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Cataract surgery is the most commonly performed operation in the United States today, with nearly 2 million cataract operations performed in the United States each year. Benign prostatic hyperplasia (BPH), an enlarged prostate, is common in older men, affecting nearly 3 out of 4 men by the age of 70 years. BPH is often treated with tamsulosin hydrochloride (Flomax), an alpha-blocking drug that accounted for more than $1 billion in sales in 2007. This BPH/cataract combination is dangerous: A study to assess the risk of adverse events following cataract surgery in older men prescribed Flomax found that exposure to tamsulosin within 14 days of cataract surgery was significantly associated with serious postoperative ophthalmic adverse events. The researchers discovered that those who took Flomax two weeks before the procedure were 2.3 time

The Alien Tort Statute, 28 U.S.C. 1350, a 1789 law, gives foreigners the right to raise tort claims in federal court to vindicate violations of 'the laws of nations.' The 10-principle Nuremberg Code was formulated as part of a war crimes trial conducted after World War II in which 15 doctors were convicted of crimes against humanity for conducting unconsented experiments. Seven of the doctors were sentenced to death. The 1789 law and the 20th Century Nuremberg Code intertwined recently as the U.S. Court of Appeals for the Second Circuit revived Nigerian families' damage claims for billions of dollars against Pfizer for allegedly secretly testing a new drug in a Nigerian hospital during a 1996 meningitis outbreak. The two cases under the consolidated caption of Abdullahi v. Pfizer, 05-4863 and 05-6768 involved claims that Pfizer allegedly secretly testing a new drug in a Nigerian hospital during a 1996 meningitis ou

The U.S. Food and Drug Administration warned clinical test giant Laboratory Corp. of America Holdings that it was marketing OvaSure, an ovarian cancer test, in violation of the law in that it did not have marketing clearance or approval from the FDA. OvaSure measures six proteins in blood samples and calculates the chances that the woman has ovarian cancer. LabCorp made the $220 test available in June, under a provision that exempts tests developed and offered by a single lab from the usual FDA review. Thus OvaSure did not go through an FDA review. But in a letter dated September 29 and released October 7, 2008, the FDA determined that because the test was developed at Yale School of Medicine but that parts of it were manufactured elsewhere, it must meet the agency's usual premarketing approval requirements, which could take up to a year. OvaSure does not diagnose cancer - it attempts to predict the likelihood of someone having the disease - which caused many experts to

Advocates for children are upset that Alloy Media and Marketing has run ads for prescription drugs from its Channel One website. Channel One provides free news and original programming to about 10,000 middle and high schools. Channel One is, in the opinion of many, a controversial in-school news program that makes viewing ads a compulsory part of the school day for grades six through twelve. One of Channel Ones drug ads links to Acneheroes.com, a kid-targeted website created by the pharmaceutical company sanofi-aventis to promote BenzaClin, a prescription drug for acne. The website features actor Cody Linley, who introduces himself as one of the stars of Hannah Montana, which airs on the Disney channel and is among the most popular television programs for children. As part of its user agreement with schools, Channel One has pledged not to market prescription drugs to its young audience. Yet ads for the prescription acne medications Differin and BenzaClin ran on the Cha

Medtronic, Inc., in what is termed a precautionary measure, has voluntary recalled selected products featuring its Carmeda BioActive surface, a coating applied to some devices used in heart bypass surgery and dialysis, because the coating includes contaminated heparin, a blood thinner that has been linked to 81 deaths. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. This action was taken subsequent to the U.S. Food and Drug Administration's April 8, 2008 recommendation to device manufacturers that heparin supplies be checked with newly-developed tests, and that affected products be evaluated for possible field corrective action. Limited lots of Carmeda-coated products were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS). The patient risk associated with the pr

For several years the U.S. Food and Drug Administration has been reviewing a set of guidelines proposed in 2004 for advertising medical devices. Now, a television advertisement for a heart stent, metal mesh devices that are used to prop open arteries after they have been cleared of blockages, has been scrutinized and attacked in an op-ed article for failing to adequately warn consumers about the potential dangers of receiving a stent, including a ruptured coronary artery. The ad does warn of heart attack and stroke. The ad for the Cypher stent, made by the Cordis subsidiary of Johnson & Johnson, was the first to market a stent directly to consumers on television and uses the tag line life wide open. Similar ad campaigns have promoted hip and knee implants, including one featuring the golfer Jack Nicklaus, who underwent a hip replacement in 1999 using a device made by Stryker. According to the article by cardiologists Dr. William E. Boden and Dr. George A. Di

Part 2 of this topic discusses new legislation regarding dangerous drugs, defective toys and sexual predators using the internet to prowl and prey. The information herein is set forth in press releases issued by the governor's office. Proposed legislation designed to protect patients from medical malpractice was discussed in Part 1 of this blog. Governor David A. Paterson has proposed legislation to limit the influence of pharmaceutical manufacturers over prescription decisions by banning gifts and payments from drug companies to physicians and other prescribers in excess of $50 per year. The bill would also require practitioners who m

Last week was a busy week for New York's Governor David A. Paterson on issues often written about in this blog - medical malpractice, dangerous drugs, defective toys and sexual predators using the internet. Some bills were signed, others introduced. The most ambitious of these was on the medical malpractice front, Governor Paterson proposed legislation that offers more transparency for patients and tougher discipline for physicians; enhanced infection control requirements will facilitate the prevention of and response to infectious disease transmissions. Part 1 will discuss this legislation, Part 2 the others. The information herein is set forth in press releases issued by the governo

Product liability litigation involving rofecoxib (Vioxx) has led to the disclosure of materials that has provided direct evidence of something that has long been suspected but well-hidden by industry; the manipulation by for-profit manufacturers of pharmaceuticals and medical devices of study results, using authors, editors, and reviewers to misrepresent research data and manipulate clinical research articles and clinical reviews. Reports published in the Journal of the American Medical Association (JAMA) based upon a review of materials disclosed by Merck & Co. in the course of the Vioxx litigation claim Merck & Co. frequently paid academic scientists to take credit for research articles prepared by company-hired medical writers, a practice called "ghostwriting". The reports also contend Merck tried to minimize deaths in two studies that showed that the now

The Food and Drug Administration yesterday raised from 19 to 62 its estimate of the number of people who may have died after suffering allergic reactions or hypotension to contaminated Chinese-produced batches of the blood thinner heparin. Last month the FDA determined that Baxter Healthcare Corporation's drug was contaminated with an unnatural chemical during production at a plant in China. The agency is still investigating whether the chemical was added accidentally or deliberately. Further information may ultimately be uncovered during any product liability lawsuits that may be brought. Also last month, the FDA announced that Baxter had extended its recall of multi-dose vials of heparin sodium for injection to also include single-dose vials of heparin sodium for injection. As a precautionary