A recent article in the New York Times highlighted a very interesting issue: why While the article starts out noting why generics “save Americans billions of dollars each year and give us access to wonderful drugs at affordable prices,” it soon discusses the “gnawing concern among some doctors and researchers that certain prescription generic drugs may not work as well as their brand-name counterparts.”
As a result, the authors assert that although this problem “is not pervasive,” it’s something consumers should be aware of — especially now that more insurers insist that patients take generic medications when they are available.”
The article then highlights “Joe Graedon, who has been writing about pharmaceuticals for three decades and runs a consumer advocacy Web site, the People’s Pharmacy (peoplespharmacy.com), was 100 percent behind generics for many years.” Mr. Graedon told NYT that he began receiving stories from patients “who were switched from a brand name drug to a generic one and had side effects or found that their symptoms returned — or even became worse than before they were medicated.” He even indicated “hearing complaints on his Web site about generic forms of the antidepressant Wellbutrin XL 300 (known as Budeprion XL 300 in one generic form), the heart medicine Toprol XL (metoprolol succinate) and the antiseizure medicine Keppra (levetiracetam).”
Consequently, he acknowledged that while “Consumers are told generics are identical to brand name drugs that is clearly not always the case.”
Other concerns about generic drugs come from specialists such as cardiologists and neurologists, who “are concerned about generic formulations of drugs in which a slight variation could have a serious effect on a patient’s health.” Specifically, the American Academy of Neurology has a position paper that says, in part, “The A.A.N. opposes generic substitution of anticonvulsant drugs for the treatment of epilepsy without the attending physician’s approval.”
In support of generic drugs, “ExpressScripts, which handles drug insurance for big employers, put out a news release announcing results of a study it sponsored that found no difference in hospitalizations or emergency-room visits for people on brand-name epilepsy drugs compared with those taking generics.” The Times also noted that Gary J. Buehler, director of the office of generic drugs for the Food and Drug Administration, stands behind generic medications and its methods for approving them. Mr. Buehler noted that the FDA has “not seen any scientific studies that show generics do not hold up as well as brand name drugs.”
The American Medical Association also came out in support, noting that “as a whole, generic drugs do work as well as name-brand drugs.”
While this support is important to consider, Mr. Graedon felt the need to work an independent laboratory, ConsumerLab.com, to test Budeprion XL, which in other generic versions is typically known as bupropion. According to the Times, “the lab found that Budeprion XL 300 released the active drug at a different rate than the brand name Wellbutrin XL 300. Mr. Graedon and the lab conjecture that the different dissolution rates might be to blame for the reported side effects and lower effectiveness of Budeprion.” In response to such findings, Mr. Buehler at the F.D.A. was “puzzled,” not exactly a comment you want to hear from the director of generics.
In response to such findings, the maker of Budeprion XL 300, Teva Pharmaceutical Industries, recently announced that it would conduct a clinical trial comparing its product against the original, Wellbutrin XL.
The problems with generics that Mr. Graedon found highlight the issues associated with F.D.A rules governing generic drugs. While the rule state that the new generic version must “have the same active ingredient, strength and dosage form” as the brand name or reference product, the only test that a maker of a generic medication must perform to receive F.D.A. approval is one that establishes the “bioequivalence” of the product.
As a result, this test is done on healthy volunteers and compares the blood levels of the reference drug to the generic one. Consequently, some specialists, believe that “this allowable range for bioequivalence is too wide, especially for patients who are taking medication to control problems like arrhythmias or seizures.”
For example, as cardiologist and professor of clinical medicine at Columbia James A. Reiffel noted, “if a patient with the heart arrhythmia known as atrial fibrillation who also has risk markers for stroke gets a blood thinner for which the levels are too low, “there is risk for stroke, and if the levels are too high it could result in bleeding.”
Another example of problems with generics included “two studies published last year in the journal Neurology, which found that patients who switched from a brand-name product to a generic one had more seizures or higher hospitalization rates.” Moreover, as Kimford Meador a professor of neurology at Emory University, noted to the times “if the absorption of the drug is slightly different between brand and generic or between generics, then the patient could have a seizure, and that seizure could lead to serious injury or perhaps even death.”
This problem can be made worse by the fact that some patients are being switched from generic to generic, and may not even know the change is happening because a pharmacy is switching prescriptions based on better deals.
Ultimately, the idea that generic drugs can save Americans billions of dollars while still providing the same relief for their symptoms of various diseases and conditions is still controversial.
While there is a spectrum for all things in medicine as to the risks and benefits of using any treatment—whether generic or brand name—science never lies. The fact that some generics may work for some people and some conditions does not underscore the need for doctors to continue using brand name drugs that were appropriately tested and invested in.
There is a reason why brand name drugs are patented and protected for so many years: because after spending years and billions of dollars on research, the evidence and science shows them to be effective. While allowing companies to use such advances to help treat patients is important for the health of Americans, not every condition or person will see the same benefits from generics as this article clearly highlights.