Thread: They are wanting to make the HPV vaccine mandatory in schools

Wouldn't you get your child their shots before school? Also, when they're babies? It will be just like that! If it's mandatory, then it will be provided just like the other shots. My kids are grown and if they could get it, then I would make sure they did. I don't think putting them on the pill at 17 made them sexually active. They're friends were pregnant and I didn't want them that way. They're both Christians and were taught to abstain, but that doesn't always work. I guess I was lucky that they didn't have problems, but you never know.

Am I the only person who finds it "interesting" that Merck which produces this vaccine is also the same that produces the varricella vaccine which they have also made "mandatory" despite poor results and spotty research ?

Follow the MONEY....


FDA approves Merck's shingles vaccine
By ANDREW BRIDGES, Associated Press Writer
Fri May 26, 10:43 PM ET

WASHINGTON - A new and more potent version of the chickenpox vaccine has won federal approval to prevent shingles, the often excruciatingly painful disease that can strike the elderly when the chickenpox virus emerges after lying dormant for decades.

The Food and Drug Administration announced Friday that it had licensed the vaccine, Zostavax, to reduce the risk of shingles in adults 60 and older. The Merck & Co. Inc. vaccine is only for adults who previously have had chickenpox.

There are roughly 1 million new U.S. cases of shingles each year. It typically affects the elderly, though anyone with a weakened immune system is vulnerable. The vaccine is not meant for anyone with HIV or who is on immune-suppressing drugs, including transplant patients, said Norman Baylor, director of the FDA's Office of Vaccines Research and Review.

Shingles can cause itching, burning and tingling, as well as a distinctive red rash that develops into pus-filled blisters that later break open and form scabs. Pain can persist in some patients for months or years.

"This vaccine gives health care providers an important tool that can help prevent an illness that affects many older Americans and often results in significant chronic pain," said Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research.

Shingles, also called herpes zoster, occurs when the chickenpox virus reactivates and resumes reproducing after a long dormancy in nerve cells in the body.

Zostavax does not prevent the initial infection by the virus, nor does it treat active cases of shingles. Instead, the vaccine helps prevent the reemergence or resurgence of the virus by boosting a patient's immunity, Goodman said.

Merck research showed the vaccine reduced the incidence of shingles by half and pain and discomfort by nearly two-thirds.

"This is going to be the first product of any kind, vaccine or anything else, that can prevent shingles," said Dr. Jeffrey Silber, senior director of clinical research on biologics and vaccines for Merck Research Laboratories.

Sharon Smith, 68, of Portland, Ore., participated in the Zostavax trials in March 2000, but she received a placebo, or dummy injection, instead of the actual vaccine. That October, she developed shingles. After two emergency room visits and a short hospital stay, Smith remained on pain medication until May 2001, when her searing pain finally ebbed.

"I used to say it was like someone pouring hot oil over my head. At points, I would be stricken with this pain after the initial shingles began, it would just literally bring me to my knees. It was almost indescribable," Smith said. She added: "I didn't know you got over it. That is a very devastating thought, that you could be facing that pain forever. It could ruin your life."

Zostavax is based on Merck's chickenpox vaccine, Varivax, but is 14 times more potent. The FDA approved Varivax in 1995 and a majority of American children now receive it.

Anyone who has had chickenpox can develop shingles. Merck estimates that half of all people who reach age 85 will develop shingles during their lifetime.

The vaccine's long-term effectiveness remains unclear. Merck has shown that it works for at least four years, and the company plans to track patients for a decade. Merck also pledged to further study the vaccine's safety after patients in clinical trials suffered a slightly higher number of serious side effects than did those who received dummy injections, the FDA said. Currently, there is no evidence the vaccine was to blame, the agency added.

The approval is welcome news for Merck, which faces thousands of lawsuits over its withdrawn painkiller Vioxx. It's also just one of several vaccines for which the Whitehouse Station, N.J. company has received — or soon expects to receive — FDA approval.

They include RotaTeq, a vaccine against a common, sometimes dangerous gastrointestinal virus in children, approved in February; and ProQuad, a combined vaccine against measles, mumps, rubella and chickenpox, approved in September.

And early in June, Merck hopes the FDA will approve its Gardasil vaccine against human papillomavirus, the main cause of cervical cancer.

European and Australian health officials earlier this month approved the shingles vaccine, Merck said.

