Consumers Against High Drug Prices
Exposing The FDA's Regulatory Quagmire
CoQ10 Wars
Assembly Line Medicine
Collapsing Within Itself
Intolerable Delays!
"Unsustainable" Cancer Drug Prices
How Government Treated Those For Whom We Now Celebrate Holidays
Horrific Conditions Inside Drug Factories
When "Rules" Are Broken
Federal Death Panels
Science by Ambush
The Looming Doctor Shortage
Former FDA Commissioner Admits Risk of Bureaucratic Delay
FDA Says Walnuts Are Illegal Drugs
The FDA's Most Heinous Drug Approval
No Real Healthcare Cost Crisis
FDA Delay of One Drug Causes 82,000 Lost Life-Years
Deadly FDA Neglect
How Much More FDA Abuse Can Americans Tolerate?
Drug Company Pleads Guilty to Health Fraud
Why American Healthcare is Headed for Collapse
The Generic Drug Rip-off
Ending the Atrocities
Millions of Needless Deaths
Would You Tolerate This Abuse?
The FDA Indicts Itself
The FDA's Cruel Hoax
Fish Oil Now Available by Prescription!
FDA Threatens to Raid Cherry Orchards
Inside the FDA's Brain
FDA Fails to Protect Domestic Drug Supply
FDA Permits New Fish Oil Health Claim
FDA Approves Deadly Drugs, Delays Lifesaving Therapies
The $50.00 Toll Bridge
Dangerous Medicine
Cardiologists Overlook Lifesaving Discovery
What You Don’t Know About Blood Sugar
Jerry Falwell Attacks Life Extension Foundation
Life Extension Achieves "Impossible" Victory in the U.S. House of Representatives
Fighting the FDA
Patient Advocates Sue FDA Over Drug Access
FDA's Lethal Impediment
Don't Blame the Doctors
One Man's Ten-Year Ordeal With Prostate Cancer
A New Day At FDA?
The FDA Versus the American Consumer
Supreme Court Roundup
The Lethal Information Gap
Consumer Rape
Dying From Deficiency
Are Offshore Drugs Dangerous?
Drugs the FDA Says You Can't Have
Does Cholesterol Cause Artery Disease?
What's Wrong with the FDA
FDA Suffers Second Massive Legal Defeat in Pearson v. Shalala
FDA Loses Case Against Compounding Pharmacies on First Amendment Grounds
Ending The Cancer Bureaucracy
Victory in the House and Senate
Life Extension Wins in the House and Senate
Congress Recognizes The Prescription Drug Problem
Americans are getting Healthier... But the FDA Remains a Major Impediment
Are We to Become Serfs of the Drug Monopoly?
A Glorious Victory Over FDA Tyranny
The Great American Rip-Off
The Plague Of FDA Regulation
Health Costs to Double Is there a free-market solution?
The FDA versus Folic Acid
They Want You Brain Dead
Life Extension vs. the FDA a Hollow Victory: Why the Agency's Approval of Ribavirin is Inadequate

FDA Delay of One Drug Causes 82,000 Lost Life-Years

By William Faloon Reviewed and Critiqued by Stephen B. Strum, MD, FACP, Medical Oncologist Specializing in Prostate Cancer Since 1983
William Faloon 
William Faloon

In 2004, I wrote an article describing how Americans die needlessly because of the FDA's delay in approving lifesaving drugs.1

One example of a delayed therapy I cited was ProvengeŽ, which in the year 2002 had demonstrated improved survival in prostate cancer patients.2

In 2007, Dr. Stephen Strum and I co-authored an article showing how enormous numbers of lives could be spared if scientists were liberated from oppressive FDA over-regulation. We described several cancer drugs that should have been approved including ProvengeŽ, which by the year 2007 had extended survival in several clinical studies.3

In 2010, the FDA finally approved ProvengeŽ.4 This was after still another FDA-mandated clinical trial documented the efficacy of this therapy.

As you're about to read, the FDA's eight-year delay in approving ProvengeŽ has resulted in a horrific number of prostate cancer victims prematurely dying!

How Effective Is ProvengeŽ?

Once the FDA finally approved ProvengeŽ in April 2010, the news media hailed it as a miracle new cancer therapy. What the media failed to convey was the fact that ProvengeŽ was not new. It had been discovered almost a decade earlier. Despite the impressive study results you are about to read, the FDA denied it for eight long years.

