Montelukast Tied to Psychiatric Adverse Events in Kids, Adults


The asthma medication montelukast (Singulair, Merck) is linked to increased reports of depression and nightmares in adults and children, as well as aggression in children, according to a review of voluntary adverse event reports published online September 20 in Pharmacology Research & Perspectives.

“Because of the high incidence of neuropsychiatric symptoms — especially nightmares — after using montelukast in both children and adults, the clinician should discuss the possibility of these adverse events with the patient and parents,” first author Meindina Haarman, MSc, from University Medical Center Groningen, The Netherlands, said in a news release.

Haarman and colleagues say this is the first study to analyze reports of adverse drug reactions related to montelukast in both children and adults.

Montelukast is used in maintenance therapy for adults and children with asthma and allergic rhinitis. Commonly reported adverse reactions include upper airway infection, fever, rash, nausea, vomiting, diarrhea, and elevated liver enzymes.

Sleep disorders and psychiatric symptoms have also been reported. In 2009, the US Food and Drug Administration mandated that the drug label of montelukast and other drugs in this class list neuropsychiatric symptoms such as depression and suicidality as possible adverse reactions.

Montelukast has also been linked to allergic granulomatous angiitis, also called Churg-Strauss syndrome, a rare autoimmune condition that causes inflammation of small and medium-sized blood vessels in people with airway allergies. The condition can affect various organs, especially the lungs and digestive tract, and can be life-threatening in some cases.

To better characterize the safety profile of montelukast in regular clinic use, the researchers conducted a retrospective study of all adverse drug reactions in children and adults reported to the Netherlands Pharmacovigilance Center Lareb and the World Health Organization (WHO) Global database (VigiBase®) up to 2016.

Overall, there were 331 montelukast-related adverse drug reactions in the Dutch database and 17,723 in the WHO database. Slightly less than one third of the reports in each database involved patients younger than 19 years (32.3% and 32.4%, respectively).

In the analysis, the researchers used the reporting odds ratio (ROR), which provides an estimate of whether an adverse event is disproportionately reported for a certain drug compared with all other drugs. Notably, ROR cannot say anything about causality.

Depression was the most frequently reported adverse reaction overall in the global WHO database (ROR, 6.93; 95% confidence interval [CI], 6.5 – 7.4). Among children only, the most commonly reported ADR was aggression (ROR, 29.77; 95% CI, 27.5 – 32.2).

In the Dutch database, headache was the most frequently reported adverse reaction overall in both adults (ROR, 2.26; 95% CI, 1.61 – 3.19), and children (ROR, 3.18; 95% CI, 2.66 – 3.70).

Other commonly reported adverse reactions in both the Dutch and WHO databases included nightmares in both children and adults. In the WHO database, suicidal ideation was also commonly reported.

Eight patients also reported allergic granulomatous angiitis to the Dutch database, whereas the WHO database had 563 reports of the condition. All patients survived.

The authors noted that the relationship between montelukast and allergic granulomatous angiitis is unclear. Some studies have suggested that the two are not connected, whereas others have suggested a causal relationship. More research is needed to clarify this relationship, they write.

“However, it has been reported that the symptoms of allergic granulomatous angiitis disappeared in some patients after withdrawing montelukast. This can be seen regarded as an argument for a causal relationship,” the authors write.

Until more data are available, “patients treated with montelukast should be followed to detect signs and symptoms of allergic granulomatous angiitis,” they advise.

They also note that the relationship between Montelukast and depression remains unclear. Asthma has been linked to increased depression and lower quality of life, so reports of depression may actually reflect symptoms of the underlying disease and not an adverse reaction to the drug.

“Further research is required to reveal the mechanism for the higher incidence of neuropsychiatric symptoms in patients using montelukast in comparison with other medications,” they conclude.

The authors mention several study limitations. Both databases relied on voluntary reporting of symptoms, which could have lead to underreporting. Also, the study cannot prove montelukast causes these adverse reactions.

FDA Expands Gardasil to Include Adults Up to Age 45


The US Food and Drug Administration (FDA) has approved a supplemental application for Merck’s 9-valent human papillomavirus vaccine (Gardasil 9) to include women and men aged 27 through 45 years.

“Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a news release.

“The Centers for Disease Control and Prevention [CDC] has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90% of these cancers, or 31,200 cases every year, from ever developing,” Marks noted.

The CDC estimates that every year about 14 million Americans become infected with HPV. About 12,000 women are diagnosed with cervical cancer and about 4000 women die from cervical cancer caused by certain HPV viruses. HPV is also associated with several other forms of cancer affecting men and women.

Gardasil, which was first approved by the FDA in 2006 to prevent certain cancers and diseases caused by HPV types 6, 11, 16, and 18, is no longer distributed in the United States.

In 2014, the FDA approved Gardasil 9, which covers the same four HPV types as Gardasil as well as five additional types (31, 33, 45, 52, and 58). Gardasil 9 was first approved for use in males and females aged 9 through 26 years.

According to the FDA, in a study in roughly 3200 women aged between 27 and 45 years followed for an average of 3.5 years, Gardasil was 88% effective in preventing the combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine.

“The FDA’s approval of Gardasil 9 in women 27 through 45 years of age is based on these results and new data on long term follow-up from this study,” the FDA said.

“Effectiveness of Gardasil 9 in men 27 through 45 years of age is inferred from the data described above in women 27 through 45 years of age, as well as efficacy data from Gardasil in younger men (16 through 26 years of age) and immunogenicity data from a clinical trial in which 150 men, 27 through 45 years of age, received a 3-dose regimen of Gardasil over 6 months,” the agency said.

The safety of Gardasil 9 was evaluated in a total of about 13,000 males and females. The most commonly reported adverse reactions were injection-site pain, swelling, redness, and headaches.

