Yourlawyer.com (Gardasil News)

Gardasil No Longer Requirement For Immigrants

Wed, 18 Nov 2009 00:00:00 -0800

Gardasil or other HPV vaccination will no longer be a requirement for immigrant girls and women seeking a green card, according to the Associated Press (AP). Currently, the U.S. Centers for Disease Control and Prevention (CDC) requires that all immigrants filing for a green card must receive a variety of shots; the HPV vaccine is currently among those required.

Effective December 14, the HPV vaccination will not be required, said the AP, in an effort to not single out immigrants. The requirement to receive at least the first dose of the HPV vaccine, which is administered in three doses, was implemented by the CDC for female immigrants between the ages of 11 and 26 in July 2008.

"More than half of the immigrants who come to the U.S. seeking opportunity are women," said Silvia Henriquez, executive director of the National Latina Institute for Reproductive Health, in a statement, quoted the AP. "We thank the CDC for restoring their dignity and reproductive justice."

There are currently two HPV vaccines approved for use in the U.S. Gardasil prevents four strains of HPV, two of which cause 70 percent of all cervical cancers. The other two HPV strains are responsible for about 90 percent of genital warts. Cervarix, approved by the Food & Drug Administration (FDA) just last month, protects against two strains of HPV that cause more than 70 percent of cases of cervical cancer in women.

HPV is the most widespread of sexually transmitted diseases in the U.S.; however, a small percentage of people infected with HPV will develop cervical cancer and other dangerous diseases, citing the AP. Also, cost efficacy has long been an issue with the Gardasil vaccine, said the AP. The shots run about $400-to-$1000 and insurers do not cover such health services for immigrants, said the AP.

The CDC's decision comes at a time when the safety and effectiveness of HPV vaccination is being questioned. Recently we reported that Dr. Diane Harper, director of the Gynecologic Cancer Prevention Research Group at the University of Missouri, noted that, to date, 15,037 girls have officially reported adverse side effects from Gardasil to the Vaccine Adverse Event Reporting System (VAERS). These adverse reactions include Guilliane-Barre syndrome, lupus, seizures, paralysis, blood clots and brain inflammation. Dr. Harper also said that the CDC acknowledged 44 reported deaths following Gardasil administration.

Dr. Harper played a role in the development of both Gardasil and Cervarix and recently asserted that neither HPV vaccine would do much to reduce cervical cancer rates in the U.S. According to an earlier report on chattahbox.com, Dr. Harper also said the HPV vaccines should not be administered to girls under 15.

Dr. Harper also warned that Merck & Co., the maker of Gardasil, had not tested Gardasil on girls younger than 15, chattahbox.com said. “It is silly to mandate vaccination of 11 to 12 year old girls. There also is not enough evidence gathered on side effects to know that safety is not an issue,” warned Harper.

Gardasil Researcher Questions Safety, Effectiveness of HPV Vaccines

Thu, 29 Oct 2009 00:00:00 -0700

A medical researcher who played a role in the development of both Gardasil and Cervarix recently asserted that neither HPV vaccine would do much to reduce cervical cancer rates in the U.S. According to a report on chattahbox.com, Dr. Diane Harper also said the HPV vaccines should not be administered to girls under 15.

Gardasil prevents four strains of HPV, two of which cause 70 percent of all cervical cancers. The other two HPV strains are responsible for about 90 percent of genital warts. Cervarix, approved by the Food & Drug Administration (FDA) just this month, protects against two strains of HPV that cause more than 70% of cases of cervical cancer in women.

Dr. Harper, director of the Gynecologic Cancer Prevention Research Group at the University of Missouri, was the lead researcher in developing both vaccines, chttahbox.com said. She was supposed to address the 4th International Public Conference on Vaccination which took place in Reston, Virginia on Oct. 2-4 on the effectiveness of both Gardasil and Cerarvix, but her remarks took a decidedly different turn.

According to chattahbox.com, Dr. Harper asserted that the evidence shows that the vaccine does little to reduce cervical cancer, beyond current preventative measures. She argued that the incidence of cervical cancer in the U.S. is already so low that “even if we get the vaccine and continue PAP screening, we will not lower the rate of cervical cancer in the U.S.”

Dr. Harper also warned that Merck & Co., the maker of Gardasil, had not tested Gardasil on girls younger than 15, chattahbox.com said. “It is silly to mandate vaccination of 11 to 12 year old girls. There also is not enough evidence gathered on side effects to know that safety is not an issue,” warned Harper.

Dr. Harper pointed out that to date, 15,037 girls have officially reported adverse side effects from Gardasil to the Vaccine Adverse Event Reporting System (VAERS). These adverse reactions include Guilliane-Barre syndrome, lupus, seizures, paralysis, blood clots and brain inflammation. Dr. Harper also said that the Centers for Disease Control has acknowledged 44 reported deaths following Gardasil administration.

According to chattahbox.com, Dr. Harper was asked why she was criticizing vaccines she helped develop. Her response: “I want to be able to sleep with myself when I go to bed at night."

CDC Says Gardasil For Boys Should Be Optional

Thu, 22 Oct 2009 00:00:00 -0700

Yesterday, the U.S. Advisory Committee on Immunization Practices voted against recommending routine Gardasil vaccination for boys. The voting does, however, allow physicians the option of recommending the vaccine for boys and men, said AJC/HealthDayNews. The Committee reports its findings to the U.S. Centers for Disease Control and Prevention (CDC).

The drug was approved by the U.S. Food & Drug Administration (FDA) for boys and men aged nine through 26 for the prevention of genital warts, and the FDA approved Gardasil’s use in females in 2006, a hotly debated topic among patient advocates.

The Gardasil vaccination prevents some forms of the Human Papillomavirus (HPV) that cause cervical cancer. AJC noted that HPV has also been associated with some rare throat, genital, and anal cancers and genital warts. Gardasil’s controversy originated when Merck & Co. attempted to make the vaccine mandatory, and because of continuing questions about its safety.

Proponents of the vaccine claim that expanding Gardasil’s use for males is beneficial since it is believed that males transmit HPV to females. Also, since HPV is linked to certain cancers, vaccinating males is believed by some to aid in the reduction of the rate of cervical cancer, said AJC.

Regardless, the cost efficacy of vaccinating males might not be as beneficial as hoped. We recently wrote about a new study that questioned the cost-effectiveness of HPV vaccination for males. According to a press release from Harvard School of Public Health (HSPH), researchers there found that if HPV vaccine coverage and efficacy are high in girls, a universal recommendation to vaccinate young boys is unlikely to provide comparatively good value for resources, compared with vaccinating girls only.

"This study found that while vaccine coverage and efficacy are high in girls, including boys in an HPV vaccination program generally exceeds what the U.S. typically considers good value for money," said lead researcher Jane Kim, assistant professor of health decision science, quoted AJC.

The FDA announced earlier this year that the Gardasil label was updated to include more prominent warnings about fainting that can occur following administration of the vaccine. According to the agency, some Gardasil fainting victims have suffered from tonic-clonic (jerking) movements and seizure-like activity, and some have fallen resulting in traumatic injuries. Roughly 13 percent of Gardasil side effects reported to the Vaccine Adverse Event Reporting System (VAERS) describe fainting.

Meanwhile, we recently wrote that Gardasil may have played a role in two fatal cases of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, citing researchers from the ALS Center at the University of California San Francisco Medical Center. According to WebMD, the researchers looking into the cases can’t confirm a connection, but are hoping that by raising awareness, they will learn of any other incidents of ALS that have followed Gardasil vaccination.

As of June 2009, 15 million girls had received Gardasil, with more than 14,000 recipients reporting adverse reactions. The complaints included reports of dizziness numbness, and blood clots. Health regulators are also looking at 43 reports of fatalities that occurred following Gardasil administration.

Researchers Name Gardasil A Suspect in Two ALS Cases

Tue, 20 Oct 2009 00:00:00 -0700

Gardasil may have played a role in two fatal cases of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, according to researchers from the ALS Center at the University of California San Francisco Medical Center. According to WebMD, the researchers looking into the cases can't confirm a connection, but are hoping that by raising awareness, they will learn of any other incidents of ALS that have followed Gardasil vaccination.

Gardasil prevents four strains of HPV, two of which cause 70 percent of all cervical cancers. The other two HPV strains are responsible for about 90 percent of genital warts. However, Gardasil has been the subject of controversy ever since it was approved in 2006. As of June 2009, 15 million girls had received Gardasil, with more than 14,000 recipients reporting adverse reactions. The complaints included reports of dizziness numbness, and blood clots. Health regulators are also looking at 43 reports of fatalities that occurred following Gardasil administration.

In June, the Food & Drug Administration (FDA) announced that the Gardasil label had been updated to include more prominent warnings about fainting that can occur following administration of the vaccine. According to the agency, some Gardasil fainting victims have suffered from tonic-clonic (jerking) movements and seizure-like activity, and some have fallen resulting in traumatic injuries. According to the agency, roughly 13% of Gardasil side effects reported to its Vaccine Adverse Event Reporting System (VAERS) describe fainting.

ALS is a rapidly progressive, fatal disease. According to WebMD, the cases documented by the ALS Center involved two young women, ages 17 and 20. The story of one, 17-year-old Jenny Tetlock, has been reported on this blog before. Both young began showing symptoms of ALS just months after receiving a Gardasil shot. In Jenny Tetlock's case, she had received her third and final vaccine in March 2007. The second victim, a 20-year-old, developed problems within four months of her fist Gardasil injection. According to WebMD, the disease progressed similarly in both young women before it took their lives. Jenny Tetlock died in March 2009, while the other young woman died 28 months after receiving Gardasil.

The ALS Center researchers concede that the development of ALS in both young women so soon after Gardasil vaccination could be a coincidence. But according to WebMD, they are concerned by a couple of factors. For one thing, the disease progressed more quickly than is usual for young ALS patients. Autopsies revealed the spinal cord of both victims was severely inflamed, something the researchers said is not typically seen with ALS. According to WebMD, the researchers believe these factors “all support a temporal association between [the illness] and vaccination.”

Gardasil For Boys May Not Be Cost-Effective

Fri, 09 Oct 2009 00:00:00 -0700

Just as U.S. regulators are set to decide on approving Gardasil for boys and young men, a new study is questioning the cost-effectiveness of HPV vaccination for that group. The study appeared online today in The British Medical Journal.

According to a press release from Harvard School of Public Health (HSPH), researchers there found that if HPV vaccine coverage and efficacy are high in girls, a universal recommendation to vaccinate young boys is unlikely to provide comparatively good value for resources, compared with vaccinating girls only.

To reach that conclusion, the researchers looked at computer-based disease models to simulate the course of HPV-related diseases in the U.S. population over time. The analysis looked at the vaccine's potential benefits on a comprehensive set of HPV-related conditions among females and males, including cervical and non-cervical HPV-related cancers, genital warts and juvenile onset recurrent respiratory papillomatosis, a rare but severe respiratory condition usually diagnosed in infancy that may be related to a mother's infection with genital warts.

The results showed that, assuming 75% vaccination coverage and lifelong vaccine protection against cervical disease, routine HPV vaccination of 12-year-old girls was associated with a cost-effectiveness ratio of $40,310 per quality-adjusted life year (QALY). Including boys in the vaccination program had a cost-effectiveness ratio of $290,290 per QALY when compared to vaccinating girls only.

QALY is a health metric used to reflect both the excess mortality and reduced quality of life associated with disease. In the U.S., interventions with cost-effectiveness ratios below $50,000 or $100,000 per QALY are informally considered good value for the money.

The results were robust across a range of alternative scenarios, such as changes in screening practice, decreased vaccine efficacy in boys, shorter duration of vaccine protection, and the inclusion of other HPV-related outcomes noted above. The authors acknowledged, however, that there are many uncertain factors that can influence the findings.

The U.S. Food & Drug Administration (FDA) is currently considering whether or not Gardasil, the HPV vaccine marketed by Merck & Co. should be approved for boys and young men. Last month, an FDA advisory panel had recommended that it be approved for boys and young men aged 9 to 26 for protection against genital warts caused by HPV. In the U.S., Gardasil is currently only approved for use in girls and young women.

FDA Delays Cervarix Decision, Glaxo Says British Death Not Behind Delay

Wed, 30 Sep 2009 00:00:00 -0700

U.S. regulators have postponed an approval decision on GlaxoSmithKline's cervical cancer vaccine, Cervarix. The Food & Drug Administration's (FDA) delay of the Cervarix decision came a day after news broke that a British girl had died only hours after receiving the vaccine.

Cervarix protects against two strains of HPV that cause more than 70% of cases of cervical cancer in women. According to the Associated Press, the FDA was supposed to announce its Cervarix ruling on Tuesday, but needed additional data. Earlier this month, an outside panel of health experts voted that Cervarix appears safe and effective for girls and women ages 10 to 25.   The vaccine is already approved in 100 other countries.

If approved in the U.S., Cervarix would compete with Merck & Co.'s Gardasil, which the FDA ok'd in 2006. Gardasil prevents four strains of HPV, two of which cause 70 percent of all cervical cancers. The other two HPV strains are responsible for about 90 percent of genital warts. According to the Associated Press, Glaxo said the death in Britain did not play a role in the FDA's decision to postpone the Cervarix ruling.

The death occurred Monday. According to BBC News, the girl, aged 14, appeared to be healthy prior to receiving the vaccine at school in Coventry. She died in the hospital, four hours after the shot was administered. A small number of girls at the school had also reported mild symptoms such as dizziness and nausea but were not admitted to hospital.   The cause of death is unknown at this time, pending an autopsy report.

According to The Wall Street Journal, Glaxo has recalled the batch of Cervarix involved in the fatal incident. Other batches of the vaccine remain available and are not affected by this recall.   The Cervarix vaccination program in Coventry has been paused for now.

According to the BBC report, Britain's Medicines and Healthcare Regulatory Agency has received 2,137 adverse reaction reports involving Cervarix between April 14, 2008 and September 23, 2009.

In the U.S. Merck's Gardasil has also been the subject of safety concerns. As of June 2009, 15 million girls had received Gardasil, with more than 14,000 recipients reporting adverse reactions. The complaints included reports of dizziness numbness, and blood clots. Health regulators are also looking at 43 reports of fatalities that occurred following Gardasil administration.

In June, the FDA announced that the Gardasil label had been updated to include more prominent warnings about fainting that can occur following administration of the vaccine. According to the agency, some Gardasil fainting victims have suffered from tonic-clonic (jerking) movements and seizure-like activity, and some have fallen resulting in traumatic injuries. According to the agency, roughly 13% of Gardasil side effects reported to its Vaccine Adverse Event Reporting System (VAERS) describe fainting.

Gardasil Killed My Granddaughter, Florida Woman Claims

Tue, 22 Sep 2009 00:00:00 -0700

A Florida woman thinks the death of her 17-year-old granddaughter may have had something to do with Gardasil. According to a report on firstcoastnews.com, Denise Melton insists that Jessie Ericzon had been in good health until she received the HPV vaccine.

Gardasil prevents four strains of HPV, two of which cause 70 percent of all cervical cancers. The other two HPV strains are responsible for about 90 percent of genital warts. However, Gardasil has been the subject of controversy ever since it was approved in 2006. As of June 2009, 15 million girls had received Gardasil, with more than 14,000 recipients reporting adverse reactions. The complaints included reports of dizziness numbness, and blood clots. Health regulators are also looking at 43 reports of fatalities that occurred following Gardasil administration.

In June, the Food & Drug Administration (FDA) announced that the Gardasil label had been updated to include more prominent warnings about fainting that can occur following administration of the vaccine. According to the agency, some Gardasil fainting victims have suffered from tonic-clonic (jerking) movements and seizure-like activity, and some have fallen resulting in traumatic injuries. According to the agency, roughly 13% of Gardasil side effects reported to its Vaccine Adverse Event Reporting System (VAERS) describe fainting.

According to her grandmother, Jessie began suffering from severe headaches after receiving a second shot of Gardasil in September 2007. The headaches were centered on the back of the head and neck, Melton said. Jessie also complained of muscle aches and joint pain. Jessie's mother took her to the doctor, but her symptoms were attributed to stress.

Jessie received her third Gardasil on February 20, 2008. A day later, she again complained of a severe headache. On February 22 - just a day shy of her 18th birthday - Jessie's mother found her daughter's body on the bathroom floor, Melton said. An autopsy has not been able to uncover the cause of Jessie's death.

Jessie's family began searching for answers shortly after her funeral, and say an internet search revealed that thousands of girls had suffered symptoms similar to Jessie's following Gardasil vaccination. There were also reports of deaths.

Melton is now convinced Gardasil played some role in her granddaughter's death. She now spends her time telling Jessie's story, trying to get out what she says is the truth about Gardasil.

