Group of U.S. Scientists and Billionaires Secret Waging 'War' Against COVID-19

Source: Newsweek
April 28 2020
By Jason Murdock

A highly-qualified cabal of scientists, academics and Nobel Prize winners, backed by billionaires, has banded together to research novel ways of fighting back against COVID-19.

The assembled group—Scientists to Stop COVID-19—has been working behind-the-scenes in recent months to compile an advisory report outlining what they believe to be the best ways of treating the infectious disease and restoring the economy.

The existence of the team was first reported by The Wall Street Journal (WSJ), which revealed its work had already been delivered to Vice President Mike Pence, who leads the White House coronavirus task force, and influenced decisions made by the Food and Drug Administration (FDA) and the Department of Veterans Affairs (DVA).

The collective, being spearheaded by physician-turned-venture capitalist Tom Cahill, is benefiting from the shared knowledge of at least a dozen men and women working at the upper echelons of the scientific and academic communities.

Current team members include Akiko Iwasaki, Professor of Immunobiology at Yale University School of Medicine, Lynn Goldman, Dean and Professor at the George Washington University, Stuart Schreiber, a Professor of Chemistry and Chemical Biology at Harvard University, and many more.

The WSJ reported Cahill has tapped connections made through his investment firm, including billionaires Peter Thiel, Jim Palotta and Michael Milken.

A report, obtained and published by the WSJ, identifies drugs that could potentially be used to treat COVID-19 and highlights American companies that are best suited to help produce, distribute or research pharmaceuticals, drugs or antibodies.

The members are sifting through peer-reviewed research to find the most promising results, then attempting to flag them to health officials and the federal government.

The 17-page report claims that none of the group members have "any direct or known indirect financial interests" in companies named in the analysis. The WSJ noted some plans appeared to be "unorthodox," including the proposed treatment of patients with drugs first intended for Ebola in higher doses than have been used in the past.

"The war against COVID-19 is being fought on multiple fronts," the report notes.

"We describe plans to develop therapeutics and vaccines, and to reopen our businesses and schools, that could be deployed in several waves.

"We are a group of passionate citizen-scientists who offer four actionable non-partisan proposals to produce safe and effective COVID-19 therapeutics and vaccines in the shortest possible time frame, and to reopen our society in a manner that reduces the risk of future COVID-19 outbreaks." They went on to detail a four-point plan.

According to the team, the first wave of therapies will be focused on the use of existing drugs, with testing during April-May 2020 and then use immediately afterwards.

The second wave will develop antibody drugs, with testing from June-August 2020. The third is the creation of vaccines, with a test timeline of March 2020-March 2021.

The fourth point, reopening of the economy, should start around May-June this year, but must be based on science-driven symptom reporting and virus testing, they say.

"It is critical that approaches to drugs, vaccines, and reopening our society be pursued and supported simultaneously," ," the paper stated. "To defeat this novel coronavirus in the United States, and around the world, will require a massive and well-organized collaborative effort from government, industry, philanthropy, and citizens. It is vital that we establish these partnerships and take actions immediately."

The group told the WSJ they are aware their ideas may not be taken on board by the U.S. government or its coronavirus task force. "We may fail," Harvard University chemist Schreiber told the newspaper. "But if it succeeds, it could change the world."

EU aims to remove obstacle to free trade deal with US

Πηγή: DW
14 June 2013

EU ministers have come together to try to overcome French resistance to free-trade talks with the US. France's desire to protect its film industry from Hollywood has put up a major hurdle for a deal.

Analysts said that Friday's meeting of EU trade ministers in Luxembourg would need to be successful in order to keep alive plans for a trans-Atlantic free-trade deal with the potential to boost struggling economies by dramatically increasing business between Europe and the US.

The pact would deliver the largest area of free trade in the world, affecting more than 800 million people, with the daily flow of goods and services between the two sides already amounting to almost 2 billion euros ($2.7 billion) daily.

EU ministers are under pressure to agree on a negotiating mandate on Friday so that the start of official negotiations can be announced at the forthcoming G8 summit in Northern Ireland next week.

Bumpy road ahead

The biggest challenge will be to overcome French reservations as the country's government and film industry have teamed up to push for an exclusion of audiovisual services from any agreement. France appeared worried that Europe's film and music sector might be harmed by Hollywood.

