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A Killer Enterprise: How One of Big Pharma’s Most Corrupt Companies Plans to Corner the Covid-19 Cure Market

“One of the most politically-connected yet scandal ridden vaccine companies in the United States, with troubling ties to the 2001 anthrax attacks and opioid crisis, is set to profit handsomely from the current Coronavirus crisis.“

By Whitney Webb & Raul Diego – The Last American Vagabond – April 9, 2020

In August 2001, biopharmaceutical company BioPort faced imminent disaster. A series of company scandals, controversial federal bail-outs and severe, adverse health reactions among U.S. troops were causing both Congress and the Pentagon to reconsider its multi-million dollar contract to provide the military with an anthrax vaccine.

Formed for the sole purpose of acquiring a publicly-owned company in Michigan that held the exclusive license to manufacture the only FDA-approved anthrax vaccine in the United States, BioPort sought to quickly expand the size and scope of its contracts with the U.S. military. This strategy was made possible thanks to the former head of the Joints Chiefs of Staff, Adm. William Crowe, who would prove highly instrumental in the rise of BioPort’s vaccine monopoly and its subsequent, aggressive hiring of former government officials as lobbyists.

Yet, soon after scoring these multi-million dollar contracts and securing a monopoly on anthrax vaccines, BioPort would claim that they were flailing financially and would subsequently be bailed out to the tune of $24 million at the Pentagon’s request, which cited “national security concerns” as justification.

However, Pentagon auditors had found that much of the money awarded to BioPort was unaccounted for and the money they were able to trace had failed to go towards renovating their vaccine production facility, which had lost its license until numerous sanitary problems (sanitary and otherwise) were fixed. Meanwhile, scores of soldiers who had suffered ill health effects from BioPort’s anthrax vaccine, some disabled for life, began speaking out, bringing BioPort’s most critical product and chief source of income under unwanted scrutiny.

While BioPort seemingly faced imminent ruin from these and other scandals in August 2001, the 2001 anthrax attacks that followed a month later came at just the right time for the company, as demand for their anthrax vaccine soon skyrocketed, resulting in new lucrative government contracts. Their license was also quickly renewed thanks to intervention from the Department of Health and Human Services (HHS) despite many of the problems with its production facility persisting.

Though they were conveniently rescued by the unfortunate events of 2001, BioPort would soon lobby for larger contracts than ever before, calling for a massive increase in government purchases of their controversial anthrax vaccine. Riding the fear caused by the 2001 anthrax attacks, they pushed for the government to stockpile anthrax vaccines, not just for the military, but for civilians, postal workers, police and many more who could potentially be put in harm’s way were the anthrax attacks to repeat themselves.

One of their biggest proponents of expanding BioPort’s contracts was working for HHS at the time — Jerome Hauer, a man who not only had foreknowledge of the anthrax attacks, but had also participated in the Dark Winter simulation that would also predict those same attacks just months prior. Hauer would, months later, be appointed to a newly created position at HHS, one which oversaw the new biodefense stockpile from which BioPort would be a major beneficiary.

BioPort would be then renamed and repackaged as Emergent Biosolutions in 2004. It would then hire even more well-connected lobbyists and add several big names from government and the private sector to its board. One of these “big names” was none other than Jerome Hauer, who was added to Emergent’s board soon after leaving HHS. Hauer still remains a company director and sits on three of its corporate governance committees.

Not only did Emergent Biosolutions profit from national anthrax fears, they would also cash in on subsequent pandemic panics and later receive substantial backing from the Bill Gates-backed Coalition for Epidemic Preparedness Innovations (CEPI). They would then turn their attention to the still-raging opioid addiction and overdose crisis by buying rights to the only drug approved for treating opioid overdoses at the scene while also suing any and all generic producers of this crucial, life-saving treatment.

Given its history, it should come as little surprise that Emergent Biosolutions is now set to profit from the Coronavirus (Covid-19) crisis. They are particularly well-suited to make record profits off of Covid-19, as they are backing not one, but two, vaccine candidates as well as an experimental blood plasma treatment already approved for trials in New York state, thanks in part to Jerome Hauer’s old boss, New York governor Andrew Cuomo. As noted in a previous article for The Last American Vagabond, the other main companies developing Covid-19 vaccines in the U.S. are strategic partners of the controversial Pentagon research agency DARPA, which has become increasingly aligned with HHS in recent years thanks to another Dark Winter participant, Robert Kadlec.

In this second installment of the series “Engineering Contagion: Amerithrax, Coronavirus and the Rise of the Biotech-Industrial Complex,” Emergent Biosolution’s rise to prominence, made possible through acts of blatant corruption and the public-private revolving door, will be explored. The clear nexus between Big Pharma, Government and University-affiliated “Biosecurity Centers” offers a startling look into the Biotech-Industrial Complex that has long dominated U.S. biodefense policy and is now guiding much of the U.S. government’s response to the Coronavirus crisis.

A Bio Threat is Born

For half a century, Vladimir Pasechnik had been a model Soviet citizen, with his scientific prowess in the field of bioweapons earning him an honorary rank of general. However, having been granted such a title didn’t seem to inspire much loyalty when he made a call to the British embassy from a phone booth in France in 1989. The famed microbiologist subsequently defected to England, a decision that preceded the fall of the Berlin Wall by a matter of months. Yet, few could have provided a more riveting view behind the Iron Curtain than Pasechnik, who regaled Whitehall with shocking tales of monstrous pathogens engineered as part of the Biopreparat, communist Russia’s top secret biological weapons program.

Pasechnik’s MI6 handler, Christopher Davis, shared all of the intelligence gathered with his counterparts in the United States, including claims that Biopreparat programs had developed antibiotic-resistant strains of anthrax, tularemia and botulinum toxin. Ancient diseases like the plague had also been modified, according to Davis. When the stories ran out, Pasechnik was given a job at Britain’s own biodefense facilities at Porton Down, where he would remain for another decade before branching out and founding his own biotech firm.

The Western geopolitical establishment, however, wasted no time in cementing a new narrative of imminent, worldwide bioweapons threats following the collapse of the Soviet Union. Gorbachev’s resignation in 1991 abruptly crashed the Cold War rhetoric market in the West and the massive military-industrial complex that had profited from those tensions remained revved up, yet lacking a boogeyman.

Pasechnik was just one of several Biopreparat alumni who had defected to Western countries, with another well-known example being Ken Alibek (born Kanatjan Alibekov), who defected to the US as opposed to the UK. Many of Alibek’s sensational claims and dire warnings regarding the Soviet bioweapons program in the 1990s would later be proven to be imaginative falsehoods. Despite this, Alibek retained influence in the biotechnology industry and Washington, where the ability to sell fear is often a sought-after trait.

Pasechnik, however, wasn’t so lucky, dying of a suspected heart attack in November 2001. He was one of 11 of the world’s top microbiologists to die under mysterious circumstances from November 2001 to March 2002.

In light of the claims made by Pasechnik, Alibek and others in the 1990s, a relatively small group of well-connected individuals — many of whom would later participate in the June 2001 Dark Winter simulation — asserted that Biopreparat presented an enduring threat, hypothesizing that defectors from the program might not turn to the West, but instead to rival regimes like Saddam Hussein’s Iraq.

Anthrax was quickly deemed to be one of the top threats by these bioweapons doomsayers and then, just months after the Soviet Union’s collapse, the U.S. Department of Defense issued a competitive bid solicitation for the production of 6.3 million doses of the anthrax vaccine. Its previous contract, only a year before, had called for merely 700,000 doses by comparison.

Sourcing Problems

The Michigan Biologic Products Institute (MBPI) had been founded in 1926 by the State to serve the vaccination needs of its largely rural population, many of whom worked on farms and required inoculation against naturally occurring anthrax spores and rabies. By the 1980s, the Institute stood alone as the only anthrax vaccine manufacturer in the U.S. after 1970s-era regulations had driven most private vaccine manufacturers out of business. MBPI’s anthrax vaccine was known as Anthrax Vaccine Adsorbed (AVA) or BioThrax.

Aligning himself with policy recommendations issued by the Mackinac Center for Public Policy – a front for the controversial Koch brothers, Michigan’s governor, John Engler, cited the MBPI’s endemic financial losses to justify putting the nation’s only licensed anthrax vaccine manufacturer up for sale in 1996. However, upon closer examination, the real reason behind the decision had more to do with a sudden spike in demand by the lab’s only customer, the US government, and the MBPI’s inability to meet it.

The Michigan facility required massive renovations if it was to fulfill the needs of a national security establishment that had come to reconstitute itself around the threat of weapons of mass destruction and biowarfare, a threat largely manufactured by the stories of Soviet defectors. The Pentagon offered to pony up $1.8 million for the necessary renovations, but there were no takers — at least, none with a US passport.

That same year, perennial US defense contractor, Dyncorp, went into business with a shadowy group of biotech entrepreneurs from across the pond, forming the DynPort Vaccine Company, LLC., a combination of DynCorp’s name with that of its UK-based partner, Porton International, Inc. The latter company’s president, Zsolt Harsanyi, would also lead DynPort as the British firm began to lay the groundwork for its second attempt at securing a crucial monopoly within the American biotech space.

Germ Monopoly

Porton International had come into existence as a result of the Thatcherite revolution that balkanized British public sector assets and distributed them among private interests that frequently had close and cozy ties with Thatcher-era officials and other UK politicians. Among these assets was the Centre for Applied Microbiology and Research (CAMR), a biotechnology arm of the United Kingdom’s infamous Defence Science and Technology Laboratory, commonly referred to as Porton Down, which also happened to house the UK’s own anthrax vaccine program.

Porton International began operations in 1982, when London financier, Wensley Haydon-Baillie, founded the company to develop a herpes medication invented by Dr. Gordon Skinner, which had stalled during clinical trials and never actually entered the market. In 1985, Haydon-Baillie secured exclusive rights to commercialize drugs developed by the CAMR, a sweetheart deal from the Thatcher government that drew in large investments from British Telecom and Lloyds Bank, among others, totaling £76 million. Haydon-Ballie profited handsomely from the venture, collecting annual dividends of half a million pounds and selling some of his shares for £24 million in 1986.

In 1989, Porton International acquired Sera-lab and Hazleton Biologics, Inc., providing it with an established distribution network. The following year, the company’s bid to outright purchase the 650-employee CAMR lab, would be accepted by British Health Secretary, Kenneth Clark, despite opposition from the staff who had voted against the takeover.

House of Fuad

By the time the sale closed, Haydon-Ballie — once the 50th richest man in England — was on the brink of being forced out of Porton International over accusations of illicit enrichment. Around the same time, the anthrax vaccine was set to enter a bull market and Porton International was now in a prime position to reap the full benefits.

A year earlier in 1989, Ibrahim El-Hibri, a Venezuelan citizen who had made a fortune working for US telecommunications companies, had become a silent partner in Porton International. His son, Fuad El-Hibri, was made director of Porton Products, Ltd, a Porton International subsidiary, which was the conduit by which the El-Hibri family had made a killing selling anthrax vaccines to Saudi Arabia and other Gulf states at $300 to $500 a dose. Fuad El-Hibri had previously been an intelligence contractor for Booz Allen Hamilton and an executive at the Wall Street giant, CitiGroup.

The elder El-Hibri had a knack for business that ran back decades to the 1970s when he lived in Qatar, where he befriended the then-head of US Central Command, Admiral William Crowe. The career military man kept in touch with El-Hibri through the years and perhaps even gave him a few business leads at a time when Crowe was also serving on the board of pharmaceutical behemoth, Pfizer. Crowe would later pick up the phone in late 1997 (officially at least, but probably well before) to make a proposition to his old friend.

