LEARN THE INCREDIBLE EXTENT TO WHICH THE FDA PERMITS MASS-MURDER BY HARMFUL PHARMACEUTICAL PRODUCTS
A review of the major investigations that have exposed a deeply saddening horror story
To what extent can you trust the safety of the drugs and vaccines your physician prescribes to you and your loved ones?
In a country whose laws ought to enforce criminal penalties on everyone who breaks the laws, did you know that there is one industry that's been exempted from criminal penalties for decades? As a result, millions of people are knowingly being harmed and murdered, most of which are innocent children and teens continuing to be prescribed ineffective drugs increasing their suicide risk, as multiple investigations have revealed. This mass-murder goes unpunished.
The facts this exposition lays out demonstrates the shocking extent to which the FDA operates more like an illicit cartel rather than a regulatory agency. This is the predictable outcome of the way bought-out politicians have been failing to enforce criminal penalties on not only the pharmaceutical industry but also on its regulators. Please self-verify the reality of this immense corruption by clicking on the links below, followed by taking action.
Experts with conflicting interests allowed into the FDA's vaccine advisory committees
“We have an advisory committee to the FDA who are made up of independent people who I trust,” told Dr. Fauci during an interview on 60 Minutes, reassuring America that everything's just fine with the FDA. Fauci had lied to the nation for the umpteenth time. The FDA, which ought to regulate America's drug supply and which has granted emergency use approval to the COVID-19 vaccines, is far from being "made up of independent people" as Fauci has claimed it is.
The integrity of the FDA's Vaccines and Related Biological Products Advisory Committee has been permitted to degrade due to a loophole worked into the system allowing the waiving of the recusal requirements for committee members. This loophole has been uncovered by the investigative organization The Project On Government Oversight (POGO). POGO states:
"Even if it [the FDA] concludes that an advisory committee member has an actual financial conflict or questionable impartiality, the FDA has the power to waive recusal requirements and allow the member to participate."
POGO has been able to obtain 2 FDA memos revealing that the agency has actually used the loophole and granted waivers from conflict of interest prohibitions to 2 temporary appointees. One of these members allowed into the committee holds sizeable amount of stock in a vaccine company, and the other new member is the president of the approved site for a clinical trial of a potential coronavirus vaccine. Being the president of the clinical vaccine trial site, this member could get paid between $500,000 and $750,000 if the FDA decided to conduct the particular vaccine trial for which her site was approved. Can such advisors be expected to selflessly decide what's best for you and I, taking large losses in the stock market or losing more than half a million dollars if the science requires they should? Or is the selection of such advisory committee members the FDA's way of ensuring that its decisions remain aligned with big pharma's and politicians' wishes?
POGO has been able to determine additional advisory committee members with disturbing financial conflicts of interest. For example, advisory committee member Dr. Archana Chatterjee has received at least $200,000 in consulting fees, travel, lodging, and other payments from companies developing the coronavirus vaccines, according to a federal database. The advisory committee's acting chairman Dr. Arnold Monto has received at least $60,000 in recent years from the vaccine manufacturers. Monto is a professor at the University of Michigan which has partnered with COVID-19 vaccine developer AstraZeneca. These are the people advising the FDA whose screening guidelines falsely inform the public that its advisory committees provide "independent, expert advice."
The integrity and independence of the FDA's Vaccines and Related Biological Products Advisory Committee has also been allowed to degenerate due to the conveniently subjective interpretation of 'impartiality' in a system overseen by corrupt directors Fauci and Collins. POGO reports the FDA has told them that the key question is "whether a reasonable person would doubt the committee member’s impartiality." The FDA has also told POGO, "interests or relationships more than a year old do not generally give rise to appearance [of conflict of interest] issues." When Dr. Chatterjee was asked if her past matters raise an appearance issue, she'd replied, “It’s hard for me to judge that. … I think, you know, appearance is in the eye of the beholder.” In the subjective and nebulous world of what constitutes appearance of conflict of interest and what doesn't in the FDA, POGO points out an FDA draft “guidance” document from 2016 which admits the law “gives FDA and other agencies significant flexibility and discretion in deciding whether a member with an appearance [of conflict of interest] issue should participate in a particular matter.”
POGO further reports that because some advisory committee members are not physicians, databases do not have records of any payments they might have received from pharmaceutical companies.