"France will oppose the opening of negotiations if culture is not excluded," Prime Minister Jean-Marc Ayrault warned unambiguously.

The EU executive has so far promised to protect existing film subsidies and quotas, but has objected a wholesale exemption of the audiovisual sector.

The US ambassador to the EU, William Kennard, told The Financial Times that there would be a price to pay if a mandate were released that constrained the negotiators.

EU and US officials expressed the hope that a deal could be concluded by mid-2014. However, the film and music sector is not the only area where negotiating problems might arise: Regulations on agricultural exports and military supplies could also prove rather tricky.

Meningitis-linked steroid may have affected 13,000 people in U.S.: CDC

A security guard looks out from the front doors of pharmaceutical compounding company New England Compounding Center (NECC), a producer of the steroid methylprednisolone acetate, in Framingham, Massachusetts October 8, 2012.

Πηγή: Reuters

By Tim Ghianni
Oct 8 2012

Some 13,000 people in 23 U.S. states may have received steroid injections linked to a rare fungal meningitis outbreak that has killed eight people, but far fewer are likely to contract the disease, the Centers for Disease Control said on Monday.

The CDC for the first time estimated the number of patients potentially affected, after previously saying only that it could be in the thousands.

So far, 105 cases of the rare form of meningitis have been confirmed in nine states. In hardest hit Tennessee another person has died, bringing the national death toll to eight, the CDC and Tennessee state authorities said on Monday.

Nearly 1,000 people in Tennessee may have received injections from the three recalled lots containing 17,676 vials of potentially tainted steroid, Tennessee Health Commissioner Dr. John Dreyzehner said on Monday. Saint Thomas Outpatient Neurosurgery Center in Nashville received some 2,000 vials, more than any other facility in the country, he said.

The widening outbreak has alarmed federal and state health officials and focused attention on regulation of pharmaceutical compounding companies such as the one that produced the drugs - the New England Compounding Center Inc in Framingham, Massachusetts.

"We anticipate finding some additional infections," said CDC spokesman Curtis Allen. He could not say if all 13,000 people had been contacted, but said efforts had been made to find them in the last few days and the recall should limit the outbreak.

In Ohio, health officials said on Monday they were mobilizing community resources, including sheriff's offices, to check on patients who have received the injections.

"If that means knocking on doors, then that's what they will do," Beth Bickford, executive director at the Association of Ohio Health Commissioners, said in a statement. The state has so far reported one case of fungal meningitis likely caused by a tainted epidural steroid injection.

The steroid is used as a painkiller, usually for the back. Meningitis is an infection of the membranes covering the brain and spinal cord, and patients started showing a variety of symptoms from one to four weeks after their injections.

The potentially tainted drugs were produced as early as May and shipped to 76 facilities in 23 states through September, the CDC and Massachusetts Health Department said.

The company, which was previously the subject of complaints, has suspended its operations while an investigation proceeds. It initially recalled the three lots of the drug, and expanded its recall on Saturday to all products compounded and distributed at its Framingham facility.

A compounding pharmacy takes medications from pharmaceutical manufacturers and makes them into specific dosages and strengths for use by doctors.

Complaints against the company in 2002 and 2003 about the processing of medication resulted in an agreement with government agencies in 2006 to correct deficiencies, the Massachusetts Health Department said.

LIMITED FDA AUTHORITY

In 2011, there was another inspection of the facility and no deficiencies were found. In March 2012, another complaint was made about the potency of a product used in eye surgery procedures. That investigation is continuing, the state health department said.

The U.S. Food and Drug administration has limited authority over the day-to-day operations of compounding pharmacies, which are regulated primarily by state boards that oversee the practices, licensing and certification of pharmacies and pharmacists.

Compounded products do not have to win FDA approval before they are sold, and the agency has no jurisdiction over how the products are manufactured or labeled for use. Instead, the FDA investigates cases of adulterated drugs in cooperation with state regulators.

The FDA has tried to exert greater authority over compounded drug products under a section of the Food, Drug and Cosmetic Act that covers new drugs. But those efforts led to federal court challenges that resulted in two separate and conflicting rulings at the appellate level.

