Presentation to FDA intended to raise awarenes of Gardasil cervical cancer vaccine risks

Critics of Gardasil vaccine speak up to FDA about Gardasil risks

FORT WAYNE, Ind.

A Fort Wayne couple is keeping their fingers crossed that a presentation Friday before Food and Drug Administration officials will open eyes about the risks associated with the Gardasil vaccine.
Multimedia.

Several FDA offices were scheduled to hear testimony on behalf of parents who say their daughters have died or suffered debilitating side effects from the drug designed to prevent cervical cancer.

Dan and Kim Chitwood's daughter Taylor has battled seizures since taking Gardasil shots two and a half years ago.

Kim Chitwood says, “Just very hopeful that this will be presented in a way that, um, nationally and worldwide, people will find out about Gardasil and things that it can cause."

Caleigh Miller of Fort Wayne is also suffering from seizures; a problem her parents are convinced is a result of Gardasil shots.

The Centers for Disease Control stand behind the vaccine, as a safe way to prevent cases of cervical cancer that health officials insist will otherwise kill thousands of women.

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Free cervical cancer vaccine funding received by Costal Health District in Georgia

Health department to offer free HPV vaccine for some women in Georgia

Savannah, GA

The Coastal Health District has received funding to provide the human papillomavirus vaccine, also known as Gardasil, free of charge to women who meet certain criteria.

The HPV vaccine is a safe and effective vaccine developed to prevent cervical cancer.

To qualify for the program, women must be 19 to 26 years of age, not pregnant and have Medicaid, Medicare, no health insurance or health insurance that does not cover the cost of HPV vaccine.

The vaccine is given in a series of three doses. It is important women who receive the vaccine get all three doses in order to obtain maximum protection from HPV.

Women who meet the criteria and have not yet started the series are eligible to receive the vaccine under this program. In addition, women who already have received one or two of the doses are eligible to complete the series under this program.

Cervical cancer is caused by certain types of HPV, and an estimated eight out of 10 women will become infected with HPV in their lifetime.

"We are thrilled to be able to offer the HPV vaccine at no charge to women who qualify for this program," said Marianne Pappas, Coastal Health District immunization coordinator. "When a woman gets the HPV vaccine, she significantly lowers her chance of getting cervical cancer. But until now, many women couldn't afford to get the vaccine."

An administrative fee of $14 will be charged for each dose. However, no one will be denied because of inability to pay. Normal cost of the vaccine is about $160 per dose. The program runs through September.

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Merck submits (cervical cancer HPV vaccine) Gardasil data for women 27 to 45

New York, NY

Merck & Co on Wednesday said it had provided U.S. regulators with new information needed for approval to market its Gardasil cervical cancer vaccine to women between the ages of 27 to 45.

Gardasil, one of Merck's biggest products, was approved in 2006 for preventing cervical cancer and genital warts in females between the ages of 9 and 26. It works by preventing infection with the sexually transmitted human papillomavirus (HPV), which causes cervical cancer.

The U.S. Food and Drug Administration early last year again withheld approval for its use by women aged 27 to 45, asking the drugmaker to submit data when a 48-month study on a test group has been completed.

Merck, in a statement on its Web site, said it had provided the completed trial data to the FDA before the end of 2009. The company said the FDA typically takes six months to review such responses.

Global sales of Gardasil fell 22 percent to $311 million in the third quarter, hurt by overseas competition from GlaxoSmithKline's rival Cervarix vaccine and continuing delays in winning expanded approval for the product.

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Cervical cancer vaccine Gardasil approved by FDA for men to prevent genital warts (HPV)

Washington, D.C.

The U.S. Food and Drug Administration approved the vaccine given to women to prevent cervical cancer for use in men and boys to prevent genital warts.

The drug, Gardasil, is already approved for women ages 9 through 26 to prevent cervical, vuvlar and vaginal cancer caused by the human papillomavirus and genital warts. The agency on Oct. 16 approved it for men in the same age group.

HPV is the most common sexually transmitted disease in the United States and most genital warts are caused by the virus, the FDA said in a statement. About 2 out of every 1,000 men in the United States are newly diagnosed with genital warts every year, according to the FDA.

The agency said that Gardasil was almost 90 percent effective in preventing warts caused by HPV.

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Clash of the Titans for the HPV Vaccine Market

New York City, NY

wo pharmaceutical giants are vying for the billions of dollars up for grabs in the market for vaccines against the human papillomavirus, or HPV, a sexually transmitted infection that can cause cervical cancer and genital warts.

Merck, which has had a monopoly on HPV vaccines in the United States with its Gardasil for young women, has asked the Food and Drug Administration to approve the drug to protect against genital warts in young men. In 2006, the agency approved Gardasil to protect girls and women ages 9 to 26 against certain strains of the virus that can cause genital warts, pre-cancerous genital lesions and cervical cancer.

Meanwhile, GlaxoSmithKline, which currently markets its Cervarix vaccine to young women in about 100 countries, is seeking to have the vaccine approved in the United States to protect girls and women ages 10 to 25 against certain HPV strains that can cause cervical cancer. Cervarix does not offer protection against strains of the virus that can cause genital warts.

On Wednesday, an advisory panel of the Food and Drug Administration voted that research data from Glaxo had demonstrated the safety and efficacy of Cervarix to protect young women against cervical cancer. The panel, composed of outside experts, also voted in favor of the safety and efficacy of Gardasil to inhibit genital warts in boys and men ages 9 to 26.

The F.D.A. typically follows the recommendations of such panels on drug approvals.

Glaxo shares were up about half a percent to $39.22 at the end of trading on Wednesday; shares of Merck were up about 1.9 percent to $31.55.

But industry analysts said that the drug companies faced a battle to expand the target audience in America for such vaccines because the drugs have limited effectiveness and unknown duration. They also have possible side effects like dizziness and fainting.

Both vaccines also require a series of three shots over six months. Both are most protective in young people who have not yet been exposed to the virus because they are either not sexually active or have just become sexually active and have had few romantic partners.

Indeed, because of the limited audience of young women, American sales of Gardasil have recently stalled, said Tim Anderson, an analyst with Sanford C. Bernstein. In the first half of this year, Gardasil had sales in the United States of $363 million, a decrease of 34 percent compared with the same period in 2008, according to a Merck financial statement.

Mr. Anderson said that Merck will find it harder to persuade parents and health insurers to pay for Gardasil shots to reduce the chance of developing a nonfatal condition like genital warts in boys than to market the vaccine to reduce a potentially deadly disease like cervical cancer in young women.

“You are asking a healthy teen to come to the doctor three times in six months,” Mr. Anderson said in an interview Wednesday. “Pretty much no healthy teen would ever do that, let alone to come back and get a shot, a shot that can cause a lot of pain.”

In a note to investors on Friday, Mr. Anderson forecast that in 2015, Gardasil would have 65 percent of an estimated $3.7 billion worldwide market for vaccines against the human papilloma virus, with Cervarix accounting for the rest.

If the agency ultimately approves Cervarix for use in young women, Glaxo will have to distinguish the drug as a longer-lasting and more comprehensive vaccine to gain a foothold in the United States market owned by Merck, analysts said.

Since the advent in the 1950s of the Pap test to detect precancerous cells in the cervix, death rates from cervical cancer in the United States have dropped by about 70 percent, said Dr. Debbie Saslow, the director of breast and gynecological cancers at the American Cancer Society. An estimated 11,000 women in the United States will develop invasive cervical cancer this year and about 4,000 women will die from the disease, most of whom have never had a pap test, Dr. Saslow said.

The Food and Drug Administration has approved Gardasil to protect against two strains of the virus, 6 and 11, which can cause genital warts, as well as two strains, 16 and 18, which are responsible for the development of about 70 percent of cervical cancers.

Now, Glaxo has submitted data to the agency, suggesting that its vaccine also provided cross-protection against several other strains responsible in total for about 86 percent of cervical cancers, the company said.

“Cervarix will prevent more cancers and save more lives than a vaccine without cross protection,” Dr. Barbara Howe, director of North American vaccine development for Glaxo, told the F.D.A. panel on Wednesday.

But an F.D.A. expert told the panel that it was difficult to measure protection against addition strains that cause cervical cancer.

The panel also examined safety questions about whether Cervarix could increase a woman’s risk of miscarriage or of autoimmune diseases, rare problems which Glaxo said it would follow in post-marketing studies.

Merck is also hoping for approval from the F.D.A. to protect boys and young men against the strains of the virus that can cause venereal warts.

But, although the F.D.A. panelists voted that Merck had demonstrated the safety and efficacy of Gardasil for boys, skepticism among a few panelists suggested that Merck may find it difficult to persuade boys to have shots for an uncomfortable but non-life-threatening problem that often resolves itself without medical intervention.

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FDA approval for Cervarix and Gardasil recommended by committees

Washington, D.C.

Last week, the FDA received recommendations to approve two vaccines against the human papillomavirus (HPV) that causes cervical cancer.