In an analysis from the first study in 2002, ProvengeŽ-treated men with a less aggressive prostate cancer (Gleason score 7 or less) were eight times more likely to live six months without disease progression compared to placebo.2

FDA Delay of One Drug Causes 82,000 Lost Life-Years

After 30 months, these same patients receiving ProvengeŽ were 3.7 times more likely to be alive. This translates into 53% of the ProvengeŽ group surviving compared to only 14% of the placebo group. The ProvengeŽ group also remained pain-free twice as long on average as the placebo group.2,3

The FDA refused to recognize these findings and ordered the company to conduct more clinical studies. We at Life ExtensionŽ were livid at the time over the FDA's decision to deny prostate cancer patients access to this therapy.

Fast forward to 2005, and the results of a new clinical study showed that three times as many advanced prostate cancer patients who received ProvengeŽ were alive compared to patients receiving a placebo.5,6 This study evaluated 127 patients with prostate cancer that did not respond to androgen-deprivation therapy. Cancer experts consider this patient subset to have a dismal prognosis, with most dying of the disease within a few years. In this ProvengeŽ study, 34% of the patients receiving ProvengeŽ were still alive after three years compared to only 11% of men who were randomly assigned a placebo.5 The FDA again refused to approve ProvengeŽ, even with this kind of data in hand.

In the most recent study on advanced prostate cancer patients, ProvengeŽ prolonged median survival by 4.5 months and produced a greater than threefold increase in survival at 36 months compared to placebo.7

As I'll explain later, any improvement in survival in advanced cancer cases is viewed favorably as these patients have already failed grueling conventional therapies. We postulate that if used earlier in the disease process and in combination with other non-toxic therapies, ProvengeŽ will be far more effective.

Based on this latest study and in conjunction with the other prior favorable studies, the FDA approved ProvengeŽ eight years later than it should have!

How Many Life-years Lost Because of FDA's Delay?

Prostate cancer killed 27,360 American men in 2009.8 This is down from prior years where it used to kill around 30,000 Americans. Earlier diagnosis is one reason for this decline. Far fewer men are diagnosed with advanced prostate cancer with bone metastases today because of PSA testing.

In determining how many human life-years have been lost because of the FDA's delay in approving ProvengeŽ, we would come up with very high numbers if we only used data from the most favorable studies.

ProvengeŽ Extends Prostate Cancer SurvivalMen
Click Here To View

Instead, we choose to use the least favorable data that looked only at median survival improvement in those with advanced stage prostate cancer who were no longer responding to conventional therapy.

We took the low number of 27,360 men who died of prostate cancer in 2009 and multiplied it times the 4.5 months of improved survival demonstrated in the latest study. The total number of human life-years lost each year the FDA delayed approving ProvengeŽ comes out to 10,260.

Multiply the eight years the FDA delayed approving ProvengeŽ, and the total number of lost life-years is a startling 82,080.To state this statistic differently, 82,080 lost life-years translates to 1,066 entire lives lost. This calculation is based on taking the 82,080 lost life-years divided by average male life expectancy of 77 years.

ProvengeŽ Is Just One of Many Delayed Drugs

The federal government refuses to consider Life Extension's longstanding recommendation of making FDA approval voluntary, as opposed to the compulsory process it is today.

If prostate cancer victims had access to ProvengeŽ when it first demonstrated efficacy in 2002, 82,000 human life-years could have been spared.

ProvengeŽ Is Just One of Many Delayed Drugs

The cover story of the September 2007 issue of Life Extension MagazineŽ was titled "Life-saving Cancer Drugs Rejected by the FDA." In that issue, we meticulously described several anti-cancer drugs (including ProvengeŽ) the FDA had not yet approved. All of these drugs had substantial scientific evidence indicating efficacy. We argued that since terminal cancer patients had no other options, they should be allowed access to these therapies.

In the case of ProvengeŽ, an FDA advisory panel recommended it be approved in the year 2007.9,10 FDA bureaucrats, however, ignored scientists on this advisory panel and mandated that more studies be done.

FDA Delay Makes ProvengeŽ Cost-prohibitive

Had ProvengeŽ been made available in year 2002 like it could have been, it might be available at a more reasonable price today. The FDA's insistence on multiple redundant clinical studies will result in the therapy costing $93,000 per patient.

It is doubtful that all insurance companies will reimburse for ProvengeŽ therapy. Either way, consumers will pay for the FDA's delay in the form of higher medical insurance premiums, higher taxes, and/or having to pay for the drug out of pocket.

As we have stated many times, a key factor in today's healthcare financial crisis is that medical progress and efficiency are obstructed by bureaucratic delays leading to hyper-inflated costs.

We Were Not the Only Ones Screaming for ProvengeŽ to Be Approved

The FDA was put under enormous pressure to approve ProvengeŽ ever since the first successful clinical study came out in the year 2002. After a second study showed even greater efficacy, prostate cancer support groups, scientific organizations, and even mainstream publications demanded that the FDA grant terminal patients the right to try this therapy.

