‘So Many Pitfalls’: Feds Push School-Based Health Centers as Critics Sound Alarm Over Lack of Parental Consent
By Suzanne Burdick, Ph.D. | The Defender | August 9, 2023
The recent push by the U.S. federal government to rapidly expand the use of school-based health centers (SBHCs) across the country has some critics concerned children will receive, or be pressured into receiving, unnecessary or unwanted medical interventions — including vaccines — without their parents’ knowledge or consent.
Georgia attorney Nicole Johnson, co-director of Georgia Coalition for Vaccine Choice and a consultant to the Children’s Health Defense’s (CHD) legal team, told The Defender :
“It’s scary because these health centers sound really good. In some of the rural and poor communities especially, this is going to seem like a really good way for children to get this care.
“And while there may be some conveniences, there are so many concerns with allowing medical exams and treatments at school. Parents need to be involved in all medical decisions and I fear they are being left out of the equation.”
SBHCs are intended to provide high-quality healthcare to kids by offering “primary care, mental health care, and other health services in schools,” particularly in underserved communities.
This includes services “to prevent disease, disability, and other health conditions or their progression” such as “immunizations” and “well-child care.”
According to the Centers for Disease Control and Prevention’s (CDC) Community Preventive Services Task Force, SBHCs can improve educational and health outcomes.
The CDC also considers SBHCs as integral to its Whole School, Whole Community, Whole Child model because they provide health services and mental health counseling.
But critics like Johnson worry that though there may be benefits to SBHCs, there are also downsides — including lack of regulation of the centers and the fact that parents may not be aware of the broad range of medical and behavioral services being provided in their children’s schools.
SBHCs have been linked to higher human papillomavirus (HPV) vaccination rates, according to a 2022 report by Harvard University’s Center for Health Law and Policy Innovation and the University of California Davis Comprehensive Cancer Center.
The report — written expressly to “address vaccine hesitancy” — concluded: “These results suggest SBHCs create a considerable opportunity … to implement successful school based HPV vaccination programs.”
Merck, the maker of the Gardasil HPV vaccine, is one of the funders of the School-Based Health Alliance, a large networking organization that “works on policy, standards, data, and training issues” regarding SBHCs.
Federal, state authorities pour taxpayer money into school-based health centers
The idea of running full-service health centers in public schools has been around for more than two decades, but events in 2022 caused SBHCs to catch on like wildfire.
Congress and President Joe Biden in June 2022 passed the Bipartisan Safer Communities Act, which allowed the U.S. Department of Health and Human Services (HHS) to award $50 million in grants to states “for the purpose of implementing, enhancing, or expanding the provision” of healthcare assistance through SBHCs using Medicaid or the Children’s Health Insurance Program (CHIP).
The legislation charged the Centers for Medicare & Medicaid Services (CMS) with expanding access to Medicaid healthcare services — including behavioral health services — in schools, and reducing the administrative burden for states and schools.
A CMS spokesperson told The Defender that Medicaid and CHIP now can provide reimbursement for services given in SBHCs for children and youth who are covered by those programs.
Additionally, in May 2022 HHS awarded $25 million in grants to 125 SBHCs “to improve and strengthen access to school-based health services in communities across the country.”
State public officials also are dedicating funds to expand SBHCs. For instance, the governor of Georgia in fall 2022 announced an investment of $125 million to expand school-based health services to rural communities in Georgia.
Pediatricians can ‘partner’ with schools
The American Academy of Pediatrics (AAP) supports SBHCs and said in a policy statement that pediatricians may act as “sponsors” by partnering with a school to establish the SBHC as an extension of their practice or by supervising the care given at a SBHC.
“Sponsors also include local hospitals that can provide prearranged after-hours and school vacation coverage and financial support for SBHCs,” the AAP said.
The Defender reached out to the AAP statement’s lead authors for comments on how parental consent is handled in SBHCs, but they did not respond by our publication deadline.
SBHCs also have the support of the School-Based Health Alliance. In addition to funding from Merck, the alliance receives financial support from HHS’ Health Resources & Services Administration.
Documents obtained in June by CHD revealed that the HHS gave $4.7 million to research headed by a Merck consultant that focused on developing “The Announcement Approach Training,” where providers simply “announce” a child will be receiving the HPV vaccine as part of a routine office visit, instead of discussing it with the family first.
The government-funded research also is testing whether financial incentives and peer pressure can “nudge” doctors to change how they talk to their patients in order to increase HPV vaccine uptake among adolescents.
Meanwhile, a fierce battle is taking place in multiple states where some lawmakers are pushing legislation that would allow minors to receive treatments to prevent sexually transmitted diseases — including Merck’s HPV vaccine — without parental knowledge or consent.
‘So many pitfalls … so many ways for someone else to be making parental decisions’
Justine Tanguay, an attorney with nearly 20 years of experience advocating for children in various areas of the law, told The Defender :
“Don’t be fooled! This year many schools will be sending home blanket consent-to-treat forms for parents to sign.
“Parents need to be aware that these forms are not the traditional authorization requests for the school nurse to give first-aid or to treat minor illnesses.”
Tanguay, CHD’s director of campaign and research, explained that the forms may give those who run the SBHC the legal authorization to provide “comprehensive healthcare.”
This could include — but may not be limited to — “the ability to provide preventative treatment, behavioral and mental health services, reproductive counseling, lab and prescription services, various medical screenings, immunizations and disease management,” Tanguay said.
Moreover, SBHC staff will have “direct access” to a minor child, Tanguay said, “as well as the ability to encourage a minor child to make personal healthcare decisions without the need to consult with and seek approval from a parent.”
“The opportunity to circumvent both parental rights and informed consent is ripe for abuse,” Tanguay warned.
Johnson agreed, saying, “There are just so many pitfalls here, so many ways for someone else to be making parental decisions.”
Johnson shared with The Defender a consent form currently used in a school district north of Atlanta, Georgia.
The form says nothing about parents being notified before, during or after treatment. It reads:
“I hereby voluntarily give my consent for [my child] to receive health services with Georgia Highlands Medical Services at Cumming Elementary School.
“I further authorize any health care provider and professional staff working for the clinic to provide such medical tests, diagnoses, procedures, and treatments as are reasonably necessary or advisable for the medical evaluation and management of my child’s health care.”
The form does not clarify who determines what services are “reasonably necessary or advisable” and does not explain how parents will be involved in that process. It states:
“I understand that my signing this consent allows the health care provider and professional clinic staff of Georgia Highlands Medical Services at Cummings Elementary Schools to provide comprehensive health services which includes physical and behavioral health services.”
Again, the form does not clarify what specifically falls into the category of “physical and behavioral health services” or how parents will be involved in the determination for what services their child may need.
“I think about my own kids when they were in school,” Johnson said, “how easily they could have been swayed to get a vaccine or a medical treatment just because an adult told them that they should.”
“It’s really dangerous to have all of these things offered to them without the parents even being aware,” she said. “A lot of kids — most kids — are compliant. They want to do what the adults are telling them to do.”
According to the CDC, a key component of its Whole School, Whole Community, Whole Child model, which includes SBHCs, is “family engagement.”
However, the agency’s 37-page document about family engagement mentions parental permission only once and does not discuss parental consent for medical treatment beyond the application of sunscreen during recess.
According to a CMS spokesperson, SBHCs “follow the same practices as any other medical center or Medicaid or Children’s Health Insurance Program (CHIP) provider … including parental consent requirements.”
The spokesperson did not go into detail on whether consent would be requested generally or for each specific medical treatment.
Where’s the regulatory oversight?
Tanguay pointed out that SBHCs exist without proper regulatory oversight.
