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Politics : Formerly About Advanced Micro Devices -- Ignore unavailable to you. Want to Upgrade?


To: J_F_Shepard who wrote (564976)5/6/2010 4:15:39 PM
From: one_less  Respond to of 1574796
 
Anecdotal may be used to refer to hearsay, which is what you accuse Brumar of but that is not the scientific usage.

Validity at least by replication is within subject not from the subject to a larger population. Validity is internal to the research subject only. This is one of the flaws in Cannibas research where the researchers often make claims based on anectotal evidence that they conclude would be true for a larger population. Some people have proposed meta-analysis but they can't agree on the rules.

Anectotal research evidence is not intended to be used to validate typical experience. In medicine, published anecdotal evidence is called a case report, which is a formalized type of evidence subjected to peer review.(Jenicek M. "Clinical Case Reporting" in Evidence-Based Medicine. Oxford: Butterworth–Heinemann; 1999:117)

Anecdotal evidence is not considered valid for drawing conclusions about a population but it is considered to have internal validity when acquired in a research setting such as single case design research.

+++++++++++++++

Requirements of a single-subject design
The following are requirements of single-subject designs: [3]

Continuous assessment: The behavior of the individual is observed repeatedly over the course of the intervention. This insures that any treatment effects are observed long enough to convince the scientist that the treatment produces a lasting effect.

Baseline assessment: Before the treatment is implemented, researcher to look for behavioral trends. If a treatment reverses a baseline trend (e.g., things were getting worse as time went on in baseline but the treatment reversed this trend) then this is powerful evidence suggesting (though not proving) a treatment effect.

Variability in data: Because behavior is assessed repeatedly, the single-subject design allows the researcher to see how consistently the treatment changes behavior from day-to-day. Large-group statistical designs do not typically provide this information because repeated assessments are not usually not taken and the behavior of individuals in the groups are not scrutinized; instead, group means are reported.
[edit] Phases within single-subject design

Baseline: this phase is one in which the researcher collects data on the dependent variable without any intervention in place.

Intervention: this phase is one in which the researcher introduces an independent variable (the intervention) and then collects data on the dependent variable.

Reversal: this phase is one in which the researcher removes the independent variable (reversal) and then collects data on the dependent variable.

It is important that the data are stable (steady trend and low variability) before the researcher moves to the next phase. Single-subject designs produce or approximate three levels of knowledge: (1) descriptive, (2) correlational, and (3) causal

en.wikipedia.org



To: J_F_Shepard who wrote (564976)5/6/2010 5:44:36 PM
From: longnshort  Respond to of 1574796
 
did you get this vaccine? you have been squealing a lot lately.


Pig virus DNA found in Merck rotavirus vaccine
Lisa Richwine
WASHINGTON
Thu May 6, 2010 5:16pm EDT

Wed, May 5 2010

WASHINGTON (Reuters) - Pieces of DNA from a pig virus were found in Merck & Co Inc's vaccine against a diarrhea-causing infection, but U.S. health officials said on Thursday there was no evidence of a risk to people.

Health

DNA from the same virus was found in a rival GlaxoSmithKline Plc vaccine. Glaxo and the Food and Drug Administration in March urged doctors to suspend use of that vaccine, but there was no similar recommendation for Merck's product.

The FDA will seek input on both vaccines, which fight rotavirus infection, at an advisory panel meeting on Friday.

Merck said the company's preliminary testing found "very low levels" of DNA from porcine circovirus, or PCV, in its Rotateq vaccine.

"There is no evidence at this time that DNA from PCV causes any disease in humans," Merck said in a statement.

The FDA said the number of virus DNA fragments in the Merck vaccine may be smaller than what has been found with Glaxo's product, called Rotarix.

"FDA has no evidence to date that these findings pertaining to Rotarix and RotaTeq pose a safety risk. Both vaccines have strong safety records, including clinical trials involving tens of thousands of patients and clinical experience with millions of patients," the agency said in a statement.

Rotavirus vaccines have a troubled history. Wyeth's Rotashield was pulled off the market in 1999 after it was linked with a rare but deadly bowel obstruction.

Merck's tests found fragments of DNA from PCV1 and a related virus called PCV2. Tests of Glaxo's vaccine found only DNA from PCV1.

Both types are common in pigs but neither is known to cause illness in humans, the FDA said. PCV2 is believed to cause post-weaning multisystemic wasting syndrome in young piglets, marked by diarrhea and an inability to gain weight.

FDA spokeswoman Shelly Burgess said the agency felt it was appropriate to hear from the advisory panel as officials consider future recommendations for both vaccines.

The vaccines prevent infection with rotavirus, which can cause severe diarrhea and kills more than 500,000 infants each year, mostly in low- and middle-income countries.

When Glaxo announced the pig virus finding in March, the World Health Organization said the risks from rotavirus outweighed any potential risks from PCV. It did not recommend any change to use of the vaccine in developing countries.

Merck said it tested Rotateq for PCV after the Glaxo findings were announced in March and immediately shared results with the FDA.

"We remain confident in the safety profile and quality of Rotateq. Rotavirus vaccines are a major public health advance," the company said.

In Glaxo's case, the virus DNA was found by accident when the company ran checks using new molecular detection techniques. The virus had apparently been there since the vaccine was first developed.

Glaxo has said no safety issues were identified with Rotarix and the company is working to replace the cell bank and virus seeds used to make Rotarix.

Merck shares fell 3.7 percent to $34.27 while Glaxo shares dropped 3.6 percent, both on the New York Stock Exchange, amid a broad market sell-off.

(Editing by Maureen Bavdek, by Tim Dobbyn and Steve Orlofsky)