More Women Saying No to Gardasil

Tue, 15 Sep 2009 00:00:00 -0700

Fewer young women and girls are getting the Gardasil vaccine. According to a report on kfyrtv.com, safety concerns may be one of the reasons behind a drop-off in Gardasil vaccinations.

Gardasil prevents four strains of HPV, two of which cause 70 percent of all cervical cancers. The other two HPV strains are responsible for about 90 percent of genital warts. However, Gardasil has been the subject of controversy ever since it was approved in 2006. Recently, a new study in the Journal of the American Medical Association found that Gardasil has a higher incidence of blood clots reported. Last month CBS News reported that Merck is also looking into cases of ALS (Lou Gehrig’s Disease) reported after vaccination, and is monitoring the number of deaths reported after Gardasil is administered. Right now, that number stands at 32.

In June, the FDA announced that the Gardasil label had been updated to include more prominent warnings about fainting that can occur following administration of the vaccine. According to the agency, some Gardasil fainting victims have suffered from tonic-clonic (jerking) movements and seizure-like activity, and some have fallen resulting in traumatic injuries. According to the agency, roughly 13% of Gardasil side effects reported to its Vaccine Adverse Event Reporting System (VAERS) describe fainting.

According to the kfyrtv.com report, sales of Gardasil declined by a third this year, with three out of four young women remaining unvaccinated. Concerns about side effects are one reason fewer are being vaccinated, the report said.

Merck & Co. is trying to revive Gardasil sales Recently, it asked the Food & Drug Administration (FDA) to approve it to prevent genital warts in boys and young men. Last week, and FDA advisory panel recommended that the agency do so.

However, Merck has dropped its controversial campaign to convince states to make Gardasil mandatory for young girls. Such efforts were met with fierce opposition by many parents. While about 2 dozen states considered mandatory Gardasil initiatives, in the end only Virginia and Washington D.C. have instituted loose Gardasil mandates. Merck quit lobbying for mandatory Gardasil in 2007.

Gardasil for Boys Gets OK From FDA Advisory Panel

Thu, 10 Sep 2009 00:00:00 -0700

Gardasil, the HPV vaccine currently marketed to young girls and women, may soon be available for boys According to a CNN report, a Food & Drug Administration (FDA) advisory panel has recommended that Gardasil be approved for boys and young men aged 9 to 26 for protection against genital warts caused by HPV.

Gardasil prevents four strains of HPV, two of which cause 70 percent of all cervical cancers. The other two HPV strains are responsible for about 90 percent of genital warts. However, Gardasil has been the subject of controversy ever since it was approved in 2006. Recently, a new study in the Journal of the American Medical Association found that Gardasil has a higher incidence of blood clots reported. Last month CBS News reported that Merck is also looking into cases of ALS (Lou Gehrig’s Disease) reported after vaccination, and is monitoring the number of deaths reported after Gardasil is administered. Right now, that number stands at 32.

In June, the FDA announced that the Gardasil label had been updated to include more prominent warnings about fainting that can occur following administration of the vaccine. According to the agency, some Gardasil fainting victims have suffered from tonic-clonic (jerking) movements and seizure-like activity, and some have fallen resulting in traumatic injuries. According to the agency, roughly 13% of Gardasil side effects reported to its Vaccine Adverse Event Reporting System (VAERS) describe fainting.

When it was first approved, Merck began an aggressive campaign to convince states to make Gardasil vaccination mandatory for young girls. However, such efforts were met with fierce opposition by many parents. While about 2 dozen states considered such initiatives, in the end only Virginia and Washington D.C. have instituted loose Gardasil mandates. In 2007, Merck suspended its mandatory Gardasil campaign.

According to CNN, at yesterday's advisory panel meeting, Merck presented data from three clinical trials that the company claims supports broadening the distribution of the vaccine to include males. According to Merck, the trials saw a 90 percent reduction in genital warts and pre-cancerous lesions caused by HPV in men, and an 89 percent reduction in genital warts incidence. Merck also claimed that no serious adverse events related to the vaccine were reported , and that side effects - such as fever and pain at the injection site - were mild.

According to the Associated Press, the advisory panel voted unanimously with one abstention that the vaccine is effective for preventing HPV, in males ages 9 to 26. The panel voted 7-1 that the vaccine is safe for those patients.

The FDA is not required to follow the recommendations of its advisory panels, but it usually does so.

Gardasil Requirement Effort Fell Flat

Wed, 02 Sep 2009 00:00:00 -0700

Three years after Gardasil first appeared on the market, Merck & Co's heavy handed attempts to convince states to make it mandatory for young girls appear to have had little success. According to the Associated Press, only Virginia and Washington D.C. have instituted loose Gardasil requirements for sixth-grade girls. In both instances, parents may opt-out of the requirement for any reason, the Associated Press said.

Gardasil has been the subject of controversy ever since it was approved in 2006. Recently, a new study in the Journal of the American Medical Association found that Gardasil has a higher incidence of blood clots reported. Last month CBS News reported that Merck is also looking into cases of ALS (Lou Gehrig’s Disease) reported after vaccination, and is monitoring the number of deaths reported after Gardasil is administered. Right now, that number stands at 32.

In June, the Food & Drug Administration (FDA) announced that the Gardasil label had been updated to include more prominent warnings about fainting that can occur following administration of the vaccine. According to the agency, some Gardasil fainting victims have suffered from tonic-clonic (jerking) movements and seizure-like activity, and some have fallen resulting in traumatic injuries. According to roughly 13% of Gardasil side effects reported to its Vaccine Adverse Event Reporting System (VAERS) describe fainting.

According to the Associated Press report, while 2 dozen states had considered making Gardasil mandatory for young girls, those efforts failed because of parental opposition. Reasons for such opposition are varied. Safety was obviously a big concern, and some socially conservative people worried Gardasil would promote promiscuity. Some states that considered providing Gardasil free-of-charge did not have the funding available once the economy fell into recession. Finally, many people were disturbed to hear that Merck had paid for the massive lobbying efforts that were pushing for mandatory Gardasil. Merck suspended that campaign in 2007, the Associated Press said.

According to the Associated Press, the Virginia and Washington, D.C Gardasil requirements go into effect this school year. In Washington, sixth-grade girls will not be allowed to attend school unless they have had Gardasil, or their parents provide the school with a form indicating they have opted out. In Virginia, parents are asked to provide documentation if their daughter had Gardasil, but there is no penalty for not doing so.

In Texas, Gov. Rick Perry had tried to order a Gardasil mandate in 2007, but was over- ruled by the state legislature. That same year, New Mexico Gov. Bill Richardson vetoed a mandate passed by that state's legislature.

Gardasil Researcher Says Better Warning on Side Effects Needed

Thu, 20 Aug 2009 00:00:00 -0700

A lead Gardasil researcher says more complete warnings should be given to patients before the vaccine is administered. In an interview with CBS News, Dr. Diane Harper also criticized Merck & Co.'s aggressive marketing of the Gardasil.

As we've reported previously, Dr. Harper has dedicated two decades of her career to research on the Human Papillomavirus (HPV), the virus that causes cervical cancer. She served as a researcher on study trials for Gardasil and another HPV vaccine, Cervarix. Dr. Harper has also been a paid speaker and consultant for Merck.

Dr. Harper's ties to Merck and Gardasil have not appeared to have affected her objectivity in regards to the vaccine. While Dr. Harper has said she is convinced HPV vaccines can help prevent cancers in the long-run, she has been critical in the past of Merck's efforts to have Gardasil declared a mandatory vaccine in many states.

Gardasil has been the subject of controversy ever since it was approved in 2006. Recently, a new study in the Journal of the American Medical Association found that Gardasil has a higher incidence of blood clots reported. According to CBS News, Merck is also looking into cases of ALS (Lou Gehrig’s Disease) reported after vaccination, and is monitoring the number of deaths reported after Gardasil is administered. Right now, that number stands at 32.

In her interview with CBS News, Dr. Harper said that patients should be told that the benefits of Gardasil vaccination may not outweigh its risks, and that protection may not last a lifetime. She pointed out that Gardasil has been associated with at least as many serious adverse events as there are deaths from cervical cancer developing each year.

Dr. Harper also told CBS News that she was concerned that Merck's Gardasil marketing campaign might be misleading women into believing they are getting more protection than the vaccine actually affords. That belief could cause some women to stop receiving cancer screenings after they are vaccinated. According to Dr. Harper, data available for Gardasil shows that it lasts five years; there is no data showing that it remains effective beyond that point.

Gardasil Side Effect Reports Included 28 Deaths, Group Says

Thu, 25 Jun 2009 00:00:00 -0700

A conservative advocacy group is charging that more than 2 dozen women and girls died in 2008 after receiving Gardasil injections. According to a press release issued by Judicial Watch, there have been a total of 47 deaths linked to Gardasil since it was brought to market in 2006.

Gardasil is a vaccination that prevents some forms of the Human Papillomavirus (HPV) that cause cervical cancer. Gardasil has been controversial because of attempts by Merck & Co. to make it mandatory, and because of continuing questions about its safety.

Earlier this month, the Food & Drug Administration (FDA) announced that the Gardasil label had been updated to include more prominent warnings about fainting that can occur following administration of the vaccine. According to the agency, some Gardasil fainting victims have suffered from tonic-clonic (jerking) movements and seizure-like activity, and some have fallen resulting in traumatic injuries. According to roughly 13% of Gardasil side effects reported to Vaccine Adverse Event Reporting System (VAERS) describe fainting.

Judicial Watch says it has obtained records from the FDA documenting 28 deaths in 2008 associated with Gardasil, up from 19 deaths in 2007. Of the 47 deaths reported since 2006, Judicial Watch said 41 occurred within a month of receiving the vaccine, and of those 17 were within two weeks of receiving the vaccine. In most of the deaths the cause is still unknown.

According to the group, the FDA documented 6,723 "adverse events" related to Gardasil in 2008, of which 1,061 were considered "serious," and 142 considered "life threatening," Judicial Watch said. The group said it obtained the data from VAERS.

Since last June, 235 cases detailed permanent disability. There were also 29 new cases of Guillain-Barre Syndrome, and 147 cases of "spontaneous abortions," or miscarriages, when the vaccine was given to pregnant women, Judicial Watch said.

Judicial Watch also documented 62 cases of Gardasil recipients who developed warts after receiving the vaccine. In additional to reports of genital warts, there were 21 reports of girls developing warts on other areas of the body, including face, hands and feet, and in one case, "all over her body."

Gardasil Fainting Warning Upgraded

Thu, 11 Jun 2009 00:00:00 -0700

The labeling for Gardasil has been updated to include more prominent warnings about fainting that can occur following administration of the vaccine. According to the Food & Drug Administration (FDA), some Gardasil fainting victims have suffered from tonic-clonic (jerking) movements and seizure-like activity, and some have fallen resulting in traumatic injuries.

Gardasil was approved by the FDA in June 2006, at which time Merck & Co. said clinical trials had shown the drug to be between 90-100 percent effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. Shortly thereafter, the U.S. Centers for Disease Control and Prevention (CDC) issued a recommendation that all young girls age of 11 and 12 receive the Gardasil vaccine. Gardasil is approved for females age nine to 26.

Gardasil has been controversial because of attempts by Merck & Co. to make it mandatory, and because of continuing questions about its safety. In January, we reported that there had been 9,749 adverse reactions and 21 reported deaths since 2006 in young girls following Gardasil vaccination with side effects that included 10 miscarriages, 78 severe outbreaks of genital warts, and six cases of Guillain-Barré syndrome, an autoimmune disorder that can result in paralysis. Side effects were reported to the FDA and CDC via the Vaccine Adverse Event Reporting System (VAERS).

According to a posting yesterday on the FDA website, roughly 13% of Gardasil side effects reported to VAERS describe fainting. In some instances, Gardasil fainting has resulted in serious injuries from falling. Such injuries often occurred while still in the healthcare provider’s office, and other fainting episodes resulted in motor vehicle accidents. Fainting has been listed as a possible side effect on the Gardasil label since 2007, but because of continued reports of this occurrence, the FDA has decided to raise the prominence of this information.

The FDA has asked Merck & Co. to move information on fainting risks to the "Warnings and Precautions" section of the Gardasil label. The revised label reminds healthcare providers that recipients of Gardasil should be closely observed for 15 minutes after vaccination. Gardasil recipients should be encouraged to remain seated or lying down for this length of time and be alert to the following warning signs and symptoms that may happen before a person faints: paleness, sweating, dizziness, ringing in ears or vision changes.

Merck Published Bogus Journal

Tue, 05 May 2009 00:00:00 -0700

TheScientist.com broke with the news that Merck & Co., the maker of controversial drugs such as the Gardasil vaccine and recalled Vioxx, paid for publication of a bogus medical journal. It seems Merck paid Elsevier to develop what TheScientist.com described as “several volumes of a publication that had the look of a peer-reviewed medical journal, but contained only reprinted or summarized articles.”

Most of the articles in the publication presented Merck products favorably, which makes it seem as if the phony journal was developed for marketing purposes without actually indicating itself as project sponsor, said TheScientist.com. "I've seen no shortage of creativity emanating from the marketing departments of drug companies," said deputy director of the public health research group at the consumer advocacy nonprofit Public Citizen, Peter Lurie. Lurie reviewed two issues of the fake journal, which was obtained by TheScientist.com and added that, "But even for someone as jaded as me, this is a new wrinkle." TheScientist noted that, other than ads for Merck’s Fosamax and Vioxx, there were minimal other advertisements.

News of the questionable, Merck-created journal started surfacing with a report by The Australian and emerged from information from a civil suit filed against Merck by a patient who suffered a heart attack while on Vioxx, said TheScientist.com. George Jelinek, an Australian physician and established member of the World Association of Medical Editors, reviewed four issues and testified at the trial, said TheScientist. Jelinek explained that the "average reader," which in this case, would be a physician, could believe the journal to be "genuine" and peer-reviewed, noting that, "Only close inspection of the journals, along with knowledge of medical journals and publishing conventions, enabled me to determine that the Journal was not, in fact, a peer reviewed medical journal, but instead a marketing publication," reported TheScientist.

Jelinek noted a good portion of the journal’s articles focused on Merck drugs with favorable verbiage. Adding to the lack of credibility, the so-called review articles contained surprisingly sparse referencing—most review articles are rife with citations and references—with a couple merely being summaries of published work with a notation they were written by "B&J Editorial," which one could infer means “Bone and Joint.” Testified Jelinek, "It appears that 'B&J' (presumably Bone and Joint) refers to the Journal, and B&J editorial presumably to the publishers or owners as there is no editor of the journal. This is a subtle attribution, and many readers may not realise that the paper was written by the owners or publishers of the journal, presuming that is who would write under the heading of 'editorial,’” quoted TheScientist.

A spokesperson for Elsevier told The Scientist, "I wish there was greater disclosure that it was a sponsored journal."

We have been writing about researchers falsifying studies linked to industry funds. A former Harvard researcher, Dr. Robert Fogel, admitted falsifying a medical study and, according to an earlier Boston.com piece, was disciplined by the Department of Health and Human Services (HHS) for faking data in a sleep apnea study funded by federal research grants. Since leaving Harvard, Fogel has been employed by Merck Research Laboratories, where he is now director of clinical research at its respiratory and allergy division in Rahway, N.J.

Legitimate medical journals have been asked to retract drug studies involving Vioxx, Celebrex, Lyrica and other drugs that were conducted by Dr. Scott S. Reuben of Baystate Medical Center; Reuben has strong ties with the pharmaceutical industry, with among others, having received funding from Merck.

Following A Girl's Death, the CDC is Finally Looking at Gardasil Links

Wed, 25 Mar 2009 00:00:00 -0700

After scores of young girls have been stricken with a variety of ailments following Gardasil injections, the U.S. Centers for Disease Control and Prevention (CDC) are looking at the possible association between the controversial injection and paralysis. Unfortunately, it took the death of a 15-year-old girl to get the agency’s attention.

We have long written about the many cases which seem to bear striking similarities to each other and follow one or more injections of the vaccine which is administered to prevent some—not all—forms of the human papillomavirus (HPV), which is linked to cervical cancer. Now, following the death of Phil Tetlock and Barbara Mellers’ daughter, Jenny—reported by U.S. News and World Report—attention is finally shifting.

U.S. News reported that Jenny died this month after developing a degenerative muscle disease when she was about 13, following a Gardasil injection. Since, her parents have been looking into the link between the disease that ultimately claimed their daughter’s life and the vaccination meant to protect her. U.S. News said Jenny likely developed a pediatric form of Lou Gehrig’s disease known as ALS or amyotrophic lateral sclerosis.

