FDA Warning: Do Not Use PNC-27 for Treatment or Cure for Cancer

PNC 27 molecule
PNC 27 molecule

The FDA is warning consumers not to buy or use PNC-27, a product promoted and sold through http://PNC27.com, as a treatment or cure for cancer. An FDA laboratory discovered the bacteria Variovorax paradoxus in a PNC-27 solution sample for inhalation.

Consumers who use a contaminated product are at risk for serious, potentially life-threatening infections. Consumers at higher risk include vulnerable populations, such as young children, elderly people, pregnant women, and people with weakened immune systems.

PNC-27 may be available in various dosage forms, such as a nebulized solution, intravenous solution, vaginal suppository, or rectal suppository. FDA has not evaluated or approved PNC-27 as safe and effective to treat any disease, including any form of cancer. The agency has not received reports of illnesses or serious adverse events related to PNC-27.

The FDA recommends patients with cancer discuss treatment options with a licensed health care professional. Patients who have used any PNC-27 product and have concerns should contact their health care provider as soon as possible.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

The FAQ at the PNC-27 website says, “PNC-27 is a tiny, nontoxic protein molecule that attaches to specific receptors only found on cancer cells, causing them to die.

“PNC is a set of investigational proteins designed to attach to malformed cells and cause them to die via cell necrosis. PNC proteins were theorized, then created using a super computer in New York by Dr. Matthew Pincus and Dr. Joseph Michl of Suny Downstate Medical Center.

“PNC-28 was the first protein investigated, followed by its more effective counterpart, PNC-27. Multiple studies in laboratories and on humans have been successfully conducted. PNC is also the subject of several US Patents.”

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Monsanto RoundUp Herbicide Found in Cheerios, Ritz Crackers and Doritos

roundup-cancerIndependent food safety testing done by Food Democracy found extremely high levels of the herbicide glyphosate — the active ingredient in Monsanto’s Roundup — in America’s most popular food products.

Roundup is the most heavily used chemical weedkiller in food and agricultural production in human history, as a result of the widespread adoption of genetically engineered crops now grown on more than 175 million acres in the U.S. and more than 440 million acres around the globe.

Roundup is used on crops, lawns, home gardens, parks, roadsides and forests. So far 38 actions have been filed against Monsanto in Roundup Products Liability Litigation, MDL No. 2741, Case 3:16-md-02741-VC.

These lawsuits allege that Monsanto’s Roundup herbicide, particularly its active ingredient, glyphosate, causes non-Hodgkin’s lymphoma (cancer of the lymph nodes). Plaintiffs each allege that they or their decedents developed non-Hodgkin’s lymphoma after using Roundup over the course of several or more years.

Plaintiffs also allege that the use of glyphosate with other ingredients, in particular the surfactant polyethoxylated tallow amine (POEA), renders Roundup even more toxic than glyphosate on its own. Also read Court Appoints Leadership In Roundup Cancer MDL.

Harm to human health

New scientific evidence shows that probable harm to human health could begin at ultra-low levels of glyphosate e.g. 0.1 parts per billions (ppb). Popular foods tested for glyphosate measured between 289.47 ppb and at levels as high as 1,125.3 ppb.

The testing and analysis were performed by Anresco Laboratories, San Francisco, an FDA-registered laboratory that has performed expert food safety testing since 1943. The laboratory found that well-known products tested for glyphosate, Original Cheerios, for example, measured levels as high as 1,125.3 ppb. Other high levels of glyphosate were found in familiar products such as Oreos, Doritos, and Ritz Crackers, among 29 foods tested.

Currently, U.S. regulators allow a very high level of daily glyphosate residue in America’s food. The acceptable daily intake (ADI) limit is set at 1.75 milligrams per kilogram of bodyweight per day (written 1.75 mg/kg bw/day) in the U.S., versus a more cautious 0.3 mg/kg bw/day in the European Union. Tolerances have been set based on corporate-sponsored studies and industry influence on the regulatory process.

New research shows that Roundup causes liver and kidney damage in rats as reflected in changes in the functions of 4,000 genes at only 0.05 parts per billion (ppb) glyphosate equivalent indicating damage. Credible independent, peer-reviewed scientific evidence now shows that the levels of harm to human health could begin at the ultra-low levels of 0.1 parts per billion (ppb) of glyphosate.

“It’s important for individuals and parents to understand that glyphosate contamination cannot be removed by washing and is not broken down by cooking or baking. Glyphosate residues can remain stable in food for a year or more, even if the foods are frozen or processed,” the report says.

Lobbying Backlash from Monsanto

In March 2015, leading cancer experts from the World Health Organization’s International Agency for Research on Cancer (IARC) declared that glyphosate is a “probable human carcinogen.” IARC reached its decision based on the research of 17 top cancer experts from 11 countries, who met to assess the carcinogenicity of 5 pesticides. The IARC review of glyphosate has led to the European Parliament calling for a complete ban on non-commercial public use of glyphosate and serious restrictions on agricultural use.

Monsanto’s furious response includes:

  • Working with CropLife America to drive efforts to cut off U.S. funding for the World Health Organization’s International Agency for Research on Cancer (IARC)
  • The EPA had planned to hold four days of public meetings – over industry objections– to examine scientific research on glyphosate. But the industry, which deemed the meetings “unnecessary” and “inappropriate,” successfully derailed those Oct. 18-21 public meetings by challenging certain scientists appointed by EPA to an advisory panel.