The vaccine Cervarix is licensed in nearly 100 countries worldwide and approved by the World Health Organization, but it has been awaiting FDA approval since its initial application in 2007 raised concerns about possible side effects. Though structured as a bivalent vaccine to protect only against HPV types 16 and 18, Cervarix has been shown in a recent trial to provide cross-protection against three other HPV types and may also produce a higher degree of protection against precancerous lesions known as grade II cervical intraepithelial neoplasias (CIN2+) than the vaccine Gardasil.

Gardasil has been approved for cervical cancer protection in females aged 9 to 26 since 2006, and targets two additional HPV types that are linked to genital warts, which can occur in males, as well. A second expert committee recommended FDA approval be extended to males in that same age group. The clinical trials on which the committee based its recommendation showed that Gardasil was 89 percent effective in preventing genital warts and had no side effects, though it was less effective in those who had already been exposed to HPV.

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Study on adverse effects Gardasil reveals two adverse effects are more common than was expected

Philadelphia, PA

Three years after the world's first cervical-cancer vaccine was hailed as a public-health breakthrough, Gardasil is facing renewed questions about its safety and value.

In today's Journal of the American Medical Association, federal researchers analyze 12,424 voluntary reports of post-vaccination "adverse events" ranging from headaches to deaths. They conclude that only two complaints - fainting and dangerous blood clots -- are more common than expected and may be related to the immunization.

But an accompanying editorial points out that many questions about Gardasil remain - key among them, whether it really will reduce the toll of cervical cancer.

Another opinion piece in JAMA looks at Merck & Co.'s marketing strategy, contending the company coopted professional medical societies to promote and recommend the vaccine.

Merck - already on the defensive over Gardasil's second-quarter sales, which slumped sharply in the United States and worldwide - said in a statement that "we welcome continued study and discussion" of the product's safety.

"The bottom line is that Gardasil has a very positive benefit-risk profile," Richard M. Haupt, head of Merck's clinical program for the vaccine, said in an interview.

Gardasil, a series of three shots, protects against two strains of the sexually transmitted human papillomavirus (HPV) that cause 70 percent of cervical-cancer cases. Gardasil also wards off two other HPV strains that cause 90 percent of genital warts in men and women.

Next month, advisers to the Food and Drug Administration will consider whether to recommend expanding Gardasil's current approval for females ages 9 to 26 to include males of the same age. Vaccinating men would reduce HPV transmission to women and protect men from very rare HPV-related anal, head, and neck cancers.

The FDA panel will also review data on would-be rival Cervarix, the cervical-cancer vaccine for which GlaxoSmithKline is seeking FDA approval. Cervarix does not protect against genital warts.

Although the theory behind these vaccines is sound - if you prevent HPV infection, you prevent cervical cancer - the reality is more complex, infectious-disease expert Charlotte Haug wrote in the JAMA editorial.

No one knows whether Gardasil will require booster shots, or whether suppressing the two main cancer-causing HPV strains will drive rarer, equally dangerous strains to fill the void. That is why vaccinated women still need to get Pap smears, the routine screening test that can catch precancerous changes years before they turn malignant.

Most of the world's 250,000 cervical-cancer deaths each year occur in poor countries. Screening has made the disease relatively rare in the United States, where there are 10,000 new diagnoses and 3,700 deaths each year.

In Haug's view, the overall benefit of vaccination is so uncertain that a regularly screened woman "should be willing to accept only a small risk of harmful effects." More >>

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Doctors on cervical cancer vaccine Garaisil: Benefts outweigh costs

Minneapolis, MN

The new vaccine designed to protect girls and young women from cervical cancer has a safety record that appears to be in line with that of other vaccines, a new government report found. Some serious complications were reported -- including 32 deaths and two cases of Lou Gehrig's disease -- but there is no way to prove they were produced by the vaccine, which has been given to 7 million girls and young women during its first years on the market.

The most common serious complications after vaccination with Gardasil were fainting episodes and an increased risk for potentially fatal blood clots, possibly related to oral contraceptive use and obesity, the study found.

But while the tone of the study, published in the Journal of the American Medical Association, was reassuring, the authors noted that the analysis was based on imperfect data drawn from voluntary reports.

"We feel confident recommending people get the vaccine; the benefits still outweigh the risks," said Dr. Barbara A. Slade, of the Centers for Disease Control and Prevention, which did the study together with the Food and Drug Administration.

Nevertheless, an accompanying editorial questioned whether any level of risk is acceptable when inoculating a healthy population against a disease that can be prevented through screening and preemptive treatment.

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The cervical cancer vaccine question: Gardasil for my daughter?

St. Petersburg, FL

When Raffi Darrow brought in her two daughters, Wendy and Alice, for their annual back-to-school checkups this week, for the first time in her career as a mom, Darrow decided to be a rebel.
Raffi Darrow decided not to get the HPV vaccine for daughters Wendy, left, 11, and Alice, 12.

Raffi Darrow decided not to get the HPV vaccine for daughters Wendy, left, 11, and Alice, 12.

Even though every federal health authority says her girls, ages 11 and 12, should get Gardasil, the vaccine that helps protect against cervical cancer and genital warts caused by the human papillomavirus, Darrow instructed the pediatrician not to give it to them.

"Up until now my children have had every vaccine doctors have recommended," says Darrow, a graphic designer in St. Petersburg, Florida. "But most friends, like me, fear the safety of something new."

Even though Gardasil is on the Centers for Disease Control and Prevention's vaccine schedule for 11- and 12-year-old girls, and is recommended by the American Academy of Pediatrics, many parents interviewed by CNN say they're not getting it right now for their daughters out of concern for side effects.

"I'm not saying I'll never do it. I just don't want to do it when they're 11 or 12," says Darrow, who debated for a year about whether to get the shots for her daughters.

Liz Schlegel, on the other hand, didn't hesitate to get Gardasil for her 15-year-old daughter. "My older sister was diagnosed with (and beat!) cervical cancer two years ago, and her doctors traced it to HPV," says the manager of a small design firm from Waterbury, Vermont. "I would hate to think that normal sexual experimentation -- the kind that my sister and I and many of our friends and peers "tried on" in college -- could result in a life-threatening illness 30 years later."

A survey of 1,122 physicians in Texas showed that about half don't always recommend Gardasil to parents of 11- and 12-year-old girls, even though the CDC recommends it. The survey was published earlier this month in Cancer Epidemiology Biomarkers & Prevention, a journal of the American Association for Cancer Research.

In an unscientific QuickVote poll, respondents were split on whether they'd get the vaccine for their daughters, with 43 percent saying absolutely they would, 40 percent saying no way, and the rest saying they weren't sure. As of Wednesday, more than 5,000 people participated in the informal survey. To cast your vote go to CNNhealth.com.

Unlike most other vaccinations, Gardasil is not required for a child to attend school. As of 2007, the latest year for which statistics are available, 25 percent of 13- to 17-year-olds had received a dose of Gardasil, according to the CDC. Read what parents and pediatricians have to say about Gardasil »
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"Although the numbers are low, we are optimistic this percentage will increase over time," says Arleen Porcell-Pharr, a spokeswoman for the federal agency. "We would like to see 100 percent adherence to the CDC schedule, [but] from previous experience, we know that it takes years for a new vaccine to gain acceptance into the market."

Darrow and other parents say they're worried about neurological problems, blood clots and deaths that have been reported to the CDC after a woman or girl has been vaccinated with Gardasil. The vaccine is given in a series of three injections. Read a discussion on TwitterMoms about Gardasil

According to the Vaccine Adverse Event Reporting System run by the CDC and the Food and Drug Administration, as of May 1, there were 13,758 reports of adverse events occurring after women and girls received Gardasil, out of the more than 24 million doses that had been given to girls and women up until that time. On its Web site, the CDC notes that these events "may or may not have been caused by the vaccine."

Most of the problems -- 93 percent -- were considered to be mild, such as headache, nausea and fever. But 7 percent involved a hospitalization, permanent disability, life-threatening illness or death.

In the data, 39 deaths were reported after vaccination with Gardasil, with 26 confirmed by the agency, six under investigation, and seven unconfirmed. "There was no unusual pattern or clustering to the deaths that would suggest that they were caused by the vaccine," according to the CDC's Web site.

Gardasil, which prevents four types of human papillomavirus that cause 70 percent of all cervical cancers and more than 90 percent of genital warts, was heralded as a breakthrough when it was introduced more than three years ago by the pharmaceutical company Merck.

Since the reports, Merck has added several adverse reactions to the labeling, stating that some people after receiving Gardasil have developed autoimmune diseases, musculoskeletal disorders, paralysis and seizures.

"It's not possible to reliably estimate the frequency [of these adverse events] or to establish a causal relationship to vaccine exposure," the label states.

Dr. Rick Haupt, the pediatrician who leads Merck's research on Gardasil, says the vaccine is safe and effective for 11- and 12-year-old girls. "We have good evidence that the vaccine is appropriate to use at this age," he says.

He added that many countries, including the United States, recommend the shot at age 11 or 12 in hopes of getting girls vaccinated before they become sexually active, because HPV is transmitted sexually. Also, he says it's beneficial to vaccinate children this age because their "immune response is very robust."

Doctors and Gardasil

When her children were younger, Darrow's pediatrician urged her to get all the vaccines on the CDC schedule. She noticed, however, that when she told the pediatrician she didn't want Gardasil for Wendy and Alice, the doctor didn't push her to reconsider.