The nine states where fungal meningitis cases have been reported are Florida, Indiana, Maryland, Michigan, Minnesota, North Carolina, Ohio, Tennessee and Virginia.

Tennessee, where the outbreak was first detected, accounted for most of the cases, with 35, including four deaths. Many patients there remain hospitalized, some in critical condition.

Virginia has 23 cases and one death, Michigan 21 cases and two deaths and one person has died in Maryland.

Fungal meningitis is not contagious, the CDC said. Symptoms include fever, headache, nausea and neurological problems that would be consistent with deep brain stroke.

The steroid was sent to California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia and West Virginia, the CDC said.

A list of facilities that received vials from the infected lots can be found via the website www.cdc.gov . (Writing by Mary Wisniewski; editing by Greg McCune and Mohammad Zargham

Pharmaceutical Giant GSK to Pay $3B in Largest-Ever Health Care Fraud Case

The company logo of GlaxoSmithKline, is seen on the headquarters building in London.

Πηγή: abc
By PIERRE THOMAS

July 2 2012

Healthcare giant GlaxoSmithKline has agreed to an unprecedented $3 billion settlement with the U.S. government over allegations that the company advertised drugs for uses not approved by the Food and Drug Administration and then used lavish gifts to convince doctors to prescribe the drugs.

The multi-billion dollar settlement is the largest in U.S. history for alleged healthcare fraud, government officials said.



In one instance, a drug was widely promoted to help treat depression even though the FDA had never tested it for such a use, according to the Department of Justice. In another, prosecutors said GlaxoSmithKline, or GSK, advertised the drug Paxil for use on children, despite the FDA not having approved antidepressant for anyone under 18. A notice posted on the website for the U.S. National Library of Medicine warned that a small number children to young adults taking Paroxetine -- which is sold under the brand name Paxil -- in clinical studies "became suicidal."

The government also said that GSK failed to report relevant safety information about the popular diabetes treatment Avandia to the FDA and even directly paid medical professionals to push the product on doctors for its alleged benefits for the heart -- even though GSK had no scientific data to back up that claim.

In all, GSK pleaded guilty to three criminal charges for which it will pay $1 billion and another $2 billion will be paid in civil liabilities under the False Claims Act.

GSK is a major manufacturer of prescription medication, vaccines and consumer healthcare products. On its website, the company boasts, "every minute more than 1,100 prescriptions are written for GSK products."

In a 2011 Corporate Responsibility Report, GSK addressed the government's allegations broadly, saying, "Some people are concerned that marketing by pharmaceutical companies may exert undue influence on doctors, that sales representatives may not always give doctors full information about the products they are promoting, or that there may be promotion of medicines for unapproved uses."

GSK goes on in that document to say that the company has "fundamentally changed our procedures for compliance, marketing and selling in the USA to ensure that we operate with high standards of integrity and that we conduct our business openly and transparently."

But critics at the Taxpayers Against Fraud non-profit group said that while recovering the money was a positive step, little is being done on a personal level to combat widespread fraud from the industry's top moneymakers – including putting executives behind bars.

"The bad news is that monetary penalties are not enough to stop rampant fraud... If we want to stop fraud, we need to recover America's stolen billions and we need to make sure that key players lose their jobs, their bank accounts, and their freedom," said Patrick Burns of Taxpayers Against Fraud. "Once the pain is personal and well-timed, the change in conduct in fraudster-companies will be very rapid."

CLICK HERE for several documents related to the case provided by the U.S. Department of Justice.

FDA staffers sue agency over surveillance of personal e-mail

Πηγή: Washimgton Post
By Ellen Nakashima and Lisa Rein
Jan 30 2012

The Food and Drug Administration secretly monitored the personal e-mail of a group of its own scientists and doctors after they warned Congress that the agency was approving medical devices that they believed posed unacceptable risks to patients, government documents show.

The surveillance — detailed in e-mails and memos unearthed by six of the scientists and doctors, who filed a lawsuit against the FDA in U.S. District Court in Washington last week — took place over two years as the plaintiffs accessed their personal Gmail accounts from government computers.

Information garnered this way eventually contributed to the harassment or dismissal of all six of the FDA employees, the suit alleges. All had worked in an office responsible for reviewing devices for cancer screening and other purposes.

