What is an inborn error of metabolism?
Inborn errors of metabolism are inherited, rare, and genetic disorders where the human body cannot metabolize (digest) food into energy. The disorders are generally caused by defects in proteins called enzymes that break down parts of food. Examples include
Defects in amino acid metabolism: phenylketonuria, homocystinuria, alcaptonuria, hereditary tyrosinemia
Defects in carbohydrate metabolism: glacatosemia, glycogen storage diseases (von Gierke, Pompe)
Defects in fatty acid oxidation: short, medium, and long chain acyl-CoA dehydrogenase deficiency
Urea Cycle defects: ornithine transcarbamylase deficiency, carbamyl phosphate synthetase deficiency
Lysosomal Storage diseases: gangliosidoses (Tay Sachs, Gaucher, Nieman Pick), mucopolysacharidoses (Hurler, Hunter)
Defects in heme pigment biosynthesis: acute intermittent porphyria
Metal Metabolism disorders: Wilson’s Disease, Hemochromatosis
Mitochondrial disorders: MERRF
Are there different types of inborn errors of metabolism?
Yes. There are acute IEM problems and chronic IEM problems. Dermetel focuses on chronic IEM problems.
Do all metabolic disorders cause odor?
No. People with lysosomal storage disorders don’t have odor problems; they have muscular degeneration problems. The Pompe people were super smart about how they got a treatment on the market because they worked hard, had faith, and maintained a positive attitude—it’s not a death sentence anymore and people get Myozyme from infancy now.
What metabolic disorders cause body or urine odor?
Phenylketonuria results in a musty/mousy odor and there is a treatment available via BioMarin. The phenylketonuria people were very smart about how they got things done; they never once played the victim, they marketed properly by publishing research, they presented themselves objectively instead of emotionally to pharmaceutical managers, etc.
Tyrosinemia and hypermethioninemia results in a boiled cabbage odor. No treatment is available, but Dermetel knows a Duke scientist working on something.
Maple syrup urine disease results in a maple syrup odor. No treatment is available.
Trimethylaminuria results in either vomiting or a rotting fish odor when certain foods cannot be digested, alongside liver failure and cardiovascular failure in primary cases. Dermetel is doing clinical trials for treatment.
Isovaleric acidemia and glutaric acidemia results in a sweaty feet odor (type 2). Dermetel has identified a potential treatment and hopes to begin working on it in 2021, after the TMAU clinical trials end.
What disease does your clinical trials cover?
Trimethylaminuria (TMAU)—both primary (type 1) and secondary (type 2). Primary means it's genetic and your symptoms will range from malodor to all-out liver failure. Secondary means it's due to antibiotics and your symptoms will range from vomiting to the development of severe food allergies. Primary cases are generally identified at birth. Secondary cases result from medical malpractice and we encourage type 2 patients to SUE physicians and hospitals responsible for treating them with the wrong antibiotics.
Why does Dermetel tell everyone to get a DNA test before getting a urinalysis test?
There are a lot of people who are self-diagnosing as TMAU type 2 when they likely have another inborn error of metabolism and the only way to know for sure is to get a whole exome DNA test as the first step. It is absolutely disgusting to do a choline challenge; it’s worse than water boarding in Guantanamo. The taste, the procedure, the urine is all beyond gross. Get a DNA test as the absolute first step. The only person who should be doing a diagnosis is a medical geneticist. A lot of the endocrinologist types are too nice and don’t know how to interpret genetic data so they’re telling people, “well, I don’t know if you have secondary TMAU or not; the urinalysis test is inconclusive” when the should be referring out to medical genetics because TMAU is not the only inborn error of metabolism out there. TMAU is the most well known of the metabolic disorders but it’s not the only one. Ideally, you want to get consults with both a medical geneticist and an endocrinologist.
How will I be able to buy the archaebacteria supplement?
We’re distributing it exclusively on our website. It will be available globally.
How long will it take until doctors can prescribe the CRISPR ERT treatment?