"There was no argument, no trying to persuade me, no 'Here's a pamphlet about Gardasil,' nothing," Darrow says.

Several pediatricians interviewed by CNN said they don't push the HPV vaccine if parents don't want it.

"I consider this to be an optional vaccine," says Dr. Arthur Lavin, associate clinical professor of pediatrics at Case Western Reserve University School of Medicine. "I tell parents it's fine with me if you wait, and it's also fine with me if you want that extra added level of protection and we proceed today."

He said about 15 percent of his patients are getting Gardasil for their 11- and 12-year-old girls.
Health Library

* MayoClinic.com: HPV infection
* MayoClinic.com: Cervical cancer
* MayoClinic.com: Cervical cancer vaccine: Who needs it, how it works

Parents researching on the Internet

Before her daughters' checkups this week, Darrow spent several hours doing research on the Internet in order to make her decision about Gardasil.

She said what tipped the scales for her were statements made in the media by Dr. Diane Harper, an obstetrician and gynecologist at the University of Missouri who helped Merck do clinical trials on Gardasil, at one point serving on the company's advisory board for the vaccine.

Harper told CNN she has concerns about the safety of the HPV vaccine for pre-adolescents, noting that a small number of girls have died or suffered neurological damage after receiving the shot.

"Gardasil is not without risks. It's not a freebie," Harper says.

Harper says she worries that not enough young girls were included in Merck's clinical trials to warrant giving the shot to all young girls.

Merck has given the vaccine to 1,121 girls between 9 and 15 years old in clinical trials without serious side effects, according to Haupt, the Merck pediatrician. He says the company will try to continue to follow these girls for 10 years.

In addition to safety concerns, Harper said she wonders whether the vaccine will still be effective for an 11- or 12-year-old after she's become sexually active.

Gardasil is "100 percent" effective against HPV five years after vaccination, according to Haupt, and Merck is studying whether its efficacy lasts longer than that.

Darrow says this is one reason she decided not to get the shots for Wendy and Alice. "Even if the shot lasts for 10 years, it would run out just when they're at their riskiest time," she says. "If I give it to my 11 year old right now, she'd need a booster at age 21."
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She added that she hasn't rejected the idea of getting Gardasil for her daughters, considering that it would give them some protection against cervical cancer.

"I'm going to revisit this again when they're 14 or 15," she said.

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Safety concerns about Gardasil HPV vaccine continue

Kansas City, MO

Since the introduction of Gardasil HPV vaccine, the FDA has reported forty seven deaths. Gardasil was approved in 2007. Cervical cancer is caused by HPV (human papillomavirus) and is easily spread. Adverse events from Gardasil in 2008 totaled 6,273, and 147 were reported at “life threatening”.



The report comes from Judicial Watch, a public interest group that monitors government corruption, obtained from the FDA. According to President Tom Fitton, "The already serious problems associated with Gardasil seem to be getting worse. No one should require this vaccine for young children."

Adverse events associated with Gardasil vaccine include cervical cancer that developed fifteen months after receiving the HPV vaccine, Guillain- Barre Syndrome after the second vaccine was given, and the death of a nineteen year old girl eleven days after receiving HPV vaccine.

The following is extracted from the FDA report: "After receiving her second dose of GARDASIL … she could crawl but … needed to use crutches or a wheel chair ... She was experienced problems breathing and had ‘super migraines' that never went away … She had swelling in her face, jaw and wrists. The patient was diagnosed with GUILLAIN-BARRE syndrome, myelin sheath degeneration and peripheral neuropathy. Patient was hospitalized twice … patient has not recovered from symptoms." Twenty nine new cases of Guillain-Barre syndrome have been seen since June 2008 in association with HPV vaccine.

Among pregnant women, 147 women who received Gardasil experienced spontaneous abortion. Genital warts developed 62 girls after the vaccine was given, appearing in other parts of the body including the hands, face and feet. One girl developed warts all over her body.

Forty one deaths occurred within one month, reported in association with Gardasil, and of those, seventeen occurred within two weeks. The cause of death is still not known.

Fitton says, "The FDA is supposed to be a guardian of public health, and yet the agency continues to turn a blind eye to what seems to be an extremely serious public health problem. The public relations push for Gardasil by Merck, politicians and public health officials needs to pause so that these adverse reactions can be further studied."

Concerns about the safety of Gardasil are not new. This year the manufacturer asked the FDA for approval of the vaccine for use in young males. The FDA is considering approval So far, twenty five percent of young women, age 9 to 26 have been vaccinated.

A mathematical study, published last year in the New England Journal of Medicine, suggested that vaccinating young women with Gardasil would be less cost effective than screening programs for cervical cancer. The cost of receiving HPV vaccine ranges from $500 to $900, and may not be covered by insurance.

Merck, the manufacturer of Gardasil responded to initial concerns about adverse events with the following statement: "Merck has analyzed the adverse events reported for Gardasil relating to the recent reports of death and paralysis, and based on the data available to Merck, believes that no safety issue related to the vaccine has been identified. These types of events are events that could also be seen in the general population."

An article published July 2008 about Gardasil safety concerns disappeared from Medscape after editorial review, and was replaced with more positive findings. You can read the original, article titled ”HPV Vaccine Adverse Events Worrisome Says Key Investigator” at Beyond Conformity. The article was replaced with “HPV Vaccine Deemed Safe and Effective, Despite Reports of Adverse Events”, and can be viewed here.

Gardasil vaccine continues to raise concerns. The medical community voiced those concerns last year, but the manufacturer of the vaccine assured the public the vaccine is safe. Judicial Watch is encouraging public health officials to step back and take a closer look at the safety concerns, and growing number of adverse events associated with Gardasil.

Diane Harper, MD, professor of community and family medicine/obstetrics and gynecology at Dartmouth Medical School, in Hanover, New Hampshire, and director of the Gynecologic Cancer Prevention Research Group at the Norris Cotton Cancer Center took part in the Gardasil clinical trials. Dr. Harper advised last year, "if you are at all concerned, then don't have the vaccine — have regular Pap smears and you will be equally protected from cervical cancer."

Escalating reports of Gardasil side effects and safety will continue to raise concerns. No one knows the long term outcomes of the Gardasil vaccine. The message to all women is, engage in regular visits to your gynecologist for cervical cancer screening. Please share your views or personal experience.

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CDC takes closer look at Gardasil and Paralysis

Washington, D.C.

Phil Tetlock and Barbara Mellers were in a race against time to save their 15-year-old daughter, Jenny. As I reported last summer, Jenny developed a degenerative muscle disease nearly two years ago, soon after being vaccinated against the cervical-cancer-causing HPV. She became nearly completely paralyzed, though her mind was perfectly intact and she could still enjoy her pet parakeet, Hannah Montana, and Twilight.

I've been E-mailing Phil regularly over the past year, and up until our last E-mail, one week ago, he had been holding out hope that they would be able to find a cure for his daughter—or to at least determine if the human papillomavirus vaccine called Gardasil had caused his daughter's illness, most likely a juvenile form of amyotrophic lateral sclerosis (aka Lou Gehrig's disease). Sadly, the clock ran out last Sunday, and Jenny passed away.

Through their efforts to publicize Jenny's case on their blog, Jenny's parents have connected with two other sets of parents whose daughters developed what appears to be ALS after being injected with Gardasil. One was 22-year-old Whitney Baird, who died last August, just 13 months after receiving Gardasil. Another is Alicia Olund, a 12-year-old who began having trouble walking after getting her third shot last September. She now uses leg braces and a walker at home as her muscles continue to deteriorate. After ruling out other conditions, her specialists at the University of California-San Francisco Medical Center—who also treated Jenny—suspect that Alicia may have the same condition. "They don't know what she has," her mother, Barbara, tells me through tears, "but it's destroying her nerves and muscles, and none of the treatments they've given her are working. Before the vaccine, she was a perfectly healthy child, going for her brown belt in karate." (They're awaiting the results of the ALS test.)

I should point out that juvenile ALS is extremely rare, affecting just 1 in 2 million young people. It's impossible to say at this point whether these girls would have developed the condition regardless of whether they received Gardasil, but government officials—who still strongly maintain that the vaccine is perfectly safe and potentially lifesaving—are now starting to investigate. Scientists from the Food and Drug Administration met recently with Jenny's neurologists at UCSF to discuss whether it's scientifically plausible for a vaccine to trigger ALS. And the Centers for Disease Control and Prevention is planning to scour its adverse-event database, called VAERS, to see whether other vaccinations have led to reports of ALS or other severe neurological complications.

Turns out, warnings concerning ALS and vaccines have been raised before. John Iskander, the CDC's associate director for immunization safety, tells me the agency previously has received reports of ALS following the anthrax vaccine. This, in addition to the deaths of Jenny and Whitney, "kind of tells us that we need to look more broadly at this issue," he says. He's quick to add that "we're doing just an initial review at this point; we don't have suspicions that these are casually related."