In 1997, then-US Secretary of Defense William S. Cohen announced a plan to vaccinate every single member of the US Armed Forces against anthrax, which ultimately resulted in the vaccination of approximately 2.4 million troops by 2003. Admiral Crowe, who was serving as the US ambassador to the UK at the time, quickly contacted El-Hibri to discuss the US government anthrax vaccine market in light of this new Pentagon policy.

The only obstacle was getting his son, Fuad El-Hibri, a U.S. passport so that he could run the business stateside. To easily and quickly circumvent this issue, the politically-connected Admiral — with his deep ties to the Pentagon intact — was made a director of BioPort and given 10% of company stock, despite not having put a single penny into the company.

The stage was set to bring Porton International into the exclusive government contract business in the United States as BioPort, Inc. As luck would have it, Porton International’s president, Zsolt Harsanyi, had just received a ten-year DoD contract worth roughly $322 million through DynPort Vaccine Company, LLC, and — thanks to Michigan’s governor — the only licensed anthrax vaccine manufacturing plant in the country was back on the auction block.

A Steal and a Scam

In September 1998, BioPort acquired the MBPI facility through a $25 million package of loans, cash and promises to pay Michigan state more for the company in the future, promises that were later broken. It was later revealed that El-Hibri and other BioPort partners had only placed $4.5 million of their own money into this package.

As previously mentioned, the MBPI plant in Lansing, MI had come with issues and had been closed for renovations six months prior to its purchase by BioPort. However, the MBPI had received millions from the Pentagon to fix the issues identified by the Food and Drug Administration (FDA) that had affected the vaccine’s “stability, potency and purity.”

Along with these issues, BioPort had also inherited military contracts worth nearly $8 million for anthrax vaccines. They quickly secured another contract for the same totaling more than $45 million, with an additional $16 million in cash for immediate renovations — a sizable deal likely due to BioPort’s aggressive hiring of former Pentagon and federal officials as lobbyists in addition to Crowe’s own deep ties to the Pentagon.

Despite the massive influx of cash, BioPort did not spend the money on renovating the plant and its sanitary issues, likely due to the fact that the deal required the Pentagon to buy anthrax vaccines from BioPort even if the plant and the vaccines it had produced lacked a FDA license.

With the Pentagon obligated to buy the vaccine, regardless of whether it was usable, BioPort spent millions renovating its executives’ offices, as opposed to the vaccine factory, and millions more on bonuses for “senior management.” Pentagon auditors would later find that still millions more had gone “missing” and BioPort’s staff were unaware of the cost of producing a single dose of the vaccine.

Despite the clear mismanagement and corruption, BioPort demanded to be bailed out by the Pentagon, requesting even more money to replace what they had lost and squandered. Though Pentagon auditors argued that the company should be abandoned, top military officials cited “national security” and awarded BioPort with an additional $24.1 million. They also upped the price to be paid for each dose of the anthrax vaccine, which only has a shelf life of 3 years, from $4.36 to $10.64.

Congress would hold hearings on the bail-out, hearings that went nowhere. During one of those hearings, then-Rep. Walter Jones (R-NC) would state the following:

“The message seems clear: If a company wants to make millions without providing a product or service, enter into a sole-source contract with the Department of Defense to produce vaccines. BioPort appears to have the government over a barrel.”

Unsurprisingly, this would only be the first of BioPort’s federal bail-outs.

Fortune favors the corrupt

With BioPort well aware of its powerful position early on, it dragged its feet in getting its factory relicensed and up to federal standards. Meanwhile, due to the nature of the contract, the Pentagon kept buying up large amounts of vaccines that were unusable, and arguably unsafe, while also still paying BioPort for storage of the useless product.

During this time, anthrax vaccine doses made prior to these renovations were being used on U.S. troops, with many of those soldiers claiming that the vaccine produced in the troubled facility had given them permanent headaches, joint pain, loss of memory and other, more severe symptoms. Some were even disabled for life. Congress again held hearings, but they were stuffed with BioPort employees posing as “experts” as well as others who supported the Pentagon’s contract with the company.

However, in 2000, the Pentagon did finally lose patience and demanded that BioPort stop making BioThrax. BioPort obliged, but kept receiving government money to keep it afloat. By August 2001, the Lansing facility was still unlicensed and BioPort was still demanding government money to keep it from going out of business. That month, Congress and the Pentagon began to publicly discuss abandoning BioPort. The Pentagon began preparing a report, due to be released in September 2001, that would detail a plan for letting BioPort go.

Fortunately for BioPort but unfortunately for the nation, the events of September 11, 2001 and the subsequent anthrax attacks led to major increases in fear and panic that anthrax attacks could become a recurrent nightmare for the American public and that radical terror groups and rival nations sought to target, not just American soldiers with anthrax, but also the country’s civilians.

The ensuing panic led the Department of Health and Human Services (HHS) to intervene, returning BioPort its license in January 2002 despite persisting safety concerns at its vaccine production facility. BioPort was not content to merely see its past contracts with the Pentagon restored, however, as it began lobbying heavily for new contracts for anthrax vaccines intended for American civilians, postal workers and others. They would get them, largely thanks to HHS’ then-counter-terrorism adviser and soon to be HHS’ newest Assistant Secretary — Jerome Hauer.

Jerome Hauer’s Curious Past

As BioPort secured its control over the only licensed anthrax vaccine producer in the country in 1998, New York’s emergency crisis manager and bioterrorism expert, Jerome Hauer, was busy working and making doomsday contingency plans from his “bunker” on the 23rd floor of World Trade Center Building 7.

Put on the job by then-NY Mayor Rudy Giuliani in 1996, Hauer had previously managed worldwide emergency response for technology giant IBM. He also was an adviser to the Justice Department, had briefed President Clinton on bioterror threats and was known to “consult regularly with Scotland Yard and the Israeli military.” It was reportedly Hauer’s idea to locate the city’s emergency management office at Building 7, even though placing it there was considered controversial at the time due to the 1993 World Trade Center bombings, bombings that were later revealed to have disturbing links to the FBI.

In 1999, the New York Times would describe Hauer’s job as “sitting around all day thinking up horrifying ways for things to be destroyed and people to die.” It would also note that Hauer described his expertise regarding specific emergency situations as follows: “helicopter crash, subway fire, water main break, ice storm, heat wave, blackout, building collapse, building collapse, building collapse.” His obsession with building collapses even led him to house “trophies” of the building collapses he had overseen and responded to. How odd then that Hauer’s multi-million dollar “bunker” itself would later fall victim to building collapse, falling into its own footprint in 7 seconds on September 11, 2001.

That fateful day, Hauer was no longer with NY’s Office of Emergency Management, having left in February 2000. However, in 2001, Hauer still worked at the World Trade center complex, running security for the buildings as managing director of Kroll Inc. Informally known as the “CIA of Wall Street”, Kroll was alleged to be an actual front for the CIA by French intelligence agencies, according to the Washington Post. Though it claimed to be mainly involved in corporate security and investigations, it also frequently investigated targets of Washington foreign policy, including Saddam Hussein. Kroll was also the company tapped to “reorganize” Enron in 2002.

Though Hauer should have been at his office at the World Trade Center on the morning of September 11, 2001, he did not show up for work that day and instead made TV media appearances, where he claimed that Osama bin Laden had been responsible for the attacks just hours after the towers collapsed in an interview with Dan Rather.

Yet, not all Kroll employees were as lucky as Hauer. John O’Neil had just begun working for Kroll and was at the World Trade Center that day, dying in the attacks. O’Neil had previously worked with the FBI and was the country’s top expert on Osama bin Laden and his activities. He had resigned in mid-2001 after his investigations into bin Laden were repeatedly blocked by his superiors, something that happened to numerous federal investigators prior to 9/11, and was subsequently offered a job at Kroll by none other than Jerome Hauer himself.

Also on the day of 9/11, Hauer had told top Bush administration officials to start taking the antibiotic Cipro to prevent infection via anthrax and Hauer would subsequently make public hints via mass media that foreign terrorists were working with Saddam Hussein to unleash an anthrax attack on the American public. All of this took place well before the first anthrax attack victim, photojournalist Robert Stevens, would even show symptoms.

Hauer had prepared for a scenario just like the anthrax attacks as part of the Dark Winter biowarfare simulation, which occurred just months prior and at a time when Hauer was a member of the Johns Hopkins Working Group on Civilian BioDefense, part of what is now the Johns Hopkins Center for Health Security, then led by Dark Winter co-author Tara O’Toole. The Dark Winter exercise and its current relevance are discussed in detail in Part I of this series.

Also of note is the fact that, while working for Kroll Inc. Hauer was also working for the Scientific Applications International Corporation (SAIC), a defense and intelligence contractor. There he became a co-worker of Stephen Hatfill, who Hauer had actually met years prior. At SAIC, Hatfill worked on developing protocols for handling “anthrax hoax letters,” a phenomenon present in Dark Winter and later during the actual 2001 anthrax attacks. Hatfill would later be accused of having committed those very attacks, but was later cleared of suspicion, winning a hefty multi-million dollar settlement from the government.

In addition to his work for SAIC and Kroll as the events of September 11, 2001 transpired, Hauer was also a national security adviser to then-head of the Department of Health and Human Services (HHS), Tommy Thompson. Hauer closely advised Thompson during the 2001 anthrax attacks and after, helping to shape HHS response and subsequent biodefense policy, which focused heavily on BioPort’s anthrax vaccine.

Hauer and HHS

As the anthrax attacks unfolded, Hauer advised Secretary Thompson to establish a new office at HHS, the Office of Public Health Preparedness (OPHP), whose first acting director was Dr. D.A. Henderson, a former official with the World Health Organization and the original founder of the Johns Hopkins Working Group on Civilian Biodefense, which had sponsored Dark Winter and included Jerome Hauer as well as Dark Winter co-authors Tara O’Toole and Thomas Inglesby. In early 2002, Hauer himself would replace Henderson as head of the newly created OPHP.

In May 2002, Hauer — while leading OPHP —  co-authored a report with members of the Johns Hopkins Working Group, including O’Toole and Inglesby. In that paper, published in the prestigious Journal of the American Medical Association (JAMA), Hauer, O’Toole, Inglesby and their co-authors argued that greater production and purchase of anthrax vaccine was necessary in light of the 2001 anthrax attacks and that government funding was also needed to research a new anthrax vaccine. They also asserted that the vaccine did not cause any significant adverse effects.

Notably, just months prior, O’Toole and Inglesby had come under scrutiny in their attempts to link the anthrax attacks to Al Qaeda, several months after that possibility had been ruled out completely by federal investigators and other independent scientists.

The paper authored by the Johns Hopkins Working Group would also come under scrutiny, particularly their recommendation that the government acquire more BioThrax. This was largely because the evidence from the attacks showed that antibiotics were much more effective and less expensive in responding to anthrax attacks, with subsequent studies claiming that calls for stockpiling more BioThrax “defy medical evidence and expert recommendations” based on lessons learned during the anthrax attacks.

Then, in June 2002, the Public Health Security and Bioterrorism Preparedness and Response Act was signed into law by President Bush, creating the post of Assistant Secretary for Public Health Emergency Preparedness, which was quickly filled by Hauer and gave him near-complete power over HHS’ biodefense policy and all HHS matters related to “national security.”

In July 2002, Hauer and his deputy William Raub helped push the Pentagon to restart vaccinating the troops, despite long-standing concerns over the vaccine’s safety. Per the new immunization program, the number of troops being vaccinated would “jump,” according to officials. However, the size of that increase was never made public. In addition, half of the Pentagon’s BioThrax purchases would be stockpiled for civilian use.

Though Hauer, O’Toole, Inglesby, the Pentagon and, of course, BioPort, continued to assert that BioThrax was safe for human use, the Government Accountability Office (GAO) would release its findings just months later that showed that the vaccine “caused adverse reactions in most recipients [85%] and helped prompt many Air Force Reserve and Air National Guard members to transfer to other units or leave the military between 1998 and 2000.” The Pentagon and HHS rejected the GAO’s conclusions.