According to Stand for Health Freedom, a nonprofit “dedicated to protecting informed consent in medical care,” SBHCs are “completely unregulated.”
For instance, it is presently unclear how HIPAA law (the Health Insurance Portability and Accountability Act of 1996) and FERPA law (the Family Educational Rights and Privacy Act) will be applied to SBHCs and students’ health information.
Stand for Health Freedom also pointed out that although in-school clinics may relieve busy parents of the burden of taking their children to the doctor, “medical ethics do not allow physicians to treat minors without a parent or guardian present, which is why parents cannot simply drop their child off at the doctor’s office and come back later to collect them.”
Stand for Health Freedom said:
“Parents must engage politically and work with state health freedom leaders to ask lawmakers to either ban SBHCs in favor of the existing limited school-nurse model, or place guardrails on SBHCs to protect parental consent and involvement in their minor children’s medical care.”
Meanwhile, proponents of SBHCs, such as the School-Based Health Alliance, argue that SBHCs are a “powerful tool for achieving health equity among children and adolescents who unjustly experience disparities in outcomes simply because of their race, ethnicity, or family income.”
Johnson said she disliked being “so skeptical of something that may potentially benefit some people” but added, “as a parent, it is your job and your right to be a part of the decisions that affect the health and well-being of your child.”
Johnson said parents who experienced or witnessed vaccine injury would be particularly skeptical of putting medical decisions in the hands of government agencies, including schools.
“And the COVID response created even more skeptics,” she said, adding:
“It’s unfortunate that we have to approach this [SBHCs] with the thought, ‘How could this be abused?’ But that’s where we are.”
The Defender on Aug. 3 reached out to the School-Based Health Alliance to ask how parental consent in SBHCs is handled and what they’d like parents who may feel distrustful of the U.S. medical system to know about SBHCs. The alliance did not respond by our publication deadline.
Suzanne Burdick, Ph.D., is a reporter and researcher for The Defender based in Fairfield, Iowa. She holds a Ph.D. in Communication Studies from the University of Texas at Austin (2021), and a master’s degree in communication and leadership from Gonzaga University (2015). Her scholarship has been published in Health Communication. She has taught at various academic institutions in the United States and is fluent in Spanish.
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
Utah Woman Is First to Sue Merck Alleging Gardasil HPV Vaccine Caused Cervical Cancer
The Defender | April 26, 2023
A lawsuit filed Tuesday in federal court alleges Merck’s Gardasil human papillomavirus (HPV) vaccine caused a young Utah woman to develop cervical cancer and other injuries.
The lawsuit, filed on behalf of Caroline Cantera, 25, by Wisner Baum (formerly Baum Hedlund Aristei & Goldman), is the first lawsuit to allege Gardasil can cause cervical cancer — the very cancer Merck asserts Gardasil prevents.
Cantera alleges New Jersey-based Merck & Co., Inc., and subsidiary Merck Sharp & Dohme oversold Gardasil as a “cervical cancer vaccine” and downplayed known health risks to enhance sales.
Cantera’s attorneys filed the complaint in the U.S. District Court for the Western District of North Carolina as part of the Gardasil multidistrict litigation (MDL). Dozens of federal Gardasil injury cases filed throughout the country have been consolidated in North Carolina.
According to the complaint, Merck never studied whether Gardasil prevents cervical cancer. Instead, the drugmaker tested Gardasil to determine if it could prevent the development of certain lesions, some of which are considered related to cancer — even though a majority of such lesions, even the most serious, regress on their own.
Public health officials have long recommended the Pap test as the most effective frontline public health response to prevent cervical cancer. Long before Gardasil was introduced to the market in 2006, cervical cancer rates had been plummeting by up to 80% with the implementation of routine Pap testing.
For those who are diagnosed with precancerous lesions or worse, cervical cancer is largely treatable if caught early.
Nonetheless, Merck sought “Fast Track” U.S. Food and Drug Administration approval of Gardasil. Once approved, Merck engaged in a relentless marketing campaign falsely proclaiming that Gardasil was a “cervical cancer vaccine” and that any young girl vaccinated with Gardasil would become “one less” woman with cervical cancer, the lawsuit claims.
Cantera alleges Gardasil can actually increase the risk of cervical cancer. The Gardasil vaccine label specifically states, “Gardasil has not been evaluated for potential to cause carcinogenicity or genotoxicity.”
Studies from the Centers for Disease Control and Prevention (CDC) suggest the suppression of the HPV strains targeted by Gardasil (there are more than 200 HPV strains and Gardasil targets between four and nine strains) may actually open an ecological niche for replacement by more virulent strains, thus increasing the risk of cervical cancer.
Merck’s own studies show that for those previously exposed to HPV (a huge percentage of the population) when vaccinated, there is an up to 44.6% increased risk of developing advanced abnormal pre-cancer cells or worse.
The complaint also cites rapidly climbing cervical cancer rates among young women in countries where Gardasil has seen a high uptake. Studies also show young women who received the Gardasil vaccine are foregoing routine Pap screening due to a false sense of security that the HPV vaccine will protect them from cervical cancer.
Bijan Esfandiari, co-lead counsel for plaintiffs in the Gardasil MDL, said:
“Merck has heavily promoted Gardasil as a cancer prevention vaccine even though the studies weren’t designed to answer that question, and its marketing has effectively resulted in young women foregoing Pap screening, the most reliable and proven method of preventing cervical cancer.
“Merck also hasn’t studied whether Gardasil can cause cancer, but we now have evidence it can increase the risk of cancer. Given Merck makes over $6 billion a year on Gardasil, it has little incentive to stop the deception.
“Through our litigation, we hope to expose the truth and hold Merck accountable for the harm it has done to Caroline and others.”
Cantera ‘had to face the painful fact that I will never be able to have children of my own’
Cantera was 19 years old when she received her first of three Gardasil shots. She said she agreed to receive Gardasil after being convinced by Merck’s prolific marketing that the vaccine is very safe and prevents cervical cancer.
Before receiving the HPV vaccine, Cantera was healthy and never had to go to the doctor for anything other than regular checkups and physical exams for sports. She received routine Pap tests, all of which were negative prior to Gardasil.
In high school, she played tennis, regularly went backpacking and loved spending time outdoors. She lived a happy, carefree life filled with friends and activities.
After her Gardasil injections, Cantera experienced unexpected fatigue, intense stomach aches and overall weakness throughout her body. The fatigue and occasional abdominal pain continued until she noticed that her period had lasted over four weeks.
After what she thought was an initial visit to a gynecologist, her life suddenly took a drastic and unexpected turn.
Cantera was diagnosed with stage four cervical cancer. She received multiple biopsies, CT scans and MRIs, had six rounds of chemotherapy, 30 radiation treatments, three brachytherapy treatments and saw countless doctors.
She was unable to go back to university for her final semester and struggled to finish the classwork necessary to receive her undergraduate degree.
Because most of her treatment was directed at her cervix, her ovaries were also affected, putting her into menopause in her 20s. She will never be able to have children of her own because her eggs are no longer viable due to the cancer treatment.
Cantera said:
“Every day since my diagnosis has been a battle. My body is still recovering from the toll of such intense treatments to fight cancer, and I live in constant fear that my cancer could come back at any time.
“On top of all that, I also had to face the painful fact that I will never be able to have children of my own. If Merck knew this vaccine can cause so much harm, why didn’t they warn people?”
In September 2022, Wisner Baum and Robert F. Kennedy Jr., chairman on leave from Children’s Health Defense, filed their first wrongful death suit against Merck, alleging the drugmaker’s Gardasil HPV vaccine caused the death of 13-year-old Noah Tate Foley.
