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believe_it

Oct 9 2009, 06:21 PM

QUOTE(Snuffysmith @ Oct 7 2009, 11:30 PM)

There's huge news today...

One of the key researchers who worked on the top cervical cancer vaccines has decided to go public with a warning about their safety. Her name is Dr. Diane Harper, and she was a researcher for both Merck and GlaxoSmithKline. She's now on the record saying these vaccines "...will not decrease cervical cancer rates at all."

This is a highly unusual development. Rarely do Big Pharma's own researchers speak out against the vaccines they've worked on. Read more about this astonishing development in today's feature story: http://www.naturalnews.com/027196_cancer_c...er_vaccine.html
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Thanks, Snuffy. According to the Washington Post article excerpted below, the CDC is scheduled to decide in October whether to approve Gardasil for boys. Gardasil needs to remain optional.

QUOTE

http://www.naturalnews.com/027196_cancer_c...er_vaccine.html

Top researcher who worked on cervical cancer vaccine warns about its dangers
Thursday, October 08, 2009
by: Mike Adams, the Health Ranger, NaturalNews Editor

(Natural News) One of the key researchers involved in the clinical trials for both Gardasil and Cevarix cervical cancer vaccines has gone public with warnings about their safety and effectiveness. This highly unusual warning against these vaccines by one of Big Pharma's own researchers surfaced in an exclusive interview with the Sunday Express in the UK over the last few days. There, Dr. Diane Harper openly admitted the vaccine doesn't even prevent cervical cancer, stating, "[The vaccine] will not decrease cervical cancer rates at all."

[...]Dr. Harper also warned that the cervical cancer vaccine was being "over-marketed" and that parents should be warned about the possible risk of severe side effects from the vaccine. She even concluded that the vaccine itself is more dangerous than the cervical cancer it claims to prevent!

In a New York Times article published last year, Dr. Harper spoke about the fear-based marketing of Gardasil by Merck: "'Merck lobbied every opinion leader, women's group, medical society, politicians, and went directly to the people -- it created a sense of panic that says you have to have this vaccine now..."

[...]That one of the industry's own researchers is willing to speak out against this is not just highly unusual; it's also highly courageous. It makes you wonder: Who, exactly, is this Dr. Harper?

Dr. Diane Harper
Dr. Harper is a graduate of the Massachusetts Institute of Technology. She studied additional courses at Stanford and received her medical degree from the University of Kansas. She was a key researcher in both Gardasil and Cervarix vaccines, and she's one of the most experienced researchers in the world on HPV-related diseases. She's done work for both Merck and GlaxoSmithKline.

http://www.med.umkc.edu/informatic_medicin...ty/harper.shtml
http://dms.dartmouth.edu/faculty/facultydb/view.php?uid=2880

Dr. Harper's warnings about cervical cancer vaccines are especially relevant considering her expertise in the cost/benefit analysis of vaccines. Her conclusion is that cervical cancer vaccines aren't worth the risks, nor are they worth all the effort being put into hyping them to the public. "This may not be the best use of our resources at this time," she said in a Washington Post article...

http://www.express.co.uk/posts/missing (ARTICLE MISSING, 'jab as deadly as the cancer')
http://timesofindia.indiatimes.com/life-st...how/5086728.cms (but here it is, FYI)

http://www.google.com/search?q=jab+as+dead...amp;rlz=1I7DMUS (and more on the UK firestorm prompted by the article here)
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QUOTE

http://www.washingtonpost.com/wp-dyn/conte...32503682_2.html

A Vaccine Debate Once Focused on Sex Shifts as Boys Join the Target Market
By Rob Stein
Washington Post Staff Writer
Thursday, March 26, 2009

...In preparation for a vote as soon as October, the CDC committee will meet again in June to consider cost-benefit analyses underway at the CDC and elsewhere. The relatively pricey vaccine costs about $500 for three shots and the associated office visits...

Federal health officials, Merck and others say they are confident that the vaccine is safe. But some experts said they are concerned that there is insufficient evidence about how long Gardasil's protection will last, whether serious side effects will emerge and whether the relatively modest benefits for boys are worth even the small risks associated with any vaccine.

