April 26, 2010
By Rob Stein
Federal health officials are investigating the first hints of any possible significant complications from the H1N1 vaccine, but stressed that the concerns will probably turn out to be a false alarm.
The latest analysis of data has detected what could be a somewhat elevated rate of Guillain-Barré syndrome, which can cause paralysis and death; Bell’s palsy, a temporary facial paralysis; and thrombocytopenia, which is a low level of blood platelets, officials reported Friday. The data is being collected through five of the networks the government is using to monitor people who were inoculated against the swine flu.
Officials stressed that it is far too early to know whether the vaccine was increasing the risk of those conditions or whether there is some other explanation, such as doctors identifying more cases because of the intensive effort to pinpoint any safety problems with the vaccine.
Based on the preliminary report, the Health and Human Services Department’s National Vaccine Advisory Committee, which has been charged with monitoring the vaccine’s safety, voted unanimously to follow up on the findings. “We’re at the first step of determining whether there is a problem,” Guthrie S. Birkhead, who chairs the committee, said during a teleconference in which a subcommittee of experts presented its latest findings on the data. “There’s a lot more work to determine whether there is.”
Marie McCormick, who led the subcommittee, said there was a good chance the indications of problems could disappear with further analysis. Even if the link with Guillain-Barrésyndrome is confirmed, the committee calculated the vaccine at most could be causing one extra case per 1 million people vaccinated.
“We have categorized this as a potential, not even a weak, signal,” McCormick said, adding that no signs of problems have been seen in the other networks of data the government has been analyzing.
Even if the possible risks turn out to be real, officials stressed that the danger of the flu remains far greater.
“From everything we know right now, the influenza vaccine, including the H1N1 vaccine, is very safe, and it’s much riskier to get influenza than the influenza vaccine,” said Anne Schuchat of the federal Centers for Disease Control and Prevention.
Officials said they were not surprised that some possible problems that turn out to be false alarms might be found, given how intensively the vaccine’s safety is being monitored.
The vaccine was administered to 350 million to 400 million people worldwide, including as many as 80 million Americans, as part of an unprecedented response to the first flu pandemic in decades.
Since the inoculation program was launched, health officials have been particularly concerned about Guillain-Barré syndrome, in part because a vaccine made in 1976 in response to a different strain of H1N1 influenza led to a small increase in the number of cases of the condition.
But officials expressed confidence that the new vaccine is safe because it was produced with the same methods employed since then to make the seasonal flu vaccine, which has been administered safely to millions of people.
Each year, about 3,000 to 6,000 people in the United States develop Guillain-Barré syndrome whether or not they were vaccinated — a rate of one to two people out of every 100,000 people. Some studies have indicated that the seasonal flu vaccine might be associated with one additional case of the syndrome out of 1 million vaccinated. And influenza itself can cause the syndrome.
Although the vaccine was produced in record time, antiquated technology and unexpected problems growing the virus fast enough to produce the vaccine meant that most of the doses did not arrive until after the second wave of infections peaked last fall. That led to widespread anxiety, frustration and lines across the country as people scrambled to find the first doses. By the time most of the vaccine was ready, the second wave was already receding and demand fell sharply, leaving millions of doses unused.
The relatively low number of deaths compared with previous pandemics and the millions spent on the vaccine have led to charges that the World Health Organization exaggerated the pandemic’s risks. That prompted the Geneva-based arm of the United Nations to launch two investigations, which are ongoing.
February 23, 2010
By Ethan A. Huff
A recent report in the West Virginia Record details a lawsuit filed against Baxter Healthcare Corp. for damage caused by their blood thinning drug, heparin. After being prescribed the drug in 2007, James Bradley quickly developed severe bodily injuries that resulted in having to have his toes amputated. He and his wife Shirley are seeking compensation for his loss and the intense pain and suffering that he experienced from the drug.
Heparin is known to cause a severe blood platelet disorder called thrombocytopenia that can cause patients to develop gangrene. The Bradley case is one of many in which patients have had to undergo amputation due to heparin-induced disease and decay.
The Bradley case is alleging that Baxter and other drug companies that market heparin are doing so falsely. They believe it is clear that the drug is not safe and that it does not work. The suit is claiming that the drug is defectively designed and fraudulent in its purpose and the claims being made by its manufacturers and marketers.
In 2008, heparin was recalled for being contaminated with a counterfeit active ingredient that was causing serious allergic reactions and even death in some patients. Chinese manufacturers that produce the drug for Baxter were found to have been using a spurious active ingredient that injured and killed hundreds of people.
Hollywood actor Dennis Quaid and his wife almost lost their twin newborn babies when multiple doses of heparin were given them rather than a more diluted form of it called HepLock. Heparin and Heplock are commonly mixed up by medical professionals which has caused many injuries and fatalities.
Nearly all of the 450,000 Americans who are on dialysis use heparin. Its listed side effects are already highly severe and are known to be possibly fatal. However the rate of amputations and death directly caused by the drug is unacceptable and demands justice.
The list of personal injury cases and class action lawsuits being filed against Baxter and the other producers of heparin is growing as increasing numbers of injured people are seeking remediation for damage caused by the drug. As the primary manufacturer of heparin prescribed in the United States, Baxter will have a lot of explaining to do concerning their apparent negligence in disclosing the truth about the dangers of heparin.
Some natural blood thinners and clot prevention nutrients include omega-3 fatty acids, vitamin E, ginseng, methyl sulfonyl methane (MSM), and white willow bark. Some foods with blood thinning properties include ginger, garlic, and onions.