Wisner Baum and Kennedy have filed numerous lawsuits against Merck alleging the company knowingly conceals the adverse events associated with its Gardasil vaccine. These include:
- Victoria Trevisan (California)
- Merrick Brunker (California)
- Emma Sullivan (New Jersey)
- Ashley Dalton (Michigan)
- Abigail Stratton (South Carolina)
- Savannah Flores (Nevada)
- Korrine Herlth (Connecticut)
- Kayla Carrillo (California)
- Michael Colbath (California)
- Sahara Walker (Wisconsin)
- Zachariah Otto (California)
- Julia Balasco (Rhode Island)
While each case is unique, all of the plaintiffs agree that if Merck had told the truth about the known dangers associated with Gardasil, they never would have consented to the HPV vaccine.
If you or your child suffered harm after receiving the Gardasil HPV vaccine, you may have a legal claim. Visit Wisner Baum for a free case evaluation or call 855-948-5098.
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
Merck’s Taxpayer-Subsidized COVID Pill Linked to New Virus Mutations, Study Finds
By Michael Nevradakis, Ph.D. | The Defender | February 3, 2023
Merck’s oral antiviral pill for COVID-19, molnupiravir — marketed under the name Lagevrio — may be fueling the development of new and potentially deadly variants of COVID-19, according to the authors of a new preprint study.
The study, released Jan. 27 by a team of U.S. and U.K researchers, found, “It is possible that some patients treated with molnupiravir might not fully clear SARS-CoV-2 infections, with the potential for onward transmission of molnupiravir-mutated viruses.”
Merck received significant taxpayer funding from the Biden administration to develop and distribute molnupiravir, and the U.S. government bought nearly 2 million courses of the drug on the taxpayer’s dime.
The study, which is pending peer review, followed the discovery by a middle school science and math teacher in Indiana who found numerous variants of COVID-19 emerged after molnupiravir began to be widely distributed.
Scientists had long warned that the development of such mutations from the use of molnupiravir was possible.
“It’s not a surprise that molnupiravir could cause [the] escape of mutant virus strains or substrains into the population,” said Dr. Harvey Risch. “Its main function is to get the virus to mutate faster.”
Risch, professor emeritus and senior research scientist in epidemiology (chronic diseases) at the Yale School of Public Health, told The Defender :
“The idea is that it will mutate itself to death. But some live mutants could get out, and this paper gives evidence that they have.”
Brian Hooker, Ph.D., P.E., chief scientific officer for Children’s Health Defense, said the study’s authors scanned global SARS-CoV-2 sequence databases looking for mutations characteristic of those by molnupiravir (G-to-A and C-to-U) and found an uptick of those mutants starting in 2022 — after molnupiravir was put on the market and specifically in countries where molnupiravir was distributed.
“Although this isn’t ‘direct proof’ that the mutations came directly from molnupiravir use,” Hooker told The Defender, “the evidence is very compelling, confirming the fears of many who warned of this prior to FDA [U.S. Food and Drug Administration] approval of the drug in late 2021.”
The FDA granted molnupiravir Emergency Use Authorization (EUA) on Dec. 23, 2021, for use in mild-to-moderate COVID-19 infections in patients 18 and over.
The EUA came just one day after the FDA authorized Pfizer’s COVID-19 antiviral treatment Paxlovid.
Merck this week announced massive revenues from sales of molnupiravir in 2022, but projected a significant decrease in those sales in 2023.
The FDA on Wednesday removed the requirement that a person has to test positive for COVID-19 in order to get a prescription for molnupiravir or Paxlovid.
‘I think we are courting disaster’
Molnupiravir “works by creating mutations in the COVID-19 genome that prevent the virus from replicating in the body, reducing the chances it will cause severe illness,” according to Bloomberg.
However, according to Science, the findings of the preprint study suggest “some people treated with the drug generate novel viruses that not only remain viable, but spread.”
This finding “underscores the risk of trying to intentionally alter the pathogen’s genetic code,” leading some researchers to “worry the drug may create more contagious or health-threatening variations of COVID,” Bloomberg reported.
Virologist William Haseltine, Ph.D., chair and president of ACCESS Health International, has repeatedly raised such concerns about molnupiravir.
“It’s very clear that viable mutant viruses can survive [molnupiravir treatment] and compete [with existing variants],” Haseltine told Science. “I think we are courting disaster.”
According to the Gateway Pundit, “When one studies how Lagevrio works, this should not come as a shock. The pill attacks the COVID virus by trying to alter its genetic code.”
The Gateway Pundit reported:
“Once inside a human cell, a virus can make 10,000 copies of its genetic code in a few hours. Each copy made increases the risk the virus makes a rare mistake and creates an inexact replica.
“This is how mutations happen as we have seen with COVID. A drug that deliberately alters a virus’s genetic code would greatly increase the mutation risk.”
Dr. Jonathan Li, a virologist and the director of Li Laboratory, associated with Harvard Medical School and Brigham and Women’s Hospital, told Bloomberg :
“There’s always been this underlying concern that it could contribute to a problem generating new variants. This has largely been hypothetical, but this preprint validates a lot of those concerns.”
According to Science, Haseltine and other scientists have long worried that molnupiravir would create COVID-19 mutations that “would survive and propagate — and perhaps turn out to be more transmissible or virulent than before.”
A Merck spokesperson described that theory as “an interesting hypothetical concern,” prior to the drug receiving EUA.
The same scientists also worried that aside from the virus, the DNA of those receiving the drug might also mutate, Science reported.
These concerns led “researchers and citizen scientists” to examine COVID-19 genome sequences cataloged in the international GISAID (Global Initiative on Sharing Avian Influenza Data) database, seeking to identify mutations likely to be caused by molnupiravir.
‘Clearly something is happening here’
Searching for these mutations was based on the premise that, “Rather than inducing random changes in the virus’ RNA genome, [molnupiravir] is more likely to cause specific nucleic acid substitutions, with guanine switching to adenine and cytosine to uracil,” added Science.
Through this process, Ryan Hisner, a middle school science and math teacher from Monroe, Indiana — described by Science as a “virus hunter” — ultimately “identified dozens of sequences that showed clusters of those hallmark substitutions.”
Hisner took to Twitter with his concerns, where he came into contact with Thomas Peacock, Ph.D., a virologist at the Imperial College London. They and other U.K. and U.S. researchers “systematically reviewed more than 13 million SARS-CoV-2 sequences in GISAID and analyzed those with clusters of more than 20 mutations,” according to Science.
The team found “a large subset showed the hallmark substitutions; all dated from 2022, after molnupiravir began to be widely used,” Science reported.
According to the preprint study, Molnupiravir, “acts by inducing mutations in the virus genome during replication. Most random mutations are likely to be deleterious to the virus, and many will be lethal.”
However, the researchers wrote:
“It is possible that some patients treated with molnupiravir might not fully clear SARS-CoV-2 infections, with the potential for onward transmission of molnupiravir-mutated viruses.
“We set out to systematically investigate global sequencing databases for a signature of molnupiravir mutagenesis. We find that a specific class of long phylogenetic branches appear almost exclusively in sequences from 2022, after the introduction of molnupiravir treatment, and in countries and age groups with widespread usage of the drug.
“Our data suggest a signature of molnupiravir mutagenesis can be seen in global sequencing databases, in some cases with onwards transmission.”
Peacock told Science these “signature clusters” were up to 100 times more likely to be identified in countries where molnupiravir was widely used, including the U.S., U.K. and Australia, as compared to countries such as Canada and France, where it was not in widespread use.
“Clearly something is happening here,” said Peacock.