"There are lots of things about this vaccine we do not know yet," said Karen K. Smith-McCune of the University of California at San Francisco. "I just want to be the voice in the room saying, 'What's the rush to vaccinate in the absence of the best available data?' "

Some also question whether the reduction in infections will mean fewer cancers in the future.

"There's probably enough data to say it probably is effective for the prevention of genital warts. They're not fun, but they're not at the same level as cancer or lethal infectious diseases," said Diane M. Harper, a professor of medicine at the University of Missouri at Kansas City who helped study the vaccine in women for Merck. "This may not be the best use of our resources at this time."

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believe_it

Oct 19 2009, 04:47 PM

QUOTE

http://www.capecodonline.com/apps/pbcs.dll.../LIFE/910150301

Cape teens: HPV vaccine made them sick

By CYNTHIA McCORMICK
October 15, 2009

It's been months since dancer and former gymnast Nicole Goodman of Pocasset has been able to do a forward jazz slide or a kick ball change move.

The 18-year-old fell ill weeks after receiving her third Gardasil shot, and she blames the vaccine for the human papillomavirus for putting her in a wheelchair.

"I was a normal teenager. I did everything," says the Bourne High School graduate. She played softball and basketball in community leagues and took lessons in lyric and jazz dance.

But weeks after receiving the third shot of the Gardasil vaccine, Goodman found herself in a downhill health slide. A charley-horse-type pain in her right leg led to spasms and tremors. She experienced fainting episodes, an irregular heartbeat and nausea so severe that she lost 15 pounds in one month and had to go on intravenous fluids.

Her left leg and foot are now stuck in a sort of permanent spasm, and Goodman says she developed a red rash on her upper body around the same time.

"So many girls have that rash," she says.

Goodman is referring to the "Gardasil Girls," an informal nickname for girls and young women who believe they have been injured by the Merck vaccine that was approved in 2006 and has been heavily marketed as a preventative for cervical cancer.

Their numbers include Rachel Whiting, 17, of Orleans and Madeline Wunder, 17, of Brewster, both students at Nauset Regional High School who experienced autoimmune-type disorders shortly after receiving Gardasil injections.

They says their side effects include digestive problems, rashes and severe muscle pain, among other ailments. "It's just a nightmare," says Rachel's mother, Kim Whiting. She brought her daughter to Boston last week for a bone marrow biopsy and other tests to find out why Rachel's lymph nodes are so inflamed.

She's in pain every day," Donna Wunder says of her daughter, Madeline, a competitive figure skater.

Wunder is convinced that Gardasil caused her daughter's symptoms, and she says she wishes she'd never approved the shots.

"I got sold the whole bill of goods that this is wonderful," she says. Wunder says Madeline had to drop out of a major skating competition this month because she can no longer land jumps or handle a four-minute routine.

As concerns over the safety of the vaccine that has been given to millions of American girls and women heat up, Merck, the Centers for Disease Control and Prevention, and the Food and Drug Administration say the vaccine - given in three separate shots - is safe and effective, with side effects including pain at the injection site and risk of fainting.

"We are confident in the safety profile of Gardasil," says Merck spokeswoman Jennifer Allen. "The benefits outweigh the risks."

A study that appeared in August in the Journal of the American Medical Association found that injections of Gardasil in the general population had resulted in a greater risk of blood clots and fainting than appeared in the clinical trials. It said the overall risk of other side effects was comparable to other vaccines.

But parents, vaccine safety advocates and even a doctor who worked on Gardasil trials as a paid consultant for Merck are questioning whether the risk of a widespread vaccination campaign is worth the benefit of hoped-for protection against cervical cancer, which in the U.S. is a rare killer of women.

The Centers for Disease Control recommends the HPV vaccine for girls starting at age 11 and says doctors may give it to girls as young as 9.

Gardasil vaccinates girls and women against four types of HPV, including two types that cause about 70 percent of cervical cancer and two types that cause about 90 percent of genital warts.

It's an expensive vaccine. A series of three shots costs $360, not counting administrative and office fees. Insurance usually covers the cost.

The problem is there's no proof that Gardasil is effective after five years, so there's no point in vaccinating such young girls, says Dr. Diane Harper of the University of Missouri in Kansas City. She was hired by Merck as a consultant to design phases 2 and 3 of Merck's clinical trials.