Copies of the e-mails show that, starting in January 2009, the FDA intercepted communications with congressional staffers and draft versions of whistleblower complaints complete with editing notes in the margins. The agency also took electronic snapshots of the computer desktops of the FDA employees and reviewed documents they saved on the hard drives of their government computers.

FDA computers post a warning, visible when users log on, that they should have “no reasonable expectation of privacy” in any data passing through or stored on the system, and that the government may intercept any such data at any time for any lawful government purpose.

But in the suit, the doctors and scientists say the government violated their constitutional privacy rights by gazing into personal e-mail accounts for the purpose of monitoring activity that they say was lawful.

“Who would have thought that they would have the nerve to be monitoring my communications to Congress?” said Robert C. Smith, one of the plaintiffs in the suit, a former radiology professor at Yale and Cornell universities who worked as a device reviewer at the FDA until his contract was not renewed in July 2010. “How dare they?”

An FDA spokeswoman, Erica Jefferson, said the agency does not comment on litigation.

But according to FDA internal documents that the scientists and doctors obtained under the Freedom of Information Act, the agency told the Department of Health and Human Services’ inspector general that they had improperly disclosed confidential business information about the devices. The agency requested that an investigation be opened in May 2010.

The scientists and doctors denied sharing information improperly. The HHS inspector general’s office, which oversees FDA operations, declined to pursue an investigation, finding no evidence of criminal conduct. It also said that the doctors and scientists had a legal right to air their concerns to Congress or journalists.

FDA officials sought a second time that year to initiate action against the scientists and doctors. “We have obtained new information confirming the existence of information disclosures that undermine the integrity and mission of the FDA and, we believe, may be prohibited by law,” wrote Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, on June 28, 2010.

The inspector general, after consulting with federal prosecutors, declined the second request, as well.

Michael Sussmann, a former federal prosecutor who is now a partner at the Perkins Coie law firm, said the FDA’s warning on its computers gave the agency latitude to conduct extensive monitoring. “Anything on this agency’s network is fair game by use of this banner, as long as they’re lawfully targeting their employee.”

Yet the case sheds light on the lengths to which a federal agency will go to monitor employees. At issue, experts say, is whether the purpose of the monitoring was legal and what level of monitoring on government computers is reasonable at a time when technology increasingly blurs the lines between work and home.

“The FDA has a huge responsibility to protect public health and safety,” Sen.Charles E. Grassley (R-Iowa) said in a statement last week. “It’s hard to see how managers apparently thought it was a good use of time to shadow agency scientists and monitor their e-mail accounts for legally protected communications with Congress.”

Concerns about devices

The FDA scientists and doctors, all of whom worked for the agency’s Office of Device Evaluation, said they first made internal complaints beginning in 2007 that the agency had approved or was on the verge of approving at least a dozen radiological devices whose effectiveness was not proven and that posed risks to millions of patients. Frustrated, they also brought their concerns to Congress, the White House and the HHS inspector general.

Three of the devices risked missing signs of breast cancer, the scientists and doctors warned, according to documents and interviews. Another risked falsely diagnosing osteoporosis, leading to unnecessary treatments; one ultrasound device could malfunction while monitoring pregnant women in labor, risking harm to the fetus; and several devices for colon cancer screening used such heavy doses of radiation that they risked causing cancer in otherwise healthy people, the FDA scientists and doctors said.

They also had expressed concern about a computer-aided imaging device that searched for signs of breast cancer. Three times, a team of experts, including Smith, recommended against approval, and middle managers agreed in each case, he said. After the third rejection, a senior manager approved the device in 2008, he said.

Most of the devices the scientists and doctors questioned have received approvals only in the past two years, making it difficult to evaluate whether the fears that the FDA scientists and doctors expressed were valid.

But the concerns were not isolated. In 2009 and 2011, the Government Accountability Office, Congress’s auditing arm, warned that some risky medical devices win approval through a process that is insufficiently stringent. The Institute of Medicine concluded in a major study last year that the FDA process for approving medical devices needed to be revised and based on “sound science.”

Though the FDA declined to comment for this story, agency officials last year dismissed an analysis by the Archives of Internal Medicine claiming that unsafe medical devices were rushed to market, saying a relatively small number were recalled between 2005 and 2009. An FDA spokeswoman also said last year the agency had made changes to make the review process safer.

