Gardasil: Dangerous Affects , Questions Go Unanswered And Merck Pushes Expansion!
No vaccine is without peril and no vaccine in today's world is without immense profit. The idea of somehow rationalizing a balance between peril and profit, benefit and harm is obscene.
We, as advanced as we like to pretend to be, are really infants in understanding the true, full and long range impact(s) of any vaccine. A set of extant theories dictates the formulation and production of vaccines that undeniably in the moment appear beneficial to society, however, the long term cellular changes in humans and later life-consequences have only begun to be explored.
We will one day look back, I am sure, and recognize the most primitive nature of our understanding and current science of immunization. It is with that thought in mind, that I am given over to caution that demands that any vaccine be subject to severe and in-depth testing and thought and that every vaccine should be monitored into the centuries ahead.
We administer Flu vaccines like we were popping aspirins for pain. Do we really know the long reaching accumulated affects of such actions, and the long range impact on humanity of any vaccine? Just think about it.
With that caution and curiosity in mind one should keep a close eye on the industry that promotes new vaccines and their test data. A rush to profit might just prove to your rush to an early grave or a crippled life of anguish. Do these words seem inflammatory? They are meant to be. They are meant to motivate you to think and ask questions and act accordingly. That is the essence of this site in all things.
January 14, 2010 — 11:15am ET | By Tracy Staton
Merck hasn't given up on broader use of its HPV vaccine in women. The company has delivered a new batch of info to the FDA in support of Gardasil use in women aged 27 to 45. The vaccine--which wards off two strains of the virus that cause cervical cancer and two others that spawn genital warts--is already OK'd for marketing to females from 9 years to 26 years.
Merck recently won another indication for Gardasil: For use in boys and young men to prevent genital warts. That's a nice expansion, but lacks the urgency that cancer prevention lends to use in females. Limited to marketing to women under 26--and now young males--Merck has seen Gardasil sales drop. Globally, revenues from the vaccine fell 22 percent, Reuters reports, to $311 million in Q3 of 2009.
Meanwhile, Merck has been trying to stay one step ahead of GlaxoSmithKline and its Cervarix shot, which won the FDA nod last year. Competition from Cervarix is one reason why Gardasil sales have slipped.
All of this is why Merck is so doggedly pursuing the chance to market Gardasil to more adult women. It's been turned down twice; most recently, FDA said it wouldn't approve the new indication without data from a 48-month study. And that's the trial data Merck delivered, before the end of 2009. News could come around midyear, because FDA tends to take around six months to review supplemental data, the company said. - read the Reuters piece
Gardasil for boys not cost-effective
Gardasil debate shifts as attention turns to boys
Vax advisors stick to the sidelines in new Gardasil debate
Study: HPV vax may also prevent cancer in men
NEW YORK, Jan 13 (Reuters) - Merck & Co (MRK.N) on Wednesday said it had provided U.S. regulators with new information needed for approval to market its Gardasil cervical cancer vaccine to women between the ages of 27 to 45.
Gardasil, one of Merck's biggest products, was approved in 2006 for preventing cervical cancer and genital warts in females between the ages of 9 and 26. It works by preventing infection with the sexually transmitted human papillomavirus (HPV), which causes cervical cancer.
The U.S. Food and Drug Administration early last year again withheld approval for its use by women aged 27 to 45, asking the drugmaker to submit data when a 48-month study on a test group has been completed.
Merck, in a statement on its Web site, said it had provided the completed trial data to the FDA before the end of 2009. The company said the FDA typically takes six months to review such responses.
Global sales of Gardasil fell 22 percent to $311 million in the third quarter, hurt by overseas competition from GlaxoSmithKline's (GSK.L) rival Cervarix vaccine and continuing delays in winning expanded approval for the product. (Reporting by Ransdell Pierson; editing by Carol Bishopric)
(CBS) Amid questions about the safety of the HPV vaccine Gardasil one of the lead researchers for the Merck drug is speaking out about its risks, benefits and aggressive marketing.
Dr. Diane Harper says young girls and their parents should receive more complete warnings before receiving the vaccine to prevent cervical cancer. Dr. Harper helped design and carry out the Phase II and Phase III safety and effectiveness studies to get Gardasil approved, and authored many of the published, scholarly papers about it. She has been a paid speaker and consultant to Merck. It’s highly unusual for a researcher to publicly criticize a medicine or vaccine she helped get approved.
Dr. Harper joins a number of consumer watchdogs, vaccine safety advocates, and parents who question the vaccine’s risk-versus-benefit profile. She says data available for Gardasil shows that it lasts five years; there is no data showing that it remains effective beyond five years.