"There will be zero change in cervical cancer (rates)," Harper says. "This whole concept of targeting 11- to 12-year-olds is a myth."

She's also concerned that women who receive the vaccine will get a false sense of security and forgo regular Pap smear tests, which detect most cases of cervical cancer.

The $30 Pap test is credited with cutting the cervical cancer death rate in the United States by 74 percent from 1955 to 1992. Currently, about 4,000 women are expected to die of cervical cancer in this country in 2009, and the New England Journal of Medicine says at least half of those deaths are among women who have never or seldom had a Pap smear.

Still a major killer in developing nations, cervical cancer no longer appears on the top 10 list of fatal malignancies among American women.

"Getting the vaccine in the U.S. is not going to make one less cervical cancer victim," Harper says, referring to Merck's advertising campaign slogan. "That is entirely marketing."

By this summer, there were more than 15,000 reports of Gardasil vaccine reactions, including more than 3,000 injuries and 48 deaths, says Barbara Loe Fisher of the National Vaccine Information Center, a vaccination watchdog group.

She says a study by her organization shows that Gardasil has resulted in more adverse reactions - such as stroke, blood clots, cardiac arrest, seizures, fainting and lupus - than occur after Menactra vaccinations against meningitis.

And Gardasil reactions may be underreported, Fisher says. She says doctors don't always take patient reports of Gardasil reactions seriously, and that's a problem, because reporting to the federal Vaccine Adverse Event Reporting System is done on a volunteer basis.

While doctors are required by the National Childhood Vaccine Injury Act to report potential adverse reactions, the act lacks teeth, Fisher says.

"Many doctors write off Gardasil-related hospitalizations, injuries and death as just a coincidence and do not report. Labeling bad things that happen after vaccination as a 'coincidence' minimizes the risks of vaccination," Fisher wrote in a report on the reporting system's Web site.

The three young Cape women who say they were injured by the Gardasil vaccine have struggled to get the medical community to take them seriously. Two of the young women responded to a Cape Cod Times online question about people's experiences with the Gardasil vaccine, and one of the families put the reporter in touch with Wunder's mother.

The teams of physicians who treated Madeline Wunder at Children's Hospital agreed that something catastrophic must have happened to cause the extreme nausea that put her on acid blockers, the muscle pain that at one time required morphine, and the "roaming paralysis" that sometimes cramps her hands into claws and numbs her feet, Donna Wunder says.

Doctors asked if it could have been a fall on the ice, she says. "They didn't want to hear about the shot."

Finally, in April, a rheumatologist at Children's Hospital wrote that Madeline most likely was suffering from postviral fatigue syndrome. Without explaining, he wrote that "it was possible" but "not very likely" that her Feb. 9 Gardasil and Menactra immunizations triggered the symptoms.

There is some evidence that having those two shots together increases the risk of side effects, Fisher says.

Rachel Whiting's pediatrician didn't think her second Gardasil shot in January had anything to do with her fevers, joint pains and debilitating hives, her mother, Kim Whiting says, and has not reported the possible adverse reaction. But a second Children's Hospital rheumatologist told her she would report it to VAERS if no one else has, Whiting says.

Despite Goodman's severe physical limitations, she says most of her physicians do not consider Gardasil a possible culprit.

Doctors at Children's Hospital told her she has a "conversion disorder," in which stress causes physiological symptoms, Goodman says. She says her ailments have been getting worse for months, ever since she got her third Gardasil shot.

Seated at home in a hospital bed with the words "love," "live" and "laughter" pasted to the blue bedroom wall above, Goodman says she had migraine-type headaches after the first two shots but didn't consider them possible side effects.

Shortly after the final shot she experienced a flurry of symptoms - including a fainting episode after driving her car - that eventually disabled her. "I haven't walked in six months," Goodman says.

She pulls up a pants leg and points to her left leg, which looks as if it's about to launch the former gymnast and cheerleader into a midair jump.

Her calf is knotted and her left foot is stuck in an arched position. Meanwhile, her right leg reverberates with periodic tremors.

A physician at a pain clinic at St. Anne's Hospital in Fall River said her muscle tone was so low it almost looked as though she had been born with cerebral palsy, Goodman says. She says he advised her to pursue the Gardasil connection but didn't tell her how.

