Features

Nov 16, 2004. The VIOXX disaster may have been prevented with better data analysis

Once again the violent combination of bad science, the desire for headlines and trial lawyers smelling money has driven a good drug, this time it's VIOXX, out of the market. In its wake, innocent investors were hurt as the total market value of pharmaceutical companies plunged by over $50 billion. Potential lawsuits could add more than $20 billion. Pain sufferers have been deprived of a valuable drug.

Based upon our 25 years of experience in data analysis, especially 'patient longitudinal data', and a thorough review of what has been published, Intercon believes that VIOXX, when prescribed and used as labeled, is an effective pain reliever that is not a direct contributor to heart attacks. VIOXX has been a preferred medication prescribed by physicians and used effectively and securely by millions of patients.

The data shows that at most 3% of VIOXX patients, mostly those who used high dosage VIOXX for extended periods, were associated with elevated incidences of CV events. These were usually patients with history of heart disease or other pre-conditions that influenced the doctor's decision to administer them with VIOXX. Doctors were well aware that the VIOXX label specifically stated that caution should be used in these cases, as the drug could become harmful when used excessively. The choice to use VIOXX, as it should be, was at the hands of the doctors, who monitored their patients' progression and wellbeing over time.

Advances in data collection, computing and data analysis allow an easy, fast and reliable way to answer many of the questions surrounding VIOXX's use and associated events. Analyzing data on the millions prescriptions of those who have taken VIOXX since its inception, could unambiguously prove VIOXX's value.

We believe that much of the chaos and confusion surrounding VIOXX has been caused by bad science and miss applied statistics. Many studies were too small or short to measure heart risk reliably. Other retrospective studies were biased by population and method. Some studies failed to properly consider all of the factors that influence heart disease such as patient age, previous ailments, use (or non use) of concomitant drugs or agents such as aspirin and pain relieving products. For examples:

• The Dr. Graham's sensational study, made public by the FDA in August and November 2004, failed to disclose that the investigated population was biased by the fact that both VIOXX and Celebrex were excluded from formulary, used only under unusual circumstances at Kaiser Permanenete. Graham applied improper methodologies, such as extrapolations on 18 patients population to 'compute' half the sensational CV toll of 27,785.

• The APPROVe study, the primary driver in Merck's decision to withdraw VIOXX, was published on selected portion of its findings in October. It was reported that for 18 months use, VIOXX had no effect on modifying heart risk whatsoever. With longer use, there was an increased incidence of CV events, as warned on the label, an increase that may also be attributable to the use of a sugar placebo on patients with surgical pre-conditions.

• Theories proposed cautiously by Fitzgerald, Topol and others were not accepted before the withdrawal of VIOXX. These theories are inconsistent, contradictory to each other and to actual clinical trial measurements.

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Disclaimer.

Intercon has not received or been promised any compensation by Merck, Pfizer or any other major participant in the discussed controversy. None of its officers or employees owns any equity or derivatives in those same companies.

For Further Information contact: Avi Shatz, in Jerusalem, ISRAEL
US toll free: 1 -888-202 9801, +972.2 653.5496

or by email: avi@ds-dataset.com