2022 or 2023.
How do the trials work?
If you have a formal diagnosis from a physician and a DNA test, then we will send you screening paperwork to complete. You submit everything and then our CRO partners—who have medical doctors on staff—will select participants; Dermetel itself is not responsible for screening. If selected, then Dermetel will pay for as much of your travel expenses to and from the testing center, as well as any infusion treatments, as we have allotted per patient. There is no cost to you; Dermetel is covering as much as possible via the funding we’ve received. We don’t know how long the trials will take. If you’re hoping to work or study in school alongside participating, then we highly recommend you get yourself into a remote working job immediately and transfer to an online-only school ASAP. You will need to be on-site quite regularly; we’re doing a lot of hormone tracking tests alongside the trials themselves because there’s a lot going on with progesterone and estrogen and the whole interaction needs to be evaluated formally. There is no way for us to do the ERT remotely. The ERT involves invasive liver surgery, regular infusions, the works; this is not an overnight you get the surgery and are cured forever, TMAU patients getting their infusions will basically be just like diabetes patients who go in for their insulin infusions. People participating are going to need to have flexibility to come in to our clinical research sites. Our treatments are not a quick fix, it is going to be time consuming because there is surgery involved, but ultimately it’ll be rewarding. Our digital psychology, current treatments, and job readiness trials are fully remote—but again, you want to have flexibility in school and/or employment so you can participate fully. There is a lot involved. All of us at Dermetel want to stress that it’s not a miracle right off the bat. Children with TMAU will get better sooner and faster than adults with TMAU and the reason is because children have smaller bodies. We’re doing what we can but we need your help to make sure you can participate. We don’t want a situation where participants say they can come and then they have an in-person job preventing them from leaving; we want to include as many patients as we can, but it’s a two way street. You need to be in a remote position so you can participate.
My age 5 child has TMAU, but my wife and I do not. My wife and I both have in-person jobs and are highly involved in our local church community. How can we make participating in the trials work?
We don’t think it’s a good idea to send your child unattended to our trials. They might get scared without their parents. If there is any way either you or your wife can quit your in-person job and shift to an online job, in order to accompany your child, then we highly, highly recommend that route. Even though Dermetel can get a nanny to supervise your child, it’s better to have at least one parent on site 100% of the time. Out of the 29 families that have contacted us, all of them have started applying for online/remote work positions so they can be with their child the entire time. Children get scared, particularly when going through surgery. It’s important that at least one parent is on hand to provide comfort, a blanket, a teddy bear, a hug, etc. There are numerous online churches—Joel Osteen’s Lakewood Church, numerous others—and it could be that a minor shift from in person church to online church is the right thing given this particular situation. The trials are extremely time consuming; at least one parent needs the flexibility to be involved. In most cases, this means the mother, the grandparent, etc. If you’re the breadwinner and provider for your family, then perhaps it makes sense if your wife takes a year or two off of working altogether to focus on your child. The ERT trials will last a minimum of 18 months and that’s only because Dermetel is particularly determined to get the treatments to market as fast as possible. Most ERT trials take years; 3 to 8 years. Our science is A-grade, on-point, and super solid, so we’re already ready to hit clinical trials.
Will my child be able to continue in school during the trials?
Yes, if they enroll in an online school. There are numerous school-aged children who are going to be participating in Dermetel’s TMAU clinical trials. All of them are going to be in online homeschool environments, so there will be other parents in the same boat as you and your child will be able to make new friends with the other participants. Dermetel is planning numerous social opportunities for parents and activities for children; there will be no boring hospital life watching soap operas every night in the Dermetel trials!
I can’t afford to take time off my job. Is it OK for me to just order the supplement when it comes out and/or to wait until the ERT gets phase 3 approval?
Absolutely! You aren’t required to participate in the trials, we just hope as many people can participate as possible because it will further the frontiers of medical genetics treatments. It’s always better to have more participants than less participants, but we understand that some people can’t shift their in-person jobs to online jobs.