This raises questions about the CDC’s recommendation that the series of shots be given to girls as young as 11-years old. “If we vaccinate 11 year olds and the protection doesn’t last... we’ve put them at harm from side effects, small but real, for no benefit,” says Dr. Harper. “The benefit to public health is nothing, there is no reduction in cervical cancers, they are just postponed, unless the protection lasts for at least 15 years, and over 70% of all sexually active females of all ages are vaccinated.” She also says that enough serious side effects have been reported after Gardasil use that the vaccine could prove riskier than the cervical cancer it purports to prevent. Cervical cancer is usually entirely curable when detected early through normal Pap screenings.
Dr. Scott Ratner and his wife, who’s also a physician, expressed similar concerns as Dr. Harper in an interview with CBS News last year. One of their teenage daughters became severely ill after her first dose of Gardasil. Dr. Ratner says she’d have been better off getting cervical cancer than the vaccination. “My daughter went from a varsity lacrosse player at Choate to a chronically ill, steroid-dependent patient with autoimmune myofasciitis. I’ve had to ask myself why I let my eldest of three daughters get an unproven vaccine against a few strains of a nonlethal virus that can be dealt with in more effective ways.”
Merck and the Centers for Disease Control and Prevention maintain Gardasil is safe and effective, and that adequate warnings are provided, cautioning about soreness at the injection site and risk of fainting after vaccination. A new study in the Journal of the American Medical Association found while the overall risk of side effects appears to be comparable to other vaccines, Gardasil has a higher incidence of blood clots reported. Merck says it continues to have confidence in Gardasil’s safety profile. Merck also says it’s looking into cases of ALS, commonly known as Lou Gehrig’s Disease, reported after vaccination. ALS is a progressive neurodegenerative disease that attacks motor neurons in the brain and spinal cord. Merck and the CDC say there is currently no evidence that Gardasil caused ALS in the cases reported. Merck is also monitoring the number of deaths reported after Gardasil: at least 32. Merck and CDC says it’s unclear whether the deaths were related to the vaccine, and that just because patients died after the shots doesn’t mean the shots were necessarily to blame.
According to Dr. Harper, assessing the true adverse event risk of Gardasil, and comparing it to the risk of cervical cancer can be tricky and complex. "The number of women who die from cervical cancer in the US every year is small but real. It is small because of the success of the Pap screening program."
"The risks of serious adverse events including death reported after Gardasil use in (the JAMA article by CDC’s Dr. Barbara Slade) were 3.4/100,000 doses distributed. The rate of serious adverse events on par with the death rate of cervical cancer. Gardasil has been associated with at least as many serious adverse events as there are deaths from cervical cancer developing each year. Indeed, the risks of vaccination are underreported in Slade's article, as they are based on a denominator of doses distributed from Merck's warehouse. Up to a third of those doses may be in refrigerators waiting to be dispensed as the autumn onslaught of vaccine messages is sent home to parents the first day of school. Should the denominator in Dr. Slade's work be adjusted to account for this, and then divided by three for the number of women who would receive all three doses, the incidence rate of serious adverse events increases up to five fold. How does a parent value that information," said Harper.
Dr. Harper agrees with Merck and the CDC that Gardasil is safe for most girls and women. But she says the side effects reported so far call for more complete disclosure to patients. She says they should be told that protection from the vaccination might not last long enough to provide a cancer protection benefit, and that its risks - “small but real” - could occur more often than the cervical cancer itself would.
"Parents and women must know that deaths occurred. Not all deaths that have been reported were represented in Dr. Slade's work, one-third of the death reports were unavailable to the CDC, leaving the parents of the deceased teenagers in despair that the CDC is ignoring the very rare but real occurrences that need not have happened if parents were given information stating that there are real, but small risks of death surrounding the administration of Gardasil."
She also worries that Merck’s aggressive marketing of the vaccine may have given women a false sense of security. "The future expectations women hold because they have received free doses of Gardasil purchased by philanthropic foundations, by public health agencies or covered by insurance is the true threat to cervical cancer in the future. Should women stop Pap screening after vaccination, the cervical cancer rate will actually increase per year. Should women believe this is preventive for all cancers - something never stated, but often inferred by many in the population-- a reduction in all health care will compound our current health crisis. Should Gardasil not be effective for more than 15 years, the most costly public health experiment in cancer control will have failed miserably."
CDC continues to recommend Gardasil for girls and young women. The agency says the vaccine’s benefits outweigh its risks and that it is an important tool in fighting a serious cancer.