Despite rejections from the Pentagon and HHS, the number of veterans suffering ill effects from BioThrax continued to mount. Even mainstream sources began to report on claims linking BioThrax to over 20 deaths and over 4,000 illnesses, 347 of which were deemed to be “serious.”

As a result, in March 2003, six military service-members and Defense Department civilian contractors sued the Pentagon, HHS and the FDA over the mandatory BioThrax vaccination policy, claiming that the way the vaccine had been administered in the 1990s and in the early 2000s was experimental.

This claim was based on the fact the FDA had not approved BioThrax for use against aerosol exposure to anthrax (i.e. anthrax inhalation). However, the Pentagon was using BioThrax to ostensibly protect soldiers from exposure to aerosol anthrax, which is the form of anthrax that would be encountered by soldiers in a bioweapon or bioterrorist scenario. Thus, the Pentagon was injecting soldiers with BioThrax for a use for which it was not federally approved, rendering its use experimental. Given that the federal mandating of experimental vaccines is illegal, a federal judge ruled that the Pentagon’s mandatory Biothrax vaccination program was illegal in October 2004.

The ruling was a blow to BioPort, which had reorganized that year and took on the name Emergent Biosolutions. However, BioPort/Emergent Biosolutions would find relief in 2006, when the Pentagon decided to resume mandatory anthrax immunizations among U.S. servicemen soon after the FDA decided to approve BioThrax as a treatment for anthrax inhalation.

Biosolution’s BioShield

Just months before the Pentagon’s BioThrax vaccine program was deemed illegal, Congress passed the Project BioShield Act, an act that was largely written by Emergent Biosolution lobbyists and greatly influenced by Robert Kadlec, who was then serving as the Homeland Security Council’s Director of Biodefense. The goal of the act was to allocate $5 billion to be used to purchase vaccines, including millions of doses of anthrax vaccine, and stockpile them in the event of a future bioterrorist attack. Given that these vaccines have a limited shelf life (three to four years in BioThrax’s case), the stockpile would continually need to be renewed as its contents gradually expired.

Not long after BioShield was signed into law, Emergent Biosolutions co-founded a lobby group called the Alliance for Biosecurity as part of its strategy to easily secure lucrative BioShield contracts. That lobby group saw Emergent Biosolutions join forces with the University of Pittsburgh’s Center for Biosecurity, which was created in 2003 and populated with former members of the Johns Hopkins Institute for Civilian Biodefense Strategies. At the time, the University of Pittsburgh’s Center was led by Tara O’Toole.

Though Emergent Biosolutions had contacts with the key organizations and people in the biodefense-industrial complex, the Bush administration and the military, BioShield initially didn’t go as planned for the company. Instead of pumping even more money into the controversial BioThrax, HHS decided to invest in a new anthrax vaccine that involved fewer doses and fewer adverse side effects, and thus less controversy.

In November 2004, HHS through BioShield awarded VaxGen Inc. a $877.5 million contract to produce a recombinant anthrax vaccine and was the first contract made via BioShield. In great contrast to Emergent’s past BioThrax contracts with the government, the VaxGen contract did not provide the company with government money until the vaccine was approved and subsequently delivered.

The VaxGen contract greatly concerned BioPort/Emergent Biosolutions for obvious reasons. In order to avoid losing their vaccine monopoly, they invested heavily in lobbying and spent $5.29 million on lobbyists from 2004 to 2007. By comparison, over that same period, VaxGen spent $720,000 on lobbyists.

One of those lobbyists was Jerome Hauer, who was also added to Emergent’s board shortly after leaving HHS. Despite Hauer having supported a new anthrax vaccine other than BioThrax while he had worked at HHS, Hauer suddenly began to insist that BioThrax was the solution. He also demanded that his replacement at HHS, Stewart Simonson, who was ultimately responsible for VaxGen’s BioShield contract, be stripped of his authority. Other lobbyists hired by Emergent at the time included two former aides to then-Vice President Dick Cheney and former aides to influential members of Congress.

The hiring of Hauer and others well-connected to the Bush administration and Congress was just part of Emergent’s aggressive lobbying against the VaxGen contract, as the company also employed mafia-esque tactics, telling lawmakers and government officials that U.S. civilians “were at risk of death without an immediately expanded stockpile of [BioThrax] anthrax vaccine” and threatening to “stop making the vaccine if the government chose not to buy its product for the stockpile.”

The war between Emergent Biosolutions and VaxGen spread to Congressional hearings, where Congressmen who had received thousands from Emergent’s then-CEO attacked the VaxGen BioShield contract, with one calling it “highly suspect” and angrily demanding that HHS explain why it had not purchased more BioThrax. It also spread to the press, where Emergent lobbyists wrote Op-Eds in influential newspapers.

Emergent even found unlikely supporters in “progressive” journalists like Jeremy Scahill, who wrote an article for The Nation in which he praised Jerome Hauer, framing him as a champion of public health preparedness who was at odds with Bush-era neocons (despite his membership in organizations stuffed with those same neocons). Scahill also strongly criticized Hauer’s successor Stewart Simonson and the VaxGen contract.

Scahill did not mention in his report that Hauer was then working as a lobbyist for Emergent Biosolutions or was a member of its board, despite interviewing him for the piece. Scahill didn’t even mention Emergent Biosolutions (or its previous name BioPort) once in the entire article, despite it being VaxGen’s main competitor.

Finally, in 2006, HHS terminated VaxGen’s contract after the company hit a developmental snag with its vaccine, declining to offer them the type of lifelines that Emergent Biosolutions had received on numerous occasions under its previous name BioPort.

After VaxGen’s contract with HHS was crushed, Emergent Biosolution’s anthrax vaccine monopoly remained intact, at least for a time. However, PharmAthene, another biotechnology company that had co-formed the Alliance for Biosecurity lobby group with Emergent, soon announced its plans to develop its own recombinant anthrax vaccine. This prompted Emergent to end up buying the essentially bankrupt VaxGen and acquiring the very VaxGen anthrax vaccine it had spent millions of dollars over several years to discredit.

A few years later, Emergent’s competitors made inroads with the Pentagon, with the military offering contracts for the anthrax vaccine developed by PharmAthene and another manufactured by PaxVax. Emergent aggressively challenged its competitors or bought them out in order to retain its monopoly, while also developing three new anthrax vaccines (one of which was the VaxGen vaccine) to satisfy government demand for a new anthrax vaccine. Only one, dubbed NuThrax, ever made any progress.

NuThrax, a combination of BioThrax and an adjuvant, would be yet another gold mine for Emergent Biosolutions. The company received $127 million from HHS’ Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID) for early development. Meanwhile, they began to dramatically scale up their production of BioThrax with even more grants from BARDA. Then, in 2016, it received an additional $198 million from HHS for further development of NuThrax as well as a government promise to purchase up to 50 million doses for the national biodefense stockpile. That promise was made as part of a contract valued at up to $1.6 billion and was also made before NuThrax received approval by the FDA. To date, NuThrax still remains unapproved by the FDA.

The A Team

It is worth noting that Hauer was not the only key government official that had aided BioPort and was later awarded with a position on its board of directors. A few years after Hauer became a board member of Emergent Biosolutions, the company added Dr. Sue Bailey to its board in 2007. Bailey had previously served as the Pentagon’s former top medical official during the late 1990s and played a key role in keeping the military’s anthrax vaccine program from being derailed from persistent concerns from veterans about its safety and adverse side effects.

Back in 1999, when Congress had held its hearings into the anthrax vaccine’s safety following concerns raised by affected veterans, Bailey was part of a panel of experts, which had included BioPort’s Admiral William Crowe. In her prepared statement, Bailey began by underscoring the urgency of the bioterrorist threat, claiming that “at least ten nation states and two terrorist groups“ possessed biowarfare capabilities and citing a 1958 study by Johns Hopkins University as proof that anthrax vaccinations were safe. She concluded by reassuring members of Congress that they had a “safe and effective vaccine to respond to a well-documented threat.” Neither of these statements would turn out to be true.

Another expert Dr. Katherine Zoon, who was then director of the FDA’s Center for Biologics Evaluation, concurred with Dr. Bailey’s assessment regarding the safety of the anthrax vaccine in her statement. Zoon, who would subsequently hold key posts at the National Institute of Allergy and Infectious Diseases (NIAID) and at the National Institutes of Health (NIH), was also added to Emergent’s board of directors.

The statements that had been made by Zoon and Bailey at that hearing were a significant divergence from the FDA’s own appraisal on the long-term safety of the vaccine, according to testimony by Kwai-Cheung Chan of the General Accounting Office (GAO). Chan practically invalidated both Bailey’s and Zoon’s testimony by revealing that the studies they had cited were carried out on a completely different anthrax vaccine that was produced by Merck, not Emergent Biosolutions, among other details. Chan’s testimony made it clear that BioThrax had no safety track record at all. Not unlike Hauer, Emergent later rewarded Bailey and Zoon for their loyalty to the private sector as opposed to public health with board positions and lucrative stock options.

“Never let a good crisis go to waste”

Though Emergent Biosolutions has enjoyed its privileged status regarding the anthrax vaccine for over two decades, it has long since branched out and profiteered from a variety of pandemic scares, including Ebola and Zika, and public health crises both globally and domestically. They have also acquired other vaccine monopolies, including the U.S.’ only licensed smallpox vaccine through their purchase of Sanofi, which came with a $425 million government contract and the promise of subsequent multi-year renewals on that contract for the ever-increasing national biodefense stockpiles.

Another drug monopoly acquired by Emergent Biosolutions has allowed them to profit handsomely off of the U.S.’ devastating opioid epidemic. In 2018, a year when the opioid crisis claimed the lives of nearly 70,000 Americans and was considered the top health crisis facing the nation, Emergent acquired the producer of Narcan, the only FDA-approved nasal spray of naloxone, which is used to treat opioid overdoses at the scene. At the time of acquisition, Emergent Biosolutions executive Daniel J. Abdun-Nabi referred to U.S. high schools and colleges as lucrative, “untapped markets” for Narcan.

Two months after Emergent completed its acquisition of the Narcan monopoly, HHS began recommending that doctors co-prescribe the drug alongside opioid painkillers. However, HHS offered no measures aimed at preventing the over-prescription of opioid painkillers like fentanyl and has remained silent regarding efforts to make opioid painkillers a controlled, schedule 1 substance. After the HHS recommendation regarding Narcan, several states subsequently passed laws requiring doctors to co-prescribe the nasal spray. Emergent’s sale of Narcan, which now costs $150 per dose, predictably spiked.

Regarding its Narcan monopoly, Emergent has long claimed that they are working to keep the drug affordable and they have even donated Narcan to public libraries and YMCAs as part of a major public relations push. However, Emergent’s same-old aggressive tactics still apply to Narcan, as they have sued any competitors aiming to market a cheaper, generic version of the drug. In addition, government promotion of Narcan as opposed to other, longer-term solutions to opioid addiction, have come under scrutiny, with some arguing that Narcan actually enables opioid addiction and may actually be worsening the crisis.

Cornering the Covid-19 market

Emergent’s history of corruption and profiteering has in no way prevented them from cashing in on the Covid-19 global health crisis. On March 10, Emergent announced a partnership with Novavax to produce a Covid-19 vaccine, a vaccine also backed by the Bill Gates-backed Coalition for Epidemic Preparedness Innovations (CEPI). CEPI had previously partnered with Emergent Biosolutions, giving them over $60 million in 2018. Emergent further expanded its partnership with NovaVax on March 31.

