Category Archives: FDA

High arsenic levels in two bottled water

Earlier this year, Consumer Reports released findings that two brands of bottled water contained nearly double the federal limit of arsenic in water.

Now, Consumer Reports‘ findings are confirmed by California’s non-profit Center for Environmental Health.

HeathDay News reports, via Medicine Net, June 21, 2019, that these two bottled water containing levels of arsenic higher than tap water in violation of federal and California guidelines, are sold at Whole Foods, Target and Walmart:

  • Penafiel, owned by Keurig Dr. Pepper.
  • Starkey, owned by Whole Foods.

High levels of arsenic can cause reproductive damage and cancer, as well as hormone disruption and organ damage, especially in children. Products that violate recommended state levels of arsenic must carry a warning, according to California law.

Michael Green, CEO of the Center for Environmental Health, said in a statement: “Customers typically purchase bottled water at exorbitantly high costs with the assumption that it is safer and healthier to drink than tap water, unaware that they are ingesting an extremely toxic metal linked to birth defects and cancer.”

But the U.S. Food and Drug Administration has not recalled either brand of bottled water.

~Eowyn

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Elite vampirism: FDA warns against young-blood transfusions

Last September, I reported on the new phenomenon of élite vampirism, wherein perfectly healthy but wealthy people get very expensive transfusions of blood plasma from young people for their alleged rejuvenating, life-extension effects.

See “Elite vampirism: Young-blood transfusions for $8k/1.5 liters

Those wealthy elites get their blood transfusions from for-profit companies, such as Ambrosia Health, reportedly the first for-profit company selling transfusions of human plasma, allegedly harvested from young adults from local blood banks, under the guise of running a clinical trial. It takes multiple donors to make one package of blood plasma. The transfusions cost $8,000 for 1 liter, pumped in across two days; for 2 liters, the company charges $12,000.

PayPal co-founder Peter Thiel is one of these “elite vampires” who, according to Gawker, spends $40,000 every 3 months on blood transfusions from 18-year-olds.

Since the company’s beginning in 2017 in Monterey, California, Ambrosia had opened another branch in Houston, Texas. Run by Jesse Karmazin, a medical school graduate in his 30s without a license to practice medicine, the company’s so-called “clinical trials” are overseen by a licensed doctor, David Wright, who was disciplined in 2015 by the California Medical Board for giving his patients intravenous treatments of vitamins and antibiotics for “non traditional” purposes. A bioethicist from McGill University maintained that Ambrosia calls its business a “clinical trial” because they would be unable to get FDA approval to sell the blood plasma transfusions otherwise.

Now, the U.S. Food and Drug Administration (FDA) has finally weighed in.

Yesterday, the FDA issued an announcement cautioning consumers against receiving young blood-plasma transfusions. As a result, Ambrosia put a notice on its website that “In compliance with the FDA announcement issued February 19, 2019, we have ceased patient treatments.”

Below is the press announcement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA Center for Biologics Evaluation and Research Peter Marks, M.D. and Ph.D., February 19, 2019:

The FDA has recently become aware of reports of establishments in several states that are offering infusions of plasma from young donors to purportedly treat the effects of a variety of conditions. The conditions range from normal aging and memory loss to serious diseases like dementia, Parkinson’s disease, multiple sclerosis, Alzheimer’s disease, heart disease or post-traumatic stress disorder. We have significant public health concerns about the promotion and use of plasma for these purposes. There is no proven clinical benefit of infusion of plasma from young donors to cure, mitigate, treat, or prevent these conditions, and there are risks associated with the use of any plasma product.

Today, we’re alerting consumers and health care providers that treatments using plasma from young donors have not gone through the rigorous testing that the FDA normally requires in order to confirm the therapeutic benefit of a product and to ensure its safety. As a result, the reported uses of these products should not be assumed to be safe or effective. We strongly discourage consumers from pursing this therapy outside of clinical trials under appropriate institutional review board and regulatory oversight.

Plasma is the liquid portion of the blood. It contains proteins that help clot blood and can be used for the management of bleeding and clotting abnormalities. The benefits of plasma have long been recognized, especially in trauma settings or in patients whose blood is unable to clot due to medications or certain illnesses. The FDA-recognized Circular of Information for the Use of Human Blood and Blood Components, published by AABB, lists recognized indications for which the administration of plasma is safe and effective; these are included in the FDA’s safety communication. For those patients receiving a plasma product for a recognized use, the benefits of treatment have been determined by the agency to outweigh its risks. But even under such recognized uses, plasma administration is not without risks. The more common risks are allergic reactions and transfusion associated circulatory overload and less common risks include transfusion related acute lung injury or transfusion associated circulatory overload and infectious disease transmission.

Our concerns regarding treatments using plasma from young donors are heightened by the fact that there is no compelling clinical evidence on its efficacy, nor is there information on appropriate dosing for treatment of the conditions for which these products are being advertised. Plasma is not FDA-recognized or approved to treat conditions such as normal aging or memory loss, or other diseases like Alzheimer’s or Parkinson’s disease. Moreover, reports we’re seeing indicate that the dosing of these infusions can involve administration of large volumes of plasma that can be associated with significant risks including infectious, allergic, respiratory and cardiovascular risks, among others.