Snapshots of desktops

After President Obama’s election, the FDA scientists and doctors wrote to his transition team in 2009, alleging corruption at the agency and warning about risks posed by the breast-cancer screening device.

After they sent the letter, which they shared with members of Congress, several news organizations reported on the concerns. In some of those reports, FDA officials said they were addressing the issues.

Within days after the news reports appeared, the president of the company that made the device, Ken Ferry of iCAD Inc., based in Nashua, N.H., wrote a letter to the FDA alleging that confidential business information had been leaked. Ferry declined to comment for this story.

Using automated software, the agency began taking snapshots of the scientists’ computer screens showing documents as they were being backed up and e-mails being moved from one file to another, the FDA documents show. The agency created a file, “FDA 9,” to store e-mails and documents gathered from nine scientists and doctors who originally had complained. (Three of them are not involved in the lawsuit filed last week.)

The first documented FDA interception was of an e-mail dated Jan. 29, 2009, shortly after the letter from Ferry. In it, device reviewer Paul T. Hardy asked a congressional aide, Joanne Royce, for assurances that “it is not a crime to provide information to the Congress about potential misconduct by another Agency employee.”

Royce replied: “[Y]ou and your colleagues have committed no crime. . . . you guys didn’t even provide confidential business information to Congress.”

Hardy, who is among the six employees who filed the suit, was fired in November after a negative performance review; an internal FDA letter obtained in separate litigation quoted managers saying they did not “trust” him. Of the other five scientists and doctors, the suit says two did not have their contracts renewed, two suffered harassment and werepassed over for promotions, and one was fired.

U.S.: Battle Escalates Against Genetically Modified Crops

Πηγή: The International News Magazine
Oct 2 2011

\WASHINGTON, Oct 1 (IPS) - Home to a fast-growing network of farmers' markets, cooperatives and organic farms, but also the breeding ground for mammoth for-profit corporations that now hold patents to
over 50 percent of the world's seeds, the United States is weathering a battle between Big Agro and a ripening movement for food justice and security.

Conflicting ideologies about agriculture have become ground zero for this war over the production, distribution and consumption of the world's food.

One camp - led by agro giants like Monsanto, DuPont and Syngenta - define successful agriculture and hunger alleviation as the use of advanced technologies to stimulate yields of mono-crops.

The other side argues that industrial agriculture pollutes, destroys and disrupts nature by dismissing the importance of relationships necessary for any ecosystem to thrive.

At the heart of this struggle is the debate about genetically modified organisms (GMOs), which were given the green light in 1990 when the U.S. Food and Drug Administration (FDA) stated, "(We) are not aware of any information showing that GMO foods differ from other foods in any meaningful or uniform way."

But a report released Wednesday by the Washington-based Food and Water Watch (FWW) on the destructive impacts of GMOs added fuel to a two-decades-long fight by farmers, economists and experts against the FDA's conclusions.

"Genetically Engineered Food: An Overview" details how the genetic engineering of seeds, crops and animals for human consumption is not the foolproof answer long championed by agribusiness and biotechnology industries to feeding the world.

To the contrary, the study found that genetically engineered/modified (GE/M) organisms do not out-perform their natural counterparts, and their proliferation into vast tracts of cropland have caused a slew of environmental and health crises, and actually increased poverty by forcing millions of farmers to "buy" patented seeds at exorbitant prices.

The report also says that three U.S. federal agencies - the FDA, the Department of Agriculture (USDA) and the Environmental Protection Agency (EPA) - are complicit in these crises due to shoddy oversight, weak enforcement of regulations and a complete absence of coordination.

It found that Big Agro spent half a billion dollars between 1999 and 2009 on lobbying to ease GE regulatory oversight, push GE approvals and prevent GE labeling.

This, after attorney Steven Druker in 1999 obtained 40,000 pages of FDA files containing "memorandum after memorandum warning about the hazards of (GE) food," including the likelihood that they contained,
"toxins, carcinogens or allergens" and testified that GE foods violated "sound science and U.S. law".

Ceci King, a member of the Black Farmers and Agriculturalists Association, told IPS that in 2011, an estimated "60 to 70 percent of all processed foods in the U.S. contain at least one GE element."

