The financial relationships between the medical industry and doctors have caused controversy in recent years. Critics have long held that such relationships create conflicts-of-interest, and could unduly influence everything from research findings to prescribing practices. Over the past several years, states, medical schools, medical societies and other entities have passed regulations requiring doctors to disclose their financial relationships with drug and device makers, and some have even tried to curb the gifts and other perks doctors can receive from medical firms.
According to The New York Times, while Congress tightened rules for the Food & Drug Administration after conflicts were found among members of its advisory panels, little attention has been paid to the CDC. That apparently was a mistake.
According to the Times, a report compiled by Daniel R. Levinson, the inspector general of the Department of Health and Human Services, found that experts who served on CDC flu and cervical cancer vaccine advisory panels in 2007 had potential conflicts that were never resolved. Many of the advisors identified in the report "either a job or a grant from a company or other entity whose interests were affected by the committees’ discussions, and a considerable number also owned stock in such companies," the Times said.
According to the report:
• 64 percent of the advisers had potential conflicts of interest that were never identified or were left unresolved by the centers.
• 13 percent failed to have an appropriate conflicts form on file at the agency at all, which should have barred their participation in the meetings entirely
• 3 percent voted on matters that ethics officers had already barred them from considering.
In a response to the Times, the CDC said it had already tightened its conflicts of interest process since the time period covered by the report.
Now, says the New Zealand Herald, a probe is in progress to determine if there is a link between a girl’s death and the vaccine. According to Health Minister Tony Ryall's office, it has confirmed that the Centre for Adverse Reaction Monitoring (CARM) located at Otago University in New Zealand, was asked to see if there is a connection, said the New Zealand Herald.
The death is still being handled by the coroner’s office and is believed to have taken place in the past “couple of months,” said the New Zealand Herald. The girl apparently died within six months of receiving a Gardasil injection; however, it remains unclear if she received the full three-injection course of the drug, which generally takes about six weeks to complete, noted the Herald.
In the United States, Dr. Dianae Harper, director of the Gynecologic Cancer Prevention Research Group at the University of Missouri, and a researcher in the development of Gardasil and Cervarix, recently asserted that the evidence shows that the vaccine does little to reduce cervical cancer.
Dr. Harper said that beyond current preventative measures, because 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.”
Also, according to Dr. Harper, Merck & Co., the maker of Gardasil, had not tested Gardasil on girls younger than 15, chattahbox.com said, previously. “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.
In New Zealand, the vaccine is offered to 12-year-old girls for free and girls from 13 to 18 years of age are also able to receive immunization.
In the U.S. as of late this year, according to Dr. Harper, 15,037 girls officially reported adverse side effects from Gardasil to the Vaccine Adverse Event Reporting System (VAERS). These reactions include Guilliane-Barre syndrome, lupus, seizures, paralysis, blood clots and brain inflammation. Dr. Harper also said that the Centers for Disease Control acknowledged 44 reported deaths following Gardasil administration.
The New Zealand Herald said that most adverse reactions reported there included “soreness, swelling, or redness at the injection site; raised temperatures; headaches; nausea; skin reactions—mostly rashes—and fainting” with more serious anaphylaxis occurring in three out of every one million doses, said the Herald.
Approved in 2006, Gardasil prevents four strains of HPV. As of June 2009, 15 million girls had received Gardasil, with complaints including reports of dizziness, numbness, and blood clots.
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. 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. The CDC acknowledged 44 reported deaths following Gardasil administration.
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, chattahbox.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 Cervarix, 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."
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.
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.”
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.
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.
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 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 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 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 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 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.
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 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 is a vaccination that prevents some forms—not all forms—of the Human Papillomavirus (HPV) that cause cervical cancer. Some of the controversy surrounding Gardasil involve attempts by Merck to make the inoculations mandatory, and because of continuing questions about the drug’s safety. It is widely known that those injected with the cervical cancer vaccination have experienced greater fainting and blood clot reactions versus people receiving other types of vaccinations, the Journal pointed out.