Merck, the manufacturer of Gardasil, maintains that its vaccine is extremely safe and points out that it could potentially save women from dying of cervical cancer. "There are unusual and rare diseases that occur in girls and women in this age group whether they're vaccinated or not," says Rick Haupt, Merck's head of the clinical program for Gardasil. "These patterns don't indicate any causality." He says no cases of ALS occurred in Merck's clinical trials but also admits that the trials—which included thousands, not millions—weren't large enough to detect such rare diseases.

Barbara Shapiro, an ALS expert and associate professor of neurology at Case Western Reserve University School of Medicine who was enlisted by a mutual friend to help the Tetlocks do their research, isn't ready to dismiss the cases as pure coincidence. She's pored over the medical records of Jenny, Whitney, and Alicia and sees a striking similarity. "Juvenile ALS tends to progress very slowly over years or even decades, but these girls all seemed to have a more rapid, progressive form." She also has uncovered another VAERS report in the CDC database that could be similar, but since it was filed by a pharmacist, the CDC told her it doesn't have details on the girl's identity. Shapiro worries that there may be more cases out there that the CDC doesn't know about.

After all, she tells me, both Whitney and Alicia came to the CDC's attention only after their parents discovered Jenny's blog and Phil Tetlock urged them to file a VAERS report. This system of voluntary reporting of adverse events related to vaccines by doctors and patients is notoriously crude. All too often, adverse events go unreported, whereas many reports that are filed turn out not to be related at all to the vaccines. When I point this out to Iskander, he tells me that while VAERS certainly isn't perfect, it's pretty good at catching rare events.

But what if doctors wouldn ' t think to link the onset of ALS with a vaccination? I press him. "Reports in the media, such as the one you're doing, are a good trigger to get doctors to file reports," he responds. In fact, largely because of media attention, reports of adverse events for Gardasil are about five times as high as the overall average for any vaccine, he adds. So I suppose he's hoping that if there are other girls out there who developed severe physical disabilities after receiving Gardasil, they'll soon be entered into the VAERS database.

Still, I'm troubled by the complexities of all of this. How will the CDC ever be able to know whether there's a true connection between Gardasil and ALS if this disease is so rare? And just how much evidence is needed? Iskander tells me he doesn't make that decision but passes on all the information he has to the government's vaccine working group, which makes recommendations about the national immunization schedule. "They are aware of these cases and that we've started discussions with neurologists and immunologists to determine if there are mechanisms that could explain how a vaccine could cause ALS," Iskander says, adding that "I haven't heard a good answer yet from these experts" when it comes to explaining a mechanism.

Shapiro says her suspicions are raised enough that she's decided not to give her own 11-year-old daughter the Gardasil vaccine. "Let's say it causes just one or two cases of ALS every year out of a million doses that are given. What if your daughter is the one?"

I haven't decided yet whether I want to have my own teenage daughter vaccinated. The arguments for Gardasil are compelling: It protects against viruses responsible for 70 percent of cervical cancers, which still kill many women in this country. Since the vaccine is so new, until more evidence emerges I think it may be prudent for concerned parents to consider holding off until their daughters reach the verge of sexual activity.

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One in four California adolescent girls has had HPV (cervical cancer) vaccine

San Bernadino, CA

A large number of California teens are showing up at medical clinics to receive the cervical cancer vaccine Gardasil, according to a UCLA survey released this week.

Less than two years after the HPV vaccine was approved as a routine vaccination for girls aged 11 and older, one-quarter of the state's adolescent girls have started the series of shots that protect against human papillomavirus, which is strongly linked to cervical cancer.

A majority of the state's teen girls, parents and young women also say they would like to have the vaccine, according to the new policy brief released this week by the UCLA Center for Health Policy Research.

"This is the very first data we have on the use of the vaccine and there appears to be a high acceptance," said David Grant, a sociologist and the survey director. "It's a positive start."

The brief, "One in Four California Adolescent Girls Have Had Human Papillomavirus Vaccination," is an early indicator of how a controversial vaccine is being accepted by the general public, he said.

The vaccine works by provoking the body's immune response to HPV without actually causing HPV infection or any of the diseases.

The vaccine contains inactivated extracts from four different types of the human papillomavirus. These types of HPV cause 70 percent of cervical cancers and 90 percent of genital warts.

The vaccine is administered in a series of three injections over a six-month period
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and targets the HPV types most commonly associated with genital warts and cervical cancer.

There were concerns about the vaccine when it was licensed for use by the Food and Drug Administration in 2006, then recommended for use by the National Centers for Disease Control and Prevention in 2007.

Much of the concern has been about its safety and worries that it might encourage girls to be sexually active.

But as more information on the vaccine has been released, it has become more accepted.

According to the survey, among teen girls in California aged 13 to 17, about 378,000 out of 1,468,000 (26 percent) reported receiving at least one dose of the vaccine.

Among California females aged 18 to 26, about 262,000 out of 2,273,000 (12 percent) reported receiving at least one dose of the vaccine in 2007 and 4 percent had completed the vaccine series.

Among those surveyed who had not yet had the HPV vaccine, not knowing enough about the vaccine was the main reason cited by young adult women age 18 to 26 (31 percent) and parents of age-eligible daughters (54 percent).

Other frequently cited explanations included concerns about the vaccine's safety and questions about its necessity.

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Cervical cancer vaccine Gardasil gains acceptance in California

Los Angeles, CA

The cervical cancer vaccine Gardasil is gaining widespread acceptance in California despite its newness and some controversy over its safety, UCLA researchers have found.

One in four teenage girls in the state -- about 378,000 out of 1.5 million -- received at least one dose of the vaccine in 2007, its first full year of distribution, according to, released Tuesday by UCLA's Center for Health Policy Research.

Among those who had not started the series of shots, a majority of teens and young adult women expressed interest in receiving the vaccine, as did their parents, the survey found.

Gardasil provides protection against four strains of the human papilloma virus, which are associated with about 70% of all cervical cancers in the United States and 90% of genital warts. The vaccine is administered in three shots over a six-month period.

Uncertainty and safety concerns typically surround the introduction of any new vaccine, and Gardasil has been more controversial than most. In March 2007, the national Centers for Disease Control and Prevention recommended the newly licensed vaccine for 11- and 12-year-old girls and beyond, up to age 26. (The vaccine works best if given before a young woman is sexually active and may have already contracted the virus.)

The recommendation sparked a flurry of objections, both scientific and social.

Critics said that the vaccine, approved in June 2006, was too new for its long-term effectiveness and safety to be judged. Others said that it was too expensive and that it was unnecessary because an effective cervical cancer screening method, the Pap smear, exists already. And some parents said that giving it to young girls implies approval of premarital sex.

A large study published last year alleviated some safety concerns, finding only three confirmed allergic reactions in girls and young women who received the vaccine in Australia. And the CDC seal of approval prompted U.S. programs for the poor as well as many private insurance plans to cover the cost.

The study, the first to look at Gardasil vaccination rates within a single state, was based on a large database called the California Health Interview Survey, in which more than 50,000 Californians are periodically interviewed by phone.

The UCLA researchers said they would soon release additional data on how different ethnic and socioeconomic groups have complied with the recommendation.

Preliminary results showed few differences by race, ethnicity or economic status among adolescent girls, said sociologist David Grant, the survey director. The federal Vaccines for Children program provides free shots for those without insurance in this age group.

But in the older age group -- age 18 to 26 -- fewer Latinas and African American women got vaccinations.

This could be because coverage for the vaccine would not be automatic in this group, Grant said.

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Merck pressing for OK to market Gardasil for males

Newark, NJ

After more than two years of selling the Gardasil vaccine as a way of protecting girls and young women against cervical cancer, Merck is asking federal drug regulators to allow the vaccine's use in boys and men between the ages of 9 and 26.

The drugmaker is counting on the expanded use to boost sales of Gardasil, which have flattened after a quick start. Getting that boost, however, may prove difficult.
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After two years on the market, Gardasil's side effects have made some pediatricians more reluctant to recommend it for their youngest patients. And despite the vaccine's early, soaring revenue -- it reached sales of $1.4 billion in its first year -- Merck has yet to capture a huge share of its primary market: young women, including college students.

The vaccine could be an even harder sell for boys.

One of the big reasons to vaccinate males is to stop the spread of the human papillomavirus, a sexually transmitted disease often referred to simply as HPV. But that may not prove as compelling a sales pitch as one that touts a vaccine as a protection against cancer.

"Boys don't get cervical cancer," said C. Anthony Butler, an analyst with Barclays Capital in New York City, "so parents could be reluctant to provide them with the vaccine.

"We want better health, but we don't want to do what's required to get it," Butler said. "It's a Catch-22."

Merck submitted an application to federal drug regulators last month requesting approval to begin selling Gardasil to boys as a protection against HPV-caused genital lesions. The U.S. Food and Drug Administration is expected to decide later this year whether Merck's application meets its standards.

Gardasil was originally approved by the FDA in 2006 as a vaccine to protect girls and young women against four strains of HPV -- known as 6, 11, 16 and 18. Health officials have blamed the latter two strains for causing an estimated 10,000 new cases of cervical cancer each year.

Yet from the beginning, the vaccine proved to be controversial, partly because of the sexual nature of the virus and partly because of Merck's focus on girls as young as 9. Compounding matters was the company's aggressive lobbying efforts to get state governments to include Gardasil as part of mandatory school-immunization programs.

