From my book: What's to be done?

[Guest guest]

27. What's to be done about all this?

LDN is caught up in a Catch 22 of sorts. The doctors won't prescribe

it because there's no FDA approval. It can't get FDA approval because

there's not enough money to be made from a generic drug to justify

spending the millions of dollars necessary to get the FDA approval.

LDN is in the same virtual position as the " orphan drugs " that

congress passed special legislation in order to help.

From Wikipedia:

In the U.S., an orphan drug is any drug developed under the Orphan

Drug Act of January 1983 ( " ODA " ), a federal law concerning rare

diseases ( " orphan diseases " ), defined as diseases affecting fewer than

200,000 people in the United States or low prevalence is taken as

prevalence of less than 5 per 10,000 in the community.

This has been adopted as a subclause of the Food and Drug

Administration (FDA) regulations. The granting of orphan drug status

is designed to encourage the development of drugs which are necessary

but would be prohibitively expensive/un-profitable to develop under

normal circumstances.

Because medical research and development of drugs to treat such

diseases is financially disadvantageous, companies that do so are

rewarded 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 prohibitively

expensive to develop, i.e. pass FDA testing. The only reason it

doesn't qualify as an " orphan drug " is that it concerns diseases that

affect millions of people in the US.

So because it could help millions rather than thousands of Americans

it doesn't qualify to get any help.

Huh??????????????

I know, it sounds completely absurd, but that's the way the law was

written.

Nobody thought about a situation where a drug that has already gone

generic would later be discovered to have a much more important use

than that for which it was originally developed.

This country has stuck to its belief that the best way to develop new

drugs and treatments is to leave it in the private sector and let the

profit motive do its thing. In many ways, that has proven to be the

right approach.

The US leads the world in new drug development.

Although the papers are filled with stories of rampant corrupt

practices among the Big Pharma companies, there is little doubt that

overall we are doing pretty well. Just considering how much life

expectancy has increased in my lifetime is enough to convince me that

we must be doing something right.

LDN represents a weird problem, but one that we can expect to occur

more and more often as the number of drugs going generic increases and

the continuing progress in using whatever is out there to help various

medical conditions increases.

Remember aspirin? A generic headache reliever, it turned out to be

one of the most effective ways of preventing heart attack and stroke.

From the American Heart Association:

The American Heart Association recommends aspirin use for patients

who'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. This

recommendation is based on sound evidence from clinical trials showing

that aspirin helps prevent the recurrence of such events as heart

attack, hospitalization for recurrent angina, second strokes, etc.

(secondary prevention). Studies show aspirin also helps prevent these

events 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 sold

over the counter. As a result you need to convince a doctor to give

you a prescription. A difficult task, as discussed earlier.

Clearly the government needs to tweak the system to deal with this

problem that will only get worse with time.

Possible Solutions:

1. Legislation extending the scope of the " Orphan Drug " law to include

those drugs out of patent for which new uses are discovered. This

would reduce the requirements for approval and allow for government

funding.

2. An Institute of Medicine [iOM] shall 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 to be

able to arrange support for any and all necessary clinical trials it

deems of value, and it shall choose those appropriate centers of

excellence at which such studies shall be performed.

(See appendix: The US System to Develop Important Health Treatments at

Low Cost is Being Hoodwinked)

3. Legislation to allow a substance to be " re-patented " when a new use

is discovered for it. Clearly, this would have to be limited to those

substances which still required a prescription.

The advantage of this approach would be to bring the significant

resources of the pharmaceutical industry to bear on new uses of old

drugs as well as new drugs. It is also likely that the industry would

actually support such a move rather than fight it, making its passage

much more likely.

Among these three possible solutions, my favorite is the last. Like

it or not, Big Pharma practically owns the congress. The chances of

pushing through legislation that they oppose is unlikely if not

impossible.

The other two solutions would be fought against tooth and nail by Big

Pharma because they would both cause big dents in the potential

profits that could be made.

I would much rather have big Pharma behind me than opposing me on the

hill. My primary concern here is getting safe and effective drugs

into the hands of people suffering, not who is making money out of the

operation. Until the US joins the rest of the world in socializing

its health care system, there really is no other choice.

Under the new system, LDN would have been re-patented 20 years ago and

already be a generic drug again by now. Big Pharma would have made

billions of dollars from it and millions of people suffering from the

host of immune system related disorders that it helps would have

gotten relief.

I personally, would never have even had to consider going to Peru to

try an ayahuasca treatment, and there would have been no reason for me

to write this book. Instead the progression of my disease would have

halted before the subcortical dementia had a chance to ruin my life.