Zoloft and other antidepressant studies often hidden ?

Unfavorable drug studies don’t get into print: report

By Gene Emery, Reuters
Wed Jan 16, 10:19 PM EST

Nearly a third of antidepressant drug studies are never published in the medical literature and nearly all happen to show that the drug being tested did not work, researchers reported on Wednesday.

In some of the studies that are published, unfavorable results have been recast to make the medicine appear more effective than it really is, said the research team led by Erick Turner of the Oregon Health & Science University.

Even if not deliberate, this can be bad news for patients, they wrote in their report, published in the New England Journal of Medicine.

“Selective publication can lead doctors to make inappropriate prescribing decisions that may not be in the best interest of their patients and, thus, the public health,” they wrote.

http://www6.comcast.net/news/articles/general/2008/01/17/NEWS-DRUGS-STUDIES-DC/print/

JAMA STANDS AGAINST MANDATED HPV VACCINE

Medical journal sides with HPV scientist

BY CINDY BEVINGTON
cindyb@kpcnews.net

CHICAGO — An editorial May 2 in what is considered the Bible of the medical profession vindicates a researcher who told this newspaper months ago that mandating the human papillomavirus (HPV) vaccine for young girls is “a great big public health experiment.”

The vaccine, Gardasil, offers protection against four of the more than 100 known HPVs, two of which scientists believe cause about 70 percent of cervical cancers.

Last week, The Journal of the American Medical Association (JAMA) took a public stand against legislation to mandate this vaccine. The article, “Mandatory HPV Vaccination: Public Health vs. Private Wealth,” was co-authored by Chicago-based JAMA editor Dr. Catherine D. DeAngelis and Washington, D.C.’s Georgetown University professor Lawrence O. Gostin. Gostin specializes in public health law.

Declaring it unethical to rush into mandates, the authors accuse Gardasil’s manufacturer, Merck & Co., of putting profits ahead of the safety of the 2 million girls and women in the U.S. who, if it were mandated, would receive the vaccine before the long-term effectiveness and safety of it had been determined.

(This blog author believes there is a deeper evil than just money at work)

Pointing out that the Federal Drug Administration’s approval of the vaccine was conditional upon Merck agreeing to further test the safety and effectiveness of it, the JAMA article says, “Making the HPV vaccine mandatory contributes to long-standing parental concerns about the safety of school-based vaccinations.”

In fact, legislating the vaccine now “could have the unintended consequence of heightening parental and public apprehensions about (all) childhood vaccinations,” the article adds.

The article also questions how vaccine recipients would be compensated in the event of their suffering adverse effects from it, since some courts may determine that the manufacturer would not be liable if the states mandated it.

The article also admonishes Merck, which could rake in billions of dollars from a mandated vaccine, for financing efforts to persuade states and public officials to mandate it. “Private wealth should never trump public health,” the article says.

Vindicated

Until the JAMA article came out, Diane Harper, a physician, scientist and professor at Dartmouth University Medical School in New Hampshire, who spent 20 years studying the virus and helping to develop a vaccine for it, had stood virtually alone among her peers in denouncing efforts to mandate the vaccine.

When she first interviewed with this newspaper, she said she’d tried to convince major print and broadcast media to “tell the whole story” about the vaccine and why she, as a lead researcher on it, believes it is premature to mandate it.

“But no one would listen,” she said. She said she was speaking out with this newspaper because “it was the only one willing to listen to the whole story.”

Answering questions by e-mail, Gostin said he was aware of Harper’s concerns. (DeAngelis sent word through an aide that she was unavailable for an interview.) He and DeAngelis were motivated to write the editorial, Gostin said, because of the states’ rush to mandate the vaccine before all of the safety and effectiveness data were collected and analyzed.

In place of mandates, Gostin’s and DeAngelis’ JAMA article encourages public education about HPV and routine, voluntary vaccination as part of a comprehensive package aimed at preventing the infection. It also suggests that a young girl’s assent to being vaccinated is as essential as her parents’ consent.