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Allergic reactions to Gardasil uncommon: study

London

A study of Merck & Co Inc's cervical cancer vaccine Gardasil found that allergic reactions were uncommon and most young women can tolerate subsequent doses, Australian researchers said on Wednesday.

The research involved 25 Australian girls with suspected hypersensitivity to the vaccine which was administered as part of a national immunization program to all females aged 12 to 26 in the country beginning in 2007.

More than 380,000 doses of the vaccine have been given under the program, Sharon Choo of the Royal Children's Hospital in Melbourne and colleagues wrote in the British Medical Journal.

"Our clinical recommendation is that females with suspected hypersensitivity to the quadrivalent vaccine should be evaluated before receiving more doses, and any challenges with the same vaccine should be carried out in a supervised setting," they said.

Choo and colleagues noted some components of Merck's treatment -- such as aluminum salts and yeast -- have been associated with allergic reactions.

But skin tests of the 25 girls with suspected hypersensitivity showed that only three of them experienced probable reactions to the jabs.

The researchers also noted that suspected reactions such as hives are often "idiosyncratic" and do not increase the risk of adverse reactions in subsequent shots.

Gardasil and GlaxoSmithKline Plc's Cervarix are designed to be given to girls and young women to protect against cancer-causing strains of the sexually transmitted human papillomavirus (HPV), which can cause cervical cancer.

Gardasil targets four strains of HPV -- two responsible for cervical cancer and two causing the less serious condition of genital warts. Glaxo's product targets the two cancer strains.

In October, the U.S. Centers for Disease Control and Prevention reported that girls and young women given Gardasil were no more likely than usual to faint, have an allergic reaction, blood clot or other adverse reaction.

The report was based on 375,000 doses of the vaccine given from August 2006 to July 2008 after the agency had received 10,326 reports of adverse events following HPV vaccination in the United States.

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New Gardasil cervical cancer vaccination requirement for immigrants stirs controversy

New York, NY

There's no question that it's a hot shot.

Gardasil, the first anti-cancer vaccine ever to come on the market in the U.S., has evoked strong pro and con reactions among parents and some doctors ever since its 2006 FDA approval. It doesn't look like the controversy surrounding it is going to stop any time soon.

Not everyone's happy over the federal requirement that all new female immigrants ages 11 to 26 receive the vaccine, which protects against cervical cancer. The new requirement, which went into effect August 1, will affect more than 130,000 immigrants a year. Cervical cancer causes about 4,000 deaths annually.

The vaccine is expensive, costing several hundred dollars for the required three doses. So far, about a quarter of U.S. teens (about 2.5 million girls) have been given at least one of the three shot series in Gardasil's first full year of distribution, according to the Centers for Disease Control.

Now, immigrants will be required to receive a vaccine that's not even required in this country.

"This is one of the most heartwarming democratic processes I've ever seen," says Dr. William Schaffner, professor and chair of the department of preventive medicine at Vanderbilt University and a member of the CDC's Advisory Committee on Immunization Practices. "Through an interesting quirk, now all these immigrant girls and young women will be protected against cancer. Immigrants will be better protected against cancer than our own population."

The high cost of the vaccine has some medical providers wondering where the funding will come from to administer it.
MORE HEALTH NEWS: FOOD ALLERGIES ON THE RISE FOR U.S. CHILDREN

"If the immigrant has to pay for it, this would be a real burden," says Dr. Jessica Sessions of the Ryan Community Health Center on the Upper West Side, which serves about 40,000 patients per year, many of them low income. "It is a great vaccine but it is extremely expensive for people without insurance."

Gardasil blocks four strains of HPV, two of which cause about 70 percent of cervical cancers. The CDC recommends the vaccine for girls as young as age 11, with catch-up shots up to age 26. It is most effective when given early, before a girl becomes sexually active and might already have contracted the virus that the vaccine blocks – the human papillomavirus, or HPV.

Most medical organizations echo the CDC's advice that Gardasil be part of routine vaccinations, but there have been some concerns about the vaccine's potential side effects. As of June 30, the FDA had received nearly 10,000 reports of adverse reactions following Gardasil injections. Most of the reports described pain at the injection site, fainting, fever and headaches.

Some parents have been reluctant to give their daughters the vaccine because they feel it encourages premarital sex. Dr. Rebecca Booth, a gynecologist and author of "The Venus Week: Discover the Powerful Secret of Your Cycle at Any Age," has administered thousands of Gardasil injections with no serious side effects. She says that exposure to the virus Gardasil protects against is always a matter of personal choice.

"A patient of mine contracted cervical cancer when she was raped," Booth says. "Women who are sexually assaulted can be exposed to the virus. There is a lot of expense, grief, pain and suffering due not just to cervical cancer, but to the precancerous lesions that HPV also causes."

Dr. Schaffner, who calls the vaccine "an extraordinary advance in women's health and the first explicit anti-cancer vaccine," believes that when Gardasil is assessed by the CDC a couple of years out, the findings will be disturbing.

"There will be a disparity in use by income and, as a consequence, by racial and ethnic background," Schaffner says. "More affluent, educated parents will have higher rates of vaccinating their children than parents of more modest means. Will we as a society be satisfied with those kinds of disparities?

"Is it appropriate, in the U.S. in the 21st century, to have substantial portions of its population at risk for cancer of the cervix when we have a vaccine that is safe and effective against 70 percent of all cervical cancer?"

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Merck aims Gardasil to women least likely to benefit

New York, NY

Merck & Co. is targeting its cervical cancer vaccine Gardasil to women who may not benefit from it after U.S. sales shrank in July and August.

The number of Gardasil vaccinations tumbled more than 33 percent in those two months from the year-earlier period, according to health research firm IMS Health Inc. Merck shifted its marketing to women ages 19 to 26, who have been less likely to get the shots. The product, designed to prevent a sexually transmitted virus that can lead to cancer, previously was aimed primarily at young girls most likely to benefit from it.

Harvard University researchers said in an August study that the $400 vaccine isn't cost-effective in the older age group, a finding that supported the American Cancer Society's recommendations. Merck disagrees and says its vaccine can provide a benefit in that age group. Gardasil sales, which reached $1.5 billion in 2007, are slowing because of questions from proposed users on cost, safety and effectiveness, said Seamus Fernandez, a Leerink Swann & Co. analyst in Boston.

``Gardasil needs to be doing better,'' said Barclays Capital analyst Tony Butler in New York, in a telephone interview. The vaccine ``has become increasingly more important from a profit standpoint because of the concerns over Singulair and Vytorin and Zetia.''

Offsetting Vytorin

Merck, of Whitehouse Station, New Jersey, is counting on Gardasil to help offset declining sales of cholesterol pills Vytorin and Zetia after a January study found they may work no better at unclogging arteries than a cheaper medicine. Sales of the asthma treatment Singulair, Merck's top-selling drug, have also slowed over safety concerns.

Merck will report third-quarter earnings on Oct. 22. Second- quarter profit rose 5 percent on higher sales of the diabetes pill Januvia. The company since suspended its 2008 earnings forecast because of plunging Vytorin and Zetia sales.

Gardasil's decline in July and August prompted Fernandez, who rates Merck market perform, to chop $2.8 billion from his revenue estimate for the vaccine over the next five years. The August prescriptions fell 40 percent to 68,330 from a year earlier, according to IMS Health, based in Norwalk, Connecticut. July fell 26 percent to 56,872. Both numbers are probably lower than actual sales because vaccine-market figures are more difficult to collect than those for other types of medicine, said Fernandez.

Merck shares rose 31 cents, or 1.1 percent, to $28.50 at 4 p.m. in New York Stock Exchange composite trading. The drugmaker lost 50 percent of its value this year, the worst performance in the 14-member Standard & Poor's 500 Pharmaceutical Index.

Approval in 2006

The U.S. approved Gardasil in 2006 to protect girls and women ages 9 to 26 against four strains of the sexually transmitted human papillomavirus, which cause 70 percent of cervical cancers and 90 percent of genital warts.

Merck has decided to target the oldest in that group because they're least likely to have been vaccinated during Gardasil's initial availability, said Bev Lybrand, the company's senior vice president of vaccines, in a telephone interview.

``We see tremendous opportunity,'' said Lybrand. ``We have a number of programs under way to get after these women.''

Among women ages 19 to 26, about 15 percent have received the shot, according to a September research report by Merrill Lynch & Co. The U.S. Centers for Disease Control and Prevention in Atlanta reported Oct. 9 that a quarter of girls ages 13 to 17 had gotten at least one Gardasil shot.

Researchers at Harvard, in Cambridge, Massachusetts, said in an August study in the New England Journal of Medicine that targeting the older population will cost the U.S. 50 percent more than what's considered cost-effective.

Best Strategy

The most effective strategy is to target girls before they become sexually active, the study said, supporting the position of the American Cancer Society, in Atlanta, that the vaccine should be given to girls 18 and younger.

The Harvard study found it would cost $150,000 to buy enough Gardasil to extend the life of one person for one year -- $50,000 more than the $100,000 standard that public health officials typically use to judge whether a product cost-effective.

