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.
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.
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 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.
Gardasil, approved by the Food & Drug Administration (FDA) in 2006 is meant to protect against several forms of the 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 a lot of moms are don't want their daughters exposed to Gardasil if they are very young. According to research presented Sunday at the Pediatric Academic Societies' annual meeting in Honolulu, only forty-nine percent of almost 10,000 respondents intended to vaccinate a daughter if she were 9 to 12 years old; 68 percent intended to vaccinate if the daughter was 13 to 15 years old; and 86 percent said they would vaccinate if the daughter was 16 to 18 years of age.
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 formal safety review of Gardasil.
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.
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.
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.
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.
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. In Europe, 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.
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.
During its first year of use, reports of girls fainting from vaccinations rose sharply. While other shots tend to hurt only at the moment of the needle stick, patients around the country are reporting that Gardasil stings and burns while the vaccine itself enters the body. Officials at Merck & Co., which makes Gardasil, acknowledge the sting. They attribute it partly to the virus-like particles in the shot. Pre-marketing studies showed more reports of pain from Gardasil than from dummy shots, and patients reported more pain when given shots with more of the particles. Merck insists this Gardasil vaccine pain is short-lived, however, some patients have reported discomfort while driving with or sleeping on the injected arm for up to a day after receiving Gardasil.
Since Gardasil came on the market in 2006, there has also been a rise in reports of vaccine-associated fainting in girls. From 2002-2004 there were about 50 reports of fainting; from 2005 until last July, there were about 230. About 180 of those cases followed a shot of Gardasil, according to the Centers for Disease Control (CDC). US health officials, however, are quick to point out that there has been no definitive proof that Gardasil is causing the fainting spells.
Still, fainting is not the only side effect reported in regards to Gardasil. Since its approval, the Vaccine Adverse Event Reporting System has received 3,461 complaints of adverse reactions to the Gardasil vaccine, and there could have been as many as eight deaths attributable to Gardasil. 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. Of the 77 women who received the Gardasil vaccine while pregnant, 33 experienced side effects ranging from spontaneous abortion to fetal abnormities.
As of now, there is no way to know exactly how - or if - Gardasil played a role in the onset of these side effects. A thorough safety review is the only way to determine if Gardasil is truly safe. But so far, the Food & Drug Administration is refusing to revisit the vaccine.
Following 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. 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 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.
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. Yet since its approval, the FDA Vaccine Adverse Event Reporting System has received 3,461 complaints of adverse reactions to the Gardasil vaccine, and there could have been as many as eight deaths attributable to Gardasil. 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. Of the 77 women who received the Gardasil vaccine while pregnant, 33 experienced side effects ranging from spontaneous abortion to fetal abnormities.
Those reports included 28 women who miscarried after receiving Gardasil. In May, 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, 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 this year in Florida - 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.
As of now, there is no way to know exactly how - or if - Gardasil played a role in these miscarriage, or in any of the other adverse events that have been reported to the FDA. A thorough safety review is the only way to determine if Gardasil is truly safe. But so far, the FDA is refusing to revisit the vaccine.
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. 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.
Both Merck and the FDA insist that the side effects reports on Gardasil are no different than other drugs, and that none of the adverse reactions have yet to be directly connected to the vaccine. Yet it seems hard to believe that all of the adverse reports linked to Gardasil could be coincidence. And taken in this light, it would seem that efforts to make the Gardasil vaccine mandatory are ill advised until more research can be done on Gardasil's potential side effects
Gardasil was approved by the Food & Drug Administration (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.
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 has been lobbying states ever since 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.
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. But recently, the conservative group Judicial Watch obtained documents from the FDA that indicates that assertion could be false. What is very telling is that Judicial Watch had to force the FDA to turn over some Gardasil documents by filing a Freedom of Information Act request because they weren’t publicly available.
What the FDA documents revealed should cause state lawmakers to consider any proposal to make the Gardasil vaccine mandatory with cynicism. Since its approval, there had been 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. Of the 77 women who received the Gardasil vaccine while pregnant, 33 experienced side effects ranging from spontaneous abortion to fetal abnormities.
Both Merck and the FDA insist that the side effects reports on Gardasil are no different than other drugs, and that none of the adverse reactions have yet to be directly connected to the vaccine. But Judicial Watch says that statistically speaking, it is doubtful that all of the side effects that have been reported in relation to Gardasil could be coincidence. Until more is known about Gardasil side effects, only parents should decide whether or not their daughters receive this vaccine.
Gardasil was approved by the Food & Drug Administration (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.
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. 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.
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 recent 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. While Judicial Watch is a conservative organization with a definite agenda of its own, what it has uncovered about Gardasil is still disturbing.
Since its approval, there have been 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. Of the 77 women who received the Gardasil vaccine while pregnant, 33 experienced side effects ranging from spontaneous abortion to fetal abnormities.
Both Merck and the FDA insist that the side effects reports on Gardasil are no different than other drugs, and that none of the adverse reactions have yet to be directly connected to the vaccine. Yet it seems hard to believe that all of the adverse reports linked to Gardasil could be coincidence. And taken in this light, it would seem that efforts to make the Gardasil vaccine mandatory are ill advised until more research can be done on Gardasil’s potential side effects.
€œThe HPV vaccine provides us with an incredible opportunity to effectively target and prevent cervical cancer, € said Perry. €œRequiring young girls to get vaccinated before they come into contact with HPV is responsible health and fiscal policy that has the potential to significantly reduce cases of cervical cancer and mitigate future medical costs. €
However, Perry €™s order has come under fire from a range of critics from staunch, abstinence-touting conservatives to civic watchdogs. For one thing, his mandate circumvented a host of legislative and regulatory processes. In addition, there have been concerns raised about a relationship between Perry and Merck, the vaccine €™s maker. Merck has undertaken an extensive and aggressive lobbying campaign in order to get their vaccine broadly distributed. In fact, one of the pharmaceutical company €™s lead lobbyists in Texas is actually Perry €™s former chief of staff.
Perhaps the most alarming fact about the order is that Gardasil has only been tested for about five years and was approved by the FDA only eight months ago, meaning that the vaccine €™s safety and efficacy has not been adequately proven. Among concerns are the long-term effects the vaccine may have on the female reproductive system, as well as the possibility that the vaccine itself may lead to cancer. It €™s also unclear for how long the vaccine is effective.
HPV, or human papillomavirus, is the most common sexually transmitted disease in the United States. According to the Texas governor €™s office, approximately 20 million people in the nation are infected, including one in four 15 to 24 year olds. Certain strains of HPV cause most cases of cervical cancer. Around 3,700 women die from cervical cancer every year, and nearly 10,000 women get the disease on an annual basis. Planned Parenthood is among the organizations that support mandatory vaccinations, and the CDC also recommends that all girls should receive it.
So far, results of clinical trials of the vaccine have been very positive. Gardasil was nearly 100 percent effective in preventing infection by two strains of HPV responsible for 70 percent of all cases of cervical cancer and it also prevented infection by HPV strains responsible for about 90 percent of cases of genital warts.
Next week, Texas lawmakers will hold a hearing to discuss the issue in greater detail, although Gov. Perry seems committed to his plan. Making the vaccine mandatory could mean a windfall of billions of dollars for Merck.