The FDA granted the Gardasil 9 application priority review status, a program that facilitates and expedites the review of medical products that address a serious or life-threatening condition.

The Vaccinated Spreading Measles: WHO, Merck, CDC Documents Confirm


The Vaccinated Spreading Measles: WHO, Merck, CDC Documents Confirm

20 years ago, the MMR vaccine was found to infect virtually all of its recipients with measles. The manufacturer Merck’s own product warning links MMR to a potentially fatal form of brain inflammation caused by measles. Why is this evidence not being reported?

The Vaccinated Spreading Measles

The phenomenon of measles infection spread by MMR (live measles-mumps-rubella vaccine) has been known for decades. In fact, 20 years ago, scientists working at the CDC’s National Center for Infectious Diseases, funded by the WHO and the National Vaccine Program, discovered something truly disturbing about the MMR vaccine: it leads to detectable measles infection in the vast majority of those who receive it.

Published in 1995 in the Journal of Clinical Microbiology and titled, “Detection of Measles Virus RNA in Urine Specimens from Vaccine Recipients,” researchers analyzed urine samples from newly MMR vaccinated 15-month-old children and young adults and reported their eye-opening results as following:

  • Measles virus RNA was detected in 10 of 12 children during the 2-week sampling period.
  • In some cases, measles virus RNA was detected as early as 1 day or as late as 14 days after the children were vaccinated.
  • Measles virus RNA was also detected in the urine samples from all four of the young adults between 1 and 13 days after vaccination.

The authors of this study used a relatively new technology at that time, namely, reverse transcriptase polymerase chain reaction (RT-PCR), which they believed could help resolve growing challenges associated with measles detection in the shifting post-mass immunization epidemiological and clinical landscape. These challenges include:

  • A changing clinical presentation towards ‘milder’ or asymptomatic measles in previously vaccinated individuals.
  • A changing epidemiological distribution of measles (a shift toward children younger than 15 months, teenagers, and young adults)
  • Increasing difficulty distinguishing measles-like symptoms (exanthema) caused by a range of other pathogens from those caused by measles virus.
  • An increase in sporadic measles outbreaks in previously vaccinated individuals.

Twenty years later, PCR testing is widely acknowledged as highly sensitive and specific, and the only efficient way to distinguish vaccine-strain and wild-type measles infection, as their clinical presentation are indistinguishable.

Did the CDC Use PCR Testing On The Disneyland Measles Cases?

The latest measles outbreak at Disney is a perfect example of where PCR testing could be used to ascertain the true origins of the outbreak. The a priori assumption that the non-vaccinated are carriers and transmitters of a disease the vaccinated are immune to has not been scientifically validated. Since vaccine strain measles has almost entirely supplanted wild-type, communally acquired measles, it is statistically unlikely that PCR tests will reveal the media’s hysterical storyline — “non-vaxxers brought back an eradicated disease!” —  to be true. Until such studies are performed and exposed, we will never know for certain.

Laura Hayes, of Age of Autism, recently addressed this key question in her insightful article “Disney, Measles, and the Fantasyland of Vaccine Perfection“:

“Has there been any laboratory confirmation of even one case of the supposed measles related to Disneyland?  If yes, was the confirmed case tested to determine whether it was wild-type measles or vaccine-strain measles?  If not, why not?  These are important questions to ask. Is it measles or not? If yes, what kind, because if it’s vaccine-strain measles, then that means it is the vaccinated who are contagious and spreading measles resulting in what the media likes to label “outbreaks” to create panic (a panic more appropriately triggered by our 25 year history of epidemic autism).

It would be what one might call vaccine fallout.  People who receive live-virus vaccines, such as the MMR, can then shed that live virus, for up to many weeks and can infect others.  Other live-virus vaccines include the nasal flu vaccine, shingles vaccine, rotavirus vaccine, chicken pox vaccine, and yellow fever vaccine.”

Additional Evidence That the Vaccinated Are Not Immune, Spread Disease

The National Vaccine Information Center has published an important document relevant to this topic titled “The Emerging Risks of Live Virus & Virus Vectored Vaccines: Vaccine Strain Virus Infection, Shedding & Transmission.” Pages 34-36 in the section on “Measles, Mumps, Rubella Viruses and Live Attenuated Measles, Mumps, Rubella Viruses” discuss evidence that the MMR vaccine can lead to measles infection and transmission.

Cases highlighted include:

  • In 2010, Eurosurveillance published a report about excretion of vaccine strain measles virus in urine and pharyngeal secretions of a Croatian child with vaccine-associated rash illness.[1] A healthy 14-month old child was given MMR vaccine and eight days later developed macular rash and fever. Lab testing of throat and urine samples between two and four weeks after vaccination tested positive for vaccine strain measles virus. Authors of the report pointed out that when children experience a fever and rash after MMR vaccination, only molecular lab testing can determine whether the symptoms are due to vaccine strain measles virus infection. They stated: “According to WHO guidelines for measles and rubella elimination, routine discrimination between aetiologies of febrile rash disease is done by virus detection. However, in a patient recently MMR-vaccinated, only molecular techniques can differentiate between wild type measles or rubella infection or vaccine-associated disease. This case report demonstrates that excretion of Schwartz measles virus occurs in vaccinees.”
  • In 2012, Pediatric Child Health published a report describing a healthy 15-month old child in Canada, who developed irritability, fever, cough, conjunctivitis and rash within seven days of an MMR shot.[2] Blood, urine and throat swab tests were positive for vaccine strain measles virus infection 12 days after vaccination. Addressing the potential for measles vaccine strain virus transmission to others, the authors stated, “While the attenuated virus can be detected in clinical specimens following immunization, it is understood that administration of the MMR vaccine to immunocompetent individuals does not carry the risk of secondary transmission to susceptible hosts.
  • In 2013, Eurosurveillance published a report of vaccine strain measles occurring weeks after MMR vaccination in Canada. Authors stated, “We describe a case of measlesmumps-rubella (MMR) vaccine-associated measles illness that was positive by both PCR and IgM, five weeks after administration of the MMR vaccine.” The case involved a two-year-old child, who developed runny nose, fever, cough, macular rash and conjunctivitis after vaccination and tested positive for vaccine strain measles virus infection in throat swab and blood tests.[3] Canadian health officials authoring the report raised the question of whether there are unidentified cases of vaccine strain measles infections and the need to know more about how long measles vaccine strain shedding lasts. They concluded that the case they reported “likely represents the existence of additional, but unidentified, exceptions to the typical timeframe for measles vaccine virus shedding and illness.” They added that “further investigation is needed on the upper limit of measles vaccine virus shedding based on increased sensitivity of the RT-PCR-based detection technologies and immunological factors associated with vaccine-associated measles illness and virus shedding.”

