How the FDA Manipulates the Media

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How the FDA Manipulates the Media

The U.S. Food and Drug Administration has been arm-twisting journalists into relinquishing their reportorial independence, our investigation reveals. Other institutions are following suit

                                     

                                    

 

How the FDA Manipulates the Media

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The U.S. Food and Drug Administration has been arm-twisting journalists into relinquishing their reportorial independence, our investigation reveals. Other institutions are following suit

 

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                 Risky Drugs: Why The FDA Cannot Be Trusted

 

 

http://Risky Drugs: Why The FDA Cannot Be Trusted

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Why is the FDA funded in part by the companies it regulates?

 

Why is the FDA funded in part by the companies it regulates?

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The FDA receives almost half its funding from companies it regulates, such as drug and medical device makers. Is this something you should be concerned about?

 

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An FDA Whistleblower's Documents: Commerce, Corruption and Death

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An FDA whistleblower's documents tell of approval of antipsychotic drugs that lack efficacy and increase risk of death

 

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Crackdown on Corruption in FDA in India

 

Crackdown on Corruption in FDA in India – Key takeaways from recent developments – Arogya Legal – The Health Laws Specialists

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Two separate incidents, one relating to India's central drug law enforcement body- the Central Drugs Standards Control Authority (CDSCO), and another relating to a State drugs law enforcement...

 

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How the FDA & Big Pharma Collusion Can Kill Us While Taking Our Money

 

How the FDA & Big Pharma Collusion Can Kill Us While Taking Our Money - SFPMG

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FDA Levies Large Fine Against Johnson & Johnson It's not Really the Good News you'd Think it Would be. Recent press releases from the FDA and Justice Department proudly announced Johnson &...

 

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PSYCHOLOGIST SAYS FDA IS CORRUPT—BAN ECT

Dr. Toby Watson, who says electroconvulsive therapy is anything but therapeutic, is outraged the FDA isn’t doing something.

 

Psychologist says FDA is Corrupt—Ban ECT

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Dr. Toby Watson, who says electroconvulsive therapy is anything but therapeutic, is outraged the FDA isn’t doing something.

 

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Among the investigation's key findings:

• Of 107 physician advisers who voted on the committees Science examined, 40 over a nearly 4-year period received more than $10,000 in post hoc earnings or research support from the makers of drugs that the panels voted to approve, or from competing firms; 26 of those gained more than $100,000; and six more than $1 million.
• Of the more than $24 million in personal payments or research support from industry to the 16 top-earning advisers—who received more than $300,000 each—93% came from the makers of drugs those advisers previously reviewed or from competitors.
• Most of those top earners—and many others—received other funds from those same companies, concurrent with or in the year before their advisory service. Those payments were disclosed in scholarly journals but not by FDA.

 

AAAS

WWW.SCIENCE.ORG

 

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Unforgivable Hypocrisy From FDA’s Career CDER Leadership

Dr. David Gortler | FDA Drug Safety & Investigational Medicine News

Contributor

Healthcare

Former FDA Medical Officer and Senior Advisor to the FDA Commissioner

 

Unforgivable Hypocrisy From FDA’s Career CDER Leadership

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The same career FDA bureaucrat who crowed about “following the science” to discredit President Trump has approved a failed Alzheimer’s drug.

[Bernard]

A Legacy Of Corruption In The FDA And Big Pharma – OpEd

Our healthcare system is broken, a fact nobody would have disputed in precovid days. Regulatory capture is a reality, and the pharmaceutical industry is fraught with examples.

Yet we trusted private-public partnerships to find an optimal solution to a global pandemic, assuming a crisis would bring out the best in historically corrupt institutions.

