The employees and appointees of the US Food and Drug Administration have caused an incredible destruction of value and progress over the time that the agency has existed. Their regulatory policies become ever more onerous with each passing year, as unaccountable bureaucrats follow their incentives: nothing good can happen to their careers as a result of approving new technologies, and nothing bad tends to happen to their careers as a result of making it really, really hard to bring new medicine to the clinic. So of course you wind up with an organization whose members collectively pay nothing more than lip service to their declared mission, while working to make sure that medicine stays moribund in a slow-motion stasis. This is most evident in the cancer research community, largely because of its size, but it applies just as evenly across all forms of medicine:
A 2010 study in the Journal of Clinical Oncology by researchers from the M.D. Anderson Cancer Center in Houston, Texas found that the time from drug discovery to marketing increased from eight years in 1960 to 12 to 15 years in 2010. Five years of this increase results from new regulations boosting the lengths and costs of clinical trials. The regulators aim to prevent cancer patients from dying from toxic new drugs. However, the cancer researchers calculate that the delays caused by requirements for lengthier trials have instead resulted in the loss of 300,000 patient life-years while saving only 16 life-years.
To add to this picture, you must also see incumbent Big Pharma entities and their executives and lobbyists - a deeply enmeshed network of regulatory capture. They are far more willing to use the current system as a weapon to suppress disruptive innovation in their industry than to be a source of innovation themselves. So it goes, just as in any other heavily regulated market. The strategic goals of the major players wind up having very little to do with creating beneficial change, and everything to do with keeping things the same as they are now.
As I've said in the past, it is a waste of energy to fight this. That's a money pit, and resources are better spent on creating actual progress than lining the pockets of politicians, their lackeys, and other corrupt cogs in the system. Work around the roadblock instead: start companies and partner for research development outside the US. Deliver services in Asia and take advantage of cheap flights and the growing medical tourism industry. The only way that the FDA will whither away is to make it entirely irrelevant - and as the bureaucrats keep piling on the costs, erecting an ever higher barrier to actually developing any new medicine in the US, that will become a more popular option. You can be sure that the wealthier and more connected individuals who make regulations and advocate for ever greater powers to accrue to the FDA will be amongst the first flying beyond the US to undergo newer therapies - treatments that they have managed to make illegal or too expensive to exist in their own country.
Some more on this topic:
Though the United States urgently needs new treatments for common illnesses such as heart disease, stroke, and diabetes, the nation's system for drug approval discourages innovation and investment, especially for our most pressing public health challenges. In this paper, we find that the main culprit is the high cost of Phase III clinical trials, which are required for FDA approval of most drugs. We examined drug development in four major public health areas and discovered that for any given drug on the market, typically 90 percent or more of that drug's development costs are incurred in Phase III trials. These costs have skyrocketed in recent years, exacerbating an already serious problem.
The enormous cost and risk of Phase III trials create incentives for researchers and investors to avoid work on medications for the chronic conditions and illnesses that pose the greatest threat to Americans, in terms of health spending and in terms of the number of people affected. This avoidance, in turn, harms overall U.S. health outcomes and drives up the cost of health care.
Source:
http://www.longevitymeme.org/newsletter/latest_rss_feed.cfm
- Vitamin K Delivers Kick to Cancer Risk [Last Updated On: August 17th, 2024] [Originally Added On: April 7th, 2010]
- Magnesium for Memory [Last Updated On: August 17th, 2024] [Originally Added On: April 7th, 2010]
- The Long Road Towards Prosthetic Nerves [Last Updated On: August 17th, 2024] [Originally Added On: April 9th, 2010]