“As for work with the states, it is important to stress that the vaccine is an important public health innovation, but it is necessary to move carefully and deliberately, taking a science-based approach,” Gostin said in his e-mail. “I think that mandatory vaccination has its place, but should be a last resort only if it is clear that it would be safe, effective and in the public’s interest. That standard has not yet been met with HPV vaccination.”

Relieved

Tuesday, Harper was at a national conference of gynecologists in San Diego when she learned of the JAMA article. Acknowledging that she’d experienced some backlash because of her views — but declining to go into specifics — Harper said she felt relieved and excited that a publication as prestigious as JAMA was basically vindicating her and validating her views.

“I’m glad we are starting to get clarification in our communications, and in understanding the details of points that need to be considered for this vaccination,” Harper said. “The Associated Press has consistently miswritten, and consistently reported information that was not accurate about HPV. I have gone to them in New Hampshire several times for corrections, and they did correct a couple of things, but the last time they were unresponsive.”

So many people had questioned her because of her non-politically-correct stance on the issue that there were times when it looked like even her research was being doubted, she said, which made her position even more troubling. However, she stood behind her convictions.

“There is a lot of colleagial pressure to conform to the message, and be united in the message,” she said. “But I think we are too early in our knowledge of information to have just one message.”

She reiterated that this is “a wonderful vaccine,” and that this is an exciting time for medicine in this area. Today, the New England Journal of Medicine (NEJM) is publishing some HPV articles that she co-authored, and that should help explain what this vaccine can and cannot do, she said.

“But there are things we still don’t know about this vaccine,” she said. “For one thing, it takes 129 women to be vaccinated to prevent one case of CIN 2/3 (a type of cervical cell dysplasia), and that is important for people to know. It will be interesting now that the JAMA article is out, and the NEJM articles about Gardasil are published, what the public understanding will be.”

For more on this story and to read past stories in the HPV vaccine series, go to http://kpcnews.com/online_features/hpv_vaccine/ on the KPC Media Group Web site.

Last modified: Friday, May 11, 2007 12:55 PM EDT

Gardasil Vaccine Not Safe For Girls (NVIC)

REMINDER FOR MOMS

DO NOT GIVE YOUR DAUGHTER THIS VACCINE.

THEY ARE GOING TO TRY TO CONVINC YOU TO GIVE OUR DAUGHTERS THIS VACCINE.

THERE COULD BE MORE TO THIS THAN MEETS THE EYE !!!! 

MERCK’S GARDASIL VACCINE NOT PROVEN SAFE FOR LITTLE GIRLS
National Vaccine Information Center Criticizes 
FDA for Fast Tracking Licensure

Washington, D.C. – The National Vaccine Information Center (NVIC) is calling on the CDC’s Advisory Committee on Immunization Practices (ACIP) to just say “no” on June 29 to recommending “universal use” of Merck’s Gardasil vaccine in all pre-adolescent girls. NVIC maintains that Merck’s clinical trials did not prove the human papillomavirus (HPV) vaccine designed to prevent cervical cancer and genital warts is safe to give to young girls.

“Merck and the FDA have not been completely honest with the people about the pre-licensure clinical trials,” said NVIC president Barbara Loe Fisher. “Merck’s pre and post-licensure marketing strategy has positioned mass use of this vaccine by pre-teens as a morality play in order to avoid talking about the flawed science they used to get it licensed. This is not just about teenagers having sex, it is also about whether Gardasil has been proven safe and effective for little girls.”