Just 8 days after partnering with Novavax, Emergent partnered with yet another producer of a Covid-19 vaccine candidate, VaxArt. Unlike the Emergent-Novavax vaccine, the vaccine candidate co-produced with VaxArt will be oral and in pill form, “offer[ing] enormous logistical advantages in the roll-out of a large vaccination campaign,” according to VaxArt CEO Wouter Latoud.

While backing two of the most prominent vaccine candidates for Covid-19 gives Emergent an advantage in terms of profiting from whatever vaccines end up being approved for use by the government, Emergent’s star has risen during the current Coronavirus crisis largely thanks to its two experimental blood plasma treatments.

Announced just one day after their Novavax vaccine partnership, Emergent’s first experimental blood plasma treatment involves pooling and concentrating blood plasma from recovered Covid-19 patients, while the second uses plasma taken from horses that have been injected with parts of the virus. These treatments were slated to begin clinical trials later this year, but have been greatly aided by HHS’ BARDA, which falls under the authority of Robert Kadlec. These treatments are now expected to begin Phase II trials by late summer.

On April 3, BARDA awarded Emergent Biosolutions $14.5 million for the development of its blood plasma treatment. Though the sum is smaller than other contracts Emergent has received from BARDA in the past, the partnership allows Emergent to overcome its greatest obstacle in developing this product, a massive supply of blood plasma from recovered Covid-19 patients. Thanks to their partnership with BARDA, Emergent will gain access to blood donations made by recovered Covid-19 to public blood centers.

Emergent’s Dr. Lisa Saward confirmed this in a recent interview with TechCrunch, stating “we are overcoming [the lack of “source material” i.e. blood plasma] with the help of partnerships like that of the Biomedical Advanced Research and Development Authority within Health and Human Services, and the National Institute of Allergy and Infectious Diseases announced earlier this week.”

However, Emergent’s use of donated plasma to develop its product may prove controversial, since the plasma donated by recovered Covid-19 patients is currently being used as a treatment for seriously ill Covid-19 patients. The use of plasma to treat critical patients began late last month after New York’s state government first authorized its use in such cases, followed by the FDA’s offer to approve its use for critical Covid-19 patients nationwide on a case-by-case basis. Yet, thanks to the BARDA and Emergent partnership, a significant amount of that plasma will instead go towards helping Emergent corner yet another key market.

April 9, 2020 Posted by | Corruption, Militarism, Timeless or most popular | , , | 2 Comments

FDA ‘Ignoring The Evidence’ on Cellphones & Cancer

RT America | November 2, 2018

A $25 million study on the effects of cellphone radiation on rats found clear evidence of tumors. But the Food and Drug Administration, which had requested the study in the first place, is casting doubt on its conclusions. RT America’s Dan Cohen has the details.

November 8, 2018 Posted by | Deception, Science and Pseudo-Science, Timeless or most popular, Video | , | Leave a comment

Big Pharma Still Tries to Push Dangerous Drug Class

By Martha Rosenberg | CounterPunch | February 16, 2018

Bisphosphonate bone drugs are among the most harmful and misrepresented drug classes still on the market. But that has not stopped Pharma-funded medical associations like the American Society of Bone and Mineral Research, the National Osteoporosis Foundation and the National Bone Health Alliance from periodically wringing their hands over low sales. [1]

This week the New York Times repeats the industry lament. “Currently, many people at risk of a fracture — and often their doctors — are failing to properly weigh the benefits of treating fragile bones against the very rare but widely publicized hazards of bone-preserving drugs, experts say,” it writes. Hip fractures among women 65 and older on Medicare are rising says the piece and Medicare reimbursements for bone density tests are falling. “Doctors who did them in private offices could no longer afford to [do them] which limited patient access and diagnosis and treatment of serious bone loss,” says a doctor quoted in the article which sounds like a Pharma plea for tax-payer funding.

But here is the back story.

The first bisphosphonate bone drug approved for osteoporosis, Merck’s Fosamax, received only a six month review before FDA approval. When its esophageal side effects were revealed, the FDA tried to unapprove it but Merck got the FDA to settle for a warning label that told patients to sit upright for an hour after taking the drug. Six months after Fosamax was approved, there were 1,213 reports of adverse effects including 32 patients hospitalized for esophageal harm. One woman who took Fosamax but remained upright for only thirty minutes was admitted to the hospital with “severe ulcerative esophagitis affecting the entire length of the esophagus” and had to be fed intravenously, according to the New England Journal of Medicine (NEJM).

Soon bisphosphonates (which include Boniva, Actonel and Zometa) were shown to weaken not strengthen bones by suppressing the body’s bone-remodeling action. Yes bone loss is stopped but since the bone is not renewed, it becomes brittle, ossified and prone to fracture. More than a decade ago, articles in the NEJM, the Annals of Internal Medicine, the Journal of Clinical Endocrinology & Metabolism, Journal of Orthopaedic Trauma and Injury warned of the paradoxical drug results. One-half of doctors at a 2010 American Academy of Orthopaedic Surgeons annual meeting presentation said they’d personally seen patients with bisphosphonate-compromised bone. “There is actually bone death occurring,” said Phuli Cohan, MD on CBS about a woman who’d been on Fosamax for years.

By 2003, dentists and oral surgeons found that after simple office dental work, the jawbone tissue of patients taking bisphosphonates would sometimes not heal but become necrotic and die. They had received no warnings though Merck knew about the jawbone effects from animal studies since 1977.

“Up to this point, this rare clinical scenario was seen only at our centers in patients who had received radiation therapy and accounted for 1 or 2 cases per year,” said the authors of an article titled “Osteonecrosis of the Jaws Associated with the Use of Bisphosphonates: A Review of 63 Cases,” published in the Journal of Oral and Maxillofacial Surgery.

Despite reports of ulcerative esophagitis, bone degradation, fractures and jawbone death Merck aggressively promoted Fosamax. It hired researcher Jeremy Allen to plant bone scan machines in medical offices across the country to drive sales and to push through the Bone Mass Measurement Act which made bone scans Medicare reimbursable paid by you and me. Hopefully that is changing.

Blaming hip fractures on not enough people taking bisphosphonates is not a new tactic for Pharma. It blamed increasing suicides on not enough people taking antidepressants (even when as much as a fourth of the population takes antidepressants). Get ready for Pharma to blame obesity on not enough people taking prescription obesity drugs. The ruse is even more dishonest because many popular drugs people are taking like GERD medications really do thin bones. First do no harm.

Notes.

[1] According to the British Medical Journal, the National Osteoporosis Foundation is funded by Bayer Healthcare, Lane Laboratories, Mission Pharmacal, Novartis, Pharmavite, Pfizer, Roche, Warner Chilcott and Eli Lilly. The American Society for Bone and Mineral Research is funded by Pfizer and Eli Lilly. The National Bone Health Alliance is a public- private partnership that is an offshoot of the National Osteoporosis Foundation.

Martha Rosenberg is an investigative health reporter. She is the author of  Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health (Prometheus).

February 16, 2018 Posted by | Deception, Science and Pseudo-Science | , , , , | Leave a comment

Catastrophe Unmasked: Prescription for Addiction

By Nayvin Gordon, MD | CounterPunch | July 8, 2016

The “Opium Wars” were fought by the British Government to legalize their control of the opium trade to China in the mid 17th Century. Reports estimated that 25% of the Chinese people were addicted to opium by 1905. That same year in the US, heroin addiction had risen to alarming rates, and the US Congress passed a ban on opium. Another American heroin epidemic began again in 1967 in Chicago and New York, and then spread widely through the early 1980’s. The son of the US Attorney General, Robert Kennedy, died of a heroin overdose in New York City on April 24, 1984. Physicians in medical school were taught that opioids were dangerously addicting substances that should be used only for short term severe pain and terminal cancer.

Despite this teaching and the raging Heroin epidemic in America, a letter was published in the New England Journal of Medicine in 1980. The author reported that of the patients in their hospital who were treated with narcotics, less than one percent became addicted. In 1986 the journal Pain,   reported on a study of only 38 patients who were treated with narcotics for several years. The authors concluded that there was little risk of addiction. There were no other significant addiction studies reported. Shortly after the study in Pain, one of the co-authors went on to head the American Pain Society. This organization was one of several similar nonprofit groups funded by the Pharmaceutical Industry like Purdue Pharma the producers of the narcotic Oxycontin.

These opioid producers also funded medical education programs and advocacy groups. Within a short time the pharmaceutical companies began an aggressive nationwide campaign to market opioids for long term non cancer pains such as back and neck pain. During the 1990’s the incidence of opioid misuse rose markedly, fueled by the number of opioid prescriptions written by many physicians and nurses. Where were the Food and Drug Administration (F.D.A.) and the American Medical Association (A.M.A.) when they were presented with blatant disregard for the truth about opioid addiction? What evidence did they demand before they abandoned 150 years of knowledge about the dangers of opioids? Where were the evidence based studies needed to refute what was known around the world about the risks of opioids?

As of February 2009, Dr Zee, writing in the Journal of Public Health, revealed that “we lack any large…rigorous prospective study addressing the issue of … addiction, during long term opioid use for chronic non cancer pain.”

The medical schools and physician training programs did not publicly denounce this unscientific pharmaceutical propaganda. Why? The F.D.A., the organization responsible for ensuring that prescription drug promotion is truthful, continued to authorize more and more forms of opioids over the years. Why? To this day, the F.D.A. and the A.M.A., have refused to demand mandatory education for opioid prescribers. Why? Furthermore, the Federation of State Medical Boards accepted money from pharmaceutical firms to produce prescribing guidelines. Why did physicians not sound the alarm to expose the fact that the pharmaceutical industry was establishing treatment guidelines for the medical profession?

Dr David A Kessler, the past commissioner of the F.D.A., from 1990-1997, the very years the epidemic was accelerating, stated in an article in the New York Times on May 7, 2016: “It has proved to be one of the biggest mistakes in modern medicine”. Doctors, regulators and drug makers “missed one fundamental: The more opioids prescribed, the more opioid abuse there will be.”

We beg to differ. This was no mistake.   The reality is that physicians in the leadership of the F.D.A., A.M.A., and The Federation of State Medical Boards, willfully abandoned their scientific integrity and over 150 years of wisdom regarding the dangers of opioids. This was simply a catastrophic violation of their duty to “do no harm”.

In their complicity with the Pharmaceutical Companies, many physicians and nurses abandoned their responsibility to their patients by writing prescriptions for addiction. The consequences are now staring us in the face. Well over a hundred thousand people have overdosed and died, and there are now 3 million addicts as the epidemic continues to devastate families across the nation.

Let’s set the record straight.

July 10, 2016 Posted by | Corruption, Deception, Science and Pseudo-Science | , , | Leave a comment

Obama’s Latest FDA Nominee: No Hidden Big Pharma Links, They Are All in Plain Sight

By Martha Rosenberg | CounterPunch | November 19, 2015

The FDA has been called an arm of the drug industry because of how often it smiles on questionable new drugs and new drug approvals only to issue greater warnings or even withdraw them after the drugs made billions. Remember Vioxx, Baycol, Trovan, Meridia, Seldane, Hismanal and Darvon? They are not around anymore. Why? Remember how popular statins, brand name asthma and psychiatric drugs and GERD drugs were? Once they went off patent, the FDA “discovered” serious side effects and began to list warnings. Sorry about that.

There is a stereotype of backwoods courtroom “justice” in which prosecutors and defense attorneys who appeared to be adversarial leave arm in arm and go for a beer after a judicial decision. No hard feelings. The same collegiality oozes at FDA hearings with FDA staffers seeming to suck up to industry, perhaps for jobs in which they return to squeeze their prior colleagues. (Who remembers former Texas Governor Rick Perry’s chief of staff leaning on Perry to vaccinate all the state’s girls with the Merck vaccine Gardasil after he left for industry?)