The administration of plasma for indications other than those recognized or approved by the FDA should be performed by a qualified investigator or sponsor who has an active Investigational New Drug (IND) application with the FDA. Clinical studies are performed under an IND to help ensure the safety of participants in the trials. When clinical trials are not conducted under an IND, it means that the FDA has not reviewed the experimental therapy to help make sure it is reasonably safe.

Simply put, we’re concerned that some patients are being preyed upon by unscrupulous actors touting treatments of plasma from young donors as cures and remedies. Such treatments have no proven clinical benefits for the uses for which these clinics are advertising them and are potentially harmful. There are reports of bad actors charging thousands of dollars for infusions that are unproven and not guided by evidence from adequate and well-controlled trials. The promotion of plasma for these unproven purposes could also discourage patients suffering from serious or intractable illnesses from receiving safe and effective treatments that may be available to them. We strongly urge individuals to consult their treating physicians prior to considering the use of such products for aging indications or for the treatment of conditions such as dementia, Parkinson’s disease, multiple sclerosis, Alzheimer’s disease, heart disease or post-traumatic stress disorder given the known and unknown risks associated with their use.

We support sound, scientific research and regulation of medical treatments. We will use our tools and authorities to protect patients from unscrupulous actors and unsafe products. As a general matter, we will consider taking regulatory and enforcement actions against companies that abuse the trust of patients and endanger their health with uncontrolled manufacturing conditions or by promoting so-called ‘treatments’ that haven’t been proven safe or effective for any use.

As a growing number of clinics offer plasma from young donors and similar therapies, we want to encourage consumers considering treatments to ask their health care providers to confirm that the FDA has reviewed any treatment that is investigational. You also can ask the clinical investigator to give you the FDA-issued IND number and to provide a copy of the FDA communication acknowledging the IND. We encourage patients to ask for this information before receiving treatment. Furthermore, we urge patients and their health care providers to report any adverse events related to treatment with plasma from young donors for aging or related indications to the FDA’s MedWatch Adverse Event Reporting program. The agency will continue to closely monitor this issue and take additional steps, as appropriate, along with state and local health departments and blood establishments.

Important Information about Young Donor Plasma Infusions for Profit

According to Wikipeida, in addition to Ambrosia, other for-profit companies selling young-blood transfusions include Alkahest and Young Blood Institute.

~Eowyn

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Johnson & Johnson knew its baby talcum powder contained asbestos

Johnson & Johnson (J&J) is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturing company founded in 1886. With worldwide sales of $70.1 billion in 2015, J&J is headquartered in New Brunswick, NJ, and includes some 250 subsidiary companies with operations in 60 countries and products sold in over 175 countries.

Among J&J’s well-known consumer products are Band-Aid bandages, Tylenol, Neutrogena skin and beauty products, Acuvue contact lenses, and Johnson’s baby products, including Johnson & Johnson Baby Powder, 70% of which is used by adults, according to the company.

Johnson’s Baby Powder grew out of a line of medicated plasters — sticky rubber strips loaded with mustard and other home remedies. When customers complained of skin irritation, J&J’s founding brothers sent packets of talc. Soon, mothers began applying the talc to infants’ diaper-chafed skin. The Johnsons took note. They sifted the talc into tin boxes and added a fragrance that would become one of the most recognizable in the world. In 1893, they began selling it as Johnson’s Baby Powder.

J&J has dominated the talc powder market for more than 100 years, its sales outpacing those of all competitors combined, according to Euromonitor International data. And while talc products contributed just $420 million to J&J’s $76.5 billion in revenue last year, Baby Powder is considered an essential facet of J&J’s carefully tended image as a caring company – a “sacred cow,” as one 2003 internal email put it. (Reuters)

Decades of solid science show that asbestos, a naturally-occurring silicate mineral, causes mesothelioma and is associated with ovarian and other cancers.  Talc can sometimes be contaminated with asbestos due to the proximity of asbestos ore (usually tremolite) in underground talc deposits.

The World Health Organization (WHO) and other authorities recognize no safe level of exposure to asbestos. WHO’s International Agency for Research on Cancer classifies talc that contains asbestos as “carcinogenic to humans.” While most people exposed never develop cancer, for some, even small amounts of asbestos are enough to trigger the disease years later. Just how small hasn’t been established.

There are many lawsuits against Johnson & Johnson claiming that its talcum powder products, like Baby Powder and Shower to Shower, gave users cancer. Most of the talc cases have been brought by women with ovarian cancer who say they regularly used J&J talc products as a perineal antiperspirant and deodorant. As examples:

  • In February 2016, J&J was ordered to pay $72 million in damages to the family of 62-year-old Jacqueline Fox, who died of ovarian cancer in 2015.
  • By March 2017, over 1,000 U.S. women had sued J&J for covering up the possible cancer risk of its Baby Powder product.
  • In August 2017, a California jury ordered J&J to pay $417 million to a woman who claimed she developed ovarian cancer after using the company’s talc-based products like Johnson’s Baby Powder for feminine hygiene.
  • In July 2018, a St. Louis jury awarded nearly US$4.7 billion in damages to 22 women and their families after they claimed asbestos in J&J talcum powder caused their ovarian cancer.
  • By December 2018, some 11,700 people have sued J&J over cancers allegedly caused by its baby powder.

Lisa Girion reports for Reuters, Dec. 14, 2018, that internal J&J documents examined by Reuters show that the company’s powder was sometimes tainted with carcinogenic asbestos and that J&J concealed that information from government regulators and the public.

And yet, we are constantly being told there are no conspiracies and that “conspiracy theorists” are loony.

After avoiding to hand over talc test results and other internal company records for decades, J&J finally was compelled to share thousands of pages of company memos, internal reports and other confidential documents with lawyers for some of the 11,700 plaintiffs suing the company, including thousands of women with ovarian cancer.

A Reuters examination of many of those documents, as well as deposition and trial testimony, shows that:

  • From at least 1971 to the early 2000s, J&J’s raw talc and finished powders sometimes tested positive for small amounts of asbestos, and that company executives, mine managers, scientists, doctors and lawyers fretted over the problem and how to address it while failing to disclose it to regulators or the public.
  • J&J successfully influenced U.S. regulators’ plans to limit asbestos in cosmetic talc products and scientific research on the health effects of talc.
  • Many of the documents were shielded from public view by court orders that allowed J&J to turn over thousands of documents it designated as confidential.
  • The earliest mentions of tainted J&J talc are in 1957 and 1958 reports by a consulting lab, describing contaminants in talc from J&J’s Italian supplier as fibrous and “acicular” needle-like  tremolite. Tremolite is one of the six minerals that in their naturally occurring fibrous form are classified as asbestos.
  • From 1957 to the early 2000s, reports by J&J’s scientists, supplier and outside labs yielded similar findings, describing contaminants in J&J talc and finished powder products as asbestos or “fiberform” and “rods” — terms that typically apply to asbestos.
  • In 1971, New York City’s environmental protection chief, Jerome Kretchmer, informed the Nixon administration and called a press conference to announce that two unidentified brands of cosmetic talc appeared to contain asbestos. The FDA opened an inquiry. J&J issued a statement: “Our fifty years of research knowledge in this area indicates that there is no asbestos contained in the powder manufactured by Johnson & Johnson.
  • In 1976, J&J assured the U.S. Food and Drug Administration (FDA) that no asbestos was “detected in any sample” of talc produced between December 1972 and October 1973 when, in fact, at least three tests by three different labs from 1972 to 1975 had found asbestos in its talc – in one case at levels reported as “rather high.”

J&J, through its outside litigation counsel Peter Bicks, rejected Reuters’ findings as “false and misleading.” Bicks wrote in email: “The scientific consensus is that the talc used in talc-based body powders does not cause cancer, regardless of what is in that talc. This is true even if – and it does not – Johnson & Johnson’s cosmetic talc had ever contained minute, undetectable amounts of asbestos.”

In 1980, J&J began offering a cornstarch version of Baby Powder – to expand its customer base to people who prefer cornstarch, the company says.

Since 2003, talc in Baby Powder sold in the United States has come from China through supplier Imerys Talc America, a unit of Paris-based Imerys SA and a co-defendant in most of the talc litigation. Imerys and J&J said the Chinese talc is safe. An Imerys spokesman said the company’s tests “consistently show no asbestos. Talc’s safe use has been confirmed by multiple regulatory and scientific bodies.”

In 2009, the FDA, responding to growing public concern about talc, commissioned tests on 34 samples, including a bottle of J&J Baby Powder and samples of Imerys talc from China. No asbestos was detected.

In August 2018, J&J said that it removed several chemicals from baby powder products and re-engineered them to make consumers more confident that products were safer for children.

The mounting controversy surrounding J&J talc hasn’t shaken investors. J&J’s share price is up about 6% so far this year. Talc cases make up fewer than 10% of all personal injury lawsuits pending against J&J, based on the company’s Aug. 2 quarterly report, in which the company said it believed it had “strong grounds on appeal.”

J&J Chairman and Chief Executive Officer Alex Gorsky has pledged to fight on, telling analysts in July: “We remain confident that our products do not contain asbestos.” Gorsky’s comment, echoed in countless J&J statements, misses a crucial point. Asbestos, like many environmental carcinogens, has a long latency period. Diagnosis usually comes years after initial exposure – 20 years or longer for mesothelioma. J&J talc products today may be safe, but the talc at issue in thousands of lawsuits was sold and used over the past 60 years.

On Wednesday, December 19, Johnson & Johnson failed to persuade Missouri trial Judge Rex Burlison to set aside a verdict awarding a record $4.69 billion in punitive and compensatory damages to 22 women who blamed their ovarian cancer on asbestos in the company’s Baby Powder and other talc products.

J&J shares were off about 1% at $128.93 in afternoon trading. The company in a statement said J&J would appeal. (Reuters)

~Eowyn

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Petition against release of millions of genetically-modified mosquitoes into Florida-Texas

This is friggin’ unbelievable.
In August 2016, the Obama Administration’s Food and Drug Administration (FDA) gave its approval to OX513A, a genetically modified male Aedes aegypti mosquito developed by a British biotech company, Oxitec. The Aedes aegypti mosquito is the primary species that carries the Zika virus. OX513A is genetically engineered to pass along a lethal gene to wild females. The gene creates a protein that interferes with cell activity, killing females’ offspring before they reach adulthood.

The FDA approval was the green light for Oxitec to use the GMO mosquito in a field trial that fall in the small Florida community of 475 homes in Key Haven, about a mile east of the island of Key West. The trial was to test how well OX513A controls the local population of Aedes aegypti. Oxitec CEO Hadyn Parry said, “Our studies show we can reduce the Aedes aegypti population by 90% over six months and keep it there by releasing small numbers of males after that. And that is very cost-effective compared to pesticides.” (CNN)

A successful field trial is required before OX513A can be sold commercially in the United States.
Even though Oxitec had already conducted field tests in Key Haven and, before that, in Brazil, Panama and the Cayman Islands, it now plans to release the GMO mosquitoes into the fragile environment of the Florida Keys and Texas, despite opposition from the local community in the Florida Keys who had passed an ordinance demanding more testing. More than 50 million of the genetically-modified mosquitoes will be released per week, 7 days a week, totaling billions of the mutant insects being released into a wide swath between Florida and Harris County, Texas.
More than 30 physicians have created a petition asking the FDA to conduct more evaluation of the risks of this genetically modified OX513A mosquitoes because they are created with E-Coli bacteria, herpes-simplex virus and other ingredients — a premature technology about which we know little, including the effects on public health and on the environment.
The petition points out that nearly all experiments with genetically-modified crops have eventually resulted in unintended consequences, such as superweeds that are more resistant to herbicides, and mutated and resistant insects. A recent news story reported that the monarch butterfly population is down by half in areas where Roundup Ready GM crops are doused with ultra-high levels of herbicides that wipe out the monarch’s favorite food, the milkweed plant.
The petition asks:

  • What’s the rush for this radical approach? Dengue fever has been absent from the Florida Keys for years, which indicates the current methods of control and public education are working. Will the more virulent Asian tiger mosquito that also carries dengue fill the void left by reductions in the Aedes aegypti mosquito population? Will the dengue virus mutate (think antibiotic resistant MRSA) and become even more dangerous?
  • Where is the third-party, peer-reviewed research on effectiveness and safety of GMO mosquitoes other than Oxitec’s own claims of success? There are other alternatives that are more natural, no-risk, faster and cheaper.

To sign the petition, go here.
H/t Big Lug
See also “Zika virus epidemic: What you should know”.
~Eowyn

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FDA: Women with breast implants have higher risk of blood cancer, plus 26 other complications

Fri, 31 Mar 2017 14:54:43 +0000

eowyn2

Behaviors have consequences.

Getting breast implants is one of those behaviors that carry medical consequences, specifically a heightened risk of developing a rare type of non-Hodgkin’s lymphoma called anaplastic large cell lymphoma (ALCL) — a blood cancer that affects the immune system and typically appears in the skin, lymph nodes, or bodily organs.

Nine people in the U.S. have died from this rare cancer associated with breast implants.

On March 22, 2017, the U.S. Drug and Food Administration (FDA) issued a warning about breast implants and a type of lymphoma, i.e., blood cancer.

It was in 2011 that the FDA first identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin’s lymphoma. But at that time, the FDA knew of few cases of this disease, and so the FDA decided to gather more information before sounding an alert about women with breast implants’ heightened risk for ALCL.

Meanwhile, the World Health Organization (WHO) concurrently determined that a rare T-cell lymphoma called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) indeed can develop following breast implants.

And so, the FDA, with concurrence from WHO and with the collection of more data in collaboration with the American Society of Plastic Surgeons (ASPS) and the Plastic Surgery Foundation (PSF), now is prepared to issue a formal warning, although the exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global implant sales data.

Here are the FDA’s findings and recommendations about Breast Implant-Associated (BIA) anaplastic large cell lymphoma (ALCL):

(1) Women with breast implants have an increased, albeit “very low” risk of developing ALCL compared to women who do not have breast implants:

  • This is the FDA’s conclusion from reviewing a “significant body of medical literature” published since 2011. That literature includes case histories and comprehensive reviews of the natural history and long-term outcomes of the disease.
  • The Australian Therapeutic Goods Administration (TGA) estimated the risk of developing BIA-ALCL to be between 1-in-1000 and 1-in-10,000 women with breast implants.

(2) BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces:

  • As of February 1, 2017, the FDA has received a total of 359 medical device reports (MDRs) of BIA-ALCL, including nine deaths. There are 231 reports that included information on the implant surface. Of these, 203 were reported to be textured implants and 28 reported to be smooth implants. In addition, 312 of the 359 reports included information on implant fill types. Of these, 186 reported implants filled with silicone gel and 126 reported implants filled with saline.
  • The Australian Therapeutic Goods Administration reported a detailed analysis of the 46 confirmed cases of BIA-ALCL in Australia, including 3 deaths. None of the cases occurred in women with smooth implants.
  • Many plastic surgeons prefer textured breast implants because they attach to the tissue surrounding the site of implant.
  • Nobody knows at present why and how textured breast implants cause ALCL. The French National Agency for Medicines and Health Products Safety (ANSM) had asked manufacturers of textured breast implants to perform biocompatibility testing (testing to determine how living tissues react to textured implants) and to report their findings within a year.

