HACKARD & HOLT IN THE NEWS
Food And Drug Administration
Endocrinologic And Metabolic Drugs Advisory Committee
Rezulin: The Fda's Catastrophic Reliance On Under-Reported Adverse Events
May 19, 2000
Holiday Inn
Ballroom
1820 Wisconsin Avenue
Bethesda, Maryland
Presentation By:
Michael A. Hackard
Hackard, Holt & Heller
11335 Gold River Drive #155
Gold River, California 95670 (916) 853-3000
PROCEEDING [10:00a.m]
Agenda Item: FDA Endocrinologic and Metabolic Drugs Advisory Committee
Meeting Concerning Rezulin.
Opening Comment
Michael A. Hackard: Mr. Chairman, members of the advisory committee, thank you for allowing me the opportunity to testify on the committee's role in the withdrawal of Rezulin from the U.S. market. My name is Michael A. Hackard. I am the senior partner of the Sacramento area based law firm of Hackard, Holt & Heller. I am not here to incite you or to show disrespect for the process that you have previously engaged in. I am here to plead that the history of Rezulin demands that those who took the drug not be forgotten. In particular, I am here to request that the makers of Rezulin use the same vigorous efforts that they used to market the drug to now inform Rezulin's former users of their possible resulting liver damage.
Disclosure of Conflicts
Prior to today's testimony I took the time to review prior committee testimony and protocol. I noticed that often the witness disclosed any conflicts of interest. In the spirit of this disclosure, you must know that I currently represent at least four dozen individuals or families that have suffered from the adverse effects of Rezulin use–at least eight liver transplant patients, thirty patients with non-alcoholic cirrhosis, and ten families who lost loved ones from complications due to Rezulin. Approximately eight of these cases have already been filed in the federal courts and the others are being prepared for filing. The defendants in all of these cases are Warner-Lambert and Parke-Davis.
I am not a disinterested observer. My firm represents these clients on a contingency fee basis. I have personally met and interviewed a substantial number of our Rezulin injured clients. To me this committee's failure to remove Rezulin from the U.S. market is not a neutral event. I cannot view it as the simple deferral of Rezulin withdrawal until safer drugs came onto the market. To me, the failure to withdraw Rezulin is so entwined with tragedy that I must admit that I cannot think about it without an overwhelming sense of regret. I see the ruined lives of people that asked me to speak here today – people that I have come to know–fathers who want to see their children graduate from high school, mothers who want to stay alive long enough to see their children grow to early adulthood, and adults and their families who are perplexed by this committee's, this government's and this manufacturer's failure to act sooner.
Failure to Inform
Those well informed might well disdain my tone, after all, approximately 100,000 Americans die every year as a result of adverse reactions to drugs and up to 25% of cases of fulminant (sudden) hepatic (liver) failure may be the result of adverse reactions to medicinal agents. Properly informed people might well be aware that some drugs for various reasons (e.g., dose, duration, metabolic effects, etc.) may prove toxic to the liver. The emphasis here is on proper information. This is where the tragedy of Rezulin begins and ends–the failure to inform–to inform patients, the FDA, and now finally those that formerly were on the drug and are still at risk. Let us just look at a brief history of this lack of information or the company provided abundance of disinformation.
There are many places to examine the information provided by the makers and marketers of Rezulin, but I am not arguing a legal case here. If I can convey any message today it is this–take the time to craft an appropriate protocol for determining the nature and extent of existing liver disease among former Rezulin users.
Your Staff Warned You of the Substantial Risk of Liver Injury
How did this committee, Warner Lambert, and Parke-Davis respond in March of 1999 when faced with a body of information confirming the lethality of Rezulin to some of its users? Parke-Davis presented testimony that 1.58 million Americans had already taken the drug. Their representative went on to estimate that the risk of developing liver failure from Rezulin had fallen from 1 in 36,000 to 1 in 57,000 since the liver-function test monitoring guidelines were revised in July of 1998.
Your own FDA epidemiologist was not so optimistic, in fact this FDA expert countered that the agency believed that only about 10% of patients who had developed liver failure had been reported (about 400 patients rather than the 43 patients the agency had investigated). Based on this, he calculated that patients taking Rezulin for six months would have a 1 in 1,800 chance of developing liver failure.
I think that I can be fairly confident that the some forty-eight (48) individuals and families that I represent were not culled from Parke-Davis's projected 1 in 57,000 injured. In fact, given my experience in this case I strongly suspect that the rate of injury is even much higher than the good faith 1 in 1800 projected by your staff in March of 1999. This brings us to our next point.
You encouraged the withdrawal of Rezulin from the U.S. market in March of this year, just one year but hundreds if not thousands of unnecessary injuries later than the March 1999 committee hearing. Hundreds of thousands of people (an estimated 500,000 people) have withdrawn from Rezulin. In all likelihood thousands of these people have liver injury– a liver injury originally proclaimed to be preventable through frequent liver function tests. All but the most biased will now acknowledge the difficulty in detecting drug-induced liver disease by liver function tests alone. So what do you do now?
What Should You Do Now?
Do you do nothing? Do you tell people formerly treated with Rezulin to take liver function tests and to hope for the best? Don't you think that they at least ought to be informed that drug-induced liver disease can be asymptomatic before entering the dangerous and potentially lethal end stage liver disease? Do you simply tell them to see their primary care physician knowing that a recent study showed that 94% of primary care physicians failed to diagnose similar injuries among alcohol users?
Your Adverse Event Reporting System is Broken
I am not a doctor. I am a lawyer–a lawyer who has seen the same symptoms over and over among those who are critically ill from Rezulin use. I am a lawyer who knows that your adverse effects reporting system is broken–when it is construed to be the complete reality of a drug's adverse events it is misinformation at its best. Shouldn't this committee embrace and acknowledge the more probable reality presented by your staff member? That is, injury due to Rezulin is at least 10 times greater than that reported. I realize that the FDA relies on a voluntary reporting system but this reporting system has become a narcotic for post-approval nonintervention. This system has also been used by companies like Warner-Lambert to minimize the risks that their drugs present. As recently as May 12, 2000 the Chief Executive Officer of Warner-Lambert trumpeted that "the number of (Rezulin) cases and the magnitude are insignificant." Hundreds of deaths, thousands of injuries–insignificant? Those that believe in basic human rights don't think so.
It might well be true that committees substantially responsible for the recommendation process of a drug have an overriding personal identification with that drug's approval. Given this identification, it might be extremely difficult to later conduct a dispassionate evaluation of the harm that the drug has caused the American public. That said, you must try. Former users of Rezulin, people who once relied on you, are waiting.
Thank you
Michael A.Hackard