Tetlock and Mellers have reached out to two other sets of parents whose daughters also seem to have been stricken with what seems to be ALS following Gardasil injections, said U.S. News. But, despite this and the other similar cases, Gardasil’s maker—Merck—maintains that its three-shot inoculations are safe, reported U.S. News. The U.S. Food and Drug Administration (FDA) scientists, reports U.S. News, have met with Jenny’s neurologists and are looking into the possibility of a vaccine prompting ALS; the CDC plans on reviewing its adverse-event database—VAERS—for cases in which nonGardasil injections led to ALS or other neurological problems.

Meanwhile, we recently reported on 17-year-old Kirstie and her mother who were participating in an Internet forum concerning serious reactions the daughter suffered following a Gardasil injection, according to an earlier Press Republican. Kirstie received her first injection last February and then fell ill with headaches, dizziness, confusion, and lethargy. Kirstie received her second Gardasil dose last April, said Press Republican, and was not improving. Her mother, Debbie LaBombard Cook, told Press Republican, “In June, she had a grand-mal seizure, and we almost lost her. Now, she has auto-immune disease, a brain disease.” Kirstie is now being treated with 14 pills three times daily. And, there are these serious cases:

After one Gardasil injection, a 13-year-old girl was diagnosed with Acute Pancreatitis, was hospitalized for over three months, and underwent two surgeries to remove Pseudocysts. Her family filed a petition for vaccine compensation, seeking damages from the government.
A group of Australian researchers found young women there who received the drug were five to 20 times likelier to suffer rare and severe allergic reactions.
In the U.S., a 20-year-old woman suffered a stroke after receiving a second Gardasil injection.
Two women overseas died after receiving their Gardasil injections and three young women died in the U.S. days after Gardasil was administered.
A 14-year-old girl experienced debilitating headaches, fainting spells, and arthritis-like stiffness and became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure.
Following a Gardasil injection, a 16-year-old girl became ill with constant exhaustion and nausea; hair falling out in clumps, ongoing fainting episodes, numbness, and paralysis; dangerously low blood pressure; and severe back spasms that cause her to stop breathing. In her case, Gardasil was administered with a meningitis vaccine.
And Jenny, who began showing signs of a degenerative muscle disease after her third injection and who was almost completely paralyzed before her death.

Another Mother Blames Gardasil for Daughters Illness

Mon, 02 Mar 2009 00:00:00 -0800

Gardasil is in the news again. This time, a 17-year-old woman and her mother will be participating in an Internet forum concerning serious reactions the daughter suffered following a Gardasil injection, said Press Republican.

This is not the first time patients have complained about similar, serious, adverse reactions to the controversial cervical cancer injection.

After one Gardasil injection, a 13-year-old girl was diagnosed with Acute Pancreatitis, was hospitalized for over three months, and underwent two surgeries to remove Pseudocysts. Her family filed a petition for vaccine compensation, seeking damages from the government.
A group of Australian researchers found young women there who received the drug were five to 20 times likelier to suffer rare and severe allergic reactions
In the U.S., a 20-year-old woman suffered a stroke after receiving a second Gardasil injection
Two women overseas died after receiving their Gardasil injections.
Three young women died in the U.S. days after Gardasil was administered.
A 14-year-old girl experienced debilitating headaches, fainting spells, and arthritis-like stiffness and became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure.
Another 13-year-old began showing signs of a degenerative muscle disease after her third Gardasil injection; she is almost completely paralyzed.

Following a Gardasil injection, a 16-year-old girl is sick with constant exhaustion and nausea; hair falling out in clumps, ongoing fainting episodes, numbness, and paralysis; dangerously low blood pressure; and severe back spasms that cause her to stop breathing. The family is convinced the reactions are a result of Gardasil vaccinations, which in her case, were given with a meningitis vaccine.

Despite all of these claims, Merck & Co. maintains that Gardasil—the three-shot inoculations that claim to prevent some—not all—types of the human Papillomavirus (HPV)—are safe.

In this recent case, 17-year-old Kirstie receive her first injection last February and then fell ill with headaches, dizziness, confusion, and lethargy. Kirstie received her second Gardasil dose last April, said Press Republican, and was not improving. Her mother, Debbie LaBombard Cook, told Press Republican, “In June, she had a grand-mal seizure, and we almost lost her. Now, she has auto-immune disease, a brain disease.” Kirstie is now being treated with 14 pills three times daily.

According to the Centers for Disease Control (CDC), said Press Republican. Over 23 million Gardasill doses have been administered in the United States, with the CDC receiving about 12,000 reports of adverse events. While 94 percent were deemed non-serious—fainting or pain and swelling at the injection site—the remainder, which were deemed serious, were found to be random reactions since experts were unable to locate a similar pattern, said Press Republican.

Kirstie and Debbie will be participating in an audio-streamed segment on KRFC FM Public Radio in Fort Collins, Colorado, which can also be accessed via Internet at 8:00 PM Monday, reported Press Republican. "There is no test that says 100 percent that these problems are caused by Gardasil, but if enough people hear about this and share information, it might get someone's attention,” Debbie Cook told Press Republican.

Gardasil: More Adverse Reactions and Scandals

Wed, 04 Feb 2009 00:00:00 -0800

Despite Merck & Co.'s claims that Gardasil is safe, stories abound over devastating reactions to the three-shot inoculations that claim to prevent some—not all—types of the human Papillomavirus (HPV).

For instance, after just one injection a 13-year-old girl was diagnosed with Acute Pancreatitis, spent nearly 100 days in the hospital, and underwent two surgeries to remove Pseudocysts. Her family filed a petition for vaccine compensation seeking damages from the government.

A group of Australian researchers found young women there who received the drug t were five to 20 times likelier to suffer rare and severe allergic reactions. In the U.S., a 20-year-old woman suffered a stroke after receiving a second Gardasil injection. Two women overseas died after receiving their Gardasil injections and those deaths followed the deaths of three other young women who died in the U.S. days after Gardasil was administered.

A 14-year-old girl experienced debilitating headaches, fainting spells, and arthritis-like stiffness and became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure. Another 13-year-old began showing signs of a degenerative muscle disease after her third Gardasil injection; she is almost completely paralyzed.

Now, the Rocky Mountain News is reporting about a 16-year-old girl who is sick all the time with constant exhaustion and nausea; hair falling out in clumps, ongoing episodes of passing out, numbness, and paralysis; dangerously low blood pressure; and severe back spasms that cause her to stop breathing. The family is convinced the reactions are a result of Gardasil vaccinations, which in her case, were given with a meningitis vaccine.

Although industry claims the Gardasil-meningitis combination is safe, and although the combination is routinely administered, Rocky Mountain News points out that Gardasil has never been clinically tested in this combination. As a matter-of-fact, the meningitis vaccine was not available when clinical testing for Gardasil was first being conducted, so the U.S. Food and Drug Administration (FDA) agreed to test it after licensure was granted said Neal Halsey, director of the Institute for Vaccine Safety at Johns Hopkins Bloomberg School of Public Health. Those clinical results remain pending.

Worse, says Rocky Mountain News, according to the National Vaccine Information Center, Gardasil reactions increase when given with the meningitis vaccine. Also, Halsey reported that general guidelines allow for two or three inactivated vaccines—and Gardasil and the meningitis vaccinations fall into this category—to be administered conjunctively without an expectation of increased adverse events.

Merck and Co.'s Gardasil was licensed in 2006 by the FDA and both the Centers for Disease Control and Prevention (CDC) and Merck say it is safe; however, as of late summer, the federal Vaccine Adverse Event Reporting System (VAERS) logged 10,326 reports of reactions to Gardasil, according to the CDC, including reports of Guillain-Barre syndrome, a rare disorder that causes muscle weakness, blood clots, and death.

Gardasil accounted for about 20 percent of reactions reported to VAERS in 2007-2008 according to Barbara Loe Fisher, co- founder and president of the National Vaccine Information Center. “To say that … 10,000 reports of reactions, injuries, 30 deaths is all a coincidence is simply not scientifically responsible," Fisher told the Rocky Mountain News. "You have perfectly healthy girls go in and get this shot and then suffer a pattern, a very clear pattern of injury, and some of them are dying. This is not acceptable." Side effects reported involve brain inflammation; immune system dysfunction; tingling and numbness in the hands, feet and legs; severe headaches; strokes; joint pain; muscle weakness; seizures; and memory loss Fisher said.

The Vue Weekly points out that many believe over-immunization is a major contributor to the rise in autoimmune disease and parents are often pressured to immunize. But, in the case of Gardasil, perhaps avoiding the vaccine might not be so irresponsible given that, as The Vue pointed out, “the research was done by those who stand to gain magnificently” and the drug has been the focus of “an extensive public relations campaign” but “has been subjected to little independent scientific review.”

Of note, the Vue points out that the Nobel Prize Committee—which awarded the 2008 Nobel Prize in Medicine to German scientist Harald zur Hauser for his work linking HPV to cervical cancer—is facing investigation over bribery allegations for taking payments from the drug company that own the patents and collects royalties on both—U.S. and overseas—HPV vaccines. Also, said the Vue, an FDA document stated that, “identifying and typing HPV infection does not bear a direct relationship to stratification of the risk for cervical cancer. Most acute infections caused by HPV are self-limiting. It is the persistent HPV infection that may act as a tumor promoter in cancer induction ... most infections are short-lived and not associated with cervical cancer.” Perhaps the vaccine is not so critical after-all.

Gardasil Rejected for Older Women Again

Mon, 12 Jan 2009 00:00:00 -0800

Despite nearly 10,000 reports of adverse reactions, Merck is looking to expand Gardasil approval for older women. Again. According to Bloomberg News, the pharmaceutical maker is likely going to experience at least a one-year delay on its plans for such approval due to questions from the U.S. Food and Drug Administration (FDA).

Gardasil was approved by the FDA in June 2006, at which time Merck said clinical trials had shown the drug to be between 90-100 percent effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. Shortly thereafter, the U.S. Centers for Disease Control and Prevention (CDC) issued a recommendation that all young girls age of 11 and 12 receive the Gardasil vaccine. Meanwhile, there have been 9,749 adverse reactions and 21 reported deaths since 2006 in young girls following Gardasil vaccination with side effects that included 10 miscarriages, 78 severe outbreaks of genital warts, and six cases of Guillain-Barré syndrome, an autoimmune disorder that can result in paralysis. Side effects were reported to the FDA and CDC via the Vaccine Adverse Event Reporting System (VAERS). Gardasil is approved for females age nine to 26.

Now, the FDA is looking for additional information from a four-year study of Gardasil’s safety and effectiveness before considering its approval for the drug for women ages 27 to 45, reports Bloomberg. The FDA delayed an earlier request for Gardasil to be approved for use in older women following an expedited review of the drug.

In Western countries like the U.S., regular Pap test screening has greatly reduced the incidence of cervical cancer and death; however, even after vaccination, regular Pap tests are needed since Gardasil does not protect against all HPV strains known to cause the cancer. According to Tim Anderson, an analyst at Sanford Bernstein & Company, “Gardasil’s efficacy drops sharply once females have been exposed to HPV, and this is probably the genesis of the problem with the older female population that Merck has been pushing for in this new application,” reports Bloomberg.

Anderson said that this second FDA rejection presents, “yet another setback” for Merck; Gardasil is “one of Merck’s key products,” he added, noting 1.5 billion in sales in 2007, according to Bloomberg, which also noted that sales have dropped in the past two years following questions regarding Gardasil’s “cost, safety, and” efficacy. Merck stocks have fallen 53 percent in the past 12 months, said Bloomberg, which added that Merck is hoping Gardasil will enable the company to recoup some of its lowered profits due to Vytorin, Zetia, and Singulair woes. The vaccine costs about $400 to administer.

Merck plans on responding to the agency by this year’s fourth quarter, said Bloomberg, which explained that this follows Merck’s response to the FDA this summer following the FDA’s first request.

Last month, Merck applied to the FDA for approval to sell Gardasil for men claiming a 90 percent reduction in risk of genital warts and pre-cancerous lesions.

Gardasil Approval for Boys Sought

Tue, 06 Jan 2009 00:00:00 -0800

Gardasil maker Merck & Co. is officially seeking approval for use of the cervical cancer vaccine in boys. The company is also asking the U.S. Food & Drug Administration to expand the approval of Gardasil in women ages 27 to 45 years. The vaccine is currently only approved for women and young girls ages 9 to 26.

Gardasil was approved by the FDA in June 2006. At the time of its approval, Merck said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. Shortly after its approval, the U.S. Centers for Disease Control (CDC) issued a recommendation that all young girls between the ages of 11 and 12 receive the Gardasil vaccine.

But not everyone has been so enthusiastic about Gardasil, mainly over safety concerns. There have been 9,749 adverse reactions following Gardasil and 21 reported deaths since 2006. Those side effects, which were reported to the FDA and CDC via the Vaccine Adverse Event Reporting System (VAERS) included 10 miscarriages, 78 severe outbreaks of genital warts and six cases of Guillain-Barré syndrome, an autoimmune disorder that can result in paralysis.

Other questions have been raised about the cost effectiveness of HPV vaccines like Gardasil. Those concerns were explored by an article in the New England Journal of Medicine this past August. The article detailed a analysis done by Harvard researchers on the cost effectiveness of Gardasil, and another HPV vaccine called Cevarix. Cevarix, made by GlaxoSmithKline, has not been approved by the FDA yet, but is widely used in Europe.

To measure the health benefit of vaccination, the researchers looked at the cost savings from preventing cervical cancer with the vaccine and Pap tests compared with prevention via the tests alone. A treatment is typically considered cost effective if it is less than $50,000 or $100,000 for one additional year of life

The Harvard analysis predicted that it would $43,600 to extend life expectancy by one year when girls are vaccinated at 12. When girls up to age 18 are included in the analysis, that ratio rises to $97,300 and to $153,000 through age 26, the study found. That’s because vaccination is less effective after a woman is sexually active, and may have already been exposed to HPV.

In Western countries like the U.S., regular screening via Pap tests has already greatly reduced incidences of cervical cancer and deaths. But even after vaccination, regular Pap tests are necessary because the shots don’t protect against all HPV strains known to cause the cancer.

Despite questions surrounding its safety and cost-effectiveness, Merck still wants the uses of Gardasil expanded. According to The Wall Street Journal, Gardasil is a key product for Merck, which estimates sales this year of as much as $1.6 billion. But sales have slowed, down 4% in the third quarter compared to a year earlier. Merck's crusade for expanded approval may be part of a strategy to lift these sagging sales.

Parents Blame Cervical Cancer Vaccine for UK Girl's Paralysis

Mon, 15 Dec 2008 00:00:00 -0800

A British media site is reporting that a 12-year-old girl in the United Kingdom became paralyzed shortly after receiving the Cervarix cervical cancer vaccine. According to Telegraph.co.uk, the parents of Ashleigh Cave believe that Cervarix is behind their daughter’s mystery illness. In the U.S., similar problems have been reported in relation to another cervical cancer vaccine, Gardasil.

According to her parents, Ashleigh suffered headaches and dizziness just moments after receiving a Cervarix injection. She lost strength in her legs, and has spent 8 weeks in the hospital, according to Telegraph.co.uk.

According to the website, the girl was initially diagnosed with "vertigo and generalized myalgia, probably due to recent vaccinations" by doctors at Frimley Park hospital in Surrey before being admitted to Alder Hey hospital on Oct 22, where she has remained ever since.

But the European Medicines and Healthcare products Regulatory Agency insists that there is no connection between Cervarix and paralysis.

Ashleigh’s parents told Telegraph.co.uk that their daughter’s doctors now maintain that the vaccine is not to blame for her condition, but they are skeptical. "At first they tried to tell us she was imagining it because she was being bullied," Ashleigh’s mother said. "They will not mention her illness and the vaccine in the same sentence."

In the U.S., another cervical cancer vaccine - Gardasil - was approved by the U.S. Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. Shortly after its approval, the U.S. Centers for Disease Control (CDC) issued a recommendation that all young girls between the ages of 11 and 12 receive the Gardasil vaccine.

Not everyone has been so enthusiastic about Gardasil, mainly over safety concerns. There have been 9,749 adverse reactions following Gardasil and 21 reported deaths since 2006. Those side effects, which were reported to the FDA and CDC via the Vaccine Adverse Event Reporting System (VAERS) included 10 miscarriages, 78 severe outbreaks of genital warts and six cases of Guillain-Barré syndrome, an autoimmune disorder that can result in paralysis.

