Generic Medications

By Barbara E. Amsler, MD

Over the past several years, there has been a growing push to switch patients to generic medications. The primary reason for this push is to reduce the cost of healthcare. Financial incentives are given to pharmacists who successfully convert brand name prescriptions to generics and insurance companies are forcing formulary generic compliance by making the brand alternative cost prohibitive.

Many physicians and patients are reluctantly forced, due to huge increases in co-pay costs, to yield to pharmacy plans and insurers as they push for generics. For financial reasons, patients change from medications that have worked well for years to a generic alternative.

In some cases, the generic is a reasonable choice and is equivalent to the brand name. This is particularly true when the original pharmaceutical manufacturer makes the generic. However, an increasing number of generic medications are made abroad with widely varying standards of production.

According to the FDA, the content of a generic medication must be within 20% above or below the brand dose. The actual value will vary from one generic house to another and hence when a pharmacy switches houses, the dose of the medication may change even though the prescription has not. People who were controlled on their medication no longer may be.

Thyroid medications are particularly difficult because the 40% swing (20% above to 20% below brand name) represents a change of almost 4 brand dose sizes. Even one dose above or below the correct one may cause symptoms. Brand names, on the other hand, are held to very strict quality control measures with the doses and pill composition.

The article below, touches on some of the frightening risks associated with generic medications. The FDA can not possibly keep pace with the billions of doses of  medications coming into the United States. We must all be wary consumers.

When switching to a generic, watch for any new symptoms or changes in side effects. An alteration in size, color or properties of the pill should alert you to a new generic manufacturer. Remember, it is critical to follow-up with your doctor to ensure that your medical issue is being controlled after switching to a generic.

Here is the article:

Gardiner Harris has written a powerful front-page story for the New York Times titled “Medicines Made in India Set Off Safety Worries” (Feb. 15, 2014). If anything, the headline downplays the seriousness of the problem. Here is the first sentence of the article:

“India, the second-largest exporter of over-the-counter and prescription drugs to the United States, is coming under increased scrutiny by American regulators for safety lapses, falsified drug test results and selling fake medicines.”

We have been warning about drugs imported from abroad for more than a decade. That’s because readers of our syndicated newspaper column and visitors to our website have been telling us for years that there were problems with the generic medicines they were taking. At first we were skeptical of these protests, thinking there might be a psychosomatic component to some people’s bad experience. (We had long been big supporters of generic drug quality and the savings that can be gained by substituting generic for brand-name medications. It was hard to accept that we might have been overly enthusiastic.)
Eventually the sheer number of complaints and the compelling nature of the stories convinced us that there was something very wrong with the way the FDA approved and monitored generic drugs. The article by Mr. Harris confirms that there is indeed a scandal of immense proportions that has pretty much been ignored by physicians, pharmacists, patients, regulators and Congress. Here’s the straight and skinny.
India now supplies roughly 40% of the active pharmaceutical ingredients found in our prescription and over-the-counter medications. Until recently, the FDA was incapable of inspecting most of India’s manufacturing plants. It didn’t have the resources or the manpower. New legislation has allowed the FDA to accept money from the generic drug industry to speed drug approvals. Some of those funds also go to inspections. Last year the FDA visited 160 Indian manufacturing facilities, triple the number from four years ago.
In the process the FDA has uncovered fudged data, shoddy plants and questionable quality control in a number of facilities, including India’s largest drug maker, Ranbaxy. Just recently, the FDA banned all active pharmaceutical ingredients made at Ranbaxy’s Indian facilities from the U.S. market. This was one of the first large foreign generic drug makers to make a splash in the U.S., starting its exports to this market in 1998. Perhaps coincidentally, that was the year we began to receive enough complaints to make us start to question our trust in the FDA’s ability to guarantee generic quality. Here is just one example of the kind of story we were receiving from readers at that time:
“I have been treated for hypothyroidism for over thirty years, and have been on Synthroid 0.125 mg for the past ten. This year my doctor wrote the prescription for a generic at the same dose.
“By the fourth day on the generic, I felt as though I was on the end of a tightly coiled spring. I couldn’t sleep; I had a slight case of diarrhea; I was sweating more than usual and my heart felt as though it would pound out of my chest. When I finally realized all this might be due to the change in medication, I had the pharmacist give me Synthroid instead. Almost immediately I calmed down, my heart stopped pounding so hard and I was back to my normal self.” [published May 18, 1998]
We now know more about the flaws in the Indian drug regulatory system. The head of the Indian drug monitoring program is G. N. Singh. In response to a question about quality control he replied that, “If I have to follow US standards in inspecting facilities supplying to the Indian market, we will have to shut almost all of those. We are not the US, the infrastructure and resources available there are much different from those in our country. Our priority is to make medicines available and affordable to all.”
If the goals of Indian regulation are availability and affordability over quality, then it is little wonder that the FDA officials are finding problems. It was alarming to read in Mr. Harris’s article that many generic drugs are under the supervision of state health departments in India rather than the national authority. He points out that:

“The making of medicines that have been on the market at least four years is overseen by state health departments, many of which are corrupt or lack the expertise to oversee a sophisticated industry.”

The other large supplier of generic ingredients and products to the U.S. and the world is China. The former head of China’s national drug regulatory authority was executed for corruption in 2007. He had taken office in 1998, the year we started hearing from our readers about increasing problems with generic medications. The FDA has historically had difficulty making unannounced inspections of drug manufacturing facilities in China. Here is whatGardiner Harris of The New York Times has to say about oversight there:
“Using its new revenues, the F.D.A. tried to bolster its staff in China in February 2012. But the Chinese government has so far failed to provide the necessary visas despite an announced agreement in December 2013 during a visit by Vice President Joseph R. Biden Jr., said Erica Jefferson, an F.D.A. spokeswoman.
“The United States has become so dependent on Chinese imports, however, that the F.D.A. may not be able to do much about the Chinese refusal. The crucial ingredients for nearly all antibiotics, steroids and many other lifesaving drugs are now made exclusively in China.”
Despite all these concerns, the FDA still maintains that generic drugs are “identical” to brand names and that“FDA requires generic drugs have the same high quality, strength, purity and stability as brand-name drugs.”
If you are having some doubts about the FDA’s ability to guarantee quality in drugs from foreign manufacturing plants, you may want to get the rest of the story. Twelve years ago we interviewed key players at the Food and Drug Administration about these very issues. You can read what we discovered in our book, Best Choices from The People’s Pharmacy. More recently, we uncovered another scandal at the FDA involving the process for approving generic drugs. We document those problems in our book Top Screwups and also provide guidelines on how to use generic drugs more safely in our Guide to Saving Monehy on Medicine.

karinGeneric Medications

Comments 3

  1. Anthea Estergard

    Hi, Dr. Amsler,
    Thank you for your comments suggesting some things the patient can watch out for when forced to substitute a generic. Otherwise, we feel rather helpless in the middle of the unexpected changes. Something similar happened to me. My insurance company informed me I could no longer receive coverage for Avalide, which I had taken for years, unless I paid about a $200 increase for each bottle. They would now only cover the generic, so I reluctantly switched, and am still not trusting the generic.

  2. Gareth Sitz

    I will continue to refuse generics for my two primary medications, as I have had the concerns you mention here. Thank you for confirming what I’ve felt for years.

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