What’s Wrong with Authoritarian FDA Control?
If you are diagnosed with a disease like pancreatic cancer, is any issue more important than gaining access to effective therapies?
Standing in your way are archaic regulations that even high-level FDA officials have harshly criticized.
Former FDA commissioner Andrew von Eschenbach, M.D. authored an editorial stating:
"We stand on the cusp of a revolution in health care. Advances in molecular medicine will allow us to develop powerful new treatments that can cure or even prevent diseases like Alzheimer's and cancer."1
"What's missing," according to Dr. von Eschenbach, "Is a modernized Food and Drug Administration that can rapidly and efficiently bring new discoveries to patients."1
Dr. von Eschenbach cited then current FDA Commissioner Margaret Hamburg's concession before Congress that, "The FDA is relying on 20th century regulatory science to evaluate 21st century medical products."1
The most compelling arguments Dr. von Eschenbach made for meaningful reform were:
"The FDA should approve drugs based on safety and leave efficacy testing for post-market studies Congress can ensure that the FDA serves as a bridge—not a barrier—to cutting-edge technologies."1
Said differently, once a potentially effective therapy has been cleared for safety, it should be made immediately available to human beings who will otherwise suffer and die.
Death by Bureaucracy
What’s scary about these FDA commissioners’ critiques is they were published in The Wall Street Journal ten years ago…and the bureaucratic obstacles may be worse today.2
For example, Professor James Kirkland at the Mayo Clinic is spearheading studies of a fruit extract called fisetin to see if it can counteract a mechanism of degenerative aging.
On December 9, 2021, Dr. Kirkland described a clinical trial where he had to complete a 450-page detailed Investigational New Drug application.
This massive document had to be submitted to the FDA for approval to do a human study using fisetin.2
The FDA then mandated that Dr. Kirkland do preclinical (animal and pharmacology) studies before “allowing” a clinical trial to commence. It took 2.5 years to gather this information, and only then could a human study begin.
What’s irrational about this delay is that fisetin has long been ingested by people in various fruits and vegetables (albeit at lower potencies). It’s also been used for years as a dietary supplement.
Bureaucratic barriers like this impede rapid testing of compounds that may effectively treat disease and slow/reverse certain aging processes.
It’s a major reason why practicing physicians remain in the dark about anti-aging interventions, despite favorable reviews published in the New England Journal of Medicine, JAMA, and other respected medical journals.
FDA Knowingly Approves Lethal Drug
Back in 2009, I reported on a drug the FDA knew caused liver failure before the agency approved it.3
So many lives were impacted that a Senate Committee subpoenaed FDA employees to explain how the agency approved this dangerous drug (Ketek®).
The Senate Committee found that the FDA employees presented fraudulent safety data to its Scientific Advisory Committee to win approval for Ketek.
How fraudulent was the data?
While the FDA was presenting the fake data, a criminal investigation was simultaneously being conducted that found the clinic where the “safety” study allegedly occurred was closed during the time the study was supposed to have taken place.
Shortly after the advisory committee meeting where the fake safety data were presented by FDA employees, the person who conducted the study was sentenced to almost five years in jail.
Even more shocking, the FDA continued to cite this safety study long after the principal investigator admitted it was fraudulent.
While the perpetrator of this “safety” study was in prison for falsifying the data, the FDA used the same study to issue a Public Health Announcement stating: “that the risk of liver injury with telithromycin [Ketek®] was similar to that of other marketed antibiotics. 4
According to the Senate Investigative Committee report, “it defies explanation why the FDA would continue to cite” this fraudulent study to the American public to imply that Ketek® is safe”. 3
Ongoing Clinical Trial Malfeasance
On October 1, 2020, an investigative report published by the journal Science found that “FDA oversight of clinical trials is lax, slow moving, and secretive—and that enforcement is declining.”4
The report cited FDA inspectors who found egregious clinical trials errors that question the authenticity of data that doctors rely on to evaluate a drug’s safety/efficacy.
According to documents obtained by Science through the Freedom of Information Act, clinical trial malfeasance might constitute "fraud, scientific misconduct," and "significant human subject protection violations." 4
Despite these obvious failings, the FDA never stopped the dubious clinical trials, never made public the alleged offenses, and did not inform people participating in the clinical trials they might have been put at risk.
Nor did the FDA tell companies sponsoring some of the clinical trials that their data might have been compromised.
Those who committed these violations continue to recruit patients for new clinical trials sponsored by pharmaceutical companies.
In a rare finding uncovered by Science, the FDA disqualified a principal investigator after he was caught backdating clinical trial reports. The backdated records indicated he saw patients in Oregon when he was really in Las Vegas, Hawaii, and elsewhere. FDA inspectors had earlier caught him falsifying records, when he admitted he had "gone fishing" on days he pretended to be examining clinical trial patients.4
No Senate Committee investigated this, despite the health risks posed to clinical trials participants and countless Americans who will be prescribed drugs approved as “safe and effective” based on problematic clinical trial data.
Someone in Congress Must Hold FDA Accountable
I’ve so far presented succinct dichotomies whereby some FDA officials place overreaching burdens on doctors seeking permission to conduct clinical trials, other FDA officials knowingly use fake data to approve a dangerous drug, while other FDA officials uncover serious misconduct but allow the clinical trial to continue and the questionable data to be utilized.
Jonathan Emord, if elected to the Senate, will serve as an FDA watchdog and introduce legislation that may save all our lives by accelerating the pace of clinical trials and approvals of therapies that demonstrate safety and efficacy.
To voice your opinion on what I may do in Palm Beach County, Florida, please complete a short survey you can access by clicking here.
If you want to donate to the Emord exploratory committee, click here.