I have TMAU and I’m getting bullied at school/university. What should I do?
Enroll in an online-only school or an online-only university until you have it under control and complete Dermetel’s clinical trials. There are lots of good options: computer science, graphic design, clinical trial management, business, clinical psychology, pharmacy, and law. The more you are around toxicity from people beneath you intellectually, the more it will wear you down. You have to protect your positive energy. Some examples follow. Creighton offers an extremely low residency PharmD program; you can take online pre-reqs in the sciences for two years and go straight into pharmacy school. Numerous top schools offer PhDs, MBAs, LLMs, and JDs online. SCAD has an entire bachelor’s and master’s program track for graphic design online. Oregon State offers computer science online with starting salaries above $150K a year. Google around your areas of interest, figure out what you’re good at and then focus in on only that. We highly recommend you find something that gives you security and flexibility because even after you’re good to go with our treatment options, there still may be residual shyness preventing you from adjusting fully right off the bat. Furthermore, if you’re a wife and mother who wants to be at home around your children, then computer science is one of the best fields out there right now.
But I’ll miss out on fun and networking opportunities if I go to school/university online.
You can still network online and there are other things you can do by yourself or with positive-minded people in a social distancing manner. You can use your time to learn a new language, a new skill, or further yourself professionally. It isn’t worth it to go to an in-person school or university if you aren’t going to make friends because of your symptoms. The entire point of school/university is to learn the material in class and to learn social/networking skills after class. If you’re not going to be able to benefit from the after class component, then do not put yourself in a situation where you’re going to be mistreated through no fault of your own. The “network” is really overestimated in a lot of cases. Plenty of people start networking after graduation when they start their first jobs because people all end up in different geographic regions after graduation. It’s arguably easier to network in adulthood because it’s much more straightforward. The key thing is making sure your formative years (ages 0 to 25) are free from toxicity. Dermetel has noticed dozens of vloggers on YouTube and commenters on forums saying they’re being bullied at school and/or at college because of their rare disease. Get out of that toxicity! Don’t put up with it and go where you’re treated best.
I’m a current college student with TMAU type 1. Should I transfer to an online degree to participate in the TMAU trials?
Nobody has to participate in our trials. We just think it’s the smart thing to do because it’s free for you and will cost a lot of money when it gets to market. If you want to participate, then definitely transfer to an online degree so you have the schedule flexibility to participate. Dermetel has lots and lots of students participating, so you’ll make lots of new friends. One thing that our entire leadership team wants to clarify is that we are determined to see to it that all of our college juniors, college seniors coming in to the trials get their degrees on time and ideally early. Dermetel is working out a deal with ProctorU to cover the proctoring fees of all the college-aged students participating. Email email@example.com if you want more detailed guidance.
How long will it take for the archaebacteria supplement to start working?
We don’t know and that’s why we’re doing clinical trials. Preliminary data suggests 3-14 days.
How long will it take for the enzyme replacement therapy to start working?
We don’t know and that’s why we’re doing clinical trials. It will likely take a long time and the reason is because CRISPR is gene editing. Children will take a smaller amount of time to get better than adults. There are no shortcuts in life and there’s no way for us to shortcut how each individual body will react. Our recommendation is for everyone to get into shape ASAP because some evidence shows that fitter people with healthy BMIs respond better and faster to CRISPR techniques than people who are heavier set.
I think I may have TMAU. Should I get a urinalysis test?