Despite the reality demonstrated, FDA Commissioner Stephen Hahn has lied to the nation in a news release, “We have not lost sight of our responsibility to the American people to maintain our regulatory independence." This statement is demonstrably false in the light of the fact that the FDA still recommends the mRNA COVID-19 vaccines despite the accumulation of more than 1000 peer reviewed studies on their adverse effects. The extent to which the FDA's advisors ignore such a body of research demonstrates how often the loophole of granting waivers from recusal must have been exploited and how far the "subjective" definition of impartiality must have gotten stretched.
The following sections shed light onto the FDA's a long history of helping increase big pharma profits at the cost of letting millions die and suffer.
Please don't postpone taking action now to help to do away with the recusal waivers, subjectivity and leeway in the FDA's advisory committee member selection process, to ensure the committee members become truly independent.
The FDA's pattern of delaying the banning of harmful drugs, knowingly letting millions suffer and die
In February 2007, a Congressional Hearing was held questioning the adequacy of the FDA to assure the safety of the nation's drug supply and medical countermeasures. At this Congressional Hearing, Senator Grassley reported a number of problems with the FDA, which he summarized on his website as follows:
I’ve identified problems at the FDA that consistently fit into a few themes.
First, scientific dissent is discouraged, quashed, and sometimes muzzled inside the Food and Drug Administration. Second, the FDA’s relationship with drug makers is too cozy. The FDA worries about smoothing things over with industry much more than it should with its regulatory responsibilities. Third, inside the FDA there’s widespread fear of retaliation for speaking up about problems. And fourth, the public safety would be better served if the agency was more transparent and forthcoming about drug safety and drug risks.
The transcript of this 2007 Congressional Hearing points out the numerous instances of the FDA’s gross regulatory failure. For example, the FDA’s misconduct before recalling the pain relievers Vioxx and Bextra sheds light on the FDA’s pattern of buying the drug manufacturers time before pulling from the market harmful blockbuster medications. Representative Stupak explains:
These pain relievers [Vioxx and Bextra] were supposed to be easier on the stomach and not cause ulcers for the chronic users. Post-marketing surveillance revealed serious cardiac side effects. Instead of focusing on these serious side effects, the FDA became entwined in a 14-month battle on how the cardiovascular risks should be labeled. FDA officials sided with the drug manufacturer and down-played the warnings and the serious side effects of Vioxx. As a result, the FDA may have allowed thousands of patients to die prematurely because of its failure to believe its own scientist and his post-market surveillance findings.
Vioxx’s manufacturer Merck & Co. was finally fined about $1 billion for "illegal marketing of Vioxx." Bextra’s manufacturer Pfizer paid $2.3 billion for misbranding medications “with the intent to defraud or mislead.” Although countless innocent people had knowingly been allowed to die, no criminal charges had been brought against those running the drug companies. “The financial rewards companies reap from engaging in these behaviors far outstrip any penalties they pay,” explains Harvard Medical School professor Eric G. Campbell who researches doctors’ conflicts of interest. Treating fines as a cost of doing business, “truly appears to be the business model in marketing drugs,” Campbell is quoted as having told. This Business Ethics artcile quoting Campbell elaborates:
"Big Pharma has written more than $30 billion in checks in the last 10 years to resolve the government allegations, according to statistics compiled by the consumer watchdog group Public Citizen. [...] Yet those sums, Public Citizen says, are essentially petty cash for the drug giants. The advocacy group, which seeks stiffer sanctions against violators, says the settlements amount to less than 5 percent of the net profits raked in by the 11 largest global pharmaceuticals firms over a similar period."
Dr. David Graham, associate director for science and medicine in the FDA’s Office of Drug Safety, has admitted, “the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless."
The rise of antidepressant prescriptions for children, despite the way it's been proven that all antidepressants increase suicide risk in youth
The cases of Vioxx and Bextra are unfortunately not the only instances exposing the FDA’s gross negligence and unwillingness to regulate big pharma. Even more horrifying is the case of the fraudulent marketing of antidepressants despite the way these drugs have been proven to increase the risk from suicide in depressed individuals. This was first discovered in 2003 when the FDA appointed medical official Dr. Andrew Mosholder to review the comprehensive antidepressant trial data obtained from GlaxoSmithKline and "manufacturers of eight other antidepressant drugs that were studied in children." After having analyzed this body of data, Dr. Mosholder announced that antidepressants increase suicide risks in children. Dr. Mosholder informed his supervisors of this conclusion in September 2003, more than a year before the FDA finally issued its black box warning in October 2004 announcing the increased suicide risk for children for all antidepressants. Dr. Mosholder was originally scheduled to present his findings at a February 2004 advisory committee meeting, but before this public advisory committee meeting occurred, Dr. Mosholder’s supervisors told him they disagreed with him. Mosholder states, “alternative conclusions were offered to me which I declined to incorporate into my written document.” His higher-ups then blocked Mosholder from giving his presentation.