The constellation of symptoms described by the three Cape teens and their families is typical of complaints reviewed by the NVIC, Fisher says. Many of the afflicted are athletes like Wunder and Goodman.

"You have to take it very seriously," she says. "These are high-functioning girls."

Fisher says it's possible that the young women's bodies are getting caught in an inflammatory process that affects their brains and immune systems.

"Why is it the healthy girls?" Fisher asks. "We don't know."

Autoimmune disorders are known to occur in teenage girls and young women, but there is nothing to suggest they are caused by the Gardasil vaccine, Allen says. "We encourage people to report adverse effects in any way they can."

Harper, in the meantime, suggests the vaccine be reserved for women 18 and over who carefully weigh risks and benefits.

Although the vaccine is approved only for women up to age 26, Harper says data indicate it will work just as well for women who already have had abnormal Pap smears.

"Gardasil is not safe for everyone. It's safe for most people," she says.

Gardasil came on the market with much fanfare, and the word "mandate" was used in many discussions. But plans to vaccinate all sixth-grade girls in Texas, for example, were dropped after parents balked at a gubernatorial executive order, Fisher says. Virginia and the District of Columbia mandate the HPV vaccine for schoolgirls, she says, but parents can "opt out" of the provision.

Although plans for large-scale HPV vaccine largely have died down, Merck is still taking jabs for heavy-handed marketing of the new vaccine.

The pharmaceutical company paid doctors several thousand dollars per talk to chat up the vaccine to fellow physicians, Harper says. She says Merck provided the physicians with slides that didn't mention adverse reactions.

"Merck controls the information flow entirely," Harper says.

A JAMA editorial took the drug manufacturer to task for playing up the risk of cervical cancer to adolescents and downplaying the sexual transmission of HPV.

"The subpopulations most at risk were practically ignored," according to Drs. Sheila and David Rothman, authors of the editorial.

For a while it seemed as if parents couldn't get away from magazine ads and TV commercials urging them to make their daughters "one less" cervical cancer statistic with the Gardasil vaccine, Wunder says.

You felt "you're a terrible mother if you don't do this," she says.

All three families interviewed for the story say their daughters' doctors championed the vaccine without mentioning the possibility of severe reactions.

Get ready for more marketing, Harper says. The FDA has approved GlaxoSmithKline's new HPV vaccine for women, Cervavix, as well as Merck's new vaccine to protect boys against genital warts.

"Merck is going to come out gangbusters promoting that," she says.

Since men transmit the HPV to women, the male vaccine is seen as a public health triumph by some.

Kim Whiting says she doesn't want to see other girls or boys go through what her daughter Rachel is experiencing.

"She is so sick. She has a bag of pills she has to take throughout the day. They still don't work. I told the pediatrician, 'I can't believe you're still giving it.'"

xyzse

Oct 20 2009, 09:14 AM

I am a firm believer of rescinding the lax laws in regards to Pharmaceutical advertising.
Way back then, direct to consumer marketing was not done due to how unworkable it was in regards to how technical medicine was.

Back then, Pharmaceutical companies marketed only to Doctors as they were required to list the side effects, cost and benefit of the drug. Nowadays, Pharma directly markets to consumers through ads, and the only side effects listed are the major ones.
See, prior laws required far more disclosure in regards to side effects and actual effects of the drug when dealing with advertising. That way, Pharmaceuticals made their advertising campaigns towards doctors and those who would understand what the drug would really do.

Of course, the problem with that system was the Pharmaceutical companies were unhappy with how slow Doctors were in regards to their changing in prescribing of new drugs. As soon as they were able to get laws to change the requirements in advertising to only the major side-effects, they were able to make promises on wonder drugs marketed to consumers who then would basically look at the generic sounding symptoms stating that they are the cure for it. Which then makes consumers ask for the drug directly from the Doctors even if they don't particularly need it after all.

There is a reason why Pharmaceutical companies use a huge amount of money towards advertising that I think it outstrips the cost of research.

