Tamiflu found to be 99% ineffective against primary flu strain

Tamiflu found to be 99% ineffective against primary flu strain

 

Following up on an initial report last month, The New York Times now says that Tamiflu is 99% of all flu strains 99% ineffective against the dominant flu strain that will strike Americans this season.

Scientists and health officials do not know why. Last winter, roughly 11% of common flu strains patients with the most common flu strain resisted showed resistance to Tamiflu, the leading antiviral drug.

No resistance to Tamiflu has been identified among other circulating viruses, according to the Centers for Disease Control and Prevention and Roche, the manufacturer.

“It’s quite shocking,” Dr. Kent A. Sepkowitz, director of infection control at Memorial Sloan-Kettering Cancer Center, told the Times. “We’ve never lost an antimicrobial this fast. It blew me away.”

So far, it’s not a public-health problem. Officials cite two reasons: the flu season has been below average, and the main strain is susceptible to other antivirals.

January and February are peak months for influenza.

Last month The Wall Street Journal reported that the CDC had alerted doctors about Tamiflu’s apparent ineffectiveness and urged them to prescribe an additional drug.

The Food and Drug Administration has more information about Tamiflu.

WebMD, citing the CDC, reports the first flu-related death of a child this season.

 

Correction: In hastily summarizing the Times article, the effectiveness of Tamiflu was misstated. The headline and text have been corrected. Apologies to all. It’s another reminder of how moving at Internet speed can sometimes kill comprehension…

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Course shows companies what NOT to put in writing

Course shows companies what NOT to put in writing

NEW YORK (Reuters) – Want to avoid those embarrassing internal emails containing concerns that an important product may be harmful, or documents that could attract the attention of an ambitious prosecutor?

The Medical Technology Learning Institute and Compliance-Alliance is offering: “Dangerous Documents: Avoiding Land Mines in Your FDA Records and Emails” — a course tailor-made for the drug industry and medical device company executive anxious to cut down on pesky multimillion-dollar legal settlements.

Dangerous Documents offers such helpful tips as: Instead of writing, “We’ll meet on Thursday to destroy the documents,” it’s better to say, “We’ll meet on Thursday to implement our document retention policy.”

The course is the brain child of Compliance-Alliance founder Nancy Singer, a former U.S. prosecutor who did litigation for the Food and Drug Administration.

Singer is using her expertise to educate company officials on how to write internal and external communications that do not contain potential “landmines,” which she describes as anything that “if it’s uncovered, it explodes.”

“Documents are like diamonds,” she is fond of saying. “They are very precious and they last forever.”

The Compliance-Alliance mission statement says the course will present “the latest thinking on what it takes to achieve and maintain compliance with FDA and CMS requirements.”

However, there appears to be more here than instruction on how to be an upstanding corporate citizen and keep government agencies happy. The course agenda reads more like a primer on how to avoid raising red flags with the regulatory police or the suspicion of prosecutors and product liability lawyers.

Some of the more eye catching topics listed in the program for the $995 course include:

* Who can be held criminally liable under the Federal Food, Drug and Cosmetic Act

* 18 words that will attract the attention of prosecutors or plaintiffs’ lawyers

* 8 common practices that are sure to get you in trouble

* The dangers in not monitoring employee emails

Singer insists this is not about how to bury negative data or avoid getting caught for nefarious practices.

“I want to educate all employees on the ramifications of how inappropriate statements can be used,” Singer said.

Indeed, in every personal injury trial in which Merck & Co defended its handling of the withdrawn pain drug Vioxx, plaintiffs’ lawyers dredged up internal Merck memos that questioned company interpretations of clinical safety data. Despite winning most of those trials, Merck finally agreed to a $4.85 billion settlement….

Never use words like illegal or negligent when you can instead say, “It could be argued that that doesn’t comply with requirements” or “perhaps we haven’t been as careful as we should be,” Singer said.

Among the pitfalls Singer discusses is what she calls the CYA (Cover Your Ass) memo, in which an employee puts concerns in writing for the files to show he or she raised the issue….

If the employee gets subpoenaed in a product liability case the CYA memo will be used against the company, Singer says, “and it’s not going to protect you from the government.”

Another common misconception, Singer says, is the belief that putting “confidential” or “internal use only” on a memo will keep it out of the hands of investigators or government agencies.

