The Danger of Generic Drugs
It is very common for people to conflate generic drugs with their brand-name counterparts, but according to Jeremy Greene, a historian of medicine at Johns Hopkins, “The average American has a series of assumptions about generic and brand-name drugs that don’t hold up to historical scrutiny.” This conflation will become even more relevant if Donald Trump takes a crack at lowering pharmaceutical prices.
Any solution coming from the White House will most likely involve the empowerment of the generic drug market, an idea supported by some due to the $230 billion that were saved in 2015 because of generic medicines. The president would also like to rescind a measure blocking the federal government from negotiating drug prices, a move that has historically been supported by the Democrats.
All Prices Rising
However, though it’s true that Trump came into the Presidency amidst a 5,000 percent increase on the toxoplasmosis treatment Daraprim and a 400 percent increase on EpiPen, an anti-allergic injection, he must also face the reality of a rise in the price of generic drugs. Prices for around 400 generic drugs went up 1,000 percent between 2008 and 2015. So shifting the focus to generics may not be the panacea for our pharmaceutical woes.
Release Mechanism
What exactly are the differences between generic and brand-names medicines? To begin with, the synthesis of a drug like Cymbalta involves, not only the combination of active ingredients, but the development of a release mechanism. Many anti-depressants control the pace at which the medicinal substance is absorbed.
Patent Control and Emerging Markets
The point is that this mechanism is protected by its own separate patent, meaning generic companies must develop their own version. In some cases, the generic version of the release mechanism is not as effective as the brand-name version, a problem currently being considered by the FDA. According to the agency, one-third of the of top 200 prescribed drugs use modified release mechanisms. The FDA acknowledges in its ongoing study that generic producers need “tools that can assess the risks related to change in release mechanism.”
With the expansion of the global market, more and more pharmaceuticals are being produced off-shore in countries such as India and China, where, according to the FDA, there may have been some number-fudging in quality control tests. The FDA has had a hard time dealing with this issue because of a diminished staff.
Complaints
There are two widely circulated generic versions of Cymbalta: Lupin Ltd. (from India) and Teva Pharmaceutical Industries Ltd. (from Israel). When these generics were first sold in 2014, the FDA received 262 complaints from patients who had switched from Cymbalta to the knock-off drugs, according to an internal report obtained by Bloomberg. A majority of the complaints were in regard to Lupin and Teva, with 61 complaints directed at the former and 47 at the latter. Perhaps most troubling is the fact that these companies refuses to acknowledge any risks. And even more troubling than that? The FDA concurs.
FDA in Denial
Sandy Walsh, an FDA spokesperson, said all generic versions of Cymbalta are safe to use. She reasoned, in an email to Bloomberg, that new generics “tend to elicit a large number of patient complaints typically within the first year after approval.” This is somewhat surprising considering that the European Medicines Agency recommended suspending Lupin generic drugs (and others) because the company used flawed research from the Semler Research Centre to show that its release mechanism operated in the same way as Cymbalta. And Teva was forced to take a drug off the market in 2012 after discovering the release mechanism was ineffective.
With so many complaints and an insufficient number of FDA investigators in foreign offices, one hopes more is done to regulate these dangerous drugs.
Leave a Reply