RunsWithScissors

Oct 20 2009, 01:22 PM

I won't say I told you so but I posted about adverse side effects of Gardasil way back when the big push was on to get it done. My older sister got mad at me because she was determined to get it for her granddaughter. It's a shame people have to be guinea pigs for the drug companies. At the end of the day it's still all about the almighty dollar and the hell with the consequences.

xyzse

Oct 20 2009, 03:14 PM

Actually, this was the one they were asking to be mandatory vaccination right? The one that I got upset with since it was invasive?

Any how, the more I hear about things such as this, the more I get convinced that we need to make the ad campaign rules of Pharmaceuticals similar to how it was before.

If they still wish to place it under commercials for the general public, I want more of the side effects and to know how long studies of the drug has been going on. Current methodology basically would be Pharma pushing foreign substances that radically change a body's chemistry. More often than not creating more problems than it solves.

believe_it

Oct 22 2009, 12:25 PM

QUOTE

http://www.nytimes.com/aponline/2009/10/22...arns-Merck.html

Merck Posts Big Profit Jump, Slight Rise in Sales

By THE ASSOCIATED PRESS
Published: October 22, 2009
Filed at 11:44 a.m. ET

TRENTON, N.J. (AP) -- Drugmaker Merck & Co. on Thursday posted a bigger profit in the third quarter due to slightly higher sales and a huge gain from selling a business.

The maker of cholesterol drugs, vaccines and asthma and allergy treatment Singulair said net income was $3.42 billion, more than triple the $1.09 billion it made a year earlier.

That's mostly due to Merck having to sell its half of the Merial animal health business so that regulators would approve its plan to buy New Jersey neighbor Schering-Plough Corp.

That sale brought in $2.8 billion, or $1.7 billion after taxes. Without it, profit would have been up roughly 58 percent from the 2008 third quarter.

Whitehouse Station, N.J.-based Merck is about to leapfrog from No. 8 to No. 2 in the pharmaceutical industry with its pending $41.1 billion acquisition of Schering-Plough. That will put it right behind Pfizer Inc., which last week bought Wyeth for $68 billion.

''We have made significant progress in our planning the past three months'' for the merger, Chief Executive Richard Clark told analysts during a conference call. ''We will be ready to hit the ground running on our first day of business as the new Merck.''

For the third quarter, Merck posted a 2 percent increase in revenue, to $6.05 billion.

It had earnings per share of $1.61, or 90 cents excluding the big gain from Merial. That beat analysts' conservative expectations for earnings per share of 82 cents without items and revenue of $6 billion.

Its diabetes drugs, Januvia and Janumet, saw big jumps, bringing in a combined $664 million, and Januvia was recently approved in China. Sales of Merck's top drug, Singulair, increased 5 percent to $1.1 billion. HIV drug Isentress was up 84 percent to $197 million, but sales of osteoporosis blockbuster Fosamax, which now has generic competition, fell 22 percent to $276 million.

Gardasil, a vaccine against a virus that causes cervical cancer and genital warts, had a 22 percent drop in sales to $311 million. Gardasil got off to a strong start when it was launched three years ago, but has seen sales slump this year and took two potential blows to sales in the last week.

Last Friday, GlaxoSmithKline PLC's rival HPV vaccine, Cervarix, got approved by the Food and Drug Administration. Then on Wednesday, the influential U.S. Advisory Committee on Immunization Practices decided not to recommend routine vaccination of boys to prevent them from getting genital warts or infecting girls with HPV. That's despite the FDA approving Gardasil for boys a week ago.

Meanwhile, concerns about the swine flu epidemic have boosted sales of another Merck vaccine, Pneumovax, which protects against 23 strains of pneumococcal disease that can cause pneumonia. Sales are up about 80 percent from a year ago, to $130 million, as government agencies have been buying the vaccine and health officials push steps to prevent pneumonia, a common flu complication that can be deadly.

Merck and Schering-Plough have been partners for several years on the cholesterol drugs Vytorin and Zetia, but their once-surging sales have been declining steadily since January 2008. That's when reports began surfacing that question whether they work any better than a much-cheaper generic cholesterol pill. In the third quarter, their combined sales fell nearly 7 percent, to $1.03 billion.

That partnership made their combination a natural. In addition, Merck really needed Schering-Plough's much stronger stable of experimental drugs in development.