“Writing ‘confidential’ doesn’t mean anything.”

Full article

New Autism Study Conducted by Boobs?

New Autism Study Conducted by Boobs?

Age of Autism Blog:

A study reports that men with autistic children do not prefer curvier women like most “normal” men.  So is it Dad’s fault for chasing down Olive Oyl or Mom’s fault for resembling a pipe cleaner (in my case, a Q-tip, thanks to the tangle of hair.) Holy Donut Holes! I knew I should have eaten more crullers in college…. You men can thank me for finding a way to get her (jerking head to thataway) on A of A. Send a donation. ;)

Someone spent money on this study.(Quick, check Autism Speaks’ grants list and get back to me, won’t you?)  KS

Men who do not find the shape of the curvier woman most attractive could be more likely to father children with autism, according to a study.

Researchers showed 100 men with autistic children pictures of curvy women, women with athletic frames and more rounded women and found that they do not have a preference on which figure they find more attractive.

The new research from the University of Bath suggests that fathers of autistic children do not share the preference of men across the world for the curvier woman.

 

The study: “A Preliminary Investigation into the Potential Role of Waist Hip Ratio (WHR) Preference within the Assortative Mating Hypothesis of Autistic Spectrum Disorders.

Brosnan M, Walker I.  J Autism Dev Disord. 2009 Jan;39(1):164-71. Epub 2008 Jul 4.

“Of particular interest to studying the etiology of Autistic Spectrum Disorders (ASDs) is the potential for multiple risk factors to combine through non-random mechanisms-assortative mating. Both genetic influences and a high-testosterone prenatal environment have been implicated in the etiology of ASDs, and given that waist-hip ratio (WHR) is indicative of a woman’s circulating testosterone level, a man attracted to higher-than-average WHR women is likely to have a higher-than-average prenatal testosterone exposure for their offspring. We show that whereas fathers of children without ASD show a statistically reliable preference for WHRs at the low end of the normal range, indicative of women with low testosterone levels, fathers of children diagnosed with ASD do not consistently show this preference.”

Taking Shots

Taking Shots

 

 

LISTEN TO “Taking Shots” (24MB MP3)

 

Whether or not vaccines pose a risk to infants and small children has been called one of the great debates of this decade. Some claim that there is a connection between vaccines and the rising rate of autism in the U.S., while others argue that vaccines are not only safe but vital to keeping kids healthy.

Oregon requires children to be vaccinated against 11 different diseases in order to attend school, but the state does allow for exemptions. These are technically religious exemptions, but religion is defined broadly as “any system of beliefs, practices or ethical values.” The exemption rate is 4.1 percent statewide but Ashland has recently drawn national attention for their unusually high rate of vaccine exemptions. More than 28 percent of kindergartners there were not vaccinated in 2007. That’s why the Centers for Disease Control will be hosting a public meeting in this southern Oregon city on Saturday to listen to parents’ concerns and gather information for a vaccine safety study.

Are you a parent? How did you decide whether or not to vaccinate your children? Were you vaccinated as a child? How has your experience informed your medical choices? With the preponderance of the medical community in favor of vaccines, but with access to plenty of anti-vaccine information, how do you decide who you can trust?

GUESTS:

 

New Type of Vaccine Delivers Enhanced Immune Response

New Type of Vaccine Delivers Enhanced Immune Response

A new vaccine platform that could bring fundamental changes to vaccine technology is being developed by scientists at the University of Copenhagen. Known as the InVacc platform, it improves upon original DNA vaccines and creates new vaccines with enhanced properties.

The platform consists of a chain of amino acids attached to a gene of the virus being vaccinated against. This “genetic cocktail” is inserted into an appropriate expression vehicle, such as an incapacitated adenovirus, and injected into the body, triggering a broad and aggressive immune response. The chain of 215 amino acids and its insertion into the adenovirus represent the key innovations of this technique.

To date, tests of the vaccine look promising. Researchers were able to provide 100% protection against various lethal strains of flu given to mice. The next phase of development and, ultimately, clinical trials are being planned.

Associate professor Jan Pravsgaard explained, “The platform has proved very effective in our recent tests and could have enormous potential. In principle, vaccines of this type could be used to inoculate against a range of deadly viruses, bacteria, and other diseasecausing agents and even be used to cure certain cancers once they take hold.”

source: Dec. 2008 issue of Ajho