There's a small ray of sunshine due to happen this year. Several block buster drugs lose their patent protection this year and will go generic. This isn't a new story. These patent expirations were predicted in 2007. Lipitor, Plavix and Singulair are just 3 of the drugs due to go generic this year.
This should be a boon to people on statin drugs and asthma sufferers, but will these price drops go through?
The short answer is maybe.
The United States purchases upwards of $250 billion per year in prescription drugs - an attractive market indeed. The way pharmaceutical companies plan to keep their market is by retiring less profitable generic drugs and introduce new drugs under a patent.
One Last push for Profit
First off, these drug makers are hiking the cost of these drugs to take advantage of the last year or two of patent protection. This will make the generic price drop look more dramatic.
Removing Drugs With Expiring Patents From Market
Finding quasi legitimate reasons to remove less profitable drugs from market has developed over time. A couple good examples of how to do this include Seldane and albuterol; two allergy/asthma medications with very different outcomes.
Just before Seldane was to lose it's patent protection it was pulled from the market because if it is taken in combination with other drugs, a heart arrhythmia can occur. The U.S. could have gone the same route as the UK (where Seldane is still sold) and simply put in a couple safeguards regarding the prescription of Seldane, but no; Seldane was pulled from the market and Allegra, a "me too" drug was introduced with full patent protection for another 20 years. Allegra is now OTC and you can bet Sanofi-Aventis is looking hard for it's next patent protected drug.
Albuterol is an asthma rescue inhaler that had been available as a generic for quite some time. The problem was the propellent was not environmentally friendly. This affected all CFC propelled asthma inhalers. The CFC's were replaced with HFC's which allowed for all the CFC asthma inhalers to get new patents. The cost of albuterol (and the other generic inhalers) went from $5-10 with CFC's to $30-60 with HFC's - a big win for pharmaceutical companies.
Singulair is being reviewed by the FDA over safety concerns. The concern is troubling - suicidal behavior, but where was this concern 10-20 years ago? Why now? Why do the review just before the patent expires? Another troubling concern is that if Singulair is removed from the market, then these patients will be placed on steroidal therapies that are even more dangerous, but in a different way. Plus, there seems to be little cross analysis of looking at the population that takes Singulair and comparing it other mood disorder risk factors. Chances are very high that both populations intersect at teenagers, but that isn't in the analysis - yet.
Other drugs with expiring patents and increasing litigation costs include Avandia, Seroquel, Fosamax and Effexor. Again, where were the warnings on these drugs 15-20 years ago?
The Free market Kills Generic Drugs
We have some peer reviewed evidence that suggest that generic drugs are just as effective as brand name drugs in treating diseases and conditions, but resistance to generics continues. The cost savings are easily documented. The anecdotes of individual patients and physicians hold sway over double blind studies which supports the idea that a single person's story is a dramatic, compelling call to action where as a well plotted and executed study is, well, just boring statistics.
Generic drugs are less profitable for the manufacturers and to borrow a GOP tub thumper, why should these corporations continue to make drugs that aren't profitable? This attitude has led to some critical drug shortages and some drugs are simply no longer available. So, there does need to be some financial incentive to drug manufacturers to continue to make generic drugs available for market. The question then becomes, "When is enough, enough?"
I heavily criticized the orphan drug approval of Mekana that prevents premature births. I get the profit motive but a quadruple digit price hike is hard to swallow; however, going from $10 to $1,500 is 150 times the original price, is mind boggling - not just "a bit excessive". Especially since KV pharmaceuticals used FDA clinical data in their orphan drug application. Some say that the FDA didn't have the authority to negotiate the price, but gee, I don't know; maybe they didn't have to award orphan drug status to Makena.
The problem is that the U.S. pursues greed based medicine. We reward it by hopping on the bandwagons of every new drug trotted out in flashy, DTC advertising. We're turning drugs into a fashionable lifestyle enterprise, which is tragic since we do it at the expense of our bodies.
Profit First, Religion Second, People's Lives a Distant Third
Is the FDA looking out for our health or pharmaceutical corporate profits? Politics often prevails over good sense in the FDA as we saw in the delayed approval of OTC Plan B and the crappy recomendation of HPV vaccines for teenage boys. I ran across this article on the intertubes and think this author sums up the situation quite well.
I would like to believe that the FDA prevents public exposure to dangerous drugs; unfortunately, I cannot. The agency’s history over the last 40 years can only lead one to believe that the public’s health is not its first priority. Sadly, it appears that its primary concern is the bottom line of the pharmaceutical industry it is charged with regulating.
And, I'll add that the FDA continually appeases religious leaders and allows religion to yank the the FDA's chain. The religious leaders who want a theocracy instead of a democracy drive science policy based upon their idea of utopia instead of reality. There was little reason to delay making Plan B OTC and there's a good reason to require HPV vaccines for all children as we are seeing a huge increase in oral HPV related cancers. Yes, I get that many religions prohibit sex outside of marriage. Unfortunately, I don't believe the members of these religious institutions practice that prohibition very effectively and religion shouldn't trump facts in medical policy.
Shouldn't We Be Grateful For the Patent Expirations?
I am delighted that some people who are on Lipitor and Plavix have the possibility of reduced costs to stay on their drug therapies. It's just that if past behavior is any prediction of the future; we'll need to stay tuned for the other shoe to drop.