``The push needs to be with the 11- to 12-year-olds,'' said Debbie Saslow, director of breast and cervical cancer for the American Cancer Society, in a telephone interview. ``It is not going to be as effective in the older women.''

Merck says its internal data show the vaccine is cost- effective for women through at least age 24 because only about 1 percent of these women have been exposed to all four types of the virus the vaccine protects against, Lybrand said.

`Firm in Belief'

``Merck is firm in its belief that its efforts are aligned with the scientific data, health economic models and CDC recommendation that support vaccination of Gardasil in females from 11 to 26,'' the company said in an e-mailed statement. ``Many young women are not exposed to all or some of the HPV types for which Gardasil protects, and can still be protected today from getting cervical cancer in their lifetime.''

Merck's $100 million television and print advertising campaign last year featured young girls who were jumping rope and chanting ``one less.'' The company's new ads show college-aged women at home with pop music in the background. Merck spent $60 million on consumer marketing this year through June, according to Nielsen Monitor Plus.

Reaching College Students

Merck is also advertising on the networking Web site Facebook.com and in college bookstores and coffee shops. The company has been selling $32 cervical-cancer awareness charm bracelets on the Internet. Merck is seeking Food and Drug Administration approval to market Gardasil to women through age 45.

``We are starting to see some encouraging feedback,'' Lybrand said.

Merck also wants to persuade more gynecologists to stock the vaccine, she said. The company last month said it would reimburse doctors for the cost of giving patients the vaccine if a health insurer refuses to pay.

``The business is more complex now than it was 10 years ago, so everyone watches the bottom line,'' said Joseph Sanfilippo, vice chairman of reproductive science at the University of Pittsburgh, in a telephone interview. ``Anything to incentivize the physicians with these kinds of programs will be very well received.''

Women over 18 pay for the vaccine either out of pocket or through private insurance, a barrier for many, doctors said. About 10 percent of private insurance plans don't cover Gardasil and few college health plans help pay, Lybrand said. The U.S. government pays for Gardasil for those 18 and younger who don't have insurance.

Question of Cost

``Merck will point out that there are individual women who haven't been exposed,'' said Saslow of the American Cancer Society. ``I would say there are also women in this age group who can't afford to buy food. If you want to get the vaccine, fine. But think about where you are financially.''

Merck's challenge to increase sales may intensify next year when GlaxoSmithKline Plc, of London, hopes to begin selling in the U.S. a similar vaccine called Cervarix.

Gardasil also faces opposition from nonprofit groups, some of which advocate sexual abstinence before marriage, that say Gardasil may not be safe and gives women false security about sexually transmitted diseases.

The CDC said it has received reports of 21 deaths and almost 10,000 side effects in women following vaccination. None of the deaths could be linked to the vaccine and 94 percent of the side effects were ``non-serious,'' such as soreness around the injection site and headaches, the CDC said.

Cervical cancer killed 3,850 women in the U.S. in 2004, and treating it costs more than $2 billion each year, according to the CDC.

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25% of teen girls vaccinated for cervical cancer, U.S. says

Los Angeles, CA

The CDC calls the rate 'very good' for a new vaccine such as Gardasil. Earlier data show, however, that only about 1% of Latina teens have received it.

About a quarter of the nation's teenage girls received the controversial cervical cancer vaccine Gardasil last year in its first full year of distribution, federal authorities said Thursday.

"For a new vaccine, 25% is really very good," Lance Rodewald, director of the division of immunization services at the Centers for Disease Control and Prevention, said in a telephone news conference releasing the data.

"We need to see that rate every year if we are going to meet our goal" of having 90% of teenagers vaccinated, he said.

But immunologist W. Martin Kast of USC's Keck School of Medicine said, "Twenty-five percent is not bad, but it's not good either."

He said data released earlier in the year by Gardasil's manufacturer, Merck & Co., show that only about 1% of Latina teens were receiving the vaccine, and "they are the population that needs it the most" because the frequency of infection is relatively high.

Researchers said the percentage of teens receiving two other relatively new vaccines also went up. About 32% of teenagers received the meningitis vaccine, up from 20%; and 30% received the tetanus, diphtheria and whooping cough vaccine, up from 19%.

CDC recommends that girls get the cervical cancer vaccine and that all children get the other two when they are 11 or 12.

Merck received Food and Drug Administration approval to begin marketing Gardasil in June 2006. Experts say it spent $100 million marketing it in 2007 and had sales of about $1.5 billion.

The vaccine protects against four strains of human papilloma virus that account for about 70% of all cases of cervical cancer in the United States.

But the vaccine has been criticized on a number of fronts. Some scientists argue that it is only modestly effective and that its safety has not been adequately proved. Conservative groups say that giving it to young girls implies approval of sexual activity. And consumer advocates bemoan its high price -- $360 for a series of three shots.

The data, published in CDC's Morbidity & Mortality Weekly Report, came from the second year of the agency's annual National Immunization Survey for Teens. Researchers conducted telephone interviews with a representative sample of nearly 3,000 teens ages 13 to 17, then confirmed their answers with vaccination records from physicians.

They found that 25.1% of girls in the group had received at least one dose of the vaccine, which translates to about 2.5 million of the country's 10 million girls. Only a quarter of that group had received all three recommended doses, but officials noted that the series takes six months and many girls had not had time to complete it.

Results are unlikely to be as good this year, however. Merck reported sales were down 9% in the second quarter, and IMS Health Inc., which monitors drug use, said U.S. sales were off 34% in July and August, probably as a result of the faltering economy.

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Michigan teen becomes center of debate over Gardasil cervical vaccine

Flint, MI

Sammie and Matia White thought they were following the law when they got their 17-year-old daughter vaccinated with Gardasil.

"The doctor told my wife it was mandatory. She said our daughter had to get the shot," Sammie White said. "We hadn't even considered it before then."

The Whites, who live in Flint, were featured on CNN earlier this month. In a short investigative report, Matia White and her daughter, Taquaria Williams, shared details of the illnesses Williams has suffered since getting her first dose of Gardasil.

The vaccine is said to help prevent cervical cancer by protecting against certain types of the human papillomavirus (HPV), which can cause the disease.

"She started having headaches, she was irritable," Sammie White said. "She just changed."

Willams received her first shot in December, and by February she had broken out with a rash all over her body and her hands and feet were swollen due to poor circulation, her father said.

Since the shot, she's also been diagnosed with connective tissue disorder, a form of lupus.

Sammie White recently said the family received news that Williams may lose her finger tips.

"She's never been sick before," Sammie White said. "Now she's taking six or seven pills a day."

The Food and Drug Administration licensed Gardasil in June 2006. Since then, the Center for Disease Control and Prevention has reported 6,667 incidents nationally of adverse events following the vaccine.

About 94 percent of the events were non-serious, including headaches and soreness at the injection site. The remaining six percent were more serious, including hospitalization, a life-threatening illness, permanent disability and death.

Seventeen young women died after getting the vaccine, but no connection between the deaths and the vaccine could be established, the CDC Web site reports.

Because Gardasil supposedly protects against HPV, a sexually transmitted disease, some conservative and religious groups oppose the vaccine because of concerns that it will promote sexual activity.

Bridget Maher, of the Family Research Council, a Christian Right non-profit think tank, told The New Scientist magazine, "Giving the HPV vaccine to young women could be potentially harmful because they may see it as a (license) to engage in premarital sex."

Ray Middleton of Flint said he's considered getting his 16-year-old daughter the Gardasil vaccine.

"We thought about it, but decided against it because our daughter isn't dating or sexually active," Middleton said. "At some point, I think we'll reconsider and at that time we'd have to consult with our doctor about the risk."

Barbara Lee Fisher, co-founder and president of the National Vaccine Information Center, said more research needs to be done on the vaccine.

"We're concerned about the number of high functioning girls that are collapsing within 24 hours of receiving the vaccine," Fisher said. "It's not just girls falling out because they're afraid of needles. It's something in this vaccine causing this collapse."

Dr. Thomas Wright, a gynecologist in the Flint area, said his private practice has vaccinated about 150 girls and young women with Gardsil.

Between 300 and 500 women and girls have received the vaccine at Women's Integrated Health, a division of Genesys Regional Medical Centers, where Wright also practices.

Despite the controversy surrounding the vaccine, Wright said he will still recommend Gardasil to his patients.

"None of this has been directly linked to the vaccine. That's what the data shows at this point," he said. "Until it's proved otherwise, I think it's safe. In fact, both of my daughters have been vaccinated with Gardasil."

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Drug makers’ push leads to cancer vaccines’ rise

New York Times

In two years, cervical cancer has gone from obscure killer confined mostly to poor nations to the West’s disease of the moment.

“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.”
Dr. Diane Harper, a professor of medicine at Dartmouth Medical School

Tens of millions of girls and young women have been vaccinated against the disease in the United States and Europe in the two years since two vaccines were given government approval in many countries and, often, recommended for universal use among females ages 11 to 26.