The FDA allowed Merck to use a potentially reactive aluminum containing placebo as a control for most trial participants, rather than a non-reactive saline solution placebo.[1] A reactive placebo can artificially increase the appearance of safety of an experimental drug or vaccine in a clinical trial. Gardasil contains 225 mcg of aluminum and, although aluminum adjuvants have been used in vaccines for decades, they were never tested for safety in clinical trials. Merck and the FDA did not disclose how much aluminum was in the placebo.[2]

Animal and human studies have shown that aluminum can cause nerve cell death [3] and that vaccine aluminum adjuvants can allow aluminum to enter the brain, [4 5] as well as cause inflammation at the injection site leading to chronic joint and muscle pain and fatigue.  [6 7] Nearly 90 percent of Gardasil recipients and 85 percent of aluminum placebo recipients followed-up for safety reported one or more adverse events within 15 days of vaccination, particularly at the injection site.[8] Pain and swelling at injection site occurred in approximately 83 percent of Gardasil and 73 percent of aluminum placebo recipients. About 60 percent of those who got Gardasil or the aluminum placebo had systemic adverse events including headache, fever, nausea, dizziness, vomiting, diarrhea, myalgia. [9 10] Gardasil recipients had more serious adverse events such as headache, gastroenteritis, appendicitis, pelvic inflammatory disease, asthma, bronchospasm and arthritis.

“Merck and the FDA do not reveal in public documents exactly how many 9 to 15 year old girls were in the clinical trials, how many of them received hepatitis B vaccine and Gardasil simultaneously, and how many of them had serious adverse events after being injected with Gardasil or the aluminum placebo. For example, if there were less than 1,000 little girls actually injected with three doses of Gardasil, it is important to know how many had serious adverse events and how long they were followed for chronic health problems, such as juvenile arthritis.”

According to the Merck product manufacturer insert, there was 1 case of juvenile arthritis, 2 cases of rheumatoid arthritis, 5 cases of arthritis, and 1 case of reactive arthritis out of 11,813 Gardasil recipients plus 1 case of lupus and 2 cases of arthritis out of 9,701 participants primarily receiving an aluminum containing placebo. Clinical trial investigators dismissed most of the 102 Gardasil and placebo associated serious adverse events, including 17 deaths, that occurred in the clinical trials as unrelated.

“There is too little long term safety and efficacy data, especially in young girls, and too little labeling information on contraindications for the CDC to recommend Gardasil for universal use, which is a signal for states to mandate it,” said Fisher. “Nobody at Merck, the CDC or FDA know if the injection of Gardasil into all pre-teen girls – especially simultaneously with hepatitis B vaccine – will make some of them more likely to develop arthritis or other inflammatory autoimmune and brain disorders as teenagers and adults. With cervical cancer causing about one percent of all cancer deaths in American women due to routine pap screening, it was inappropriate for the FDA to fast track Gardasil. It is way too early to direct all young girls to get three doses of a vaccine that has not been proven safe or effective in their age group.”

The National Vaccine Information Center (NVIC), founded in 1982 by parents of vaccine injured children, has been a leading critic of one-size-fits-all mass vaccination policies and the lack of basic science research into biological mechanisms and high risk factors for vaccine-induced brain and immune system dysfunction. As a member of the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC), Barbara Loe Fisher urged trials include adequate safety data on pre-adolescent children and warned against fast tracking Gardasil at the November 28-29, 2001 VRBPAC meeting .[11]

Full 2001 FDA Transcript: http://www.fda.gov/ohrms/dockets/ac/cber01.htm#Vaccines & Related Biological

For more information go to www.NVIC.org.

CHEMICALS AND BREAST CANCER: New Study

A groundbreaking research study coordinated by the non-profit Silent Spring Institute and recently published by the American Cancer Society found that synthetic chemicals have likely played a large role in the rising incidence of breast cancer throughout the world over the last half-century. The study identified 216 man-made chemicals-including those found in everyday products like pesticides, cosmetics, dyes, drugs and gasoline (and diesel exhaust)-that have been shown to cause breast cancer in animals. Researchers believe these substances, many of which “mimic” naturally occurring hormones once inside the body, are also to blame for the increasing prevalence of human breast cancer. Read the rest at:

http://www.alternet.org/environment/54492/

WWW.MEATRIX.COM

www.meatrix.com

 Based on THE MATRIX

 A great video series for kids to learn about how important it is to protect animals from farming abuses.