In addition to this evidence for the disease-promoting nature of the measles vaccine, we recently reported on a case of a twice vaccinated adult in NYC becoming infected with measles and then spreading it to two secondary contacts, both of which were vaccinated twice and found to have presumably protective IgM antibodies.

This double failure of the MMR vaccine renders highly suspicious the unsubstantiated claims that when an outbreak of measles occurs the non- or minimally vaccinated are responsible. The assumption that vaccination equals bona fide immunity has never been supported by the evidence itself. We have previously reported on a growing body of evidence that even when a vaccine is mandated, and 99% of a population receive the measles vaccines, outbreaks not only happen, but as compliance increases vaccine resistance sporadic outbreaks also increase — a clear indication of vaccine failure.

There is also the concerning fact that according to the MMR vaccine’s manufacturer Merck’s own product insert, the MMR can cause measles inclusion body encephalitis (MIBE), a rare but potentially lethal form of brain infection with measles.  For more information you can review a case report on MIBE caused by vaccine strain measles published in the journal Clinical Infectious Diseases in 1999 titled “Measles inclusion-body encephalitis caused by the vaccine strain of measles virus.

Global Measles Vaccine Failures Increasingly Reported

China is not the only country dealing with outbreaks in near universally vaccinated populations. Between 2008-2011, France reported over 20,000 cases of measles, with adolescents and young adults accounting for more than half of cases.[4] Remarkably, these outbreaks began when France was experiencing some of their highest coverage rates in history. For instance, in 2008, the MMR1 coverage reached 96.6% in children 11 years of age. For a more extensive review of measles outbreaks in vaccinated populations read our article The 2013 Measles Outbreak: A Failing Vaccine, Not A Failure to Vaccinate.

Given that clinical evidence, case reports, epidemiological studies, and even the vaccine manufacturer’s own product warnings, all show directly or indirectly that MMR can spread measles infection, how can we continue to stand by and let the media, government and medical establishment blame the non-vaccinated on these outbreaks without any concrete evidence?


References

[1]  Kaic B, Gjenero-Margan I, Aleraj B. Spotlight on Measles 2010: Excretion of Vaccine Strain Measles Virus in Urine and Pharyngeal Secretions of a Child with Vaccine Associated Febrile Rash Illness, Croatia, March 2010. Eurosurveillance 2010 15(35).

[2] Nestibo L, Lee BE, Fonesca K et al. Differentiating the wild from the attenuated during a measles outbreak. Paediatr Child Health Apr. 2012; 17(4).

[3] Murti M, Krajden M, Petric M et al. Case of Vaccine Associated Measles Five Weeks Post-Immunisation, British Columbia, Canada, October 2013. Eurosurveillance Dec. 5, 2013; 18(49).

[4] Antona D, Lévy-Bruhl D, Baudon C, Freymuth F, Lamy M, Maine C, Floret D, Parent du Chatelet I. Measles elimination efforts and 2008-2011 outbreak, France. Emerg Infect Dis. 2013 Mar;19(3):357-64. doi: 10.3201/eid1903.121360. PubMed PMID: 23618523; PubMed Central PMCID: PMC3647670. Free full text Related citations

New male contraceptive is safe, effective and inexpensive — but no company has agreed to sell it.


Doctors are on the cusp of launching the first new male contraceptive in more than a century. But rather than a Big Pharma lab, the breakthrough is emerging from a university startup in the heart of rural India.

Years of human trials on the injectable, sperm-zapping product are coming to an end, and researchers are preparing to submit it for regulatory approval. Results so far show it’s safe, effective and easy to use-but gaining little traction with drugmakers. That’s frustrating its inventor, who says his technique could play a crucial role in condom-averse populations.

A new birth control method for men has the potential to win as much as half the $10 billion market for female contraceptives worldwide and cut into the $3.2 billion of annual condom sales, businesses dominated by pharmaceutical giants Bayer AG, Pfizer Inc. and Merck & Co., according to estimates from the last major drug company to explore the area. India’s reversible procedure could cost as little as $10 in poor countries, and may provide males with years-long fertility control, overcoming compliance problems and avoiding ongoing costs associated with condoms and the female birth-control pill, which is usually taken daily.

It could also ease the burden on the 225 million women in developing countries, who the World Health Organization says have an unmet need for contraception. Yet so far only a U.S. non-profit has taken up development of the technology abroad.

For Sujoy Guha, 76, the biomedical engineer who invented the product, the challenge is to find a company that wants to sell it. But male contraception is an area Big Pharma has so far shown little interest in.

“The fact that the big companies are run by white, middle-aged males who have the same feeling-that they would never do it-plays a major role,” said Herjan Coelingh Bennink, a gynecology professor who helped develop the contraceptives Implanon and Cerazette as head of research and development in women’s health for Organon International from 1987 to 2000. “If those companies were run by women, it would be totally different.”

