Former FDA Commissioner Admits Risk of Bureaucratic DelayDecember 2012
By William Faloon
Ted Kennedy was diagnosed with a brain tumor in May 2008. He received the best conventional treatment at Duke University Medical Center, which enabled him to survive until August 2009—a total of 15 months.
I'll never forget being told when I was age 14 about a young girl who was dying of a brain tumor. I asked a lot of ignorant questions as to why doctors could not cure it, but no one had any logical answers.
That was back in 1968, yet a person stricken today with the most common brain tumor (glioblastoma multiforme) will only live a few miserable months longer than in the past.1 Over the years, the media has announced the discovery of promising cancer therapies, but most never make it to the clinical testing stage.
We at Life Extension® have been harshly critical of the FDA's drug approval process, arguing that medical innovation has been suffocated by high costs and bureaucratic uncertainties.
An increasing number of respected individuals are agreeing that delaying lifesaving therapies can no longer be tolerated, including former FDA Commissioner Andrew von Eschenbach.
Dr. von Eschenbach is a former director of the National Cancer Institute and served as FDA Commissioner from 2005 to 2009. He authored an editorial published in The Wall Street Journal that was critical of the FDA's ability to evaluate and approve new life-saving therapies.2
The editorial opened by Dr. von Eschenbach 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."2
"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."2
Dr. von Eschenbach cited 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."3
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."2
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.
Brain tumor patients, for example, don't have years to wait for FDA-mandated efficacy studies. They need rapid access to new therapies that offer some hope of saving their lives.
Bridging the FDA's "Death Valley"
Newly diagnosed cancer patients are usually given several treatment choices, all laden with guaranteed side effects with no promise of a cure or even a significant remission.
For most types of cancer, progress has been excruciatingly slow, even though there are more scientific studies being published about cancer now than at any time in human history. The term "death valley" is increasingly being used to describe the gap that separates what is discovered in the scientific setting from what actually makes it into patients' bodies.
The sad fact is there are so many bureaucratic roadblocks that potentially effective therapies aren't making it out of the laboratory setting. The high costs of conducting human efficacy trials deny smaller companies equal opportunity to bring what may be superior medications to market.
Dr. von Eschenbach's proposal to allow new therapies on the market as soon as safety is established would liberate many promising therapies currently trapped in the FDA's oppressive quagmire.
Who Does Not Want Faster Approval
There are those who financially benefit by maintaining the current system that requires enormous capital expenditures and many years of delay before new therapies are approved.
Large pharmaceutical companies enjoy a quasi-monopoly on the development of new drugs because virtually no one else can afford the gargantuan costs of FDA approval. When small companies make a medical discovery, pharmaceutical giants often buy out the technology because smaller companies lack the resources to afford currently-mandated efficacy studies.
There's also the issue of the enormous profitability on existing therapies. Just look at the melanoma drug called Yervoy® made by Bristol Myers Squib. It costs $120,000 for this treatment that only extends survival in advanced melanoma patients an average of 108 days.5 It is in the economic interests of Bristol Myers Squib that no other melanoma therapy be approved for the next 20 years so they can collect $120,000 from every melanoma patient that is not cured in the early stage.
Pharmaceutical giants stand to earn enormous profits as long as it costs so much to comply with FDA efficacy requirements that competition from superior therapies is stifled.
Where We Don't Agree With Dr. von Eschenbach
There is a misconception in the mainstream that if the FDA were given more resources, that it could properly do its job.
This fallacy was exposed in a report the FDA commissioned wherein it revealed that the FDA had systemic internal flaws that could not be corrected by the mere input of more money.6 While Dr. von Eschenbach emphasizes the need to modernize the FDA "from the bottom up" to include a "comprehensive external review of the agency's regulatory processes,"7 the track record of federal agencies improving themselves is abysmal, especially with powerful special interests like pharmaceutical companies vehemently opposing any change.
Why "Efficacy" is Sometimes More Important Than "Safety"
The public rightfully fears the risks posed by unsafe drugs, and we at Life Extension have written many exposés on dangerous medicines the FDA should have never approved.
Yet the reality is that even the worst side-effect-prone drugs only affect a minority of patients. When it comes to treating terminal diseases like Alzheimer's and certain cancers, efficacy becomes paramount to safety because these patients will die unless an experimental therapy happens to work for them.
So restricting promising therapies to only those with proven safety will continue to condemn certain Americans to guaranteed death, which is why some patients need even earlier access to experimental treatments than what Dr. von Eschenbach proposes.
Lethal Consequences of Denial
Politicians are debating a lot of topics right now, but the most important problem facing Americans is not being discussed.
Once you or a loved one is diagnosed with a serious disease, all other issues become largely irrelevant. Your only concern is whether there is a non-toxic cure available.
That's why it's imperative that free market reforms are enacted that place the FDA in an advisory role that allows rapid medical progress unimpeded by central government bureaucrats.
In response to Dr. von Eschenbach's editorial, a number of doctors responded with complimentary letters, but emphasized that even more deregulation of FDA authoritarian control is needed to bring about cures for today's killer diseases.19 Some of these letters exposed how dysfunction and unpredictability at the FDA is precluding vital early-stage scientific research.
The sad fact is that most of the American public remains in a state of denial about the lethal consequences of today's antiquated regulatory structure. This denial turns into harsh reality when one is diagnosed with an illness for which there is no current cure.
We at Life Extension continue our relentless campaign to alert policy makers and the public about the urgent need to accelerate the introduction of new therapies. This can only happen if the major roadblock (i.e., the FDA) is relegated to an advisory role, away from its current dictatorial role.
Unlike any other issue, failure to affect meaningful FDA reform will result in millions of Americans needlessly suffering and dying every single year.
This is no longer just the opinion of health freedom fighters like me, but also the current and former Commissioners of the FDA!
For longer life,
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