Finance Committee Statement: "U.S. Food and Drug Administration (FDA), Merck & Co, INC. and the Worldwide Withdrawal of Vioxx"

November 18th, 2004

FINANCE COMMITTEE STATEMENT: "U.S. FOOD AND DRUG ADMINISTRATION (FDA), MERCK & CO., INC. (MERCK), AND THE WORLDWIDE WITHDRAWAL OF VIOXX"

Statement of Senator Orrin G. Hatch before the Senate Finance Committee

"U.S. Food and Drug Administration (FDA), Merck & Co., Inc. (Merck), and the Worldwide Withdrawal of Vioxx" Mr. Chairman, I appreciate your giving me the opportunity to deliver an opening statement today. Let me make this perfectly clear: none of us want people to be hurt by unsafe drugs. Our country's pharmaceutical approval process has been widely heralded as the "gold standard" throughout the world. And, if there are problems with it, they must be fixed. But, first and foremost, the heart of the issue before the Committee is science. In a few minutes, we will hear from a number of witnesses, primarily scientists, who have differing opinions on the side effects of Vioxx, a drug that was prescribed primarily for arthritic pain. Concerned for the health of patients throughout the world, Merck voluntarily removed Vioxx from its world-wide market within one week of receiving new data. To say the least, Vioxx's removal from the shelves in September has created a feeding frenzy for the trial attorneys. In fact, plaintiffs' attorneys are already promoting that they have a slam dunk case against Merck. If you don't believe what I am saying is true, take a look at a sample, of how trial attorneys are fishing for future clients. Let me read you the headline: "Get Your Million Dollars From Vioxx Lawsuit." Embedded in this misleading promotion, Vioxx consumers are advised on how they can "benefit from this once-in-life-time opportunity to become a millionaire." The website also says "There are still places selling Vioxx after the recall, you can find them online. Merck is still 100% fully responsible for any side effect. If you purchase Vioxx now, not only you can sue Merck, you can also sue the pharmacy store for selling recalled products." Again, if there are problems, let us look at them in a deliberative way, examining all the facts so that we can protect the public health. To be fair, Mr. Chairman, I do have concerns about why this Committee is holding this hearing, and holding it now. True, Medicare and Medicaid have reimbursed for Vioxx, along with almost every other drug. But, my study of this issue leads me to believe the questions you have raised - and I emphasize that they are legitimate questions - largely relate to the approval process of the FDA, which obviously is a HELP Committee issue. In addition, this is a complex issue. Finance Committee members were only given eight days' notice of the hearing. Although this is technically within the Committee rules, it is not enough time to understand this very complicated issue. In fact, I assigned three staffers-including a physician and a lawyer-to go through the confidential documents in the Committee office. Over a period of several days, my staff was not able to review even one-third of the material. One staffer told me it took two hours to get through one half of one binder due to the complexity of the documents. To make matters worse, because these documents are protected by court-order, Finance Committee staff members could not make copies of the materials or remove the information from the Committee office. Bottom line-it was physically impossible for any office to study those documents in time to prepare for today's hearing. This alone, puts me and other members of the Committee at a great disadvantage going into this hearing, and threatens the objectivity of this discussion. And it is important to keep an open mind and hear all of the facts before deciding if anyone is guilty of wrong doing. Unfortunately, I am worried that is not the case with today's hearing and that Committee staff may have jumped to conclusions by taking serious issues out of context. For example, it has been alleged that Merck trained its sales representatives to "dodge" tough questions from doctors about Vioxx. I have reviewed the Merck training manual and I can tell members of the Committee this is not the case. Merck sales representatives in training participate in a game called "dodge ball" where they are given flash cards that have questions, termed as obstacles, about Merck's drugs. According to the game's rules, if a person selects a "dodge" flash card, then he or she doesn't have to answer a question and receives two points. The rules for the game of dodge ball are clear - just read the manual. From what I have read, no where in this manual are trainees encouraged to "dodge" tough questions that physicians may ask about Merck drugs as reported by some sources. Mr. Chairman, I ask that the Merck training manual be entered into the record. I also am interested in hearing the comments of the first two panels but I hope that members will stay to hear the testimony of the FDA and Mr. Gilmartin, the CEO of Merck because they have important information to share with the Committee as well. I think it is unfortunate that such critical witnesses have been placed on the last two panels. Finally, I want to make one thing perfectly clear - along with my colleagues, I want to ensure that the American drug supply is the safest in the world. But today, some are trying to punish one drug company for acting appropriately within the framework of our current regulatory system. If the mechanism by which the FDA examines drug safety needs to be critically evaluated, let's do that. But I think we must be fair and allow all the facts to be reviewed carefully. So I will conclude by urging that my colleagues open-minded during this hearing and evaluate all of the facts before making a decision on this issue. Thank you Mr. Chairman.