My submission to 60 Minutes to do a story on LDN
Google: LDN !
How could it be that a drug that relieves cancer, AIDS, MS, and immune system
disorders for less than a dollar a day remains unknown 20 years after its discovery?
My name is Joseph Wouk. I’m the son of novelist Herman Wouk.
BA Columbia College 1975
JD Columbia Law School 1979
Israeli Navy 1981-1983 (Fought in the first Lebanon war on a Dabur warship)
Film, TV & Stage producer 1984-1994. (Exec. Producer, Robert Altman’s The Caine Mutiny Courtmartial 1988)
Returned to Israel Navy for first Gulf War, Jan-Feb 1991
Book published on Gulf War experience: Ground Zero: From Hollywood to the Holy land 1992
Worked for the (ADD: Ross) Perot campaign as west coast Jewish Community coordinator 1992.
(Came up with the title, United We Stand, which was adopted as the 3rd party’s name)
My connection to this story:
I have been suffering from progressive relapsing multiple sclerosis for at least the last 7 years. There is no FDA approved treatment for progressive MS. I took copaxone for two months for the relapsing part of my disease, but the side effects were so awful that I had to stop. My condition had become so extreme that in desperation I was getting ready to go to Peru to try a shamanic cure.
About a week before I was going to go, all my symptoms disappeared. The only drug I had been taking for 3 months prior was Low Dose Naltrexone, known as LDN. I knew nothing about the drug but had asked for it because my neurologist who specializes in multiple sclerosis, Dr. Douglas Goodin at UCSF had been personally involved in a patient funded study of it there.
I had actually gone to see Dr. Goodin to ask him to prescribe me a very risky drug, Tysabri. You might have read about this drug, because it has been shown to sometimes cause a deadly brain disease as a side effect. For that reason, it had been taken off the market awhile back, and then put back on the market, but with a black box warning. As I said, I was desperate.
But, when I went to see Dr. Goodin, kind of as an afterthought, I asked about the LDN study. He said that though he had expected nothing, there were some positive results from the 8 week study. He gave me a prescription for that as well. Because of the nonchalant way in which he treated the issue, I just took the LDN hoping that maybe it would help prevent relapses. I didn’t bother to research the drug, and frankly, I didn’t expect much.
The bureaucracy took 2 months before they were ready to give me the Tysabri. My personal physician recommended I wait till getting back from Peru before beginning the Tysabri in order to avoid potential conflicts with the ayahuasca. But miraculously and unexpectedly, a week before I was supposed to leave, all my symptoms disappeared.
I was in complete shock. This wasn’t even possible, and yet it had happened to me.
I had already started writing a book entitled, PLACEBO – A Rationalist Seeks a Miracle Cure about my planned Peruvian adventure. The book is now completely different. It is called:
Google: LDN !
How an Overlooked Drug Relieves Cancer, AIDS,
MS, and Immune System Disorders for a Dollar a Day
Please check out my book so far at: https://sclerotics.wordpress.com/
Today, about the only way to find out about LDN is to Google the word itself; hence the title of my book. This simple fact means that millions of patients who could benefit from it remain ignorant of it.
The extent of the unnecessary suffering and deaths caused by this is truly mind boggling. I became aware of this when I finally Googled LDN myself. The information is there, just not accessible to anyone who doesn’t know the acronym “LDN”.
I still find it difficult to believe. It’s simply too big and too outrageous to accept easily.
I keep thinking that, if I had known about LDN, one of my best friends might not have died. She had multiple myeloma. I researched the disease online endlessly and never came across anything about LDN.
Yet, patients with multiple myeloma had been saved with LDN for 10 years before she died.
It is my firm belief that the central reason this drug remains essentially unknown more than 20 years after its beneficial effects for the immune system were discovered is that it has been out of patent.
Nobody will pay the millions to do the sort of double blind tests the FDA requires for approval.