The company is eyeing the roughly 50 million Americans and 100 million Europeans age 60 and older as its largest markets for the single-dose vaccine.

The vaccine could become a $1 billion or more a year seller for Merck, said analyst Steve Brozak, with WBB Securities in Westfield, N.J. A dose will cost $152.50. "Anything that doesn't have to do with Vioxx should be perceived as good news," said Brozak, adding that the approval is a "breath of fresh air" for the company.

Merck shares rose 17 cents to close at $34.56 on the New York Stock Exchange.

http://news.yahoo.com/s/ap/20060527/ap_on_...GZoBHNlYwM3NTE-
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On the Net:

Food and Drug Administration: http://www.fda.gov/

Merck & Co. Inc.: http://www.merck.com/



Shingles vaccine OK'd
May 27, 2006

A new vaccine to prevent painful attacks of shingles in people 60 and older has received federal approval and is expected to be on the market in about a week.

The Food and Drug Administration announced yesterday that it has cleared the way for Merck & Co. to begin shipping the vaccine, called Zostavax. A five-year study showed it can protect about half the people who get it from developing shingles, a rash that can lead to a more devastating painful condition, post-herpetic neuralgia.

As many as 1 million Americans develop shingles each year, according to the National Institutes of Health, and about 20 percent of them progress to post-herpetic neuralgia, which can cause excruciating pain for months or years.

Shingles can emerge in older people when their immune systems weaken, allowing the virus that causes childhood chickenpox, which has stayed dormant in the body, to reawaken, said Dr. Penny Tenzer, vice chairman of the Department of Family Medicine at the University of Miami's Miller School of Medicine. "Shingles is very uncomfortable and can interfere with everything you do, but the real [problem] is if they get post-herpetic neuralgia. If they get it on the back, for example, they can't wear a shirt because anything touching it hurts," she said.

Shingles first causes pain, itching or tingling in an area of skin on one side of the body or face. A painful blistering rash then develops and can take up to four weeks to heal. Anyone who has had chickenpox - most adults in the United States - could develop shingles, but not all will. The two major risk factors are increasing age and declining immunity. About half of the people who live to age 85 will get the disease if they had chickenpox as a child. "The virus sits around in nerves near the spinal cord and reactivates years and years later," Tenzer said.

http://www.baltimoresun.com/news/health/ba...ealth-headlines

my fear is that the drug hasnt been researched enough and what happens if they are WRONG and a whole generation of girls have problem with their reproductive organs because of the shots. My fear....

Originally Posted by dlwt

my fear is that the drug hasnt been researched enough and what happens if they are WRONG and a whole generation of girls have problem with their reproductive organs because of the shots. My fear....

yeah I agree that it should NOT be made to be required, just like all new things there is always something gonna come out 20 yrs from now but I do intend to find out if my daughter can get it because I would rather be safe than sorry (at least hopefully not sorry)

I agree, too. BUT I will be getting as much info as possible. While I don't want them having sex, I also know it's a danged struggle these days to keep them from it. At least I was 18 before I lost it. And at that time we were only hearing a teeny peep about some disease that could kill, noone really knew. I am lucky. And I will protect my children as much as possible.

If this vaccine turns out to be safe through more testing and long-term results I will consider it. But my dd is 9 now, so I'm not sure how long they'll follow children since they were cutting the trials off early for most.

Being mandated? NO, absolutely NOT. The difference with this and measles/mumps/reubella is that MMR are CONTAGIOUS. The other is only transmitted with sexual behavior. So the government should have NO right to tell me my child has to have this. When would it stop?

Originally Posted by YankeeMary

I agree with what you are saying completely. The only thing I would be hesitant about IF I had daughters would just be there isn't enough info long term for me.

You can catch a LOT of things from toilet seats-herpes, other STDs(they said this for YEARS and now some are saying you can't, but the tests they've done before said you can-which one do you trust?). You can also catch them from panties-which is why you can't return panties to the store.

http://72.14.209.104/search?q=cache:...s&ct=clnk&cd=8
Most sexually transmitted diseases cannot survive once exposed to air (exceptions are the herpes virus, which can live for a few hours, and hepatitis B, which can linger for seven days (there are others, too not mentioned here). To catch a disease, the seated party would have to have some sort of break in the skin to allow the virus to enter.

