Order from a Major Online Bookstore
Ultimate Book Price Comparison Engine
Save Your Time And Money
| AnyBook4Less.com | Order from a Major Online Bookstore |
|
| Home | Store List | FAQ | Contact Us | | ||
| Ultimate Book Price Comparison Engine Save Your Time And Money |
||
 |
Title: To America's Health: A Proposal to Reform the Food and Drug Administration (Hoover Institution Press Publication, 482) by Henry I. Miller M.D., Terry L. Anderson ISBN: 0-8179-9902-7 Publisher: Hoover Inst Pr Pub. Date: September, 2000 Format: Paperback Volumes: 1 List Price(USD): $14.95 |
Average Customer Rating: 3.5 (2 reviews)
Rating: 2
Summary: Not impressed
Comment: While it may be true that some reform at the FDA is needed, the way this book portrays the problem is seriously flawed. This is surprising as it comes from a guy that actually worked at the FDA. The book is filled with number fudging, half truths and ridiculous distortions. For example, the book cited that the FDA raised the bar for clinical research that resulted in the time required for drug development to increase from 8.1 years to 15.2 years from 1960s to 1997 (Page 24). Why is that bad? Remember the law that requires a drug to be effective was only passed in 1962. Back then, a scientifically sound clinical study for effectiveness wasn't even defined. As the science progresses, the bar has to be raised. Moreover, a lot of drugs nowadays have to be taken for years (for example, statin drugs). The only way to know the long term safety of these drugs is to do long term study. Hence, long time required for clinical studies. Even with this kind of rigor, there are still drugs like Baycol out there harming people. In another place, the author quoted that the number of safety discontinuations as a percentage of total new drug introductions in each country were similar - about 4 percent in UK and 3 percent in US. The author thus concluded that a marketed drug will be removed from the market is not appreciable different in the UK and US (page 27). This is number fudging at its best. Sure, 4% and 3% are all small numbers. But 4%/3% is 1.33. That means UK approves 33% more harmful drugs than US. No wonder the FDA is viewed as the "gold standard."
I highly recommened a report by Public Citizen on the brandname drug industry. When people see how profitable they are and how little they actually devote to research, they won't believe all this whining on behalf of these companies.
Rating: 5
Summary: Excellent Look At How Regulations Can Cost Lives
Comment: In politics, many different rules and regulations create problems for consumers. Regulations that cause people to die - or contribute to their deaths - should bear the highest possible level of scrutiny. In this book, medical doctor and former Food and Drug Administration official Henry Miller addresses problems with the way the FDA reviews and approves new medicines. His analysis is extremely important because, when the government delays the introduction of critical medical innovations, people can die.
The key point in Miller's argument is that imposing excessive regulatory costs on American pharmaceutical firms forces them to experience corporate mergers, reduced competition, and higher prices. In the long run, this leads companies to focus on shorter-term, lower-risk research and development intended for larger patient populations. Thus, smaller groups of patients in need of new medical innovations that require long-term study at higher per-capita costs suffer the most from delays in approving new products.
Miller addresses the myth that there must be a tradeoff between promoting more efficient drug research and improving drug safety. Efficiency and safety can both be improved simultaneously by introducing competition where regulatory oversight has become excessive and changing the FDA's role in the process. Rather than evaluating data itself, it should allow other organizations to evaluate clinical testing and focus on monitoring their efforts instead.
A key problem that many drug manufacturers face is that regulations are not static. When new rules are enacted, regulators generally adopt narrow interpretations of them, but broaden those interpretations as time goes on. Because of this, regulators must be viewed as a special interest group - expanding their turf by skirting congressional oversight and gradually inflating burdens for manufacturers underneath the radar screen.
These problems lead many companies to alter their research priorities. Instead of focusing solely on prospective benefits for consumers when choosing which products to develop, firms must account for potential regulatory costs as well. The high costs of getting drugs approved reduces the diversity of products being prepared - leading many companies to devote more energy to dealing with the regulatory apparatus. Innovation suffers as a result.
The biggest problem with the FDA's current system, though, is its lack of accountability to the public. Consumers cannot participate in its product-review process and cannot obtain judicial review of its decisions. In addition, seldom is information about delayed or rejected drugs and medical devices made available to the media. Thus, the nature of the evaluation process itself reduces consumers' freedom of choice and individual autonomy. It leads many frustrated consumers to travel abroad to obtain safe drugs and services not available here in the U.S.
Fortunately, Miller offers a solution to the problem: allow independent, non-profit drug certifying bodies - instead of the FDA - to review test results from companies. Then allow the FDA to monitor the technical, scientific, and managerial expertise of these bodies to ensure they perform proper reviews. This would be similar to OSHA's accreditation process for testing laboratories. It would also introduce much needed competition, innovation, and efficiency into the oversight process and help alleviate many of the perverse incentives regulators face when interpreting new standards.
Overall, America's drug review procedure is in need of reform. Excessive regulations that lead to increased suffering or death among consumers should be repealed. In addition, when the regulatory process itself delays new technologies or innovations that can reduce suffering or death among the public, the procedure itself should be closely examined. Miller's book sheds new light on a frequently-ignored cost of overregulation: how preventing the adoption of new products or services that save lives can be just as costly as overlooking those that cost lives. His arguments should be given careful consideration by anyone who is concerned about the state of health care in the United States.
 |
Title: Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation by Philip J. Hilts ISBN: 037540466X Publisher: Knopf Pub. Date: 25 March, 2003 List Price(USD): $26.95 |
 |
Title: Hazardous to Our Health? FDA Regulation of Health Care Products by Robert Higgs, Ronald W. Hansen, Paul H. Rubin ISBN: 0945999410 Publisher: Independent Institute Pub. Date: 01 February, 1995 List Price(USD): $14.95 |
 |
Title: Innocent Casualties : The FDA's War Against Humanity by Elaine Feuer ISBN: 0805938192 Publisher: Dorrance Publishing Co Pub. Date: 01 January, 1998 List Price(USD): $18.00 |
 |
Title: Over Dose: The Case Against the Drug Companies: Prescription Drugs, Side Effects, and Your Health by Jay S. Cohen ISBN: 1585421235 Publisher: Penguin USA (Paper) Pub. Date: 11 October, 2001 List Price(USD): $24.95 |
 |
Title: The Merck Druggernaut: The Inside Story of a Pharmaceutical Giant by Fran Hawthorne ISBN: 0471228788 Publisher: John Wiley & Sons Pub. Date: 28 February, 2003 List Price(USD): $24.95 |
Thank you for visiting www.AnyBook4Less.com and enjoy your savings!
Copyright� 2001-2021 Send your comments
