The Medical Prize Charitable Trust is duly registered under the Charities Act 2005 (NZ) (Reg. No. CC49977). The current trust board comprises Savva Kerdemelidis, LLM(First Class Hons), BSc(Hons), IP/commercial lawyer, and Andreiko Kerdemelidis, BE(Elec), Social Media Strategist. We have partnered with the Gut Health Network, a world-leading group of IBD researchers and Incentives for Global Health, a prestigious think-tank behind the proposed Health Impact Fund, who are both providing expert assistance. We are in the process of partnering with additional charities.
Crowd Funded Cures (CFC) is an initiative of the Medical Prize Charitable Trust, a non-profit organisation dedicated to helping prove that cheap and natural therapies work, by using crowdfunded prizes for clinical trials.
The pilot project of Crowd Funded Cures involves crowdfunding a Crohn’s Disease medical prize fund of at least US$10m that will reward successful randomised controlled trials (RCTs) of unmonopolisable therapies for Crohn’s disease (e.g. diets such as SCD, LOFFLEX, enteral nutrition, dietary supplements such as Vitamin D, fish oil, curcumin, second uses of generic drugs such as LDN, and natural therapies such as helminths and fecal transplantation). Donor funds will be allocated annually to sponsors of successful clinical trials according to objective measures of clinical impact.
The mission of our first Crowd Funded Cures project is to help put cost-effective and natural treatments and cures for Crohn’s Disease into the public medicine chest.
Crowd Funded Cures is an initiative of the Medical Prize Charitable Trust for crowdfunding an incentive prize fund for unmonopolisable therapies which lack private incentives for development under the current patent system. It occurred to us that our current system pays over US$500 billion per annum in monopoly markups to pharmaceutical companies for developing patentable therapies. Approximately US$100 billion are put back into R&D of patentable therapies (and the rest on marketing/administration). This means there are no private incentives to fund clinical trials for “unmonopolisable therapies”, even if they could be effective treatments or cures. Unfortunately, the absence of clinical trial data, this area suffers from quack remedies, misinformation and anecdotal reports. We hope that Crowd Funded Cures could raise awareness of this problem and help validate cost-effective and natural therapies which actually work.
Why Crohn’s disease?
Crohn’s disease also has a very high disease burden as it is incurable and requires a lifetime of strong immunosuppressant medication. It has been estimated to cost over US$10-15 billion per annum in the US alone on medication, surgeries and outpatient care. One of the main treatments for Crohn’s disease, Humira, is the highest-selling drug in the world, with over US$8 billion in annual sales, which are borne by payers (government reimbursement agencies/health insurers) and ultimately, by society due to increased taxes/premiums. We are hoping to partner with payers, who can fund prizes for clinical trials of cost-effective therapies.
What are Unmonopolisable Therapies?
‘Unmonopolisable therapies’, are therapies with potentially high social value which lack private incentives for development as they cannot be exploited using patents. Examples of such therapies include second indications for cheap generic drugs or drug combinations for which patents cannot be used to prevent “off-label” use by doctors or patients (see Eisenberg (2005)). For the same reason, patents cannot be used practically to enforce monopoly prices for diets, dietary supplements, lifestyle interventions, surgical methods, “natural” remedies, and many complementary and alternative medicines. Unmonopolisable therapies fall within a broader subset of “unprofitable therapies” which include therapies for neglected/third world diseases, as an innovator company could not recover enough money from the market to justify significant R&D investment, even if they had patent protection. Crucially, the inability to enforce property rights over a medical therapy has no correlation to its medical value. There is systemic bias towards ‘monopolisable therapies’ which are becoming more expensive to produce over time, at the expense of ‘unmonopolisable therapies’ (which comprise ‘non-excludable’ information – see Kapczynski & Syed (2013)).
Crowd Funded Cures will crowdfund an incentive prize for showing safety and efficacy of unmonopolisable therapies with randomised controlled trials.
How will the prize fund be ‘implemented?
The prize fund will be implemented as follows:
1. Donors pledge money towards an incentive prize fund;
2. Randomised controlled clinical trials (RCTs) of at least 100 patients showing clinical efficacy of an unmonopolisable/unprofitable therapy for a particular disease are “registered” with the prize fund for 5 years; and
3. Prize panel allocates rewards to the registered RCTs proportional to clinical impact in 5 annual instalments.
As donors only pay for successful RCTs, the risk of RCT failure is shifted to the market. RCTs of unmonopolisable therapies cost US$1-2 million, therefore, an annual US$2 million prize fund can provide a viable ROI. With payment of fixed annual rewards, the mechanism (based on the Health Impact Fund proposed by Incentives for Global Health) is self-correcting, as the registration of additional RCTs will decrease the amount of likely rewards and vice-versa. This means sponsors of RCTs are not under or overcompensated. The larger the prize, the greater the incentives to fund RCTs. Notably, the prize does not pay for failed RCTs, which still comprise highly valuable information.