“The first question that this raises is quite simple: Why?” asked Representative Joe Barton at a Congressional Hearing that took place in February 2004. “What was the harm in allowing Dr. Mosholder an opportunity to present his data, his analysis, and his opinion to a group of experts?” told Barton, who's the chairman of the Committee on Energy and Commerce whose subcommittee on Oversight and Investigations accused the FDA of inadequacy.
Approximately three months after Dr. Mosholder had announced his supposedly "wrong" conclusions on September 2003, the British equivalent of the FDA (MHRA) announced the banning of all the new generation antidepressants except Prozac for children due to their risk of increasing suicidality in young people on December 2003. MHRA had come to this conclusion as a result of its own independent review of the same data Mosholder had reviewed. But even after the British regulators had confirmed Mosholder’s conclusion, the FDA delayed issuing strong enough warnings. The agency required Mosholder’s conclusions to be unnecessarily re-analyzed, wasting 8 more months caught up in trying to better label the misclassified suicidal events in the trial data. This was exactly the same thing the FDA had done in the case of the deadly medications Vioxx and Bextra, stalling to buy the drug manufacturers a bit more time to let them make more profit from their "bluckbusters."
It seems that the FDA's hesitancy was due to the way the antidepressant manufacturers had paid the agency off after having started 2 highly profitable scams called TMAP and TEENSCREEN, both of which had been implemented in cahoots with the Bush administration to unnecessarily drug school children with harmful psychiatric medications, greatly expanding the market share for the big pahrma's newest and most expensive antidepressants and antipsychotics. These 2 scams had been approved by George W. Bush’s New Freedom Committee on Mental Health on July 2003, just two months before Mosholder had announced his findings. Mosholder's conclusions had rained on the parade of big pharma and bought-out Bush Administration enriching themselves.
How many school children or teens may have committed suicide due to the antidepressants they've continued to take as the FDA knowingly did nothing about the suicide risks they'd known about?
“There is something terribly rotten at the FDA” exclaimed Representative Deutsch at the September 2004 Congressional Hearing. “I am appalled but, frankly, not surprised by the systematic efforts of the FDA to suppress information that could have prevented the senseless deaths of too many children,” told Representative Bart Stupak in the same hearing.
The FDA has never banned the prescription of the deadly antidepressants still up to this day, instead only putting a black box warning on the labels of the deadly drugs. Misleading drug marketing practices have continued, causing the number of antidepressant prescriptions for yound people to keep rising despite the black box warnings spelling out the way these drugs increase suicide risk in youth. Number of young children prescribed antidepressants has risen by 41% since 2015," reports a Pharmaceutical Journal article. Nothing is being done about this massacre of innocent children which continues to enrich big pharma as well as politicians. The media, which doesn't want to burn bridges with the drug giants, refrains form exposing the fraud in a country allowing drug advertisements. "Increasing antidepressant prescriptions are related to more youth suicide attempts and more completed suicides among American children and adolescents," states a February 2020 article in the pier reviewed journal Frontiers in Psychiatry, the third top journal in its field. But who cares that children are knowingly massacred as such, when everyone's been profiting from it?
Not only do antidepressants increase the risk of suicide in children, but they also have no benefits, studies have discovered. Although experiments with antidepressants have not been able to demonstrate efficacy in children, this had been hidden from doctors and parents for several years by the FDA. In the 2004 Congressional Hearing, the representatives had also asked the FDA why it had not promptly required the antidepressant labels to reflect the fact that clinical trials had not demonstrated efficacy in children. Representative Greg Walden told:
Why wouldn’t you put that on the label? Why shouldn’t the label reflect that information? I note that the Advisory Committee just recommended that this labeling change take place, but the point is that the FDA knew about the lack of efficacy in these trials several years ago, and nothing has been done to change the label to inform doctors, patients and parents of this finding.
“Shockingly, the FDA made a deliberate decision to withhold information on the clinical failures from parents as well as pediatricians and other prescribers,” stated Representative Peter Deutsch.
“Today, SSRI’s remain on the market without a clear medical benefit to the patient,” Representative Stupak stated three years later in a 2007 Congressional Hearing.
