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NIDAs mission focuses on harms of illicit drugs, and drug treatment. FDA is not in favor of psychedelics or marijuana, just in favor of research.
However, we werent aware at this time of this change, or its positive implications.
Sasha Shulgin courageously speaks out. NIDA recommends human research resume so animal data doesnt become meaningless.
March 10, 1995. FDAs Dr. Curtis Wright sent a memo to Dr. Frank Vocci, NIDAs Director of MDD, urging NIDA to facilitate ibogaine research.
NIDA/MDD doesnt agree with Dr. Wrights advice, ceases investments in ibogaine research.
NIDA in 2003
More than 8 years after NIDA decided not to invest further in ibogaine research, situation remains the same.
No realistic hope for NIDA-funding in the near future unless NIDA presented with promising data from clinical research and new political support for ibogaine research.
Where does this number come from? Does it apply to ibogaine for heroin withdrawal, reductions in drug abuse?
Major Papers
DiMasi J, Hansen R, Grabowski H, Lasagna L. Cost of innovation in the pharmaceutical industry. J Health Econ 10 (Jul 1991) 2:107-42. DiMasi J, Hansen R, Grabowski H, Lasagna L. Research and development costs for new drugs by therapeutic category. A study of the US pharmaceutical industry. 7 (Feb 1995) 2:152-69. DiMasi J. Lasagna L. The Economics of Psychotropic Drug Development. in (eds.) Bloom F, Kupfer D. New York: Raven Press, 1995:1890.
Whittling Away
1. Opportunity Cost on money invested, often for longer than 10 years, at 11% discount rate. 2. The cost of developing all the drugs that never were approved,amortized over approvals 3. Cost of all preclinical, safety, efficacy studies. 4. Large-company overhead, no volunteers.
Opportunity Cost
income foregone from investing in development for a period before returns are earned (time costs).
When opportunity costs of 11% are subtracted from Dr. DiMasis 2003 estimate of $802 million, the estimate is reduced to $403 million, about a 50% reduction.
Cost of Failures
The costs of compounds abandoned during testing were linked to the costs of compounds that obtained marketing approval. DiMasi. J. et al.
5000 chemicals synthesized and screened 250 brought into animal testing 5 into human testing 1 approved by FDA
Pharmaceutical R & D: Costs, Risks and Rewards, Office of Technology Assessment, Washington, DC, 1993.
About 1/3 of remaining research costs are from pre-clinical research, of which FDA doesnt need much if any more for ibogaine.
Cost of Success
Mean cost of clinical research totals $127 million.
Median cost of clinical research is $96 million. Cost for smaller firms is lower.
There is one more factor to take into account. Psychedelics are pariah drugs!
Quasi-Underground Research
For pharmaceutical companies, all data must come from government-approved studies.
For ibogaine, some safety data can be gathered from quasi-underground clinics and submitted to regulatory agencies. Data will not be used directly but can increase FDAs comfort level in approving research.
80 subjects in three groups and 40 in the placebo group, would be sufficient for FDA, 280 subjects per group. This was the size of the studies for the recent FDA approval of Zoloft for PTSD.
MAPS MDMA/PTSD Pilot Study is about $10,000 per subject, larger studies cost less.
Summary Estimates
Assume $8,000 per subject (economies of scale) and 610 total subjects. Cost =$4.88 million. Add $620,000 for consultants, lawyers, lunches, and we need $5.5 million, over 5 years, or:
Relative Costs
$9 million or so spent on State Medical Marijuana Initiatives of non-deductible $$ Canadian Government allocated $5 million just to grow marijuana.
Reduced from $500,000 because data from St. Kitts could be provided to FDA, decreasing the number of dose levels and reducing the number of subjects.
Step 4: Standardize
Additional pilot studies with about 30 or so subjects to standardize therapeutic approach.
Non-Profit v. For-Profit
Ibogaine soon to be off-patent, no monopoly opportunities. For-profit can focus on 18-MC and noribogaine. Large number of patients treated in quasiunderground clinics around the world. This generates successfully-treated subjects who may wish to donate, and further reduces profit potential for FDA-approved drug.
If Psychedelics Become Prescription Medicines, How Should They be Regulated? Certainly this question is many years away, yet it is still worth a bit of time to consider. For some regulators, this eventuality may seem so frightening that research might be halted prematurely so that the data cannot be generated to argue persuasively for prescription availability.
DEA Fear: Legalization for Medical Use = Legalization for All uses. For example, the possibility that the medical use of marijuana could be approved by FDA drives DEA nuts.
From DEAs perspective, legalization for medical use by prescription is virtually the same as legalization for non-medical use since there are few effective ways for it to limit use to certain classes of patients.
DEA Relatively Weak After Drug Approved for Marketing DEA does hassle physicians who prescribe large amounts of pain meds, but DEA usually has to obtain the support of State Medical Boards to punish the physicians if theft or direct diversion is not involved. Unlike DEA, FDA does have substantial regulatory authority to impose requirements on the marketing of drugs that pose special risks to consumers and society.
If ibogaine is approved for the treatment of substance abuse, or MDMA is approved for PTSD, or psilocybin approved for OCD or for anxiety in cancer patients, what happens next?
We run the risk of creating an isolated and feared medical priesthood that excludes skeptics and the risk averse if we mandate that every treating psychiatrist, physician or psychologist must try psychedelics.
Staffing Requirements
Rule 7. The patient shall never be left alone during the active phase of a treatment session.
A minimum of two treatment professionals should be present in the facility during the active phase of the treatment session, though they need not both be in the treatment room.
Staffing Requirements
Staffing requirements would be designed to reduce opportunities for sexual abuse of patients in vulnerable and trusting states .
Advertising
Rule 9. Advertisements, if any, should be targeted to patients or their physicians, with a voluntary restriction on ads in general media. This is to be sensitive to the mostly irrational concerns about sending the wrong message to adolescents.