Furthermore, there is reason to believe that the pharmaceutical industry may be actively trying to prevent the knowledge from spreading. For good reason. Tysabri costs $3,000 a month and must be taken for the remainder of the MS sufferer’s life. Copaxone and the interferon treatments (CRABS) cost about $1,500 a month, also for the rest of your life?
LDN costs $10 a month.
When you combine this fact with the horrible side effects from all the CRABS treatments and even deaths associated with Tysabri, (Google news: Tysabri) and compare them to the almost complete lack of side effects from LDN, it is easy to understand the pharmaceutical companies’ fears.
There are literally billions of dollars at stake here.
Please Google LDN yourselves. This drug can help anybody with immune system related diseases. I’m sure there will be more than one family at CBS that will need this information the way I did.
60 Minutes is the program to break this story.
I am putting together this proposal for 60 minutes to investigate why this drug remains essentially unknown to the public more than 20 years after its benefits to immune system related disorders was discovered.
I have come up with a number of possible explanations:
1. Drug is out of patent. No financial incentive to anyone to invest the millions of dollars required to conduct double blind studies to get FDA approval.
2. Drug companies are actively dissuading people from taking the drug seriously. Many of the larger support boards are infiltrated by members who demonize anyone who mentions success with LDN. I experienced this first hand when I reported on one patient support forum I belonged to that all my symptoms had disappeared from LDN. Afterwards I received a number of emails from other patients who had either experienced it themselves or saw it done to others on their forums. It is possible that these people are affiliated with drug companies and the marketing companies affiliated with those drug companies.
3. Search engines turn up nothing on LDN when a disease itself is searched. This despite approximately 50,000 sites mentioning the treatment online. I’m not sure why this happens, but I suspect that there is manipulation behind the scenes. There is a whole science behind “search engine optimization” (SEO) that is available to those with the cash to utilize it. (This is actually an interesting story in its own right.)
4. Doctors either don’t know about LDN or are reluctant to prescribe an “off label” use of a drug that is routinely characterized as “experimental” and whose success stories are labeled as “anecdotal”. Anecdotal actually only means that the FDA required tests have not been run, but it is a “loaded” word that gives one the impression that it is an “old wives’ tale” or a flaky new age non-treatment. Also, the theory behind how it works sounds almost homeopathic, something MDs are just not used to.
5. People who actually do get some information are scared off by the fact that it seems to be effective on almost EVERY major disease. This gives it an unrealistic aura and lends it to being characterized as a phony “snake oil” cure-all. When I began researching, it had that effect on me.
“NO drug can do all this!”
But apparently it helps so many major diseases because it does not directly address any of the diseases themselves but instead helps restore the immune system. The body then fixes itself as it ordinarily would.
Each one of the topics listed above would qualify as a good segment on 60 Minutes. The resources CBS could bring to bear on these issues could uncover much more than I have been able to. Given the amount of money involved, it is hard to believe that there is not a lot more than happenstance involved in the drug’s remaining unknown to the public.
All of the FDA-approved medications for multiple sclerosis are dangerous, ineffective and expensive. Copaxone, Betaseron, Rebif, Novantrone, Avonex and Tysabri all have ghastly side effects and extremely low patient satisfaction.
From available evidence, LDN appears to be helpful in approximately 80% of the patients who try it. This is almost twice the percentage of satisfaction with the treatments listed above. For instance, hundreds of patients evaluated LDN extremely favorably on AOL-founder Steve Case’s Revolution Health website. See http://www.revolutionhealth.com/drugs-treatments/rating/naltrexone
Although I have a personal stake in getting this life saving information out to my fellow sufferers, I also believe that the story, if taken on by 60 minutes, is Pulitzer Prize material.
It isn’t only the personal suffering and financial ruin that this story could help prevent; it is also the savings to our society which is currently spending billions of unnecessary dollars on dangerous and ineffective treatments.
The word about LDN is slowly beginning to get out. Eventually it will become unstoppable. Although I do not yet have a publishing contract for my book, I am confident it will come out this winter. .