- More on DAF-16 and Longevity in Nematodes [Last Updated On: August 17th, 2024] [Originally Added On: April 9th, 2010]
- Rapamycin and Alzheimer's Disease [Last Updated On: August 17th, 2024] [Originally Added On: April 9th, 2010]
- Rapamycin and Alzheimer's Disease [Last Updated On: August 17th, 2024] [Originally Added On: April 9th, 2010]
- Better Understanding Cytomegalovirus [Last Updated On: August 17th, 2024] [Originally Added On: April 9th, 2010]
- On Mitophagy and Aging [Last Updated On: August 17th, 2024] [Originally Added On: April 9th, 2010]
- A Trial of Giving Stem Cells Orders [Last Updated On: August 17th, 2024] [Originally Added On: April 9th, 2010]
- Methuselah Foundation Launches NewOrgan Prize [Last Updated On: August 17th, 2024] [Originally Added On: April 9th, 2010]
- The Contributions of Mitochondria to Longevity [Last Updated On: August 17th, 2024] [Originally Added On: April 9th, 2010]
- Dual Action Antibodies Versus Cancer [Last Updated On: August 17th, 2024] [Originally Added On: April 9th, 2010]
- Longevity and the End of Empire [Last Updated On: August 17th, 2024] [Originally Added On: April 9th, 2010]
- The Long Road Towards Prosthetic Nerves [Last Updated On: August 17th, 2024] [Originally Added On: April 10th, 2010]
- More on DAF-16 and Longevity in Nematodes [Last Updated On: August 17th, 2024] [Originally Added On: April 10th, 2010]
- Rapamycin and Alzheimer’s Disease [Last Updated On: August 17th, 2024] [Originally Added On: April 10th, 2010]
- Better Understanding Cytomegalovirus [Last Updated On: August 17th, 2024] [Originally Added On: April 10th, 2010]
- On Mitophagy and Aging [Last Updated On: August 17th, 2024] [Originally Added On: April 10th, 2010]
- A Trial of Giving Stem Cells Orders [Last Updated On: August 17th, 2024] [Originally Added On: April 10th, 2010]
- Methuselah Foundation Launches NewOrgan Prize [Last Updated On: August 17th, 2024] [Originally Added On: April 10th, 2010]
- The Contributions of Mitochondria to Longevity [Last Updated On: August 17th, 2024] [Originally Added On: April 10th, 2010]
- Dual Action Antibodies Versus Cancer [Last Updated On: August 17th, 2024] [Originally Added On: April 10th, 2010]
- Longevity and the End of Empire [Last Updated On: August 17th, 2024] [Originally Added On: April 10th, 2010]
- Longevity Meme Newsletter, April 12 2010 [Last Updated On: August 17th, 2024] [Originally Added On: April 12th, 2010]
- Printing New Tissue Directly Onto the Body [Last Updated On: August 17th, 2024] [Originally Added On: April 12th, 2010]
- Reprogramming Autoimmune Disease [Last Updated On: August 17th, 2024] [Originally Added On: April 12th, 2010]
- Diet and Exercise Can Override the Genetic Disposition towards Obesity [Last Updated On: August 17th, 2024] [Originally Added On: April 12th, 2010]
- Your Heart Truly Loves Chocolate! [Last Updated On: August 17th, 2024] [Originally Added On: April 12th, 2010]
- CSC news roundup 2010-04-11 [Last Updated On: August 17th, 2024] [Originally Added On: April 13th, 2010]
- Longevity Meme Newsletter, April 12 2010 [Last Updated On: August 17th, 2024] [Originally Added On: April 13th, 2010]
- Printing New Tissue Directly Onto the Body [Last Updated On: August 17th, 2024] [Originally Added On: April 13th, 2010]
- Reprogramming Autoimmune Disease [Last Updated On: August 17th, 2024] [Originally Added On: April 13th, 2010]
- Diet and Exercise Can Override the Genetic Disposition towards Obesity [Last Updated On: August 17th, 2024] [Originally Added On: April 13th, 2010]
- Your Heart Truly Loves Chocolate! [Last Updated On: August 17th, 2024] [Originally Added On: April 13th, 2010]
- Trialing Stem Cells to Heal Heart Damage [Last Updated On: August 17th, 2024] [Originally Added On: April 13th, 2010]
- Selection Effects and Longevity Genes [Last Updated On: August 17th, 2024] [Originally Added On: April 13th, 2010]
- How Exercise Can Awaken Your Creative Genius Within [Last Updated On: August 17th, 2024] [Originally Added On: April 13th, 2010]
- Trialing Stem Cells to Heal Heart Damage [Last Updated On: August 17th, 2024] [Originally Added On: April 14th, 2010]
- Selection Effects and Longevity Genes [Last Updated On: August 17th, 2024] [Originally Added On: April 14th, 2010]
- How Exercise Can Awaken Your Creative Genius Within [Last Updated On: August 17th, 2024] [Originally Added On: April 14th, 2010]
- WILT, ALT, and Zscan4 [Last Updated On: August 17th, 2024] [Originally Added On: April 14th, 2010]
