It seems as if the Federal Emergency Management Agency (FEMA) lied about the dangers formaldehyde in all those Toxic FEMA Trailers that are still home to over 40,000 beleaguered Katrina and Rita hurricane survivors.

Two Democratic leaders of a House science subcommittee alleged yesterday that FEMA manipulated scientific research into the danger of the Toxic FEMA Trailers.  In a letter to Homeland Security chief Micheal Chertoff, the lawmakers said  FEMA “ignored, hid and, manipulated government research on the potential impact of long-term exposure to formaldehyde.” Representatives Brad Miller (N.C.) and Nick Lampson (TX) cited agency documents provided to Congress that that they say prove  that the federal Centers for Disease Control and Prevention (CDC) was “complicit in giving FEMA precisely what they wanted” to suppress information about the adverse health effects of living in the Toxic FEMA Trailers. (more…)

Fosamax has been named in a lawsuit filed by a Connecticut woman who claims the osteoporosis drug caused multiple stress fractures and suppressed bone regeneration in her legs.  JoAnn Moranski, who took Fosamax for 10 years, is just the latest plaintiff to file suit against Merck as a result of health problems caused by the medication.  Another 400 plaintiffs have Fosamax lawsuits pending that allege the bone medication caused a bone-wasting condition known as osteonecrosis of the jaw (ONJ).

Fosamax, a popular osteoporosis drug, has been reviewed by the Food & Drug Administration (FDA) over a number of safety issues.  One of the most serious is its association with ONJ.  In July 2005, the FDA had Merck update the Fosamax label to include a warning on this condition.  ONJ is a disorder in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. Signs and symptoms of ONJ may include:  jaw pain, swelling of the gums, loose teeth, drainage, exposed jaw bone, numbness, or a feeling of heaviness in the jaw. (more…)

The Jacksonville plant explosion at T2 Laboratories in Florida was worse than first thought. Early reports said that 14 people were injured in the fatal blast that occurred at T2 Laboratories in December, but now it appears that more than double that number were actually hurt by the Jacksonville plant explosion. Flying debris from the T2 Laboratories explosion apparently hit 19 other people not on the Jacksonville plant’s grounds, causing minor injuries like cuts and bruises. In addition to the 33 injured, the Jacksonville plant explosion killed four workers at T2 Laboratories.

The explosion at T2 Laboratories occurred 1:30 p.m. on Dec. 19. Witnesses to the Jacksonville plant explosion reported seeing a bright flash followed by a tremendous explosion. The blast was massive enough to blow open doors at a hotel several miles away, and shattered the windows of buildings nearby. Flames and a plume of smoke formed by the T2 Laboratories explosion shot at least 20 feet into the air, and could be seen for miles around. (more…)

Connecticut can now be added to the list of states investigating Vytorin. According to The Wall Street Journal, Connecticut Attorney General Richard Blumenthal announced that his office investigating Merck and Schering-Plough for claims the companies made about Vytorin. Over the weekend, New York State Attorney General Andrew Cuomo announced a similar Vytorin investigation, and several congressional committees are also investigating the drug makers. Vytorin has been under intense scrutiny since a study, known as ENHANCE, was released earlier this month showing the cholesterol lowering drug was no more effective at preventing clogged arteries than a cheaper, generically available statin.

Vytorin is a combination of cholesterol lowering Zetia and the statin Zocor. The point of the ENHANCE study was to determine how well Vytorin prevented clogged arteries by reducing the formation of plaque. ENHANCE focused on a group of 720 patients with a rare condition predisposing them to high cholesterol. The patients were given either Vytorin or a high dose of simvastatin, the generic form of Zocor. Vytorin did not provide any significant benefit versus the statin drug Zocor in slowing down clogging of the arteries. Overall, the study failed to meet its primary goal, which was to show whether Vytorin was more effective than Zocor alone in preventing progression of atherosclerosis in the carotid artery, which is in the neck. (more…)

The Food & Drug Administration (FDA) has not been able to keep up with its inspections of overseas plants that produce foods, drugs and medical devices sold in the US, and is now so understaffed that it will take decades – and in some cases centuries – to clear the backlog.  That startling information comes from a series of reports on the FDA’s performance authored by the Government Accountability Office (GAO) recently obtained by The New York Times.   The GAO’s investigation is just the latest probe of the FDA to find that the agency is in serious trouble.