Merck: ‘no evidence’ any antiviral agent has contributed to the emergence of circulating variants’
Theo Sanderson, Ph.D., a geneticist at the Francis Crick Institute and co-author of the preprint, told Science “We are not coming to a conclusion about risk” just yet, with regard to whether or not these mutations may lead to more severe COVID-19 variants.
Indeed, according to the preprint study, the variants identified by the researchers have not been shown to be more lethal or more evasive to immunity than other existing strains of COVID-19.
However, Haseltine illustrated the potential risk via the analogy of owning a pet lion: “Just because it didn’t bite you yesterday doesn’t mean it won’t bite you today.”
According to the Gateway Pundit :
“Merck was warned by multiple scientists their drug might create problematic mutations which would render the virus more dangerous and difficult to treat. The company decided to blow off any concerns and put Lagevrio [molnupiravir] on the market anyway.”
As previously reported by The Defender, Dr. James Hildreth, president and CEO of Meharry Medical College and member of Biden’s COVID-19 Health Equity Task Force, expressed concerns about mutant variants escaping.
In 2021, Hildreth told an FDA advisory panel, “Even if the probability is very low, one in 10,000 or 100,000, that this drug would induce an escape mutant from which the vaccines we have do not cover, that could be catastrophic for the whole world actually.”
Also in 2021, Haseltine told Science :
“You are putting a drug into circulation that is a potent mutagen at a time when we are deeply concerned about new variants. I can’t imagine doing anything more dangerous.
“If I were trying to create a new and more dangerous virus in humans, I would feed a subclinical dose [of molnupiravir] to people infected.”
Two other recent studies also called out molnupiravir, questioning its effectiveness and raising concerns the drug may help lead to the development of new COVID-19 variants.
A December 2022 preprint by a team of Australian researchers, found “this commonly used antiviral can ‘supercharge’ viral evolution in immunocompromised patients, potentially generating new variants and prolonging the pandemic.”
And a study published Jan. 28 in The Lancet found, “Molnupiravir did not reduce the frequency of COVID-19-associated hospitalisations or death among high-risk vaccinated adults in the community.”
University of Cambridge clinical microbiologist Ravindra Gupta, Ph.D., told Science that while it’s unclear whether molnupiravir will cause deadlier COVID-19 variants, the overall results of these recent studies “call into question whether molnupiravir should be used.”
Merck spokesperson Robert Josephson defended the product, telling Bloomberg, “There is no evidence that any antiviral agent has contributed to the emergence of circulating variants.”
Molnupiravir ‘different’ than Paxlovid — and ‘riskier’
Although molnupiravir is similar to Paxlovid in that both are oral antiviral treatments for COVID-19, Hooker told The Defender there are significant differences in how the two drugs work:
“Molnupiravir acts on the SARS-CoV-2 virus by directly inducing mutations in the RNA genome. This is a completely different mode of action compared to Pfizer’s product, Paxlovid, and in my estimation is quite dangerous.
“Merck claimed the mutation rate induced by molnupiravir would kill the virus and that mutants wouldn’t escape, but that has been shown to be false in studies of immunocompromised patients.”
Hooker said Paxlovid — and the COVID-19 vaccines — can potentially lead to the development of mutations as well.
But in his view, the “mechanism of action” used by molnupiravir is different — and far riskier — than Paxlovid and COVID-19 vaccines, which merely increase the virus’ lifetime in the human body, giving the virus a greater opportunity to naturally mutate.
Hooker said:
“In contrast, molnupiravir directly induces mutations and thereby vastly increases the mutation rate of the virus in the human host.
“In my estimation, this is a very dangerous way to treat such an infection, given the implications of creating random mutants.”
Merck made billions from molnupiravir — thanks to taxpayers
In 2022, sales of Merck’s molnupiravir hit $5.68 billion, fueled in part by strong fourth-quarter sales of the drug in Asia.
Fourth-quarter sales of molnupiravir reached $825 million, more than doubling analyst expectations of $358 million.
These strong earnings were boosted by government — or taxpayer — support.
In June 2021 — with molnupiravir still in clinical trials, which weren’t completed until October 2021 — the federal government signed a $1.2 billion contract with Merck for 1.7 million courses of the drug, at a cost of approximately $712 per patient.
An analysis by Melissa Barber of the Harvard T.H. Chan School of Public Health and Dzintars Gotham of King’s College Hospital in London found the cost of production of molnupiravir was approximately $1.74 per unit — or $17.74 for a five-day regimen.
By those calculations, the U.S. government paid a near-4,000% markup.
In March 2022, during his State of the Union address, President Biden announced the “Test to Treat” initiative, which allowed those who tested positive for COVID-19 at a pharmacy to obtain free antiviral pills — including molnupiravir — on the spot.
One month earlier, the Biden administration had proceeded with a new purchase of 3.1 million courses of molnupiravir, with the option to purchase more.
Estimates for Merck, and other COVID-19 drugmakers, are less rosy for 2023, as the public tires of all things pandemic and Biden looks to end the COVID-19 national emergency in May.
According to Reuters, sales of molnupiravir are expected to fall to about $1 billion this year, contributing to an expected decline in sales for Merck from $59.3 billion in 2022 to $57.2-$58.7 billion this year.
Merck’s stock price dropped by about 2% with Thursday’s announcement.
Despite these large earnings, overall sales of molnupiravir lagged significantly behind Paxlovid in 2022. Sales of Paxlovid reached $18.9 billion last year.
Michael Nevradakis, Ph.D., based in Athens, Greece, is a senior reporter for The Defender and part of the rotation of hosts for CHD.TV’s “Good Morning CHD.”
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
WHO Wants To Run the World?
By Paul Frijters, Gigi Foster, Michael Baker | Brownstone Institute | July 11, 2022
In Geneva in late May at the 75th meeting of the WHO’s decision-making body, the World Health Assembly (WHA), amendments to its International Health Regulations (IHRs) were debated and voted upon. If passed, they would grant the WHO the right to exert unconscionable pressure on countries to accept the WHO’s authority and health policy actions if the WHO decides that there is a public health threat that might spread beyond a country’s borders.
As Ramesh Thakur, the second man at the UN for years, noted, the amendments would mean “the rise of an international bureaucracy whose defining purpose, existence, powers and budgets will depend on outbreaks of pandemics, the more the better.”
This is the first clear instance of a globalist coup attempt. It would subvert national sovereignty worldwide by putting real power into the hands of an international group of bureaucrats. It has long been suspected that the authoritarian elites arisen during covid times would try to strengthen their positions by undermining nation states, and the this 75th jamboree is the first solid evidence of this being true.
What an opportunity then to see who is in the conspiring club. Who drafted the amendments? What was in them? Which individuals supported them or spoke out against them?
WHO were the conspirators?
The amendments on the table at the May WHA meeting had been transmitted to the WHO by the US Department of Health and Human Services on January 18, circulated by WHO to its member states (‘States Parties’) on January 20 and formally introduced to the WHA on April 12.
The proposals, according to an announcement on January 26, were co-sponsored by 19 countries plus the European Union. Even if some co-sponsors had little direct involvement in drafting them, they all would have approved in principle the overarching goal of tightening up the WHO’s authority over member states in the face of a public health event.
Loyce Pace, the HHS’s Assistant Secretary for Global Affairs – the leading US official nominally responsible for the proposed amendments – arrived at the Biden administration fresh from a stint as executive director of an advocacy organization called the Global Health Council.
That council receives funding from the Bill & Melinda Gates Foundation and its members include Eli Lilly, Merck, Pfizer, Abbott Labs, and Johnson & Johnson. You get the idea. Via one of the foxes-turned-chicken-guard, it appears the HHS ‘worked closely’ on these amendments with large pharmaceutical companies, who will be chomping at the bit for a more proactive (read: profitable) response to any public health emergency, real or imagined.