Unstoppable proliferation? 

According to the report, over 365 million acres of GE crops were cultivated in 29 countries in 2010 alone, representing 10 percent of global cropland.

"The United States is the world leader in GE crop production, with 165 million acres, or nearly half of global production," Patty Lovera, assistant director of FWW, told IPS.

"From only seven percent of soybean acres and one percent of corn acres in 1996, GE cultivation in the U.S. shot up to 94 percent of soybean and 88 percent of corn acres in 2011," she added.

The bulk of these crops came from seeds owned by Monsanto.

"Eighty-four percent of GM crops in the world today are herbicide-resistant soybeans, corn, cotton or canola, predominantly Monsanto's 'Roundup Ready' varieties that withstand dousing with herbicide," Bill Frees, science policy analyst at the Center for Food Safety (CFS) and author of 'Why GM Crops Will Not Feed the World', told IPS.

"Pesticide and chemical companies like Monsanto, DuPont, Syngenta, Dow and Bayer have bought up many of the world's largest seed companies, and now call themselves biotech companies - this represents a historic merger of the pesticide and seed industries, which allows them to profit twice by developing expensive GM seeds that increase use of the company's herbicide products," he added.

Seed patents, an off-shoot of the "agro-biotech revolution" that also spawned GE/M, have had two negative consequences since their original issuance by the U.S. Patent Office in the mid-1990s, Frees told IPS:
"They enticed pesticide companies to buy up seed firms; and they led to criminalisation of seed-saving."

"Farmers have saved seeds from their harvest to replant the next year for millennia," he added. "Monsanto is changing that. The company has already sued thousands of farmers in the U.S. for saving and replanting its patented seeds and won an estimated 85 to 160 million dollars from farmers, in lawsuits that have ruined farmers' lives, and (partially explains) why we have ever fewer farmers in America."

The pushback

Ray Tricomo, a mentor at the Kalpulli Turtle Island Multiversity in Minnesota, told IPS, "People of colour must re-radicalise themselves and go on the offensive including the return to land bases, from Turtle Island to Africa and Asia."

"Ancient knowledge systems are to be painstakingly recovered, even if it takes centuries," he added.

And this is exactly what is happening.

Despite the deep pockets and aggressive efforts of Big Agro, a major pushback from a broad coalition of forces has limited 80 percent of GE/M planting to just three export-oriented countries: the U.S., Brazil and Argentina.

Nearly two dozen other countries, including the European Union and China, have passed mandatory GE/M labeling, and millions around the world are refusing seed patenting and developing seed banks to protect, share and preserve their seeds.

In Florida, the 4,000-strong Coalition of Immokalee Workers (CIW) is organising to resist farm wage-slavery and "seed-servitude". The Landless Workers Movement (MST) in Brazil has organised 400,000 peasants to join forces with the nearly half-billion farms around the world that are responsible for producing 70 percent of the world's food.

Navdanya, an organisation in the Indian State of Andhra Pradesh, has united 500,000 farmers in their struggle to fight chemical dependency and save indigenous seeds, including preserving over 3,000 varieties of rice.

"For five years, the United Nations Conference on Sustainable Development (CSD) had indigenous farmers from all over the globe come to speak against destructive farm practices and GMOs," King told IPS.

"During the Indigenous People's Permanent Forum, there were complaints about the harm caused by industrial agriculture and the acts in the name of agribusinesses. Farm workers like the (CIW) are protesting their fate," she added.

"They are picketing companies like Trader Joes and Whole Foods, letting the public know that their tomatoes were picked from workers who are basically slave labour."

"Third World Network is fighting back by exploring the problem of GMOs and publishing findings that scientists working on GMOs are capitalists using humans as guinea pigs in a global lab experiment," she added.

"[Numerous] deaths and disabilities have been traced back to a GM product emulating tryptophan. It took nearly 20 years to find the source of the problem," King told IPS.

"GM technology is antithetical to an agroecological approach to agriculture, our only hope for truly sustainable food production," Frees told IPS.

"Without radical change we will continue to have famines," he added.

"Haiti is a good example of what happens when a country's farmers are put out of business by cheap, subsidised imports from a rich producer nation (here the U.S.)."