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; these actions are to be monitored by pharmacy benefit … Read the rest
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 professional 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 … Read the rest
In the event that the Supreme Court applies the federal doctrine of preemption to permit the pharmaceutical industry to avoid accountability for the harm dangerous drugs cause, the only remedy would be for Congress to pass a law expressly stating that preemption does not preclude state court lawsuits for compensation.
And that, hopefully, is the goal of the process engaged in by Chairman Rep. Henry A. Waxman of the Committee on Oversight and Government Reform of the U.S. House of Representatives this past Wednesday, May 14, 2008. Similarly, Reps. Frank Pallone (D-N.J.) and Waxman (D-Calif.) have drafted legislation, the Medical … Read the rest
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 of pharmaceutical studies 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 … Read the rest
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 … Read the rest
“Disease mongering” is a term coined by some drug-marketing critics to describe what they view as an effort by pharmaceutical companies to enlarge the market for a drug by convincing people that they are suffering from something that can be medically treated and encouraging them to ask their doctor to prescribe the drug in order to enlarge the market for drug treatment and promote a particular product.
An example of such a tactic is advertising for Restless Leg Syndrome (RLS), a neurological disorder characterized by unpleasant feelings in the legs with an associated uncontrollable urge to move when resting because … Read the rest
The U.S. Food and Drug Administration said the number of deaths possibly associated with the drug heparin, made from pig intestines, had risen to 21 from 4. The reported number of those suffering adverse reactions increased from approximately 350 to 455. Both increases have been reported within just a 2 week time period. But the F.D.A. cautioned that many of those patients were already seriously ill and that the drug might not have caused their deaths.
Officials described the linkage of heparin to the additional 17 deaths as more tenuous than the 4 initially reported. Federal drug regulators said … Read the rest
Since Baxter International announced recently that it was suspending sales of its multidose vials of heparin after four patients died and 350 suffered complications including allergic reactions, many of them serious and potentially life-threatening, significant concerns have arisen as to the effectiveness of the U.S. Food and Drug Administration’s oversight of imported drugs. Baxter bought the active ingredient for heparin, which is derived from an enzyme in pig intestines, from Scientific Protein Laboratories, which produces heparin’s active ingredient in its factory in Changzhou, China.
Scientific Protein moved production to China three years ago because the country is the world’s largest … Read the rest
The U.S. Food and Drug Administration (FDA) on February 1, 2008, issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings concerning Chantix (varenicline), a prescription medication used to help patients stop smoking.
Serious neuropsychiatric symptoms have occurred in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. Chantix has been suggested as being a possibly significant contributing factor to the bizarre and tragic death of musician Carter Albrecht on September 5, 2007.
The FDA action adds credibility to the belief that Chantix … Read the rest
Merck and Schering- Plough, the makers of the popular cholesterol drug, Zetia, announced that Zetia and Vytorin, a pill containing Zetia and Zocor, had failed to benefit patients of a two-year trial which was completed in April of 2006. Merck and Schering-Plough’s press release stated that Zetia not only failed to slow down the accumulation of fatty plaque in the arteries, it contributed to the formation of plaque. Patients taking Vytorin to reduce the growth of fatty plaque in the arteries actually experienced a growth of plaque in their arteries twice as fast as those taking Zetia alone.
This … Read the rest