The congressional investigations mentioned above have also unearthed the unethical tactics the FDA utilizes to cover its tracks, which demonstrate the way the agency’s operation resembles that of a criminal organization rather than a regulatory agency. After the FDA had prevented Dr. Mosholder from presenting his findings about antidepressants, someone from within the agency had leaked what had happened to the San Francisco Chronicle, causing the outlet to publish how the FDA “squelched its own investigator’s report." This had caused the FDA to start an inappropriate internal criminal investigation to find out who had leaked the information to the media. “It is readily apparent that the probe [of this criminal investigation] was not about information but, rather, about intimidation,” told Representative Deutsch at the 2004 hearing.
The FDA’s attempts to cover up its corrupt deeds does not stop with threatening to criminally penalize those trying to alert the public. The agency had also attempted to obliterate the fact that such an inappropriate criminal investigation had occurred. Right before the 2004 Congressional Hearing, the FDA had tried to get Dr. Mosholder to submit an altered document to the hearing instead of the original document revealing the occurrence of the criminal investigation. After consulting with his lawyer, Dr. Mosholder had resisted signing that fake document.
It gets even worse.
In 2003, the FDA had gone so far, it had stopped a pharmaceutical company from warning about the suicidal thoughts or behavior and hostility caused by its antidepressant Venlafaxine (Effexor). Wyeth Pharmaceuticals had, on their own, made a labeling change for Effexor mentioning the increased suicidal ideation, hostility and self-harm caused by their drug “based on the company’s re-analyses of data from the Effexor pediatric trials.” Wyeth had also sent out a warning letter to health care professionals about this labeling change in August 2003, telling them that Effexor is “not recommended for use in pediatric patients." But in March 2003, the FDA had asked Wyeth to “remove this stronger labeling.” The FDA had mandated Wyeth and other antidepressant makers to all use the same labeling that did not recommend doctors to stop prescribing antidepressants for children, recommending only that doctors “carefully monitor patients receiving antidepressants for possible worsening of depression or suicidality.” Representative Barton told at the 2004 Congressional Hearing:
"It is incredible that this agency charged with protecting the public health would stop a company from warning the public about risks associated with the use of its products by children."
Just like the prevention of Mosholder’s conclusion to the FDA's advisory committee in 2003, the FDA had also prevented the suicide risks of Sertraline (Zoloft) and paroxetine (Paxil) from being presented to its advisory committee on 1991, despite knowing the increased suicide risk from similar antidepressants for 2 years. In 1996, the FDA’s drug reviewer James F. Knudsen had again tried to point out the reports of suicidal ideation and behavior in children and adolescents exposed to Zoloft, but his conclusions were supposedly “disputed” by a supervisor and obliterated just like in Mosholder's case.
At the time the FDA was being questioned by Congress in 2004, it had not yet issued its black box warning on all antidepressants, but the FDA’s advisory panel had recommended the agency to do. The FDA would probably have kept ignoring its advisory committee's advice if not for the pressure coming from Congress. In the 2004 hearing, Representative Deutsch had warned, “I expect that the FDA will tell us at this hearing that it will adopt the recommendations of its Advisory Committee.” To make sure that the FDA would not ignore or further delay implementing the recommendations of its advisors, Senator Grassley had also sent the FDA a letter after the hearing, stating:
I trust that the FDA will very quickly and fully consider the Advisory Committee’s recommendations about the “black box” and “med guides”, before the lives of more children are needlessly lost because parents and others lack adequate, readily understandable information when they most need it.
Thus the FDA had been forced to issue the black box warning.
Why haven't the representatives force the FDA to ban all antidepressants for children which cause them to kill themselves without improving depression?
How many more drugs are out there whose warnings are not adequate, or are misleading or missing?
How many more deadly or harmful treatments without justifiable benefits continue to fill the shelves of pharmacies?
The information below further reveals the horrifying reality.
Charles Seife's investigations have revealed additional egregious FDA misconduct knowingly harming and killing millions of people
In 2008, nine senior FDA scientists informed the government of the FDA's deep corruption in a series of letters to Congress and to President Obama, asking the government to restructure the agency. Their evidence further confirms that the FDA’s “managers have ordered, intimidated and coerced scientists to manipulate data in violation of the law.” But years later, the FDA was just as corrupt and nothing had changed, which has been exposed by experienced journalist Charles Seife.
