As reports of drug shortages continue, particularly in cases such as cancer treatment, consumers ask why something is not being done to mitigate these shortages. Imagine how depressing it must be when a doctor tells a patient the medicine successfully treating a tumor has to be discontinued because the drug is unavailable. As other reports have noted (see also this blog post May 31, 2011) the problems seem to occur far more frequently with brand name drugs—those still under patent—than with generic, less expensive drugs.
Some patients might wonder why drug patents last so long, preventing less expensive versions from reaching the market. Answering this very logical question turns out to be quite difficult. U.S. Patent Law is one of the most complex areas of government regulation. Obviously, without patent protection for any invention in any field, there would be little encouragement for inventors to bring new products to the public. In the case of drug patents, these last for 20 years. However, the effect life of the patent is much shorter. Most companies file for a patent when development of a new drug begins, well before much research and testing in order to protect their product. By the time clinical trials and approval from the FDA is received, it is years later before the drug becomes available to the public. At that point, often the remaining patent protection may be as little as ten years. This shortens the time the pharmaceutical company has to recover development costs and make some profit.
There are some ways to extend a patent, such as improving a drug or claiming exclusive rights to market the drug. In any case, hopes to shorten patent life on a drug that has become in short supply probably are completely unrealistic given the legal claims of patent law and the undoubtedly massive lobbying effort that pharmaceutical companies would mount.
Indeed, there are arguments that the effective patent life on drugs is too short. Forbes ran an online article May 11, 2009 titled “Are Short Drug Patents Hurting Patients?” The article used a drug called Angiomax, a blood thinner as an example. The maker missed by one day requesting a patent extension caused by delays in the regulatory process, cutting the patent life by five years. While Angiomax could have other applications than the original FDA approval, this meant there was no financial incentive for the company to conduct additional tests in new areas. The Forbes article points out that, “Studying a new treatment can require late-stage studies in 15,000 patients that last five years in order to prove a new drug has benefits beyond the already effective arsenal of blood-pressure meds, cholesterol-lowerers, and blood-thinners.”
Despite the general public opinion of big pharmaceutical companies as rapacious entities (with some justification it seems), pharma does suffer in some cases from a shortened patent life. As the Forbes write noted, “Pfizer spent $1 billion studying its heart drug torcetrapib only to find out the drug was killing people. Of course, besides the dollar loss, people lost their lives as well!
The downside of the current 20 year patent period comes when coupled with a lengthening time in getting approval to market a new drug is that companies will rush to market the drug as soon as possible before all needed safety tests are completed. Some experts even advise never taking a new drug until it has been on the market for seven years. This presentsa terrible dilemma for patients with deadly disease like cancer, where a new and little-tested drug may be the only way to save their lives. If you or someone you know, is suffering from a condition where new drug treatments might help, please check out the ClinicalTrials.gov database, where you can “Find trials for a specific medical condition or other criteria in the ClinicalTrials.gov registry. ClinicalTrials.gov currently has 109,390 trials with locations in 174 countries.”
There is some hope for legislative action to lessen drug shortages. A current U.S. Senate bill (S. 296) introduced by Senators Amy Klobuchar (Minnesota) and Robert Casey (Pennsylvania) on February 7, 2011 has gathered nine more co-sponsors (see list below). The bill title is “Preserving Access to Life-Saving Medications Act.” It requires drug manufacturers to give “six months’ notice of any discontinuance or planned interruption or adjustment, and (2) notice as soon as practicable after becoming aware of such interruption or adjustment in the case of any other interruption or adjustment.” The bill currently has been referred to the Committee on Health, Education, Labor, and Pensions. No doubt there will be lobbying against the bill by the pharmaceutical representatives, but if this is important to you, contact Senator Klobuchar and/or one of the co-sponsors through their websites: