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Thread: Former FDA Commissioner Admits Risk of Bureaucratic Delay

  1. #1

    Default Former FDA Commissioner Admits Risk of Bureaucratic Delay

    How many years are we going to keep going down the same road without addressing the antiquated and outmoded FDA that may mean the difference between life and death for millions of people? This article quotes Dr. Andrew von Eschenbach, former FDA commissioner and is well worth the read. His Letter to the Editor follows the article.

    Life Extension
    December, 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.

    Dr. von Eschenbach Discusses Regenerative Medicine
    Dr. von Eschenbach wrote:

    "Breakthrough technologies deserve a breakthrough in the way the FDA evaluates them. Take regenerative medicine. If a company can grow cells that repair the retina in a lab, patients who've been blinded by macular degeneration shouldn't have to wait years while the FDA asks the company to complete laborious clinical trials proving efficacy. Instead, after proof of concept and safety testing, the product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies."4

    This common sense approach has been advocated by Life Extension for more than 30 years. It's refreshing to see a former FDA Commissioner concur.
    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.

    The FDA Has Long Delayed Life-Saving Drugs
    The current and former Commissioners of the FDA state that the FDA is incapable of approving 21st century technologies in a timely fashion.

    What they may not know is that the FDA delayed approval of life-saving therapies for much of the 20th century.

    A chilling example is that of propranolol, a beta-blocker that saves the lives of tens of thousands of Americans each year. Propranolol was used in Europe many years before FDA approved it in the US.8-9 If you multiply the number of lives that could have been saved each year if US patients had gained access to propranolol—times the multi-year delay—the total number exceeds 30,000 Americans who needlessly died because of FDA's delay in approving this ONE drug.9

    The anti-diabetic drug metformin was approved in England in 1958, but the FDA did not get around to allowing it in the United States until 1994.10 Metformin is now the first line treatment for early-stage diabetes.11-13 The number of type II diabetics who perished needlessly because they did not have access to metformin is incalculable.

    The anti-viral drug ribavirin was used throughout the world in the early 1980s, but FDA did not approve it for use in America until 1998.14-18 Ribavirin increases the efficacy of interferon in treating hepatitis C. It is a broad-spectrum drug that can eradicate a wide range of lethal viruses, yet Americans died while ribavirin was sold over-the-counter in some countries.

    Since the early 1960s, when Congress granted the agency authoritarian new powers, the FDA has functioned as a roadblock that denies Americans access to improved medical therapies. The timeline from when a drug demonstrates safety and the inordinate number of years it takes to gain regulatory approval speaks for itself.

    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,

    William Faloon

    AS THIS ARTICLE WAS GOING TO PRESS...
    A White House advisory body on September 25, 2012, unveiled a plan to increase the number of new prescription drugs that go on the market each year by more quickly approving drugs to treat high-risk patients.

    The President's Council of Advisors on Science and Technology urged the FDA to expand its use of faster drug approvals to a wider range of diseases. The council suggested the FDA could begin to approve drugs that may help only a narrow and high-risk patient population, such as people who are morbidly obese, under what the council called "special medical use" approvals.

    While it is encouraging to see The White House agree with our long-standing position about the lethal consequences of drug delays, these kinds of changes are inadequate to address the cumbersome bureaucracy that impedes scientific discoveries from reaching the clinical setting where they are desperately needed by terminally ill humans.

    References

    1. Henriksson R, Asklund T, Poulsen HS. Impact of therapy on quality of life, neurocognitive function and their correlates in glioblastoma multiforme: a review. J Neurooncol. 2011 Sep;104(3):639-46. Epub 2011 Apr 6.

    2. Available at: http://online.wsj.com/article/SB1000...399350874.html. Accessed on July 16, 2012.

    3. Available at: http://www.fda.gov/downloads/AboutFD.../UCM244196.pdf. Accessed April 4, 2012.

    4. Available at: http://www.policymed.com/2012/04/for...n-for-fda.html. Accessed April 10, 2012.

    5. Available at: http://www.nytimes.com/2011/03/26/bu...drug.html?_r=1. Accessed April 10, 2012.

    6. Available at: http://www.fda.gov/ohrms/dockets/AC/...Technology.pdf. Accessed April 10, 2012.

    7. Available at: http://eyewiretoday.com/view.asp?201...market_studies. Accessed July 16, 2012.

    8. Available at: http://www.fdareview.org/harm.shtml. Accessed April 12, 2012.

    9. Available at: http://www.isil.org/resources/lit/death-regulation.html. Accessed April 12, 2012.

    10. Available at: http://onlinelibrary.wiley.com/doi/1...11.03469.x/pdf. Accessed April 12, 2012.

    11. Bennett WL, Maruthur NM, Singh S, et al. Comparative effectiveness and safety of medications for type 2 diabetes: an update including new drugs and 2-drug combinations. Ann Intern Med. 2011 May 3;154(9):602-13. Epub 2011 Mar 14.