More Doctors Say Gardasil Shouldn't Be Mandatory

Wed, 12 Nov 2008 00:00:00 -0800

Increasingly, experts are agreeing that the government should not mandate Gardasil immunization for girls. Merck’s Gardasil was approved two years ago and is prescribed for girls aged nine-to-26 to protect against sexually transmitted diseases caused by four Human Papilloma Virus (HPV) strains responsible for 70 percent of cervical cancers and 90 percent of genital warts. Since Gardasil’s approval, the government has received over 10,000 reports of adverse events and 27 deaths reportedly linked to the controversial medication.

In the Journal of Law, Medicine & Ethics, three academics—Gail Javitt of Johns Hopkins’s Berman Institute of Bioethics, Deena Berkowitz of George Washington University School of Medicine, and Lawrence Gostin of Georgetown University Law Center—contend state and local governments should not require girls receive Gardasil vaccinations. The three cite public health and constitutional reasons saying that Gardasil does not address the same level of public health threat as existing mandates for polio, measles, and other childhood vaccinations. Because of this, they note, courts will likely not uphold the constitutionality of a mandate for vaccination against HPV. “We should be careful about adding more and more vaccine requirements when they exceed the original purpose of mandatory, school-based vaccinations,” Javitt said, recommending instead that states educate parents about the benefits “because it will allow parents to make informed decisions without coercing them.”

Controversy over Merck’s lobbying of states to require vaccination led it to cease those attempts and prompted governments to lean more toward education and funding efforts. Merck spokeswoman Amy Rose announced that Merck stopped lobbying for Gardasil school-requirements and is focused on educating policy and lawmakers looking at Gardasil use about HPV, cervical cancer, and the vaccine. “Merck’s goal is to ensure that Gardasil … is used to its fullest appropriate extent to help reduce the burden of cervical cancer and other HPV-related diseases in the United States,” Rose wrote.

Gardasil was sped through US Food and Drug Administration (FDA) approval after a brief six-month period. Critics, including scientists, have long wondered if Gardasil’s benefits are outweighed by its serious and sometimes fatal risks, saying it is only modestly effective and its safety has not been adequately proved. After just one injection a 13-year-old girl was diagnosed with Acute Pancreatitis, has spent nearly 100 days in the hospital, and underwent two surgeries to remove Pseudocysts. Her family just filed a petition for vaccine compensation seeking damages from the government. A group of Australian researchers found that young women there who received Gardasil were five to 20 times likelier to suffer rare and severe allergic reactions. In the U.S., a 20-year-old woman suffered a stroke after receiving a second Gardasil injection. Two women oversees died after receiving their Gardasil injections and those deaths followed the deaths of three other young women who died in the U.S. days after Gardasil was administered. A 14-year-old girl experienced debilitating headaches, fainting spells, and arthritis-like stiffness and became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure. Another 13-year-old began showing signs of having been stricken with a degenerative muscle disease after her third Gardasil injection; she is now almost completely paralyzed.

Merck's Marketing of Gardasil to Older Women Questioned

Mon, 20 Oct 2008 00:00:00 -0700

In an effort to boost sales of Gardasil, Merck & Co. has been marketing the controversial cervical cancer vaccine to women who may not benefit from it, according to a report on Bloomberg.com.    Merck's Gardasil marketing effort now focuses on women aged 19-26, the vast majority of whom are already sexually active, the Bloomberg article said. But most experts agree that Gardasil offers the most protection - and is most cost-effective - when administered to younger girls.

Gardasil was approved by the Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. Shortly after its approval, the Centers for Disease Control (CDC) issued a recommendation that all young girls between the ages of 11 and 12 receive the Gardasil vaccine.

Not everyone has been so enthusiastic about Gardasil, mainly over safety concerns. There have been 9,749 adverse reactions following Gardasil and 21 reported deaths since 2006.   Those side effects, which were reported to the Vaccine Adverse Event Reporting System (VAERS) included 10 miscarriages, 78 severe outbreaks of genital warts and six cases of Guillain-Barré syndrome, an autoimmune disorder that can result in paralysis.

Gardasil may also cause more allergic reactions than other vaccines. Last month, Australian researchers at the Children’s Hospital at Westmead are reported that young women in that country who received Gardasil to prevent cervical cancer were five to 20 times more likely to suffer a rare and severe allergic reaction - anaphylaxis - versus other girls who received other vaccines in comparable school-based vaccination programs.

Side-effect concerns are taking their toll, and many parents don't want their young daughters exposed to such a questionable vaccine. According to Bloomberg.com, US sales of Gardasil dropped by 33 percent this past summer. Since then, Merck shifted its marketing efforts to older women. To reach the older age group, Bloomberg.com reports that Merck is advertising on the networking Web site Facebook.com and in college bookstores and coffee shops. The company has also been selling $32 cervical-cancer awareness charm bracelets on the Internet. And, Merck is seeking FDA approval to market Gardasil to women through age 45.

But Merck's latest Gardasil marketing efforts are being questioned on some fronts, as it is unclear how much older women would benefit from the vaccine.   In August, a study in the New England Journal of Medicine questioned the cost effectiveness of such an approach. A treatment is typically considered cost effective if it costs health systems less than $50,000 or $100,000 for one additional year of life. The analysis, conducted by Harvard researchers, predicted that it would cost $43,600 to extend life expectancy by one year when girls are vaccinated at 12. But when girls up to age 18 are included in the analysis, that ratio rises to $97,300 and to $153,000 through age 26.

The American Cancer Society is on record as recommending that Gardasil vaccination efforts focus on younger girls. ``The push needs to be with the 11- to 12-year-olds,'' Debbie Saslow, director of breast and cervical cancer for the American Cancer Society, told Bloomberg.com. ``It is not going to be as effective in the older women.''

But Merck is not really interested in how effective Gardasil might be for women in the older age group. Faced with declining sales of other drugs in its product line - specifically Vytorin and Zetia - and questions about the safety of the asthma drug Singulair, its top-selling product, Merck desperately needs to prop up Gardasil sales.

One-Quarter of U.S. Girls Receive Controversial Gardasil Vaccine

Fri, 10 Oct 2008 00:00:00 -0700

Federal authorities report that about 25 percent, or one-quarter, of U.S. teenage girls have received the cervical cancer vaccine Gardasil in its first full year of distribution. The figures represent the government's first substantial study of Gardasil vaccination rates. Gardasil is Merck and Company's heavily advertised, three-shot vaccination series that targets the sexually transmitted human papillomavirus, or HPV.

Gardasil was approved by the US Food and Drug Administration (FDA) two years ago for girls aged nine-26 and protects against sexually transmitted diseases caused by four particularly dangerous HPV strains in women that are responsible for 70 percent of cervical cancers and 90 percent of genital warts. "For a new vaccine, 25 percent is really very good," Lance Rodewald, director of the division of immunization services at the Centers for Disease Control and Prevention (CDC) said. "We need to see that rate every year if we are going to meet our goal" of having 90 percent of teenagers vaccinated, he added. But immunologist W. Martin Kast, of the University of Southern California's Keck School of Medicine, said, "Twenty-five percent is not bad, but it's not good either." Last May, the U.S. Centers for Disease Control and Prevention (CDC) said Gardasil is linked with a higher risk of fainting.

The vaccine has been criticized by scientists who say it is only modestly effective and its safety has not been adequately proved; conservative groups who say that giving it to young girls implies approval of sexual activity; and consumer advocates who say its price, $360 for a series of three shots, is prohibitive. Meanwhile, we reported on a group of Australian researchers who found that young women there who received Gardasil to prevent cervical cancer were five to 20 times more likely to suffer rare and severe allergic reaction versus other girls who received other vaccines in comparable school-based vaccination programs.

In July, Gardasil was criticized for possible links to a 20-year-old woman who suffered a stroke after receiving a second Gardasil injection. In June, Merck added more possible adverse reactions to Gardasil’s growing list, including fatigue, weakness, and muscle pain. Since its approval, 18 women who received the Gardasil vaccine died; blood clots were responsible for four, according to a report released by watchdog group Judicial Watch. We reported on the deaths of two women oversees apparently linked to Gardasil and which followed the deaths of three other young women—ages 12, 19, and 22—who died in the U.S. days after Gardasil was administered. A 14-year-old girl experienced debilitating headaches, fainting spells, and arthritis-like stiffness and became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure. Recently, a 13-year-old, who was seemingly healthy 15 months prior to receiving her third Gardasil shot began showing signs of having been stricken with a degenerative muscle disease; she is now almost completely paralyzed.

U.S. News & World Report says there are other possible adverse side effects linked to Gardasil and the New York Post reports Gardasil has been associated to medical problems. Meanwhile, researchers and Merck are collecting data to consider whether boys should receive Gardasil as well.

Gardasil Immigration Rule Proving Controversial

Wed, 01 Oct 2008 00:00:00 -0700

A new rule that makes the Gardasil vaccine mandatory for young women seeking U.S. citizenship has sparked anger and protest from immigration advocates and healthcare policy experts. Immigration groups call the Gardasil rule discriminatory, and charge that it places an unfair financial burden on female immigrants. Meanwhile, policy experts see the requirement as excessive and unnecessary.

The U.S. Citizenship and Immigration Services added the Gardasil vaccination requirement in July, and it went into effect on August 1. Under a 1996 immigration law, any vaccination recommended by the U.S. government for its citizens becomes a requirement for anyone seeking permanent residency in the U.S. The Centers for Disease Control recommended Gardasil for girls ages 11 through 26 shortly after it was approved in 2006.

Anyone who applies for permanent residency must visit a U.S. - approved physician or clinic to get vaccines and undergo tests in order to receive health clearance. Of the 14 required vaccines, 13 are designed to combat infectious diseases that are transmitted by respiratory route and are considered highly contagious. But the virus Gardasil targets – HPV – is spread through sexual contact.

One public health expert told The Wall Street Journal that the Gardasil rule is not needed because of the way HPV is spread. "We don't want someone coming into the U.S. who hasn't been vaccinated against measles or chickenpox," said Dr. Abramson, chairman of the department of pediatrics at Wake Forest University School of Medicine in Winston-Salem, N.C. "HPV can only be communicated by sexual contact....This is not something that endangers kids in a school setting or puts your population at risk."

Some immigrant advocates see the Gardasil rule as a ploy to discourage legal immigration by making the process more expensive. The 3-shot Gardasil series can cost between $300 and $1,400. "What we have noticed is that applying for citizenship decreases as the fees go up," Ana Correa, executive director of the Texas Criminal Justice Coalition, told the Dallas Morning News. "I don't think it's a coincidence that they're pushing for a policy that would provide a burden on immigrants."

Others complain that the safety of Gardasil still has not been established. "Given the controversy over the vaccine's effectiveness and adverse side effects, mandating the vaccine for immigrant women is premature and is arguably equivalent to using them as test subjects," Priscilla Huang, policy and program director at the National Association of Pacific American Women's Forum, told The Wall Street Journal

Officials at the CDC say that the agency’s Gardasil recommendation was not meant to make the Gardasil vaccine mandatory for immigrants. A CDC spokesperson told The Wall Street Journal that the vaccination committee did not realized the way its Gardasil recommendation would impact immigrants.

Gardasil maker Merck & Co. – which has been aggressively lobbying states to make the vaccine mandatory for young girls - claims it had nothing to do with the immigration rule. "We were not aware of the policy and we did not lobby for this provision in any way,” a Merck spokesperson said in a statement to the Journal. However, the statement said that Merck would not engage in any efforts to address the new immigration requirement.

Gardasil Requirement for Immigrants Questioned

Thu, 18 Sep 2008 00:00:00 -0700

Since Gardasil came on the market, Merck & Co. has been pushing for it to be made mandatory for young women in the U.S. Now that has happened - at least in regards to one group of women. Nearly unnoticed, the U.S Citizenship and Naturalization Service has changed its vaccination policy, and is now requiring that immigrant girls and women, ages 11 through 26, be immunized for the Human Papillomavirus (HPV) if they want to apply for citizenship. Gardasil is the only HPV vaccine currently approved for use in the U.S.

The U.S. Citizenship and Naturalization Service added the HPV vaccination requirement in July, when it revised the Centers for Diseases Control's (CDC) Technical Instructions to Civil Surgeons for Vaccination Requirements. The Service is also requiring immigrants applying for citizenship to be vaccinated against hepatitis A, rotavirus, meningitis and chicken pox. But those are highly contagious disease, while HPV is not.

The new regulation is causing quite a bit of controversy because current U.S citizens are not required to have the Gardasil vaccine. "If the government is trying to take care of everyone, they should be doing it also with the citizens," Ginky-Lee Torres, an immigration lawyer, told a North Carolina TV station.

Even the CDC - which recommends Gardasil for girl and women ages 11 to 26 - has not advocated mandatory vaccination for anyone. Dr. Jon Abramson, chairman of the CDC's advisory committee on immunization practices said in February 2007 he opposed mandatory vaccination because sexually transmitted HPV is not a contagious disease like measles. Abramson also cited the cost of Gardasil as another reason for his opposition.

Immigrant advocates are also concerned that Gardasil's high cost would be a burden to immigrants who do not have health insurance. At $162 per shot, the 3-dose Gardasil vaccine is the most expensive vaccine on the market.

And finally, there are serious concerns about the safety of Gardasil. There have been 9,749 adverse reactions following Gardasil and 21 reported deaths since 2006. Those side effects, which were reported to the Vaccine Adverse Event Reporting System (VAERS) included 10 miscarriages, 78 severe outbreaks of genital warts and six cases of Guillain-Barré syndrome, an autoimmune disorder that can result in paralysis.

Gardasil Approved for More Cancers As Side Effect Reports

Mon, 15 Sep 2008 00:00:00 -0700

Despite growing safety concerns about Gardasil, the Food & Drug Administration (FDA) approved it to prevent two more cancers. Gardasil targets four strains of the human papillomavirus (HPV) that cause most cases of cervical cancer. Two of those HPV strains can also cause some vulvar and vaginal cancers.

Gardasil was approved by the FDA in June 2006. At the time of its approval, Merck said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. Shortly after its approval, the Centers for Disease Control (CDC) issued a recommendation that all young girls between the ages of 11 and 12 receive the Gardasil vaccine. Since the CDC recommendation, Merck has been aggressively marketing Gardasil. In at least 24 states, the company is trying to convince state legislatures to make Gardasil mandatory for young girls.

Not everyone has been so enthusiastic about Gardasil, mainly over safety concerns. There have been 9,749 adverse reactions following Gardasil and 21 reported deaths since 2006. Those side effects, which were reported to the Vaccine Adverse Event Reporting System (VAERS) included 10 miscarriages, 78 severe outbreaks of genital warts and six cases of Guillain-Barré syndrome, an autoimmune disorder that can result in paralysis.

Gardasil may also cause more allergic reactions than other vaccines. Earlier this month, Australian researchers at the Children’s Hospital at Westmead are reported that young women in that country who received Gardasil to prevent cervical cancer were five to 20 times more likely to suffer a rare and severe allergic reaction - anaphylaxis - versus other girls who received other vaccines in comparable school-based vaccination programs.

It is also not known how long the immunity from Gardasil lasts, and whether eliminating some strains of HPV will decrease the body’s own immunity to other strains. Finally, others have questioned the cost effectiveness of the expensive injections.

Still, the FDA has approved new language for the Gardasil label that states the vaccine also protects against cancers of the vagina and vulva, which affect more than 5,000 women in the U.S. each year. It was not immediately clear what the additional indication would mean for sales of the vaccine, which have fallen short of the company expectations, partly because of safety worries.

According to Forbes.com, Merck has already scaled back full-year sales estimates for Gardasil from between $1.9 billion and $2.1 billion to between $1.4 billion and $1.6 billion.

Gardasil Linked to More Allergic Reactions

Wed, 03 Sep 2008 00:00:00 -0700

Gardasil, the Merck and Co. vaccine approved to target the human papillomavirus (HPV), is again at the epicenter of controversy. Australian researchers are reporting that young women in Australia who received Gardasil to prevent cervical cancer were five to 20 times more likely to suffer rare and severe allergic reaction versus other girls who received other vaccines in comparable school-based vaccination programs. The researchers reported that the Gardasil reactions were unusual and manageable.

The researchers were led by Dr. Julia Brotherton of The Children's Hospital at Westmead and studied 114,000 young women vaccinated with Gardasil as part of a 2007 vaccination program in New South Wales. Of the girls vaccinated, 12 experienced suspected cases of anaphylaxis. Anaphylaxis is a potentially life-threatening allergic reaction that can cause difficulty breathing, nausea, and rashes. Eight of the 12 experienced “an estimated rate of reaction of 2.6 per 100,000 doses administered” as compared with “a rate of 0.1 per 100,000 doses in a 2003 school-based meningitis vaccination program.” In a commentary on the study, Dr. Neal Halsey of Johns Hopkins University in Baltimore wrote, "It's just a reminder that there are rare adverse effects. It doesn't change the strong recommendations for all adolescent girls to get this vaccine but we just have to watch them to make sure they don't have this allergic reaction," he added.