FDA advisory panels, whose recommendations the FDA usually follows, are supposed to include “patient representatives” to see that the public’s interests are balanced against Big Pharma consultants. So many doctors and researchers now live on 5 and 6 digit drug company stipends, the FDA actually relaxed conflict of interest rules a few years ago–it could not find enough unlinked doctors!

But the “patient representatives” can be a sham. At one meeting I attended, one “patient representative” was a member of the drug industry-funded National Alliance on Mental Illness (NAMI) which was investigated by Congress for its hidden Pharma income and many consider a front group. The other so-called patient representative” had given keynote speeches at NAMI. So much for transparency.

Because of the huge amount of money to be made from a blockbuster drug like Lipitor—it was the best selling drug in the world—there is a natural tension between drug companies who want to hurry the march to Wall $treet and drug regulators who want to slow it down to protect the public.

That is why the nomination of unapologetic drug industry supporter, Robert M. Califf, for FDA Commissioner is so concerning. A disclosure statement on the website of Duke Clinical Research Institute lists 25 drug companies Califf receives “research” funds from including drug giants like Johnson & Johnson, Lilly, Merck, Schering Plough and GSK.

Califf has gone on record that collaboration between industry and regulators is a good thing. He told NPR, “Many of us consult with the pharmaceutical industry, which I think is a very good thing. They need ideas and then the decision about what they do is really up to the person who is funding the study.” What?

He is known for defending Vioxx which is reported to have caused at least 50,000 heart attacks and events before its withdrawal. (Merck is said to have known about Vioxx’ cardio effects but marketed the blockbuster drug anyway.)

Califf was instrumental in the Duke drug trial of the blood thinner Xarelto and a cheerleader of the drug despite medical experts’ objections to its approval and 379 subsequent deaths. Duke, where Califf directed clinical research, is still recovering from a major research fraud scandal that resulted in terminated grants, retracted papers and a Sixty Minutes special. It is the least appropriate place from which to choose an FDA Commissioner.

If approved as FDA Commissioner, as many expect, will Califf recuse himself from decisions on the dozens of drugs whose manufacturers pay him? Or will he rule on them anyway? Either way, his nomination is a slap in the face of every honest doctor, researcher and regulator and the public that puts its trust in the FDA. In fact, if the FDA Commissioner is funded by industry, why have an FDA?

Martha Rosenberg is an investigative health reporter. She is the author of  Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health (Prometheus).

November 20, 2015 Posted by | Corruption, Progressive Hypocrite | , , , | 2 Comments

Here comes the 21st Century Cures Act: Say Goodbye to Vaccine Safety

Science by Barbara Loe Fisher | July 22, 2015

A 2015 Pharma-driven bill blessed by the FDA seriously compromises the integrity of the vaccine licensing process and is sailing through the U.S. Congress. Act to protect vaccine safety and join http://www.NVICadvocacy.org and learn more at http://www.NVIC.org.


See also :

21st Century Cures Act Gets a Revision

By Randi Hernandez | PharmTech | July 7, 2015

The 21st Century Cures Act will see some revisions before the House votes on the bill later this week. On July 2, 2015, the House Committee on Energy and Commerce released a summary of major changes to the bill that reduce the funding to the National Institutes of Health (NIH) and Cures Innovation Fund to approximately $8.75 billion over the next five years instead of the $10 billion that was originally proposed. The funding amount was amended “to clarify the availability of a $9.3 billion advanced appropriation for FY2016–FY2020. $110 million is made available for FDA regulatory modernization activities annually from FY2016–FY2020.”

Other changes to the proposed bill include not requiring companies that receive NIH funding to report their data, and additional changes to how drugs are reimbursed, specifically, payment amounts for branded drugs and infused specialty drugs. … continue


See also :

Is The 21st Century Cures Act Good Or Bad For The Biopharmaceutical Industry?

Forbes | June 8, 2015

… “An underlying premise of the bill is the need to accelerate approval for new products, but this process is already quite efficient. A third of new drugs are currently approved on the basis of a single pivotal trial; the median size for all pivotal trials is just 760 patients. More than two-thirds of new drugs are approved on the basis of studies lasting 6 months or less – a potential problem for medications designed to be for a lifetime. Once the FDA starts its review, it approves new medications about as quickly as any regulatory agency in the world, evaluating nearly all drug applications within 6 to 10 months, an impressive turnaround for such complex assessments.” … Full article

July 28, 2015 Posted by | Civil Liberties, Corruption, Science and Pseudo-Science, Video | , , , , , | 1 Comment

Does Long Term Use of Psychiatric Drugs Cause More Harm Than Good?

By Peter C Gøtzsche, Allan H Young, John Crace | British Medical Journal | May 15, 2015

We could stop almost all psychotropic drug use without deleterious effect, says Peter C Gøtzsche, questioning trial designs that underplay harms and overplay benefits. Allan H Young and John Crace disagree, arguing that evidence supports long term use.

Psychiatric drugs are responsible for the deaths of more than half a million people aged 65 and older each year in the Western world, as I show below.1 Their benefits would need to be colossal to justify this, but they are minimal.1 23 4 5 6

Summary of Article

Overstated benefits and understated deaths

The randomised trials that have been conducted do not properly evaluate the drugs’ effects. Almost all of them are biased because they included patients already taking another psychiatric drug.1 7 8 9 10 Patients, who after a short wash-out period are randomised to placebo, go “cold turkey” and often experience withdrawal symptoms. This design exaggerates the benefits of treatment and increases the harms in the placebo group, and it has driven patients taking placebo to suicide in trials in schizophrenia.8

Under-reporting of deaths in industry funded trials is another major flaw. Based on some of the randomised trials that were included in a meta-analysis of 100 000 patients by the US Food and Drug Administration, I have estimated that there are likely to have been 15 times more suicides among people taking antidepressants than reported by the FDA—for example, there were 14 suicides in 9956 patients in trials with fluoxetine and paroxetine, whereas the FDA had only five suicides in 52 960 patients, partly because the FDA only included events up to 24 hours after patients stopped taking the drug.1

For antipsychotics, I used a meta-analysis of placebo controlled trials in patients with dementia because they would be less likely to have been receiving psychiatric drugs before randomisation. The absolute death … Full article 

Peter C Gøtzsche, professor, Nordic Cochrane Centre, Rigshospitalet, DK-2100 Copenhagen, Denmark, Allan H Young, professor of mood disorders, Institute of Psychiatry, Psychology and Neurosciences, King’s College London, UK,  John Crace, psychiatric patient and parliamentary sketch writer, Guardian, London, UK 

June 25, 2015 Posted by | Corruption, Deception, Science and Pseudo-Science | , , | Leave a comment

The New Challenge to Monsanto

By COLIN TODHUNTER | CounterPunch | May 26, 2015

In a challenge delivered to Monsanto’s headquarters on May 20, 2015, US public interest attorney Steven Druker calls on that corporation to find any inaccurate statements of fact in his new book:  “Altered Genes, Twisted Truth – How the Venture to Genetically Engineer Our Food Has Subverted Science, Corrupted Government, and Systematically Deceived the Public

The thoroughly documented and referenced book exposes the substantial risks of genetically engineered foods and the multiple misrepresentations that have enabled them to permeate world markets.

Druker asserts that if Monsanto cannot prove that his book is essentially erroneous, the world will have a right to regard these controversial foods as unacceptably risky – and to promptly ban them.

‘Altered Genes, Twisted Truth’ was released in March 2015 and is the result of more than 15 years of intensive research and investigation by Druker, who initiated a lawsuit against the US Food and Drug Administration (FDA) that forced it to divulge its files on GM foods.

The book indicates that the commercialisation of GM food in the US was based on a massive fraud. The FDA files revealed that GM foods first achieved commercialisation in 1992 but only because the FDA covered up the extensive warnings of its own scientists about their dangers, lied about the facts and then violated federal food safety law by permitting these foods to be marketed without having been proven safe through standard testing.

If the FDA had heeded its own experts’ advice and publicly acknowledged their warnings that GM foods entailed higher risks than their conventional counterparts, Druker says that the GM food venture would have imploded and never gained traction anywhere.

He also argues that that many well-placed scientists have repeatedly issued misleading statements about GM foods, and so have leading scientific institutions such as the US National Academy of Sciences, the American Association for the Advancement of Science and the UK’s Royal Society.

Druker states that contrary to the claims of biotech advocates, humans have indeed been harmed by consuming the output of genetic engineering. He also explains that laboratory animals have also suffered from eating products of genetic engineering, and well-conducted tests with GM crops have yielded many troubling results, including intestinal abnormalities, liver disturbances, and impaired immune systems.

Druker says: “Contrary to the assertions of its proponents, the massive enterprise to reconfigure the genetic core of the world’s food supply is not based on sound science but on the systematic subversion of science – and it would collapse if subjected to an open airing of the facts.”

Now, in his open letter dated 19 May, Druker challenges Monsanto’s Chief Technology Officer to: “Face Up to the Extensive Evidence Demonstrating that Genetically Engineered Foods Entail Unacceptable Risks and Should Be Promptly Removed from the Market.”

Druker finishes his letter by saying:

“If by July 20th you and your allies have not been able to refute the essential factual accuracy of Altered Genes, Twisted Truth according to the terms set forth above, the world will have a right to assume that it is as sound as the experts who reviewed it have affirmed – and to conclude that GE foods are unacceptably risky and must be banned.

Access the letter in full here.

alteredgenesColin Todhunter is an extensively published independent writer and former social policy researcher based in the UK and India.

May 27, 2015 Posted by | Book Review, Deception, Science and Pseudo-Science, Timeless or most popular | , , , , | Leave a comment

FDA So Slow to Respond to GAO Recommendations about Secret Food Additives that It’s like not Responding at all

By Noel Brinkerhoff and Steve Straehley | AllGov | April 16, 2015

In 2010, the Government Accountability Office (GAO) examined the process used by the Food and Drug Administration (FDA) for regulating food additives and came up with six ways the FDA could improve this function. Five years later, FDA officials have satisfied only one of the GAO suggestions.

“It’s really clear that we have no basis to make almost any conclusions about the safety of the current food supply,” Laura MacCleery, an attorney with the Center for Science in the Public Interest, a consumer advocacy group, told the Center for Public Integrity. “We don’t know what people are eating.”

The GAO report even stated that the FDA’s oversight process does not help ensure the safety of all new food ingredients, and it criticized companies’ ability to use new added ingredients deemed generally recognized as safe (GRAS) without informing federal food regulators.

GRAS came about as a way to exempt simple ingredients in long use, such as table salt, from FDA review after food regulations were strengthened in the 1950s. However more items are added to the list each year as manufacturers use the GRAS list as a loophole to avoid having their products evaluated by the FDA.

The recommendation (“Develop a strategy to help ensure the safety of engineered nanomaterials that companies market as GRAS substances without the agency’s knowledge”) resulted in the FDA issuing a final guidance on nanotechnology last June, according to the Center for Public Integrity.

A second recommendation to develop a strategy to finalize a 1997 proposed rule that defines how companies can voluntarily submit safety determinations to the FDA for a cursory review will be completed by August 2016, according to the Center for Public Integrity.

The GAO’s four other recommendations were:

-Develop a strategy to require any company that conducts a GRAS determination to provide FDA with basic information, including the ingredient’s identity and intended uses, and post the information on the agency’s website.

-Develop a strategy to minimize the potential for conflicts of interest in companies’ GRAS determinations.

-Develop a strategy to monitor the appropriateness of companies’ GRAS determinations through random audits or some other means.

-Develop a strategy to conduct reconsiderations of the safety of GRAS substances in a more systematic manner including responding to citizen petitions in a timely manner.