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Plaintiffs Seek to Consolidate Lawsuits Charging that Roundup Causes Cancer

WHO-says-Roundup-probably-causes-cancerPlaintiffs in 14 different federal courts are seeking to create the new MDL No. 2741 in southern Illinois to hear their lawsuits that Monsanto’s weed killer Roundup causes non-Hodgkin’s lymphoma — cancer of the lymph nodes.

The International Agency for Research on Cancer (IARC), the specialized intergovernmental cancer agency of the World Health Organization, declared in March 2015 that glyphosate, the chemical in Roundup, is a “probable carcinogen.”

“Any firm would be wise to get younger lawyers involved because this will be a long, hard fight,” said John Ray, a mass tort expert speaking in a recent webinar. Click to see the Slides & Recording for NTL Webinar: Mass Torts Update for Plaintiff Attorneys.

Learn more about the Roundup litigation at the Sept. 23-26 Mass Tort Nexus Course.

Timothy Litzenburg of the Miller Law Firm, which is involved with the motion to consolidate, will speak about the litigation.

To attend, contact Barbara Capasso at barbara@masstortnexus.com or call (954) 383-3932.

“This chemical interferes with the metabolic process, as a method for killing plants. There is no reason to believe it wouldn’t have the same effect on people,” Ray said. “The question is how much exposure is necessary to cause problems. Non-Hodgkin’s lymphoma is the tip of the iceberg. This chemical could affect the future of our species. It will be decades before we know everything that it did.”

The Roundup motion to consolidate (PDF) seeks to organize the litigation in the Southern District of Illinois before Judge Nancy Rosenstengel or David Herndon. A similar motion is pending to consolidate the cases in the US District Court of Hawaii. The first action was filed on October 9, 2015.

Roundup, manufactured by Monsanto of St. Louis, has been on the market for 40 years.

  • It is the most widely-used agriculture chemical in history.
  • Each year, approximately 250 million pounds of glyphosate are sprayed on crops, commercial nurseries, suburban lawns, parks, and golf courses.
  • In 2010, an estimated 70% of corn and cotton and 90% of soybean fields in the United States contained Roundup Ready seeds. The company accounts for 27% of the world seed market.

Roundup is used in 130 countries and is found in rivers and groundwater, according to numerous studies. Plants absorb glyphosate and it cannot be removed by washing or peeling produce or by milling, baking or brewing grains. It has been found in food, in the urine of agricultural works and even in the urine of urban dwellers who are not in direct contact with glyphosate. Those most at risk are farm workers, landscapers and employees of garden centers and nurseries.

Campaign of misinformation

“Monsanto has championed falsified data and has attacked legitimate studies that revealed Roundup®’s dangers. Monsanto has led a prolonged campaign of misinformation to convince government agencies, farmers and the general population that Roundup® is safe,” states the complaint in John D. Sanders and Frank Tanner v. Monsanto Company, Case No. 5:16-cv-00726-pa-kk.

Monsanto was aware of glyphosate’s carcinogenic properties as early as the 1980s. The US EPA classified glyphosate as “possibly carcinogenic” in 1985. But after pressure from Monsanto, the EPA changed its classification to “evidence of non-carcinogenicity in humans” in 1991. However, the EPA made clear that the designation did not mean the chemical does not cause cancer.

On two occasions, the EPA found that the laboratories hired by Monsanto to test the toxicity of its Roundup® products for registration purposes committed fraud:

  • Monsanto, in seeking initial registration of Roundup by the EPA, hired Industrial Bio-Test Laboratories. In 1976 the EPA found “routine falsification of data” at the company.  Three top executives of IBT were convicted of fraud in 1983.
  • Monsanto hired Craven Laboratories in 1991 to perform studies about Roundup. In that same year, the owner of Craven Laboratories and three of its employees were convicted of fraudulent laboratory practices in the testing of pesticides and herbicides.

rats with tumors

Professor Giles-Eric Seralini and his research team at the University of Caan in France provided pictures of rats fed Monsanto GMO corn saturated with Roundup weed killer. Their study published in Food and Chemical Toxicology (FCT) discovered that rats fed GMOs developed tumors and died prematurely.

This began a highly-organzied media attack against Seralini by pro-GMO scientists and journalists. When former Monsanto scientist Richard E. Goodman was installed in a newly-created editorial position at FCT, Seralini’s paper was removed from the journal in 2013, a full year after it was initially peer reviewed and published.

Seralini’s study was re-published in 2014 by Environmental Sciences Europe. He also won a libel suit in France against the  former chairman of France’s Biomolecular Engineering Commission, who accused Seralini of “scientific fraud.”

Government crackdowns

Many government agencies have cracked down on Monsanto regarding Roundup.

In 1996 the New York Attorney General sued Monsanto for false advertising over claims that is was “safer than table salt” and “practically non-toxic.” That year Monsanto agreed to cease advertising that Roundup was safe, biodegradable, “good” for the environment, safer that common consumer products or “practically non-toxic.”

In 2009, France’s highest court ruled that Monsanto had not told the truth about the safety of Roundup. The French court affirmed an earlier judgment that Monsanto had falsely advertised its herbicide Roundup as “biodegradable” and that it “left the soil clean.”

Roundup has been banned for sale in the Netherlands, France, Bermuda and Sri Lanka.

 

 

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