Re: From my book: What's to be done?

[Guest guest]

I had no trouble getting LDN prescribed or made up by a local pharmacy.

[low dose naltrexone] From my book: What's to be done?

27. What's to be done about all this?LDN is caught up in a Catch 22 of sorts. The doctors won't prescribeit because there's no FDA approval. It can't get FDA approval becausethere's not enough money to be made from a generic drug to justifyspending the millions of dollars necessary to get the FDA approval.LDN is in the same virtual position as the "orphan drugs" thatcongress passed special legislation in order to help.From Wikipedia:In the U.S., an orphan drug is any drug developed under the OrphanDrug Act of January 1983 ("ODA"), a federal law concerning rarediseases ("orphan diseases"), defined as diseases affecting fewer than200,000 people in the United States or low prevalence is taken asprevalence of less than 5 per 10,000 in the community.This has been adopted as a subclause of the Food and DrugAdministration (FDA) regulations. The granting of orphan drug statusis designed to encourage the development of drugs which are necessarybut would be prohibitively expensive/un-profitable to develop undernormal circumstances.Because medical research and development of drugs to treat suchdiseases is financially disadvantageous, companies that do so arerewarded with tax reductions and marketing exclusivity (a"monopoly")on that drug for an extended time (seven years post-approval).If you enjoy irony, you'll love this.LDN is exactly like an orphan drug in that it is prohibitivelyexpensive to develop, i.e. pass FDA testing. The only reason itdoesn't qualify as an "orphan drug" is that it concerns diseases thataffect millions of people in the US.So because it could help millions rather than thousands of Americansit doesn't qualify to get any help.Huh??????????????I know, it sounds completely absurd, but that's the way the law waswritten.Nobody thought about a situation where a drug that has already gonegeneric would later be discovered to have a much more important usethan that for which it was originally developed.This country has stuck to its belief that the best way to develop newdrugs and treatments is to leave it in the private sector and let theprofit motive do its thing. In many ways, that has proven to be theright approach.The US leads the world in new drug development.Although the papers are filled with stories of rampant corruptpractices among the Big Pharma companies, there is little doubt thatoverall we are doing pretty well. Just considering how much lifeexpectancy has increased in my lifetime is enough to convince me thatwe must be doing something right.LDN represents a weird problem, but one that we can expect to occurmore and more often as the number of drugs going generic increases andthe continuing progress in using whatever is out there to help variousmedical conditions increases.Remember aspirin? A generic headache reliever, it turned out to beone of the most effective ways of preventing heart attack and stroke.From the American Heart Association:The American Heart Association recommends aspirin use for patientswho've had a myocardial infarction (heart attack), unstable angina,ischemic stroke (caused by blood clot) or transient ischemic attacks(TIAs or "little strokes"), if not contraindicated. Thisrecommendation is based on sound evidence from clinical trials showingthat aspirin helps prevent the recurrence of such events as heartattack, hospitalization for recurrent angina, second strokes, etc.(secondary prevention). Studies show aspirin also helps prevent theseevents from occurring in people at high risk (primary prevention).Who could have anticipated this?LDN is in the same position as aspirin was, except that it is not soldover the counter. As a result you need to convince a doctor to giveyou a prescription. A difficult task, as discussed earlier.Clearly the government needs to tweak the system to deal with thisproblem that will only get worse with time.Possible Solutions:1. Legislation extending the scope of the "Orphan Drug" law to includethose drugs out of patent for which new uses are discovered. Thiswould reduce the requirements for approval and allow for governmentfunding.2. An Institute of Medicine [iOM] shall be empowered to become thehealth "czar", overseeing certain major decisions concerning all newmedical treatments and devices. It may overrule the FDA when it deemsnecessary. The new IOM will be sufficiently funded and staffed to beable to arrange support for any and all necessary clinical trials itdeems of value, and it shall choose those appropriate centers ofexcellence at which such studies shall be performed.(See appendix: The US System to Develop Important Health Treatments atLow Cost is Being Hoodwinked)3. Legislation to allow a substance to be "re-patented" when a new useis discovered for it. Clearly, this would have to be limited to thosesubstances which still required a prescription.The advantage of this approach would be to bring the significantresources of the pharmaceutical industry to bear on new uses of olddrugs as well as new drugs. It is also likely that the industry wouldactually support such a move rather than fight it, making its passagemuch more likely.Among these three possible solutions, my favorite is the last. Likeit or not, Big Pharma practically owns the congress. The chances ofpushing through legislation that they oppose is unlikely if notimpossible.The other two solutions would be fought against tooth and nail by BigPharma because they would both cause big dents in the potentialprofits that could be made.I would much rather have big Pharma behind me than opposing me on thehill. My primary concern here is getting safe and effective drugsinto the hands of people suffering, not who is making money out of theoperation. Until the US joins the rest of the world in socializingits health care system, there really is no other choice.Under the new system, LDN would have been re-patented 20 years ago andalready be a generic drug again by now. Big Pharma would have madebillions of dollars from it and millions of people suffering from thehost of immune system related disorders that it helps would havegotten relief.I personally, would never have even had to consider going to Peru totry an ayahuasca treatment, and there would have been no reason for meto write this book. Instead the progression of my disease would havehalted before the subcortical dementia had a chance to ruin my life.