So the conspiring club consists primarily of the US government and its Western allies in lockstep with Big Pharma, and they are looking to undermine both the sovereignty of their own governments and that of other countries, presumably with the idea that the Western elites would do the running.
What was in them? A blizzard of acronyms and euphemisms
To understand what the US proposed at the WHA, we need first to understand how things have worked in the WHO to this point.
The IHRs in their current form have been in force as international law since June 2007. Among other things, they impose requirements on countries to detect, report and respond to ‘public health events of international concern,’ or PHEICs. The WHO Director-General consults with the state where a possible public health event has occurred, and within 48 hours they are meant to come to a mutual agreement on whether or not it actually is a PHEIC, whether or not it needs to be announced to the world as such, and what counter-measures, if any, should be taken. It’s essentially an early-warning system on major health crises. This is a good thing if it’s run by people you can trust and if it has checks and balances to rein in expansionary tendencies.
The proposed amendments would greatly strengthen the power of the WHO relative to this baseline, in a number of ways.
First, they lower the threshold for the WHO to declare a public health emergency by empowering its Regional Directors to declare a ‘public health event of regional concern’ (PHERC, italics ours) and for the WHO to put out a new thing called an ‘intermediate public health alert.’
Second, they permit the WHO to consider allegations about a public health event from non-official sources, meaning sources other than the government of the state concerned, and allow that government only 24 hours to confirm the allegations and a further 24 hours to accept the WHO’s offer of ‘collaboration.’
Collaboration is essentially a euphemism for on-site assessment by teams of WHO investigators, and concomitant pressure at the whim of WHO personnel to enact potentially far-reaching measures such as lockdowns, movement restrictions, school closures, consumption of medicines, administration of vaccines and any or all of the other social, economic, and health paraphernalia that we have come to associate with the covid circus.
Should the state’s government acceptance of the WHO’s ‘offer’ not be forthcoming, the WHO is empowered to disclose the information it has to the other 194 WHO countries, while continuing to pressure the state to yield to the WHO’s invitation to ‘collaborate.’ A non-collaborating country would risk becoming a pariah.
Third, the proposal includes a new Chapter IV, which would establish a ‘Compliance Committee’ consisting of six government-appointed experts from each WHO region tasked with permanently nosing around to ensure the member states are complying with IHR regulations.
There are more crossings-out of the existing IHR language and new language added in, but the flavour of what the US-led alliance is shooting for is a WHO that can unilaterally decide whether there is a problem and what to do about it, and can isolate countries that disagree.
Compliant WHO member states could act as a supporting cast in the isolation effort, through the distribution of their own health budgets and their ‘health-related’ policies, which would include travel and trade restrictions. The WHO would become a kind of command-and-control center for globalist agendas, pushing the produce of (Western) Big Pharma.
Why and how would this work?
We learned during covid times why it would make sense that the US and its allies are insisting on these amendments.
Lowering the bar for declaring a global (or regional) public health threat triggers a huge opportunity for Western pharmaceutical companies. As legal experts have observed: “WHO emergency declarations can trigger the fast-track development and subsequent global distribution and administration of unlicensed investigational diagnostics, therapeutics and vaccines.
This is done via the WHO’s Emergency Use Listing Procedure (EULP). The introduction of an ‘intermediate public health alert’ in particular will also further incentivise the pharmaceutical industry’s move to activate domestic fast-track emergency trial protocols as well as for advance purchase, production and stockpile agreements with governments before the existence of a concrete health threat to the world’s population has been detected, as is already the case under WHO’s EULP via the procedures developed for a ‘pre-public health emergency phase’.”
You can bet that the WHO ‘expert teams’ sent in to make on-the-ground assessments, under the banner of ‘collaboration’ with the host country experiencing the health event, will be chock-a-block with operatives from the CDC and who knows what other Western agencies, all poking around potentially sensitive facilities that a host government might justifiably claim a sovereign right to keep to itself. Likewise with the ‘Compliance Committee’ proposed by the US under the new Chapter IV of the IHRs: its government-appointed members have an open-ended brief, enshrined in international law, to be busybodies.
In layman’s terms, the WHO would be turned into an international thug, with its member states offered the role of backyard gang members.
As a bonus for Western elites, the proposals are a sneaky form of rewriting history. By cementing authority within an international organisation to determine the existence of public health crises and direct potentially draconian emergency responses, Western governments would get to enshrine and legitimise their own extreme responses to the covid outbreak, as we have pointed out previously. Their backsides would thereby be given some protection from legal challenges.
The refusniks: Developing countries
The proposals were pushed primarily by Western countries: the US was joined by Australia, the UK and the EU in arguing for passage. The resistance was led by developing countries who saw it as a colonialist ambush in which their ability to set policy and respond to health threats in a manner commensurate with their domestic situations would be overridden.
Brazil reportedly went so far as to threaten to withdraw from the WHO, and the African group of almost 50 countries, along with India, argued that the amendments were being rushed through without adequate consultation. Russia, China and Iran also objected.
Failure on the first try, but the US and its allies in the West will get more shots to push it through.
How do we expect them to do this? Well, when a proposal gets bogged down inside a giant bureaucratic machine like the WHO, the inevitable response is to set up committees to work in the background and circle back with a new set of proposals to be presented at a future meeting. True to form, a ‘working group’ and ‘expert committee’ are being assembled to accept member state proposals on IHR reform by the end of September this year. These will be ‘sifted through’ and reports will be prepared for review by the WHO’s executive board in January next year. The objective is to have a fresh set of proposals on the table when the WHA convenes for the 77th time in 2024.
Not all was lost
Salvaging something from the fact that the WHA failed to get a consensus around its biggest agenda item, the US and its allies got a small victory on the point of when they can try again – though in their desperation they needed to violate the IHRs’ own rules to accomplish it. Article 55 of the IHRs states unambiguously that a four-month notice period is required for any amendments.
In this instance, revised amendments were presented on May 24, the same day that the first lot were rejected. These were discussed, further amended on May 27 and then adopted on the same day. The approved amendments halve the two-year period for any (further) approved amendments to the IHRs to take effect. (The IHRs that came into force in 2007 were agreed to in 2005 – but under the new resolution, anything agreed to in 2024 would come into effect in 2025 rather than 2026.)
Yet, what was achieved in terms of fast-tracking the force of new amendments was lost in slow-tracking their implementation. Nations would have up to 12 months – double the previous suggestion of six months – to implement any IHR amendments that newly enter into force of law.
State of play
Where is all this going?
If the WHO takes the reins on decisions about what constitutes a health crisis, and can pressure every country into a one-size-fits-all set of responses that it, the WHO, also determines, that’s bad enough. But what about if its invitation to ‘collaborate’ with countries is backed up with teeth, such as sanctions against those who demur? And what about if it then broadens the definition of ‘public health’ by, for example, declaring that climate change falls under that definition? Or racism? Or discrimination against LBTQIA+ people? The possibilities thereby opened up for running the world are endless.
A global ‘health’ empire would bring huge harms to humanity, but a lot of power and money is pushing for it. Don’t think it can’t happen.
Paul Frijters is a Professor of Wellbeing Economics at the London School of Economics: from 2016 through November 2019 at the Center for Economic Performance, thereafter at the Department of Social Policy
Pfizer Document Dump Shows Doctor With Ties to Gates Foundation Deleted Trial Participant’s Vaccine Injury
By Michael Nevradakis, Ph.D. | The Defender | May 18, 2022
An 80,000-page cache of Pfizer-BioNTech COVID-19 vaccine documents released by the U.S. Food and Drug Administration (FDA) sheds light on Pfizer’s extensive vaccine trials in Argentina, including the unusually large size of the trials and the story of a trial participant whose vaccine reaction was “disappeared.”