In June, the U.S. Food and Drug Administration (FDA) announced that Gardasil’s label was updated to include more prominent warnings about fainting that can occur following administration of the vaccine. 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 FDA; about 13 percent of Gardasil side effects reported to its Vaccine Adverse Event Reporting System (VAERS) describe fainting.
The JAMA piece, as well as a related safety study piece, about Gardasil raised issues concerning safety, efficacy, and marketing tactics, especially given that some experts have questioned the medication’s cervical cancer fighting abilities, said the Journal, which noted that the drug’s approval was for two, not all, strains of cancer-causing HPV. Worse, noted the Journal, the vaccine was not broadly tested; only a “few hundred 11- and 12-year-old-girls” were involved in the test group, said the Journal. Some feel that this number was insufficient to declare the drug safe for that demographic.
Merck has also been long criticized for its ongoing fights to require HPV vaccination in a variety of states, something from which it finally eased in 2007, said the Journal.
This June we wrote about how over two dozen women and girls died in 2008 after receiving Gardasil injections and that, according to Judicial Watch, 47 deaths have been linked to Gardasil. Judicial Watch says it obtained records from the FDA documenting 28 deaths in 2008 associated with Gardasil, up from 19 in 2007. Of 47 deaths reported since 2006, Judicial Watch said 41 occurred within a month of the vaccine; of those, 17 were within two weeks of receiving the vaccine.
The group said—citing VAERS—that the FDA documented 6,723 “adverse events” related to Gardasil in 2008, of which 1,061 were considered “serious,” and 142 considered “life threatening.” Since last June, 235 cases detailed permanent disability, with 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 genital warts, there were 21 reports of girls developing warts on other areas, including face, hands and feet, and, in one case, “all over her body.” Despite these findings, the American health authorities who managed the safety review continue to assert the vaccine’s safety, claiming its benefits outweigh its risks, said the Journal, noting that JAMA described Merck’s marketing of the drug “pushy” and “disturbing,” it quoted.
Merck’s sales of the drug have dropped in the past year and Merck has been unable to gain favor among older teenagers and young women, but continues in its efforts for a version of the drug targeted to males, said the Journal.
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 its 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."
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.
Thir13en Ghosts buy 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-Barr 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).
The Aviator filmAccording 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.
Blind Date move Instinct to Kill trailer 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.
Overboard film
All of the publications were developed in the same way, to look like—but only to look like—a legitimate, peer-reviewed medical journal, pointed out The Scientist. Elsevier, considered a scientific publishing giant, said The Scientist, is undergoing an “internal review” of its publishing practices since news broke that it produced a company-funded journal, but did not indicate that the so-called journal was actually a corporately sponsored piece that many see as a thinly veiled marketing tool.
The Scientist noted that the claims relate to the Australasian Journal of Bone and Joint Medicine. The alleged journal was paid for by Merck and was really simply a collection of “reprinted scientific articles and one-source reviews,” said The Scientist. Most of the articles in the publication presented Merck products favorably, which appears as if the phony journal was developed for marketing purposes without actually indicating itself as project sponsor, said TheScientist.com in its prior report. The so-called review articles contained surprisingly sparse referencing—most review articles are rife with citations and references—with a couple just summaries of published work with a notation they were written by “B&J Editorial,” which one could infer means “Bone and Joint.”
A spokesperson from Elsevier told The Scientist that six titles in a "series of sponsored article publications" were released by its Australia branch with the Elsevier Excerpta Medica imprint from 2000 to 2005 and included: the Australasian Journal of General Practice, the Australasian Journal of Neurology, the Australasian Journal of Cardiology, the Australasian Journal of Clinical Pharmacy, the Australasian Journal of Cardiovascular Medicine, and the Australasian Journal of Bone & Joint [Medicine].
