Generic drugs: are they really ‘exactly’ the same as brand name drugs?

Joe Graedon, who has been writing about pharmaceuticals for three decades and runs a consumer advocacy website, The People’s Pharmacy , was 100% behind generic drugs for many years. “We were the country’s leading generic enthusiasts,” he told the New York Times in November.  But over the last eight or nine years, Graedon began hearing about “misadventures” from people who read his syndicated newspaper column, also called The People’s Pharmacy.

The stories were typically from patients who were switched from a brand name drug to a generic one, and then had side effects or found that their symptoms returned — or even became worse than before they were medicated.

Most recently, Joe Graedon has been hearing complaints on his website about generic forms of the anti-depressant Wellbutrin XL 300mg (known as Budeprion XL 300 in one generic form*), the heart medicine Toprol XL (metoprolol succinate) and the anti-seizure medicine Keppra (levetiracetam). His opinion?

“Consumers are told generics are identical to brand name drugs, but that is clearly not always the case.”

The term generic drug, according to Health Canada, is used for products that contain the same medicinal ingredients as the original brand name drug, but which are generally cheaper in price. The principal difference between them is that only after the patents on brand name drugs have expired may a generic company produce their products. Nearly 30% of all prescriptions filled by pharmacies use a generic brand, and hospitals use generic drugs a lot. Chances are that you have received a generic drug at some time, whether you realize it or not.

The ingredient in any drug that helps to make you feel better is called the medicinal or active ingredient. Joe Graedon adds:

“Government regulators maintain that all generic drugs are identical to their brand name counterparts. Of course, the word ‘identical’ does not mean the same thing to everyone. Most of us assume that identical means exactly the same. For example, identical twins have the same exact DNA. If you drop your iPhone down the toilet and want to replace it with an identical iPhone, you can be confident that your new iPhone will be exactly the same as the old one.

“Regulators, however, have a different definition for ‘identical’, especially when the word refers to generic drugs: ‘A generic drug is identical–or bioequivalent – to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use’ says the American Food & Drug Agency.

“What the FDA does not tell you in this sentence is that generic drugs can have different inert ingredients or fillers.”

While the FDA categorically insists that generic drugs are indeed as safe and effective as brand name drugs, the Agency is investigating Graedon’s claims.

Dr. Harry Lever, a cardiologist at the Cleveland Clinic, actually shares Graedon’s concerns about the number of patient complaints. In particular, he has been puzzled by occasional reports from patients that they fared better on the brand name drug Toprol XLa beta blocker drug used to treat cardiac conditions such as high blood pressure – than they did when taking the generic version. Since the time-release formula of the generic Toprol is not identical to the brand name, Dr. Lever now claims it may not be as effective.

His suspicion was heightened earlier this year after two pharmaceutical companies, Sandoz and Ethex, stopped producing the generic version. FDA inspections found that both companies were not following manufacturing guidelines.

But not every expert agrees that generics are not every bit as effective and safe as expensive, widely-advertised brand name drugs. According to Harvard Medical School’s Family Health Guide:

“Researchers from Harvard-affiliated Brigham and Women’s Hospital identified 38 randomized controlled trials (the gold standard of medical research) that measured a clinical or safety endpoint in tests of ACE inhibitors, beta blockers, statins, and other cardiovascular drugs. In 35 of the 38 studies, the brand name and generic drugs worked equally well. In the other three, the differences were small and unrelated to the drug’s action (Journal of the American Medical Association, Dec. 3, 2008).”

This publication adds that most people who change to a generic drug notice only the savings – sometimes modest, sometimes spectacular.

“Take Toprol XL, for example. Instead of paying $520 for a year’s supply of this beta blocker, you could get generic metoprolol for $240. Big Box chain stores offer an even sweeter deal — hundreds of generic medications, including metoprolol, for just $48 a year.”

Keep in mind that all major drug companies would, of course, have you believe that the newest, most expensive, brand name drugs are always best, and have used powerful marketing tactics to actively discourage consumers from asking for generic and other classic drugs. According to PharmedOut.org in their report called Fast Facts On Generic Drugs:

“Demanding older, classic drugs will not only personally save you money, it will help drive down health care costs. It may even decrease your chances of drug-related adverse effects.

“Taking classic drugs is a sound health care decision. Don’t let fancy packaging and glossy ads tell you otherwise.”

Read more about Joe Graedon in the rest of the New York Times article.

* Read more about the FDA’s statement on the generic antidepressant  Budeprion XL 300 that was recalled in October 2012 for being “not therapeutically equivalent to Wellbutrin XL 300 mg.”

See also:


What do YOU think about generic drugs?

11 thoughts on “Generic drugs: are they really ‘exactly’ the same as brand name drugs?

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  5. Hi Carolyn,

    Yes, I agree. Having atrial fibrillation, I was taking Toprol XL years ago to control my rate. It didn’t work nearly as well as the generic Metoprolol that I have been taking for the last 10 years. I’m sure that there is a HUGE placebo effect with brand name drugs, especially if the doctor believes that they are better. I’m sure many do. Patients do want to “please” their doctors.

    Dan

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  7. I have a daughter with OCD and depression. I have documented her through out her childhood. In high school we saw significant changes with in weeks from switching her meds from generic back to name brand. I have the conference reports of several teachers to back it up. I’m not saying this is always the case but it can and does happen!
    Becky

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    • I have been taking Lexapro, brand name, for about 18 years, for depression with great results. I switched to the generic equivalent about 7 years ago and within 3 months I went downhill rapidly. I had to go back on the brand name. But now, the brand name costs me over $700 for 3 months which I think is outrageous. I have written to the company with no response. I am now 87 years old, in good health, physically fit but on an adequate but fixed income. What is someone like me supposed to do to pay for these exorbitant charges for necessary medications?

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  8. What I find odd is why on earth anticonvulsants are given in generic form. We’re talking about seizures that can end your darn life for goodness sakes. One bad fall, one status epilepticus event and it’s good bye life. You’re dead. There should be a law that it’s ILLEGAL to give anyone with epilepsy a generic anti-convulsant aka anti epileptic drug (AED)

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  9. The question is incomplete. Rephrase it to:
    Are all Generic Drugs, no matter where manufactured, no matter how distributed, exactly the same as brand name drugs?

    Unless there is proof otherwise, I suspect that the testing to establish the utility of generic drugs was performed on samples from manufacturers of known merit. Likewise, hospital purchasing agents are likely cognizant of which suppliers to use and which to avoid. A longer distribution chain of an assortment of distributors and brokers affords greater opportunities for substation of counterfeits. What criteria do your vendor of generics use – lowest cost or known good quality? If you are harmed, is the government of the generics source country likely to help or impede you in seeking redress?

    See a recent article in The New York Times (February 15, 2014, p. A1 entitled “Medicines made in … set off safely worries.” Phrases in the article include “… falsifying drug test results …”. “… selling fake medicines …”’ … the world health organization estimates that one in five drugs made in … are fakes. “… 100,000 useless pills continued to be dispensed …”

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