The case of Augusto Roux in Argentina suggests that in at least one instance, a trial participant whose symptoms were determined to be connected to the COVID-19 vaccine was later listed, in official records, as having experienced adverse events that were not related to the vaccination.
Vaccine trials in Argentina also appear to have glossed over adverse events suffered by other trial participants, and the potential connection between the adverse events and the vaccine.
The FDA on May 2 released the latest cache of documents, which pertain to the Emergency Use Authorization of Pfizer’s vaccine, as part of a court-ordered disclosure schedule stemming from an expedited Freedom of Information Act request filed in August 2021.
As previously reported by The Defender, the documents included Case Report Forms from Pfizer COVID vaccine trials in the U.S., and the “third interim report” from BioNTech’s trials conducted in Germany, both of which listed adverse events sustained by participants in the U.S. and German trials.
Many of these adverse events were indicated as being “unrelated” to the vaccines — even in instances where the patients were healthy or otherwise had no prior medical history related to the injuries they sustained.
Story of ‘disappeared patient’ goes public
Several bloggers and online investigators called into question various aspects of the Argentine vaccine trials, pointing out the number of participants in the Argentine trials dwarfed that of other, typically smaller trials at other locations in different countries.
They also pointed out the large number of participants appeared to have been recruited to the trial in a remarkably short time, and questioned the connections between one of the key figures of the Argentine trial to vaccine manufacturers, Big Pharma and the Bill & Melinda Gates Foundation.
The large number of trial participants in Argentina may be related to the fact that the trial appears to have been held simultaneously in 26 hospitals.
The large number of participants is revealed in another of the documents released this month, where on page 2,245, the list of randomized participants at trial site 1231 begins, while on page 4,329, the list of participants at trial site 4444 begins.
Site 1231 refers to the main trial site location and 4444 (page 24) most likely refers to the disparate hospitals participating in the trial outside the main location.
Commenting on the revelation, blogger David Healy wrote:
“About 5,800 volunteers were enrolled, half getting the active vaccine. This is almost 4 times more than the next largest centre in this trial.
“Amazingly 467 doctors were almost instantly signed up and trained as assistant investigators in the study.”
In all, 4,501 patients participated in the Argentine trials, representing 10% of all Pfizer trial participants worldwide.
Complete information about adverse events during this extensive trial in Argentina does not appear to have been released as of this writing.
However, Roux’s experience has since become public.
Roux, often referred to as the “disappeared” patient, volunteered for the trial (volunteer number 12312982) and received his first dose of the Pfizer vaccine on Aug. 21, 2020.
According to Healy, Roux “felt pain and swelling in his arm right after the injection. Later that day he had nausea, difficulty swallowing, and felt hungover.”
After a series of symptoms, Roux — during a clinical trial visit on Aug. 23, 2020 — was classified as experiencing a “toxicity grade 1 adverse effect.”
He nevertheless received his second dose on Sept. 9, 2020.
According to Healy:
“On the way home by taxi, he started feeling unwell. At 19:30, he was short of breath, had a burning pain in his chest and was extremely fatigued. He lay on his bed and fell asleep. He woke up at 21:00 with nausea and fever (38-39 C) and was unable to get out of bed due to the fatigue.
“Over the next two days, he reports a high fever (41 C) and feeling delirious.
“On September 11, he was able to get out of bed and go to the bathroom when he observed his urine to be dark (like Coca-Cola). He felt as if his heart expanded, had a sudden lack of breath and fell unconscious on the floor for approximately 3 hours.
“Once he recovered, he felt tired, was uncomfortable, had a high heart rate on minor movement, was dizzy when changing posture. He had a chest pain which radiated to his left arm and back.”
On Sept. 12, 2020, Roux was admitted to the Hospital Alemán, where he stayed for two days. It was initially believed he had COVID-19, but he tested negative for the virus. His symptoms also were found to not correspond with viral pneumonia.
After a series of X-rays, CT scans and urine tests, Roux was discharged Sept. 14, 2020, after being diagnosed with an adverse reaction — specifically, an unequivocal pericardial effusion — to the coronavirus vaccine (high probability), according to his discharge summary.
Doctor who altered Roux’s record had ties to Gates, NIH, Big Pharma
However, on Sept. 17, Dr. Fernando Polack, Pfizer’s lead investigator for the Argentine trials according to a Pfizer document released in December 2021, reported in Roux’s record that his “hospitalization was not related to the vaccine.”
Even after Roux’s discharge, his health difficulties continued. As reported by Healy:
“On November 13 [2020], he had negative IgG and IgM SARS COV-2 (QML technique), which is unusual post vaccine.
“On February 24, 2021, a liver scan showed a minor degree of abnormality. In March 2021 and February 2022, his liver enzymes remained abnormal.”
Ultimately, Roux lost 14 kilograms (30.8 pounds) in a period of three to four months, and continued to suffer from fever and bouts of breathlessness for several months afterward.
Polack, who reported Roux’s hospitalization as unrelated to the vaccination, is known for his close ties with various vaccine manufacturers, pharmaceutical companies and the Bill & Melinda Gates Foundation.
For instance, he is listed as the lead author in a Dec. 31, 2020, New England Journal of Medicine (NEJM) article on the purported efficacy of the Pfizer COVID-19 vaccine.
According to Healy, Polack also appears to be the founder of iTRIALS, a trial site management company, and another organization located at the same physical headquarters, the Fundación INFANT.
Healy wrote:
“When COVID struck Argentina, [Polack] and his Fundación became involved in a trial of immune plasma, taken from patients who had recovered from COVID, given to patients who had recently acquired the disease.
“In May 2020 he speculated that this would make COVID like an ordinary cold, and the Gates Foundation would offer financial support. He used high-profile press conferences to disseminate his exciting message.”
The conclusion of the study published in the NEJM following the plasma study reads:
“Funded by the Bill and Melinda Gates Foundation and the Fundación INFANT Pandemic Fund; Dirección de Sangre y Medicina Transfusional del Ministerio de Salud number, PAEPCC19, Plataforma de Registro Informatizado de Investigaciones en Salud number, 1421, and ClinicalTrials.gov number, NCT04479163.”
According to Healy, “[a] subsequent systematic review and meta-analysis failed to confirm these findings, noting ‘very serious imprecision concerns.’”
Healy pointed out that Polack, in his NEJM disclosure statement, did not indicate any conflict of interest or financial interest in the COVID-19 vaccine trials in Argentina, but:
“Polack reported grants from Novavax and personal fees from Janssen, Bavarian Nordic A/S, Pfizer, Sanofi, Regeneron, Merck, Medimmune, Vir Bio[technology], Ark Bio, Daiichi Sankyo outside the submitted work.
“At least eight of these companies are engaged in RSV vaccine research in babies and pregnant women. Fernando has mentioned a combined RSV, flu and COVID vaccine.”
And, in relation to Polack’s relationship with the Bill & Melinda Gates Foundation, Healy reported:
“[Polack] also doesn’t mention his extensive financial involvement with the Bill & Melinda Gates Foundation. This organization supports industry vaccine trials including Covid and RSV. Fernando is heavily involved through his Gates-sponsored Fundación INFANT in Buenos Aires in RSV trials and research.
“Gates sunk $82,553,834 into Novavax’s RSV vaccine ResVax which was shown to be ineffective in clinical trials in pregnant women.”