NO. Get a whole exome DNA test. There are people giving out horrible advice to get urinalysis testing. The problem with urinalysis testing is that a 2-3 day choline challenge is not enough for people with secondary TMAU. There are people with secondary TMAU—most of whom developed TMAU as a result of antibiotic usage to treat infectious mononucleosis and strep throat—who end up getting negative urinalysis test results. If a patient is following the low choline diet and taking recommended supplements then they need weeks and weeks eating a high choline diet in order to test positive for the disease. Furthermore, doing a choline challenge means that you set back your entire disciplined regimen and have to stay in lockdown for at least 90 days to reset your body with supplements and the low choline, otherwise you’ll end up with problems. Dermetel has always advised patients to go and get a whole exome DNA test. It only involves spitting into a test tube; there is no urine anywhere, you don’t have to stop taking your supplements or to change your low choline diet, there’s no requirement to go ship your urine bottles on ice, and crucially there’s no gross/bad taste factor. The choline itself tastes disgusting and smells like fish, and no, mixing it with yogurt doesn’t make it more palatable. People are honestly better off eating a lot of smoked salmon, salmon sushi, steak, eggs benedict for 14 days, than imbibing the disgusting choline challenge. Yes, DNA testing costs about $400 more, but it’s worth it. The results are 100% on point for the rest of your life. We suspect a substantial number of people may have another inborn error of metabolism and merely think that they have TMAU because there aren’t a lot of tests out there for isovaleric acidemia. You have to get tested.
I can’t afford to get tested or to see a medical geneticist. What should I do?
Relax. Dermetel has a relationship with a DNA testing center and will be covering 100% free DNA tests for all patients with 100% free medical genetics consultations in our revamped free clinic.
How are people developing secondary TMAU?
A lot of people are developing it as a result of antibiotic usage to treat infectious mononucleosis or strep throat as children, young adults, and sometimes even older adults. Dermetel’s team is authoring numerous case studies of people who are otherwise healthy developing the condition as a result of taking Neomycin—ironic, because it’s an antibiotic often recommended for treating TMAU by people Dermetel knows about. Avoid Neomycin at all costs. There are women who go from being sorority presidents to TMAU patients solely due to Neomycin. There are middle schoolers who go from being the life of the party, social butterfly types, who get strep throat, take Neomycin, and get slapped with TMAU, even when their DNA tests do not indicate any FMO3 mutations.
Can the DNA test catch secondary TMAU?
We don’t know. A lot of people who think they have secondary TMAU actually have primary TMAU. Secondary is extremely hard to diagnose which is why Dermetel was determined to get an over-the-counter archaebacteria supplement treatment together. Even if the DNA test comes back negative precluding patients from our ERT trials, then we have something strong in place for those ‘left out.’
Is there ANY medication that works for primary and secondary TMAU?
There is only one medication: Metronidazole. Take it and you will show absolutely no outward symptoms and go through the day as if there is nothing wrong. It doesn’t work forever and it only works for a maximum of 14 days at a time. But if you don’t complete the dosage, or take it too much, or only take it a day and then drop it off, then you’ll become antibiotic resistant for the rest of your entire life. We have two case study papers in the works of patients who took Metronidazole and Amoxicillin and then became fully resistant. The impetus for Dermetel developing an archaebacteria supplement is due to people we know and love developing severe antibiotic resistance. A group united by a love of gourmet food, Dermetel thinks everyone in society should be able to enjoy prime ribeye steak, eggs benedict, and smoked salmon.
I have a special event, wedding, Christening, etc. coming up before the trials start. How hard is it to get a Metronidazole prescription?
If you are a woman with access to an online physician, then tell them you have bacterial vaginosis in order to get a prescription. Say something like this: “I’ve noticed a lot of discharge in my underwear, and it’s not white. My old doctor prescribed me Metronidazole and it worked to address my symptoms. I was on a 10 day dose of 500 mg four times a day before, but I threw out the prescription bottle. Can we try the same thing to address this?” Make it believable and don’t give too many details about the discharge. They won’t test you to verify you have or do not have discharge. To get brownie points, look up the symptoms of bacterial vaginosis and describe them in detail because if you say you have TMAU, then you will be met with severe skepticism and referred to psych. If you are a guy, then make up a story about how you have pelvic inflammatory disease or endocarditis, and get a prescription from an online doctor or a really stressed out GP working long hours. Is this moral relativism? Yeah, but you do what you need to do.
