Johnson & Johnson Altered Birth-Control Patch Data to Hide Risks |
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David Voreacos Bloomberg |
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November 29, 2007—Johnson & Johnson misled doctors and regulators for years by altering and withholding medical data about the health risks of its Ortho Evra birth-control patch, lawyers for women suing the company claim in court papers. J&J, the world's largest maker of health-care products, faces lawsuits by 2,400 women who claim the patch releases high levels of estrogen that cause strokes, heart attacks, and blood clots in the legs and lungs. Internal documents and pre-trial interviews with J&J scientists show the company learned the risk in 1999 and misled the Food and Drug Administration when seeking approval in 2001 to market the device, the filings state. The company "withheld and altered data from the clinical trials which proved that the patch delivered significantly higher levels" of estrogen than oral contraceptives, according to a motion filed by patch users Nov. 20 in federal court in Toledo, Ohio. "Obviously unaware of the withheld information, the FDA approved Ortho Evra for marketing." Five million women have used Ortho Evra since it went on the market in 2002. The filing offers the first detailed look at evidence previously deemed confidential by the judge and may indicate why J&J settled dozens of cases without allowing any to go to trial. J&J won't release financial terms of any of the settlements. The FDA warned in November 2005 that the patch may cause clots and expose women to 60 percent more estrogen than oral contraceptives. In February 2006, another study found a twofold increase in the risk of clots compared with use of the pill. 1,500 SuitsAbout 1,500 lawsuits are pending in federal court in Toledo, where U.S. District Judge David Katz designated seven women as "bellwether" plaintiffs for trials in June or July. The motion last week asks Katz to dismiss some of the company's defenses and outlines new disclosures about the drug's development. J&J spokeswoman Gloria Vanderham said the filing "takes out of context a few documents produced by the defendants in the course of this litigation to create a misleading and unfair presentation." "The proper forum for these documents is the courtroom where, looked at in context, the evidence will show" that Ortho Evra is safe and effective, said Vanderham, a spokeswoman for Ortho Women's Health & Urology unit, a division of Ortho-McNeil Pharmaceutical Inc., a J&J subsidiary. Another StudyThe filing details a clinical trial in 1999, known internally as PHI-014. It measured the amount of ethinyl estradiol, or EE as the estrogen component is called, released into the bloodstream every 24 hours. The company said the study proved the level was 20 micrograms. The actual results showed the patch released 30.4 micrograms when applied to the abdomen and 38.1 micrograms when applied to the buttocks, according to the motion. A company pharmacologist, Dr. Larry Abrams, applied a "60% correction factor" to lower the results, the motion said. Abrams, who has retired, said in a pre-trial interview that the "correction factor" related to the rate at which users of the pill cleared estrogen from the body, the motion said. "Other company pharmacologists, who uncovered the use of the '60% correction factor' in 2005 while reviewing prior data on the patch, rejected Dr. Abrams' rationale," the filing says. "Not only was FDA unaware of the use of the 60% correction factor, but even key company employees profess to know nothing about it." In a journal article in February 2002, the company omitted the use of the correction factor in the formula, meaning doctors "had no way to know that the figures reflected were obtained through lowering the actual data by a factor of 60%." Another study in 1999, known as PHI-017, measured the concentration of estrogen from the patch compared with three forms of the pill, the motion said. The results showed the patch delivered two times more estrogen than one pill and three times more than the other pills. 'Agonizing Two Years'Abrams "spent an agonizing two years in delaying and obfuscating the results" before the company submitted them to the FDA in October 2001, one month before the patch was approved, the motion said. "Over the ensuing six years and to the present date, defendants have never mentioned to the FDA the results of PHI- 017," it said. "Clearly, defendants' omission of PHI-017 was no accident, but instead a very deliberate plan intended to deceive regulators about the high levels of EE delivered by the patch." The seven bellwether plaintiffs are all from Ohio. They include Sienna Tomko, who was 14 when she suffered a deep vein thrombosis in 2005. They also include Robert Douglas Rosfeld, whose wife, Stephanie, was 25 when she died of a heart attack after using the patch for a month. She was an assistant volleyball coach at the University of Cincinnati. Janet Abaray, a Cincinnati attorney for the seven women, declined to comment. The case is In re Ortho Evra Products Liability Litigation, MDL 1742, U.S. District Court, North District of Ohio (Toledo). |
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