Here is a brief list of less-than-savory behavior demonstrated by our titans of healthcare: 

• Pfizer and Johnson & Johnson plead guilty to “misbranding with the intent to defraud or mislead” and paying “kickbacks to health care providers to induce them to prescribe [their] drugs,” resulting in fines of $2.3 billion in 2009 and $2.2 billion in 2013, respectively. 
• Pfizer settled another lawsuit for “manipulating studies” and “suppressing negative findings” just a few years later. 
• Moderna has never developed an approved drug, yet one of their board members was placed in charge of Operation Warp Speed. This certainly is unrelated to the fact that they received the most federal vaccine research and development funding and have received over $6 billion from our government since the start of the pandemic.
• Gilead Sciences paid $97 million in fines, because it “illegally used a non-profit foundation as a conduit to pay the Medicare co-pays for its own drug.”
• In 2005, AstraZeneca’s drug Crestor was shown to be linked to a life-threatening muscle disease while the company withheld evidence of this and two dozen other effects from the public.
• In 2012, GlaxoSmithKline paid $3 billion in fines, as it “failed to include certain safety data” relating to their drug, since labeled as connected to heart failure and attacks.

Thankfully, our public health guardians are in place to protect us from the greed and deceit of the private sector, right? Wrong. Enjoy another brief list:

• The Food and Drug Administration (FDA) worked behind the scenes with company Biogen to alter previously conducted trials of their $56,000 per year Alzheimer’s treatment, and “by removing the subset of people for whom the drug didn’t work, they found a slight statistical effect in favor of the drug.” Even after doing this, an advisory committee voted 10–0 against approving the drug. The FDA approved the drug anyway, causing three committee members to resign.
• In that case, the third-party advisors did the right thing. This is not always the case: a study by Science Magazine tracking 107 FDA advisors for four years found that 62 percent received money from related drug makers, with 25 percent receiving over $100,000 and 6 percent receiving over $1 million. It only takes a few corrupt advisors to fix a panel and feign medical consensus.
• In 2017, it was revealed that the acting Centers for Disease Control and Prevention (CDC) director for heart disease and stroke prevention had been secretly communicating with Coca-Cola, providing guidance on how “to influence world health authorities on sugar and beverage policy matters.”

The American healthcare system remains mired in good old-fashioned crony capitalism, fascism, corporatism, mercantilism, protectionism … fancy words for when private companies work with governments to subvert the forces of competition. The suppression of research into off-patent drugs is a nasty symptom of this problem.

While there are countless drugs to which this applies, we will discuss ivermectin. First, addressing the drug’s dismissal by its own manufacturer, Merck, let it be known that ivermectin is no longer under patent. Merck no longer owns exclusive rights to the drug’s production. The forces of competition have been bestowed upon the drug, thus making it far cheaper. Meanwhile, Merck is also currently rolling out an oral covid treatment, which the US government is providing $1.2 billion in funding to research. This would be under patent and may explain the company’s opposition to using ivermectin.

The usefulness of ivermectin remains debatable. However, it’s important to note that in early April 2020,  a study at the University of Monash in Australia suggested it can be effective. Moreover, the drug is FDA approved, has existed for forty years, won a Nobel Prize, and is extremely safe when used at recommended levels. Given the crisis and ivermectin’s safety—safe even if not conferring big benefits for covid sufferers—the rush to condemn use of the drug appears suspect. Indeed, a week after the Australian study was published, the FDA advised against using ivermectin for COVID-19 treatment, forcing desperate people to the black market and to self-prescribe versions of the drug intended for animals.

The FDA noted subsequently that “additional testing is needed.” Yet, to date, there has not been a single completed government-funded study on the effectiveness of ivermectin against covid-19. Meanwhile, they have funneled billions toward research into vaccines and patented treatments. The National Institutes of Health (NIH) funded trials for remdesivir, still under patent with Gilead, despite it being less effective and having more severe side effects than ivermectin. The FDA approved remdesivir under emergency use authorization (EUA) despite published trials, later stating “remdesivir was not associated with statistically significant clinical benefits.”

One would think that if “additional testing” is so important, the US government might be interested in funding research to examine the potential benefits of cheap, safe, and proven drugs that have shown some promise in treating covid. But that’s clearly not what going on. Funding is geared toward helping huge pharmaceutical companies develop new patented drugs. As long Big Pharma wants it, and if there’s a profit to be made, apparently our government will be there to provide funding.

