Swine Flu ‘Emergency Use Authorizations’ fail to meet the legal standard

The swine flu pandemic triggered a variety of government responses throughout the world. In the United States, plans to deal with the disease required that a variety of emergency procedures be used. Both the HHS Secretary and President had to declare emergencies. CDC advised FDA, which issued Emergency Use Authorizations. To invoke the Public Readiness…

Academic Researchers’ Conflicts of Interest Go Unreported/ NY Times

Excerpts from another excellent Gardiner Harris piece: In a report expected to be made public on Thursday, Daniel R. Levinson, the inspector general of the Department of Health and Human Services, said 90 percent of universities relied solely on the researchers themselves to decide whether the money they made in consulting and other relationships with…

Medical Faculty ‘Ghostwriting’ Equals Plagiarism: Senator Grassley/ NY Times

Sen. Charles Grassley has been pursuing various forms of medical malfeasance for years. On November 17 he honed in on the practice of ‘ghostwriting,’ in which medical ‘opinion leaders’ are sought after as authors of medical journal articles supporting a new drug, vaccine or medical device. Only problem is, the articles they ‘author’ were actually…

Doctors say most Britons reject swine flu vaccine/ Reuters

Excerpts from this Reuters article indicate, imho, that the pregnant patients have more sense than the doctors offering them vaccine. … “In all the pregnant women we’ve offered it to, I think only about one in20 has agreed,” Dr Chris Udenze, a family doctor based in Nottingham, centralEngland, said in the survey… Original estimates that…

A pandemic response to a disease of predominantly seasonal intensity/ Medical Journal of Australia

From Dr. Heath A. Kelly, head of the epidemiology unit at Victoria’s Infectious Disease Reference Laboratory, comes this well-documented and clearly reasoned piece reviewing Australia’s experience with swine flu. Here are the main points: From the recognition of the swine flu pandemic in late April 2009, health professionals, politicians and the public needed to know…

Canadian Swine Flu Vaccine “Interim Order” uses identical language as US “Emergency Use Authorization”

Canada’s Minister of Health, Leona Aglukkaq (a politician with no medical training) issued an “interim order” for the sale of swine flu vaccine in Canada on October 13, 2009. Under the section titled “Authorization for Sale” are the following requirements that must be met to issue an interim order. These are: “… it is reasonable…

Flu vaccination campaign a ‘mess’ that should be discontinued: Canadian health official/ National Post

Excerpts from an article in the National Post, detailing remarks by Dr. Richard Schabas, Ontario’s former chief medical officer and a top health officer in the province: “In eastern Ontario where I live and work the outbreak is effectively over. If we’re immunizing people now essentially you’re barring the barn door after the horse is…

FDA Commissioner acknowledges adjuvant risk: “There wasn’t experience with that vaccine in other populations, including pregnant women and children”

U.S. Food and Drug Administration Commissioner Dr. Margaret Hamburg spoke at the Reuters Health Summit in New York, November 12, 2009. An excerpt from the Reuters article on her talk follows: Some experts have suggested the government could have increased supplies by embracing adjuvant vaccine technology that is widely used in Europe. Adjuvanted vaccines contain…

Did US cases peak or not?

CDC updated its tables today with last week’s data. Swine flu hospitalizations for the last week of October increased more than 1,000 from CDC’s figure last week, presumably due to late reporting. Deaths similarly increased. However, the percentage of positive tests for flu has fallen over 20% from its peak, during the last 2 weeks…

Suddenly there are many more deaths from swine flu, per CDC

Using modelling to estimate the number of flu-related deaths makes a lot of sense when many of those who die are in nursing homes, not hospitalized, and not tested for flu. “Many are close to death, with flu being only one factor leading to their demise,” notes today’s Washington Post. I would expect that several…

Swine Flu: One killer virus, three key questions/ Nature

Nature (Brendan Maher & Declan Butler) report from three laboratories scrutinizing the pandemic flu virus.This is an interesting article about basic research on the swine flu virus at CDC Atlanta, Mount Sinai School of Medicine, NY, and INSERM at Lyon. Plenty of background as in a Laurie Garrett story, but no amazing new insights.