(3) Symptoms of ALCL in women with breast implants:

ALCL has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma — a pocket of clear serous fluid (pale yellow, transparent bodily fluid) that sometimes develops in the body after surgery. Late onset symptoms of ALCL are pain, lumps, swelling, or asymmetrical breasts.

(4) Recommendations to physicians:

  • Most cases of breast implant-associated ALCL are treated by removal of the implant and the capsule surrounding the implant and some cases have been treated by chemotherapy and radiation.
  • Prophylactic breast implant removal in patients without symptoms or other abnormality is not recommended.
  • Provide the manufacturers’ labeling as well as any other educational materials to patients before breast implant surgery and discuss with them the benefits and risks of the different types of implants.
  • Consider the possibility of BIA-ALCL when you have a patient with late onset, persistent peri-implant seroma.
  • When testing for BIA-ALCL, collect fresh seroma fluid and representative portions of the capsule and send for pathology tests to rule out BIA-ALCL. Diagnostic evaluation should include cytological evaluation of seroma fluid with Wright Giemsa stained smears and cell block immunohistochemistry testing for cluster of differentiation (CD) and Anaplastic Lymphoma Kinase (ALK) markers.
  • If you have a patient with suspected BIA-ALCL, refer her to an appropriate specialist for evaluation.
  • Develop an individualized treatment plan in coordination with the patient’s multi-disciplinary care team. Consider current clinical practice guidelines, such as those from the Plastic Surgery Foundation or the National Comprehensive Cancer Network (NCCN) when choosing your treatment approach.
  • Report all confirmed cases of ALCL in women with breast implants to the FDA. In some cases, the FDA may contact you for additional information. The FDA will keep the identities of the reporter and the patient confidential.
  • Submit case reports of BIA-ALCL to the PROFILE Registry to contribute to a better understanding of the causes and treatments of BIA-ALCL.
  • Professional organizations including the Plastic Surgery Foundation and the National Comprehensive Cancer Network (NCCN) published information to help physicians understand the disease and provide diagnosis and treatment.

(5) Recommendations to women:

  • Educate yourself about breast implants before agreeing to surgery. Breast implants approved in the U.S. can be filled with either saline or with silicone gel. They come in different sizes and shapes and have either smooth or textured surfaces (shells). Additional information is available on FDA’s Breast Implants website.
  • Talk to your health care provider about the benefits and risks of textured-surface vs. smooth-surfaced implants.
  • If you have breast implants, you should follow standard medical recommendations including:
    • Follow your doctor’s instructions on how to monitor your breast implants. If you notice any changes, contact your health care provider promptly to schedule an appointment. Get routine mammography screening and ask for a technologist specifically trained in performing mammograms on patients with breast implants.
    • If you have silicone gel-filled breast implants, get periodic magnetic resonance imaging (MRI) to detect ruptures as recommended by your health care provider. The FDA-approved product labeling for silicone gel-filled breast implants states that the first MRI should occur three years after implant surgery and every two years thereafter.

Breast augmentation continues to be the most common cosmetic surgical procedure performed in the U.S. Aside from increased risk of ALCL, the FDA also lists 26 potential complications that can result from implants, ranging from breast pain to necrosis (dead issue). The number of implant removals had increased last year (2016) from the year before. (Source: AOL.news)

This is a GIF I had made of what breast implant surgery looks like. Why any woman would have this entirely medically-unnecessary surgery escapes me.

H/t FOTM‘s MomOfIV

See also:

~Eowyn

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FDA is considering lifting ban on sodomites as blood donors

HIV is transmitted from person to person via bodily fluids — blood, semen, and to a lesser degree, saliva.
From the beginning, most people with HIV/AIDS have been homosexual males. They are called by the politically-correct term, “men who sex with men” or MSM. But a more descriptively correct and, therefore, more appropriate term is “sodomites,” which denotes specifically men who have anal sex with other men — a sexual behavior that is highly risky for HIV and other infections because anal penetration tears the delicate skin of the anal cavity, which is not biologically designed for sexual penetration.
According to the FDA in 2009, “Men who have had sex with men since 1977 have an HIV prevalence . . . 60 times higher than the general population, 800 times higher than first time blood donors and 8000 times higher than repeat blood donors.”
After the explosion of HIV/AIDS into a national (and global) epidemic, in order to protect the safety of America’s blood supply and the lives of people who receive blood transfusions, the Food and Drug Administration (FDA) sensibly installed a lifetime ban on homosexual males as blood donors.
That policy began to change less than a year ago.
As reported by Tony Perkins for FRCAction, the legislative affiliate of Family Research Council, the FDA first did away with the lifetime ban on homosexual males as blood donors, and replaced it with a ban or deferral on only men who had had sex with men in the past year.
Now, even that ban is being challenged.
The challenge is spearheaded by freshman Congressman Jared Polis (D-Colorado), who self-identifies as “gay,” after the mass shooting on June 12, 2016, at Pulse gay nightclub in Orlando, Florida, which killed 50 and wounded 53.
As reported by Colorado’s 9News, Polis was outraged that many of the friends and family members of the wounded were prevented from donating blood because of the revised FDA regulation banning blood donation from men who had had sex with other men in the past year.
Playing the victim card, Polis calls the FDA regulation “a relic of the stigma that LGBT people faced.” He told 9News:

“I’m … hopeful that we can remove the ban that the FDA has on gay people donating blood, because guess what? Many of the spouses and loved ones of the victims who need blood can’t even donate blood right now. It’s just a double tragedy that so many are facing the shortage of blood.”

Polis instead argues that restrictions on donating blood should be based on behavior rather than sexual orientation:

“It really doesn’t matter whether you’re gay or straight, what matters obviously is if you’ve used drugs or you’ve had unprotected sex. Those are the risk factors. It has nothing to do with whether you’re gay or straight.”

But Polis’ assertion of “a shortage of blood” is simply not true.
According to an Orlando Sentinel story on the afternoon of the shooting, within hours of the shooting, hundreds of Central Floridians had lined up that morning at the OneBlood blood center on West Michigan Avenue. Overwhelmed by people wanting to donate, OneBlood actually asked donors to stop coming, and instead schedule appointments over the next few days.
The FDA has invited the public to submit comments on Polis’ proposal to abolish the ban on homosexuals as blood donors altogether. Instead, the FDA would ask potential blood donors about specific high-risk behaviors. The FDA claims its decisions will be based on “scientific information” and declares that “the process must be data-driven.” But the FDA’s own statistics that the incidence of HIV is 60 times higher among sexually-active homosexual males than in the general population should be sufficient “scientific information” to reject Polis’ proposal.
By the way, there are compelling reasons that the Orlando shooting was a false flag. See “Orlando shooting: How we know it’s all a lie”.
WASHINGTON, DC - JANUARY 20: Congressman Jared Schutz Polis, D-CO-02, son Caspian Julian, and partner Marlon Reis attend 2013 Green Inaugural Ball at NEWSEUM on January 20, 2013 in Washington, DC. (Photo by Taylor Hill/Getty Images)
Freshman Congressman Jared Schutz Polis, 41, is Jewish and one of the wealthiest members of Congress with an estimated networth of $387.86 million. He made his fortune from a series of very lucrative business ventures that he later sold, including:

  • American Information Systems, an internet access provider, co-founded by Polis when he was a college student.
  • Bluemountain.com, a free electronic greeting-card website.
  • ProFlowers, the California-based online florist.

Polis and his husband, Marlon Reis, have a son, 5, and a daughter, 2.
See also:

H/t John Molloy
~Eowyn

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New study says statins are useless because cholesterol does not cause heart disease

Do you have high cholesterol?
Are you taking statins to lower your cholesterol?
If so, you should know that new studies show that:

  1. A cholesterol-lowering drug has no effect on reducing risks of cardiovascular diseases.
  2. Cholesterol does not increase risks of cardiovascular diseases any way.

cholesterolHigh cholesterol is commonly caused by an unhealthy diet and of eating high levels of saturated fat in particular, as well as smoking. It is carried in the blood attached to proteins called lipoproteins and has been traditionally linked to cardiovascular diseases such as coronary heart disease, stroke, peripheral arterial disease and aortic disease.
Statins are a class of lipid-lowering medications that inhibit the enzyme HMG-CoA reductase which plays a central role in the production of cholesterol. Prescribed by doctors to lower cholesterol, statins are one of the most commonly prescribed medications in the U.S., taken by an estimated 1 in 4 middle-aged adults. New cholesterol guidelines, introduced last November, could push that number to as many as 1 in 2 adults over age 40, according to a recent analysis in the New England Journal of Medicine.
But Ashley Welch reports for CBS News, April 4, 2016, that a large clinical trial found that although the drug evacetrapib does lower the “bad” cholesterol LDL and increases levels of “good” cholesterol HDL, the drug is not effective in helping protect patients from major cardiovascular events like heart attack and stroke.
Evacetrapib is a class of drugs known as cholesteryl ester transfer protein (CETP) inhibitors that disrupt the natural process by which HDL cholesterol is converted into LDL cholesterol in the body.
The research, presented at the American College of Cardiology’s 65th Annual Scientific Session, involved more than 12,000 patients from approximately 540 global health centers at high risk for serious cardiovascular health problems. The participants were randomly selected to receive either 130 milligrams of evacetrapib or a placebo pill daily for at least 18 months. The patients also received standard medical therapy — the majority of which included statins or other cholesterol-lowering drugs — throughout the trial.
The research showed that compared to the other patients taking the placebo, patients taking evacetrapib on average lowered their “bad” cholesterol by 37% and increased their “good” cholesterol by 130%. However, the drug’s favorable effects on cholesterol did not translate into a reduced risk of heart attack, stroke, coronary artery bypass surgery, hospitalization for chest pain, or amount of time until cardiovascular death.

Dr. Stephen Nicholls, the study’s lead author and a professor at Australia’s University of Adelaide and cardiologist at Royal Adelaide Hospital, said in a statement: “Here we’ve got an agent that more than doubles the levels of good cholesterol and lowers bad cholesterol and yet has no effect on clinical events. We were disappointed and surprised by the results” that a drug that seems to do all the right things in terms of blood cholesterol levels doesn’t then translate into reducing clinical events.

That leads us to this next report by Henry Bodkin for The Telegraph, June 13, 2016.
A review of research involving nearly 70,000 people found there was no link between “bad” cholesterol and the premature deaths of those over 60 years old from cardiovascular disease. In other words, cholesterol does not cause heart disease in the elderly and trying to reduce it with drugs like statins is a waste of time.
Published in the BMJ Open journal, the new study found that 92% of people with a high cholesterol level actually lived longer and had less heart disease!
Co-author of the study Dr. Malcolm Kendrick, an intermediate care GP, acknowledged the findings would cause controversy but defended them as “robust” and “thoroughly reviewed”. He said, “What we found in our detailed systematic review was that older people with high LDL (low-density lipoprotein) levels, the so-called ‘bad’ cholesterol, lived longer and had less heart disease.”
He and his co-authors have called for a re-evaluation of the guidelines for the prevention of cardiovascular disease and atherosclerosis, a hardening and narrowing of the arteries, because “the benefits from statin treatment have been exaggerated”.
Lead author Dr. Uffe Ravnskov, a former associate professor of renal medicine at Lund University in Sweden, went so far as to say there is “no reason” to lower high-LDL-cholesterol.
Dr. Ravnskov’s co-author, vascular and endovascular surgery expert Professor Sherif Sultan from the University of Ireland, said cholesterol is one of the “most vital” molecules in the body and prevents infection, cancer, muscle pain and other conditions in elderly people. “Lowering cholesterol with medications for primary cardiovascular prevention in those aged over 60 is a total waste of time and resources, whereas altering your lifestyle is the single most important way to achieve a good quality of life,” he said.

The study, however, prompted immediate scepticism from other academics who questioned the paper’s balance:

  • Professor Colin Baigent, an epidemiologist at Oxford University, said the new study had “serious weaknesses and, as a consequence, has reached completely the wrong conclusion”.
  • Another skeptic, consultant cardiologist Dr. Tim Chico, said he would be more convinced by randomised study where some patients have their cholesterol lowered using a drug, such as a stain, while others receive a placebo. He said: “There have been several studies that tested whether higher cholesterol increases the risk of heart disease by lowering cholesterol in elderly patients and observing whether this reduces their risk of heart disease. These have shown that lowering cholesterol using a drug does reduce the risk of heart disease in the elderly, and I find this more compelling than the data in the current study.”
  • The British Heart Foundation also questioned the new research, pointing out that the link between high LDL cholesterol levels and death in the elderly is harder to detect because, as people get older, more factors determine overall health. A spokesman said, “There is nothing in the current paper to support the author’s suggestions that the studies they reviewed cast doubt on the idea that LDL Cholesterol is a major cause of heart disease or that guidelines on LDL reduction in the elderly need re-valuating.”

What the skeptics don’t say is that the U.S. Food and Drug Administration (FDA) itself is warning about the dangers of taking statins, that:

  • Cognitive (brain-related) impairment, such as memory loss, forgetfulness and confusion, has been reported by some statin users.
  • People being treated with statins may have an increased risk of raised blood sugar levels and the development of Type 2 diabetes.
  • Some medications interact with lovastatin (brand names include Mevacor) and can increase the risk of muscle damage.

Here’s Dr. Mercola‘s low down on cholesterol and statins:

Like saturated fat, cholesterol has also been wrongly demonized despite the fact that 60 years’ worth of research has utterly failed to demonstrate any correlation between high cholesterol and heart disease.
Despite this, many, even most health professionals still cling to the idea that cholesterol raises your risk for heart disease, and that strategies that lower cholesterol also lower your heart disease risk. […]
Cholesterol is actually one of the most important molecules in your body; indispensable for the building of cells and for producing stress and sex hormones, as well as vitamin D.
It’s also important for brain health, and helps with the formation of your memories. Low levels of HDL cholesterol have been linked to memory loss and Alzheimer’s disease, and may also increase your risk of depression, stroke, violent behavior, and suicide. […]
Since the cholesterol hypothesis is false, this also means that the recommended therapies — low-fat, low-cholesterol diet, and cholesterol lowering medications — are doing more harm than good. Statin treatment, for example, is largely harmful, costly, and has transformed millions of people into patients whose health is being adversely impacted by the drug.

~Eowyn

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It’s not paranoia: Maker of DTaP vaccine admits it causes autism

Autism is a neurodevelopmental disorder characterized by impaired social interaction, verbal and non-verbal communication, and restricted and repetitive behavior. It occurs four to five times more often in boys than girls. Parents usually notice signs in the first two years of their child’s life.

The number of people diagnosed with autism has been increasing dramatically since the 1980s. In the United States, about 1.5% of children (1 in 68) are diagnosed with autism as of 2014, a 30% increase from 2012. Globally, autism is estimated to affect 21.7 million people as of 2013. The question of whether actual rates have increased is unresolved, partly due to changes in diagnostic practice and government-subsidized financial incentives for named diagnoses.