Originally Posted by Pepsi4me

I was even told by a doctor years ago that you an get some from a toilet seat. People can also be carriers & not even know they have an STD.

Am I the only person who finds it "interesting" that Merck which produces this vaccine is also the same that produces the varricella vaccine which they have also made "mandatory" despite poor results and spotty research ?

Merck lobbies states over cancer vaccine
By LIZ AUSTIN PETERSON, Associated Press Writer
Tue Jan 30, 5:38 PM ET

AUSTIN, Texas - Merck & Co. is helping bankroll efforts to pass state laws requiring girls as young as 11 or 12 to receive the drugmaker's new vaccine against the sexually transmitted cervical-cancer virus.

Some conservatives and parents'-rights groups say such a requirement would encourage premarital sex and interfere with the way they raise their children, and they say Merck's push for such laws is underhanded. But the company said its lobbying efforts have been above-board.

With at least 18 states debating whether to require Merck's Gardasil vaccine for schoolgirls, Merck has funneled money through Women in Government, an advocacy group made up of female state legislators around the country.

A top official from Merck's vaccine division sits on Women in Government's business council, and many of the bills around the country have been introduced by members of Women in Government. "Cervical cancer is of particular interest to our members because it represents the first opportunity that we have to actually eliminate a cancer," Women in Government President Susan Crosby said.

Gardasil, approved by the federal government in June, protects girls and women against strains of the human papillomavirus, or HPV, that are responsible for most cases of cervical cancer. A government advisory panel has recommended that all girls get the shots at 11 and 12, before they are likely to be sexually active. But no state has yet to add Gardasil to the list of vaccinations youngsters must have under law to be enrolled in school.

Merck spokeswoman Janet Skidmore would not say how much the company is spending on lobbyists or how much it has donated to Women in Government. Crosby also declined to specify how much the drug company gave. But Skidmore said: "We disclosed the fact that we provide funding to this organization. We're not in any way trying to obscure that."

The New Jersey-based drug company could generate billions in sales if Gardasil — at $360 for the three-shot regimen — were made mandatory across the country. Most insurance companies now cover the vaccine, which has been shown to have no serious side effects. ( at this time ... )

Cathie Adams, president of the conservative watchdog group Texas Eagle Forum, said the relationship between Merck and Women in Government is too cozy. "What it does is benefit the pharmaceutical companies, and I don't want pharmaceutical companies taking precedence over the authorities of parents," she said.

Adams said Merck's method of lobbying quietly through groups like Women in Government in addition to meeting directly with legislators are common in state government but still should raise eyebrows. "It's corrupt as far as I'm concerned," she said.

A mandatory vaccine against a sexually transmitted disease could be a tough sell in the Lone Star State and other conservative strongholds, where schools preach abstinence and parents' rights are sacrosanct. But Merck has doubled its spending on lobbyists in Texas this year, to between $150,000 and $250,000, as lawmakers consider the vaccine bill for girls entering the sixth grade.

Also, the drugmaker has hired one of the state's most powerful lobbyists, Mike Toomey, who once served as Republican Gov. Rick Perry's chief of staff and can influence conservatives who see him as one of their own. "What we support are approaches that achieve high immunization rates," said Skidmore, the Merck spokeswoman. "We're talking about cervical cancer here, the second-leading cancer among women worldwide."

The legislation already has the enthusiastic support of the conservative governor. "I look at this no different than vaccinating our children for polio," Perry said. "If there are diseases in our society that are going to cost us large amounts of money, it just makes good economic sense, not to mention the health and well being of these individuals to have those vaccines available."

Proposals for mandates have popped up from California to Connecticut since the first piece of legislation was introduced in September in Michigan. Michigan's bill was narrowly defeated last month. Lawmakers said the requirement would intrude on families' privacy, even though, as in most states' proposals, parents could opt out. Even with such opt-out provisions, mandates take away parents' rights to make medical decisions for their children, said Linda Klepacki of the Colorado-based evangelical organization Focus on the Family. The group contends the vaccine should be available for parents who want it, but not forced on those who don't.

But Texas Rep. Jessica Farrar said her proposal is aimed at protecting children whose parents are less informed about or less interested in preventive care. "Not everybody has equal sets of parents," said Farrar, a Houston Democrat who had precancerous cells removed from her cervix several years ago. "I think this is a public health issue and to not want to eradicate cervical cancer is irresponsible."

