Showing posts with label Report Adverse reactions. Show all posts
Showing posts with label Report Adverse reactions. Show all posts

Saturday, March 17, 2007

Vaccine Information
Although these links are from previous years, the information and conclusions of the doctors and surgeons remain relevent today and are good sources of study for those that question the safety of vaccinations.



Association of American Physicians and Surgeons, Inc.

A Voice for Private Physicians Since 1943

Omnia pro aegroto

SOURCE: American Physicians and Surgeons
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Sunday, February 25, 2007

VACCINE SAFETY GROUP RELEASES GARDASIL REACTION REPORT

Calls on FDA and CDC to Warn Doctors and Parents to Report to VAERS

PRNewswire

(Feb. 21) Washington, D.C. – The National Vaccine Information Center (NVIC) today released a new analysis of the federal Vaccine Adverse Event Reporting System (VAERS) reports of serious health problems following HPV vaccination (Merck’s GARDASIL) during the last six months of 2006. Out of the 385 individual GARDASIL adverse event reports made to VAERS, two-thirds required additional medical care and about one-third of all reports were for children 16-years-old and under, with nearly 25 percent of those children having received simultaneously one or more of the 18 vaccines that Merck did not study in combination with GARDASIL. NVIC is calling on the FDA and CDC to warn parents and doctors that GARDASIL should not be combined with other vaccines and that young girls should be monitored for at least 24 hours for syncopal (collapse/fainting) episodes that can be accompanied by seizure activity, as well as symptoms of tingling, numbness and loss of sensation in the fingers and limbs, all of which should be reported to VAERS immediately.

“Because Merck only studied GARDASIL in fewer than 1200 girls under age 16 in pre-licensure trials, it is critical that doctors and parents be made aware of the nature of the initial adverse event reports coming into VAERS and that they report serious health problems after vaccination when they occur,” said NVIC President Barbara Loe Fisher. “There are twice as many children collapsing and four times as many children experiencing tingling, numbness and loss of sensation after getting a GARDASIL vaccination compared to those getting a Tdap (tetanus-diphtheria- acellular pertussis) vaccination. There have been reports of facial paralysis and Guillain-Barre Syndrome. And doctors who give GARDASIL in combination with other vaccines are basically conducting an experiment on their young patients because Merck has not published any safety data for simultaneous vaccination with any vaccine except hepatitis B vaccine.”

According to NVIC’s report, a majority of GARDASIL adverse event reports to VAERS involved those who suffered fever, nausea, headache or pain; 14 percent were for syncopal episodes with or without neurological signs; and 8 percent experienced tingling, numbness and loss of sensation, facial paralysis or Guillain-Barre Syndrome. Although adverse event reports to VAERS do not prove causation, they can provide an early warning sign that a new vaccine may be causing health problems that could be important. For example, reports to VAERS of bowel blockage (intussusception) in babies following receipt of Merck’s Rota Teq (rotavirus) vaccine prompted the FDA to issue a public warning to doctors and consumers on Feb. 13.

“About 4 reports per day were filed with VAERS in December 2006 for the HPV vaccine,” said NVIC Health Policy Analyst Vicky Debold, RN, Ph.D. “Some of these girls are being injured when they collapse after getting the vaccine and others are complaining of neurological symptoms that should not be ignored. Doctors and nurses should take note of the patient safety issues related to giving this vaccine. Giving GARDASIL simultaneously with any of the 18 vaccines Merck did not study in combination is not an evidence- based guideline and should involve informed consent and a signed patient release. To avoid unnecessary injuries, teenage girls should be vaccinated laying down, not be left unattended and probably should not walk or drive themselves home from the doctor’s office after they get vaccinated.”

NVIC also found that there were several VAERS reports of HPV infection, genital warts and cervical lesions after GARDASIL vaccination. It is unknown if the girls were infected with HPV before being vaccinated or if GARDASIL failed to protect them. One case of HPV infection occurred in a 22-year-old girl who had participated in a Merck GARDASIL trial in 2003 when she had shown “strong conversion to all 4 vaccine types” but “tested positive for high risk HPV” in 2006, according to the VAERS report.

In a May 18, 2006 Background Document for the FDA Vaccines and Related Biological Products Advisory Committee (VRPBAC), the FDA staff stated that Merck clinical trial data indicated there may be “the potential for GARDASIL to enhance cervical disease in subjects who had evidence of persistent infection with vaccine-relevant HPV types prior to vaccination.” Girls and women now being vaccinated with GARDASIL are not routinely being tested for active HPV infection before vaccination.

The FDA staff also questioned whether the “HPV types not contained in the vaccine might offset the overall clinical effectiveness of the vaccine.” There are more than 15 types of HPV associated with cervical cancer but GARDASIL only contains HPV types 16 and 18. It is unknown whether non-vaccine HPV types will become more dominant in the future. However, there are indications this could occur because some of the seven strains of pneumococcal contained in Wyeth’s PREVNAR vaccine, which was recommended by the CDC for universal use in all babies in 2000, have been replaced by some of the more than 80 other pneumococcal strains not contained in the vaccine.