Charles Seife, M.S. is a versatile professor, author, journalist, and mathematician all in one, holding an M.S. in journalism from Columbia University and an M.S. in mathematics from Yale. He currently teaches journalism at New York University. In April 2015, Seife published a paper titled “Research Misconduct Identified by the US Food and Drug Administration – Out of Sight, Out of Mind, Out of the Peer-Reviewed Literature” in JAMA Internal Medicine. In this study, Seife tracked 78 studies in which the FDA's inspectors had found significant research misconduct including submission of false information, problems with adverse events reporting, inadequate or inaccurate record keeping, protocol violations, and other fraud. Of these 78 studies, the papers of 75 never mentioned the objectionable conditions or practices the FDA had determined during its inspections. Siefe reports that “no corrections, retractions, expressions of concern, or other comments acknowledging the key issues determined by the inspection were subsequently published,” allowing physicians and researchers to remain oblivious to the tainted nature and false results of these studies. Siefe concludes:
When the FDA finds significant departures from good clinical practice, those findings are seldom reflected in the peer-reviewed literature, even when there is evidence of data fabrication or other forms of research misconduct.
This demonstrates the sad reality of the extent to which the FDA appears to be doing its job without yielding actual benefits to physicians and patients.
On February 2015, Seife published another article in Slate which mentions many other cases of the FDA’s misconduct. In two of these cases, the FDA’s inspectors had discovered research fraud regarding the studies determining the safety and effectiveness of the anti-blood-clotting agent Rivaroxaban and the antibiotic Ketek. But the FDA’s managers had deliberately withheld the evidence of this fraud from their advisory committees, which had caused the approval of these harmful drugs. This resulted in wrongful death lawsuits for Rivaroxaban and reports of liver damage and blurred vision associated with Ketek. Congress had had to step in to investigate the FDA’s misconduct about Ketek. Siefe quotes Senator Grassley who'd said “every excuse under the sun has been used to create roadblocks.” Grassley has also told that the FDA had been unwilling to cooperate “even in the face of congressional subpoenas requesting information and access to FDA employees.” Siefe sums up the problem: “the FDA has a history of not notifying the public about the misconduct it finds.”
In the same 2015 article in Slate, Seife also mentions that a research firm called Cetero was “caught faking data from more than 1,400 drug trials.” This falsified data was used to supposedly demonstrate the safety and effectiveness of about 100 generic drugs. But even after Cetero’s malpractice was uncovered, Seife found “fraud-tainted data on the FDA approved drug labels” of these generic drugs, misleading physicians and the public about safety and benefits. Additionally, Cetero’s fake data had caused some of these generic drugs to appear more similar to their name brands than they actually were. The FDA had never corrected the bioequivalence ratings of these generics indicating their similarity to their name brands. Seife then mentions a similar case of fraud committed by a research firm called GVK Biosciences. About 40 drugs were approved and released into the U.S. market as a result of the fraudulent practices of this firm. But the FDA had neither disclosed the names of these drugs nor pulled them off the market after GVK’s fraudulence had been uncovered.
Seife summarizes the situation:
Despite being called out numerous times over the years for its bad behavior, including from some very pissed-off members of Congress, the agency is stubbornly resistant to change. It’s a sign that the FDA is deeply captured, drawn firmly into the orbit of the pharmaceutical industry that it’s supposed to regulate. We can no longer hope that the situation will get better without firm action from the legislature.
When the bought out legislature in chaoots with big pharma has for decades refrained from taking strong enough action, millions of children and adults continue to swallow their harmful medications in the U.S.
Simple Internet searches show that the unethical drug marketing scams covered here are far from being exhaustive. Here are 10 horrifying cases of fraud that have resulted in big pharma's biggest fines in history. Here is a report on the fraudulent marketing of the deadly statins killing millions. And then there's this article and this article on the illegitimate kickbacks big pharma pays to doctors. And then there's also this well-researched article titled "Companies Pay Millions To Promote Some Of Their Most Unremarkable Drugs." In the bountiful world of medical fraud, this long exposition has only addressed a small portion of the problem.
When jails and prisons are filled with petty drug dealers who haven't made enough money to buy anyone out, the drug cartels of the pharmaceutical world keep making gargantuan profits from the unregulated fraud and deceit.
The problem could have been exposed, caused an outcry and solved long ago if the legislature did not allow the media too to get a share of big pharma's huge profits. This corruption can only be expected to keep festering if the legislature continues to allow pharmaceutical product advertisements, please don't postpone taking action to force changes and save the lives of millions.