Drug-industry analyst Steve Brozak of W.B.B. Securities has projected Gardasil sales of at least $1 billion per year — and billions more if states start requiring the vaccine. "I could not think of a bigger boost," he said.

http://news.yahoo.com/s/ap/20070130/...ZoBHNlYwM3NTE-


Merck shares fall after reports
By LINDA A. JOHNSON, AP Business Writer
Tue Jan 30, 6:43 PM ET

TRENTON, N.J. - Shares of drug makers Merck & Co. took a hit Tuesday after disappointing earnings reports, Merck's profit plunged due to ongoing legal and restructuring costs. Merck surprised some analysts by boosting its reserve for litigation over withdrawn Vioxx for a second straight quarter. That charge and others cut Merck's fourth-quarter profit by 58 percent despite higher revenues.

Shares fell 60 cents, or 1.6 percent, to $44.91 with nearly double normal trading volume.

Whitehouse Station, N.J.-based Merck, the maker of Fosamax for osteoporosis and Singulair for asthma and allergies, reported net income of $473.9 million, or 22 cents per share, down from $1.12 billion, or 51 cents per share, in 2005's last quarter.

Merck would have posted 50 cents in the last quarter, matching analysts' forecast, if not for charges of 7 cents per share for restructuring and 21 cents to buy Sirna Therapeutics, a small biotech company with gene-silencing technology that holds promise for developing cancer and other drugs. "If it harms this quarter or next quarter, that is not a big deal," analyst Steve Brozak of WBB Securities said of the $1.1 billion acquisition.

Revenues increased 5 percent to $6.04 billion, well above analysts' expectations. "The sales gains were achieved despite facing the largest patent loss in our history," said Richard Clark, chairman and chief executive officer.

Zocor, a cholesterol drug that had been Merck's top seller, lost patent protection last June; sales were $379 million for the fourth quarter, down 65 percent from the same period a year ago.

Sales of Zetia and Vytorin, newer cholesterol drugs Merck sells with joint venture partner Schering-Plough Corp., jumped 46 percent to $1.1 billion. Four relatively new vaccines brought in a total of $482 million, including $155 million for Gardasil, which prevents cervical cancer. Sales of Singulair and blood pressure drugs Cozaar and Hyzaar rose by double digits, but Fosamax saw flat sales.

"On a continuing operations basis, they are doing quite well," said analyst Joseph F. Tooley of A.G. Edwards & Sons Inc.

The sharp drop in net income was due mainly to generic competition for Zocor and could be covered by future sales increases for new products such as Gardasil and Januvia, a diabetes drug, he said.

Restructuring charges totaled $222 million in the quarter, when Merck eliminated another 900 jobs out of the 7,000 to be scrapped by the end of 2008.

As of Dec. 31, Merck faced about 27,400 lawsuits alleging harm from Vioxx and another 265 potential class-action lawsuits. The company pulled the one-time blockbuster arthritis pill from the market in September 2004 after research showed it increased risk of heart attacks and strokes.

The company said it added $75 million to its Vioxx legal defense fund in the quarter; it has reserved $1.64 billion to date.

Despite the problems, Merck repeated its forecast for 2007 earnings per share of $2.51 to $2.59, excluding 10 to 15 cents for restructuring charges. Analysts expect $2.60, excluding charges.

Barbara Ryan of Deutsche Bank-North America noted in a research report that Merck has been following a strategy to "understate and overperform," raising its earnings forecast three times last year.

For the full year, Merck posted net income of $4.43 billion, or $2.03 per share, down 4 percent from $4.63 billion, or $2.10 per share, in 2005. Revenues totaled $22.64 billion, up 3 percent.
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AP Business Writer Jeffrey Gold in Newark, N.J., contributed to this story.

http://news.yahoo.com/s/ap/20070130/...NqBHNlYwM3NDk-

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On the Net:

Merck & Co.: http://www.merck.com

FDA proposes report cards on new drugs
By ANDREW BRIDGES, Associated Press Writer
Tue Jan 30, 6:54 PM ET

WASHINGTON - The public outcry over the withdrawal of the painkiller Vioxx ( produced by Merck ... ) is leading to closer government scrutiny of new drugs to identify and disclose late-developing safety problems.

