Generic drugs not as effective as brands? Show us the evidence.

Consumer Reports has long advocated the use of generic drugs because they are not only as effective and safe as their branded counterparts but cost less too. So when a segment aired last week on the Today Show that warned about the use of generic drugs to treat epilepsy and other disorders, based on a feature story from the June issue of SELF magazine, we took note.

There have been many anecdotal reports of epilepsy patients who noted an increased numbers of seizures after switching to a generic drug from a branded drug (or even from one generic to another). That is not a new story. But anecdotes don’t prove cause and effect. However, this issue has been observed by neurologists for many years, despite the available scientific evidence that finds generic drugs have the same effect in the body as the brand-name drugs. But reports—from both patients and physicians—of problems occurring when switching supposedly identical drugs continue to crop up. Clinical trials could help resolve this issue, but as far as we are aware, no trials have been done or are in the works.

This crux of the problem revolves around a few drugs that have what is called a "narrow-therapeutic index," which means that the drug is effective and safe within a small dosing range. Too little active ingredient and the drug doesn’t work; too much and it becomes toxic. While this may be a real concern, the FDA makes it clear that their criteria for approving generic drugs takes this issue into account and ensures that generic drugs are just as safe and effective for patients as the branded medicines.

One major, recently published systematic review of studies of certain drugs to treat cardiovascular disease—including studies of a few drugs with narrow-therapeutic indices—showed no difference in patient outcomes when patients used a generic or a brand name drug.

What we find interesting is that the subject of generic efficacy and safety rears its head every few years, and especially now as several popular branded drugs to treat epilepsy have been recently scheduled to go off-patent*: Lamictal (lamotrigine), Keppra (levetiracetam) and Depakote (divalproex sodium). Once that happens, generic drug makers can copy the brands and sell them for substantially less. Last year, consumers and their insurance companies spent about $3 billion* on these three drugs alone in retail sales, placing them among the 100 top-selling drugs.

Clearly, drug makers have a huge financial interest in keeping their branded drugs to treat epilepsy on the market and free from competition from low-cost generics.

Besides the issue of drugs to treat epilepsy, the Today Show host also warned viewers that most generic drugs are manufactured overseas. What was not mentioned is that the majority of bulk pharmaceutical ingredients used by manufacturers to produce drugs in the U.S. are also manufactured overseas*, according to the FDA.

Along those same lines, our recent analysis of drug manufacturers found that from 2004 to 2008 generic drug companies actually received fewer FDA warnings about manufacturing problems than did branded manufacturers. That's particularly notable, since there are far more generic than brand-name drugs on the market. Overall, generic drugs appear no more likely than brand-name drugs to pose risks, according to our review of available data and interviews with experts.

Indeed, we agree that the FDA must improve its inspection of overseas drug manufacturing plants. The FDA admits* that at their current pace, it would take 13 years to inspect all drug manufacturers overseas, compared with 2.7 years for domestic plants. So we applaud the FDA’s move to open new international offices to help correct that problem. We also eagerly await any government-funded, head-to-head trials that compare generic drugs to branded drugs, especially drugs to treat epilepsy, or other medicines with narrow therapeutic indices.

We continue to do our part to help consumers make informed choices by offering our Best Buy Drug reports, which are based on a rigorous analysis of the scientific evidence, and often recommend generic versions of older drugs because—in addition to being less costly—they frequently turn out to be safer and just as effective (sometimes more so) than other, newer and expensive brand-name medicines used to treat the same condition.

In the meantime, when your physician prescribes a drug, ask if there is a generic version or a therapeutic substitution that would be just as effective and safe, but less costly. The evidence, to date, should encourage and form the basis for such inquiries. But, bear in mind that some physicians, because of their own or others’ observations may not want to take even a theoretical risk that would not be in the best interests of their patients.

—Consumer Reports Health editors and medical advisors

* Links to PDF

Image: sillyishrose

Comments

[Original Blog]

The controversy "Brands versus Generics" has been continued on for years. Will there be a definite answer? It would require the generic manufacturer to conduct well controlled studies to provide the clear prove their medications are as effective as the "brand name".

[herbal biz]

EXCELLENT BLOG ENJOYED READING GOOD CONTENT

[RichardMW]

Reply to George Jonah, who suggested testing dissolution times of generic vs. brand tablets in a glass of water.

Wrong test.