We Were Not the Only Ones Screaming for ProvengeŽ to Be Approved

The January 26, 2004 issue of the Wall Street Journal featured an editorial stating:

"We know that it works, and we know why it works. In any rational regulatory environment, that would be reason to speed ProvengeŽ to market."11

By 2007, there was a revolt underway against the FDA for continuing to reject ProvengeŽ, including threats by members of Congress to conduct a full scale investigation and lawsuits filed by patient support groups. FDA bureaucrats, however, steadfastly refused to budge (until April 29, 2010).12

Even though ProvengeŽ therapy is now officially approved, it will only be available to treat about 2,000 patients over the next year.13 That's because it requires specialized laboratories to be established throughout the United States to take each cancer patient's blood and create an individualized vaccine. The problem is that more than 27,000 men will die of prostate cancer over the next twelve months, meaning that fewer than 8% of these fellow human beings will have access to ProvengeŽ before they die.

How the FDA Stifles New Cancer Drug Development

When an experimental therapy prolongs life by only a few months in advanced cancer cases, the public often assumes the treatment is of little value.

The reason new cancer therapies often show mediocre results in clinical studies are FDA mandates that these new drugs only be tested in advanced-stage patients who have failed currently approved therapies. This creates a major obstacle because therapies that might cure cancer (or induce durable remissions) if used in earlier stages may be ineffective in advanced stages of the disease.

Once the drug is approved, however, it can be used (off-label) sometimes more effectively in treating earlier-stage disease patients. It can also be used in combination with other therapies to yield better survival results, something that is usually not allowed in clinical trial designs the FDA tightly controls.

How the FDA Stifles New Cancer Drug Development

The reason that it is so difficult to kill advanced-stage, treatment-resistant cancers is that they have mutated and acquired multiple survival mechanisms. These advanced-stage cancer cells are thus extremely difficult to eradicate with any therapy.

Now that ProvengeŽ has been approved by the FDA, innovative oncologists can prescribe it to early-stage prostate cancer patients whose cancers have not developed a resistance to androgen deprivation therapy. These earlier-stage patients may respond better than the advanced hormone refractory cases that the drug was tested on in the clinical trials.

When one understands the many roadblocks the FDA erects against promising cancer treatments, it becomes clear why more effective therapies have not been discovered to eradicate this insidious disease.

In an ideal setting, ProvengeŽ would have been made available to those who wished to "opt-out" of the FDA's regulatory stranglehold, and we would have learned long ago how effective ProvengeŽ therapy was against a wide range of prostate cancers.

At this point, we don't even know how effective ProvengeŽ will be outside the clinical study setting. Not all drugs shown effective in tightly controlled studies are as efficacious in the real-world, which is another reason to get drugs out faster in order to enable those dealing with real-world cancer patients to ascertain safety and efficacy.

FDA Interference Worse Than What Most Experts Think

For the past 30 years, Life Extension has identified effective medications that languished too long in the FDA's archaic approval process.

When lifesaving new drugs are delayed, the inevitable consequence is needless human suffering and death. An equally insidious problem is the chilling effect that bureaucratic roadblocks have on the development of better drugs that might 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 delay a drug with documented efficacy for eight years, as was done with ProvengeŽ.

Another problem with the FDA's unpredictable approval pattern is the outrageous cost of cancer drugs that do make it to market. Insurance companies do not always pay for these new drugs, thus forcing desperate cancer victims to pay out-of-pocket for new drugs that can exceed $12,000 per month. The media has reported on heart-wrenching stories of cancer patients who choose to die rather than condemn their families into bankruptcy in order to pay 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 inefficient drug approval process that now exists.

Why Drugs Like ProvengeŽ Take So Long to Approve

The fundamental problem with today's byzantine drug approval process is bureaucratic inefficiency and corruption.

Why Drugs Like ProvengeŽ Take So Long to Approve

What the public does not understand is that when a new therapy like ProvengeŽ is being considered for approval, companies selling older (less effective) drugs have a tremendous incentive to block the better medicine. It can be quite cost-effective to persuade the FDA to erect barriers against newer therapies that compete with highly profitable existing drugs. Allegations ran rampant that the FDA delayed ProvengeŽ because large pharmaceutical companies did not want to lose revenue from toxic chemotherapy drugs that advanced prostate cancer patients were forced to use in lieu of ProvengeŽ.