According to the GOA report, the FDA would need at least 27 years to inspect every foreign medical device plant that exports to the US, 13 years to check every foreign drug plant and 1,900 years to examine every foreign food plant.   Of course, that’s only if FDA inspectors could actually  find these overseas manufacturing facilities.  The GAO says that FDA computer systems are so awful that the agency doesn’t even know how many overseas plants it should be inspecting, and it cannot produce a list of those that have not been inspected.   (more…)

Could the Consumer Products Safety Commission (CPSC) soon be headed by an industry crony? Although no official announcement has been made, the White House is said to be reviewing candidates to replace acting CPSC chairman, Nancy A. Nord.  The three-member commission has been without an appointed leader since former chairman Harold Stratton stepped down in 2006.  Word is that the top choice is Gail Charnley, a scientist who has testified and written on behalf of the energy, pesticide, and tobacco industries. Many consumer advocates fear his industry ties make him a poor choice for CPSC commissioner.

The CPSC, the nation’s chief product-safety regulator, has been accused of not protecting consumers, prompting some Democrats in Congress demanded Nord resign.  Many where incensed at Nord for opposing provisions of a bill to allow CPSC more authority to disclose information about product hazards and raise the maximum penalty for manufacturers failing to report problems. (more…)

Ambien—trade name Zolpidem in the United States—has been linked to six deaths in the United Kingdom and a large number of adverse reactions.  Ambien is the sleeping drug which actor Heath Ledger admitted taking just weeks prior to his death.  Ledger was found dead by his housekeeper at his New York apartment last Tuesday, and Ambien was among the prescriptions drugs found in his apartment.  Results of a postmortem examination last week on the actor were inconclusive and additional toxicology testing is being conducted; however, there has been growing speculation that Ledger died from an accidental overdose of sleeping pills.

In Britain, were it is marketed as Stilnoct, Ambien is suspected in six fatal suspected adverse drug reactions since 2002, according to the  Medicines and Healthcare products Regulatory Agency (MHRA) since 2001.  In addition to the deaths, there have been nearly 200 other  incidents of adverse reactions, ranging from psychiatric and cardiac disorders to injuries and eye disorders reported to the MHRA since 2001.

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Botox has been implicated in the deaths of four children, prompting calls for more warnings on the drug’s label. Taken together, side effects from both Botox and Mylobloc, another drug made with botulinum toxin, have been linked to 16 fatalities and 87 additional adverse events that required hospitalizations. In all of the cases, the botulinum toxin spread inside the bodies of the patients, killing some and injuring others.

Botox is best known for smoothing facial wrinkles, but the drug is also medically approved by the Food & Drug Administration (FDA) for treating cervical dystonia, or rigid neck muscles. In some cases, Botox is also used to treat stroke victims and other medical conditions including excessive sweating. Myobloc is only approved for the neck condition. (more…)

The maker of the defective Kugel Mesh Hernia Patch will now have to face even more lawsuits over faulty hernia patches.  Earlier this month, a Federal Court charged with hearing all claims related to the Kugel Mesh Hernia Patch ruled the proceedings would be expanded to include claims against any of Davol Inc’s defective mesh patches, even those that were not involved in the original Kugel Mesh Hernia Patch recall.

When it was first introduced, the Kugel Mesh Hernia Patch was heralded as an innovation in hernia treatment. Unfortunately, by 2005, the Food & Drug Administration (FDA) was receiving more and more reports of failure with the Kugel Patch. The reports were so alarming that the FDA issued a Class I recall of the Bard Composix Kugel Mesh X-Large Patch. Apparently, the recoil ring that opened the patch could break. When the ring broke, patients experienced bowel perforations and other serious problems. A Class I recall means that the recalled product poses a serious danger to patients still using it. The FDA warned doctors to quite using the patch. The FDA also warned patients who received the patch to seek medical attention if they experienced unexplained fever, persistent abdominal pain, or tenderness to the incision site. By February 2007, the Kugel Patch recall had been expanded twice to several other sizes of the device.

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Once you have recovered from the effects of food poisoning, do the negative health effects remain with you for months and years later?  Unfortunately, the answer is sometimes no.  According to emerging research, bouts of food poisoning can have long-term, lasting effects that can either linger for months or years.  In some cases, patients who thought they were fully recovered from an episode of food poisoning can experience related health problems years down the road.

Various food poisoning studies found that some children who suffered severe cases of E. coli developed health problems later in life, such as kidney problems, high blood pressure, and kidney failure.  And there is no way of knowing who is safe and who is not –  the health problems could show up as late as 10 to 20 years later.  The research also found people who suffered salmonella or shigella can end up suffering from Reiter’s Syndrome, a type of  arthritis later in life and.  And for those who exhibited even mild campylobacter, Guillain-Barre Syndrome, a type of paralysis, can strike months later. (more…)