    12. Available at: http://care.diabetesjournals.org/con...ent_1/S13.full. Accessed April 13, 2012.

    13. Available at: http://www.ncbi.nlm.nih.gov/books/NBK55754/. Accessed July 16, 2012.

    14. Knight V, McClung HW, Wilson SZ, Waters BK, Quarles JM, Cameron RW, Greggs SE, Zerwas JM, Couch RB. Ribavirin small-particle aerosol treatment of influenza. Lancet. 1981 Oct 31;2(8253):945-9.

    15. Davis GL, Balart LA, Schiff ER, et al. Treatment of chronic hepatitis C with recombinant interferon alfa. A multicenter randomized, controlled trial. Hepatitis Interventional Therapy Group. N Engl J Med. 1989 Nov 30;321(22):1501-6.

    16. Reichard O, Norkrans G, Frydén A, Braconier JH, Sönnerborg A, Weiland O. Randomised, double-blind, placebo-controlled trial of interferon alpha-2b with and without ribavirin for chronic hepatitis C. The Swedish Study Group. Lancet. 1998 Jan 10;351(9096):83-7.

    17. de Lédinghen V, Trimoulet P, Winnock M, et al; French Multicenter Study Group. Daily or three times per week interferon alpha-2b in combination with ribavirin or interferon alone for the treatment of patients with chronic hepatitis C not responding to previous interferon alone. J Hepatol. 2002 Jun;36(6):819-26.

    18. Ali S, Nazir G, Khan SA, Iram S, Fatima F. Comparative therapeutic response to pegylated interferon plus ribavirin versus interferon alpha-2b in chronic hepatitis C patients. J Ayub Med Coll Abbottabad. 2010 Oct-Dec;22(4):127-30.

    19. Available at: http://online.wsj.com/article/SB1000...193886650.html. Accessed July 16, 2012.

    __________________________________________________ __________________________________________________ __________________________
    Medical Innovation: How the U.S. Can Retain Its Lead
    The FDA should approve drugs based on safety and leave efficacy testing for post-market studies.

    Wall Street Journal
    Opinion
    Feb. 14, 2012
    By ANDREW VON ESCHENBACH

    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. Tomorrow's high-tech cures can also slash health-care costs and eliminate ineffective treatments.

    What will it take to realize the potential of the new medicine? The United States has the world's most innovative drug and device companies and research universities, plus the unparalleled National Institutes of Health. What's missing is a modernized Food and Drug Administration that can rapidly and efficiently bring new discoveries to patients.

    The FDA is the regulatory gatekeeper for every drug and medical device sold in the U.S. But there is a growing recognition—at the agency, in the industry and among patients' groups—that it is at serious risk of falling behind its core responsibility of evaluating new medical products in a timely and predictable manner. Without an FDA that is as innovative and sophisticated as the companies it regulates, patient health and U.S.-based innovation will suffer.

    FDA Commissioner Margaret Hamburg conceded to Congress in 2010 that "the FDA is relying on 20th century regulatory science to evaluate 21st century medical products." That's not the only problem.

    Unanticipated side effects of high-profile drugs like Vioxx have pushed the agency to require more data and larger clinical trials from companies to search for rare adverse events. The Tufts Center for the Study of Drug Development has reported that clinical trials from 2003-2006 were nearly 70% longer than those from 1999-2002. Longer (and more complicated) trials have led to skyrocketing drug-development costs. High costs discourage investment in much-needed new therapies for conditions like obesity, diabetes and heart disease.

    The agency is also broken into Centers dealing with drugs, biologics and devices. Yet increasingly, diagnostic devices will be paired with therapeutics.

    And crucially, efforts to prevent diseases like Alzheimer's will require an entirely new approach to designing clinical trials—one that relies on "biomarkers" to rapidly measure a drug's effectiveness and safety in small, targeted groups of patients rather than in large, randomized clinical trials with thousands of patients that can take years to complete and analyze. In a world where science is advancing at an exponential pace, the FDA must be capable of ensuring that its reviewers know just as much about advances in emerging sciences as the creators of the products they regulate.

    Other countries such as Israel, Singapore and China are already preparing to leapfrog the U.S. for leadership of the global life-sciences industry. And investors and companies are shifting jobs and research abroad as part of an offshore strategy to cut costs and reach the market faster.

    According to the 2012 California Biomedical Industry Report (published by the California Health Institute, BayBio, and PricewaterhouseCoopers), about 80% of life-sciences CEOs surveyed didn't believe that the FDA regulatory approval process "is the best in the world," and 81% believed that "within five years, another country could conceivably recreate the ecosystem that has made the U.S. the leading biomedical region in the world"—threatening a mass exodus of jobs and R&D.