Guha’s technique for impairing male fertility relies on a polymer gel that’s injected into the sperm-carrying tubes in the scrotum. The gel, which has the consistency of melted chocolate, carries a positive charge that acts as a buffer on negatively charged sperm, damaging their heads and tails, and rendering them infertile.

The treatment, known as reversible inhibition of sperm under guidance, or RISUG, is reversed with a second shot that breaks down the gel, allowing sperm to reach the penis normally.

The procedure is 98 percent effective at preventing pregnancy-about the same as condoms if they are used every time-and has no major side effects, according to R. S. Sharma, head of reproductive biology and maternal health at the Indian Council of Medical Research. About 540 men have received it in India, where it continues to prevent pregnancies in their partners 13 years after treatment, he said.

A submission to regulators this year will seek approval for RISUG as a permanent method of birth control. That will be appended with clinical data supporting reversibility, Sharma said. India has more married women with an unmet need for family planning than any other country, and social stigma and a lack of privacy in stores has kept condom use to less than 6 percent.

A new option for male birth control could garner as much as half the female contraceptives market, according to research by Organon in the 1990s, when the Dutch drugmaker partnered with Germany’s Schering AG on the last major effort to develop a male birth control pill. Demand would come from couples in long-term relationships looking to share family-planning responsibilities and single men looking for an alternative to condoms to prevent an unintended pregnancy from casual sex, Coelingh Bennink said.

Still, there were questions at Organon about whether it would be worthwhile financially to develop a new entrant in the low-margin contraceptives market, and the project was eventually shelved, he said.

Efforts on a hormone-based male contraceptive continued in 2008 in a study co-funded by the Bill & Melinda Gates Foundation and UN agencies that was published in October. While the injected regimen’s efficacy was “relatively good” compared to other methods, the study was terminated early after a safety review. The authors noted a “relatively high” frequency of mild to moderate mood disorders, sparking a media uproar over perceived double standards in the development of contraceptives because the side effects seemed similar to those women experience on the pill.

Bayer, which bought Schering in 2006, stopped all research and development activities around male fertility control about a decade ago, said Astrid Kranz, a company spokeswoman.

Although an earlier clinical trial involving the administration of hormones via injection and an implant was “efficient, with a tolerable side effect profile,” Kranz said, the Leverkusen, Germany-based drugmaker wasn’t convinced this “inconvenient” regimen would find sufficient market acceptance.

Male contraception isn’t an area of active research for Pfizer and Merck either, representatives said. Both companies sell products for female fertility control.

Side effects aside, it would take about $100 million and 10 years to bring a hormone-based male birth control pill to market-a low-priority undertaking for pharmaceutical executives, Coelingh Bennink said.

That’s now the dilemma Indian inventor Guha faces.

“In doing anything abroad, quite substantial money is required, and that can only come from the pharmaceutical industry,” Guha said, surrounded by dusty stacks of paper, books and prototype inventions that bury every surface in his office at the Indian Institute of Technology in Kharagpur, about 80 miles west of Kolkata.

In the face of disinterest from the pharmaceutical industry, Guha licensed the technology to the Parsemus Foundation, a U.S.-based non-profit, to help establish a market for it outside India, he said.

Parsemus is working on its own version, called Vasalgel, that it plans to manufacture and distribute at near cost-or potentially $10 to $20 per person in low- and middle-income countries-and $400 to $600 per person in wealthier markets, Elaine Lissner, the foundation’s founder, said in an email.

The foundation, based in Berkeley, California, is seeking donations to fund costly human trials starting next year after a study in 16 rhesus monkeys published last month showed Vasalgel was successful in preventing conception while the primates fraternized with females for 5 to 24 months.

Kinkar Ari, 39, a day laborer from a nearby village, said that when he and his wife decided they didn’t want more children they had a choice between tubal ligation for her or vasectomy for him, but neither could afford the time off to recuperate from the surgery.

When a public health worker told the couple about Guha’s promising alternative, Ari decided to enroll in the study. The injection took 15 minutes with local anesthesia, and after half an hour of observation at the clinic, he said, he was able to walk the 2.5 kilometers home. Two days later, he was back at work. Ari was so enthused by the procedure he convinced two other couples to have it done, he said.

Such stories encourage Guha to persist, he said, even though patents on his invention have long since expired and he won’t see any personal financial gain even if it takes off worldwide.

“Why should the burden be borne by the female only?” he said in his office after the three couples had left. “There has to be an equal partnership.”

Source:chicagotribune.com

Young woman’s ovaries destroyed by Gardasil: Merck ‘forgot to research’ effects of vaccine on female reproduction.


A newly-published study has revealed that Merck & Co., the corporate mastermind behind the infamous Gardasil vaccine for human papillomavirus (HPV), conveniently forgot to research the effects of this deadly vaccine on women’s reproductive systems. And at least one young woman, in this case from Australia, bore the brunt of this inexcusable failure after discovering that her own ovaries had been completely destroyed as a result of getting the vaccine.

Published in the peer-reviewed British Medical Journal (BMJ), the harrowing recount of this young 16-year-old girl’s experience should give pause to all parents currently being pressured by their doctors into having their young daughters jabbed with Gardasil. Robbed of her natural ability to experience full womanhood, this young woman experienced early menopause, in which her ovaries completely shut down before they were even able to fully develop.

Entitled Premature ovarian failure 3 years after menarche in a 16-year-old girl following human papillomavirus vaccination, this latest case study provides solid evidence that Gardasil is, at the very least, a serious threat to normal ovarian function. Not only was the damaged girl examined and verified to have had healthy ovaries prior to the shots, but there were no other identified factors besides Gardasil that could have possibly been involved in her sudden ill-fate.