Prize rewards will allocated by the prize panel according to incremental clinical impact vs usual care. For example, a “registered” RCT may show that an unmonopolisable therapy for Crohn’s disease lowers CDAI by 150 points over usual care on average and another RCT shows a reduction of 100 points and another RCT shows a reduction of 70 points. In that case, the $2m annual rewards will be allocated in a ratio of 150/100/70 for that year (with RCTs eligible to receive rewards for 5 years in total). Notably, each of these “registered” RCTs show an improvement over usual care and therefore represent a clinical breakthrough for patients.
Why use prizes rather than grants?
With prizes, donors are guaranteed to fund medical breakthroughs. The prize fund “de-risks” the potential efficacy of an unmonopolisable therapy so charities and/or government organisations would fund larger trials to test whether the results can be reproduced. Without such “de-risking”, charities and/or government organisations rarely fund large RCTs preferring to leave this to private industry. In the event larger RCTs do not confirm efficacy, the RCT will be “de-registered” from the prize fund. Importantly, prizes enable donors to obtain valuable information on which unmonopolisable therapies do not work for ‘free.’ All clinical trial data will be published and made available to the public, enabling systematic reviews to confirm efficacy (or not).
Examples “Unmonopolisable Therapies” for Crohn’s disease:
· Vitamin D for treatment of Crohn’s disease – http://www.ncbi.nlm.nih.gov/pubmed/20491740
· Semi-vegetarian diet for treatment of Crohn’s disease – http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2877178/
· Specific carbohydrate diet (IBD-AID) for treatment of Crohn’s disease – http://www.umassmed.edu/uploadedFiles/MBD_Poster59_EDITED_5-15-2011.pdf
· EEN for treatment of Crohn’s disease – http://www.ncbi.nlm.nih.gov/pubmed/16928225
· Enteric-coated fish oil capsules for treatment of Crohn’s disease http://www.nejm.org/doi/full/10.1056/NEJM199606133342401; http://www.ncbi.nlm.nih.gov/pubmed/17443620
· Cannabis for treatment of Crohn’s disease – http://www.ncbi.nlm.nih.gov/pubmed/21910367
· Off-patent Low-dose-naltrexone (LDN) for Crohn’s disease – http://www.ncbi.nlm.nih.gov/pubmed/21380937 ; http://www.ncbi.nlm.nih.gov/pubmed/17222320; http://www.ncbi.nlm.nih.gov/pubmed/23188075
· Anti-MAP therapy (combination of generic antibiotics) for treatment of Crohn’s disease – http://www.sciencedirect.com/science/article/pii/S1590865802800561
· Low starch diet for treatment of Crohn’s disease and ankylosing spondylitis through inhibition of Klebsiella pneumonia microbe – http://www.ncbi.nlm.nih.gov/pubmed/21955846
· Soluble plant fibres (plantain and broccoli) for treatment of Crohn’s disease – http://www.nature.com/nrgastro/journal/v7/n12/full/nrgastro.2010.180.html; http://www.eurekalert.org/pub_releases/2010-08/bmj-pab082510.php
· N-acetyl glucosamine for treatment of Crohn’s disease – http://www.ncbi.nlm.nih.gov/pubmed/11121904
· Hydroxytryptophan and L-tyrosine (serotonin and dopamine amino acid precursors) for treatment of Crohn’s disease – http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3108661/
· Helminthic therapy for treatment of Crohn’s disease – http://gut.bmj.com/content/54/1/87.short
· Fecal transplantation for treatment of Crohn’s disease and Ulcerative Colitis – http://www.nature.com/nrgastro/journal/v9/n2/abs/nrgastro.2011.244.html; http://www.ncbi.nlm.nih.gov/pubmed/12811208
· Saccharomyces boulardii (probiotics) in Maintenance Treatment of Crohn’s Disease – http://link.springer.com/article/10.1023/A:1005588911207
· Mesenchymal stromal cells (stem cells) for treatment of Crohn’s disease – http://gut.bmj.com/content/59/12/1662.short
· Autologous and/or allogenic hematopoietic cell transplantation (HCT) for treatment of Crohn’s disease – http://bloodjournal.hematologylibrary.org/content/116/26/5790.full
Examples of “Unmonopolisable Therapies” for cancer and other diseases:
· Off-patent NSAID oxyphenbutazone (OPB) for treatment of drug resistant tuberculosis – http://www.genengnews.com/gen-news-highlights/1950s-nsaid-kills-resistant-tuberculosis/81247295/
· Vitamin C for treatment of HIV – http://www.ncbi.nlm.nih.gov/pubmed/1698293?dopt=Abstract
· Vitamin C for treatment of drug resistant tuberculosis – http://www.nature.com/ncomms/journal/v4/n5/full/ncomms2898.html
· Vitamin C for treatment of Alzheimer’s disease – http://www.ncbi.nlm.nih.gov/pubmed/12076225
· Vitamin C to improve outcomes after surgery – http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1422648/
· Vitamin E for treatment of Alzheimer’s disease – http://jama.jamanetwork.com/article.aspx?articleid=1810379
· Vitamin B for treatment of Alzheimer’s disease – http://www.pnas.org/content/110/23/9523.abstract
· Vitamin B6 for prevention of colon cancer – http://www.ncbi.nlm.nih.gov/pubmed/20233826.