There is another book entitled “The Promise of Naltrexone” coming out in September, which is targeted to the medical profession.
In October, The Fourth Annual Low Dose Naltrexone (LDN) Conference will be held. It is reasonable to hope that it will help spread the word as well.
While no network news stories have yet been done on the story, a number of local network affiliates have done stories which can be seen on youtube.com. Also quite a few radio interviews have aired.
The following is from Dr. David Gluck who runs the main LDN information website, http://www.lowdosenaltrexone.org:
As a Board-certified specialist in both Internal Medicine and in Preventive Medicine, the continuing availability of newly effective medical therapies – treatments to help deal with the problems of devastating disorders such as cancers, HIV, or autoimmune diseases – is a critical issue, not only for those patients who are immediately effected but also for their families and for society in general.
Recent years have demonstrated that the methods we had taken for granted, the unswerving commitment of the pharmaceutical companies to develop more effective treatments, is no longer the case.
Within the past month, I contacted the Medical Director of a pharmaceutical company that had recently had an article about its own new drug use published within the New England Journal of Medicine. I told him of the continued excellent results with an unusual medication that he had been first told about in the 1980’s. Recently, because of contributions by individuals, this off-label medication had been able to accomplish a small but positive study at Penn State in 2007 on Crohn’s disease, and in 2008 two new important studies will be published, one from Milan, Italy and one from the University of California in San Francisco, both on its usefulness in treating multiple sclerosis.
The drug, low dose naltrexone [LDN], is available as an off-label prescription. It is generally taken orally as a 4.5mg capsule once a night at bedtime. Naltrexone itself at 50mg was FDA approved in the early 1980’s as a treatment for heroin abuse. It is off patent and is a generic medication. The Medical Director told me that he has no problem with the question of efficacy of LDN, he knows it works quite well, his problem lay in convincing his Board that they should lay out 10 or 20 million dollars for a clinical trial for FDA approval and thus risk that the company makes no profits from that cost because anyone can obtain the original drug as a liquid and be able to have the small dose that way.
Therefore, under our present system, millions of people who would have benefited from this inexpensive medication, which has absolutely no toxicity and virtually no side effects, will never discover this brilliant medication, which acts by strengthening one’s immune system.
LDN thus far has demonstrated its ability to halt the further progression of any autoimmune disease (such as rheumatoid arthritis, Crohn’s disease, systemic lupus erythematosus, multiple sclerosis, etc.), and often has considerably useful effects on any cancer or HIV infection.
In addition, many people with Parkinson’s disease and motor neuron diseases (including ALS) have reported improvements or a halt in progression through taking LDN, and a specialist in Neurology has discovered that some 75% of families whose children with autism use it are reporting impressive changes in the child’s willingness to play with others.
There is no question in terms of LDN’s efficacy. Unquestionably positive reports, both small studies and scientific trials, are continuing to find their way into esteemed peer-reviewed medical journals – and that information joins with over 20 years of strongly supportive anecdotal reports. See “Clinical & Animal Trials of LDN” at http://www.ldninfo.org.
From the first, FDA approval of LDN’s special uses has been blocked, perhaps unintentionally, by the existing system which sets up the large well-financed pharmaceutical firms as the virtual “gatekeepers”.
Given that the existing system is based on the legal approval of each newly proposed drug by the FDA, and that the FDA requires clinical trials’ results of great cost, it is only the funding pharmaceutical companies’ determination of the potential profitability of any individual candidate drug, no matter its potential therapeutic usefulness, which decides whether a new medication will or will not have an opportunity to reach the public marketplace and thus contribute to the public health.
Thus, the stated health-related mission of a pharmaceutical company is generally not at all compatible with that of its necessary primary motivation, which is to gain earnings and profits.
This leads to an erosion of medical advances, paradoxically in an era of severely mounting medical costs, in that an off-patent generic drug with a newly found 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.
(Note: I’ve attached the official information regarding a study being conducted by Hadassah Medical School regarding the use of LDN to help autistic children.)