Worse is the fact that information later obtained from the Australian Therapeutic Goods Administration (TGA) for the case — TGA is Australia’s equivalent of the Food and Drug Administration (FDA) in the U.S. — revealed that Merck had never even conducted safety testing on Gardasil in relation to its effects on women’s ovaries. According to the report, Merck had only tested Gardasil’s effects on male testes.

“Although the TGA’s Australian Public Assessment Report for Human Papillomavirus Quadrivalent Vaccine, February 2011, does report on the histology of vaccinated rat testes and epididymides, no histological report has been available for vaccinated rat ovaries,” explains the report. “[A] histological report of the ovaries of vaccinated rats remained unavailable beyond a numbering of the corpora lutea present at postweaning euthanasia following the first litter.”

In other words, Merck either intentionally or accidentally — either option is completely unacceptable, by the way — failed to check whether or not Gardasil has the potential to damage young women’s reproductive systems, even though young women have always been the primary target market for the vaccine. Only recently have young boys been pulled into the Gardasil fray, despite the fact that the long-term side effects of the vaccine in males is still largely unknown.

Gardasil loaded with additives known to damage female reproduction

As reported by investigative journalist Heidi Stevenson, there are at least two additive ingredients in Gardasil that may be responsible for damaging women’s ovaries. These ingredients are polysorbate 80, an emulsifying preservative, and L-histidine, a natural amino acid. Both of these ingredients are, of course, used in processed foods, which millions of people consume every day. But injecting them into the body has a much different biological effect than simply consuming them.

As it turns out, polysorbate 80, which also goes by the names Tween 80, Alkest, and Canarcel, has been shown in studies to damage female reproduction. Not only does this chemical additive greatly accelerate sexual maturation in women, but it also tends to reduce the weight and function of both the ovaries and the uterus. Similarly, L-histidine, when injected into muscle tissue, can cause the body to develop an autoimmune response to the natural substance, which can lead to many of the serious side effects being observed in many young girls who have been jabbed with Gardasil.

Be sure to read the following two reports by Heidi Stevenson to learn more about how Gardasil appears to damage female reproduction:
http://www.thelibertybeacon.com
http://gaia-health.com
Gardasil

Merck Says FDA Accepts Its SBLA For Keytruda For Treatment Of Head & Neck Cancer


Merck & Co. Inc. (MRK), known as MSD outside the United States and Canada, Wednesday announced that the U.S. Food and Drug Administration has accepted its supplemental Biologics License Application for Keytruda. It will be reviewed under the FDA’s Accelerated Approval program. The compound is intended for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy.

The company noted that the application envisages Keytruda as single agent at a dose of 200 mg administered intravenously every three weeks.

Keytruda is a humanized monoclonal antibody that can increase the ability of the body’s immune system to help detect and fight tumor cells. Keytruda blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Former Merck rep explains how mandatory vaccination is pushed for Big Pharma profit, not public health .


For five ruthless years, Merck & Co. knowingly deceived and poisoned 80 million people around the world with their infamous and deadly drug Vioxx. The drug was taken off the market in 2004 after a study revealed that Vioxx doubled the risk of heart attack and stroke in those who took the drug. The psychopaths who run Merck knowingly falsified safety data on Vioxx, which ultimately led to numerous heart attacks and strokes in unsuspecting patients.

All of Merck’s sales representatives must have realized at that point that they were nothing more than pawns for one of the most guile, criminal operations on the planet. Upon hearing the news in 2003, one sales rep decided to quit, disillusioned by the corruption she had become an acolyte for. As her eyes were opened and her life journey pressed on, it became apparent that her greatest desires for truth in medicine were going to express themselves as her reality unfolded. Her name is Brandy Vaughan.

Dismissed for asking questions

After moving to Europe and having her first son, she decided to move back to the U.S. to live in San Francisco, California. She didn’t trust pharmaceutical companies, but she did take her son to a wellness visit. The doctor pushed for several vaccinations for her son, who was at the precious age of six months. The doctor grew angry with Vaughan because she asked to see the vaccine inserts. After storming out of the office, the angry doctor sent a nurse in to tell Vaughan that she and her son were not welcome back.

Vaughan, who knew very little about vaccines at the time, was simply asking questions. After getting no answers from her doctor and getting the cold shoulder, she grew passionate about learning what vaccines were, what they were for, and what was in them.

Uncovering the sinister plot behind mandatory vaccinations

With no reason to trust pharmaceutical companies, Vaughan sought out information on her own. She soon learned that the vaccine industry not only had legal immunity from the damage vaccines caused, but she also found flawed safety data on vaccines that mirrored the Vioxx situation. The more she learned about vaccine toxins, the more she became passionate about not vaccinating her son.

As she started to raise awareness about the risks of vaccines, she began to realize a more sinister plot: pharmaceutical companies want to use the force of government to mandate vaccine schedules on all children. In 1952, that vaccine schedule included about seven doses. Today, the CDC’s vaccine schedule includes up to 49 doses before a child turns six years old. There are hundreds of vaccines currently being developed. It has become a game where pharmaceutical companies profit from the fears of disease instead of actually providing education to improve public health through nutrition. Profits are made by poisoning the blood of children with toxic adjuvants like aluminum.

Vaughan speaks out in new interview

The former Merck rep understood that “just because things are on the market, does not mean they’re safe.” Vaughan now does everything she can to inform parents about their power to choose what’s best for their children. She speaks out ardently against California’s SB 277 forced vaccination law.