Since its approval, 18 women who received the Gardasil vaccine died; blood clots were responsible for four, according to a report released by watchdog group Judicial Watch. We reported on the deaths of two women oversees apparently linked to Gardasil and which followed the deaths of three other young women—ages 12, 19, and 22—who died in the U.S. days after Gardasil was administered. A 14-year-old girl experienced debilitating headaches, fainting spells, and arthritis-like stiffness and became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure. Recently, 13-year-old, who was seemingly healthy 15 months prior to receiving her third Gardasil shot began showing signs of having been stricken with a degenerative muscle disease; she is now almost completely paralyzed.

U.S. News & World Report says there are other possible adverse side effects linked to Gardasil and the New York Post reports Gardasil has been associated to medical problems. Meanwhile, researchers and Merck are collecting data to consider whether boys should receive Gardasil as well.

Unanswered Questions Put Moms Off Gardasil

Wed, 27 Aug 2008 00:00:00 -0700

The reluctance of some mothers to allow their young daughters to receive Gardasil has more to do with concerns over the vaccine than their attitudes toward premarital sex, a small study has found. The study, conducted at the University of Texas Medical Branch (UTMB) at Galveston, was partially funded by Merck & Co., the maker of Gardasil.

Gardasil was approved by the Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. Shortly after its approval, the Centers for Disease Control (CDC) issued a recommendation that all young girls between the ages of 11 and 12 receive the Gardasil vaccine.

Since the CDC recommendation, Merck has been aggressively marketing Gardasil. In at least 24 states, the company is trying to convince state legislatures to make Gardasil mandatory for young girls. One of those states was Texas, where mandatory Gardasil vaccination became the subject of a contentious debate in 2007. That year, Gov. Rick Perry issued an executive order that would have required schoolgirls to be inoculated with it. Eventually, however, Perry's order was overturned by the state legislature.

As the debate over Gardasil has grown louder, opponents of vaccination are often portrayed as social conservatives whose biggest concern is that girls will become sexually active once they receive it. But this new study indicates that such worries may have little to do with mothers' attitudes towards Gardasil.

The study, published in the September Journal of Adolescent Health, surveyed about 150 mothers at a UTMB pediatric clinic in 2007. The women were of mixed background, both socioeconomically and ethnically. The study found that mothers who wanted their daughters to remain virgins until marriage were just as likely to have them get Gardasil as those who didn't expect their daughters to wait until marriage to have sex.

Susan Rosenthal, a UTMB pediatric psychologist and the study's lead author, said that , "Mothers who haven't had their daughter vaccinated yet most often said they want more time to learn about the vaccine."

The moms in the survey do have a point - there are many answered Gardasil questions. For one thing, there have been 9,749 adverse reactions following Gardasil and 21 reported deaths since 2006. Those side effects, which were reported to the Vaccine Adverse Event Reporting System (VAERS) included 10 miscarriages, 78 severe outbreaks of genital warts and six cases of Guillain-Barré syndrome, an autoimmune disorder that can result in paralysis.

It is also not known how long the immunity from Gardasil lasts, and whether eliminating some strains of HPV will decrease the body’s own immunity to other strains. Finally, others have questioned the cost effectiveness of the expensive injections.

Gardasil, Cervarix Effectiveness and Cost Questioned

Thu, 21 Aug 2008 00:00:00 -0700

Two articles in the New England Journal of Medicine (NEJM) are raising more concerns about the cervical cancer vaccines, Gardasil and Cervarix. The first, an editorial, questions the widespread use of Gardasil and Ceravix, despite a lack of evidence about their effectiveness. The second article, a study that looked at the high cost of the vaccines, concludes that Gardasil and Cevarix are only cost effective if they are used in specific ways.

Gardasil, Merck & Co.'s vaccine, was approved by the Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. Shortly after its approval, the Centers for Disease Control (CDC) issued a recommendation that all young girls between the ages of 11 and 12 receive the Gardasil vaccine.

Cevarix, made by GlaxoSmithKline, has not been approved by the FDA yet, but is widely used in Europe.

In the NEJM editorial, Dr. Charlotte J. Haug writes, "Despite great expectations and promising results of clinical trials, we still lack sufficient evidence of an effective vaccine against cervical cancer." Dr. Haug contends that the uncertainty surrounding the vaccines provides reason to be cautious.

According to the editorial, Gardasil and Cevarix were studied in clinical trails for at most six and a half years. It is still not known how long the immunity will last, or whether eliminating some strains of HPV will decrease the body’s own immunity to other strains.

The other NEJM article details a Harvard analysis that explored the cost effectiveness of the vaccines. Both Gardasil and Cevarix are given as a series of three injections, and can cost as much as $1,000 to complete. In Western countries, like the U.S. and Great Britain, regular screening via Pap tests has already greatly reduced incidences of cervical cancer and deaths. But even after vaccination, regular Pap tests are necessary because the shots don't protect against all HPV strains known to cause the cancer.

To measure the health benefit of vaccination, the researchers looked at the cost savings from preventing cervical cancer with the vaccine and Pap tests compared with prevention via the tests alone. A treatment is typically considered cost effective if it is less than $50,000 or $100,000 for one additional year of life

The Harvard analysis predicted that it would $43,600 to extend life expectancy by one year when girls are vaccinated at 12. When girls up to age 18 are included in the analysis, that ratio rises to $97,300 and to $153,000 through age 26, the study found. That's because vaccination is less effective after a woman is sexually active, and may have already been exposed to HPV.

However, the analysis assumed that Gardasil and Cevarix will be effective for life - something that is as of now unknown - and that women get regular screenings to detect the first signs of cervical cancer. If the vaccine's protection against HPV stops after 10 years, the cost of vaccinating preteen girls would more than triple to $144,100 per year of life gained, the study said. In those case, the researchers said that cervical cancer prevention through Pap testing alone would make more sense from a cost standpoint.

Merck's Gardasil Push Ignored Important Questions

Wed, 20 Aug 2008 00:00:00 -0700

In the past two years, Merck & Co. has been spending big to market its Gardasil vaccine, and the effort has been paying off. Catchy television commercials urging parents to make sure their daughter is "one less" victim of cervical cancer, coupled with aggressive lobbying of women’s group, medical societies and politicians has made Gardasil one of Merck's fastest growing products. But critics of Merck say that the company's Gardasil marketing campaign has created a panic about a type of cancer that - in Western countries anyway - is preventable through other means, and ignores serious questions about the vaccine's safety and effectiveness.

Gardasil was approved by the Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. Shortly after its approval, the Centers for Disease Control (CDC) issued a recommendation that all young girls between the ages of 11 and 12 receive the Gardasil vaccine.

That's when Merck's Gardasil marketing campaign really took off. And according to a recent article in The New York Times, those efforts haven't just include catchy commercials. Hundreds of doctors across the country have been recruited and trained by Merck to give talks about Gardasil. The Times reports that those doctors can be paid as much as $4,500 for a lecture, with some making hundreds of thousands of dollars as a result of their Gardasil work. Merck has also held receptions for politicians and other officials where they are urged them to pass legislation that, among other things, would make Gardasil mandatory in many states.

Merck has seen a big payoff from these efforts. According to The New York Times, Gardasil has now been 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.

But critics of Merck say the company has overstated Gardasil's proven potential. Gardasil was only studied in clinical trials for five years. Some data from those trials indicated immunity may wane after three to five years. That means young girls immunized at 11 could have no protection by the time they enter college.

Others say Merck is exploiting fears of a type of cancer that can be easily prevented through regular Pap tests. In fact, cervical cancer has not been a major killer in western countries like the U.S. for decades. And Gardasil vaccination doesn't even eliminate the need for regular Pap tests because it doesn't protect against all forms of HPV.

Then there are the reported Gardasil side effects. According to an analysis released June 30 by the Washington, D.C.-based public interest group Judicial Watch, there have been 9,749 adverse reactions following Gardasil and 21 reported deaths since 2006.   Those side effects, which were reported to the Vaccine Adverse Event Reporting System (VAERS) included 10 miscarriages, 78 severe outbreaks of genital warts and six cases of Guillain-Barré syndrome, an autoimmune disorder that can result in paralysis. Earlier this week, Australian regulators said they were investigating three cases of pancreatitis that followed Gardasil administration.

No one can say for sure if any of these side effects are the result of Gardasil. But many believe the vaccine was not subject to enough pre-market scrutiny. According to The New York Times, the FDA expedited Gardasil's approval application, and gave it the ok in just six months. It was recommended by the CDC just weeks later.

A researcher who worked on Gardasil clinical trials told The New York Times that both the CDC and FDA acted too quickly.   Dr. Diane Harper, director of the Gynecologic Cancer Prevention Research Group at Dartmouth Medical School, said that most vaccines take three years to get such a CDC recommendation, and then 5 to 10 more for universal acceptance.

Despite her work on the vaccine's development,   Dr. Harper has been quoted in many media outlets criticizing the speed of Gardasil's approval, as well as Merck's marketing push. "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.”

Gardasil Suspected in Australian Pancreatitis Cases

Mon, 18 Aug 2008 00:00:00 -0700

Australian regulators have been investigating several cases of pancreatitis that might be linked to the cervical cancer vaccine Gardasil. In the U.S., Gardasil has been the subject of numerous side effect reports, but both the Food & Drug Administration (FDA) and its manufacturer, Merck & Co., continue to insist that the vaccine is safe.

In Australia, three women developed pancreatitis shortly after the administration of Gardasil. Acute pancreatitis is a sudden, debilitating attack of severe upper abdominal pain. Pancreatic enzymes irritate and burn the pancreas, and leak out into the abdominal cavity. Complications include respiratory, kidney or heart failure, all of which can be fatal.

One of the Australian women is still under the care of a doctor, while a second recovered after a few days. An account of a third patient's experience recently appeared in the Medical Journal Of Australia.

According to that article, the 26-year-old woman was admitted to the hospital four days after receiving her first dose of Gardasil. She presented with a fever, rash, severe pain and vomiting and was diagnosed with pancreatitis. After 10 days the symptoms settled and she was discharged from the hospital.

An extensive investigation could find no other cause for the pancreatitis and while a coincidental illness could not be ruled out, the authors of the article said that the Gardasil vaccine could not "be excluded as a potential cause". They wrote that pancreatitis should "be considered in cases of abdominal pain following HPV vaccination."

The concerns raised by the article have prompted Australia's Therapeutic Goods Administration (TGA) to investigate the potential Gardasil - pancreatitis link. The TGA will try to establish if the vaccine does pose a threat or whether the cases were mere coincidence.

According to the TGA, 3.7 million doses of Gardasil, have already been distributed in Australia and to date there have been about 1,013 reported adverse reactions. These have included soreness, swelling, redness or other reaction at the injection site, headaches, dizziness, nausea and vomiting.

In the U.S., there have been thousands of reports of side effects following Gardasil vaccination. According to an analysis released June 30 by the Washington, D.C.-based public interest group Judicial Watch, there have been 9,749 adverse reactions following Gardasil and 21 reported deaths since 2006. Those side effects, which were reported to Vaccine Adverse Event Reporting System (VAERS), included 10 miscarriages, 78 severe outbreaks of genital warts and six cases of Guillain-Barré syndrome, an autoimmune disorder that can result in paralysis.

VAERS is a voluntary system used by doctors, patients and drug companies to report side effects with vaccines to the FDA. However, a 2004 study published in the New England Journal of Medicine found that only around 10 percent of all side effects are ever reported to VAERS. So the true number of Gardasil side effects could be significantly higher.

Merck's Manufacturing Problems at Gardasil Factory May be Easing, but There Are Still Problems

Mon, 04 Aug 2008 00:00:00 -0700

Not too long ago, Merck received a Food & Drug Administration (FDA) warning letter citing good manufacturing practice violations at its vaccine operations in West Point, Pennsylvania following an inspection that cited 49 Form 483 observations. Among the products made at the plant is the cervical cancer vaccine, Gardasil. During its second-quarter earnings call, Merck reported that the FDA closed out the warning letter that claimed bulk drug substances for many of Merck’s vaccines were adulterated.

“On July 10, Merck received a letter from the FDA closing out its recent inspection at the West Point manufacturing facility. As a result, any filed sBLAs which were held up due to the inspection can now move through the agency’s normal review and approval process,” Merck CEO Dick Clark said. “Concerning supplements, we have at least two supplements with the FDA concerning Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] and they will move through the [review] process,” he said. Merck states the supplements are for expanded labeling for Gardasil and that it will respond to an FDA complete response letter for the use of the vaccine in women 27–45 years of age.

Gardasil was approved by the US Food and Drug Administration (FDA) two years ago for girls aged nine-26 and protects against sexually transmitted diseases caused by four particularly dangerous HPV strains in women that are responsible for 70 percent of cervical cancers and 90 percent of genital warts. Merck said 16 million doses have been administered since its approval. Last month, Merck added more possible adverse reactions to Gardasiil’s growing list, including fatigue, weakness, and muscle pain; however, many feel this is not enough. Merck doesn't list blood clots as a Gardasil risk, and doesn't warn of adverse reactions with other drugs.

Katherine Davison, 20, suffered a stroke after receiving a second Gardasil injection. Davison began feeling dizzy and developed flu-like symptoms; she lost feeling in the left side of her body, her left eye was drooping, her pupils were unevenly dilated, and the dizziness persisted. "Before the shot I was fine, and there is no reason I should have had a stroke," said Katherine who says she still can't sense pain or temperature on her left side, sometimes feels dizzy and tires easily, and takes seven medications daily.

Since its approval, 18 women who received the Gardasil vaccine died; blood clots were responsible for four, according to a report released last month by watchdog group Judicial Watch. We reported on the deaths of two women oversees apparently linked to Gardasil and which followed the deaths of three other young women—ages 12, 19, and 22—who died in the U.S. days after Gardasil was administered. Fourteen-year-old Katherine Kimzey experienced debilitating headaches, fainting spells, and arthritis-like stiffness and became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure. Katherine’s symptoms began soon after she received her second Gardasil shot and seemed to match many of the 5,000 reports filed through a national database. Recently, 13-year-old Jenny, who was seemingly healthy 15 months prior to receiving her third Gardasil shot began showing signs of having been stricken with a degenerative muscle disease; Jenny is now almost completely paralyzed.

Despite Deaths, Other Reactions, Feds Say Gardasil is Safe

Wed, 23 Jul 2008 00:00:00 -0700

Federal health regulators are insisting that Gardasil is safe, despite thousand of reports of adverse events related to the controversial cervical cancer vaccine. Officials at the Food & Drug Administration (FDA) and Centers for Disease Control (CDC) said they have reviewed the adverse event reports, and said that they cannot find a connection between Gardasil and the reported problems

Gardasil was approved by the U.S. Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck & Co. said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of HPV that cause cervical cancer. The approval of Gardasil was much hyped, with Merck claiming that it had the potential to eventually eliminate most cervical cancers.

Just weeks after its approval, the CDC recommended that all young girls between the ages of 11 and 12 receive the Gardasil vaccine. Merck was more than happy to echo the CDC recommendations, and actually began an intensive lobbying effort to convince state health authorities to make Gardasil vaccinations mandatory for young girls.

As of June 30, 2008, there have been 9,749 Vaccine Adverse Event Reporting System (VAERS) reports of adverse events following Gardasil vaccination. Of these, 6 percent were deemed serious. The adverse event reports included 20 deaths, as well as reports of a rare neurological condition called Guillain-Barré Syndrome.

Despite these disturbing reports, the FDA and CDC are standing by Gardasil. "There was not a common pattern to the deaths that would suggest they were caused by the vaccine," the FDA and CDC said in a statement.

Regarding other serious problems reported in relation to Gardasil, the CDC and FDA claimed the data "do not currently suggest an association" between Gardasil and the conditions.

Earlier this month, the FDA and Merck announced that the prescribing information for Gardasil was being updated to include warnings about some of the more minor reactions seen after the vaccine, including joint and muscle pain, fatigue, physical weakness and general malaise. At the time, FDA spokeswoman Karen Riley told The Washington Times that the label updates have “nothing to do with” the serious cases that have been reported. She said the updates were made at Merck’s request and touch on possible “mild” symptoms.

Meanwhile, efforts are still underway in some states to place Gardasil on the roster of vaccines that are mandatory for girls. Even one researcher who worked on Gardasil is against such a move. Dr. Diane Harper, a top expert on the HPV who, while working as a professor at Dartmouth College, served as a researcher on study trials for Gardasil. In May during with a Florida TV station, Dr. Harper criticized Merck’s efforts to make Gardasil mandatory. In the interview, Dr. Harper said that there has not been enough post-marketing surveillance of Gardasil to insure that it is free of side effects that could prove particularly dangerous to young girls. “We don’t know yet what’s going to happen when millions of doses of the vaccine have been given and to put in place a process that says you must have this vaccine, it means you must be part of a big public experiment. So we can’t do that until we have more data.” she said.

