What did Merck know, and when did they know it?

Merck e-mails suggest they knew some risks of Vioxx in 2000 four years before its removal from the market. Internal Merck e-mails indicate concern about adverse FDA reaction over Vioxx safety. The New York Times reported on April 24, 2005, that internal e-mails between Merck executives did not properly classify a heart attack death in the data used to evaluate the approval of Vioxx to the FDA. The e-mail seems to indicate Merck's knowledge of the dangers of Vioxx long before the removal from the market of the drug in September 2004. The e-mails show that Merck persuaded a scientist to classify a patient in the drug clinical trial, a 73-year-old female, whose death was listed as "unknown" when the death certificate placed the cause of death as a "hypertensive heart disease."

The cardio vascular dangers of Cox-2 drugs form the basis of many lawsuits through out the country. Like Vioxx, Merck's drug Bextra has been removed from the market in the spring of 2005. What other information discovery in the suit will reveal remains to be seen, however it is likely that undisclosed safety concerns during their development will be brought to light in the crucible of a trial before a jury.

Like the 25 million Americans prescribed Vioxx between 1999 and 2004, 58-year-old Hortense Juarez started taking Bextra in July 2003 for Arthritis pain. She was not informed about the serious risks to her health from the drug. In December 2004 Mrs. Juarez suffered a heart attack and now has a defibrillator pacemaker. The stopping of her heart has curtailed many of her daily activities and placed an emotional and financial strain on herself and her whole family. She feels lucky to be alive. Fortunately her husband was at home when the cardiac incident happened and he performed CPR while the minutes seemed like days waiting for the ambulance to arrive. Mrs. Juarez thinks, "People need to be more aware of what they are taking, all the risks, because the results can be very traumatic."

Prescribed Bextra for arthritis pain in her legs, 44 year-old Evelyn Brown believes it caused her "heart to act up" in 2003. Brown became very frightened when she suffered an irregular heartbeat, which she says is "scary," because "arrhythmias are still there." Mrs. Brown had no prior history of heart arrhythmias. She feels "mad that somebody could put a drug out that hurts people" and that she will have to live with it for the rest of her life. The drug impaired the quality of life for Mrs. Brown as she is no longer able to perform her normal activities such as playing with children, doing housework or gardening, as well as no longer being able to take long walks.

"How many deaths will it take?"

It has been estimated that approximately 20 million United States citizens have used COX-2 inhibitors and another 50 million people throughout the world. Whistleblower Dr. David Graham of the FDA estimates following review of data that 26,000 to 55,600 patients may have died as a result of taking COX-2 inhibitors. Still the FDA does not consider the COX-2's unreasonably dangerous drugs. They apparently have to kill and cripple more Americans. Ask yourself, how many people have to die before the FDA calls a drug unsafe, 100,000 people, 1,000,000 people, or just your spouse, parent or child, even yourself?

"One death is too many," according to Attorney Jim S. Adler who believes that helping individuals serves not only those persons but also contributes to greater safety awareness for all consumers. He believes it also puts pressure on drug manufactures to produce less dangerous drugs. Speaking of the COX-2 inhibitor anti-inflammatory medication, he believes that, "These drugs should not be tested on the public." Mr. Adler views his mission as, "to right the wrongs suffered by consumers" of defectively dangerous drugs through the jury system.

Where do you go if your spouse, child or parent dies, develops a condition in which their organs burn out from the inside out? Who is going to have the experience, tenacity and knowledge to protect your rights if a dangerous drug hurts you?

This series of events surrounding the Cox-2 drugs illustrate the systemic failures of the FDA and miss weighted priorities of the drug industry.