And as Pfizer has just done, Merck is looking to diversify beyond its strength in vaccines and traditional pills. Buying Schering-Plough gives it a strong biotech operation, more veterinary medicines and a host of well-known consumer health products such as the Coppertone sun care and Dr. Scholl's foot care lines.

Clark said the combined company will be focused on health care reform, ''anticipating customer needs'' and growth areas including emerging markets, biotech drugs and vaccines.

Merck has suffered some setbacks with experimental drugs, including a September announcement it will stop developing a potential treatment for acute migraines, MK-3207, because of potential liver problems.

But late in September, Merck entered an exclusive deal with Australian flu vaccine maker CSL Biotherapies to distribute its Afluria seasonal flu shot in the U.S. starting next fall. The deal pays Merck based on how many Afluria doses it distributes and runs through the 2015-16 flu season.

In morning trading, Merck shares fell 38 cents to $32.30.

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believe_it

Oct 22 2009, 12:30 PM

QUOTE

http://www.nytimes.com/2009/10/22/health/p...ccine.html?_r=1

Vaccine Against Virus in Girls May Be Given to Boys

October 22, 2009
By NATASHA SINGER

Gardasil, the vaccine used to immunize girls and young women against the sexually transmitted virus that causes cervical cancer, may now be given to boys and young men to protect them from genital warts, a federal advisory group recommended Wednesday.

But the panel of independent medical experts stopped short of urging its routine use in boys, as it has recommended for girls. And members questioned whether vaccinating boys was a cost-effective way to protect their future sexual partners against cervical and other types of cancer caused by human papillomavirus, or HPV.

Gardasil, made by Merck, works against four strains of the virus — two strains that are responsible for 70 percent of cervical cancers and two strains responsible for about 90 percent of genital warts. But it is expensive, requiring a series of three injections that cost $130 each.

The vaccine was approved last week by the Food and Drug Administration for use in boys and men ages 9 to 26. Wednesday’s action, by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, is intended to guide national policy on use of the vaccine; its recommendations are typically adopted by professional medical associations and set the standards of practice for physicians.

The new recommendation means, in effect, that doctors and clinics may now administer the vaccine at their discretion to boys and men ages 9 to 26, but they are not expected to offer it. Parents may consider the vaccine as an option for their sons, but some health insurers may choose not to cover the shots.

Gardasil for girls and young women has caused heated debate among some public health and cancer experts. The debate over the use of the vaccine in boys is likely to be equally heated.

At a time when the Pap smear test has greatly reduced the death toll from cervical cancer in the United States, some epidemiologists argue that offering the test to women who do not have routine access to gynecologists would have a greater effect than Gardasil.

“What we need is a public policy that gets the resources to where the women are who need it the most,” said Dr. Peter B. Bach, an epidemiologist at Memorial Sloan-Kettering Cancer Center in Manhattan. “But what you end up with is the wealthiest families getting the vaccine for their daughters.”

The Food and Drug Administration approved Gardasil in 2006 for use in girls and women ages 9 to 26 for the prevention of cervical cancer and genital warts. Last year in the United States, about 37 percent of girls ages 13 to 17 started the HPV vaccine series, a national immunization survey showed, and about half of them completed it.

In an interview last month, Dr. Richard M. Haupt, Merck’s director of research for Gardasil, said that vaccinating young men could reduce the amount of the virus circulating in the population and ultimately lower the incidence of HPV-related cancers in both sexes.

But genital warts are a significant problem in themselves, he said. Each year in the United States, he estimated, there are at least 250,000 new cases in males, each of which typically results in three visits to a doctor.

A clinical trial of about 4,000 young men, sponsored by Merck, reported that the vaccine prevented 89 percent of genital warts.

But experts at the vaccine advisory committee meeting debated whether it was appropriate and cost-effective to vaccinate boys for a problem that can be embarrassing and uncomfortable but is not life-threatening.

Harrell W. Chesson, a health economist at the disease control centers, said that to reduce HPV, it would be more cost-effective to increase vaccination among girls than among boys.

The committee said it would take up the issue of the vaccine’s effectiveness in preventing HPV-related male cancers at its next session in February, when more data should be available. Merck plans to present studies sometime next year on the efficacy of the vaccine against anal pre-cancers in men who have sex with men, a company spokeswoman said.

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