“If there’s a risk, there has to be a choice,” says Vaughan. She has been repeatedly intimidated. Her house has been broken into several times since her rally against SB 277 at the California state capitol. Police told her that her home was likely “tapped” during one break-in. Her computer was tampered with in another break-in. Despite the intimidation, Vaughan continues to speak out. She founded the non-profit Council for Vaccine Safety, which strives to “increase public awareness and education on the risk of vaccines while advocating for safer vaccines.”

Learn more: http://www.naturalnews.com/051241_mandatory_vaccination_Brandy_Vaughan_Big_Pharma_profits.html#ixzz3mLpnnZzN

Merck’s Former Doctor Predicts Gardasil To Become The Greatest Medical Scandal Of All Time


dr-bernard-dalbergue
“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine” –(source) Marica Angell. She is a physician and author, along with being the first woman to serve as editor-in-chief of The New England Journal of Medicine – regarded as one of the most prestigious peer-reviewed medical journals in the world.

Since the Food and Drug Administration (FDA) approved Merck & Co.’s Gardasil vaccine in 2006, it has been surrounded by tremendous amounts of information, controversy and misinformation. This controversy has garnered much attention as people become more aware of the importance of paying attention to what goes into their bodies. It’s imperative that one examines a large body of evidence before believing what is seen on TV or stated on a radio advertisement, and people are slowly starting to wake up to this fact.

“It is a vaccine that’s been highly marketed, the benefits are over-hyped, and the dangers are underestimated.” –  (Taken from the ONE MORE GIRL DOCUMENTARY) – Dr. Chris Shaw, Professor at the University of British Columbia, in the department of Neuroscience, Ophthalmology, and Visual Sciences.

Gardasil, also known as the Human papilloma virus (HPV) vaccine, is given as a series of three shots over 6 months to protect against HPV infection and its associated health problems. Two vaccines (Cervarix and Gardasil) are said to protect against cervical cancers in women. Gardasil is also said to protect against genital warts and cancers of the anus, vagina and vulva. Both vaccines are available for females, while only Gardasil is available for males.

The Centers For Disease Control (CDC) claims that the HPV vaccine offers the best protection to girls and boys who receive all three vaccine doses and have time to develop an immune response before being sexually active.  This is why it is recommended for children who have reached the age of 11 or 12.

There is a long list of educated people speaking out about this vaccine. This time around, it’s Dr. Bernard Dalbergue, a former pharmaceutical industry physician with Gardasil manufacturer Merck who has started to raise his voice against the HPV vaccine, along with the pharmaceutical industry as a whole. He joins a long list of experts from within the industry who have slammed the rampant manipulation and control of clinical research done by the pharmaceutical industry.

This quote is taken from an interview that happened in April of 2014, from an issue of the French magazine Principes de Santé (Health Principles):

“The full extent of the Gardasil scandal needs to be assessed: everyone knew when this vaccine was released on the American market that it would prove to be worthless.  Diane Harper, a major opinion leader in the United States, was one of the first to blow the whistle, pointing out the fraud and scam of it all.I predict that Gardasil will become the greatest medical scandal of all time because at some point in time, the evidence will add up to prove that this vaccine, technical and scientific feat that it may be, has absolutely no effect on cervical cancer and that all the very many adverse effects which destroy lives and even kill, serve no other purpose than to generate profit for the manufacturers. Gardasil is useless and costs a fortune!  In addition, decision-makers at all levels are aware of it! Cases of Guillain-Barré syndrome, paralysis of the lower limbs, vaccine-induced MS and vaccine-induced encephalitis can be found, whatever the vaccine.” (source) – Dr. Bernard Dalbergue

Dr. Dalbergue has also recently released a book titled “Omerta dans les labos pharmaceutiques: Confessions d’un medicine,” which goes into more detail about corruption in the medical/pharmaceutical industry. He also recently made an appearance on a popular radio show in France, you can watch here. Althought it’s in French, it’s nice to put a face to the name so that you can see he is real.

Scandal, misinformation, and data manipulation have become part and parcel of clinical research and pharmaceutical drug development. It is important that we realize this as fact and not hearsay; apart from whistle-blowers, there are numerous documents that illustrate this reality. One of the best examples (out of many) comes from Lucija Tomljenovic, PhD, from the Neural Dynamics Research Group in the Department of Ophthalmology and Visual Sciences at the University of British Columbia. In 2011 she obtained documents which reveal that vaccine manufacturers, pharmaceutical companies, and health authorities have known about the multiple dangers associated with vaccines but have chosen to withhold them from the public. The documents were obtained from the UK Department of Health (DH) and the Joint Committee on Vaccination and Immunization (JCVI), who advise the Secretaries of State for Health in the UK about diseases preventable through immunizations.

Another doctor making noise regarding the HPV vaccine is Dr. Diane Harper. 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 papers about it. She has been a paid speaker and consultant to Merck. It’s very unusual for a researcher to publicly criticize a medicine or vaccine she helped get approved, it is a credit to her character for doing so. It also says a lot that she agreed to participate in the ONE MORE GIRL documentary, which implies (I believe) there is a chance she resonates with the other information that’s stated in the documentary that she has not said publicly.

ONE MORE GIRL is an answer to Merck & Co’s One Less Girl marketing campaign for the HPV vaccine Gardasil. The parents who encouraged their daughters to get the HPV vaccine did so on the advice of their doctors, their government, and their belief in pharmaceutical industry. They were not “anti-vaccine,” they played by the rules, and now they are paying the price. It’s a documentary that has several experts from the industry, various doctors, and university researchers speaking out about the vaccine.

“They created a huge amount of fear in mothers, and appealed to mothers’ sense of duty to get them to get their daughters vaccinated” – Dr Diane Harper (source)

The above quote was taken from the film, and here is an excerpt of her raising some important things to consider regarding the vaccine.

