ISMP QuarterWatch: Cannot "rule out, or state definitively, whether defective digoxin tablets led to hundreds of patient deaths"
(Posted by Tom Lamb at DrugInjuryWatch.com)
On January 15, 2009 The Institute for Safe Medication Practices (ISMP) released QuarterWatch: 2008 Quarter 2, which includes an analysis of how the Digitek recall has been handled by Actavis, the drug maker, and FDA, the regulatory agency, which demonstrates how ineffectual the FDA has become when it comes it critical issues of drug safety in the U.S.
As background, the IMSP QuarterWatch Project Team consists of the following individuals:
- Thomas J. Moore, Senior Scientist, Drug Safety and Policy, ISMP;
- Michael R. Cohen RPh, MS, ScD, President, ISMP; and,
- Curt D. Furberg, MD, PhD, Professor of Public Health Sciences, Wake Forest University School of Medicine.
The Digitek recall was classified as Class I recall by the FDA, meaning there is “a reasonable probability... a violative product will cause serious adverse health consequences or death." (21 CFR 7.3 Recall Classification).
This new ISMP QuarterWatch report, however, reveals that the FDA has seemingly taken a back seat and let Actavis determine how the Digitek recall would be done. To start:
Although this is one of the largest Class I drug recalls we know of—affecting more than 1 million vulnerable heart patients—the FDA allowed the company to manage public notification of consumers, doctors, pharmacies and wholesalers. The public notice from the Center for Drug Evaluation and Research was a reproduction of a brief company statement.
For its Digitek recall analysis, the ISMP QuarterWatch Project Team attempted to get some new information from Actavis and the FDA about what has been learned thus far about the extent of defective Digitek (digoxin) pills that were dispensed to patients in terms of time frame and number of pills. As can be seen by the following statements, however, both Actavis and the FDA are continuing to be vague, at best, when it comes to divulging that type of information:
- In April 2008 the Actavis Group announced the voluntary Class I, consumer level recall of 800 million digoxin tablets, the entire unexpired production of its Little Falls, NJ plant over a 26-month period, and about 60% of the entire U.S. supply of an important generic heart drug.
- The company stated that it had no evidence that any defective tablets had in fact entered commercial distribution, and that it had recalled nearly 1 billion tablets and closed its plants “out of an abundance of caution.”
- Neither the company nor the FDA will estimate how many tablets actually reached consumers; nor will either party reveal how many tablets have been recovered through the Class I recall. Neither the FDA nor the company has tested the recalled tablets to determine how many might have been defective.
In this new QuarterWatch report, at least, there is no indication by Actavis about the fate of the Digitek pills that have been collected as regards whether those pills are still available for testing in the future. Another issue that was not addressed is whether the pills that were "returned" by patients through Stericycle are being preserved and kept separate such that any future testing would reveal which patients, if any, had been dispensed Digitek pills that had the "double-thickness" defect and up to twice the active ingredient, thereby putting them at risk for digoxin toxicity (also called digitalis poisoning).
The ISMP analysis contained in this January 2009 QuarterWatch report gives rise to well-deserved criticism of the FDA as regards the Digitek recall -- which, essentially, goes far beyond the Digitek recall:
Because of limitations in the U.S. system for post-market surveillance, the characteristics of the drug, and the nature of the system for recalling defective drugs, it is not possible to estimate how many patients might have died or become seriously injured by defective [Digitek] tablets....
Without extensive testing of distributed and recalled tablets, it is difficult to separate cases caused by defective tablets from other causes, including declining kidney function, decreasing cardiac output and failure to monitor blood levels of the medication.
Largely because of how this Digitek recall has been conducted, i.e., letting the drug company call the shots as opposed to the FDA acting in the interest of patients who took Digitek, the ISMP QuarterWatch report reached this conclusion:
The existing evidence does not permit us to either rule out, or state definitively, whether defective [Digitek] pills led to hundreds of patients deaths.
Of course, while the FDA might feel that is an acceptable endpoint, the attorneys who represent people who developed digoxin toxicity while using Digitek as well as the families of people who died due to an overdose of digitalis in product liability lawsuits will not be as easy on Actavis.
And as for the FDA, let us hope that the Obama Administration will act so as to restore the FDA to its proper role, which is protecting patients and not protecting drug makers.
In closing, a hat tip to Ed Silverman, formerly of the Pharmalot blog and now writing for The RPM Report, where we first read about this ISMP QuarterWatch Digitek analysis in his January 19, 2009 online article, "ISMP Draws Attention to Drug Safety Issues In New Report".
Stay tuned for our future reports on what is learned from Actavis in the discovery aspect of these Digitek lawsuits about the extent of defective Digitek pills dispensed to patients in terms of time frame and number of pills.