Bureaucratic ineptitude has been highlighted by the failures of the Securities and Exchange Commission (SEC) to prevent widespread financial fraud.14 As you may know, even when outsiders conducted meticulous investigations and handed cases like that of Ponzi schemer Bernie Madoff to the SEC on a silver platter, the SEC did nothing to stop Madoff from defrauding more victims.

When complaints are made about FDA drug delays, a kneejerk response from some in Congress is "we need to give the FDA more money." It is regrettable that politicians can't see past the simple fact that providing more money and power to incompetent and corrupt agencies results in more incompetence and corruption.

This Is No Longer a Debatable Issue

ProvengeŽ is by no means the first drug Life Extension recommended years or decades before the FDA permitted it to be sold to Americans. For example, we fought for nearly two decades to force the FDA to approve ribavirin as an adjuvant treatment for hepatitis C and low-dose aspirin for heart attack prevention. In both cases, we faced criminal investigations by FDA agents who felt it more productive to put us in jail rather than approve these lifesaving therapies.

Sadly, most of the drugs Life Extension has identified as having probable efficacy are never allowed on the American market because the sponsor company runs out of money jumping through the FDA's impossibly high regulatory hurdles.

Potential of ProvengeŽ Recognized Long Before FDA Approval
Stephen B. Strum, MD, FACP 
Stephen B. Strum, MD, FACP

In 2002, Stephen Strum, MD and Donna Pogliano, the significant other of a man with prostate cancer, published a book titled The Primer on Prostate Cancer (Life Extension Media, 2002). Within that outstanding guide to prostate cancer diagnosis and management, a section was devoted to "Treatments on the Horizon". The very first treatment discussed in detail was ProvengeŽ.

We now know that if Americans had the freedom to try ProvengeŽ as early as the year 2002, countless numbers of premature deaths could have been prevented. (The Primer on Prostate Cancer is still in print and available from Life Extension.)

The FDA now says (in 2010) that ProvengeŽ is effective in prolonging survival in men with advanced prostate cancer. That means the drug was also effective in the year 2002, when the FDA first suppressed it.

With ProvengeŽ (and many other drugs), there is nothing more to debate. The FDA's delay of this one drug caused the equivalent loss of over 1,000 entire lives. This is the same as terrorists killing 1,000 newborn babies, yet no one in the media even suggested that the FDA was tardy in approving ProvengeŽ. Americans can no longer tolerate this ongoing atrocity, either from a financial or morality standpoint.

What You Can Do to Stop Needless Cancer Deaths

Scientists have identified novel ways of treating cancer, but too little of this new technology is being used in clinical practice. When new discoveries are made, drug companies spend years seeking a patent, and then more years carrying the drug through the cumbersome bureaucratic approval process. A major reason so many cancer patients die today is an antiquated regulatory system that causes effective therapies to be delayed (or suppressed altogether).

This system must be changed if the 1,500 American cancer patients who perish each day are to have a realistic chance of being saved.

Our longstanding proposal has been to change the law so that anyone can opt out of the FDA's umbrella of "protection." This approach will allow companies to sell drugs that have demonstrated safety and a reasonable likelihood of effectiveness, which are clearly labeled "Not Approved by the FDA." Patients who wish can still use only FDA-approved drugs, while those willing to take a risk, in consultation with their doctors, will be allowed to try drugs shown to be safe that are still not approved.

We believe that this initiative will result in a renaissance in the practice of medicine similar to the computer technology revolution of the past three decades. In the liberated environment we propose, many lethal diseases will succumb to cures that are less expensive than is presently the case. And greater competition will help eliminate the health care cost crisis that exists today.

Today's broken system results in terminally ill people learning of scientific discoveries that might well cure their disease, but sadly hearing their newscaster say the therapy is years away from FDA approval. We think that seriously ill people, in consultation with their doctors, should be able to make up their own minds about what drugs they are willing to try.

Tell Congress You Want the Law Changed!

For the past three decades, Life Extension has sought to expose an insidious drug approval process that causes human beings to die, even though effective therapies to treat their diseases already exist.

The Abigail Alliance: A Relentless Campaign to Reform the FDA
Abigail Burroughs
Abigail Burroughs

The Compassionate Access Act of 2010 has been introduced into Congress based on the relentless efforts of an organization called The Abigail Alliance.

This non-profit organization was founded based on the heart-wrenching events surrounding a young girl (Abigail Burroughs) who was denied access to what the FDA now admits is an effective cancer drug.

Abigail Burroughs was diagnosed at age 19 with a squamous cell carcinoma that had invaded her neck and lungs. Abigail was an honor student and high school athlete, a confident yet humble person who was wise beyond her years. And she was compassionate, devoting much of her young life to charity work, making beds at homeless shelters and creating a free tutoring program for 50 families who couldn't afford tutors. Abigail had a great love of life and a deep respect for all beings.