This article was published by the MISES Institute

 

 

A Legacy Of Corruption In The FDA And Big Pharma – OpEd – Eurasia Review

WWW.EURASIAREVIEW.COM

 

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GAB | The Global Anticorruption Blog

Law, Social Science, and Policy

 

Regulatory Discretion and Corruption in the FDA

Posted on September 25, 2017 by Jetson Leder-Luis

In the United States, the regulatory agency responsible for ensuring safe food and medicine, the Food and Drug Administration (FDA), has been marred by numerous scandals – from a 2016 insider trading prosecution to a 2009 politicized medical device approval to a 2013 ProPublica investigation that found the FDA overlooked fraudulent research and let potentially unsafe drugs stay on the market. These scandals have, understandably, undermined public confidence in the FDA. What’s the explanation for these problems? Why is there such a large public perception of corruption, and so many questionable incidents, at the FDA?

Much of the explanation has to do with institutional design: Corruption blooms where transparency and accountability are lacking, yet the FDA has vast discretion over the regulations it sets, incredibly loose restrictions on the money it can receive from industry, and little public accountability. The following steps can be taken to reform the FDA, in the interest of rooting out corruption and restoring public confidence in the agency:

 

1. End the Influence of Corporate Money in FDA Regulation—The FDA is responsible for the approval of pharmaceuticals, which are incredibly expensive to develop, in the hundreds of millions of dollars per drug. Drug companies therefore spend heavily on lobbyists to influence FDA approval policy. As in other contexts where well-resourced interest groups spend heavily to influence government policy, this conduct, even if lawful, raises at the reasonable suspicion of impropriety and undermines public confidence in the agency. Furthermore, the FDA suffers from a pervasive “revolving door” problem: many FDA administrators, either before or after their time at the agency, receive payments from (and sit on the boards of) large pharmaceutical companies. For example, President Trump’s nominee for FDA Commissioner, Scott Gottlieb, received $200,000 in 2015 from drug companies. But this is not a new or partisan issue: President Obama’s FDA Commissioner, Robert M. Califf, received $30,000 from drug companies in the year preceding his nomination, and President George W. Bush’s former FDA Chair continues to receive $50K-$70K from drug companies, mostly for “consulting.” When FDA administrators stand to make hundreds of thousands of dollars in the years following their service from the very companies they are charged with regulating, they face strong incentives to behave in ways favorable to those companies. The ability to pay a drug administrator for approval is antithetical to the need for safe and fair drug trials; that the payments come a few years before and after their service does not change this fact. The federal government could take steps to limit the revolving door with a mandatory deferral time of at least a few years between employment at the FDA and participation in FDA-related lobbying activities.

2. Improve Transparency of the FDA’s Regulatory Processes—While the FDA makes claims about the safety of certain food and drugs, there is little transparency into what goes into the decision-making process behind those claims. The agency’s secretive behavior contributes to the public perception of wrongdoing and the lack of trust in the agency’s conclusions. The Regulatory Affairs Professionals Society has an excellent post describing some basic reforms that would improve transparency and generally improve the way in which the agency conducts business. The recommendations are astoundingly simple, including “Making public FDA’s clinical and statistical reviews of products not approved or for which the marketing applications are abandoned or withdrawn.” Current FDA regulations that limit public information are self-imposed, rather than statutory, and therefore could be changed if the agency faced pressure to do so.

3. Provide Oversight of the Agency—The FDA falls under the purview of Department of Health and Human Services (HHS), an agency also charged with administering Medicare and Medicaid. The FDA is a very small part of HHS, receiving about $2.7 billion of HHS’s $1 trillion This organizational structure means that the main oversight agency for the FDA is the Office of the Inspector General for HHS, an office also tasked with overseeing the massive federal insurance programs. This lack of effective oversight, when coupled with FDA’s vast regulatory discretion, substantially increases the risks of improper behavior. Decisions by the agency are mostly final and lack an effective appeals process, and failure to act by the agency requires litigation by activists to correct. If so much discretion and secrecy are truly necessary to the FDA’s regulatory process, there must be a third-party oversight body whose main focus is the integrity of this agency.