Some Research

If we are talking about recent research regarding the HPV vaccine, a new review was just published  in the journal Autoimmunity Reviews titled, “On the relationship between human papilloma virus vaccine and autoimmune disease.” 

The authors of this study came to the same conclusion as Dr. Harper, a doctor that was directly involved with the clinical trials for the approval of the vaccine (mentioned earlier in the article). They concluded that:

“The decision to vaccinate with HPV vaccine is a personal decision, not one that must be made for public health. HPV is not a lethal disease in 95% of the infections; and the other 5% are detectable and treatable in the precancerous stage.” (If you are interested you can access the paper here)

They also listed several conditions in which HPV vaccination is most likely the culprit, having been linked to a variety of autoimmune diseases which include: Multiple sclerosis, Guillain-Barre syndrome, primary ovarian failure, and more.

The 2008 FDA Closing Statement on Gardasil reports that 73.3% of the ‘healthy’ girls who participated in the clinical trials developed ‘New Medical Conditions. The list below highlights some of the ‘New Medical Conditions’ reported in the 2008 FDA Closing Statement on Gardasil. (source)

    • Blood & Lymphatic System Disorders 2.9% = 1 in 34
    • Gastrointestinal Disorders 13.4% = 1 in 7
    • General & Administration Site Conditions 3.8% = 1 in 33
    • Immune System Disorders 2.4% =1 in 50
    • Infections & Infestations 52.9% = 1 in 2
    • Injury, Poisoning, & Procedural Complications 8.0% =1 in 12
    • Investigations 11.8% =1 in 9
    • Musculoskeletal & Connective Tissue Disorders 6.8% =1 in 14
    • Nervous System Disorders 9.4% = 1 in 10
    • Pregnancy, Puerperium & Perinatal Conditions 2.0% = 1 in 50
    • Psychiatric Disorders 4.4% =1 in 22
    • Renal Disorders 2.7% =1 in 37
    • Reproductive & Brest Disorders 24.8 % = 1 in 14
    • Respiratory, Thoracic & Mediastinal Disorders 5.5% = 1 in 18
    • Skin & Subcutaneous Tissue Disorders 7.4% = 1 in 13
    • Surgical Procedures = Appendectomy 10.2% = 1 in 10

A year ago the vaccine was taken off the recommended vaccine schedule in Japan due to it’s adverse effects. What’s even more concerning is the fact that today’s vaccine has twice the amount of aluminum in it.

Related CE Article:

This is what can happen to children who receive aluminum containing vaccines.

Another groundbreaking article titled “Quantifying the possible cross-reactivity  risk of an HPV16 vaccine, published in the Journal of Experimental Therapeutics and Oncology concluded that:

“The number of viral matches and their locations make the occurrence of side autoimmune cross-reactions in the human host following HPV16-based vaccination almost unavoidable.” (source)

The list is literally endless, and for the sake of not turning this article into an essay, I’ll stop here. Hopefully I’ve provided you with enough information to further your research if interested. If you want to look at more scientific data, you can check out:

Giant Database of Studies Regarding The Gardasil Vaccine.

Sources:

All other sources are linked throughout the article.

 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2964337/

http://www.greenmedinfo.com/anti-therapeutic-action/vaccination-hpv-gardisil

http://www.sciencedirect.com/science/article/pii/S1568997214000664

http://onemoregirlmovie.com/

http://www.cbsnews.com/news/gardasil-researcher-speaks-out/

 http://nsnbc.me/wp-content/uploads/2013/05/BSEM-2011.pdf

Giant Database of Studies Regarding The Gardasil Vaccine.

Merck’s Former Doctor Predicts that Gardasil will Become the Greatest Medical Scandal of All Time | Health Impact News


Dr Bernard Dalbergue Mercks Former Doctor Predicts that Gardasil will Become the Greatest Medical Scandal of All Time

Health Impact News Editor

Dr. Dalbergue (pictured above), a former pharmaceutical industry physician with Gardasil manufacturer Merck, was interviewed in the April 2014 issue of the French magazine Principes de Santé (Health Principles).

Excerpts:

The full extent of the Gardasil scandal needs to be assessed: everyone knew when this vaccine was released on the American market that it would prove to be worthless!  Diane Harper, a major opinion leader in the United States, was one of the first to blow the whistle, pointing out the fraud and scam of it all.

Gardasil is useless and costs a fortune!  In addition, decision-makers at all levels are aware of it!

Cases of Guillain-Barré syndrome, paralysis of the lower limbs, vaccine-induced MS and vaccine-induced encephalitis can be found, whatever the vaccine.

I predict that Gardasil will become the greatest medical scandal of all times because at some point in time, the evidence will add up to prove that this vaccine, technical and scientific feat that it may be, has absolutely no effect on cervical cancer and that all the very many adverse effects which destroy lives and even kill, serve no other purpose than to generate profit for the manufacturers.

There is far too much financial interest for these medicines to be withdrawn.

As we have reported in many previous articles here at Health Impact News, the HPV vaccine has become a huge international controversy, while enjoying widespread mainstream media and medical acceptance here in the United States. Any mainstream media reporter who dares to report on the controversy surrounding Gardasil faces ridicule and a potential loss of their career. (Just ask Katie Couric.)

U.S. law prevents anyone from suing Merck or any other vaccine manufacturer as the U.S. Congress gave them total immunity from civil lawsuits in 1986, and that legal protection which gives them a free pass to put as many vaccines into the market as they want to, was upheld by the U.S. Supreme Court in 2011. In addition, the National Institute of Health receives royalties from the sales of Gardasil. So don’t expect objective, true information from the U.S. mainstream media, or your U.S. doctor.

But Merck does not have the same legal protection outside the U.S., and it is here we must find information regarding lawsuits over injuries and deaths related to Gardasil.

Gardasil: An International Scandal

SaneVax, Inc.