Dr. Harper says the risk-benefit analysis for Gardasil in other countries may shape up differently than what she believes is true in the US. “Of course, in developing countries where there is no safety Pap screening for women repeatedly over their lifetimes, the risks of s erious adverse events may be acceptable as the incidence rate of cervical cancer is five to 12 times higher than in the US, dwarfing the risk of death reported after Gardasil.”
"The FDA adverse event reports on the HPV vaccine read like a catalog of horrors. Any state or local government now beset by Merck’s lobbying campaigns to mandate this HPV vaccine for young girls ought to take a look at these adverse health reports."
On June 8, 2006, the Food and Drug Administration (FDA) approved the drug Gardasil. Gardasil is a vaccine against certain types of human papillomavirus (HPV) which is the primary cause of cervical cancer in women.
Several state and local governments have proposed requiring the vaccine for school girls entering the 6th grade.
Gardasil is approved for girls as young as nine years old, despite the fact that the youngest girls participating in clinical trials were 11-12 years old.
A recent study, published in the New England Journal of Medicine, also questioned the general effectiveness of Gardasil. Additionally, there has not been a chance to study long term side effects of the vaccine.
Judicial Watch, concerned about the rush to market and mandate a drug with possible serious adverse effects, filed its first Freedom of Information Act (FOIA) request on May 9, 2007, and received 1,637 adverse event reports on May 15, 2007. These reports are submitted to the Vaccine Adverse Event Reporting System (VAERS) and used by the FDA to monitor the safety of vaccines.
On August 20, 2007 Judicial Watch filed a request for updated adverse event reports and received 1,824 reports on September, 13 2007. Judicial Watch then filed a complaint against the FDA on October 3, 2007 for failing to fully respond to the May 9, 2007 FOIA request.
Judicial Watch has posted links to the adverse event reports below and continues to monitor VAERS reports submitted to the FDA in relation to Gardasil.
- Judicial Watch Special Report: Examining the FDA's HPV Vaccine Records - June 30, 2008
- Examining the FDA's HPV Vaccine Records - Appendices - June 30, 2008
- Vaccine Adverse Effects Report System (VAERS) cumulative deaths report - June 16, 2009
- Vaccine Adverse Effects Report System (VAERS) serious effects report from May 1, 2008 to May 15, 2009 - May 15, 2009
- Vaccine Adverse Effects Report System (VAERS) serious effects report from January 1, 2008 to June 10, 2008 - June 30, 2008
- Vaccine Adverse Effects Report System (VAERS) cumulative deaths report - June 30, 2008
- Vaccine Adverse Effects Report System (VAERS) reports on Guillane-Barre Syndrome, spontaneous abortions, and all life-threatening cases from 2008 - June 30, 2008
- Vaccine Adverse Effects Report System (VAERS) cumulative Gardasil adverse effects report (Warning, this is a very large file) - June 30, 2008
- Merck's application to the FDA to patent the Gardasil vaccine - February 22, 2008
- Merck's standard Gardasil information publication
- Merck's report to the FDA giving the details of Gardasil and its clinical test results - February 22, 2008
- A transcript of the Vaccines and Related Biological Products Advisory Committee's meeting to discuss Gardasil - February 22, 2008
- Document from the FDA giving a determination of Regulatory Review Period for Purposes of Patent Extension for Gardasil - February 22, 2008
- Gardasil Related Deaths Reported to VAERS as of September 7, 2007
- Gardasil Related Deaths Reported to VAERS as of May 11, 2007
- Vaccine Adverse Event Reporting System (VAERS) Reports as of September 7, 2007
- Vaccine Adverse Event Reporting System (VAERS) Reports as of May 11, 2007
- Complaint for Injunctive and Declaratory Relief - October 3, 2007
- New FDA Records Obtained by Judicial Watch Indicate 28 Deaths Related to Gardasil in 2008 - June 22, 2009
- Judicial Watch Uncovers New FDA Records Detailing Ten New Deaths & 140 "Serious" Adverse Events Related to Gardasil - June 5, 2009
- Judicial Watch Uncovers New FDA Records Detailing Ten New Deaths & 140 “Serious” Adverse Events Related to Gardasil - June 30, 2008
- Judicial Watch Uncovers New FDA Records Detailing Deaths in 1,824 Adverse Reaction Reports Related to HPV Vaccine - October 4, 2007
- Judicial Watch Uncovers Three Deaths Relating to HPV - May 3, 2007
News Stories, Reports and Informational Links
New England Journal of Medicine
Previous Gardasil Issue Posts