You need to test dissolution times in the stomach fluids to see if there is a difference. Your stomach is not filled with water. It is filled with acids and enzymes. The time it takes to dissolve a tablet in your stomach is very different from the time it takes to dissolve in water.

A more accurate test would be to dissolve the tablet in an acid solution, like Pepsi Cola. Everything dissolves quickly in a cola solution.

The FDA test criteria for allowing generic drugs to be marketed is to look at the concentration of the active ingredient in your blood about an hour after you take the tablets. The FDA requires that generics show the same concentration as the brand name if they are to be marketed.

The problem addressed by the CR article is that the FDA currently does not do quality tests of prescription drugs after they are on the market. That concern effects both generic and brand name drug manufacturers.

[george Jonah]

There is now no consumer testing for thier generic drugs compared to brand.

One simple test is the dissolution of tablets which can be done by any one at home.

Place one Brand tablet and one generic "equivalent" in a shot glass side by side. Fill half of each glass with tap water and compare the dissolution in 1 minute and 2 minutes without stirring. You may be surprised at how unlike they react.

[Brian]

One additional consideration regarding my previous post:

Maybe a different standard for equivalence needs to be considered for antidepressants since the true efficacy of an antidepressant (unlike that of a blood pressure medicine, for instance) is ultimately measured in subjective terms: how it makes the patient feel. This is because researchers don't know precisely how antidepressants work -- therefore an equivalence determination based on objectively measurable criteria alone is not possible. This means that a finding of equivalence is problematic in the case of antidepressants. One of the many questions that this issue begs is:

If a Brand Name antidepressant makes one feel Great, what would the equivalent drug need to do? make someone feel OK?

[Brian]

One reason there may only be anecdotal evidence for generic drug shortcomings is that there is no economic interest in proving that the pills are not effective. We need a thorough impartial investigation that is not funded by the drug companies (nor, of course, by any consumers with an axe to grind). My doctor tells me that the efficacy requirements for antidepressant generics are as low as 70% for certain overseas manufacturers. To say that 70% efficacy is equivalent to the full medication is not just misleading, but a lie. Also, patients receiving generics should be informed how the FDA and overseas manufacturers are using the term "equivalent" -- because it is apparently NOT in the sense that everyone commonly understands it.

I have experienced depression relapse last year -- and the doc said to try regular prozac versus the blue pill that I was getting from India. I know this evidence of mine is just anecdotal, but I felt better almost immediately after switching to the brand medication of prozac.

[Michael]

I had to used Generic in place of name brand when the price got over $100.00 it droped the price $70.00 i asked the pharmacy was there anything to worry about they said its the same thing well when i started takeing them i could not sleep for two days???.

[Lisa Boylan]

The evidence on the concerns about medication switching is not limited to anecdotal evidence. Two recent studies point to the potential dangers of medication switching for people with epilepsy. One is "Case-control Analysis of Ambulance, Emergency Room, or Inpatient Hospital Events for Epilepsy and Antiepileptic Drug Forumation Changes." http://www3.interscience.wiley.com/cgi-bin/fulltext/120696410/PDFSTART?CRETRY=1&SRETRY=0
Another is a recent study published in "Neurology" magazine, "Generic Substitution in the Treatment of Epilepsy," http://www.neurology.org/cgi/content/abstract/71/7/525 which found that changing from a brand antiepileptic drug to a generic may result in seizures. For more information about epilepsy and switching medications, visit www.epilepsyfoundation.org

[Ann Ricci]

Why don't you make it more known to people that there are different fillers and dyes and that they are what does make the difference in generic drugs effects on illnesses, instead of making it sound like they are all the very same, not true.

[Martha]

Sometimes generics differ from manufacturer to manufacturer. My son takes generic trileptal. One brand worked great, when I refilled it at another pharmacy I noted that it looked different but really didn't think anything about it. By evening he'd broken out in a rash and was very irritable. I called his psychiatrist who sent me back to my original pharmacist to get the first brand. He said the filler and dyes used in the second one could have been the culprit. So we have "brand necessary" - his script is written for the generic made by a certain manufacturer.

[alyssa]

as a person who was switched to a generic that did not work the way it should have, it's hard to swallow this bitter pill. pun intended.

i believe that most generic drugs are fine and work well. but when they don't, the few of us who need the brand name are penalized financially and health-wise.