To Learn More:

Why the FDA Doesn’t Really Know What’s in Your Food (by Erin Quinn and Chris Young, Center for Public Integrity)

Loopholes and Weak Enforcement Lead to Unapproved Chemicals Added to Foods (by Noel Brinkerhoff and Danny Biederman, AllGov )

35% of Food Additives Deemed Harmless were Evaluated by Manufacturer or Contractor Hired by Manufacturer (by Noel Brinkerhoff, AllGov )

April 16, 2015 Posted by | Corruption | , , | Leave a comment

25 Facts About the Pharmaceutical Industry, Vaccines and “Anti-Vaxers”

By Julie Lévesque | Global Research | February 25, 2015

During the recent measles outbreak, the mainstream media blamed the epidemic solely on non vaccinated children, even though people who were vaccinated caught the disease and some vaccines have proven to be inefficient in the past. Without the slightest nuance, the mainstream media constantly portrays people reluctant to accept just any vaccine as “anti-vaxers”, irresponsible and misinformed people, relying on irrational fears and the one and only “fraudulent” Andrew Wakefield study linking autism to vaccines. (Watch Lina B. Moreco’s documentary Shots in the Dark, which features Dr. Wakefield and thankful parents of his young patients with autism.)

In reality, many so-called “anti-vaxers” are not ALL totally against vaccines. While some people may be totally against any kind of vaccination, many, including doctors and health specialists, question certain vaccines, ingredients in the vaccines and/or the vaccination schedule. This is not based on a survey but on my own perception resulting from the fair amount of articles on vaccines and the pharmaceutical industry that I’ve read over the last five years as a journalist. There are a large number of doctors and health specialists who have done truly independent research and who criticize vaccination based on scientific studies and solid evidence.

Why is the media so keen on portraying Big Pharma critics as crazy, uneducated, unscientific and irresponsible people?

Dr Marcia Angell worked for over two decades as editor of The New England Journal of Medicine.  She was fired after criticizing the pharmaceutical industry, which had exerted an overriding and negative influence on the scientific literature. She said:

“It is simply no longer possible to believe much of the clinical research that is published.”

Numerous journalists say the same goes for the mainstream media.

We bring to the attention of our readers 25 facts which constitute only part of a larger body of independent scientific research and articles on vaccines and the pharmaceutical industry. Some mainstream articles have been included as well to show how the media overlooks stories it has published in the past because they don’t fit with their “anti-vaxer” portrait.

The objective of this list is to provide independent research and sources of information on vaccination and Big Pharma, which is what the mainstream media fails to do and instead blindly promotes the narrative and agenda of Big Pharma.

(All emphasis added. Most titles are quotes from the articles they are linked to.)

25 Facts About the Pharmaceutical Industry, Vaccines and “Anti-Vaxers”

1- China has measles outbreaks but 99% are vaccinated

A recent study published in PLoS titled, “Difficulties in eliminating measles and controlling rubella and mumps: a cross-sectional study of a first measles and rubella vaccination and a second measles, mumps, and rubella vaccination,” has brought to light the glaring ineffectiveness of two measles vaccines (measles–rubella (MR) or measles–mumps–rubella(MMR) ) in fulfilling their widely claimed promise of preventing outbreaks in highly vaccine compliant populations. (Sayer Ji, Why Is China Having Measles Outbreaks When 99% Are Vaccinated?, GreenMedInfo 20 September 2014)

2- Mandatory Chickenpox Vaccination Increases Disease Rates, Study Shows

Varicella, or the chicken pox vaccination, has been mandated in South Korea since 2005. Infants from 12 to 15 months are required by law to receive a vaccination. By 2011, the country reached a near universal compliance rate, however, varicella patients did not decrease; they have increased since reaching this mandated level of vaccination.

The number of chicken pox patients reported to the Korea Centers for Disease Control and Prevention (KCDC) has increased from 22.6 cases per 100,000 in 2006 to 71.6 cases per 100,000 in 2011.  That’s a huge difference and ample proof that the vaccination program isn’t working to control the spread of the disease. (Christina Sarich, With 97% Compliance Chicken Pox Vaccine Still Causes Outbreaks, Natural Society, January 08, 2015)

3- In a 2012 measles outbreak in Quebec (Canada) over half of the cases were in vaccinated teenagers

An investigation into an outbreak in a high school in a town that was heavily hit by the virus found that about half of the cases were in teens who had received the recommended two doses of vaccine in childhood — in other words, teens whom authorities would have expected to have been protected from the measles virus.

It’s generally assumed that the measles vaccine, when given in a two-dose schedule in early childhood, should protect against measles infection about 99 per cent of the time. So the discovery that 52 of the 98 teens who caught measles were fully vaccinated came as a shock to the researchers who conducted the investigation. (The Canadian Press, Measles among vaccinated Quebec kids questioned, CBC, October 20, 2011)

4- In 1987 a measles outbreak was documented among a fully immunized group of children

In 1987, for example, a study published in the New England Journal of Medicine (NEJM) documented a measles outbreak that occurred in Corpus Christi, Texas, in the spring of 1985. Fourteen adolescent-age students, all of whom had been vaccinated for measles, contracted the disease despite having been injected with the MMR vaccine. Researchers noted that more than 99 percent of students at the school — basically all of them — had also been vaccinated, with more than 95 percent of them showing detectable antibodies to measles. (Ethan A. Huff, Measles Outbreak Documented Among Fully Immunized Group of Children, Natural News 15 February 2015)

5- Centers for Disease Control’s (CDC) Own Data Shows Links Between Vaccines and Sudden Infant Death Syndrome (SIDS)

What happens when the actual evidence from the scientific and clinical literature produced by these very agencies contradicts their own vaccine policies?

This is exactly what has happened with the publication of a new study in the Journal of Pediatrics titled ,”Adverse Events following Haemophilus influenzae Type b Vaccines in the Vaccine Adverse Event ReportingSystem, 1990-2013,” wherein CDC and FDA researchers identify 749 deaths linked to the administration of the Hib vaccine, 51% of which were sudden infant death linked to the administration of Hib vaccine. (Sayer Ji, Centers for Disease Control’s (CDC) Own Data Shows Links Between Vaccines and Sudden Infant Death Syndrome (SIDS), GreenMedInfo 23 January 2015)

6- Japan banned the MMR vaccine in 1993 “after 1.8 million children had been given two types of MMR and a record number developed non-viral meningitis and other adverse reactions.”

The Japanese government realised there was a problem with MMR soon after its introduction in April 1989 when vaccination was compulsory. Parents who refused had to pay a small fine.

An analysis of vaccinations over a three-month period showed one in every 900 children was experiencing problems. This was over 2,000 times higher than the expected rate of one child in every 100,000 to 200,000. (Jenny Hope, Why Japan banned MMR vaccine, Daily Mail)

7- A study concluded nations that require more vaccine doses tend to have higher infant mortality rates.

The US childhood immunization schedule requires 26 vaccine doses for infants aged less than 1 year, the most in the world, yet 33 nations have better IMRs [Infant Mortality Rates]

Some countries have IMRs that are less than half the US rate: Singapore, Sweden, and Japan are below 2.80. According to the Centers for Disease Control and Prevention (CDC), “The relative position of the United States in comparison to countries with the lowest infant mortality rates appears to be worsening.”

These findings demonstrate a counter-intuitive relationship: nations that require more vaccine doses tend to have higher infant mortality rates. (Neil Z Miller and Gary S Goldman, Infant mortality rates regressed against number of vaccine doses routinely given: Is there a biochemical or synergistic toxicity?,  U.S. National Library of Medicine, September 2011)

8- The U.S. has a vaccine court apparently designed to “Shield Manufacturers from Liability”

For years, the corporate media was reluctant to admit that it even existed. But the special court system designed to handle vaccine injury cases — and ultimately sweep them under the rug as quickly as possible — has hit the mainstream news for its failure to adequately and propitiously compensate families of vaccine-injured children. (Ethan A. Huff, Secretive Vaccine Court Exposed: Designed to Shield Manufacturers from Liability, Natural News, November 19, 2014)

9- Beyond admitting to fraud in a 2004 Centers for Disease Control (CDC) study that exonerated the MMR vaccine, Dr. William Thompson, a CDC scientist, asserts there is a connection between mercury (thimerosal) in vaccines and autism. (Jon Rappoport, U.S. Centers for Disease Control Whistleblower: Mercury (Thimerosal) in Vaccines Causes Autism, No More Fake News, September 05, 2014)

10- Back in 2002, William Thompson was already aware of study results linking the MMR vaccine to a very large increase in autism risk among African-American children. See Brian Hooker’s published paper here, with a full analysis of the CDC’s own data revealing a 340% increased risk of autism in African-American children following the MMR vaccine. (Mike Adams, Autism Links to Vaccines: Whistleblower Reveals Evidence of Criminal Coverup by the Centers for Disease Control (CDC), Natural News August 26, 2014

11- According to a CDC epidemiologist named Tom Verstraeten, who had analyzed the agency’s massive database containing the medical records of 100,000 children, a mercury-based preservative in the vaccines — thimerosal — appeared to be responsible for a dramatic increase in autism and a host of other neurological disorders among children. (Robert F. Kennedy Jr, Vaccinations: Deadly Immunity. Government Cover-up of a Mercury / Autism Scandal Rollingstone.com, 20 July 2005)

12- Instead of taking immediate steps to alert the public and rid the vaccine supply of thimerosal, the officials and executives [discussed] how to cover up the damaging data. (Ibid.)

The CDC paid the Institute of Medicine to conduct a new study to whitewash the risks of thimerosal, ordering researchers to “rule out” the chemical’s link to autism.

It withheld Verstraeten’s findings, even though they had been slated for immediate publication, and told other scientists that his original data had been “lost” and could not be replicated. And to thwart the Freedom of Information Act, it handed its giant database of vaccine records over to a private company, declaring it off-limits to researchers. By the time Verstraeten finally published his study in 2003, he had gone to work for GlaxoSmithKline and reworked his data to bury the link between thimerosal and autism.

11- Since 1991, when the CDC and the FDA had recommended that three additional vaccines laced with the preservative be given to extremely young infants […] the estimated number of cases of autism had increased fifteenfold [in 2005], from one in every 2,500 children to one in 166 children.(Ibid.)

Here is the CDC chart available today on its website:

An MIT researcher has linked autism to glyphosate, the chemical herbicide used in Monsanto Roundup.

12- Vaccine manufacturers […] continued to sell off their mercury-based supplies of vaccines until last year [2004].

The CDC and FDA [bought] up the tainted vaccines for export to developing countries and allowed drug companies to continue using the preservative in some American vaccines — including several pediatric flu shots as well as tetanus boosters routinely given to eleven-year-olds. (Ibid.)

13- Senate Majority Leader Bill Frist, who has received $873,000 in contributions from the pharmaceutical industry, has been working to immunize vaccine makers from liability in 4,200 lawsuits that have been filed by the parents of injured children. (Ibid.)

14- Seasonal Flu Shots still contain thimerosal.

Look at the monographs. For example the one from Vaxigrip from Sanofi Pasteur states on page 4 the mercury-based preservative is in its multidose vial:

“Clinically Relevant Non-medicinal Ingredients: thimerosal* , formaldehyde, Triton® X-100†, neomycin”

15- Dr. Scott Reuben former member of Pfizer’s speakers’ bureau published dozens of fake study in medical journals

Dr. Reuben accepted a $75,000 grant from Pfizer to study Celebrex in 2005… His research, which was published in a medical journal, has since been quoted by hundreds of other doctors and researchers as “proof” that Celebrex helped reduce pain during post-surgical recovery. .. No patients were ever enrolled in the study!

He also faked study data on Bextra and Vioxx drugs… [T]he peer-reviewed medical journal Anesthesia & Analgesia was forced to retract 10 “scientific” papers authored by Reuben… 21 articles written by Dr. Reuben that appear in medical journals have apparently been fabricated, too, and must be retracted. (Big Pharma researcher admits to faking dozens of research studies for Pfizer, Merck (opinion), Mike Adams,  NaturalNews.com, February 18, 2010)

16- To this day thimerosal is still used in flu vaccines

For example, in the Vaxigrip monograph says: “The multidose vial of this vaccine contains thimerosal as a preservative. Thimerosal has been associated with allergic reactions.”