    Over the years, Congress has repeatedly expanded the FDA's responsibilities, and today the agency monitors products that account for 25 cents of every dollar in U.S. consumer spending—including tobacco, the food supply, cosmetics and drugs ranging from aspirin to the latest biotech medicines for patients and pets. It has not ensured that the agency is keeping pace with the enormous scientific advances made since the human genome was decoded in 2000. Congress and the Obama administration need to make that a priority.

    The stakes couldn't be higher for our health. The U.S. biomedical industry is one of the crown jewels of the American economy. It employs 1.2 million people directly and over five million throughout its supply chain, with a total output of $519 billion in 2009, according to a 2011 Milken Institute report, "The Global Biomedical Industry: Preserving U.S. Leadership." Many of the firms are among the world's most innovative: From 2001-2010, the report shows, U.S.-based companies produced nearly 60% of the world's new medicines, up from 42% the previous decade.

    But U.S. firms won't continue to lead unless the FDA retains its role as the world's "gold standard" for evaluating new medical products. Thankfully, the opportunity to remake—not merely tweak—the agency is here today, if policy makers can seize it. Congress is currently considering legislation to reauthorize the agency to collect the fees companies pay for the review of every new drug and medical device application submitted to the FDA. This presents a rare opportunity to examine the FDA's overall needs and performance.

    Congress should not only set the fees and add resources for the agency but also modernize it from the bottom up. This includes a comprehensive external review of the agency's regulatory processes. It also means creating FDA pilot programs to bring promising therapies to patients more quickly by allowing them to be approved based on safety, with efficacy to be proven in later trials.

    Breakthrough technologies deserve a breakthrough in the way the FDA evaluates them. Take regenerative medicine. If a company can grow cells that repair the retina in a lab, patients who've been blinded by macular degeneration shouldn't have to wait years while the FDA asks the company to complete laborious clinical trials proving efficacy. Instead, after proof of concept and safety testing, the product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies.

    By empowering the FDA to create new paradigms for evaluating the most promising innovations, Congress can ensure that the FDA serves as a bridge—not a barrier—to cutting-edge technologies.

    Dr. von Eschenbach is the chairman of the Manhattan Institute's Project FDA. He is former director of the National Cancer Institute and Commissioner of the U.S. Food and Drug Administration (2005-2009).
    First treatment in 2007. Pioneering ever since.

    Barbara

  2. #2

    Default

    I agree that FDA regulations are antiquated, and millions are at jeopardy from a slow approval process. However, our main argument is that autologous stem cell treatments have no business being regulated by the FDA, antiquated or not. FDA’s regulatory structure is antiquated, but the problem is their regulations are structured for the mass production of chemical drugs and not for individualized medical treatments that are incapable of being bottled or mass produced.

    Besides the sleuth of conflicted interests of having autologous stem cell treatments unjustly categorized as a drug, the progression of SCT’s will never progress under the FDA, since there is no profit opportunity to spend millions on a clinical trial that cannot be bottled for the general public. This argument alone makes the FDA’s arguement to regulate autologous SCT’s as a drug utterly ridiculous. Even if the FDA turbo charges their approval process, autologous stem cell treatments would stay untouched as an individual medical treatment. This is where we need to make our compelling argument that autologous SCT’s should be categorized as medical treatment and fall under medical state boards’ jurisdiction and not the FDA.

  3. #3

    Default

    Autologous treatments should be administered as the practice of medicine. I certainly am in agreement with that. Realistically, the FDA with pressure from those who wish to protect their own interests, does not show any signs of relenting (Celltex being a good example) on their regulatory policy that our stem cells are drugs.

    If Dr. Centeno's lawsuit does not end in a favorable ruling for him (and for patients) that will pave the way to remove the regulations that FDA has set, then Dr. von Eschenbach's idea is something that should be implemented. It would simply require that patients be tracked in a system which could then help determine efficacy. This is similar to what ICMS proposed. There would be no placebo based clinical trials. Anyone who wanted the treatment would be allowed to get it.
    First treatment in 2007. Pioneering ever since.

    Barbara

  4. #4

    Smile

    Barb,

    We both can agree that ideally autologous stem cell treatments as a medical procedure is our best option. Otherwise, I just do not see an alternative to SCT’s progressing as long as FDA has some sought of control over it. The conflict of interests cross my mind like setting as many future regulatory speed bumps as possible to prevent decreasing dependence on chemical drugs. I mean SCT’s can potentially revolutionize medical practice. You know like the light bulb. However, I will stay optimistic. Maybe the progress from other nations will somehow start some sought of outcry from the public. If you really think about it Centeno's outcome is really really important. We are hanging on the balance with Dr. Centeno's case.

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