Governments collapse when ineptitude and corruption reach such egregious magnitudes that the citizenry has no choice but to revolt.
Once you or a loved one is diagnosed with a serious disease, all other issues become 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 allows rapid medical progress unimpeded by central government bureaucrats.
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 a 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, but also the current and former Commissioners of the FDA!
FDA Allows Criminals to Oversee Clinical Trials
At the heart of the FDA’s rationale for existence is its supposed ability to evaluate findings from clinical drug trials. The FDA’s ultimate decision to approve or reject a new drug is based on how the drug performs in these human trials.
If you ever wonder why a drug passes clinical testing, but inflicts lethal side effects after FDA approval, one part of the answer is that the clinical trials themselves are often fraudulent.
In a widely reported revelation, a crooked clinic helped conduct 170 drug studies for nearly every major pharmaceutical company and routinely falsified data and patient records.1 The clinic’s criminal conduct rendered the findings from these human trials meaningless. The FDA relied on these fraudulent findings, however, to approve drugs used by tens of millions of Americans.
FDA does not stop criminal activity
The shocker is that after those who perpetrated these illegal acts pled guilty to fraud, the FDA did not ban them from participating in additional human clinical drug trials!
According to federal law, the FDA had five years from the criminal conviction to ban the perpetrators from conducting further drug research. In this case, the FDA did nothing for over four years, and then sent the revocation notice to the wrong address. The frightening result is that those involved in these criminal acts were free to continue conducting human clinical trials.2
When Congress learned of the FDA’s gross incompetence, they conducted hearings where FDA officials appear before a Congressional oversight committee to explain how such a blatant error could occur.
Congressional investigators found the FDA pays little attention to its responsibilities to ban researchers convicted of fraud and is totally disorganized about carrying out revocation procedures.2
The General Accounting Office reviewed 18 instances of research fraud and found the FDA took between one and 11 years to ban these criminals.2,3 FDA negligence enabled those convicted of fraud to conduct human experimentation for years. Is it any wonder why so many FDA-approved drugs kill their users either from side effects or lack of efficacy?
Former FDA Commissioner Attacks FDA
We at Life Extension Foundation 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 2009.4 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.5
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."5
"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."5
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."5
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."5
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.
Healthcare Crisis Caused by Overregulation
Radical overhaul of today’s broken healthcare system is mandatory to save this country from economic insolvency. Band-Aid approaches are no longer an option.
Those who read the financial news will recognize some of the harsh realities. Heavily indebted federal, state, and local governments can no longer afford healthcare entitlements, nor can individuals pay for them out of pocket. The reaction of politicians and bureaucrats is to point fingers as to who should pay more and who should receive less. It is not mathematically possible, however, for enough additional tax revenue to be collected, nor benefits reduced, to resolve this impending crisis.
Congress must enact legislation to allow free market forces to drive down sick care costs, better enable disease prevention, and facilitate rapid development of improved medical therapies. This is the only realistic solution!
Regulatory reform in a nutshell
The regulatory restructuring required to reap these rewards is simple. Congress must pass laws that prohibit regulatory agencies (Federal and State) from taking enforcement action that:
- Impede competition
- Drive up costs
- Stifle innovation
- Chill free speech
- Grant privileges to certain groups that are denied to others
- Mandate governmental approval or licensing
- Create wasteful and corrupt bureaucracy
These seven fundamental changes to healthcare regulation must by enacted into law to drive down medical costs, while creating a scientific renaissance across the broad spectrum that we define today as “healthcare”.
By way of example, the FDA should no longer be able to prohibit the sale of any drug, device or other product that has undergone scientific testing, but has not been formally approved as safe and effective based on FDA’s current Byzantine standards.
The FDA should also be prohibited from censoring claims about any food, dietary supplement, hormone, drug, device or other product that is based on scientific study.
There is an important caveat. Liberating health sciences from today’s archaic stranglehold does not mean that fraud or overt criminal activity should be tolerated. The difference is that those engaged in real criminal activity, such as hiding the dangers of lethal drugs will be prosecuted, as opposed to threatening walnut and cherry growers who make health claims about their food on a website.
Any product or claim not recognized by FDA must have a disclaimer stating:
“This product or the health claims relating to this product are not approved or recognized by the FDA. Use this product at your own risk.”
To ignite this revolution that will spare us the agonies of healthcare’s financial collapse, we must enlighten Congress to the absurdity of inane regulations that cause conventional medicine to be so outlandishly overpriced and natural therapies suppressed.
I ask each of you to click here to join a group of health freedom activists who are determined to tear down the bureaucratic barriers that deny Americans access to safe and effective therapies to prevent and treat disease.
Act Up, Speak Out
Silence = Death
1. Available at: http://www.ahrp.org/cms/content/view/640/106/. Accessed January 22, 2013.
2. Available at: http://www.nytimes.com/2009/10/22/health/policy/22fda.html?_r=0. Accessed January 22, 2013.
3. OVERSIGHT OF CLINICAL INVESTIGATORS: Action Needed to Improve Timeliness and Enhance Scope of FDA’s Debarment and Disqualification Processes for Medical Product Investigators. Available at: http://www.gao.gov/new.items/d09807.pdf. Accessed January 22, 2013.
4. Available at: http://www.fda.gov/AboutFDA/CommissionersPage/ucm110697.htm. Accessed January 22, 2013.
5. Medical Innovation: How the United States Can Retain Its Lead. Available at: http://www.milkeninstitute.org/publications/publications.taf?function=detail&ID=38801307&cat=ART. Accessed January 21, 2013.