Shortages of Life Saving Drugs

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 database, where you can “Find trials for a specific medical condition or other criteria in the registry. 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:

Franken— Minnesota
Schumer—New York
Mikulski Maryland
Brown— Ohio

Get Your Daily Hospital Dangers Horror Story from the FDA

Would you believe that one of the best sources for all the dangers you might face upon checking into a hospital is the FDA? It’s true. The daily listing of recalled medical devices used mostly in hospital settings is enough to scare anyone facing a hospital stay. Not only do the notifications come from the FDA, but the agency who approved these devices and drugs supposedly in our best interests, is also the FDA. Please—stop doing us these favors!

Check these headlines and summaries from the FDA, in just one day:

Maquet Datascope Corp. Intra-Aortic Balloon Pumps: Recall – Shuts Off Without Warning (Used during cardiac surgery)

A defective fan in the power supply may cause overheating and shut down the device without visible or audible alarms. Consequences of unanticipated interruption of therapy may include the inability to decrease already-present ischemia, thrombus formation, organ injury or other serious events.

Terumo Coronary Ostia Cannula 10, 12, 14 Fr: Recall – Fragments of Adhesive and Plastic in the Cannula Tip May Embolize
Foreign fragments of adhesive and plastic in the cannula tip may embolize causing arterial injury, hemorrhaging or other serious events requiring unplanned surgery.

Boston Scientific iCross and Atlantis SR Pro 2 Coronary Imaging Catheters: Recall – Catheter Tip Can Break Inside of the Patient
The catheter tip can break inside of the patient and embolize causing tissue and blood vessel injury, heart attack or other serious events requiring additional unplanned surgery.

Also brought to you and your loved ones by your friendly FDA was one of the most dangerous drugs ever approved by the Agency.

In 1993, the FDA approved a drug for use in humans named Trasylol (Aprotinin) made by Bayer. This was in spite of data demonstrating this drug caused severe kidney damage in animals. After the drug was approved, as reported by Life Extension Magazine, June 2011, p. 8, “One surgeon observed that the most common side effect seen in patients given Trasylol was renal dysfunction.” Even though originally the FDA noted that kidney toxicity was a problem with this drug, as a result of heavy lobbying by Bayer, the FDA approved the drug for all heart bypass patients in 1998. Bayer was selling $300 million worth of Trasylol by 2005.

Life Extension Magazine went on to report that In 2006, a study showed the current dangers of Trasylol, with “a 55 percent increase in the risk of myocardial infarction or heart failure (P<0.001) and a 181 percent increase in the risk of stroke or encephalopathy”(New England Journal of Medicine, 2006 Jan 26; 354(4):353-65). Bayer commissioned a study of 70,000 patients, and the report confirmed the dangers. When the FDA finally got around to having a hearing, Bayer withheld the study, leading the FDA to continue its approval.

The Canadians and the Germans took care of their people. Canada stopped a study in 2007 because too many people were dying. Germany banned Trasylol completely. Bayer, in 2008, after many lawsuits, withdraw the drug. Life Extension Magazine wrote, based on analysis by experts, that 22,000 lives could have been saved had the FDA never approved this drug.

The rest of this story? The FDA never took any follow-up action against Bayer for the cover-up. This did not teach the FDA a lesson. Trasylol has been replaced with Tranexamic acid ( Lysteda).
“Aprotinin (Trasylol) was withdrawn from the market in 2007. Since then, tranexamic acid (TXA) has become the antifibrinolytic treatment of choice in many heart centers. . . . The use of high-dose TXA is questioned, as our data suggest an association between higher mortality and minor efficiency while the safety profile of this drug is not consistently improved. Further confirmatory prospective studies evaluating the efficacy and safety profile of TXA are urgently needed to find a safe dosage for this antifibrinolytic drug.  [Source: “Mortality associated with administration of high-dose tranexamic acid and aprotinin in primary open-heart procedures: a retrospective analysis,” Crit Care. 2010;14(4):R148. Epub 2010 Aug 3.]

Major Hospital Drug Recall

The Food and Drug Administration on Friday, June 3, 2011 issued an alert regarding a nationwide voluntary recall of all repackaged drugs from Aidapak Services, LLC because of “potential cross contamination with Beta Lactam Products.” The notice follows a press release from Aidapak Services, located in Vancouver, Washington and dated June 1, 2011, warning of possible contamination of their products with some non-penicillin drug products repacked in the same building. The release warned of a “serious anaphylactic reaction in patients with known hypersensitivity to beta-lactam or penicillin products.”

Anaphylactic shock is a very serious allergic reaction to some substance. Typical symptoms are dizziness, loss of consciousness, swelling of the tongue and breathing tubes, falling blood pressure, and even heart failure and death. The list of affected products is lengthy—317 pages with 13,301 individual listings. However, many specific drugs are listed multiple times for different formulations and lot dates. Drugs include many  prescription strength medicines as well as common items such as aspirin, acetaminophen and vitamins. These are re-packaged drugs in customized containers intended for hospital, clinic and long term care inpatient pharmacies. You can find a specific list on Aidapak’s Web site.

As noted by Aidapak, repackaging is a complex process and costly if done in-house, therefore repackaging services can supply custom-labeled drugs based on specific pharmacy needs.

For the consumer this process seems to add one more link as a possible point of dangerous failure in getting medications to a patient.