· Vitamin D for treatment and prevention of breast cancer – http://www.sciencedaily.com/releases/2013/01/130122142911.htm.
· Vitamin D for treatment of Type 2 diabetes – http://www.ncbi.nlm.nih.gov/pubmed/18279409.
· Falcarinol (natural compound present in carrots) for treatment and/or prevention of colon cancer – http://www.ncbi.nlm.nih.gov/pubmed/15740080.
· S-adenosylmethionine (SAMe) – supplement for treating depression – http://well.blogs.nytimes.com/2010/08/31/study-shows-same-may-ease-depression/
· Off-patent chlomipramine for treatment of brain tumors – http://www.canceractive.com/cancer-active-page-link.aspx?n=1096
· Off-patent imipramine and promethazine (antidepressants) for treatment of small cell lung cancer – http://www.sciencenewsline.com/articles/2013092711260001.html
· Ketogenic Diet for treatment of epilepsy – http://www.ncbi.nlm.nih.gov/pubmed/18301085
· Medical food L-methylfolate for treatment of depression – http://www.medicalnewstoday.com/releases/189730.php
· Beetroot juice/nitrate supplementation for hypertension – http://www.bbc.co.uk/news/health-22152901
· Curcumin for treatment of prostate cancer – http://www.ncbi.nlm.nih.gov/pubmed/23042094
· Curcumin for treatment of Alzheimer’s Disease – http://www.ncbi.nlm.nih.gov/pubmed/17472706
· Curcumin for maintenance of remission for Ulcerative Colitis – http://www.ncbi.nlm.nih.gov/pubmed/17101300
· Coenzyme Q10 for treatment of heart disease – http://www.sciencedaily.com/releases/2013/05/130525143852.htm
· Garlic for treatment of hypertension – http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2442048/
· Dark chocolate for treatment of hypertension – http://www.biomedcentral.com/1741-7015/8/39
· Green tea for lowering cholesterol – http://www.ncbi.nlm.nih.gov/pubmed/11897173
· Grapeseed extract for prevention of prostate cancer – http://www.ncbi.nlm.nih.gov/pubmed/21598177
· Generic ibuprofen for treatment of Parkinson’s Disease – http://www.neurology.org/content/early/2011/03/01/WNL.0b013e31820f2d79
· Generic pioglitazone for treatment of Parkinson’s Disease – http://www.ninds.nih.gov/disorders/clinical_trials/NCT01280123.htm
· Cannabis for treatment of cancer – http://www.ncbi.nlm.nih.gov/pubmed/21475304; http://www.ncbi.nlm.nih.gov/pubmed/16501583; http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3442177/
· Avastin for (relatively) cheap treatment of age related macular degeneration – http://www.bmj.com/content/344/bmj.e3162
· Antibiotics for treatment of peptic ulcer disease – http://www.cdd.com.au/pages/disease_info/heliobacter_pylori.html
· Antibiotics for lower back pain – http://www.guardian.co.uk/society/2013/may/07/antibiotics-cure-back-pain-patients
· Generic Bacillus Calmette-Guérin Tuberculosis vaccine for reversing Type I diabetes – http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0041756
· Oral rehydration therapy (i.e. sugar, salt and water) for treatment of cholera – http://en.wikipedia.org/wiki/Oral_rehydration_therapy
· Male circumcision for prevention of HIV transmission – http://www.sciencedirect.com/science/article/pii/S0140673607603122
· Low calorie crash diet for treatment and potential cure of Type II diabetes – http://link.springer.com/article/10.1007%2Fs00125-011-2204-7
· Gastric bypass surgery for treatment and potential cure of Type II diabetes and treatment of cardiovascular disease – http://www.ncbi.nlm.nih.gov/pubmed/24018646
· Exercise for prevention of depression – http://www.sciencedirect.com/science/article/pii/S0749379713004510
· High EPA fish oil for prevention of onset of psychotic disorders – http://archpsyc.jamanetwork.com/article.aspx?articleid=210554; http://summaries.cochrane.org/CD001257/polyunsaturated-fatty-acid-supplementation-for-schizophrenia
· An extensive list of unmonopolisable dietary supplements and herbs is available on the Memorial Sloan Kettering Cancer Centre Website with evidence regarding their efficacy for treatment and prevention of various diseases – http://www.mskcc.org/cancer-care/integrative-medicine/about-herbs
NOTHING POSTED ON THIS PAGE CONSTITUTES MEDICAL ADVICE.
Please seek the opinion of a medical professional before considering whether to try any “unmonopolisable therapy” referred to on this page.
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