Merck is also moving ahead with plans to obtain approval to have Gardasil administered to boys.

Gardasil Injection Followed by Stroke

Mon, 21 Jul 2008 00:00:00 -0700

Gardasil, the vaccine approved to target the human papillomavirus (HPV) is being criticized again for possible links to a 20-year-old woman who suffered a stroke after receiving a second Gardasil injection. Gardasil was approved by the US Food and Drug Administration (FDA) two years ago for girls aged nine-26 and protects against sexually transmitted diseases caused by four particularly dangerous HPV strains in women that are responsible for 70 percent of cervical cancers and 90 percent of genital warts. Merck & Company—Gardasil’s maker—said 16 million doses have been administered since its approval. Last month, Merck added more possible adverse reactions to Gardasiil’s growing list, including fatigue, weakness, and muscle pain; however, many feel this is not enough.

Mary Davison daughter Katherine, 20, and her two younger sisters received their first Gardasil shots in November 2007—three shots are given over six-months—their second this January. Katherine began feeling dizzy and developed flu-like symptoms on February 1; on February 2, her family doctor gave her a phenergan shot for vomiting believed caused by the flu. On February 3, Katherine lost feeling in the left side of her body, her left eye was drooping, her pupils were unevenly dilated, and the dizziness persisted. Physicians determined she suffered a stroke, but her doctors and doctors at Johns Hopkins were unable to determine the cause. Merck doesn't list blood clots as a Gardasil risk, and doesn't warn of adverse reactions with other drugs. "Before the shot I was fine, and there is no reason I should have had a stroke," said Katherine who says she still can't sense pain or temperature on her left side, sometimes feels dizzy and tires easily, and takes seven medications daily. Mary Davison said her family doctor told her not to bring her younger two daughters in for their third shot.

Since its approval, 18 women who received the Gardasil vaccine died; blood clots were responsible for four, according to a report released last month by watchdog group Judicial Watch. We reported on the deaths of two women oversees apparently linked to Gardasil and which followed the deaths of three other young women—ages 12, 19, and 22—who died in the U.S. days after Gardasil was administered. Fourteen-year-old Katherine Kimzey experienced debilitating headaches, fainting spells, and arthritis-like stiffness and became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure. Katherine’s symptoms began soon after she received her second Gardasil shot and seemed to match many of the 5,000 reports filed through a national database. Recently, 13-year-old Jenny, who was seemingly healthy 15 months prior to receiving her third Gardasil shot began showing signs of having been stricken with a degenerative muscle diseasel; Jenny is now almost completely paralyze
d.

U.S. News & World Report says there are other possible adverse side effects linked to Gardasil and the New York Post reports Gardasil has been associated to medical problems. Meanwhile, researchers and Merck are collecting data to consider whether boys should receive Gardasil as well.

Another Girl Stricken Following Gardasil Injection

Wed, 16 Jul 2008 00:00:00 -0700

Gardasil was approved by the US Food and Drug Administration (FDA) two years ago for girls aged nine-26 and protects against sexually transmitted diseases caused by four particularly dangerous strains of HPV (Human Papillomavirus) in women that are responsible for 70 percent of cervical cancers and 90 percent of genital warts. Three shots are given over six-months. Merck & Company—Gardasil’s maker—said 16 million doses have been administered since its approval.

Now, one Northern California family is wondering if Gardisal injections have nearly paralyzed a healthy 13-year-old girl. Jenny’s story was recently highlighted on CBS News and focused on how Jenny was seemingly healthy 15 months prior to receiving her third shot of Gardasil. Following the third Gardasil injection, Jenny began showing signs of having been stricken with a degenerative muscle disease. The family says Jenny is now almost completely paralyzed and believes "there may be a link” between the paralysis and the Gardasil injection and has opened a blog in the hopes of determining if Jenny’s paralysis and Gardasil are, indeed, linked and is urging other girls with similar “post-vaccination” responses to speak out at: http://www.jenjensfamily.blogspot.com/

Merck’s response? "Based on the facts that we've received, the information does not suggest that this event was causally associated with vaccination." Also, the U.S. Centers for Disease Control and Prevention (CDC) recommends 11- and 12-year-old girls receive Gardasil as part of school vaccination efforts.

But there have been problems. Serious problems. U.S. News & World Report says there have been other possible adverse side effects linked to Gardasil and the New York Post reports that Gardasil has been associated to medical problems. We also recently reported on a 14-year-old girl named Katherine Kimzey who experienced debilitating headaches, fainting spells, and arthritis-like stiffness. She became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure. Because Katherine’s symptoms began soon after she received her second shot and symptoms seemed to match many of the 5,000 reports filed through a national database that monitors vaccine safety, Katherine’s mother, Michelle, believes the problems stem from Gardasil. "When you read everybody's stories, they're too similar not to be related," Kimzey said. CBS News stated that other reports of possible problems stemming from Gardisil have been received on the CDC and FDA's VAERS (Vaccine Adverse Event Re
porting System), on which anyone can report side affects they feel they are having to a drug or shot.

Despite the adverse reactions emerging in girls following Gardasil injections, researchers are now looking at whether Gardasil should be given to boys to prevent HPV transmission in the rarer and deadly cancers that can occur in men and Merck is collecting data to “consider whether boys should receive the inoculation as well.”

Gardasil Label Will Warn of Minor Side Effects, But Not Death or Paralysis

Thu, 10 Jul 2008 00:00:00 -0700

The labeling for Gardasil will be changed to warn of the drug's minor side effects, but will not make mention of more serious adverse reactions - including death and paralysis - reported to health officials. The Food & Drug Administration (FDA) contends that there is not enough conclusive evidence linking Gardasil to the more serious side effects to warrant their inclusion on the labeling.

According to the Centers for Disease Control (CDC), there were 7802 reports of Gardasil side effects between June 2006 and April 2008 to the Vaccine Adverse Event Reporting System (VAERS). VAERS is a national program of the CDC and the FDA that monitors the safety of vaccines after they are licensed. About 7 percent of the reported side effects were serious, including 15 deaths and 31 instances of Guillain-Barré Syndrome (GBS), a neurological condition that causes temporary paralysis.

According to The Washington Times, in June, the FDA decided to expand the possible adverse reactions to the drug to include joint and muscle pain, fatigue, physical weakness and general malaise. The new warning will be added to the package insert and to an information sheet given to patients.

But FDA spokeswoman Karen Riley told The Washington Times that the label updates have "nothing to do with" the serious cases that have been reported. She said the updates were made at Merck's request and touch on possible "mild" symptoms.

"The bottom line is that we have not seen any safety signals in the adverse events other than [fainting]," she said. "We continue to look at these reports."

However, many are not convinced and are calling on the FDA to take another look at Gardasil. Tom Fitton, president of Judicial Watch, a conservative organization that has monitored Gardasil adverse event reports, says he does not believe Merck or federal regulators are taking the side effect reports seriously. "I think we've uncovered a lot of disturbing things about Gardasil," Fitton told the Times. "All we're asking for is further investigation of its safety."

Merck Defends Gardasil

Wed, 09 Jul 2008 00:00:00 -0700

With Gardasil side effect complaints nearing 8,000, it was only a matter of time before Merck & Co. would have to respond to the controversy. Yesterday, the company issued a statement insisting that there were no safety issues with its controversial cervical cancer vaccine. It is doubtful though that Merck's reassurances will do much to quiet concerns about the potential risks of Gardasil.

Gardasil was approved by the Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck & Co. said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of Human Papillomavirus (HPV) that cause cervical cancer. The approval of Gardasil was much hyped, with Merck claiming that it had the potential to eventually eliminate most cervical cancers. Merck also claimed that Gardasil was practically side effect free.

But over the past year, concerns over the safety of the vaccine have mounted. Yesterday, the Centers for Disease Control (CDC) announced that there were 7,802 reports of Gardasil side effects between June 2006 and April 2008 to the Vaccine Adverse Event Reporting System (VAERS). About 7 percent of those reports were for serious problems. The CDC said 31 people developed Guillain-Barré Syndrome (GBS) - a neurological condition that leads to temporary paralysis - after receiving the vaccine. Another 15 patients died after receiving Gardasil.

The VAERS report was preceded by several high-profile news stories about young women who experienced paralysis after receiving Gardasil. Lawsuits against Merck are pending in two of those cases. In a third, the father of a California girl is waging a very public campaign to try to determine if Gardasil is responsible for his daughter's near-total paralysis.

So far, the CDC has not been able to determine if any of these reactions were caused by Gardasil, but the concerns are expected to take a toll on sales of the vaccine. Already, several drug industry analysts have downgraded Gardasil sales forecasts, a development that was followed by drop in the price of Merck stock.

In an attempt to stem the bleeding, Merck issued a statement saying it had analyzed relevant data relating to the side effects, and concluded the reported events could be seen in the general population, even in the absence of vaccination. So basically, the company is considering these incidents to be coincidences. The statement said Merck is still "confident in the safety profile of Gardasil".

Both the CDC and Merck said they will continue to study the Gardasil side effect reports. Still Merck is standing by Gardasil, and the CDC has not changed its recommendation that young girls be given this questionable drug.

Gardasil Side Effect Reports Near 8000

Tue, 08 Jul 2008 00:00:00 -0700

Nearly 8,000 adverse events associated with Gardasil were reported to the Centers for Disease Control (CDC) since June of 2006, further igniting concerns about the controversial vaccine's safety. While the majority of the reports involved complaints about pain and swelling at the injection site, at least 7 percent were more serious, and included reports of paralysis and deaths.

Gardasil was approved by the U.S. Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck & Co. said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of HPV that cause cervical cancer. The approval of Gardasil was much hyped, with Merck claiming that it had the potential to eventually eliminate most cervical cancers.

Just weeks after its approval, the CDC recommended that all young girls between the ages of 11 and 12 receive the Gardasil vaccine. Merck was more than happy to echo the CDC recommendations, and actually began an intensive lobbying effort to convince state health authorities to make Gardasil vaccinations mandatory for young girls.

According to the CDC, there were 7802 reports of Gardasil side effects between June 2006 and April 2008 to the Vaccine Adverse Event Reporting System (VAERS). VAERS is a national program of the CDC and the FDA that monitors the safety of vaccines after they are licensed. VAERS receives reports of adverse events that occur after people receive vaccines.

According to the CDC, VAERS received 15 reports of death following Gardasil vaccination in the US. The CDC says it has not been able to establish a link between Gardasil and 10 of the deaths. The agency did not have enough information about the remaining five to make any determination.

According to the CDC, while Gardasil was being tested in the US before it was licensed, 10 people in the group that received the HPV vaccine and 7 people in the placebo group died during the trials. None of the deaths was considered vaccine-related.

VAERS also received 31 reports of Guillain-Barré Syndrome (GBS), an illness that leads to temporary, but often total body paralysis, after Gardasil vaccination in the US. Ten of those cases have been confirmed, five of which occurred when Gardasil was administered with another vaccine.

In a statement, Merck insisted that an adverse event report "does not mean that a causal relationship between an event and vaccination has been established -- just that the event occurred after vaccination." Merck said it would continue to evaluate reports of adverse reactions. It said it "updates product labels with new safety information as appropriate."

Gardasil Associated with Paralysis

Mon, 07 Jul 2008 00:00:00 -0700

Gardasil has been implicated in the paralysis of a 13-year-old girl who developed a degenerative muscle disease shortly after receiving the vaccine. Meanwhile, Merck, the maker of Gardasil, has been named in two lawsuits that allege the vaccine caused paralysis in two other girls.

Gardasil was approved by the Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck & Co. said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of Human Papillomavirus (HPV) that cause cervical cancer. The approval of Gardasil was much hyped, with Merck claiming that it had the potential to eventually eliminate most cervical cancers.

Recently, the FDA refused to approve the use of Gardasil in women ages 27-45, but Merck is working to convince the agency to approve it for boys.

Merck claims Gardasil is practically side-effect free. But reports in the last year have contradicted those claims. A 2007 analysis by Judicial Watch of Gardasil adverse event reports revealed that there had been at least 3,461 complaints of adverse reactions to the Gardasil vaccine. Since the Judicial Watch report, more Gardasil adverse events have been reported to the FDA. Those reports now total 8,000 and include nausea, vomiting, seizures, paralysis, autoimmune disorders and 18 deaths which are under investigation due to the timing between the receipt of the vaccine and the young women's deaths.

According to a recent article in US News and World Report, 13-year-old Jenny Tetlock began experiencing muscle weakness about a month after receiving Gardasil. Within 15 months, the California native was almost completely paralyzed. Both Merck and the FDA have dismissed suggestions that Jenny's condition is related to Gardasil.

But the girl's father, a psychology professor at UC-Berkley, is not convinced that Gardasil did not play some role in his daughter's illness. According to US News, Philip Tetlock believes Jenny may carry genes that predisposed her to problems with the Gardasil vaccine. At age 10, Jenny developed a rare skin disease called pityriasis lichenoides that's thought to be triggered by an overactive immune system, and her grandmother died of a nervous system disease.

At least two other girls have experienced paralysis after being administered Gardasil, and both have filed suit against Merck. According to her lawsuit, Jessica Parsons, 15, has been ill and in and out of the hospital since she received Gardasil. Her lower arms and legs were paralyzed as a result, but she is now learning to walk again.

Brittany LeClaire, 13, alleges that she suffered paralysis as well within days of receiving her last dose of Gardasil. She began having severe headaches and lethargy immediately after the injections, and then developed paralysis in her left leg. Following weeks of having to use a walker, Brittany still walks with a limp.

Unfortunately, Gardasil has not been subjected to enough testing to insure its safety. Even one of the researchers who worked on this vaccine has made this argument. In May, Dr. Diane Harper, a top expert on the HPV who, while working as a professor at Dartmouth College, served as a researcher on study trials for Gardasil, questioned efforts to make the vaccine mandatory.

In an interview with a Florida TV station, Dr. Harper said that there has not been enough post-marketing surveillance of Gardasil to insure that it is free of side effects that could prove particularly dangerous to young girls. “We don’t know yet what’s going to happen when millions of doses of the vaccine have been given and to put in place a process that says you must have this vaccine, it means you must be part of a big public experiment. So we can’t do that until we have more data.” she said.

Gardasil Not Approved for Older Women

Thu, 26 Jun 2008 00:00:00 -0700

Merck & Co. has failed in its quest to convince federal regulators to expand approval of Gardasil for older women. Yesterday, the Food & Drug Administration (FDA) said it was delaying its approval of Merck's application at this time because it had questions regarding Gardasil's effectiveness in women ages 27 - 45. Gardasil is already approved for use in girls and women ages 9 - 26.

Gardasil was approved by the Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck & Co. said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of Human Papillomavirus (HPV) that cause cervical cancer. The approval of Gardasil was much hyped, with Merck claiming that it had the potential to eventually eliminate most cervical cancers.

Merck has been working on expanding the approved uses of Gardasil in an effort to spur sales growth. But in a letter to the company, the FDA said there were questions that Merck will need to answer before the agency can complete its review. Merck would not specify what those questions were, but said it would reply to the FDA's letter next month.

Some experts have questioned the wisdom of approving Gardasil for the older group, because most women in that age group who are sexually active have already been exposed to the strains of HPV Gardasil is supposed to prevent.

Merck said it also failed to win FDA approval to expand Gardasil to protect against more strains of HPV, and is dropping those efforts. However, the company still plans to work to gain approval for Gardasil to be administered to boys.

Gardasil has been the subject of controversy ever since Merck introduced it. Just weeks after its approval, the Centers for Disease Control (CDC) recommended that all young girls between the ages of 11 and 12 receive the Gardasil vaccine. Merck was more than happy to echo the CDC recommendations, and actually began an intensive lobbying effort to convince state health authorities to make Gardasil vaccinations mandatory for young girls. Merck has made similar efforts in Europe. Merck’s heavy promotion of Gardasil has been effective, as some analysts estimate that Gardasil could net the company as much as $1.4 billion in its first full year on the market.

But many have questioned Merck's heavy-handed attempts to make Gardasil mandatory, as well as the company's claims that it is virtually side effect free. Earlier this month, the European Medicines Agency reported that two young women died shortly after being administered Gardasil, and three such deaths have been reported in the US.