 

Regulatory Discretion and Corruption in the FDA | GAB | The Global Anticorruption Blog

GLOBALANTICORRUPTIONBLOG.COM

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In the United States, the regulatory agency responsible for ensuring safe food and medicine, the Food and Drug Administration (FDA), has been marred by numerous scandals – from a 2016 insider trading...

 

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Institutional corruption of pharmaceuticals and the myth of safe and effective drugs

Abstract

Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA's prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication; independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few, if any, new clinical benefits; and the creation of a National Drug Safety Board.

© 2013 American Society of Law, Medicine & Ethics, Inc.

Institutional corruption of pharmaceuticals and the myth of safe and effective drugs - PubMed

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Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of...

 

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Institutional Corruption of Pharmaceuticals

Risky Drugs: Why The FDA Cannot Be Trusted

By Donald W. Light
Harvard University, The Lab @ Edmond J. Safra Center for Ethics

A forthcoming article for the special issue of the Journal of Law, Medicine and Ethics (JLME), edited by Marc Rodwin and supported by the Edmond J. Safra Center for Ethics, presents evidence that about 90 percent of all new drugs approved by the FDA over the past 30 years are little or no more effective for patients than existing drugs.

All of them may be better than indirect measures or placebos, but most are no better for patients than previous drugs approved as better against these measures. The few superior drugs make important contributions to the growing medicine chest of effective drugs.

The bar for “safe” is equally low, and over the past 30 years, approved drugs have caused an epidemic of harmful side effects, even when properly prescribed. Every week, about 53,000 excess hospitalizations and about 2400 excess deaths occur in the United States among people taking properly prescribed drugs to be healthier. One in every five drugs approved ends up causing serious harm, while one in ten provide substantial benefit compared to existing, established drugs. This is the opposite of what people want or expect from the FDA.

Prescription drugs are the 4th leading cause of death. Deaths and hospitalizations from over-dosing, errors, or recreational drug use would increase this total. American patients also suffer from about 80 million mild side effects a year, such as aches and pains, digestive discomforts, sleepiness or mild dizziness.

The forthcoming article in JLME also presents systematic, quantitative evidence that since the industry started making large contributions to the FDA for reviewing its drugs, as it makes large contributions to Congressmen who have promoted this substitution for publicly funded regulation, the FDA has sped up the review process with the result that drugs approved are significantly more likely to cause serious harm, hospitalizations, and deaths. New FDA policies are likely to increase the epidemic of harms.

 

Institutional Corruption of Pharmaceuticals - PNHP

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Risky Drugs: Why The FDA Cannot Be TrustedBy Donald W. LightHarvard University, The Lab @ Edmond J. Safra Center for EthicsA forthcoming article for the special issue of the Journal of...

 

[Bernard]

FDA Corruption and Bad Science (The TRUTH!)

A Lethal Problem

More than 100 million Americans have received prescriptions for unsafe drugs that later had to be pulled from the market because of safety concerns. Every year, about 2 million Americans experience significant side effects from FDA-approved drugs.

And every year, about 100,000 Americans die as a result.

This according to a 2006 study in the International Journal of Health Sciences.

The same study found that out of every 100 new drugs that make it through the U.S. Food and Drug Administration’s drug evaluation process, there are 27 “black-box” safety warnings and outright market withdrawals within the first 16 years.

Why are so many Americans falling victim to adverse drug effects? The reasons are complex, but many of them are attributable to structural problems with the drug approval process, and with corruption within the U.S. Food and Drug Administration itself.

Who Funds the FDA?

Many people think the FDA is funded directly by the taxpayer. But this is only partially true. As of Fiscal Year 2019, only about 55% of the FDA’s $5.9 billion budget came via Congressional authorization. The other 45%, about $2.7 billion, comes from “user fees” paid by the regulated food and drug companies themselves — an arrangement many observers believe leads the Agency into serious conflicts of interest.

