Ford Motor Company is recalling more than 650,000 vehicles because of a defective power break assist hose.  According to Ford, the hoses on some of its F-150 and Mark LT trucks has a defect that may making braking difficult. There have been reports of 11 minor accidents caused by the brake hose issue, but no injuries.

The Ford recall covers 2005 and 2006 F-150 and Mark LT trucks equipped with the 5.4-liter three-valve engine, according to the National Highway Traffic Safety Administration (NHTSA) website.  The brake hose may swell over time causing the hose to become detached from the intake manifold, NHTSA reported. As a result the agency warned, applying the brakes could require increased pressure on the brake pedal.  More than 600,000 of the recalled trucks are in the U.S. and roughly 50,000 are in Canada. Another 1,500 pickups are in other countries. (more…)

A 60-second television ad for the Cypher drug coated stent—made by the Cordis subsidiary of Johnson & Johnson—is under fire.  It seems the ad failed to fully warn consumers about the potential dangers of receiving a stent, according to an article published by The New England Journal of Medicine.  The Journal says the ad promotes the Cypher stent’s potential benefits but minimizes its risks and this may be deceptive and should be reviewed by federal regulators.

The ad uses the tag line “life wide open,” a play on words. Stents are an important element in heart-disease treatment.  Tiny wire-mesh tubes, stents prop open arteries once doctors clear them of blockages.  Stents are implanted to maintain arterial blood flow and there is long, ongoing debate over drug-coated versus bare metal stent use. (more…)

In a report scheduled for release today, the Congressional Government Accountability Office (GAO) reveals a widespread “understatement of deficiencies,” that include malnutrition, severe bedsores, overuse of prescription medications, and nursing home resident abuse in the nation’s nursing home inspection reports.  The report states that nursing home inspectors routinely ignore or minimize problems that pose serious, immediate patient threats.

Facilities are generally inspected once yearly by state employees who work under contract with the federal government.  Federal officials attempt to validate state inspector work by joining them on visits or conducting follow-ups.  It was in a follow-up that the GAO discovered the state missed at least one serious deficiency in 15 percent of all inspections.  Worse, in nine states—Alabama, Arizona, Missouri, New Mexico, Oklahoma, South Carolina, South Dakota, Tennessee, and Wyoming—inspectors missed serious problems in over 25 percent from 2002 to 2007. (more…)

The recent heparin safety problems have spawned even more concerns about the drug. Baxter International’s decision to suspend heparin manufacturing earlier this year had already stoked fears of a heparin shortage. But as other manufacturers have stepped in to fill the void left by Baxter, medical facilities are receiving shipments of different quantities and strengths than what most practitioners are used to. Heparin is one of the top five drugs associated with medication errors, and pharmacists and others worry that the confusion now surrounding the drug might cause patients to receive improper doses.

Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. In March, the Food & Drug Administration (FDA) confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-thinning properties. Baxter, which supplied roughly 50 percent of the heparin injections used in US, temporarily suspended heparin manufacturing, and is said to be considering getting out of the business all together. (more…)

Trasylol is being removed from the market for good.  Bayer AG had suspended marketing of Trasylol, a drug used to prevent bleeding during heart surgery, in November, after a clinical trial found patients treated with Trasylol were dying at higher rates than others.  Now, the results of that trial are in, and the death risk has been confirmed.  Yesterday, Bayer notified the Food & Drug Administration (FDA) that it was removing the remaining Trasylol stock from the market.

