VIII. FDA is the pivotal regulatory gatekeeper entrusted with:

“protecting the public health by assuring the safety and efficacy, of drugs, biological products, medical devices, and our nation’s food supply” and “helping the public get accurate, science-based information they need to use medicines and foods to improve their health.”

FDA’s preeminent authority to determine whether a drug or device is approved is its assumed scientific expertise and honest, independent review of safety and performance data from scientifically valid, controlled clinical trials.  However, FDA has radically shifted its priorities.

Surveys of FDA scientists[1] reveal widespread discontent with management for disregarding safety issues, for persistent interference with their scientific evaluations, and fear of retaliation for raising concerns about safety.  A substantial number of respondents indicated that FDA decisions were overly influenced by political interests (55%) or business interests (40%). And over a third of respondents reported first-hand experience of interference in their work in the past year. [2]

FDA’s reviewing process is no longer governed by scientific evidence: the process has been corrupted under the influence of commercial expediency, which has led to the approval of unsafe, harmful drugs, vaccines and medical devices.

Numerous independent investigations by highly credible authoritative entities all confirmed serious deficiencies in FDA’s scientific base and organizational structure that severely undermine its ability to fulfill its mission.

See, Synopses of the 7 Investigative Reports Evaluating FDA Performance.

In 2006, the Institute of Medicine issued a devastating report[3] confirming significant interference with the FDA’s scientific work, compromising the agency’s ability to fulfill its mission of protecting public health and safety.

An unseemly record shows that long after lethal effects of a drug were detected and thousands of people died, FDA protected manufacturers by failing to take timely action to protect consumers from further harm. The agency’s deviant policies have precipitated an entirely preventable deadly epidemic:

• ·         FDA adheres to an irrational–95%– certainty standard before recognizing a lethal risk.

• ·         FDA-licensed prescription drugs are the fourth leading cause of death in the US.[4] [5] [6]

• ·         Medical device recalls due to safety hazards SOARED in 2012.[7] [8]

According to ExpertRECALL Index, which tracks FDA recalls, more than 123 million medical device units were recalled in the second quarter of 2012, and 82 million units were recalled in the first quarter.

Medical devices include products such as ventilators, cardiac defibrillators, pacemakers, replacement heart valves, coronary artery stents, knee replacements, catheters, syringes, and gels used in ultrasound procedures, dental implants, surgical clamps, and many more.

• “…what is troublesome is the dramatic increase in units affected by the recalls and the continued number of repeat offenders. It’s scary to think about given the increasing number of devices that American patients rely on to maintain and improve their health. Consumer and patient safety should be the number-one priority for every manufacturer, distributor, retailer, doctor’s office and healthcare facility.” [9]

What is more troublesome is: How did those devices pass FDA’s approval process?
And does anyone track the number of people who have been harmed or died from exposure to defective medical devices?

See, List of Prescription Drugs Recalled for Safety Issues from US Market:

See, www.RxISK.org–a new interactive website that seeks consumer input about adverse drug effects.

FDA’s mission to protect the public health from unsafe and ineffective medical products has been undermined by its financial dependence on industry since passage of the Prescription Drug User Fee Act (PDUFA 1992).[9]  This legislation opened the FDA to undue industry influence, allowing ready access to FDA officials behind closed doors—thereby ensuring that industry’s interests would take precedence over public safety. The result is measurable in human casualties due to medical products that have not been adequately tested prior to their licensure.

To ensure approvals, FDA stacks its advisory committees with members who have a financial conflict of interest, and claims the agency is “prohibited from giving the public any information contained in a financial disclosure.” [10]

“Lack of disclosure undermines the credibility of the advisory committee process and undermines public trust in the fairness of the regulatory process.” Steve Nissen, MD.

“While the FDA allowed the three to vote, the agency removed the voting rights of another panel member, public-interest doctor Sidney M. Wolfe, because he had publicly criticized the drugs’ safety in newsletters published by his Public Citizen Health Research Group.”