Not long after her diagnosis, the Burroughs family learned of an investigational cancer drug that showed good response in early trials. Abigail's prominent oncologist at Johns Hopkins Hospital believed the drug had a significant chance of saving her life. But every effort on the part of her family, physician, and supporters to procure the drug for Abigail failed. She was ineligible for a clinical trial and the drug company couldn't provide it for her for compassionate use. The FDA was unmoved by her life-and-death situation.

In November 2000, Abigail was recovering from a round of chemotherapy and radiation treatment when she said to her father, "Dad, if I make it, I'd like you and I to devote our lives to helping people with cancer and other illnesses where there's an unmet need." After seven months of battling to acquire the experimental drug for Abigail, she died, her young life tragically cut short by an indifferent system that has cost an untold number of lives. The drug was later approved by the FDA as being effective against her type of cancer.

Hours after she died, through his tremendous grief, her father Frank Burroughs realized that the inability of seriously ill patients to obtain effective drugs still under study was a critical unmet need. His daughter had wanted to help not only herself, but others like her, and Burroughs knew then that he had to continue fighting the system.

Burroughs explained, "Hundreds of thousands of Americans die every year awaiting drug approval, a catastrophe of immense proportions. I said to myself, "˜Why should I quit now? There are other people out there who are just as precious as Abigail.' She had planted the seed of an idea. She was the embodiment of the unmet need. But we certainly weren't the only ones."

To learn more about the Abigail Alliance, log on to:

To ask your Representative to co-sponsor the Compassionate Access Act of 2010 (H.R. 4732), log on to the Legislative Action Center.

The FDA is able to suppress innovative therapies because the public has failed to demand that our elected officials rein in the FDA's arbitrary authority. The first step in changing today's outmoded system is to communicate the urgent need for change to Congress.

A bill titled the Compassionate Access Act of 2010 (H.R. 4732) has been introduced into the House of Representatives.16 This bill would amend the Food, Drug, and Cosmetic Act to create a new conditional approval system for drugs, biological products, and devices for seriously ill patients.

Tell Congress You Want the Law Changed!

While this bill will not enable patients to "opt-out" of the FDA's regulatory stranglehold, it is an important first step that will demonstrate that human lives can be spared if earlier access to experimental therapies is permitted.

I urge all Life Extension supporters to use our convenient Legislative Action Center to ask your Congressional Representative to co-sponsor the Compassionate Access Act of 2010 (H.R. 4732). Passage of this legislation will enable cancer patients (and others with serious diseases) to obtain therapies far enough along in the clinical trials process to be deemed safe, but not yet approved by the FDA.

We at Life Extension have long contended that any person with a serious illness should have the individual right to choose therapies that have not yet received official FDA approval.

For the benefit of yourself and your loved ones, please use our convenient system to contact your Representative about the critical need to co-sponsor the Compassionate Access Act of 2010. You can easily contact your Representative today by logging on to the Legislative Action Center.

For longer life,

For Longer Life 

William Faloon

Stephen B. Strum, MD, FACP 

Stephen B. Strum, MD, FACP


1. Faloon W. Are you afraid of terrorists? Life Extension MagazineŽ. 2004 Jun;10(6).

2. Available at: Accessed June 29, 2010.

3. Faloon W, Strum S. FDA rejects promising prostate cancer drug. Life Extension MagazineŽ. 2007 Sept;13(9).

4. Available at: Events/Newsroom/PressAnnouncements/ucm210174.htm. Accessed August 4, 2010.

5. Small EJ, Schellhammer PF, Higano CS, et al. Placebo-controlled phase III trialof immunologic therapy with sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer. J Clin Oncol. 2006 Jul 1;24(19):3089-94.

6. Available at: Accessed August 5, 2010.

7. Higano CS, Schellhammer PF, Small EJ, et al. Integrated data from 2 randomized, double-blind, placebo-controlled, phase 3 trials of active cellular immunotherapy with sipuleucel-T in advanced prostate cancer. Cancer. 2009 Aug 15;115(16):3670-9.

8. Available at: Accessed August 5, 2010.

9. Available at: Accessed August 5, 2010.

10. Available at: Accessed August 5, 2010.

11. New cancer drugs. Wall Street Journal. January 26, 2004.

12. Available at: Accessed June 29, 2010.

13. Available at: Accessed July 1, 2010.

14. Available at: Accessed July 1, 2010

15. Available at: Accessed July 2, 2010.

16. Available at: Accessed July 2, 2010.