Trasylol was approved in 1993 and has been used in  a third of all heart surgery patients in the US. However, Trasylol has been the subject of concern for years, and its safety has been reviewed several times.  Last November, the Canadian Data Safety Monitoring Board had stopped a Trasylol trial - known as the BART clinical study - after a data analysis indicated that the 30-day mortality risk in the study’s Trasylol patients was nearing “statistical significance”. Following the revelations over the Canadian Trasylol study, Bayer suspended sales of the drug in the US, Canada and Germany.   (more…)

A Senate bill under revision would require drug makers and medical device makers to publicly report gifts over $500 annually to doctors; the previous bill was more stringent and required all gifts valued over $25 be reported.  Penalties for drug and device makers were reduced to fines of between $1,000 and $50,000 per violation, a change from the earlier proposal released last year with higher penalties from $10,000 to $100,000 per violation. The new version pushes back when the bill would go into effect, from 2008 to 2011 and also includes several changes sought by industry, including having the federal law preempt state laws requiring gift disclosure.

The bill would require drug and device makers to submit an annual report to the federal government, which would post it on the Internet. It is unclear if similar legislation would be introduced in the House. (more…)

Elevators and escalators offer a convenient way to travel from one building floor to another.  But escalators and elevators are not without serious risks.

According to the U.S. Consumer Product Safety Commission (CPSC) approximately 90 billion people ride an escalator annually, from which, approximately 11,000 related injuries occurred in 2007.  The CPSC reports that most of these accident injuries are the result of falls; however, 10 percent occur when hands, feet, or shoes are trapped in escalators, with the most common entrapment being to the foot.   From 1992 to 2001 the CPSC reported 20 non-work related deaths of escalator passengers and 39 non-work related deaths of elevator passengers. (more…)

Restless Legs Syndrome (RLS) is a relatively new term that has become somewhat ubiquitous following a multi-million dollar ad campaign spearheaded by drug maker GlaxoSmithKline.  Given that the US Food and Drug Administration (FDA) has approved generic versions of Requip, RLS may have run its course, according to experts.

In 2005, the FDA approved the first drug for RLS—a twitching condition affecting the legs—launching a new household term, a new designer disorder, and a multi-million-dollar consumer ad campaign.  Television ads hyping ropinirole hydrochloride, a drug originally used to treat Parkinson’s disease, sent patients to doctors demanding brand name, Requip.  In under a year, Requip sales doubled from $165 million in 2005 to nearly $330 million in 2006.  By last year, 4.4 million prescriptions were written, with sales of nearly $491 million, according to IMS health, an industry information agency. (more…)

Immucor, a maker of blood-testing supplies, has received a warning letter from the Food & Drug Administration (FDA) because of problems with its manufacturing procedures.  The letter, dated May 2,  said Immucor had 15 working days to make corrections. Should it fail, the FDA warned Immucor it could face license suspension and/or revocation, seizure and/or injunction.

The warning letter stems from an FDA inspection of Immucor in  Norcross, Georgia, between January 8 and January 17, 2008.  The FDA warning letter says the company allowed products into its inventory that had previously tested positive for microbial growth and were put on hold by the FDA. The blood reagent products were allegedly allowed back into Immucor’s inventory before the FDA could complete its investigation. The FDA also claims Immucor “failed to establish and maintain procedures for implementing corrective and preventive action, including requirements for investigating the cause of nonconforming product and identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems.” (more…)

In 2005, Robert F. Kennedy, Jr. published a lengthy examination of the history of Eli Lilly´s deadly mercury compound, thimerosal, in vaccines and its decades-long history of suppressed data about dangers to those receiving it, especially via injection.  Following is some excerpted information from that paper.  In the coming days, we will provide more information from this important paper on this dangerous health issue.

In June 2000, a group of government scientists and health officials met for a secret, highly-secluded meeting convened by the Centers for Disease Control and Prevention (CDC) to discuss issues over the safety of a variety of ubiquitous childhood vaccines routinely given to infants and young children. The CDC issued no public announcement of the session; 52 private invitations were sent to attendees including high-level CDC and Food and Drug Administration (FDA) officials, the top vaccine specialist from the World Health Organization (WHO) in Geneva, and representatives from every major vaccine manufacturer, including GlaxoSmithKline, Merck, Wyeth, and Aventis Pasteur.  Meeting information was strictly “embargoed”; there would be no copying or removing documents. (more…)