A 2007 analysis by Judicial Watch of Gardasil adverse event reports revealed that there had been at least 3,461 complaints of adverse reactions to the Gardasil vaccine, and there could have been as many as eight deaths attributable to Gardasil. According to Judicial Watch, in several instances, blood clots were reported to have occurred after the administration of Gardasil. The Gardasil side effect reports also included 28 women who miscarried after receiving Gardasil. Other side effects reported to the FDA included paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures were also reported. Oddly, Judicial Watch was only able to obtain the FDA’s reports on Gardasil after it filed a Freedom of Information Act request with the agency.

As some have pointed out, Judicial Watch is a conservative organization with an agenda. But Judicial Watch is not along in voicing concerns about the safety of Gardasil. In May, Dr. Diane Harper, a top expert on the HPV who, while working as a professor at Dartmouth College, served as a researcher on study trials for Gardasil, questioned efforts to make the vaccine mandatory. In an interview with a Florida TV station, Dr. Harper said that there has not been enough post-marketing surveillance of Gardasil to insure that it is free of side effects that could prove particularly dangerous to young girls. “We don’t know yet what’s going to happen when millions of doses of the vaccine have been given and to put in place a process that says you must have this vaccine, it means you must be part of a big public experiment. So we can’t do that until we have more data.” she said.

Despite Serious Reactions in Girls, Merck Looking at Gardasil for Boys

Tue, 17 Jun 2008 00:00:00 -0700

Merck & Co., the maker of the Gardasil cervical cancer vaccine, has boys in its crosshairs. Merck already heavily promotes - and some say forces - the use of Gardasil for young girls. Now Merck is conducting research to see if Gardasil could also be administered to boys. But not everyone is convinced that giving Gardasil to girls or boys is a good idea, because the vaccine has been tied to a number of side effects, and even fatalities.

The American Social Health Association reports that over half of all people will suffer from a sexually transmitted disease or infection at some point in their lives. The human papillomavirus, or HPV, is one of the least noticeable, but potentially most life-threatening of such infections. Worse, most HPV carriers are never diagnosed and never realize they carry the virus. HPV is the leading cause of cervical cancer and has become the second-leading cause of cancer death for women worldwide.

"It's never detected, they are never aware of it, and their immune system suppresses it before they ever know about it in the vast majority of cases," said Fred Wyand, spokesman for the American Social Health Association.

Researchers are now looking at whether Gardasil should be given to boys to prevent HPV transmission in the rarer and deadly cancers that can occur in men. "There is probably no reason to think it would not be effective in boys and because HPV is passed back and forth, immunizing a large part of the population would limit transmission," said Dr. Jonathan L. Temte, associate professor in the Department of Family Medicine at the University of Wisconsin School of Medicine and Public Health. Although men don't risk cervical cancer, they are half of the equation when it comes to sexually transmitted diseases and are at increased risks for throat, genital, and anal cancers from HPV infection. The maker of Gardasil, Merck & Co., is collecting data to “consider whether boys should receive the inoculation as well.”

Gardasil was approved by the FDA two years ago for girls aged 9-26 and protects against sexually transmitted diseases caused by four particularly dangerous strains of HPV in women that are responsible for 70 percent of cervical cancers and 90 percent of genital warts. Three shots are given over six-months. Merck said 16 million doses have been administered since its approval.

The U.S. Centers for Disease Control and Prevention recommends 11- and 12-year-old girls receive Gardasil as part of school vaccination efforts. But there have been serious problems. A 14-year-old girl named Katherine Kimzey experienced debilitating headaches, fainting spells, and arthritis-like stiffness. She became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure. Because Katherine’s symptoms began soon after she received her second shot and symptoms seemed to match many of the 5,000 reports filed through a national database that monitors vaccine safety, Katherine’s mother, Michelle, believes the problems stem from Gardasil. "When you read everybody's stories, they're too similar not to be related," Kimzey said.

In January, we reported on the deaths of two young women oversees that were apparently linked to Gardasil. Those deaths followed the deaths of three other young women—ages 12, 19, and 22—who died in the U.S. days after Gardasil was administered, with 1,700 other patients suffering adverse reactions. Last week, European regulators reported two more Gardasil linked deaths.

Two Die Following Gardasil Shots

Thu, 12 Jun 2008 00:00:00 -0700

Gardasil has been implicated in the deaths of two more young women, the European Medicines Agency (EMEA) has reported. Though no official cause of death has been listed, the young women apparently died shortly after receiving Gardasil, and the EMEA is characterizing their deaths as "sudden and unexpected."

The two deaths bring the total number of fatalities possibly linked to the Merck cervical cancer vaccine to five. In the U.S., three young women have reportedly died after receiving Gardasil. However, there could be more such incidents, as health officials believe that adverse effects of medication are widely underreported.

Gardasil was approved by the U.S. Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck & Co. said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of HPV that cause cervical cancer. The approval of Gardasil was much hyped, with Merck claiming that it had the potential to eventually eliminate most cervical cancers.

Just weeks after its approval, the U.S. Centers for Disease Control (CDC) recommended that all young girls between the ages of 11 and 12 receive the Gardasil vaccine. Merck was more than happy to echo the CDC recommendations, and actually began an intensive lobbying effort to convince state health authorities to make Gardasil vaccinations mandatory for young girls. Merck has made similar efforts in Europe. Merck’s heavy promotion of Gardasil has been effective, as some analysts estimate that Gardasil could net the company as much as $1.4 billion in its first full year on the market.

But Gardasil may not be as safe as Merck claims. A 2007 analysis by Judicial Watch of Gardasil adverse event reports revealed that there had been at least 3,461 complaints of adverse reactions to the Gardasil vaccine, and there could have been as many as eight deaths attributable to Gardasil. According to Judicial Watch, in several instances, blood clots were reported to have occurred after the administration of Gardasil. The Gardasil side effect reports also included 28 women who miscarried after receiving Gardasil. Other side effects reported to the FDA included paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures were also reported. Oddly, Judicial Watch was only able to obtain the FDA’s reports on Gardasil after it filed a Freedom of Information Act request with the agency. As some have pointed out, Judicial Watch is a conservative organization with an agenda. But Judicial Watch did not fabricate these adverse event reports, and the seriousness of some of them indicate a need for further investigation.

In May, Dr. Diane Harper, a top expert on the HPV who, while working as a professor at Dartmouth College, served as a researcher on study trials for Gardasil, questioned efforts to make the vaccine mandatory. In an interview with a Florida TV station, Dr. Harper said that there has not been enough post-marketing surveillance of Gardasil to insure that it is free of side effects that could prove particularly dangerous to young girls. “We don’t know yet what’s going to happen when millions of doses of the vaccine have been given and to put in place a process that says you must have this vaccine, it means you must be part of a big public experiment. So we can’t do that until we have more data.” she said.

Gardasil Side Effects Still Being Reported

Fri, 06 Jun 2008 00:00:00 -0700

Garadsil, Merck's controversial cervical cancer vaccine, has been the subject of numerous side effects. In one case, a 14-year-old woman named Katherine Kimzey, began experiencing debilitating headaches, fainting spells, and arthritis-like stiffness. She became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure. Because Katherine’s symptoms began soon after she received her second shot and symptoms seemed to match many of the 5,000 reports filed through a national database that monitors vaccine safety, Katherine’s mother, Michelle, believes the problems stem from Gardasil. "When you read everybody's stories, they're too similar not to be related," Kimzey said.

Despite such anecdotes, officials with the Centers for Disease Control and Prevention (CDC) and doctors nationwide argue that concerns over the vaccine to prevent against cervical cancer—Gardasil—are unfounded and the significant side effects being reported are not related to Gardasil. "The safety of the vaccine is being very closely monitored," said John Iskander, acting director for immunization safety at the CDC, which runs the database along with the Food and Drug Administration (FDA).

“There certainly have been high-profile suspected side effects, some reports of deaths," Iskander said, "but those have been investigated and they don't appear to have been causally related."

In January, we reported on the deaths of two young women oversees that were apparently linked to Gardasil. Those deaths followed the deaths of three other young women—ages 12, 19, and 22—who died in the U.S. days after Gardasil was administered, with 1,700 other patients suffering adverse reactions.

But, Iskander maintains the recommendations have not changed and the vaccine will remain available. Jennifer Allen, a spokeswoman for New Jersey-based Merck & Co.'s vaccine division, which makes Gardasil, said the company conducted clinical trials for 10 years and it remains confident in its product.

Gardasil was approved by the FDA two years ago for girls aged 9-26 and protects against sexually transmitted diseases caused by the human papillomavirus, or HPV, responsible for 70 percent of cervical cancers and 90 percent of genital warts. Three shots are given over a six-month period. Merck said 16 million doses have been administered since its approval.

Texas Governor Rick Perry issued an executive order last year requiring all sixth-grade girls get the shot; however, parents and conservative groups fought the mandate and the Legislature defeated the order. The National Vaccine Information Center agreed, saying vaccine testing was not sufficient in girls under 12 and warned of adverse reactions such as extreme fatigue, arthritis, and loss of consciousness. Co-founder and president, Barbara Loe Fisher, said she's frustrated the CDC "assumed safety" for Gardasil, which has been tested only with the Hepatitis B vaccine. Girls often receive Gardasil with a meningitis vaccine and a tetanus, diphtheria, and pertussis booster.

The FDA approved the vaccines separately, but studies on administering them together continue. "Not only was Gardasil put on the fast track and licensed quickly," said Fisher, "but to say safety is assumed and you can give any vaccine with it is even more shocking." The Texas Department of Health and Human Services said it had 210 reports of Gardasil reactions last year, eight required hospitalization.

Merck's Gardasil Claims Questioned

Tue, 13 May 2008 00:00:00 -0700

Gardasil, the controversial cervical cancer vaccine developed and marketed by Merck & Co., has been hyped as a means to eliminate almost all types of cervical cancer. Merck has been so aggressive in its campaign to encourage Gardasil vaccination that roughly 20 states are considering making the vaccine mandatory for young girls. But a new report at foodconsumer.org is questioning many of the claims Merck is making about Gardasil, as well as the company's efforts to force the vaccine on young girls.

Gardasil was approved by the Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck & Co. said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of Human Papillomavirus (HPV) that cause cervical cancer. Merck said that would have the effect of eliminating most cervical cancers. But the foodconsumer.org report takes issue with those claims. According to the article, Gardasil was only tested against pre-cancerous lesions, which potentially lead to cervical cancer, but not cervical cancer. Thus, Gardasil trial results offered no direct evidence to prove the vaccine is effective in preventing cervical cancer. What's more, the Gardasil clinical trials were conducted for a short term only. No one knows if a Gardasil booster is needed after 5, 10, or 20 years.

Merck has also claimed that Gardasil is virtually side-effect free, with pain and swelling at the injection site the most common reactions. But according to foodconsumer.org, by October, 2007, the US government had received 3,461 reports of side and adverse effects including 11 cases in which women died after receiving Gardasil. Despite such reports, the FDA has no intention of conducting a safety review for Gardasil.

The foodconsumer.org article also criticizes Merck for its efforts to make Gardasil mandatory for girls ages 11 and 12. For one thing, the report claims Gardasil clinical trials did not include a large enough number of girls age 11 and 12 for whom the vaccine is recommended. Because of this, the trial results including efficacy and safety may not be applicable to the age group of girls.

Those concerns echo others raised by Dr. Diane Harper, a top expert on the HPV who, while working as a professor at Dartmouth College, served as a researcher on study trials for Gardasil. Last week in an interview with a Florida TV station, Dr. Harper criticized Merck's efforts to make Gardasil mandatory. In the interview, Dr. Harper said that there has not been enough post-marketing surveillance of Gardasil to insure that it is free of side effects that could prove particularly dangerous to young girls. “We don’t know yet what’s going to happen when millions of doses of the vaccine have been given and to put in place a process that says you must have this vaccine, it means you must be part of a big public experiment. So we can’t do that until we have more data.” she said.

Gardasil Researcher Criticizes Moves to Make HPV Vaccine Mandatory

Thu, 08 May 2008 00:00:00 -0700

A scientist who helped Merck & Co. conduct clinical trials for the cervical cancer vaccine Gardasil is questioning efforts to mandate the controversial vaccine for young girls, whether their parents want them to have it or not. Dr. Diane Harper, a top expert on the Human Papillomavirus (HPV), says Merck's aggressive campaign to convince states to adopt mandatory Gardasil vaccine guidelines enters into a "real danger zone."

Gardasil was approved by the Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck & Co. said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of HPV that cause cervical cancer. The approval of Gardasil was much hyped, with Merck claiming that it had the potential to eventually eliminate most cervical cancers.

Just weeks after its approval, the Centers for Disease Control (CDC) recommended that all young girls between the ages of 11 and 12 receive the Gardasil vaccine. Merck was more than happy to echo the CDC recommendations, and actually began an intensive lobbying effort to convince state health authorities to make Gardasil vaccinations mandatory for young girls. Merck’s heavy promotion of Gardasil has been effective, as some analysts estimate that Gardasil could net the company as much as $1.4 billion in its first full year on the market.

Dr. Harper, who has dedicated two decades of her career to research on HPV, told Florida TV station WFOR-TV that the rush to recommend and mandate the vaccination of very young girls "went too fast without any breaks." Dr. Harper says that there has not been enough post-marketing surveillance of Gardasil to insure that it is free of side effects that could prove particularly dangerous to young girls. "We don't know yet what's going to happen when millions of doses of the vaccine have been given and to put in place a process that says you must have this vaccine, it means you must be part of a big public experiment. So we can't do that until we have more data." Dr. Harper said.

Dr. Harper's concerns are well-founded as the FDA has received reports of possible reactions to Gardasil. A 2007 analysis by Judicial Watch of Gardasil adverse event reports revealed that there had been at least 3,461 complaints of adverse reactions to the Gardasil vaccine, and there could have been as many as eight deaths attributable to Gardasil. According to Judicial Watch, in several instances, blood clots were reported to have occurred after the administration of Gardasil. The Gardasil side effect reports also included 28 women who miscarried after receiving Gardasil. Other side effects reported to the FDA included paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures were also reported. As some have pointed out, Judicial Watch is a conservative organization with an agenda. But Judicial Watch did not fabricate these adverse event reports, and the seriousness of some of them indicate a need for further investigation.

While working as a professor at Dartmouth College Dr. Harper served as a researcher on study trials for Gardasil and another HPV vaccine, Cervarix, which is being developed by GlaxoSmithKline. In fact, she is the lead author on two Cervarix papers. While Dr. Harper said says she is convinced HPV vaccines can help prevent cancers in the long run, she believes that parents and women should have a choice. Dr. Harper said she would also be opposed to any measure to make Cervarix mandatory if it receives FDA approval.

Merck Gardasil Vaccine Plant Cited In FDA Warning Letter

Thu, 01 May 2008 00:00:00 -0700

Merck & Co. has received a warning letter from the Food & Drug Administration (FDA) regarding conditions at the plant where the company makes the cervical cancer vaccine Gardasil, along with several children's vaccines. Late last year, Merck issued a recall for 1.2 million doses of some pediatric vaccines made at the West Point, Pennsylvania plant cited in the warning letter.

Last week, The Philadelphia Inquirer reported that an FDA inspection of the Merck vaccine plant had uncovered 45 areas of concern, including contaminated packaging of children’s vaccines, unwanted fibers on vaccine vial stoppers, failure to follow good management practices, and contamination of bulk vaccine lots. An FDA spokesperson told The Philadelphia Inquirer that the agency sent the letter, dated April 28, because it did not believe the company was moving fast enough to correct past problems.

FDA inspectors spent a total of 30 days at the West Point plant between Nov. 26, 2007, and Jan. 17, 2008. The warning letter said the company had failed to ensure that equipment for manufacturing and processing was "calibrated, inspected or checked according to a written program designed to assure proper performance." The letter also said that in the course of making vaccines, "failures are not fully investigated and documented".

The FDA specifically cited unwanted fibers that were showing up on vial stoppers for such vaccines as MMR, or measles, mumps and rubella. These stoppers are placed in special bags for sterilization. The FDA said the company was using "lesser quality" bags that were breaking down slightly and producing the fibers. The FDA cited Merck for only discarding vaccines where the fibers were found. The company should have assessed all potentially affected products, the FDA said.

In December, Merck recalled over 1.2 million doses of defective vaccines—11 lots of PedvaxHIB vaccine and two lots of Comvax vaccine—when quality control checks revealed production equipment might not have been properly sterilized. Merck also quarantined a nearly one-year supply of other potentially suspect doses. Vaccines involved protect against Hib—or Haemophilus influenzae type b—disease and other conditions; Comvax also prevents against hepatitis B. The vaccines were distributed beginning April 2007 and all but one lot was distributed in the United States. Merck supplies about half the 14 million doses of Hib vaccine used in the U.S. annually. FDA inspectors visited the Montgomery County plant on 30 separate occasions from November through January.