VAERS is a passive surveillance system and depends upon voluntary reporting of serious health problems following vaccination, even though safety provisions in the National Childhood Vaccine Injury Act of 1986 mandated that health care providers report vaccine adverse events. There have been estimates that fewer than 10 percent, even as low as 1 to 4 percent, of adverse events which occur after prescription drug or vaccine use are ever reported to government adverse event reporting systems.

“If only 1 to 4 percent of all adverse events associated with GARDASIL vaccination are being reported to VAERS, there could have been up to 38,000 health problems after GARDASIL vaccination in 2006 which were never reported,” said Fisher. “How many girls are really having short-term health problems associated with getting this vaccine that could turn into long-term neurological or immune system disorders? And how many will go on to develop fertility problems, cancer or damage to their genes, all of which Merck admits in its product insert that it has not studied at all? We just don’t know enough to be mandating GARDASIL for anyone, much less vulnerable 11 to 12 year old girls entering puberty.”

For a copy of NVIC’s Report on VAERS and GARDASIL, references for this statement and information about how to report a vaccine reaction to VAERS, go to www.nvic.org.

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Merck suspends lobbying for cervical cancer vaccine mandate

Star-Telegram
Associated Press
February 20, 2007

LINDA A. JOHNSON

TRENTON, N.J. - Merck & Co., bowing to pressure from parents and medical groups, is immediately suspending its lobbying campaign to persuade state legislatures to mandate that adolescent girls get the company's new vaccine against cervical cancer as a requirement for school attendance.

The drug maker, which announced the change Tuesday, had been criticized for quietly funding the campaign, via a third party, to require 11- and 12-year- old girls get the three-dose vaccine in order to attend school.

Some had objected because the vaccine protects against a sexually transmitted disease, human papilloma virus, which causes cervical cancer. Vaccines mandated for school attendance usually are for diseases easily spread through casual contact, such as measles and mumps.

"Our goal is about cervical cancer prevention and we want to reach as many females as possible with Gardasil," Dr. Richard M. Haupt, Merck's medical director for vaccines, told The Associated Press.

"We're concerned that our role in supporting school requirements is a distraction from that goal, and as such have suspended our lobbying efforts," Haupt said, adding the company will continue providing information about the vaccine if requested by government officials.

Merck launched Gardasil, the first vaccine to prevent cervical cancer, in June. It protects against the two virus strains causing 90 percent of cervical cancer and two strains that cause most genital warts.

Sales totaled $235 million through the end of 2006, according to Merck.

Last month, the AP reported that Merck was channeling money for its state-mandate campaign through Women in Government, an advocacy group made up of female state legislators across the country.

Conservative groups opposed the campaign, saying it would encourage premarital sex, and parents' rights groups said it interfered with their control over their children.

Even two of the prominent medical groups that supported broad use of the vaccine, the American Academy of Pediatricians and the American Academy of Family Practitioners, questioned Merck's timing, Haupt said Tuesday.

"They, along with some other folks in the public health community, believe there needs to be more time," he said, to ensure government funding for the vaccine for uninsured girls is in place and that families and government officials have enough information about it.

Legislatures in roughly 20 states have introduced measures that would mandate girls have the vaccine to attend school, but none has passed so far. However, Texas Gov. Rick Perry on Feb. 2 issued an executive order requiring Texas girls entering the sixth grade as of 2008 get the vaccinations, triggering protests from lawmakers in that state.

Perry defended his order on Tuesday, a day after House lawmakers in Austin held a lengthy hearing on the issue but failed to act on a bill to override the order.

Dr. Anne Francis, who chairs an American Academy of Pediatrics committee that advocates for better insurer reimbursement on vaccines, called Merck's change of heart "a good move for the public."

"I believe that their timing was a little bit premature," she said, "so soon after (Gardasil's) release, before we have a picture of whether there are going to be any untoward side effects."

Given that the country has been "burned" by some drugs whose serious side effects emerged only after they were in wide use, including Merck's withdrawn painkiller Vioxx, Francis said, it would be better to wait awhile before mandating Gardasil usage.

She said she also was concerned about requiring a vaccine for a disease that is not communicable and so does not have a big public health impact. While doctors expect Gardasil to have a huge effect in poor countries where women do not get Pap smears, in this country those tests limit the incidence of cervical cancer to about 9,710 new cases and 3,700 deaths each year.

The National Vaccine Information Center has been publicizing reports of side effects - mostly dizziness and fainting - in several dozen people getting Gardasil, which is approved for use in females ages 9 to 26. The center, a group of parents worried that vaccines harm some children, questions whether the vaccine was tested in enough young girls.

Officials with the Centers for Disease Control and Prevention, however, say that reports of side effects through the end of January don't raise any red flags.

The vaccine also is controversial because of its price - $360 for the three doses required over a six- month stretch. Because of that cost and what pediatricians and gynecologists say is inadequate reimbursement by insurers, many are choosing not to stock the vaccine or requiring surcharges to administer it, increasing the cost for many families and making the vaccine hard to come by.

Merck shares were down in after-hours trading on the New York Stock Exchange, falling 35 cents to $44.15 after rising 22 cents in regular trading to close at $44.50.

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MORE INFORMATION AT: Vaccination Page
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