And FDA delays taking action (often for years) after toxic drugs and defective devices cause immeasurable harm.  FDA procedures and actions demonstrate that public safety is clearly not a priority for FDA’s decision makers. Their intervention on behalf of manufacturers has resulted in hundreds of thousands of preventable deaths every year.

A secret internal FDA document (2006)[11] obtained by the Project on Government Oversight reveals that senior officials at the Center for Device and Radiological Hardware (CDRH) made a unilateral administrative decision—over the objections of scientists—not to comply with FDA regulatory safeguards requiring medical devices such as cardiac defibrillators, pacemakers, replacement heart valves, and coronary artery stents to be tested according to good laboratory practices (GLP) in nonclinical laboratory studies. That decision accommodates industry’s commercial interests—but it puts patients’ lives at risk.

“The decision by top CDRH officials to not enforce the GLP regulation is stunning in its contempt for the protection of patients and its indifference to standards that comply with federal regulations. Their decision, which was made over the strong objections of CDRH scientists, is no harmless blunder. It is a high‑stakes, unknown‑odds gamble with the lives of patients. It was also made without public notice.”88

In January 2012, a whistleblower lawsuit[12] filed by 8 FDA scientists, revealed that a vast iIlegal FDA spying operation had been initiated under the Obama administration (2010) against scientists who blew the whistle about medical device safety hazards to Congress—as is their legally protected right. The relevant documents in this case are posted on the website of the National Whistleblowers Center.

News reports[13] documenting a massive surveillance scandal in which FDA high ranking officials illegally intercepted legally protected communication–including communication with attorney-client privilege, communication with Congress and communications with the Special Counsel–shine a light on the hostile culture within the agency and the lawless tactics of intimidation that FDA executives deployed when they sought to silence scientists who expressed concerns about the licensing of unsafe devices.  This is not an isolated case of misconduct and abuse of power by FDA officials.

But the scale of the 2010 spying operation—that was “explicitly authorized” by the FDA General Counsel’s office, with full knowledge of FDA Commissioner, Margaret Hamburg—raises this case to the Watergate level for its lawless abuse of power.[14] No one in the media questioned the President about the abuse of power by his administrators who rode roughshod on legally protected safeguards.

Media coverage of the FDA spying scandal failed to grasp the essential issues and the magnitude of harm posed by unsafe medical products that carry the FDA seal of approval.

FDA managers routinely overrule FDA’s own scientists’ objections to approval of products when they detect serious safety hazards.

Numerous FDA scientists have collided with administrators about safety issues .[15]  

The FDA seal of approval on unsafe medical products that injure and kill debases the essence of medicine, undermines physicians’ ability to heal, and erodes public trust in medicine.  One Senator recognized the affront of FDA’s arrogance and culture of lawless abuse of power. Senator Chuck Grassley made a Statement from the Senate floor on July 17, 2012, in which he characterized FDA’s aggressive spying operation as befitting the Gestapo and the East German Stasi rather than a consumer protection agency in a free country.

He accused the FDA of having “forgotten that it works for the American public. This is an agency that has gotten too big for its britches. Some of its officials have forgotten who pays their salaries.”[16]

But therein lays the rub: the collision between FDA safety officers and FDA management is largely the result of a legislatively initiated conflict of interest.

With passage of PDUFA,  FDA’s focus and priority shifted from protecting the public health to speeding the review process by minimizing safety testing for new patented drugs, devices, and vaccines. FDA administrators have been running roughshod over its scientists, overruling their safety concerns to approve new drugs, vaccines, and devices—regardless of their lack of clinical value—disregarding evidence of fraud in plain sight.