Polack’s own bio from a 2017 medical conference states “[h]is work is funded by the Bill & Melinda Gates Foundation, the National Institutes of Health [NIH], the Thrasher Research Fund, the Optimus Foundation and other international organizations.”
That same year, Polack testified at an FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting, where he “acknowledged having financial interests in or professional relationships with some of the affected firms identified for this meeting, namely Janssen [producer of the Johnson & Johnson COVID vaccine], Novavax, and Bavarian Nordic.”
According to Dr. Joseph Mercola, Polack “also happens to be a consultant for the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC),” and “a current adjunct professor at Vanderbilt University in Tennessee.”
Michael Nevradakis, Ph.D., is an independent journalist and researcher based in Athens, Greece.
COVID-19: RDIF Points to Absence of Long-Term Studies on Vaccines Based on Monkey Adenoviral Vectors
By Aleksandra Serebriakova – Sputnik – 09.09.2020
The third round of trials for the AstraZeneca anti-COVID-19 drug is now on pause over “potentially unexplained illness” in a participant in the UK. On 11 August, Russia registered its own Sputnik V anti-coronavirus vaccine, which is said to have been developed in a different way.
The Russian Direct Investment Fund (RDIF) the investor which has funded the development of Russia’s Sputnik V anti-coronavirus vaccine, could not comment on the halt of AstraZeneca trials, it said in a statement.
However, RDIF pointed out that the fund’s CEO Kirill Dmitriev had previously discussed the differences between the human adenoviral vector-based platform used in Russia’s Sputnik V vaccine and those used by some of their international colleagues, that rely on “novel unproven technologies such as monkey adenoviral vectors or mRNA”.
“The safety of the human adenoviral vector used in Sputnik V has been proven over decades in over 250 clinical studies, as human adenovirus has been shown to be the safest vaccine delivery mechanism and the most ‘organic for humans’, as human adenovirus has coexisted with humans for over 100,000 years,” RFID said.
Meanwhile, “mRNA and monkey adenoviral vector-based platforms have not been studied over a long period of time,” RDIF CEO Dmitriev pointed out this Tuesday.
Commenting on the so-called “pledge of safety” earlier voiced by the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi in relation to the development of the first COVID-19 vaccines, Dmitriev stressed that this plea was “insufficient” as it did not “discuss the lack of long-term studies on the carcinogenic effects and impact on fertility of newly-developed vaccine technologies”.
“Since some of the companies developing these vaccines have taken the ‘pledge of safety’, we would like to stress that public health and safety requires not only short-term evidence of a lack of serious adverse effects, but also the safety and efficacy proved by the results of long-term studies,” Dmitriev added.
AstraZeneca COVID-19 Vaccine Trials on Pause
It was revealed this week that the third round of trials for the AstraZeneca anti-COVID-19 vaccine has been halted due to a “potentially unexplained illness” which had developed in a participant in the United Kingdom, without further specifications about the nature of possible side effects. The vaccine in question was developed in partnership with Oxford University and has reportedly involved around 30,000 participants in the UK, US, Brazil and South Africa. AstraZeneca described the pause as “routine” so as to allow for a “standard review process” of “safety data”.
Russia’s First Anti-Coronavirus Vaccine
On 11 August, Russia registered the world’s first vaccine against COVID-19, called Sputnik V, which was developed by the Gamaleya National Research Centre of Epidemiology and Microbiology and the RDIF after several rounds of clinical trials. On Monday, the vaccine was made available to the public.
According to RDIF, Russia has now received requests for 1 billion doses of the vaccine; at least 20 countries, including the UAE, Saudi Arabia, Indonesia, Philippines, Mexico, Brazil and India, have expressed an interest in obtaining Sputnik V.
Big Pharma Still Tries to Push Dangerous Drug Class
By Martha Rosenberg | CounterPunch | February 16, 2018
Bisphosphonate bone drugs are among the most harmful and misrepresented drug classes still on the market. But that has not stopped Pharma-funded medical associations like the American Society of Bone and Mineral Research, the National Osteoporosis Foundation and the National Bone Health Alliance from periodically wringing their hands over low sales. [1]
This week the New York Times repeats the industry lament. “Currently, many people at risk of a fracture — and often their doctors — are failing to properly weigh the benefits of treating fragile bones against the very rare but widely publicized hazards of bone-preserving drugs, experts say,” it writes. Hip fractures among women 65 and older on Medicare are rising says the piece and Medicare reimbursements for bone density tests are falling. “Doctors who did them in private offices could no longer afford to [do them] which limited patient access and diagnosis and treatment of serious bone loss,” says a doctor quoted in the article which sounds like a Pharma plea for tax-payer funding.
But here is the back story.
The first bisphosphonate bone drug approved for osteoporosis, Merck’s Fosamax, received only a six month review before FDA approval. When its esophageal side effects were revealed, the FDA tried to unapprove it but Merck got the FDA to settle for a warning label that told patients to sit upright for an hour after taking the drug. Six months after Fosamax was approved, there were 1,213 reports of adverse effects including 32 patients hospitalized for esophageal harm. One woman who took Fosamax but remained upright for only thirty minutes was admitted to the hospital with “severe ulcerative esophagitis affecting the entire length of the esophagus” and had to be fed intravenously, according to the New England Journal of Medicine (NEJM).
Soon bisphosphonates (which include Boniva, Actonel and Zometa) were shown to weaken not strengthen bones by suppressing the body’s bone-remodeling action. Yes bone loss is stopped but since the bone is not renewed, it becomes brittle, ossified and prone to fracture. More than a decade ago, articles in the NEJM, the Annals of Internal Medicine, the Journal of Clinical Endocrinology & Metabolism, Journal of Orthopaedic Trauma and Injury warned of the paradoxical drug results. One-half of doctors at a 2010 American Academy of Orthopaedic Surgeons annual meeting presentation said they’d personally seen patients with bisphosphonate-compromised bone. “There is actually bone death occurring,” said Phuli Cohan, MD on CBS about a woman who’d been on Fosamax for years.
By 2003, dentists and oral surgeons found that after simple office dental work, the jawbone tissue of patients taking bisphosphonates would sometimes not heal but become necrotic and die. They had received no warnings though Merck knew about the jawbone effects from animal studies since 1977.
“Up to this point, this rare clinical scenario was seen only at our centers in patients who had received radiation therapy and accounted for 1 or 2 cases per year,” said the authors of an article titled “Osteonecrosis of the Jaws Associated with the Use of Bisphosphonates: A Review of 63 Cases,” published in the Journal of Oral and Maxillofacial Surgery.
Despite reports of ulcerative esophagitis, bone degradation, fractures and jawbone death Merck aggressively promoted Fosamax. It hired researcher Jeremy Allen to plant bone scan machines in medical offices across the country to drive sales and to push through the Bone Mass Measurement Act which made bone scans Medicare reimbursable paid by you and me. Hopefully that is changing.
Blaming hip fractures on not enough people taking bisphosphonates is not a new tactic for Pharma. It blamed increasing suicides on not enough people taking antidepressants (even when as much as a fourth of the population takes antidepressants). Get ready for Pharma to blame obesity on not enough people taking prescription obesity drugs. The ruse is even more dishonest because many popular drugs people are taking like GERD medications really do thin bones. First do no harm.
Notes.
[1] According to the British Medical Journal, the National Osteoporosis Foundation is funded by Bayer Healthcare, Lane Laboratories, Mission Pharmacal, Novartis, Pharmavite, Pfizer, Roche, Warner Chilcott and Eli Lilly. The American Society for Bone and Mineral Research is funded by Pfizer and Eli Lilly. The National Bone Health Alliance is a public- private partnership that is an offshoot of the National Osteoporosis Foundation.