Press Release from Michèle Rivasi, MEP France

Michèle Rivasi, MEP Vice-Chair of the Greens/EFA in the European Parliament, organized a press conference in Paris on April 2, the topic was Gardasil, a vaccine from Sanofi-Pasteur MSD against certain human papillomavirus responsible for cancer.

In the space of seven years, nearly 2 million young women aged 13-26 years received at least one dose of this vaccine in France, reimbursed at 65% by the Social Security … even though the evidence of its effectiveness has not yet been proven.`

For Michèle Rivasi, it is likely that clinical trials of Gardasil were not conducted following the rules of science. Normally, to evaluate safety, the treatment must be compared with placebo. However, in the case of this vaccine, the “placebo” that was used was the vaccine adjuvant itself.

The French Agency for Sanitary Safety of Health Products (AFSSAPS) registered Gardasil on its list of drugs under surveillance after the crisis of the Mediator.

Today in Europe, many young women, aged 18-24 years without medical history are affected with very debilitating diseases that could be attributed directly to vaccination. Océane Bourguignon was 15 when she received two injections of Gardasil. Within months she was hospitalized for multiple sclerosis. She temporarily lost her sight and the use of her legs. Her father, Jean-Jacques, was present at the conference with their lawyer, Jean-Christophe Coubris, together with the mother of Orianne Lochu, another young victim.

Today, many whistleblowers, researchers, physicians and health professionals are against the objective set in the Cancer Plan announced by François Hollande on February 4, which is to double the “coverage “of vaccination of young girls with Gardasil until 2021 because:

– Cervical cancer in France is no longer a public health problem (1.7 % of all cancers)

– The vaccine is only effective against infections caused by some strains of the virus: Gardasil contains antigens only for strains of type 6, 11, 16 and 18 and the other vaccine, Cervarix, for 2 strains. However, infections with strains 16 and 18, established as scarecrows by manufacturers, seem rarer in Europe. Note that there are more than 100 strains, including 18 considered high-risk oncogenic

– There is no evidence to date demonstrating efficacy of the vaccine against the occurrence of cervical cancer! 20 years back would still be necessary to obtain such evidence, however, the duration of vaccine protection is limited in time.

– The presence of aluminum adjuvant is very problematic, as shown by scientists Chris Shaw and Lucija Tomljenovic, from the University of British Columbia, and Professor Authier and Gherardi, from Hospital Henri-Mondor (Créteil), all present at the conference. The aluminum migrates into the body and reaches the brain, where it accumulates. There are many adverse effects noted: death, convulsions, syncope, Guillain-Barré syndrome, transverse myelitis, facial paralysis, chronic fatigue syndrome, autoimmune diseases, pulmonary embolisms, myofasciitis macrophages, pancreatitis…

– The effectiveness of conventional smears to detect cervical cancer has been proven.

– Deal with these risks. Austria refused to include these vaccines in the vaccination schedule and Japan no longer recommends this vaccination; many challenges exist in other countries.

– A dose of Gardasil costs 123.44 euros in France, or 370.32 euros for 3 injections required, this is far too expensive. This cost could increase if boosters were necessary, because the duration of protection of initial vaccination is still not known. The period of “catch-up” could generate a cost to social security of 926 M°  euros. In subsequent years the annual cost would be € 148 M °.

-An indecent campaign of communication was engaged years ago to promote this vaccine: lobbying campaigns and aggressive advertising are conducted by laboratories that play on the fears and guilt, especially of mothers: “Protect your daughter, this is what is more natural for a mother.” One of these commercials has also been banned by the Medicines Agency in August 2010 for “lack of objectivity “.

For all of these reasons, MEP Michèle Rivasi calls for a moratorium: member states must stop recommending this vaccine until more studies are conducted on Gardasil, its effectiveness and dangers.

Lipitor Without a Rx? Pfizer Pushes Ahead With OTC Plans.


Pfizer, the maker of Lipitor, is pushing forward with efforts to sell its drug to patients without a doctor’s prescription, according to the Wall Street Journal.

The company recently launched a 1200-patient study to investigate whether patients could successfully take over-the-counter (OTC)atorvastatin to lower their LDL-cholesterol levels. Patients in the trial, which is currently recruiting at 35 US pharmacies, would get their own blood tests and would make decisions based on those results.

A positive study would determine whether Pfizer will file for regulatory approval of its OTC medication, according to the Journal.

Simvastatin has been available OTC at the 10-mg dose in the UK for nearly 10 years. Merck has gone before the US Food and Drug Administration three times since 2000, but the agency has turned away its drug, lovastatin (Mevacor) 20 mg, each and every time. Merck sought approval of OTC lovastatin in moderate-risk patients and aimed to market its drug to the “motivated health-conscious consumer.”

Like Merck, Pfizer says an OTC Lipitor would close the gap for people at risk of cardiovascular disease but who are not currently taking the lipid-lowering therapy.

Dr Neil Stone (Northwestern University Feinberg School of Medicine, Chicago, IL), the chair of the American College of Cardiology (ACC)/American Heart Association (AHA) guidelines for the treatment of cholesterol, told the Journal the new guidelines do not support OTC use of statins. In fact, the new guidelines don’t recommend treating to LDL targets any longer but instead recommend a moderate- or high-potency statin based on patient’s 10-year risk of cardiovascular disease.

Given that Pfizer is investigating the feasibility of just a 10-mg dose of Lipitor, undertreatment is a concern. “There’s a chance that a lot of people would take less than needed,” Dr Steven Nissen (Cleveland Clinic, OH) told the Journal.

At one stage, Lipitor was the world’s biggest-selling drug, with sales peaking at $13 billion in 2006, but since the patent expired sales have declined to $2.3 billion in 2012, reports the Journal.