pharmaceuticals used to come from more developed countries, through donations and small purchases. So when Indian drug reps offering cheap generics started arriving, the initial feeling was positive. But Africa soon became an avenue to “to send anything at all,” said Kwabena Ofori-IKwake, associate professor in the pharmaceutics department at the Kwame Nkrumah University of Science and Technology in Kumasi, Ghana.
Many hospitals also keep a stash of what they call “fancy drugs” — either brand name drugs or higher-quality generics — to treat patients who should have recovered after a round of treatment but didn’t.
Dr. Aaron Kesselman, writing for JAMA, said: “When people hear the word ‘generic,’ they associate it with inferior quality, but for the vast majority of people, generic drugs are as safe and effective as brand name drugs.”
I personally take several drugs, all generic, and am very satisfied with the results. I would recommend that anyone who suddenly has a problem with a drug that formerly was no problem, ask the pharmacist if they were dispensing a different manufacturer than before. Your physician is your best guide to whether your medical condition requires a brand name drug when a generic is available, not your insurance company.
Bertram Drachtman
Great Neck