There have been persistent rumors that vaccines cause autism — a hypothesis that is rejected by both government and science, with believers dismissed as tin-foil hat-wearing “conspiracy theorists,” as if there are no true conspiracies.

Anyone heard of the Watergate conspiracy? For a real doozy of a U.S. government conspiracy, see “Operation Northwoods: A true U.S. government conspiracy for those who mock conspiracy theories“.

Now, those “conspiracy theorists” are vindicated by an admission by none other than the manufacturer of the DTaP vaccine, Sanofi Pasteur Inc., that an “adverse reaction” of the vaccine is autism.

DTaP (also confusingly called Tdap) is a “tripedia” or combination of three vaccines: Dipheria, Tetanus Toxoids, and an accellular form of Pertussis vaccine.

The definition of “accellular” is “not made up of or divided into cells.”

Sanofi Pasteur’s admission is found in a 13-page U.S. Food and Drug Administration (FDA) publication titled “Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Tripedia®“.
Beginning on page 6 of the FDA document is the section, “Adverse Reactions” to DTaP, which the document sometimes refers to as “Tripedia vaccine”. On page 11, under the sub-section “Additional Adverse Reactions” is this last paragraph:

Adverse events reported during post-approval use of Tripedia vaccine include idiopathic thrombocytopenic purpura, SIDS, anaphylactic reaction, cellulitis, autism, convulsion/grand mal convulsion, encephalopathy, hypotonia, neuropathy, somnolence and apnea. Events were included in this list because of the seriousness or frequency of reporting. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequencies or to establish a causal relationship to components of Tripedia vaccine.²

² Sanofi Pasteur Inc., Data on File – 072503.

“Post-approval” means after the DTaP vaccine had been approved by the FDA.
Here’s a screen shot I took of page 11, with the critical paragraph bracketed in yellow, and the word “autism” highlighted:

At the end of the FDA document on page 13, we are told that the DTaP or Tripedia vaccine is manufactured by Sanofi Pasteur Inc., Swiftwater, PA 18370, and the Research Foundation for Microbial Diseases of Osaka University, Japan.

Writing for Activist Post, Catherine J. Frompovich asks what is in the DTaP vaccine that can interfere with brain chemistry and neurology to cause autism?

Catherine J. Frompovich (website) is a retired natural nutritionist with advanced degrees in Nutrition and Holistic Health Sciences, Certification in Orthomolecular Theory and Practice plus Paralegal Studies. A consumer healthcare researcher for 35 years, Frompovich is published in national and airline magazines since the early 1980s, and has authored numerous books on health issues, the latest one being Vaccination Voodoo, What YOU Don’t Know About Vaccines.

According to the Tripedia vaccine’s package insert, the vaccine’s ingredients include bovine extract, formaldehyde, ammonium sulfate, aluminum potassium sulfate, and two growth mediums — modified Mueller and Miller, and Stainer-Scholte.

The Mueller and Miller medium is a mixture of sugar, salt, amino acids, vitamins, and minerals, including:

glucose, sodium chloride, sodium phosphate dibasic, monopotassium, phosphate, magnesium sulfate hydrate, ferrous sulfate heptaphydrate, cystine hydrochloride, tyrosine hydrochloride, urasil hydrochloride, Ca-pantothenate in ethanol, thiamine in ethanol, pyridoxin-hydrochloride in ethanol, riboflavin in ethanol, biotin in ethanol, sodium hydroxide, beef heart infusion (de-fatted beef heart and distilled water), casein [milk protein] solution.

The Stainer-Scholte medium has the following ingredients:

tris hydrochloride, tris base, glutamate (monosodium salt) [MSG], proline, salt, monopotassium phosphate, potassium chloride, magnesium chloride, calcium chloride, ferrous sulfate, asorbic acid, niacin, glutathione.

Furthermore, the DTaP vaccine is formulated without preservatives, but also contains trace amounts of:

  • Thimerosal, a mercury derivative.
  • Aluminum.
  • Residual formaldehyde.
  • Gelatin and polysorbate, which are used in the production of the pertussis concentrate.

Frompovich suggests that the “probable cause” ingredients in the TDaP vaccine which lead to especially neurological “adverse reactions” are:

  1. Casein, to which some children are allergic;
  2. MSG, an excitotoxin (excitotoxin are amino acids that damage or kill our nerve cells by overstimulate them);
  3. Thimerosal-ethylmercury;
  4. Aluminum;
  5. Formaldehyde;
  6. Gelatin; and
  7. Polysorbate.

Alarmingly, Frompovich notes that “most of the mandated vaccines for infants and children, contain many of the above ingredients.
That the DTaP vaccine causes autism is bad enough. A clinical psychologist named Kathy J. Forti maintains that it is the DTaP vaccine, not the Zika virus raging in South America (especially Brazil) and increasingly afflicting the U.S., which causes microcephaly birth defects. (See “Zika virus epidemic: What you should know“)

Update (May 18, 2019):

The FDA’s link to the publication no longer works. Instead, I got the message: “Page Not Found”.

Hmm . . . .

However, I was able to find the publication online in PDF format here. I also uploaded the entire article to FOTM‘s media library, “Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Tripedia“.

Below is a screenshot of the relevant paragraph:

~Eowyn

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