JAMA Slammed Over Lexapro Study Debacle

A nonprofit group has criticized the Journal of the America Medical Association (JAMA) over its treatment of a researcher who questioned a Lexapro study it published. According to The Wall Street Journal, the Alliance for Human Research Protection is calling for the suspension of two JAMA editors because of their role in the debacle. The Alliance is a group that has long criticized the ties between the drug industry and academia, the Journal said.

In a letter to the chairman of the JAMA board of trustees, Vera Sharav, President of the Alliance, wrote that the organization was “deeply concerned about the unbecoming and unethical conduct of the Editor-in-chief and Executive Deputy Editor of the Journal of the American Medical Association, who were reported to have used unprofessional and intimidating tactics against a conscientious academic, Dr. Jonathan Leo.” More JAMA Slammed Over Lexapro Study Debacle

Poor Records Hamper FDA Food Poisoning Investigations

The many, well-publicized food recalls and food borne illness outbreaks in recent months have consumers, advocates, and even the government looking at what is to blame and how the problems can be rectified. According to Reuters, poor record keeping at the food handler level is, in part, at fault.

Because a good amount of food handlers in this country do not keep appropriate tracking records for food products such as milk and oatmeal, said Reuters, when outbreaks occur, it becomes nearly impossible to track the source. More Poor Records Hamper FDA Food Poisoning Investigations

Leaky Roof Eyed in Salmonella Outbreak

The historic salmonella outbreak linked to Peanut Corporation of America (PCA), which has sickened and hospitalized hundreds; was linked to nine deaths; prompted thousands of food recall; and resulted in governmental investigations, bankruptcies, and dozens of lawsuits, might all have originated with a leaky roof.

PCA has been cited for horrendous sanitary conditions that include all manner of vermin and associated carcasses and excrement, as well as a leaking roof. The Associated Press (AP) also recently reported that the House Energy and Commerce investigations subcommittee just released information revealing that PCA hired the private inspectors who failed to cite PCA for these disgusting conditions. More Leaky Roof Eyed in Salmonella Outbreak

Settlement Proposed in Paxil Class Action Lawsuit

A settlement has been proposed in the so-called Paxil “split pill” class action lawsuit. According to a press release, if approved, the settlement will provide up to $28 million to claimants and their insurance companies.

Paxil is part of a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). Paxil was approved to treat symptoms of depression, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), panic disorder, generalized anxiety disorder (GAD), social phobia/social anxiety disorder, and premenstrual dysphoric disorder (PMDD). Paxil was the first antidepressant formally approved in the US for the treatment of social anxiety disorder.

The drug has been linked to a variety of problems, including birth defects, as well as suicide and suicidal tendencies when taken by young people and children. Yet in spite of these risks, by 2006 Paxil was the fifth most-commonly prescribed antidepressant in the US, with more than 19.7 million prescriptions.

The Paxil “spit pill” class action lawsuit alleges that Paxil “controlled release” (CR) tablets made between April 1, 2002 and March 4, 2005, contained a manufacturing defect that caused them to split apart. According to the complaint, Paxil CR tablets are intended to deliver the active ingredient over a period of time, and not all at once. When one splits apart, the outside coat breaks up and the drug is released while the tablets are still in the stomach. Patients end up with all of the active ingredient, without the benefits of the controlled-release, and received the entire dose at once. Or they get only the controlled-release ingredient without the active ingredients, the complaint says.

In March 2005, armed marshals with the Food and Drug Administration The Sandlot release (FDA) raided GlaxoSmithKline plants in Puerto Rico and Tennessee after learning that some pills manufactured there had split apart. The FDA had originally discovered the problem at the Puerto Rico plant in February 2002, and the problem continued despite repeated warnings and inspections, the complaint charges.

If approved, the $28 million settlement will be split between consumers who paid for their Paxil and insurance companies seeking to be reimbursed for their expenditures. The amount each class member recovers will depend on how many defective pills they bought, with a maximum recovery of $150 per person. A final approval hearing will be held on July 10, 2009.

Under the settlement, GlaxoSmithKline denies liability and all of the claims in the lawsuit.

Vets Endangered by Improperly Sterilized Equipment

Even though the Veterans Administration (VA) isn’t saying much, it seems as if thousands of military veterans might have been exposed to dangerous, life-threatening pathogens from colonoscopies and endoscopies they underwent as long as five years ago. The Associated Press (AP) reports that military veterans in the southern United States are awaiting word about potential and serious infections.