Elsevier did not provide sponsor names, but its Health Sciences Division CEO, Michael Hanson, did state, "It has recently come to my attention that from 2000 to 2005, our Australia office published a series of sponsored article compilation publications, on behalf of pharmaceutical clients, that were made to look like journals and lacked the proper disclosures. This was an unacceptable practice, and we regret that it took place," quoted The Scientist. When originally confronted, said The Scientist, Elsevier said it was not planning on looking into the allegations; however, the publisher has since changed its plans, said The Scientist. Hanson stated "We are currently conducting an internal review but believe this was an isolated practice from a past period in time,” quoted The Scientist.
In a similar ongoing farce, we have been writing about researchers falsifying studies linked to industry funds. A former Harvard researcher, Dr. Robert Fogel, admitted misrepresenting 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, New Jersey.
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 had received funding from Merck.
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.The Lion in Winter trailer Lust Connection rip Robin Hood movie
Now, Web MD Health News is writing that girls and women being injected with Gardasil may be at increased risk of developing the serious Guillain-Barre syndrome (GBS). GBS is a peripheral nervous system disorder linked to some illnesses in the early days following injection. “… there is clear evidence from our database of an increased incidence of Guillain-Barre syndrome in the first six weeks, especially the first two weeks, after vaccination,” Nizar Souayah, MD, of the University of Medicine and Dentistry of New Jersey in Newark, told Web MD.
According to Web MD, 26 in 10 million in the first two weeks and 30 in 10 million in the first six weeks after being vaccinated come down with the life-threatening GBS, said Souayah. GBS is usually prompted by an infection, said Web MD, with the body's immune system attacking the nervous system; sometimes, surgery or vaccines will provoke GBS. The study looked at data from the Vaccine Adverse Event Reporting System (VAERS), which is managed by the CDC and the U.S. Food and Drug Administration (FDA) and found that there were 53 cases of Guillain-Barre reported after Gardasil vaccinations in the United States from 2006 to 2008, said Web MD, noting that the majority developed within six weeks of receiving the shot and over one-third within the first two weeks.
Concerns between GBS and vaccinations were noticed after a link was revealed during the 1976-1977 swine flu season, said Web MD. Since, “there is always a concern when any vaccine program is introduced,” says Ken Gorson, MD, a neurologist at Tufts University/St. Elizabeth’s Medical Center in Boston, quoted Web MD.
In a report earlier this year, The Vue Weekly pointed 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 reported 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 owns 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.”Ben Folds: Live at My Space full movie
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 article. 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.
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.
Both girls were hospitalized with one just being released from intensive care and the other remaining in the hospital; both received their injections from the same Gardasil batch, according to the FindingDulcinea.com news report, which noted that the girls received their shots as part of a government vaccination program in Spain that is targeting teenagers.
We have long been reporting about the numerous adverse, sometimes deadly, events associated with Gardisal injections, the three-shot vaccine that claims 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.
- 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 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.
- Most recently, a 16-year-old girl reported being constantly ill with 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.
Interestingly, one of the developers of Gardasil, Dr. Diane Harper, also a cervical cancer researcher and professor of medicine at Dartmouth Medical School, has been a quite vocal against the push to make Gardasil a mandatory vaccination, noting that clinical trial results have not been conducted long enough to reveal risks. “Merck lobbied every opinion leader, women’s group, medical society, politician, and went directly to the people—it created a sense of panic that says you have to have this vaccine now,” Dr. Harper said in an interview with the New York Times in August.
Spain’s health ministry said that while Gardasil will continue to be administered, the batch linked to the two illnesses—NH52670—has been recalled; 76,000 vaccines from the recalled batch have been distributed throughout Spain, said FindingDulcinea.com.
Despite nearly 10,000 reports of adverse reactions, including paralysis and death, the U.S. Food and Drug Administration (FDA) has deemed the vaccine safe.
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 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-Barr 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 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-Barr 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.
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.