LDN Editor’s Blog
From the Desk of David Gluck, MD
Updated: Jan 11, 2014
A Modest Proposal — January 2014
Not new, but worth repeating...
There is no longer any serious question remaining about the efficacy and safety of LDN. Unquestionably positive reports, both small studies and scientific trials, have found their way into esteemed peer-reviewed medical journals – and that information joins with over 25 years of many thousands of strongly supportive anecdotal reports. (See Research Trials of LDN at www.ldninfo.org.)
From the first, FDA approval of LDN’s special uses has been blocked, perhaps unintentionally, by the current system, which depends on the large well-financed pharmaceutical firms acting as virtual “gatekeepers”. Given that the existing procedure is based on the legal approval of each newly proposed drug by the FDA, and that the FDA requires results of clinical trials which are very costly, progress is essentially left to the determination of the funding pharmaceutical companies. Big Pharma clearly uses the potential profitability of any individual candidate drug, no matter its potential for general therapeutic usefulness, to decide whether a new medication will or will not be tested and thus have any opportunity to reach the public marketplace and thereby contribute to the public health.
Thus, the stated health-related mission of any large pharmaceutical company is generally not at all compatible with its obvious primary motivation, which is to expand earnings and profits. This has led to an erosion of medical advances, paradoxically in an era of mounting medical costs, in that any off-patent generic drug with a newly discovered usefulness, which could significantly heal the sick and/or prevent further illness, even while substantially reducing health care costs, is for all intents and purposes, made unavailable by our system to the public because of its low profit potential for Big Pharma.
In order to remedy this system of non-performance, and to permit governmental agencies to truly serve the health of the citizenry, systematic change is called for. Some key elements of suggested change:
A newly fashioned Institute of Medicine [IOM] should be empowered to become the health “czar”, overseeing certain major decisions concerning all new medical treatments and devices. It may overrule the FDA when it deems necessary. The new IOM will be sufficiently funded and staffed should it need to arrange support for any necessary clinical trials it deems of value, and it shall choose those appropriate centers of excellence at which such studies shall be performed. The IOM shall freely seek out potential treatments which encompass the human organism.
The professional directors of the IOM shall be retained and remunerated in a fashion parallel to that of the U.S. Supreme Court, and members shall hold their assignments (unless duly impeached) until a preset age (? age 75) or until prior resignation. No member shall be permitted to join with or consult for any pharmaceutical company in any capacity at any time during, or at any time after, his or her IOM tenure.
Members shall be nominated by the President of the United States, and each must be duly confirmed by the Senate, as entirely disinterested medical academics and/or research experts of unimpeachable reputations. Highest qualifications must be sought in all cases, and a member’s total commitment to the most significant goals for the public’s improved health at the most reasonable expense shall be mandatory.
A mandated function of the IOM must include the continual detailed screening of all submitted ideas for improved treatments from medical practitioners and from the general public as well as from career researchers. Summary reports and comments shall be distributed to both the President and appropriate members of the cabinet, and published inprint and online at least quarterly throughout the calendar year. Significant penalties for staff performance inadequacy in this area will be mandatory. An exclusive attention to only those ideas generated by known medical research centers and/or by Big Pharma must be rigorously avoided.
It is expected that, other than as above provided, current functions of the NIH, CDC, Attorney General, FDA, and our Patent system should be generally unimpaired by this new system, with which they will cooperate, and which will be devoted to serving the development of new, useful, and cost-saving medication and medical devices for the public health in a truly disinterested manner.
Let us hope that there are enough representatives in government who will see the importance of the United States having other than its current medical free market system, which has been badly handicapped by the pharmaceutical industry’s need for profits, and instead allow leadership by committed, disinterested medical professionals in order to encourage the discovery of new useful treatments at the lowest prices.