- Damage in Early Life Shortens Life Expectancy [Last Updated On: August 17th, 2024] [Originally Added On: April 14th, 2010]
- WILT, ALT, and Zscan4 [Last Updated On: August 17th, 2024] [Originally Added On: April 15th, 2010]
- Damage in Early Life Shortens Life Expectancy [Last Updated On: August 17th, 2024] [Originally Added On: April 15th, 2010]
- Synthetic Biology and the Extracellular Matrix [Last Updated On: August 17th, 2024] [Originally Added On: April 15th, 2010]
- The Tithonus Error as Prospection Error [Last Updated On: August 17th, 2024] [Originally Added On: April 15th, 2010]
- F.D.A. Says Millions Got Unapproved Drugs, Should the new bioequivalence and bioanalytical guidelines for 2010, be made more stringent [Last Updated On: August 17th, 2024] [Originally Added On: April 16th, 2010]
- Synthetic Biology and the Extracellular Matrix [Last Updated On: August 17th, 2024] [Originally Added On: April 16th, 2010]
- The Tithonus Error as Prospection Error [Last Updated On: August 17th, 2024] [Originally Added On: April 16th, 2010]
- Towards an Artificial Pancreas [Last Updated On: August 17th, 2024] [Originally Added On: April 16th, 2010]
- Immortality Isn't Unethical [Last Updated On: August 17th, 2024] [Originally Added On: April 16th, 2010]
- Immortality Isn't Unethical [Last Updated On: August 17th, 2024] [Originally Added On: April 16th, 2010]
- Alcohol in Adolescence: A Cancerous Combination? [Last Updated On: August 17th, 2024] [Originally Added On: April 16th, 2010]
- Green Tea for Weight Loss [Last Updated On: August 17th, 2024] [Originally Added On: April 16th, 2010]
- Towards an Artificial Pancreas [Last Updated On: August 17th, 2024] [Originally Added On: April 17th, 2010]
- Immortality Isn’t Unethical [Last Updated On: August 17th, 2024] [Originally Added On: April 17th, 2010]
- Alcohol in Adolescence: A Cancerous Combination? [Last Updated On: August 17th, 2024] [Originally Added On: April 17th, 2010]
- Green Tea for Weight Loss [Last Updated On: August 17th, 2024] [Originally Added On: April 17th, 2010]
- On Calorie Restriction Research [Last Updated On: August 17th, 2024] [Originally Added On: April 17th, 2010]
- AGE Precursor Methylglyoxal Also an Issue? [Last Updated On: August 17th, 2024] [Originally Added On: April 17th, 2010]
- On Calorie Restriction Research [Last Updated On: August 17th, 2024] [Originally Added On: April 18th, 2010]
- AGE Precursor Methylglyoxal Also an Issue? [Last Updated On: August 17th, 2024] [Originally Added On: April 18th, 2010]
- Longevity Meme Newsletter, April 19 2010 [Last Updated On: August 17th, 2024] [Originally Added On: April 19th, 2010]
- Let Them Eat Wheat [Last Updated On: August 17th, 2024] [Originally Added On: April 19th, 2010]
- An Appetite for Alzheimer’s Avoidance [Last Updated On: August 17th, 2024] [Originally Added On: April 19th, 2010]
- Steps Towards Controlling Regeneration [Last Updated On: August 17th, 2024] [Originally Added On: April 20th, 2010]
- Another View of What to Do About Aging [Last Updated On: August 17th, 2024] [Originally Added On: April 20th, 2010]
- Rare flowers and common herbal supplements get unmasked with plant DNA barcoding [Last Updated On: August 17th, 2024] [Originally Added On: April 21st, 2010]
- Steps Towards Controlling Regeneration [Last Updated On: August 17th, 2024] [Originally Added On: April 21st, 2010]
- Another View of What to Do About Aging [Last Updated On: August 17th, 2024] [Originally Added On: April 21st, 2010]
- Stopping Metastasis [Last Updated On: August 17th, 2024] [Originally Added On: April 21st, 2010]
- Humanity+ Summit at Harvard [Last Updated On: August 17th, 2024] [Originally Added On: April 21st, 2010]
- Stopping Metastasis [Last Updated On: August 17th, 2024] [Originally Added On: April 22nd, 2010]
- Humanity+ Summit at Harvard [Last Updated On: August 17th, 2024] [Originally Added On: April 22nd, 2010]
- An Update on Scent and Longevity [Last Updated On: August 17th, 2024] [Originally Added On: April 22nd, 2010]
- Tissue Engineered Skin Progresses [Last Updated On: August 17th, 2024] [Originally Added On: April 22nd, 2010]
- Because Someone Has to State the Obvious [Last Updated On: August 17th, 2024] [Originally Added On: April 23rd, 2010]
- Deciphering Regeneration [Last Updated On: August 17th, 2024] [Originally Added On: April 23rd, 2010]
- Politics and Historical Aspirations to Engineered Longevity [Last Updated On: August 17th, 2024] [Originally Added On: April 24th, 2010]
- Exercise and Alzheimer's Disease [Last Updated On: August 17th, 2024] [Originally Added On: April 24th, 2010]