The Merck plant also makes Gardasil, the controversial cervical cancer vaccine. A 2007 analysis by Judicial Watch of Gardasil adverse event reports revealed that there had been at least 3,461 complaints of adverse reactions to the Gardasil vaccine, and there could have been as many as eight deaths attributable to Gardasil. According to Judicial Watch, in several instances, blood clots were reported to have occurred after the administration of Gardasil. The Gardasil side effect reports also included 28 women who miscarried after receiving Gardasil. Other side effects reported to the FDA included paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures were also reported. Despite such reports, Merck has made aggressive efforts to convince state legislatures to make Gardasil mandatory for young girls.

In a posting on its website, the FDA said it "does not believe that the issues identified will affect the safety of the vaccines manufactured by Merck." The FDA also said it did not expect the deficiencies to affect availability of the firm's vaccines, except for the recalled PedvaxHIB and COMVAX vaccines. The FDA has given Merck 15 working days to correct the violations cited in the warning letter.

Efforts to Make Gardasil Mandatory Stall in Some States

Thu, 24 Apr 2008 00:00:00 -0700

Merck Inc.'s efforts to make the controversial Gardasil vaccine mandatory for young girls has hit a roadblock in one state. In February, the Massachusetts State Senate sent a Gardasil bill “to study,” making it unlikely that a vote on the proposed legislation will occur in the 2008 legislative session.

Gardasil, approved by the Food & Drug Administration (FDA) in 2006 is meant to protect against several forms of the Human Papillomavirus (HPV) that cause cervical cancer. The vaccine has been much hyped, and Merck has waged an aggressive campaign to convince state legislatures to make it mandatory for girls before they are likely to become sexually active. Recently, 20 states pushed for federal mandates to make Gardasil mandatory for sixth grade girls.

But many parents are opposed to making the vaccine mandatory, and in some states, like Massachusetts, the efforts have stalled. Some parents are opposed to mandatory vaccination on moral grounds, believing that vaccinating their daughters against a sexually transmitted disease sends the message that sexual activity at such a young age, or even prior to marriage, is acceptable. Others simply believe that the government has no right to usurp parental authority by mandating a vaccine for a disease that is not spread through casual contact. Still others worry that Gardasil is too new, and hasn't been subjected to enough scrutiny. They fear harmful Gardasil side effects may not become apparent for several years, and would like to wait before subjecting their daughters to the vaccine.

When it was approved, Merck said that Gardasil was virtually side effect free. But some dispute this, and point to adverse events reported to the FDA that seem to be associated with the administration of Gardasil. Supporters of Gardasil argue that it has not been proven that the vaccine had anything to do with any of the reported side effects. But vaccine critics say a link has not been disproved either, and argue that the existence of the reports warrants further study of the vaccine's safety.

A 2007 analysis by Judicial Watch of Gardasil adverse event reports revealed that there had been at least 3,461 complaints of adverse reactions to the Gardasil vaccine, and there could have been as many as eight deaths attributable to Gardasil. According to Judicial Watch, in several instances, blood clots were reported to have occurred after the administration of Gardasil. The Gardasil side effect reports also included 28 women who miscarried after receiving Gardasil. Other side effects reported to the FDA included paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures were also reported. Oddly, Judicial Watch was only able to obtain the FDA’s reports on Gardasil after it filed a Freedom of Information Act request with the agency. As some have pointed out, Judicial Watch is a conservative organization with an agenda. But Judicial Watch did not fabricate these adverse event reports, and the seriousness of some of them indicate a need for further investigation.

There have also been a handful of deaths that occurred following the administration of Gardasil. Three young women in the US died shortly after receiving Gardasil, while two other women in Europe also died after the vaccine was administered. Despite all of these reports, Merck continues to market Gardasil as virtually side-effect free. Thus far, the FDA has refused to conduct a formal safety review of Gardasil.

The Gardasil controversy won't go away anytime soon, especially if the FDA continues to reject calls for more studies on Gardasil side effects. Right now, the only recourse is for parents opposed to mandatory Gardasil vaccination to make sure lawmakers know how they feel. With so much uncertainty about Gardasil side effects, the decision whether to vaccinate or not should be left with parents.

FDA to Rush Expanded Approval of Gardasil

Thu, 20 Mar 2008 00:00:00 -0700

Gardasil, Merck's cervical cancer vaccine, could soon be approved for use in women ages 27 through 45. The Food and Drug Administration (FDA) has agreed to put Merck's application for expanded approval of Gardasil - already approved for women and girls ages 9 through 26 - on the fast track. The FDA decision to grant Merck's Gardasil application priority review will surely disturb many who are concerned over the high number of side effects reported in relationship to Gardasil, and who object to Merck's heavy handed attempts to convince state legislatures to make Gardasil mandatory for young girls.

At the time of its approval, Merck said that clinical trials had proven Gardasil to be between 90-100% effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. But Gardasil is not without risks that, some say those risks have been downplayed by Merck and the FDA. A 2007 analysis by Judicial Watch of Gardasil adverse event reports revealed that there had been at least 3,461 complaints of adverse reactions to the Gardasil vaccine, and there could have been as many as eight deaths attributable to Gardasil. Oddly, Judicial Watch was only able to obtain the FDA’s reports on Gardasil after it filed a Freedom of Information Act request with the agency.

According to Judicial Watch, in several instances, blood clots were reported to have occurred after the administration of Gardasil. The Gardasil side effect reports also included 28 women who miscarried after receiving Gardasil. Other side effects reported to the FDA included paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures were also reported. There have also been a handful of deaths that occurred following the administration of Gardasil. Three young women in the US died shortly after receiving Gardasil, while two other women in Europe also died after the vaccine was administered. Despite all of these reports, Merck continues to market Gardasil as virtually side-effect free. Thus far, the FDA has refused to conduct a formal safety review of Gardasil.

Now, the FDA has agreed to speed up its review of Merck's application to expand marketing of its Gardasil cervical cancer vaccine to women aged 27 through 45. The designation means that the FDA is expected to make its decision on the marketing application within 6 months, rather than within the agency's typical 10-month review period.

Gardasil has been the subject of controversy, not just because of possible side effects associated with it, but also because of Merck's extremely aggressive campaign to make Gardasil mandatory for young girls. Following its approval, the Centers for Disease Control recommended that all young girls between the ages of 11 and 12 receive the Gardasil vaccine. Merck was more than happy to echo these recommendations, and actually began an intensive lobbying effort to convince state health authorities to make Gardasil vaccinations mandatory for young girls. Recently, 20 states pushed for federal mandates to make Gardasil mandatory for sixth grade girls.

This strategy has worked well for Merck. Gardasil had fourth-quarter global sales of $339 million, helping to drive Merck's total global revenue from vaccines to $1.1 billion.

Gardasil Vaccine Side Effects Reason for Concern

Mon, 03 Mar 2008 00:00:00 -0800

Gardasil, the HPV vaccine marketed by Merck has been the subject of controversy ever since it was approved by the Food & Drug Administration (FDA) in 2006. While some conservative groups oppose Gardasil for philosophical and moral reasons, other patient advocates are disturbed by Gardasil side effect reports and the aggressive campaign Merck has waged to make the vaccine mandatory for girls in the US.

At the time of its approval, Merck & Co., the maker of Gardasil, said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. The approval of Gardasil was much hyped, with Merck claiming that it had the potential to eventually eliminate most cervical cancers. Merck also claimed that Gardasil was practically side effect free.

The claims of few Gardasil side effects, however, are not borne out by the FDA's own statistics. A 2007 analysis by Judicial Watch of Gardasil adverse event reports revealed that there had been at least 3,461 complaints of adverse reactions to the Gardasil vaccine, and there could have been as many as eight deaths attributable to Gardasil. According to Judicial Watch, in several instances, blood clots were reported to have occurred after the administration of Gardasil. The Gardasil side effect reports also included 28 women who miscarried after receiving Gardasil. Other side effects reported to the FDA included paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures were also reported. Oddly, Judicial Watch was only able to obtain the FDA’s reports on Gardasil after it filed a Freedom of Information Act request with the agency. While Judicial Watch does promote a conservative agenda, it's findings on Gardasil are still cause for concern.

There have also been a handful of deaths that occurred following the administration of Gardasil. Three young women in the US died shortly after receiving Gardasil, while two other women in Europe also died after the vaccine was administered. Despite all of these reports, Merck continues to market Gardasil as virtually side-effect free. Thus far, the FDA has refused to conduct a formal safety review of Gardasil.

But Merck has done more than simply market Gardasil. The company has waged an extremely aggressive campaign to make Gardasil mandatory for young girls. Following its approval, the Centers for Disease Control recommended that all young girls between the ages of 11 and 12 receive the Gardasil vaccine. Merck was more than happy to echo the CDC recommendations, and actually began an intensive lobbying effort to convince state health authorities to make Gardasil vaccinations mandatory for young girls. Recently, 20 states pushed for federal mandates to make Gardasil mandatory for sixth grade girls.

Merck’s heavy promotion of Gardasil has been effective, as some analysts estimate that Gardasil could net the company as much as $1.4 billion in its first full year on the market.

Gardasil A Prime Suspect in Two Deaths

Fri, 25 Jan 2008 00:00:00 -0800

Gardasil has been linked to the deaths of two women in Europe, prompting more concerns about the controversial cervical cancer vaccine. In the U.S., the Food and Drug Administration (FDA) approved Gardasil in 2006 to prevent against four Human Papilloma Virus (HPV) strains which are responsible for 70 percent of all cervical cancer cases. The European Medicines Agency (EMEA) said one of the young women who received Gardasil died in Germany, the other in Austria. No ages have been released.

This week’s deaths follow the deaths of three other young women—ages 12, 19, and 22—who died in the U.S. days after Gardasil was administered, with 1,700 other patients suffering adverse reactions.

Gardasil has been hailed as a breakthrough by the United Kingdom’s (UK) Department of Health, which backs an annual vaccination program, effective September, for girls aged 11 to 13 years. The department claims the policy will reduce yearly cervical cancer deaths by 1,000.

An EMEA spokesman said 1.5 million people had received the vaccine in Europe and there are no plans to change advice on the use of the vaccine. Gardasil, made by Merck, is one of the injections to be used initially. The other is Cervarix, made by Glaxo-SmithKline. Dr Nicholas Kitchin, medical director at Sanofi Pasteur MSD, which markets Gardasil, said, "The authorities in the two countries have looked intensively at these two cases and have not established a causal link, and this has been endorsed by the EMEA. The fact that the EMEA is not taking any action on the back of this should be seen as reassuring that the product remains safe."

Some feel mandating Gardasil would protect all women. Others oppose a vaccine that prevents a sexually transmitted infection, believing usurps parental authority, while some religious groups believe it could lead to promiscuity. Gardasil has been recommended for young girls because they are the least likely to have been exposed to HPV, making the vaccine—in theory—more effective. FDA estimates indicate that by the time they reach age 50, about 80% of all women have been exposed to one or more strains of HPV.

Shortly after its approval, a Centers for Disease Control (CDC) Advisory Panel voted unanimously to recommend all girls between 11 and 12 receive the vaccine, concluding Gardasil appeared to have no side effects other than injection site soreness. This recommendation, along with intense lobbying by Merck, caused 20 states to push for federal mandates to make Gardasil mandatory for sixth grade girls; N.Y. was not among them. Emerging research suggests the CDC erred. FDA documents indicate Gardasil may be responsible for at least eight deaths. Since its approval, there had been 3,461 complaints of adverse reactions to Gardasil. In several instances, blood clots were reported following injection; other side effects include paralysis, Bells Palsy, Guillain-Barre Syndrome. Of 77 women who received the Gardasil vaccine while pregnant, 33 experienced side effects ranging from spontaneous abortion to fetal abnormities. Despite this, Merck is marketing Gardasil as being nearly side effect free.

Gardasil Lawyer Injury Side Effects Attorney Blood Clots Lawsuit Miscarriage Death

Fri, 25 Jan 2008 00:00:00 -0800

Gardasil Side Effects and Injuries - Free Case Review by our Gardasil Lawyers and Attorneys.

Keywords: Gardasil | Lawyer | Injury | Side Effects | Attorney | Blood Clots | Lawsuit | Miscarriage | Death

The lawyers and attorneys at our firm are investigating instances of serious side effects linked to Gardasil, an HPV vaccine, including blood clots and deaths. Since Gardasil was approved by the Food & Drug Administration (FDA), its maker, Merck Inc., has undertaken an aggressive campaign to force families to subject their daughters to the Gardasil vaccine. And even thought Gardasil side effect reports are increasing, the FDA has refused to review the safety of this vaccine. Our Gardasil side effect lawyers are offering free consultations to anyone who suffered serious complications from Gardasil or their families. The Gardasil side effect lawyers at our firm will work hard to make sure Gardasil victims receive the compensation they deserve.

Gardasil was approved by the FDA in June 2006. At the time of its approval, Merck & Co., the maker of Gardasil, said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. The approval of Gardasil was much hyped, with Merck claiming that it had the potential to eventually eliminate most cervical cancers. The investigation conducted by our Gardasil side effect lawyers has concluded that the FDA erred in its rush to approve Gardasil, and did not study the vaccine's possible side effects thoroughly.

The Gardasil side effect lawyer at our firm are disturbed at Merck's attempts to force Gardasil vaccines on your women. Following its approval, the Centers for Disease Control (CDC) recommended that all young girls between the ages of 11 and 12 receive the Gardasil vaccine. Recently, 20 states pushed for federal mandates to make Gardasil mandatory for sixth grade girls

Merck was more than happy to echo the CDC recommendations, and actually began an intensive lobbying effort to convince state health authorities to make Gardasil vaccinations mandatory for young girls. Merck’s heavy promotion of Gardasil has been effective, as some analysts estimate that Gardasil could net the company as much as $1.4 billion in its first full year on the market.

Gardasil Linked to Blood Clots, Miscarriages and Deaths

Since its approval, Merck has claimed that Gardasil is practically side effect free, with pain at the injection site being the most common complaint about the vaccine. However, a 2007 Judicial Watch analysis of the FDA’s Vaccine Adverse Event Reporting System reveals that Gardasil has not been as side effect free as Merck claims. Oddly, Judicial Watch was only able to obtain the FDA’s reports on Gardasil after it filed a Freedom of Information Act request with the agency.

Since its approval, there have been at least 3,461 complaints of adverse reactions to the Gardasil vaccine, and there could have been as many as eight deaths attributable to Gardasil. According to Judicial Watch, in several instances, blood clots were reported to have occurred after the administration of Gardasil.

Other side effects including paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures were also reported. Our Gardasil side effect attorneys believe that even these Gardasil adverse event reports could be underestimating the true number of serious Gardisil side effect incidents that have actually occurred. For that reason, we are seeking to speak with anyone who experienced serious Gardasil side effects.

Gardasil has also been linked to an increased instance of fainting following administration of the vaccine. From 2002-2004 there were a total of about 50 reports of vaccine-related fainting. But from 2005 until last July, reports of vaccine-related fainting spiked to about 230. About 180 of those cases followed a shot of Gardasil, according to the CDC).

The Gardasil side effect reports also include 28 women who miscarried after receiving Gardasil. In May 2007, a 24-year-old woman suffered a miscarriage, which an investigator in a report issued to the federal government said, “may have been caused by Gardasil because the patient received the injection within 30 days of the pregnancy.” In July 2007, a 17-year-old girl from Texas was unaware she was pregnant when she got her second dose of Gardasil. She miscarried, but the cause of the miscarriage hasn’t been determined, according to a report.

The reasons for two other miscarriages in Florida in 2007 - one by a 16-year-old and another by a 24-year-old both - are undetermined, according to reports. But it is known that both women had Gardasil vaccinations shortly before the miscarriages. If you or someone you know suffered a miscarriage following the administration of Gardasil, it is important that you contact one of our Gardasil side effect lawyers in order to protect your rights.

Most disturbing among the Gardasil side effect reports are those that involve the deaths of young women. Three young women in the US died shortly after receiving Gardasil, while two other women in Europe also died after the vaccine was administered. Despite all of these reports, Merck continues to market Gardasil as virtually side-effect free. Our Gardasil side effect lawyers believe that Merck has misled the public about Gardasil's potential dangers, and our law firm intends to hold Merck accountable for these dangerous Gardasil side effects.

Legal Help for Gardasil Side Effect Victims

If you or someone you know suffered a serious Gardasil side effect, you have valuable legal rights. Please fill out our online form or call as at 1-800 LAW INFO (1-800-529-4636) to speak with a qualified Gardasil side effect lawyer.