Furthermore, in order to keep the user fees flowing, the FDA must negotiate new user fee terms with the drug industry every five years, as the Prescription Drug User Fee Act expires. This means that the drug industry has a great deal of leverage over their regulators.

As a result, the FDA has to serve the industry it regulates, more than it needs to serve the tax-paying public. But it’s the public who bears the cost of unsafe drugs.

Lower user fees may help lower the cost of new drug development. But it also increases the risk of unsafe drugs being released on the market.

 

AstraZeneca and the FDA

In one such case, U.K.-based drug manufacturer AstraZeneca, one of the world’s largest pharmaceutical companies, paid hundreds of thousands of dollars to a single cardiologist on the panel that approved the drug ticagrelor – a promising heart medication marketed under the brand name Brilinta.

The company didn’t disclose any conflict of interest at the time. Instead, the payments to the cardiologist came in the form of consulting fees and honoraria over several years.

As it happened, Brilinta was a huge commercial success. And it is effective at helping to prevent blood clots in heart disease and heart attack patients. The drug made the company more than $1 billion. Which meant there was plenty of money for them to pay to the members of the approval panel.

But this one cardiologist wasn’t alone.

AstraZeneca also paid $63,000 to a Duke University cardiologist who sat on a panel that approved quetiapine, an antipsychotic medication marketed under the brand name Seroquel.

But Seroquel, when used in combination with certain other drugs, is associated with a statistically significant risk of sudden cardiac death. This is also true of other compounds that are chemically similar to Seroquel.

According to Science Magazine, the problem arose when AstraZeneca officials were pitching FDA review panels to approve the drug for additional applications: schizophrenia and childhood bipolar disorder. Although researchers knew that Seroquel and similar compounds increased the risk of sudden cardiac death, the company minimized those risks in presenting to the panels.

The panels approved the drug – and the panel members received significant consulting fees, speaking fees, honorariums, and other payments in the months and years after they approved the medication.

This is an example of what critics call a “pay-later” conflict of interest.

According to an investigation by Science magazine:

• 40 out of 107 physician advisors on drug approval committees studied received at least $10,000 in consulting fees, honoraria, or other benefits within four years of granting approval.
• Twenty-six of those physician advisors received at least $100,000.
• Six of them received over $1 million.
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FDA Corruption and Bad Science (The TRUTH!) - Side Effects

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Drugs are big business in the United States. Between consumers, health care institutions, and insurance companies, Americans spent nearly half a billion dollars on medicines in 2018. And Americans...

 

[Bernard]

FDA's top vaccine leaders are leaving

 

Two of the FDA's top vaccine regulators, Marion Gruber and Phil Krause, are leaving the agency, which was first reported by BioCentury.

Why it matters: The FDA appears to be increasingly rudderless at a crucial time in the pandemic. The agency still has no permanent commissioner and now is losing two highly regarded vaccine experts all while officials weigh full approval of the COVID-19 vaccines for adults, initial authorization for kids, and booster shots for many.

State of play: Gruber is retiring in October, and Krause is leaving in November, according to a memo from Peter Marks, a top drug director at the FDA. Gruber and Krause weren't immediately available for comment.

What they're saying: The departures shocked people throughout the industry, considering the FDA still has consequential decisions to make about the COVID-19 vaccines and that Gruber and Krause are considered top experts in this field.

• Luciana Borio, a former top FDA scientist, said on Twitter the agency is "losing two giants who helped bring us many safe and effective vaccines over decades of public service."

Between the lines: The Biden administration left a bad taste within the science community last month after officials said booster doses of the mRNA vaccines would be available for Americans starting Sept. 20, pending FDA evaluation of data.

• But many vaccine researchers thought the Biden administration neutered the FDA by saying boosters were going to happen on a specific date, even though the FDA's review had barely begun.
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Top FDA vaccine regulators are leaving right before agency's big COVID-19 vaccine decisions

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The FDA appears to be rudderless at a critical time.