Mandatory Vaccinations: No, we’re not there yet, but why have we started going down that road?

“Once you start requiring doctors to get it, doctors are going to think it’s reasonable to make patients get it. It starts you down that mandatory route, and I don’t think we want to go there.” So said George Annas, renowned bioethicist, NEJM columnist and department chair of Health Law at Boston University School of…

Gulf War Syndrome: Additional information presented to House Vets Affairs Health Subcommittee by me in 2007

I happened to stumble across this Congressional website tonight. It includes my answers to additional questions posed by the Committee after I testified on GWS in July 2007. It also includes my Senate testimony on GWS of September 2007. However, of special interest is a list of statistical analyses and informal studies conducted by the…

What if you “suffer specified injuries” from a Swine Flu countermeasure?

Sorry for repeating myself regarding this new method of dealing with injuries, but this is what the US government (DHHS) says: The PREP Act also authorizes a fund to provide compensation to eligible individuals who suffer specified injuries from administration or use of a countermeasure pursuant to the declaration. Any requests for compensation must be…

New York Clinics See Few Crowds for Free Vaccine/ NY Times

Excerpts from this NY Times article: … While the city’s health commissioner, Dr. Thomas A. Farley, said the clinics had the staff and enough vaccine to accommodate about 500 middle- and high-school students per clinic per hour — or as many as 31,500 vaccinations a day — a department spokeswoman put the total vaccinations administered…

Polish PM: Poland not buying swine flu vaccination unless it has been properly tested/ Canadian Press

Funny that I was only able to find one US news source (a Texas TV station) that carried this AP story. From the Canadian Press: Polish Prime Minister Donald Tusk said Friday that his government won’t buy vaccines for swine flu that have not been properly tested or from producers who won’t take responsibility for…

THE PANDEMIC VACCINE PUZZLE Part 4: The promise and problems of adjuvants

A well-researched piece on adjuvants from CIDRAP (Oct. 30, 2007), by Maryn McKenna. US citizens will need to be concerned about novel adjuvants when the next pandemic strikes, but people in the rest of the world will be offered swine flu vaccine with these adjuvants now. Excerpts: There is currently no regulatory pathway by which…

Rulings stop mandatory vaccination for University of Iowa hospital employees/ Gazette Online

Another hospital’s mandatory flu vaccination program will end after rulings were made Monday in favor of two unions. Who’s fooling who? If, as the NEJM reported, the live nasal flu vaccine used last winter was only 29% effective in adults, mandatory vaccination of employees who use this vaccine will still leave 71% susceptible to the…

Peramivir Update/NY Times

By the NYT’s Andrew Pollack; excerpts follow: On Thursday, the federal government ordered, on an emergency basis, 10,000 treatment courses of peramivir for its national stockpile. It is paying $22.5 million, or about $2,250 a patient. Shares of BioCryst rose nearly 13 percent, to $11.39. Peramivir is given intravenously, making it usable by hospitalized patients…

Blackout: Military Personnel Banned From H1N1 Vaccine Sites/Huffington Post

By Huffington Post’s Allen McDuffee: …Mandatory vaccine programs are a sensitive subject in the military, so it’s not a huge surprise that swift and visceral reactions to the [swine flu vaccine] program gained speed. With a vaccine that was so new and little known about it, like many Americans, troops were heading to the web…

Misrepresenting smallpox vaccine in pregnancy findings

Re: Evaluation of Preterm Births and Birth Defects in Liveborn Infants of US Military Women Who Received Smallpox Vaccine. Margaret A. K. Ryan, Gia R. Gumbs, Ava Marie S. Conlin, Carter J. Sevick, Isabel G. Jacobson, Katherine J. Snell, Christina N. Spooner, Tyler C. Smith, for the Department of Defense Birth and Infant Health Registry…

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