17- There are at least 97 studies showing links between vaccines and autism.

18- The CDC claims “there is no convincing evidence of harm caused by the low doses of thimerosal in vaccines”, but that health authorities “agreed that thimerosal should be reduced or eliminated in vaccines as a precautionary measure.”

On thimerosal, the CDC website states:

“Since 2001, with the exception of some influenza (flu) vaccines, thimerosal is not used as a preservative in routinely recommended childhood vaccines. Thimerosal is a mercury-containing preservative used in some vaccines and other products since the 1930′s. except for minor reactions like redness and swelling at the injection site. However, in July 1999, the Public Health Service agencies, the American Academy of Pediatrics, and vaccine manufacturers agreed that thimerosal should be reduced or eliminated in vaccines as a precautionary measure.“

19- Industry-sponsored trials published in medical journals consistently favor sponsors 

In view of this control and the conflicts of interest that permeate the enterprise, it is not surprising that industry-sponsored trials published in medical journals consistently favor sponsors —largely because negative results are not published, positive results are repeatedly published in slightly different forms, and a positive spin is put on even negative results. A review of seventy-four clinical trials of antidepressants, for example, found that thirty-seven of thirty-eight positive studies were published. But of the thirty-six negative studies, thirty-three were either not published or published in a form that conveyed a positive outcome.” – Marcia Angell, MD (Dr. Gary G. Kohls, Beware the Drug Companies, How they Deceive Us: “Criticizing Big Pharma” Global Research, February 16, 2015)

20- Nearly half of published articles in scientific journals contain findings that are false. (Dr. Gary G. Kohls, Beware the Drug Companies, How they Deceive Us: “Criticizing Big Pharma”Global Research, February 16, 2015)

“Six years ago, John Ioannidis, a professor of epidemiology at the University of Ioannina School of Medicine in Greece, found that nearly half of published articles in scientific journals contained findings that were false, in the sense that independent researchers couldn’t replicate them. The problem is particularly widespread in medical research, where peer-reviewed articles in medical journals can be crucial in influencing multimillion- and sometimes multibillion-dollar spending decisions. It would be surprising if conflicts of interest did not sometimes compromise editorial neutrality, and in the case of medical research, the sources of bias are obvious.

21- Most medical journals receive half or more of their income from pharmaceutical company advertising and reprint orders, and dozens of others [journals] are owned by companies like Wolters Kluwer, a medical publisher that also provides marketing services to the pharmaceutical industry.” — Helen Epstein, author of “Flu Warning: Beware the Drug Companies” (http://aaci-india.org/COI/Flu_web_final.pdf) (Dr. Gary G. Kohls, Beware the Drug Companies, How they Deceive Us: “Criticizing Big Pharma” Global Research, February 16, 2015)

22- The FDA’s own web page admits that the drugs it certifies as safe contribute to over 100,000 deaths per year. (Constitutional Attorney on US Federal Drug Administration (FDA) Corruption, Disinformation and Cover Up of Health Dangers, Activist Post,  8 February 2015)

23- The FDA routinely approves drugs over objections from its own medical reviewers. (Ibid.)

24- The FDA does zero independent medical testing of its own.

It is a system built upon conflicts of interest that leaves consumers completely in the dark about the true consequences of taking Big Pharma products. (Ibid.)

25- In 2012 GlaxoSmithKline Pleaded Guilty and Paid “$3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data”

According to the US Justice Department:

The resolution is the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company. …

GSK agreed to plead guilty to a three-count criminal information, including two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce and one count of failing to report safety data about the drug Avandia to the Food and Drug Administration (FDA).

March 29, 2015 Posted by | Mainstream Media, Warmongering, Science and Pseudo-Science | , | 1 Comment

Drug-Induced Dementia isn’t Alzheimer’s

By Dr. Gary G. Kohls | Global Research | February 26, 2015

“More than 50 conditions can cause or mimic the symptoms of dementia.” and “Alzheimer’s (can only be) distinguished from other dementias at autopsy.” – from a Harvard University Health Publication entitled What’s Causing Your Memory Loss? It Isn’t Necessarily Alzheimer’s

“Medications have now emerged as a major cause of mitochondrial damage, which may explain many adverse effects. All classes of psychotropic drugs have been documented to damage mitochondria, as have statin medications, analgesics such as acetaminophen, and many others.” – Neustadt and  Pieczenik, authors of Medication-induced Mitochondrial Damage and Disease

“Establishing mitochondrial toxicity is not an FDA requirement for drug approval, so there is no real way of knowing which agents are truly toxic.”  – Dr. Katherine Sims, Mass General Hospital –http://www.mitoaction.org

“It is difficult to get a man to understand  something, when his salary depends upon his not understanding it!” – Upton Sinclair, anti-fascist, anti-imperialist American author who wrote in the early 20thcentury

“No vaccine manufacturer shall be liable… for damages arising from a vaccine-related injury or death.” – President Ronald Reagan, as he signed The National Childhood Vaccine Injury Act (NCVIAof 1986, absolving drug companies from all medico-legal liability when children die or are disabled from vaccine injuries.

Over the past several decades there have been a number of well-financed campaigns, promoted by well-meaning laypersons, to raise public awareness to the plight of patients with dementia. Suspiciously, most of these campaigns that come from “patient support” groups lead the public to believe that every dementia patient has Alzheimer’s dementia (AD).

Not so curiously, it turns out that many – perhaps all – of these campaigns have been funded – usually secretly – by the very pharmaceutical companies that benefit economically by indirectly promoting the sale of so-called Alzheimer’s drugs. Such corporate-generated public relations “campaigns” are standard operating procedure for all of BigPharma drugs, especially its psychopharmaceutical drugs. BigPharma has found that the promotion and de-stigmatization of so-called “mental illnesses” (for which there are FDA-approved drugs) is a great tool for marketing their drugs.

Recently Alzheimer’s support groups all around the nation have been sponsoring the documentary about country singer Glen Campbell who has recently been diagnosed by his physicians with Alzheimer’s disease (of unknown etiology) despite the obvious fact that Campbell was infamous for his chronic heavy use of brain-damaging, dementia-inducing, addicting, and very neurotoxic drugs like cocaine and alcohol. And, just like so many other hard-living celebrities like the recently suicidal Robin Williams, Campbell was known to have received prescriptions of legal drugs from their prescribing boutique psychiatrists and physicians, just adding to the burden that their failing livers, brains and psyches had to endure.

Since it is known that Alzheimer’s disease can only be truly diagnosed by a microscopic examination of the cerebral cortex (at autopsy), we have to question the very alive Glen Campbell’s diagnosis. And we also have to question the veracity and motivations of the sponsoring patient support groups and their BigPharma sponsors.

Is the Alzheimer’s Epidemic Actually a Drug-Induced Dementia Epidemic?

Synchronous with the huge increases (over the past generation or so) in

1) the incidence of childhood and adult vaccinations,

2) the widespread use of psychotropic and statin (cholesterol-lowering) drug use, and

3) the increased ingestion of a variety of neurotoxic substances – including food additives, there has been a large parallel increase in the incidence of

a) chronic illnesses of childhood, including autistic spectrum disorders,

b) “mental illnesses of unknown origin”, and also

c) dementia, a multifactorial reality which, via clever marketing and the studied ignorance of what is scientifically known about the actual causes – and diagnosis – of dementia, which has been primarily – and mistakenly – referred to as Alzheimer’s disease (of unknown etiology).

It is important to ask and then demand an honest answer to the question “could there be a connection between America’s increasingly common over-prescribing of immunotoxic, neurotoxic, synthetic prescription drugs and vaccines and some of the neurodegenerative disorders that supposedly “have no known cause”?

Could the economically disabling American epidemic of autoimmune disorders, psychiatric disorders, autism spectrum disorders, etc (all supposedly of unknown origin) that have erupted over the past several decades be found to have recognizable root causes and therefore be treatable and, most importantly, preventable?

These are extremely important questions, especially in the case of the current dementia epidemic, because the so-called Alzheimer’s patient support groups seem to be totally unaware of the powerful evidence that prescription drugs known to damage brain cells (especially by poisoning their mitochondria) would be expected to cause a variety of neurological and psychological disorders because of the brain cell death that eventually happens when enough of the mitochondria (the microscopic hearts and lungs of every cell) have been wounded irretrievably or killed off. (See more info on drugs and mitochondria below.)

One of the big problems in America’s corporate-controlled culture, corporate-controlled media and corporate-controlled medical industries is that the giant pharmaceutical corporations, who are in the business of developing, marketing and selling known mitochondrial toxins (in the form of their drugs and vaccine ingredients) have a special interest in pretending that there is no known cause for the disorders that their synthetic chemicals are causing (or they use the unprovable “it’s probably genetic” subterfuge).

It should be a concern of everybody who knows a demented patient, that some AD patient support groups are known to be front groups for the pharmaceutical companies that profit from the marketing to patients and their doctors the disappointingly ineffective drugs for Alzheimer’s like Aricept, Exelon, Namenda, Hexalon, and Razadyne.

Prescription Drug-Induced – and Vaccine-Induced – Mitochondrial Disorders

Acquired mitochondrial disorders (as opposed to the relatively rare primary mitochondrial disorders like muscular dystrophy) that can be caused by commonly prescribed drugs are difficult to diagnose and are generally poorly understood by most practitioners. When I went to med school, nobody knew anything about what synthetic drugs or vaccines did to the mitochondria.

A lot of mitochondrial research, especially since the 1990s, has proven the connections between a variety of commonly prescribed medications and mitochondrial disorders. That evidence seems to have been cunningly covered-up by the for-profit pharma groups (who control medical education and much of the media) and various other powers-that-be because of the serious economic consequences if the information was allowed in the popular press. The stake-holders in the pharmaceutical and medical industries, most of whom profit mightily from the routine and increasing usage of neurotoxic drugs and vaccines, supposedly operating in the name of Hippocrates, would be very displeased if this information got out. I submit that BigPharma’s cover-up of the connections is totally unethical and, in the opinion of many other whistleblowers, criminal.

An Honest Patient Guide for Dementia Patients from Harvard!

So I was pleasantly surprised to find a reasonably honest guide for dementia patients on a Harvard University website.

(The entire guide can be accessed at http://www.helpguide.org/harvard/whats-causing-your-memory-loss.htm#top.)

The information at that website stated that there were over 50 conditions that could cause or mimic early dementia symptoms. I hadn’t been taught anything about that reality when I went to med school, and I doubt that many of my physician colleagues were either. And besides, what medical practitioner in our double-booked clinic environment, even if he or she was aware, has the time to thoroughly rule out the 50 conditions when confronted with a patient with memory loss?

I have often said to my patients and my seminar participants: “it takes only 2 minutes to write a prescription, but it takes 20 minutes to not write a prescription”. And in the current for-profit clinic culture, time is money and few physicians are given the “luxury” of spending adequate time with their patients. (In defense of the physicians that I know, they are not happy about that reality but don’t know what to do about it.)

It is so tempting to use the popularized, but rather squishy label of AD (of unknown etiology) rather than to educate ourselves about the possibility of drug- or vaccine-induced dementia. But what is so important is that many of the 50+ conditions are preventable or reversible, which will be therapeutic only if the conditions are identified before permanent brain damage occurs.

The Harvard guide actually said that “medications are common culprits in mental decline. With aging, the liver becomes less efficient at metabolizing drugs, and the kidneys eliminate them from the body more slowly. As a result, drugs tend to accumulate in the body. Elderly people in poor health and those taking several different medications are especially vulnerable.”