One of the vaccines, Gardasil, from Merck, is made available to the poorest girls in the country, up to age 18, at a potential cost to the United States government of more than $1 billion; proposals to mandate the vaccine for girls in middle schools have been offered in 24 states, and one will take effect in Virginia this fall. Even the normally stingy British National Health Service will start giving the other vaccine — Cervarix, from GlaxoSmithKline — to all 12-year-old girls at school this September.

The lightning-fast transition from newly minted vaccine to must-have injection in the United States and Europe represents a triumph of what the manufacturers call education and their critics call marketing. The vaccines, which offer some protection against infection from sexually transmitted viruses, are far more expensive than earlier vaccines against other diseases — Gardasil’s list price is $360 for the three-dose series, and the total cost is typically $400 to nearly $1,000 with markup and office visits (and often only partially covered by health insurance).

Award-winning advertising has promoted the vaccines. Before the film “Sex and the City,” some moviegoers in the United States saw ads for Gardasil. On YouTube and in advertisements on popular shows like “Law and Order,” a multiethnic cast of young professionals urges girls to become “one less statistic” by getting vaccinated.

The vaccine makers have also brought attention to cervical cancer by providing money for activities by patients’ and women’s groups, doctors and medical experts, lobbyists and political organizations interested in the disease, sometimes in ways that skirt disclosure requirements or obscure the companies’ involvement.

Even critics of the marketing efforts recognize the benefits of the vaccines. Girls who get the shots are less likely to have Pap tests with worrisome results that would lead to further treatment, saving themselves anxiety and discomfort and, in those cases, saving money. When it occurs, cervical cancer is a dreadful disease; genital warts, partly prevented by the Merck vaccine, can be a painful nuisance.

But some experts worry about the consequences of the rapid rollout of the new vaccines without more medical evidence about how best to deploy them. They say that because of the aggressive marketing, even parents of girls who are far from being sexually active may feel pressured into giving them a vaccine that is not yet needed and whose long-term impact is still unclear. Legislative efforts to require girls to have the vaccine only add to the pressure.

In the United States, hundreds of doctors have been recruited and trained to give talks about Gardasil — $4,500 for a lecture — and some have made hundreds of thousands of dollars. Politicians have been lobbied and invited to receptions urging them to legislate against a global killer. And former state officials have been recruited to lobby their former colleagues.

“There was incredible pressure from industry and politics,” said Dr. Jon Abramson, a professor of pediatrics at Wake Forest University who was chairman of the committee of the Centers for Disease Control and Prevention that recommended the vaccine for all girls once they reached 11 or 12.

“This big push is making people crazy — thinking they’re bad moms if they don’t get their kids vaccinated,” said Dr. Abby Lippman, a professor at McGill University in Montreal and policy director of the Canadian Women’s Health Network. Canada will spend $300 million on a cervical cancer vaccine program.

Merck’s vaccine was studied in clinical trials for five years, and Glaxo’s for nearly six and a half, so it is not clear how long the protection will last. Some data from the clinical trials indicate immune molecules may wane after three to five years. If a 12-year-old is vaccinated, will she still be protected in college, when her risk of infection is higher? Or will a booster vaccine be necessary?

Some experts are concerned about possible side effects that become apparent only after a vaccine has been more widely tested over longer periods.

And why the sudden alarm in developed countries about cervical cancer, some experts ask. A major killer in the developing world, particularly Africa, where the vaccines are too expensive for use, cervical cancer is classified as very rare in the West because it is almost always preventable through regular Pap smears, which detect precancerous cells early enough for effective treatment. Indeed, because the vaccines prevent only 70 percent of cervical cancers, Pap smear screening must continue anyway.

“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,” said Dr. Diane Harper, a professor of medicine at Dartmouth Medical School. Dr. Harper was a principal investigator on the clinical trials of both Gardasil and Cervarix, and she spent 2006-7 on sabbatical at the World Health Organization developing plans for cervical cancer vaccine programs around the world.

“Because Merck was so aggressive, it went too fast,” Dr. Harper said. “I would have liked to see it go much slower.”

In receiving expedited consideration from the Food and Drug Administration, Gardasil took six months from application to approval and was recommended by the C.D.C. weeks later for universal use among girls. Most vaccines take three years to get that sort of endorsement, Dr. Harper said, and then 5 to 10 more for universal acceptance.

“In that time, you learn a lot about safety and side effects and how to use it,” Dr. Harper said. “Those getting it early should be the ones who really want it and willing to accept the risk.”

Dr. Richard Haupt, medical director at Merck, said the vaccine had not been rushed into use, saying that five years in clinical trails was normal before applying for licensing. He said Merck educated physicians, politicians and the public about the new vaccine to “accelerate and facilitate access.”

Spokesmen for Merck and Glaxo say all indications are that their vaccines are safe and effective, and there is no evidence that a booster shot will be needed. A Glaxo spokeswoman, Sarah Alspach, said its formulation produces a “stronger and longer-lasting immune response” than conventional vaccines.

Continue reading, "Drug makers’ push leads to cancer vaccines’ rise"

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Cervical cancer vaccine Gardasil linked to Pancreatitis

Palm Peach, FL

Gardasil, the cervical cancer vaccine, which is being advised for all young women, may be causing pancreatitis, a painful, debilitating disease that can be fatal. Australian sources reported that three women developed pancreatitis shortly after receiving the vaccine.

Gardasil protects women from strains of the HPV (human papillomavirus) that cause 70 percent of all cervical cancer. But numerous cases of young women being stricken with various potentially deadly complications have arisen all over the world. Eighteen deaths have been reported as well as 8,000 adverse reactions which include paralysis and seizures. Australia alone reported over 1,000 suspected reactions to the vaccine, although most were not life-threatening and included headaches, dizziness and vomiting.

Acute pancreatitis is characterized by sudden, severe abdominal pain. Pancreatic enzymes burn and irritate the pancreas, then leak out into the abdominal cavity. Complications can include heart, respiratory or kidney failure, all of which can be fatal.

Dr. Amitabha Das, writing in the Medical Journal of Australia, said, “We suggest that pancreatitis be considered in cases of abdominal pain following HPV vaccination.

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New Harvard study shows cervical cancer vaccine Gardasil worth the cost

Washington, D.C.

According to a new study released by Harvard researchers, the cervical cancer vaccine Gardasil is well worth the cost to protect girls against the virus.
Harvard researchers took part in a study which looked at just how cost-effective the cervical cancer vaccine Gardasil actually was.
What they found was that the most cost-effective way to fight the virus using Gardasil would be to vaccine all 12-year old girls.
Beyond that, you would also have to immunize all women under the age of 21, and revise screening guidelines.
Their study on how cost-effective the cervical cancer vaccine is has been published in the August 21 issue of the New England Journal of Medicine.
The cervical cancer vaccine Gardasil helps protect against two strains of HPV, which are responsible for 70% of cervical cancer cases around the world.
Gardasil was approved back in 2006 and was recommended by the CDC for girls who are ages 11 or 12-years old.
The Harvard researchers also found that the cervical cancer vaccine may not be as cost-effective for older women, over the age of 21.

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Wall Street Journal: Study questions cost-effectiveness of Gardasil cervical cancer vaccine

From The Wall Street Journal

A new study suggests that giving Merck & Co.'s cervical-cancer vaccine Gardasil to women through their mid-20s may not be worth the price, despite U.S. recommendations that this age group receive the costly shot.

The study, published online Wednesday by The New England Journal of Medicine, comes as Merck already is having difficulty persuading college-age and older women to get the vaccine, which was introduced in 2006 and costs about $360 for a three-dose regimen. This has contributed to a slowdown in Gardasil sales, casting a cloud on Merck's financial outlook.

Questions surrounding Gardasil's cost-effectiveness also could make for tougher market conditions for GlaxoSmithKline PLC's Cervarix, a cervical-cancer vaccine that is available outside the U.S. and is under review by the U.S. Food and Drug Administration.

Gardasil is designed to prevent infection by four strains of the human papillomavirus, or HPV, which is transmitted through sexual activity. Two of the targeted HPV strains are believed to cause about 70% of all cervical-cancer cases, while the other targeted strains cause most cases of genital warts. HPV also can cause other, rare tumor types such as vaginal and anal cancers. Gardasil isn't guaranteed to prevent cervical cancer because it doesn't protect against certain cancer-causing HPV strains.

The FDA approved Gardasil for use in females ages 9 to 26. The Centers for Disease Control and Prevention recommends routine HPV vaccination for girls 11 and 12 years old, as well as a temporary "catchup" vaccination for girls and women ages 13 through 26 who were never immunized. The CDC says it's ideal to get vaccinated before becoming sexually active, but vaccination after becoming sexually active can still offer protection because girls and women may not become exposed to all four HPV strains for many years. The vaccine doesn't treat existing infections, however.

The study published by researchers from the Harvard School of Public Health suggests Gardasil's cost is justified in pre-adolescent girls, partly because they are less likely to have already been exposed to HPV. But among older females, the cost-effectiveness of Gardasil becomes less and less favorable, researchers concluded. "Under most scenarios, extending the catchup to 26 wasn't cost-effective," Jane Kim, an assistant Harvard professor, said in an interview.

Merck, Whitehouse Station, N.J., disputed the conclusions, saying its own health-economic models suggest the vaccine is worth the cost. "We believe there's important value in vaccinating all women who are in the indicated age groups," said Rick Haupt, Merck's head of clinical research for Gardasil.

