Lawyers for the group filed a temporary restraining order (TRO) in a Washington federal court against government medical regulators they claim rushed H1N1 vaccines to the public without adequately testing their safety and efficacy.
"None of the vaccines against H1N1 have been properly tested," attorney Jim Turner, one of half a dozen lawyers working on the case.
The class action suit was brought on behalf of a group of doctors, nurses and other medical personnel in New York, where health care professionals who see patients are required to be vaccinated against H1N1, Turner said.
If the complaint is upheld, it would stop the roll-out of the H1N1 vaccine nationwide, said Turner, who accused public health officials of hyping the swine flu outbreak but failing to back up their stance with adequate testing of the vaccine.
"Officials have said the virus is so much like the ordinary flu virus that they don't need to do special new drug testing on it because it's just the same old virus with a minor change to it," said Turner.
"We're saying, if that's the case, then all the hype about this thing being a worldwide threat is misplaced and they've stampeded the state of New York into taking an action they never would have taken if it were just another flu."
Last week, some 2.4 million doses of nasal spray vaccine made of greatly weakened, but live, H1N1 virus were delivered to state and local health authorities around the United States.
This week, even larger stocks of injectable vaccine were delivered and administered to people in groups deemed to be at particular risk from swine flu, including children and health care professionals.
US public health officials want to vaccinate tens of millions of Americans by year's end against swine flu, which has claimed more than 4,500 lives worldwide since an outbreak of H1N1 was first reported in Mexico in April.
WASHINGTON REDSKIN'S CHEERLEADING HOPEFUL DEVELOPS NEUROLOGICAL PROBLEMS AFETR FLU SHOT.
ASHBURN, Va.(10/14/2009) -- Desiree Jennings thought it would be a good idea to get the seasonal flu shot. Her job offered incentives for it, and she didn't want to get sick.
Ten days after she got the shot at a Reston Safeway, she did get sick.
"I got flu-like symptoms -- nausea, vomiting, body aches, fever -- then was lethargic for a week and started blacking out," said Jennings, an AOL employee and Washington Redskins ambassador hoping to one day be a cheerleader for the team, the Loudoun Times-Mirror reported.
Doctors couldn't figure out why her ability to speak and walk were so adversely affected. She saw neurologists, physical therapists and psychologists.
Finally, doctors at Johns Hopkins figured it out, diagnosing dystonia, a rare neurological condition with no cure brought on by infections, brain trauma or, as is believed in her case, reaction to medication. It causes body jerks and abnormal or repetitive movements.
"A simple conversation with two people -- you and I could converse on the couch, and if the phone were to ring it would send her into a violent convulsion," said her husband, Brendan Jennings.
Strangely enough -- as she can't walk forward five feet without stumbling -- with some effort, she can perform one of her life's passions: running. And she walks backward with ease -- oddly empowering, now. After her ordeal began, "My insurance wasn't going to pay for another hospital visit. Matter of fact, they called us as we were driving to Johns Hopkins not to offer a specialist but instead to offer a hospital bed and a wheelchair for our house. I told them I wanted to know what was happening to me and that I didn't want to be in a wheelchair."
Her reaction is one in a million, doctors said.
"I would've much rather won the lottery and bought that ticket instead of gotten the flu shot if I knew that risk existed," she said.
Know the Difference between Cold and H1N1 Flu Symptoms
Fever
Fever is rare with a cold.
Fever is usually present with the flu in up to 80% of all flu cases. A temperature of 100°F or higher for 3 to 4 days is associated with the flu.
Coughing
A hacking, productive (mucus- producing) cough is often present with a cold.
A non-productive (non-mucus producing) cough is usually present with the flu (sometimes referred to as dry cough).
Aches
Slight body aches and pains can be part of a cold.
Severe aches and pains are common with the flu.
Stuffy Nose
Stuffy nose is commonly present with a cold and typically resolves spontaneously within a week.
Stuffy nose is not commonly present with the flu.
Chills
Chills are uncommon with a cold.
60% of people who have the flu experience chills.
Tiredness
Tiredness is fairly mild with a cold.
Tiredness is moderate to severe with the flu.
Sneezing
Sneezing is commonly present with a cold.
Sneezing is not common with the flu.
Sudden Symptoms
Cold symptoms tend to develop over a few days.
The flu has a rapid onset within 3-6 hours. The flu hits hard and includes sudden symptoms like high fever, aches and pains.
Headache
A headache is fairly uncommon with a cold.
A headache is very common with the flu, present in 80% of flu cases.
Sore Throat
Sore throat is commonly present with a cold.
Sore throat is not commonly present with the flu.
Chest Discomfort
Chest discomfort is mild to moderate with a cold.
Chest discomfort is often severe with the flu.
Swine Flu Prevention
Prevent Swine Flu - Good Advice
Neti pots and sinus rinse kits are available at the drug store and relatively inexpensive….under $15.
Dr. Vinay Goyal is an MBBS,DRM,DNB (Intensivist and Thyroid specialist) having clinical experience of over 20 years. He has worked in institutions like Hinduja Hospital , Bombay Hospital , SaifeeHospital , Tata Memorial etc. Presently, he is heading our Nuclear Medicine Department and Thyroid clinic at Riddhivinayak Cardiac and Critical Centre, Malad (W).
The following message given by him, I feel makes a lot of sense and is important for all to know
The only portals of entry are the nostrils and mouth/throat. In a global epidemic of this nature, it's almost impossible to avoid coming into contact with H1N1 in spite of all precautions. Contact with H1N1 is not so much of a problem as proliferation is.