The guide continued with a list of the possible classes of prescription drugs that number in the hundreds:

 “The list of drugs that can cause dementia-like symptoms is long. It includes antidepressants, antihistamines, anti-Parkinson drugs, anti-anxiety medications, cardiovascular drugs, anticonvulsants, corticosteroids, narcotics, sedatives.”

The Harvard guide went on to emphasize that Alzheimer’s can only be accurately diagnosed on a post-mortem examination. The guide states that “Alzheimer’s is distinguished from other dementias at autopsy by the presence of sticky beta-amyloid plaques outside brain cells (neurons) and fibrillary tangles within neurons (all indicative of cellular death). Although such lesions may be present in any aging brain, in people with Alzheimer’s these lesions tend to be more numerous and accumulate in areas of the brain involved in learning and memory.”

“The leading theory is that the damage to the brain results from inflammation and other biological changes that cause synaptic loss and malfunction, disrupting communication between brain cells. Eventually the brain cells die, causing tissue loss In imaging scans, brain shrinkage is usually first noticeable in the hippocampus, which plays a central role in memory function.”

But even the Harvard guide inexplicably failed to mention known mitochondrial toxins such as statin drugs, metformin, Depakote, general anesthetics, fluoroquinolone antibiotics, fluorinated psychotropic drugs, NutraSweet (every molecule of aspartame, when it reaches 86 degrees F, releases one molecule of the excitotoxin aspartic acid and one molecule of methanol [wood alcohol] which metabolizes into the known mitochondrial poison formaldehyde [embalming fluid]), pesticides (including the chlorinated artificial sweetener Splenda, which was initially developed as a pesticide) or the mercury (thimerosal), aluminum and formaldehyde which are common ingredients in vaccines. These are only some of the synthetic drugs that are capable of causing mitochondrial damage in brain cells – with memory loss, confusion and cognitive dysfunction, all early symptoms of dementia.

It is tragic, but all–too-common, for reversible and preventable drug-induced dementias (therefore of known cause and thus not Alzheimer’s) to be mis-diagnosed as Alzheimer’s disease “of unknown etiology” and to then be prescribed costly, essentially ineffective and potentially toxic drugs – whose mitochondrial toxicities have not been tested for.

(The pharmaceutical industry, it should be noted, is not required by the FDA to test its drugs for mitochondrial toxicity when it is doing its studies for marketing approval, again exhibiting the total disdain for the Precautionary Principle by both industry and the regulatory agencies such as the FDA, the CDC and WHO.)

There is much more in the basic neuroscience literature proving the connections, at least from authors who do not have conflicts of interest with BigPharma and BigMedicine. The authors of these articles have raised the questions and have published the proof that concerned families of patients and their physicians desperately need to know.

Don’t expect BigPharma to respond or to offer apologies or mea culpas. Do expect denials, dismissals, distractions, discrediting and then the delaying of real legitimate explorations of the real scientific evidence that exposes its subterfuge in the name of maintaining large profits for their stakeholders.

Here are the abstracts from just two of the many peer-reviewed articles from various science journals that support the thesis of this column.

Medication-induced mitochondrial damage and disease

Published in the Molecular Nutrition and Food Research journal ; 2008 Jul;52(7):780-8.

Authors: Neustadt, J,  Pieczenik SR.

Abstract

Since the first mitochondrial dysfunction was described in the 1960s, the medicine has advanced in its understanding the role mitochondria play in health and disease. Damage to mitochondria is now understood to play a role in the pathogenesis of a wide range of seemingly unrelated disorders such as schizophrenia, bipolar disease, dementia, Alzheimer’s disease, epilepsy, migraine headaches, strokes, neuropathic pain, Parkinson’s disease, ataxia, transient ischemic attack, cardiomyopathy, coronary artery disease, chronic fatigue syndrome, fibromyalgia, retinitis pigmentosa, diabetes, hepatitis C, and primary biliary cirrhosis. Medications have now emerged as a major cause of mitochondrial damage, which may explain many adverse effects. All classes of psychotropic drugs have been documented to damage mitochondria, as have statin medications, analgesics such as acetaminophen, and many others. While targeted nutrient therapies using antioxidants or their precursors (e. g., N-acetylcysteine) hold promise for improving mitochondrial function, there are large gaps in our knowledge. The most rational approach is to understand the mechanisms underlying mitochondrial damage for specific medications and attempt to counteract their deleterious effects with nutritional therapies. This article reviews our basic understanding of how mitochondria function and how medications damage mitochondria to create their occasionally fatal adverse effects.

Mitochondrial Dysfunction and Psychiatric Disorders

From: The Journal of Neurochemical Research 2009 Jun;34(6):1021-9.

Abstract

Mitochondrial oxidative phosphorylation is the major ATP-producing pathway, which supplies more than 95% of the total energy requirement in the cells. Damage to the mitochondrial electron transport chain has been suggested to be an important factor in the pathogenesis of a range of psychiatric disorders. Tissues with high energy demands, such as the brain, contain a large number of mitochondria, being therefore more susceptible to reduction of the aerobic metabolism. Mitochondrial dysfunction results from alterations in biochemical cascade and the damage to the mitochondrial electron transport chain has been suggested to be an important factor in the pathogenesis of a range of (so-called) neuropsychiatric disorders, such as (psychotropic drug-treated) bipolar disorder, depression and schizophrenia….Alterations of mitochondrial oxidative phosphorylation in (anti-psychotic drug-treated) schizophrenia have been reported in several brain regions and also in platelets. Abnormal mitochondrial morphology, size and density have all been reported in the brains of (anti-psychotic drug-treated) schizophrenic individuals. Considering that several studies link energy impairment to neuronal death, neurodegeneration and disease, this review article discusses energy impairment as a mechanism underlying the pathophysiology of some psychiatric disorders, like (psychotropic drug-treated) bipolar disorder, depression and schizophrenia.

Dr Kohls is a retired physician who practiced holistic mental health care for the last decade of his career, and took seriously the Hippocratic Oath that he swore when he received his medical degree. He is also a peace and justice advocate and writes a weekly column for the Reader Weekly, an alternative newsweekly published in Duluth, Minnesota, USA. The last three years of Dr Kohls’ columns are archived at http://duluthreader.com/articles/categories/200_Duty_to_Warn.

February 26, 2015 Posted by | Deception, Science and Pseudo-Science | , , , , , , , , , , , , , | Leave a comment

FDA Antibiotic Guidance Is Gift To Big Pharma and Big Meat

By Martha Rosenberg | Dissident Voice | December 23, 2013

This month’s FDA guidance for reducing livestock antibiotics will actually make things worse, animal welfare and food activist groups are saying. “The FDA is using a garden hose on a forest fire,” says Farm Sanctuary Senior Policy Director Bruce Friedrich. The guidance is a “diversion” that pretends to address the problem of factory farm-driven antibiotic resistance while accomplishing nothing. Antibiotic resistant infections, widely seen as driven by factory farming, sicken 2 million a year in the US and kill 23,000, says the CDC. By asking drug makers to voluntarily renounce the use of antibiotics for livestock growth on their labels, the guidance “won’t cost the industry a penny” or reduce antibiotic use at all, says Friedrich. The reason? Factory farm antibiotics are also used to treat sickness which the crowded conditions tempt — a use that is still allowed under the guidance. Only the wording will change, says Friedrich.

In a December 11 conference call, the FDA’s Michael (“Monsanto”) Taylor, deputy commissioner for foods and veterinary medicine, William T. Flynn, deputy director for science policy and USDA’s Thomas J. Myers, associate deputy administrator, told reporters that the government is asking drug makers to voluntarily restrict the uses on their antibiotic labels –yes, asking – in a shocking gift of self-regulation. Similar honor systems exist at slaughterhouses since Hazard Analysis and Critical Control Points (HACCP) was instituted in 1998 in which industry creates its own safety plan which the government simply cosigns. A similar honor system called the Hazard Analysis and Critical Control Point-Based Inspection Models Project (HIMP) is imminent for poultry slaughterhouses.

Why are the FDA and USDA allowing industry to write its own ticket? (And why would industry write itself out of its own profits?) Because to mandate the changes would require “hundreds of separate regulations” and actions, whined government officials on the conference call. It is easier to just say please to industry.

To many reporters on the conference call, the plans sounded like fluff. If the changes are voluntary, “what will enforce” them and serve as an “incentive” asked an ABC reporter? Food producers and drug companies need no incentive retorted Michael Taylor because they are starting to phase out antibiotics “for their own reasons” — citing McDonald’s and KFC. Right.

If factory farmers actually phased out antibiotics (which prevent animals from becoming sick in high density-farming) won’t livestock producers “have to move to different buildings” asked a reporter from Reuters. That’s why we are giving industry three years to comply replied William Flynn.

Will you release the identifies of drug companies who do not comply asked another reporter? No, replied Flynn. We will give an “overview” of  the level of “engagement” of  industry but not individual company names. (USDA has also protected the identities of US ranches that released mad cows into the US food supply and restaurants who served them according to newspaper and government sources.)

Animal welfare groups like Farm Sanctuary, American Society for the Prevention of Cruelty to Animals and the Animal Legal Defense Fund are not the only ones calling the FDA guidance toothless and a serious capitulation to industry. Congresswoman Louise M. Slaughter, the only microbiologist in Congress, called the guidance “an inadequate response to the growing antibiotic resistant crisis caused by overuse of antibiotics on the farm.” Industry has spent over $17 million to block a bill Rep. Slaughter developed, in conjunction with the late Sen. Ted Kennedy, called the Preservation of Antibiotics for Medical Treatment Act (PAMTA), says a press release from her office.

This is not the first time government has caved to drug makers over the regulation of livestock antibiotics. In 2008, the FDA had announced that there was “evidence that extralabel use of these drugs [cephalosporins] in food-producing animals will likely cause an adverse event in humans and, as such, presents a risk to the public health,” and called for their prohibition. Notice the FDA says “will likely cause” not “could likely cause” and “presents a risk” not “could present a risk”?

But by the time hearings were held two months later and lobbyists had worked their magic, the “Cephalosporin Order of Prohibition” had somehow become a “Hearing to Review the Advances In Animal Health Within The Livestock Industry.” Prohibition — advances, same idea, right?

At the hearings, the American Veterinary Medical Association (AVMA), the Animal Health Institute, a Big Pharma trade group and the egg, chicken, turkey, milk, pork and cattle industries whined that they could not “farm” without antibiotics because more feed would be required and the animals would get sick from being immobilized over their own manure.

Afterwards, W. Ron DeHaven, DVM, who was the USDA’s top vet before leaving for industry and helming the AVMA, penned a rambling, almost incoherent 18-page letter with 62 footnotes to the FDA. Cephalosporin resistant “human pathogens” aren’t increasing, says the letter, and even if they are, they’re not affecting human health, and even they’re affecting human health, how do you know it’s from the livestock drugs, and even if it’s from the livestock drugs, the FDA has no legal authority to ban cephalosporin. Got that?

Alternately maudlin and accusatory, the letter plays on terrorism fears by calling a cephalosporin ban a “food security issue” affecting “the number of animals available for the food supply.” It also plays on humanitarian sentiments by claiming a ban would impede veterinarians’ ability “to relieve the pain and suffering of animals” as if cephalosporins are pain killers and other drugs aren’t available. (And as if antibiotics are given for animals’ welfare instead of revenue welfare!) But less than a month after the letter was sent, on November 25 the FDA quietly revoked the prohibition. Good hire, AVMA!

It is no surprise that factory farm operators fight to keep their antibiotics says Farm Sanctuary’s Bruce Friedrich. Without them, in their profit-driven “filth chambers,” the animals would simply die.

December 26, 2013 Posted by | Corruption, Deception, Economics, Environmentalism | , , , | 1 Comment