Ms. Kim and Harvard colleague Sue Goldie concluded that it cost about $43,600 per "quality-adjusted life year" gained, when HPV vaccine is administered to 12-year-old girls. This falls below the $50,000 per quality-adjusted life year threshold that some researchers use as a maximum for cost-effectiveness. Other researchers use a higher maximum benchmark of $100,000 per QALY to gauge cost-effectiveness.

It would cost $97,300 per QALY, however, to vaccinate girls and women through age 18, $120,400 per QALY for girls and women up to age 21, and $152,700 for girls and women up to age 26. The cost-effectiveness becomes more attractive when protection against genital warts is factored in.

The researchers arrived at these numbers by projecting HPV infection rates in various age groups, gauging the effectiveness of the vaccine and estimating cervical-cancer screening rates. Screening via Pap smear is recommended for women who are sexually active, even with the availability of Gardasil. The screenings can detect pre-cancerous lesions that can be removed; the availability of these tests has helped reduce the cervical-cancer death rate in the U.S. dramatically since the 1950s.

Merck's Dr. Haupt said the company's own models show that the cost per QALY is "well under $50,000" for women up to age 26. Among the differences between the models were that the Harvard researchers included patient time and travel costs, while Merck didn't, and the Harvard researchers didn't include genital warts in males, while Merck did, according to the CDC.

At least one of the factors in the primary Harvard calculations may be a relatively optimistic assumption -- that vaccination would produce lifelong immunity. Because the vaccine was only studied for five years and has been on the market for two years, no one knows for certain if its protection is lifelong, or if it wanes over time.

The Harvard researchers concluded that the cost per QALY would rise if the vaccine's effect wanes after 10 years.

Merck says the vaccine will offer protection well beyond five years, Dr. Haupt said. The Merck economic model that arrived at the cost per QALY below $50,000 assumed lifelong immunity, he said.

Still, the study is likely to fuel skepticism about Gardasil, which has already faced questions surrounding its safety and effectiveness (Merck and the CDC maintain it is safe and effective, with the most common side effect being soreness at site of injection.)

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Drug makers’ push leads to cancer vaccines’ rise

New York, NY

In two years, cervical cancer has gone from obscure killer confined mostly to poor nations to the West’s disease of the moment.

“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.”
Dr. Diane Harper, a professor of medicine at Dartmouth Medical School
Tens of millions of girls and young women have been vaccinated against the disease in the United States and Europe in the two years since two vaccines were given government approval in many countries and, often, recommended for universal use among females ages 11 to 26.

One of the vaccines, Gardasil, from Merck, is made available to the poorest girls in the country, up to age 18, at a potential cost to the United States government of more than $1 billion; proposals to mandate the vaccine for girls in middle schools have been offered in 24 states, and one will take effect in Virginia this fall. Even the normally stingy British National Health Service will start giving the other vaccine — Cervarix, from GlaxoSmithKline — to all 12-year-old girls at school this September.

The lightning-fast transition from newly minted vaccine to must-have injection in the United States and Europe represents a triumph of what the manufacturers call education and their critics call marketing. The vaccines, which offer some protection against infection from sexually transmitted viruses, are far more expensive than earlier vaccines against other diseases — Gardasil’s list price is $360 for the three-dose series, and the total cost is typically $400 to nearly $1,000 with markup and office visits (and often only partially covered by health insurance).

Award-winning advertising has promoted the vaccines. Before the film “Sex and the City,” some moviegoers in the United States saw ads for Gardasil. On YouTube and in advertisements on popular shows like “Law and Order,” a multiethnic cast of young professionals urges girls to become “one less statistic” by getting vaccinated.

The vaccine makers have also brought attention to cervical cancer by providing money for activities by patients’ and women’s groups, doctors and medical experts, lobbyists and political organizations interested in the disease, sometimes in ways that skirt disclosure requirements or obscure the companies’ involvement.

Even critics of the marketing efforts recognize the benefits of the vaccines. Girls who get the shots are less likely to have Pap tests with worrisome results that would lead to further treatment, saving themselves anxiety and discomfort and, in those cases, saving money. When it occurs, cervical cancer is a dreadful disease; genital warts, partly prevented by the Merck vaccine, can be a painful nuisance.

But some experts worry about the consequences of the rapid rollout of the new vaccines without more medical evidence about how best to deploy them. They say that because of the aggressive marketing, even parents of girls who are far from being sexually active may feel pressured into giving them a vaccine that is not yet needed and whose long-term impact is still unclear. Legislative efforts to require girls to have the vaccine only add to the pressure.

In the United States, hundreds of doctors have been recruited and trained to give talks about Gardasil — $4,500 for a lecture — and some have made hundreds of thousands of dollars. Politicians have been lobbied and invited to receptions urging them to legislate against a global killer. And former state officials have been recruited to lobby their former colleagues.

“There was incredible pressure from industry and politics,” said Dr. Jon Abramson, a professor of pediatrics at Wake Forest University who was chairman of the committee of the Centers for Disease Control and Prevention that recommended the vaccine for all girls once they reached 11 or 12.

“This big push is making people crazy — thinking they’re bad moms if they don’t get their kids vaccinated,” said Dr. Abby Lippman, a professor at McGill University in Montreal and policy director of the Canadian Women’s Health Network. Canada will spend $300 million on a cervical cancer vaccine program.

Merck’s vaccine was studied in clinical trials for five years, and Glaxo’s for nearly six and a half, so it is not clear how long the protection will last. Some data from the clinical trials indicate immune molecules may wane after three to five years. If a 12-year-old is vaccinated, will she still be protected in college, when her risk of infection is higher? Or will a booster vaccine be necessary? Read more, "Drug makers’ push leads to cancer vaccines’ rise."

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Cervical cancer vaccine most effective for young teens

Rochester, NY

A vaccine developed at the U of R Medical Center aimed at preventing cervical cancer is the most effective when given to 11 and 12 year old girls.

Harvard researchers studied Gardasil and found the vaccine is beneficial for young teens, but not necessarily for women in their 20's because they've already been exposed to sex and the HPV virus which can lead to cervical cancer.

The shot is given in three doses and some patients say it's painful.

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HPV vaccine Gardasil's side effects prompt CDC study

Washington, D.C.

Merck is likely quite displeased with the barrage of negative press about its cervical cancer vaccine's side effects, especially after a public interest group, Judicial Watch, released a report at the end of last month saying there were 9,749 adverse reactions and 21 reported deaths related to Gardasil in the last two years.

According to the report, there have been 78 severe outbreaks of genital warts, six cases of Guillain-Barré syndrome and at least 10 miscarriages reported to the Vaccine Adverse Event Reporting System (VAERS) since the approval of Gardasil. However, a study in the New England Journal of Medicine found that clinicians, patients and drug companies report only about 10 percent of side effects to VAERS, so the actual number of Gardasil side effects could be much higher.

Some experts say Merck has also overstated the vaccine's effectiveness and that the evidence just isn't there yet. In light of the potential side effects and the drugs' young female target audience, many also are questioning Merck's continual push to place the drug on state mandatory vaccine lists.

For its part, Merck says there is no evidence that the vaccine and the reported side effects and deaths are related, and the CDC plans to release a study in October that will help determine whether a true linkage between Gardasil and the reported adverse reactions exists.

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Cervical cancer preventin: Gardasil HPV vaccine doubts grow

Los Angeles, CA

The safety and effectiveness of the HPV vaccine Gardasil as a preventive cervical cancer treatment for girls are questioned in a report.

Sandra Levy wants to do everything she can to safeguard the health of her 11-year-old daughter -- and that, of course, includes cancer prevention. She has had her child inoculated with one shot of Gardasil, the human papilloma virus vaccine that may prevent cervical cancer. But now, she says, she has serious reservations about going ahead with the next two injections of the course.

"It's very confusing, and we really don't know if it's 100% safe," says Levy, of Long Beach. "I'm not against vaccines, but I don't want to do anything that would harm my daughter."

Though most medical organizations strongly advocate using the HPV vaccine, some doctors and parents, like Levy, are asking whether the vaccine's benefits really outweigh its costs. They say they aren't convinced that the expensive shots offer any more protection than preventive measures already available -- principally, regular screening via the Pap smear test.

A handful worry that blanket immunizations of the nation's adolescents could backfire by lulling them into a false sense of security that leads them to neglect regular screening. If that happened, vaccination could eventually boost cervical cancer rates instead of lowering them.

In addition, because Gardasil protects only against the HPV strains linked most strongly to cervical cancer, "we don't know if it will make a difference in the ultimate rates of cancer," says Abby Lippman, an epidemiologist at McGill University in Montreal who has researched the HPV vaccine. "The jury is still out on how much benefit we're actually going to get with this vaccine."

A report released in June stirred up more doubts. Although cause and effect were not proved, the report listed serious events -- such as seizures, spontaneous abortions and even deaths -- among teens, preteens and young women who had earlier had Gardasil shots.

As a result, the decision -- to vaccinate or not? -- has become controversial. Sorting through the pros and cons can be daunting for many parents.

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