FDA: Failure, Deception, Abuse

From the Introduction: Victory Over the FDA (1996)

THE FDA RAIDS THE FOUNDATION

On Feb. 26, 1987, I was in California, meeting with anti-aging scientists whose research was being funded by the Foundation. Early in the day, I called Foundation headquarters in Florida and knew immediately that something was wrong when no one answered the phone. After an hour, I reached an employee at home, who told me that the Foundation had been raided by the FDA.

I didn’t find out the details of the raid until later that evening when I finally reached Bill Faloon at his home in Florida. I was in shock all that day, assuming that the FDA had seized the Foundation’s assets and shut it down. I wondered if Faloon had been arrested and whether he was in jail.

WHAT IT WAS LIKE AT THE FOUNDATION

At the Foundation, Faloon didn’t have time to think about such things. He had his hands full dealing with the battalion of troops that had invaded the Foundation. Here’s what Faloon had to confront that day, as noted in the April–May 1987 issue of Life Extension Report:

On Feb. 26, 1987, an armed force of about 25 FDA agents and US Marshals smashed down the glass doors of our store . . . and stormed into our nearby warehouse with guns drawn.

At 10 AM, Bill Faloon received a phone call telling him that the FDA was breaking into our store with a battering ram. As Bill started to leave the warehouse, he suddenly found himself staring down the barrel of a .45-caliber pistol, which belonged to one of a second group of FDA agents, who were simultaneously attacking our warehouse!

TERRORIZED EMPLOYEES

The reaction of the Foundation’s employees to the raid was absolute terror. To get some idea of what is was like for them on that day, let’s return to the same issue of Life Extension Report:

When Helen Bishop walked to the back of the warehouse, she heard someone say “hello.” She thought it was a delivery man, but the next thing she knew “cops were rushing in from both doors to surround us.”

One of them stopped her, showed her his badge, and forced her to line up against the wall with the other employees. A search was then conducted of the personal belongings of every employee.

Al Wood, one of our advisors, was working on the upper level of the warehouse when a marshal came up the stairs with his gun drawn and said “Get up!” Wood immediately threw his arms up and was told to march down the stairs. “Everyone moved slowly,” he recalls, “so they wouldn’t excite the Marshal waving his gun. When we asked him what this was all about, he said he had a search warrant.”

ILLEGAL SEARCH AND SEIZURE

We later discovered that the search warrant had been obtained with perjured testimony by FDA agent Martin Katz before Magistrate Lurana S. Snow. This pattern continued throughout the day as FDA agents engaged in continuous illegal and unconstitutional behavior.

From 2009: Why American Healthcare is Headed for Collapse

THE MAGNITUDE OF THIS ISSUE

Very soon, Medicare will start paying out more in hospital bills than the premiums (taxes) it will collect. When that time arrives, the federal government will have to tap some other source to cover this gargantuan unfunded liability. One obstacle is that the federal government is over $11 trillion in debt and is projected to run trillion dollar deficits for the next several years. If these numbers sound high, they pale in comparison to Medicare’s unfunded liability of $34 trillion.

To put this in perspective, the government collects only about $2 trillion each year in total tax revenue (including Medicare premium taxes). There are virtually no reserve funds left to pay promised Medicare (and Medicaid) benefits. The government is relying on the money it takes in each day to cover its enormous Medicare cost burden.

As the country ages, Medicare will devour huge chunks of US economic output and eventually overwhelm every other item on the federal budget. While politicians stick their heads in the sand and disregard this issue, no one can argue against the math showing a financial disaster of unprecedented magnitude.

MEDICARE SCAMS

The government points to rampant fraud as one reason behind Medicare problems. It is estimated that 20% of every dollar Medicare pays out goes to criminals who submit claims for nonexistent or bogus services. For example, it was recently discovered that Medicare paid out $100 million for wheelchairs, canes, prescription drugs, and other items prescribed by dead doctors. In other words, people working at doctor’s offices pretended their doctors never died and falsely billed Medicare for medical treatments that were never rendered.

The government brags when it cracks down on Medicare fraud, but they only catch a fraction of the crimes perpetrated. The reality is that the living con artists defraud Medicare out of far more than dead doctors do.