While you are still healthy and not showing any symptoms of H1N1 infection, in order to prevent proliferation, aggravation of symptoms and development of secondary infections, some very simple steps, not fully highlighted in most official communications, can be practiced (instead of focusing on how to stock N95 or Tamiflu):
1. Frequent hand-washing (well highlighted in all official communications).
2. "Hands-off-the-face" approach. Resist all temptations to touch any part of face (unless you want to eat, bathe or slap).
3. *Gargle twice a day with warm salt water (use Listerine if you don't trust salt)... *H1N1 takes 2-3 days after initial infection in the throat/ nasal cavity to proliferate and show characteristic symptoms. Simple gargling prevents proliferation. In a way, gargling with salt water has the same effect on a healthy individual that Tamiflu has on an infected o ne. Don't underestimate this simple, inexpensive and powerful preventative method.
4. Similar to 3 above, *clean your nostrils at least once every day with warm salt water. *Not everybody may be good at Jala Neti or Sutra Neti (very good Yoga asanas to clean nasal cavities), but *blowing the nose hard once a day and swabbing both nostrils with cotton buds dipped in warm salt water is very effective in bringing down viral population.*
5. *Boost your natural immunity with foods that are rich in Vitamin C (Amla and other citrus fruits). *If you have to supplement with Vitamin C tablets, make sure that it also has Zinc to boost absorption.
6. *Drink as much of warm liquids (tea, coffee, etc) as you can. *Drinking warm liquids has the same effect as gargling, but in the reverse direction. They wash off proliferating viruses from the throat into the stomach where they cannot survive, proliferate or do any harm.
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University Doctors Got Paid in Drug's Sales Campaign.
Money for speeches highlights murky area for conflicts of interest
Fourteen university-affiliated physicians collected more than $400,000 from the makers of the anti-cholesterol drug Vytorin as part of a campaign to encourage the use of the medication. The 2008 campaign went on after an internal company study showed that the drug, with several billion dollars in sales, had little or no overall value for most patients.
The physicians, many of them prominent in the field of cardiovascular disease, accepted the money from the manufacturers Merck and others.
When questioned last week, the National Institutes of Health declined to comment on the cases of 14 university-affiliated physicians who took money from the drug maker Merck as part of the company's plan to promote its controversial anti-cholesterol drug Vytorin. Now Sen. Charles E. Grassley of Iowa is demanding that the NIH give some answers.
Senator Grassley, the top-ranking Republican on the U.S. Senate Finance Committee, wrote on 26 October to Francis S. Collins, director of the NIH, saying he was "troubled" by the payments and wanted an explanation by November 16 as to how the agency would handle the matter.
In an article citing a letter from Merck to Senate investigators showed that Merck paid more than $400,000 to the 14 doctors as part of a strategy to sell Vytorin even though the company's own internal tests showed the drug, with several billion dollars in sales, was not significantly better than far cheaper alternatives for most patients.
Senator Grassley told Dr. Collins he was especially concerned that the Baylor College of Medicine said it saw no need to inform the NIH of the payments to one of its doctors, Christie M. Ballantyne, even though Dr. Ballantyne was also involved with several NIH grants that concern cardiovascular studies. A spokeswoman for the Baylor College of Medicine, Lori E. Williams, told The Chronicle that her institution felt it needed to tell the NIH about the matter only if it believed Dr. Ballantyne "had a relevant NIH grant."
When asked about the payments from Merck, Ms. Williams had said that the college's Conflict of Interest Committee reviewed all NIH grants involving Dr. Ballantyne "from 2007 and the years just prior in which human subjects were involved. None of these," she said, "involved any validating of any drugs produced by any company."
Dr. Ballantyne collected more than $34,000 from Merck during the company's program of payments, which ran from November 2007 to March 2008. At least four other university doctors paid by Merck during that period also had NIH grants in the same year.
In the case of David E. Cohen, an associate professor of medicine at Harvard Medical School who was paid $50,488 by Merck, a university spokesman said the doctor's "financial interest in Merck was, in his judgment, not relevant to his NIH-funded research, and accordingly, under hospital policy and NIH regulations, it did not need to be disclosed in connection with his NIH grants."
In the case of Antonio M. Gotto Jr., dean of Weill Cornell Medical College, who was paid $27,146 by Merck, a university spokesman said the university counsel "determined that there was no conflict of interest with Dr. Gotto's advisory relationship with Merck and his role as institutional representative on Weill Cornell's NIH General Clinical Research Center grant.
Academic scientists appear to have put their names on papers that are actually ghostwritten by for-profit companies and then published in medical journals, a new study indicates. Some of the scientists accused of doing so deny any wrongdoing, but journal editors are already outlining measures to prevent future breaches of academic integrity.
In the April 16 issue of The Journal of the American Medical Association, four scientists published the results of a search of court documents.
Journal Editor Quits Over Conflict of Interest
The editor of a medical journal has resigned after drawing sharp criticism for failing to disclose his financial ties to a medical-device manufacturer after publishing an paper that endorsed one of its products. The editor, Charles B. Nemeroff, chairman of Emory University’s department of psychiatry and behavioral sciences, was also a co-author of the paper, which said the device was an effective treatment for depression. The medical society that publishes the journal, Neuropsychopharmacology, attributed his resignation, in part, to bad publicity over the paper.
All of that news comes from today’s Wall Street Journal, which last month published a long article about the medical journal’s failure to note that Dr. Nemeroff and seven of his eight academic co-authors had financial ties to the manufacturer, Cyberonics Inc. A ninth co-author was an employee of the company. The medical journal subsequently published a correction noting those relationships.
The Wall Street Journal article appeared at a time when other medical journals were also under fire for failing to enforce their conflict-of-interest policies.
This is an issue I have been following quite closely. Thank you for all the updates and information posted. It is difficult to make sense out of this weekend's announcement by our President, in light of such information to the contrary.
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