The 60 Minutes Segment
If 60 minutes decides to do this story, they will naturally have their own way of constructing the segment. Below I have laid out the way I would do the story for you to do with as you please.
1. Google LDN!
2. LDN – Penicillin for the Immune System?
My story or any of the others helped by LDN. See the 150 page volume attached:
Health Case Studies of Low Dose Naltrexone (LDN) in the treatment of a range of diseases
Naltrexone developed in the 60’s and pushed by the Nixon administration as a way to help heroin addicts.
Naltrexone is a drug called an opiate antagonist. Used to treat opiate drug addiction, it blocks the response to opiate drugs, such as heroin or morphine. Doses for this are 50-150mg. The idea of using LDN for MS was devised by Dr. Bernard Bihari, a practicing neuro-physician in New York, USA. Low-dose Naltrexone (LDN) has been in use in the United States in the treatment of MS since 1985.
Interview with Bernard Bihari M.D. (See attached Curriculum Vitae )
Interview with David Gluck M.D. (Leading expert on LDN therapy)
1. FDA approval requirements prevent any drug that is out of patent from getting approved.
· “Orphan Drug” law not applicable because drug helps more than the maximum number of patients required by the legislation.
· The amount of money required to do the testing required for FDA approval makes it impossible for the investor to get a return unless the drug is under patent.
2. Pharmaceutical companies are actively discouraging and preventing information about LDN from reaching the patients.
· Use of phony “patients” in online forums to attack and discredit people who mention the treatment as an alternative to the CRABs and Tysabri. I have received similar reports from forums for other diseases that LDN helps.
· Possible manipulation of search engine results through the use of SEO (Search Engine Optimization) techniques. (I have no proof of this, only suspicions given the amount of money involved and the tactics mentioned above.)
3. Doctors are ill informed and are hesitant to prescribe off-label drugs.
· Doctors do not refer to the smaller academic studies which are the only ones possible without a huge investment. The UCSF study was patient funded and was conducted with a small budget of $25,000. See http://www.ldners.org/.
· Treatments like LDN are for the most part unknown by most of the medical establishment. Reliance on the FDA’s testing, flawed though it is, is their only way of feeling safe from potential malpractice suits.
· Off label prescriptions of FDA approved drugs are legal in most states, yet doctors are hesitant to give them. I’m not sure where the insurance companies stand on this issue, though mine, Blue Cross, is paying for my prescription.
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.
Per David Gluck:
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 attached: 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.
This story represents a chance for 60 Minutes to directly contribute to the health and welfare of literally millions of people around the world. Even if no government action ever resulted, the widespread dissemination of information about LDN would make it much more difficult for the pharmaceutical companies to continue to prevent widespread acceptance of this inexpensive and effective treatment.
The number of people’s lives that would be saved and the amount of suffering that could be prevented is so large that it is impossible for me to think of any precedent in broadcasting history.
The savings to the US economy are hard to estimate, but there is little doubt it would run into billions of dollars per year.
The only way of changing the current flawed system of getting FDA approval for drugs is through extreme pressure on the legislative branch. This segment would likely galvanize the support necessary for this to happen.
These are the reasons why I said in the opening paragraphs that I felt it was Pulitzer Prize material, if handled properly. This is why I decided to submit this proposal exclusively to 60 Minutes. Your show has the best record of doing what is right for the country, even when it may be unpopular among the powers that be.
4 Comments »
- LDN in Seven Minutes
- My submission to 60 Minutes to do a story on LDN
- WSJ – Brain Infections Return for Multiple Sclerosis Drug Tysabri
- Patient LDN experiences
- LDN & Multiple Sclerosis – FAQ
- Patientslikeme.com is big Pharma Country – Stay away!
- The History of Naltrexone
- How LDN works and was discovered – Interview with Dr. Bihari
- 28. How did this happen?
- Background and Information on LDN Therapy for Immune System Diseases
- 27. Miracle Cure?
- 26. Back to Square One ???