What the government does not like to admit is that another 20% of Medicare dollars are paid out in the form of overpayments to those with political connections. What companies do is lobby Congress to enact legislation mandating that Medicare pay inflated prices for certain products and services that can be obtained for a fraction of the price on the free market. This enables those who are politically connected to grossly overcharge Medicare because Congress mandates the inflated expenditures.

From 2008: The FDA Indicts Itself

The FDA, in collusion with pharmaceutical giants and conventional medical orthodoxy, is the leading cause of suffering and death in the United States.

Back in the early days, the FDA would defend its position by proclaiming that it served to protect the public’s health. An endless number of well-publicized scandals have caused the FDA itself to admit that it is incapable of carrying out its mission.

If all the FDA did was act so cautiously that it almost never approved a dangerous drug, then at least the agency could point to some consumer value it provides. Instead, we are plagued by an antiquated regulatory agency that stifles the development of novel life-saving medications, while allowing a slew of drugs to be sold that have cumulatively cost millions of lives.

Americans thus suffer the “worst of both worlds” as they are poisoned by FDA-sanctioned prescription drugs, but denied the fruits of novel approaches to disease prevention and treatment.

In response to a barrage of criticisms, FDA commissioner Dr. Edward von Eschenbach requested that a special committee assess whether the FDA is capable of doing its job. The premise for the FDA’s massive audit of itself was the fear that “the nation is at risk if FDA science is at risk.”

Their sixty-page report, entitled “FDA Science and Mission at Risk,” states that “the world of drug discovery and development has undergone revolutionary change,” but the FDA’s “evaluation methods have remained largely unchanged over the last half century. ”

The following are exact quotes from the report:

• The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.
• The FDA cannot fulfill its mission because its scientific work force does not have sufficient capacity and capability.
• The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate.
• The FDA does not have the capacity to ensure the safety of food for the nation.
• The development of medical products based on “new science” cannot be adequately regulated by the FDA.
• There is insufficient capacity in modeling, risk assessment, and analysis.
• The FDA science agenda lacks a coherent structure and vision, as well as effective coordination and prioritization.
• The FDA has substantial recruitment and retention challenges.
• The FDA has an inadequate and ineffective program for scientist performance.
• The FDA has not taken sufficient advantage of external and internal collaborations.
• The FDA lacks the information science capability and information infrastructure to fulfill its regulatory mandate.
• The FDA cannot provide the information infrastructure support to regulate products based on new science.

Most appalling is the FDA’s own finding that it “cannot even keep up with the advances in science.” Said differently, this means that the FDA cannot keep up with scientific breakthroughs that could cumulatively save millions of human lives!

From 2007: Life-Saving Cancer Drugs Not Approved by the FDA

For the past 27 years, Life Extension has identified life-saving medications that languished too long in the FDA’s archaic approval process.

When effective new drugs are delayed, the inevitable consequence is needless human suffering and death. An equally insidious problem is the chilling effect bureaucratic roadblocks have on the development of better drugs that might actually cure the disease.

Just imagine the difficulty of raising the tens of millions of dollars needed to get a new cancer drug into the approval pipeline when prospective investors see the FDA deny a drug with documented efficacy, as was done recently with Provenge®.

Another problem with the FDA’s unpredictable approval pattern is the outrageous cost of the cancer drugs that actually make it to market. Even when classes of cancer drugs are finally approved, the out-of-pocket cost of these new drugs can exceed $12,000 per month. The media has reported on heart-wrenching stories of cancer patients who choose to die rather than send their families into bankruptcy from paying these costs.

It’s easy to point fingers at drug companies for charging such extortionist prices, but the harsh reality is that getting these medications approved by the FDA is so costly and risky that the high prices can arguably be justified by the hideously inefficient drug approval process that now exists.

There are many drugs that have been shown to be effective against cancer, but are not yet approved by the FDA. While there are dozens of anti-cancer drugs in various stages of the approval process, the sad truth is that thousands of compounds with anti-cancer activity will never be submitted for FDA approval due to lack of patentability, lack of investor funding, or just plain unwillingness to deal with today’s cancer bureaucracy.