Controversy exists over the growing trend in medicine to prescribe generic versions of medication. They are in most cases less expensive than their branded counterparts. The FDA allows them, so they must be perfectly fine! Right?
Well, no actually! This issue is a perfect example of conflicts of interest.
Branded products go through a rigorous testing process costing the the developer of the medicine millions and millions of dollars. Getting a product that is finally approved to market adds much more to the cost of development. The FDA, on the one hand, insists upon multiple long-term trials in humans before any product can be prescribed and sold.
For several years afterward, the developer of the the medicine can depend upon having no competition so that they can recover at least part of the costs of development.
Once this period has passed, generic manufacturers can come to market with products they claim are “bio-identical”. They must contain the same ingredient as the branded product. But that is where the similarity may end! And the FDA doesn’t require that these products be actually identical.
What significance could there be in this seemingly semantic difference? Well, there is more to the effectiveness of a medicine than merely its ingredients! Consider the example of a musical band. It is made up of several musicians all playing from the same sheet of music. If they all are in tune and on the same note at the same time, it sounds great. However, if one is off key or out of synch, there is just something not right about the music!! It may be hard to hear the deficiency, but it is still there.
Back to generic medications – generic medications may not be absorbed the same way as branded products because, maybe to save money, the generic doesn’t use the same overall formulation as the branded product. The pharmacokinetics (medication availability once taken) may be very different and preclude adequate absorption. It may interact differently with other medications, it may be absorbed faster, slower or not at all when compared to the branded product it replaced. Remember, the generic medication does not go through the same trial as the branded product so there is really no way to know if the generic medication you are taking is, indeed, working as you expect after having taken the branded medication before!
What’s more, until 2015, the FDA had not globalized their inspection authority of the 76% of all drug manufacturers who are overseas. By 2017, only 46% of never before inspected drug manufacturing facilities outside the U.S. had finally been inspected. Why is overseas manufacturing so popular? There is a dramatic difference in labor, energy and transportation costs in the foreign countries where medications are produced. Although inspections are ongoing, they are announced, and the inspections focus on environmental issues rather than formulation issues.
There are at least two glaring examples of this in eyecare. First is the product Xalatan, now marketed in generic form under the name Latanoprost. These are drops for treating glaucoma (link to an explanation of glaucoma here). After Xalatan went generic, we ophthalmologists noticed that some previously well-controlled glaucoma patients escaped control when treated with generic Latanoprost whereas they were well-controlled on Xalatan. Investigators soon realized that there were vast differences between some of the generics and their branded counterparts. Some didn’t work at all, some worked but not long enough between doses, some were irritating more than the branded. When the investigators concluded their work, they revealed that there were some 75 manufacturers of Latanoprost worldwide and they were in many cases both different than the branded product and even from each other! This accounted for why the generic medication was resulting in variable outcomes and for the fact that some glaucoma patients continued to lose vision from their disease despite treatment. The research clearly indicated that the generic needed to be identical in ALL RESPECTS to the branded to be sure it would be effective.
Yet another instance involved the use of NSAID drops. These non-steroidal anti inflammatory drugs are used to assist patients during recovery from ocular surgery and from some ocular inflammatory diseases. Inflammation is very damaging to the eye and can result in loss of vision or blindness if untreated or under treated. Once the branded NSAID product went generic, there were many reported cases of severe damage to the cornea of the eye by some of these products. The cornea underwent structural changes and in some cases the damage was so severe that the vision and eye were lost. Again research investigators determined that the problem was the formulation of the drop containing the generic medication. Remember, the generic product doesn’t get used on a single subject before it is marketed!
Why, then, the great rush to move to generics? Generic medications are a lot less expensive than branded products. The generic manufacturer does not have to recoup the development costs of a medication. The research and development has been done for them. It all boils down to dollars! The insurance companies “recommend” generics since they are less expensive than branded products. The recommendations become a mandate when the patient sees the dramatic difference in price or the the branded product becomes unavailable due to exclusion from the company’s formulary. Herein lies the conflicts of interest- to save money, products that may not be best are being recommended to patients by insurers and informed consent is lacking.
Are these comments representative of ALL generic manufacturers? Certainly not! But how is one to know when every successive refill may be with a generic from a different manufacturer? The point is, using generics is not as dependable as using branded products. If switching from branded to generic, or if using generics routinely, close follow-up is needed to be sure patients do not escape the control they are used to.
We see this every day in our office. We wish patients would understand better the challenges of generic medications. We wish something would change so that patient and doctor alike could be more confident in the medications being sold. Someday, maybe!!