As part of a pilot program, the Food and Drug Administration will issue drug "report cards" that would detail unexpected side effects that emerge within 18 months of a drug's approval. The reports also would include follow-up studies and details about how the drugs are being used.

The proposal is among more than a dozen initiatives the FDA unveiled Tuesday in response to a recent report by a committee of experts at the Institute of Medicine that criticized the agency's handling of drug safety in the wake of the Vioxx case. Nor will it be the last word, said FDA Commissioner Dr. Andrew von Eschenbach. "It will be a continuous process of improvement. The initiatives we are announcing today are not the full story, nor are they the final chapter in that story," von Eschenbach told reporters.

Their release comes just days before Sens. Edward Kennedy, D-Mass., and Mike Enzi, R-Wyo., introduce legislation to overhaul how the FDA handles drug safety. "Today's report is thoughtful and provides important recommendations for administrative action, but only legislation can give FDA the tools it needs to ensure that FDA is the gold standard for safety," Kennedy said in a statement.

The Institute of Medicine report was prompted in part by the 2004 withdrawal of Vioxx after research showed it increased risk of heart attacks and strokes. The report said the FDA needs more funding, people and authority to ensure it focuses on the safety of drugs while they remain on the market.

The FDA also hopes to step up its mining of large public and private health care databases to detect emerging safety problems, said agency drug chief Dr. Steven Galson. The Department of Veterans Affairs recently signed an agreement to share such information with the FDA.

The agency also said it would regularly publish newsletters to summarize its safety reviews of older drugs and disclose emerging issues. However, the newsletters would be scrubbed of whatever the FDA deemed confidential commercial and predecisional information, the agency said.

The Institute of Medicine, part of the federally chartered National Academy of Sciences, had pushed for even more public disclosure of that underlying information, said Alta Charo, a member of the committee that wrote the report who is also a University of Wisconsin professor of law and bioethics. "Crucial to our recommendation was that these postmarketing data be shared with an advisory committee made up of independent safety experts. Their proposal would have the data remain internal," Charo said.

Both the FDA and the drug industry are concerned that broad disclosure of preliminary information about apparent safety problems could do more harm than good. "One thing we don't want to see happen is if patients get concerned and they decide to stop therapy and don't talk to their doctors," said Alan Goldhammer of the Pharmaceutical Research and Manufacturers of America, a drug industry group.

The FDA did not address the Institute of Medicine report's specific recommendations for Congress, including its push for additional agency funding and authority. Without that, the FDA's proposals amount to "small potatoes," said Bill Vaughan, a senior policy analyst at Consumers Union.

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On the Net:

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Why are they doing something like this without the goverment mandating it ?? Why are they not waiting until the product has been on the market for 18 months ( or more ) before trying to make it a REQUIREMENT for our children ?

Texas is the first...

AUSTIN -- Gov. Rick Perry signed an order Friday making Texas the first state to require that all schoolgirls be vaccinated against the sexually transmitted virus that causes cervical cancer.

By issuing an executive order, Perry apparently sidesteps opposition in the Legislature from conservatives and parents’ rights groups who fear such a requirement would condone premarital sex and interfere with the way parents raise their children.

Girls will have to get Gardasail, Merck & Co.’s new vaccine against strains of the human papillomavirus, or HPV.

Merck is bankrolling efforts to pass laws in state legislatures across the country mandating Gardasil for girls as young as 11 or 12. It doubled its lobbying budget in Texas and has funneled money through Women in Government, an advocacy group made up of female state legislators around the country.

Details of the order were not immediately available.

Perry, a conservative Christian who opposes abortion and stem-cell research using embryonic cells, counts on the religious right for his political base. But he has said the cervical cancer vaccine is no different from the one that protects children against polio.

“If there are diseases in our society that are going to cost us large amounts of money, it just makes good economic sense, not to mention the health and well-being of these individuals to have those vaccines available,” he said.

Perry has several ties to Merck and Women in Government. One of the drug company’s three lobbyists in Texas is Mike Toomey, his former chief of staff. His current chief of staff’s mother-in-law, Texas Republican state Rep. Dianne White Delisi, is a state director for Women in Government.

http://www.khou.com/topstories/stori....449a21e1.html

Why is this vaccine not made mandatory for boys? Same virus and they are the ones spreading it from girl to girl.