FDA’s budget in 2012 is $4.5 billion—of which industry user fees comprise about $2 billion.[17]

A congressional report found that there has been a sharp decline in FDA enforcement actions against pharmaceutical companies since December 2001.[18] In light of the unprecedented number of successful criminal and civil lawsuits against pharmaceutical companies, FDA’s inactive enforcement is even more astonishing.
See, Pharma’s Rap Sheet: Civil & Criminal Settlements

After reviewing the records, Dr. Jerry Avorn wrote the House Reform Committee: “In all of FDA’s once-proud recent history, I cannot recall a time of greater concern about its work on the part of doctors, patients, and policy researchers.”

The FDA has become complicit in outright fraud.

FDA’s approval process for the Sanofi-Aventis’ antibiotic drug, Ketek, the details of which were brought to light by several FDA safety officers[19] during congressional hearings and criminal prosecutions, reveals a pattern of FDA approval that disregards scientific fraud and endangers public safety.[20]

Ketek was approved in 2004 less than one month AFTER one of the principal US researchers in the trial was sentenced to 57 months in prison for falsifying her Ketek data.

Another physician, in charge of the third-largest Ketek trial site, was a cocaine addict who submitted his data to the F.D.A. the same month that he was arrested while holding his wife hostage at gunpoint. [21] FDA inspectors recommended that 4 of the 10 Ketek clinical trial sites be referred for criminal investigation.

In 2003, FDA managers had deliberately misled an advisory committee when they presented Study 3014 but prevented an FDA scientist from mentioning the data integrity problems to the committee.  Unaware of the fraud, the committee voted overwhelmingly to recommend approval of Ketek based on invalid optimistic data.

Reports of severe adverse reactions, including liver damage, and deaths, came pouring into the FDA. Nevertheless, a pediatric experiment had been sanctioned over the objections of the F.D.A.’s safety reviewers. The trial involved 4,000 infants and children, some as young as six months, who were recruited in more than 12 countries for an experiment to assess Ketek’s effectiveness in treating ear infections and tonsillitis—hardly justifying the risk of liver damage and death.

Dr. Johann-Liang, an FDA safety scientist, called for an end to the ongoing pediatric trials, stating “How does one justify balancing the risk of fatal liver failure against one day less of ear pain?”

Dr. John Powers, another FDA physician, testified that the trial should never have been approved. Initiation of the trial was “inappropriate and unethical because it exposed children to harm without evidence of benefits.”[22]

Dr. David Ross, who had been the F.D.A.’s chief reviewer of new drugs for 10 years, and is now the national director of clinical public-health programs for the U.S. Department of Veterans Affairs, explained his objections, by offering a litany of complicit misconduct by FDA administrators that could be applied to any number of other drugs:

• “Because F.D.A. broke its own rules and allowed Ketek on the market.

• Because dozens of patients have died or suffered needlessly.

• Because F.D.A. allowed Ketek’s maker to experiment with it on children over reviewers’ protests.
• Because F.D.A. ignored warnings about fraud.

• And because F.D.A. used data it knew were false to reassure the public about Ketek’s safety.” [21]

“With an estimated 2 to 4 million serious injuries each year, drug therapy stands as one of the most significant perils to health resulting from human activity.”

Indeed, each year, FDA-approved drugs kill more Americans than died in the Vietnam War and the 9/11 terrorist attacks combined. No one counts the number of people killed by FDA-approved defective medical devices, or the number or children killed or maimed by FDA-approved, government-mandated vaccines.

No one tracks the number of Americans who are killed by defective, FDA-licensed devices.

Vaccine-injured, brain damaged children are the pariahs that public health agents don’t recognize.

Some have said that the greatest threat to our safety is not terrorism. The FDA currently poses the greatest threat to the health and safety of the American people, far outweighing the threat of terrorist attacks or violent crime.

Vera Sharav

This is Part V of a series.

See, Part I: America’s Healthcare Crisis–The Whole System is Broken

Part II: What Do We Get for All That Money?

Part III: The Untouchable Third Rail in Healthcare- Vaccine Controversy

Part V: Vaccine Injury Compensation

REFERENCES