WSMV reports that no less than 10 patients have tested positive for hepatitis B or C or HIV. At least one man has consulted with malpractice attorneys and more are expected. The man, who is in his 50s, tested positive for hepatitis C; he and his lawyers believe a colonoscopy at the Murfreesboro Veterans Administration two years prior to be the culprit, said WSMV. Now, the long-married father must endure protected sex with his wife for the rest of their lives, it noted. More Vets Endangered by Improperly Sterilized Equipment

GAO Sting Raises Questions About Medical Trial Oversight

A sting operation that allowed investigators to gain approval to test a fake medical device is raising serious questions about the oversight of medical trials. According to the Associated Press, as part of the sting, the Government Accountability Office (GAO) was also able to register a fictitious institutional review board with the Health and Human Services Department (HHS).

The GAO investigation focused on institutional review boards, which are charged with ensuring the safety of humans in trials involving medical products. According to Dow Jones Newswire, the GAO investigation ran from January 2008 to earlier this month, and was done at the request of the investigative subcommittee of the House Energy and Commerce Committee. More GAO Sting Raises Questions About Medical Trial Oversight

CPSC Inspecting Chinese Drywall Homes in Florida

Investigators from the Consumer Products Safety Commission (CPSC) are on the ground in Florida trying to determine if defective Chinese drywall used in some newer homes in the state poses a health threat.

According to HeraldTribune.com, the Florida Health Department has received at least 155 complaints about Chinese drywall that produces a “rotten eggs” odor in homes. The fumes from the drywall have also been linked to corroding metals in many of the homes, and people living with the material have reported sinus and respiratory problems. Many Florida homeowners have had to leave their homes because the Chinese drywall has made them unlivable, and some builders in the state are scrambling to gut homes and replace the drywall. More CPSC Inspecting Chinese Drywall Homes in Florida

Groups Urge Change at FDA

Following President Barack Obama’s announcements that two health specialists would be appointed to key positions at the the Food and Drug Administration (FDA), and that a new group would be appointed to look at reforming food safety laws, two advocacy organizations are urging Obama’s administration to appoint a senior food safety official in the FDA.

Earlier this month, President Obama selected Dr. Margaret Hamburg, a biodefense expert and former New York City health commissioner, to serve as FDA commissioner, and Baltimore health commissioner Dr. Joshua Sharfstein as principal deputy commissioner. The president also announced plans for a Cabinet-level group to advise on food safety improvement, reported Reuters. More Groups Urge Change at FDA

Pilot Error Likely to Blame in Buffalo Plane Crash

Federal investigators have been analyzing the events leading up to the Buffalo, New York plane crash that killed 50 people in February, and are specifically looking at pilot training and the pilot’s responses in his final moments. Now, according to CNN, the crew might be to blame in its handling of the plane’s stall.

On February 12, the Continental Connection Flight 3407—a Colgan Air Bombardier Dash 8 Q400—crashed into a home near the Buffalo-Niagara International Airport, killing all 49 passengers and crew and one man in the house. More Pilot Error Likely to Blame in Buffalo Plane Crash

American Psychiatric Association Phasing Out Industry-Supported Symposia, Meals

In an effort to increase industry transparency and amid media reports, investigations, and legal actions surrounding medical and pharmaceutical industry ties, the American Psychiatric Association (APA) has joined the growing number of entities seeking distance from conflict-of-interest issues. The Association just issued a release stating that its Board of Trustees voted this month to not only phase out industry-supported symposia, but to phase out industry-supplied meals at its annual meetings, as well.

“Although we took great care to avoid biased reporting at all our symposia, we came to the conclusion that the only way to totally eliminate the risk is to have the symposia supported by the APA alone,” said Nada L. Stotland, M.D., M.P.H., president of the APA. The Association explained that, “symposia at major medical meetings that supply doctors with continuing medical education credits are sometimes funded by pharmaceutical companies, a practice that has invited a concern that the sessions may be biased in favor of the sponsoring company’s medications.” More American Psychiatric Association Phasing Out Industry-Supported Symposia, Meals

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Defective Chinese Drywall Misery

It's estimated that more than 500 million pounds of possibly deficient Chinese drywall entered America between 2004 and 2008. An Associated Press statement said that was enough material to build about 100,000 homes. If you or a loved onehas been experiencing problems with corroding metals, foul odors, or sinus and respiratory ailments, your home may have been built with Chinese drywall. Get the facts!
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