Martha Rosenberg is an investigative health reporter. She is the author of Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health (Prometheus).
TPP: Big Pharma’s Big Deal
By Joyce Nelson | CounterPunch | October 7, 2015
We still don’t know all the details of the Trans-Pacific Partnership (TPP) trade deal tentatively agreed to on Oct. 5 by negotiators from 12 Pacific Rim countries, but already critics are slamming it for many reasons, including its generous concessions to the pharmaceutical industry.
Doctors Without Borders claims the TPP will “go down in history as the worst trade agreement for access to medicines in developing countries.” [1] That’s because the TPP will extend patent protection for brand-name drugs, thereby preventing similar generic drugs (which are far less costly) from entering the market. This will drive up the prices.
Judit Rius Sanjuan, legal policy adviser for Doctors Without Borders, told vox.com that TPP creates patent-related obligations in countries that never had them before. People in “Peru, Vietnam, Malaysia, and Mexico” will be especially affected, she said. “They’ll face higher prices for longer periods of time.” [2]
Ruth Lopert, a professor at George Washington University, told Bloomberg News that provisions in the TPP agreement will affect health-care budgets and drug access in all signatory countries, but especially the poorest. “She said as many as 40,000 people in Vietnam, the poorest country in the agreement, could stop getting drugs to fight HIV because of provisions that will boost the price of [pharmaceutical] therapy.” [3]
Other countries like Canada will also be hit with higher costs. The Council of Canadians says that if the TPP is ratified, “[p]harmaceutical patents will be extended, delaying the release of more affordable generic drugs and adding $2 billion to our annual public health care bill.” [4] In the U.S., many people already cannot afford to pay for the expensive medicines that could save their lives, and they try to access generics available elsewhere.
Extending patent rights for life-saving drugs is an obvious gift to Big Pharma. Conor J. Lynch at opendemocracy.net has called it “a clear corporate handout that would greatly affect international access and most definitely cause preventable deaths. The clear objective here is to increase industry profits, plain and simple. This is not surprising, that’s what private industry does, but there is a serious moral dilemma here.” [5] That moral dilemma is made even more apparent by recent findings.
Tax Cheats
In an ironic coincidence, the TPP agreement was reached on the same day that a damning report on corporate tax-avoidance – Offshore Shell Games 2015 – was released by Citizens for Tax Justice and the US Public-Interest Research Group Education Fund. The report reveals the extent to which top U.S. companies use tax havens like Bermuda, Luxembourg, Cayman Islands, and the Netherlands to set up “tax haven subsidiaries” that are usually little more than a post-office box.
Of the top 30 Fortune 500 companies with the most money held in offshore tax-havens, nine are pharmaceutical companies: Pfizer ($74 billion held offshore), Merck ($60 billion), Johnson & Johnson ($53.4 billion), Proctor & Gamble ($45 billion), Amgen ($29.3 billion), Eli Lilly ($25.7 billion), Bristol Myers Squibb ($24 billion), AbbeVie Inc. ($23 billion), and Abbott Laboratories ($23 billion). [6]
Concerning Pfizer, the world’s largest drug maker (declared profits of $22 billion in 2013), the report states: “The company made more than 41 percent of its sales in the U.S. between 2008 and 2014, but managed to report no federal taxable income for seven years in a row. This is because Pfizer uses accounting techniques to shift the location of its taxable profits offshore. For example, the company can transfer patents for its drugs to a subsidiary in a low- or no-tax country. Then when the U.S. branch of Pfizer sells the drug in the U.S., it ‘pays’ its own offshore subsidiary high licensing fees that turn domestic profits into on-the-books losses and shifts profit overseas.”
Overall, the study found that the 500 largest U.S. companies hold more than US$2.1 trillion in accumulated profits offshore. “For many companies, increasing profits held offshore does not mean building factories abroad, selling more products to foreign customers, or doing any additional real business activity in other countries,” but simply establishing a PO box.
Some companies use the money supposedly “trapped” offshore as “implied collateral” in order to borrow funds at negligible rates for investing in U.S. assets, paying dividends to shareholders, or repurchasing stock.
Of course, as the report makes clear, “Congress, by failing to take action to end this tax avoidance, forces ordinary Americans to make up the difference. Every dollar in taxes that corporations avoid by using tax havens must be balanced by higher taxes on individuals, cuts to public investments and public services, or increased federal debt.”
The report finds that, through a variety of tax-avoidance measures, an estimated US$620 billion in U.S. taxes is collectively owed by the 500 largest companies with headquarters in the U.S.
Corporate Coup
Now the TransPacific Partnership – which is being called “NAFTA on steroids” – would award Big Pharma and other multinationals even more corporate “rights” in more countries, including the controversial investor-state dispute settlement (ISDS) mechanism by which they can sue signatory governments for regulatory changes that affect their profits.
As the Canadian website rabble.ca notes: “The Canadian government is currently being sued through NAFTA by Eli Lilly, an American pharmaceutical company, for invalidating the firm’s patent extensions on two mental health drugs. A Canadian Federal Court decided in 2010 that the patent extensions had not delivered the promised benefits and the drugs should therefore be opened up to generic competition. Generic drugs significantly reduce the cost for end users, but Eli Lilly cried foul and launched an ISDS claim against the government, demanding US$500 million in compensation for lost profits. The case is still in progress, but regardless of the outcome we can expect the TPP to lead to similar ISDS disputes. Powerful multinational pharmaceutical companies will use any available means to cling to over-priced drug monopolies. Greater intellectual property protections in the TPP will give these companies an even stronger quasi-legal basis to sue governments and crowd out generic [drug] competition.” [7]
The final text of the TransPacific Partnership agreement won’t be available for at least a month, likely weeks after the Canadian federal election on October 19. The details will undoubtedly reveal more generous concessions to the multinationals. It will be up to the elected legislators in all twelve countries to approve or reject the TPP. In Canada, NDP leader Tom Mulcair has pledged to scrap the deal if elected as Prime Minister, explaining that the Stephen Harper government had no mandate to sign it during an election campaign when it is merely a “caretaker” government.
The U.S. website zerohedge.com calls the Trans-Pacific Partnership “a Trojan horse” and “a coup by multinational corporations who want global subservience to their agenda.” In no uncertain terms, it adds: “Buyer beware. Citizens beware.” [8]
Footnotes/Links:
[2] Julia Belluz, “How the Trans-Pacific Partnership could drive up the cost of medicine worldwide,” Vox, October 5, 2015.
http://www.vox.com/2015/10/5/9454511/tpp-cost-medicine
[3] “Pacific Deal Rewrites Rules on Trade in Autos, Patented Drugs,” Bloomberg News, October 5, 2015.
http://www.bloomberg.com/news/articles/2015-10-05/pacific-deal-rewrites-rules-on-trade-in-autos-patented
[4] Council of Canadians, “Tell party leaders: Reject the TPP,” October 6, 2015.
[5] Conor J. Lynch, “Trans-Pacific Partnership’s Big Pharma giveaway,” Open Democracy, February 14, 2015.
http://www.opendemocracy.net/conor-j-lynch/transpacific-partnership%E2/80%/99s-big-pharma-giveaway
[6] http://ctj.org/ctjreports/2015/10/orrshore_shell_games_2015.php//executive
[7] Hadrian Mertins-Kirkwood, “Trans-Pacific Partnership a big win for corporate interests,” Rabble.ca, October 6, 2015.
[8] Tyler Durden, “Trans-Pacific Partnership Deal Struck As ‘Corporate Secrecy’ Wins Again,” Zero Hedge, October 5, 2015.
http://www.zerohedge.com



