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Wednesday, 9 October 2013

Generics - It's More Than an Image Problem

There was an article called "Bad Rap on Generic Drugs" in the New York Times on October 5th, 2013. The article found a lot of skepticism about generics, not only among the poor and disadvantaged but also among doctors. In this study designed to "understand barriers to cost-effective medicine use," 50% of doctors who responded to a survey had "negative perceptions about the quality of generic drugs." Dr. William Shrank is the lead of 6 authors listed on the paper.  Three of the remaining five authors are employees of CVS Caremark which also provided a research grant for the study. 

The New York Times article by Katie Thomas went on to discuss other cases that might lead to a lack of faith in generic drugs including the Ranbaxy settlement, and FDA warnings about generic Wellbutrin. These are not the only generics that do not have the same effects as the original brands.
                                   

                                                     
Dr. Shrank is quoted in the article as the lead author of a paper titled "Patients' Perceptions of Generic Drugs".  One of the other authors is a Senior Director of Research at ExpressScripts. That paper details reasons that some groups gave for not wanting to use generic drugs as well as the ways socio-economic status affected purchasing behaviour.

In both Canada and the US generic drugs are required to have a bioequivalence of between 80% to 125% of the brand name "innovator" product. Bioequivalence means that the rate and extent of absorption of the generic drug will produce the same therapeutic effect as the brand name drug. That seems like a lot of flexibility to me.

In Canada we have seen recalls lately on 2 types birth control pills and it has been unclear where either was manufactured. It is not necessary for the drug company to disclose that information.

It should not take years of patient complaints to make a difference as it did with generic Wellbutrin.

I do not yet know about the situation in Canada but I was dismayed to find that in the USA generic drug companies do not share the same level of responsibility as the brand name manufacturer and do not have to update their labels when new risks emerge. In fact the Supreme Court in ruling in 2011 says the rules are different for generic drug manufacturers


                                 Justice Sotomayor. WikimediaCommons

Justice Sonia Sotomayor dissented saying that "These divergent liability rules threaten to reduce the consumer demand for generics... Nothing in the court's opinion convinces me that, in enacting the requirement that generic labels match their corresponding brand name labels, Congress intended these results" (Quote from CNN story in link)

I'm not arguing against all generic drugs. The money required to use brand name drugs all of the time would be astronomical. My worry is that patients are not treated fairly in the 'Save Money, Use Generics' equation and that there are exceptions to every general rule.

We need to do four things:
1. Mandate better equivalency and quality testing on generics.

2. Make generic drug makers responsible for harm done to consumers, in the same way as with brand name drugs (see below).

3. Actually inspect factories where drugs are manufactured for use in our countries.


4. Have an effective appeals process for patients who can't tolerate generics for reasons such as allergies to non medical ingredients called fillers.

The next post will have stories of how this situation affects some real patients.

graphic by dmckinnon ©  

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