But I want a GP doctor who knows about TMAU!
Then you need to print out literature review papers about TMAU and find the smartest GP you can find, one who will take the time to read the papers you send. Dermetel recommends using ZocDoc, and then calling the office to send the doctor a personal email with all the papers organized clearly. If you can’t email, then bring print outs to your consultation; for every symptom you present, get PubMed peer-reviewed paper backup. This goes for dentists too. Have backup ready to go. If you go in without peer reviewed papers, then you will be treated with disrespect and derision from a physician significantly less intelligent than you accusing you of “imagining symptoms.” It’s horrible, but it’s the reality, and you have to accept that this is reality.
Hey, Dermetel, I don’t want to have to do this! I want a smart doctor!
Then go see a board-certified medical geneticist.
Can I go buy Metronidazole in bulk from Canada? I mean, I know how to Photoshop…
Yes, but make sure you have a real prescription. Be cautious because if you forge a prescription then you are risking jail time because it is a felony to forge a prescription even for something as innocuous as antibiotics that help you lead a normal life. Obviously, it’s really annoying that a lot of doctors only prescribe it for a week at a time. Rotate amongst doctors and pharmacies if you need to and repeat the same BV/PID storyline. (I.e., Doctor A week 1, CVS; Doctor B in a different area week 2, Walgreens in a different city, etc.) Don’t do anything stupid and smuggle antibiotics via a forged prescription. Forging a prescription means JAIL TIME in a number of different countries, even Canada and even if you’re an American citizen. Dermetel is aware of an American TMAU patient who spent 3 days in jail for smuggling antibiotics by forging a signature of his primary care doctor, just to get more Metronidazole to control his symptoms. Get a legitimate prescription from a credible doctor and then make sure you take it consistently.
Why do family members often think you’re crazy for thinking you have primary TMAU?
They are genetic carriers. The primary version of TMAU is an autosomal recessive genetic condition. Both of your parents are carriers. You would not have the primary condition if both of your parents were not carriers. They are born TMA anosmic, which means they can’t smell it. Other people in the world aren’t TMA anosmic, though, so they can smell it. What happens is that TMAU patients are gaslighted constantly—the world tells them they have symptoms, but they come home and their family tells them it’s in their head. We guarantee you that it’s not in your head.
Is it in my head? Do I have olfactory reference syndrome?
No. There are a lot of brain dead psychiatrists who go to third tier medical schools and earn third tier USMLE scores. Just because you’re asymptomatic at the time of an appointment does NOT mean it is in your head. If you go see a doctor in person, then get a test result in your hand and only go to someone who is a super nerd: elite test scores, kicked ass on their exams in medical school, graduated AOA, extremely sharp in every category. Medical geneticists and dermatologists are the smartest in any medical school class.
Should I take XYZ antidepressant or anti-anxiety medication?
You do you. If you need medication to function, then take it. All of us at Dermetel think you can get even better results from positive psychology, and we intend to prove that with our clinical trial. The problem with antidepressants is that they foster learned helplessness. Mindset shifts come from gratitude and rewiring the brain through hard work and discipline, not from taking a pill. It takes work to work out, to practice gratitude daily, to follow the 360 protocol, but that’s better than popping a pill and being so doped out you lose awareness of your surroundings. The best edge people have in life is intense realism. Losing that to go into a happy bubble blinds you from reality.
What can be done about TMAU that manifests as halitosis?
Take ProFresh and buy a tongue scraper. ProFresh utilizes chlorine dioxide. Normal toothbrushes and toothpaste alone do not work for people with TMAU and halitosis. The reality is that TMAU is a self-discipline issue. It will take about 25 minutes every morning and evening and consistent, twice daily use of chlorine dioxide mouthwash on top of extremely rigorous tongue scraping to get it under control. You will need to be in lockdown for at least 21 days with consistent usage to see results.
Can’t I just get tongue surgery?
There are no shortcuts in life. Dermetel hasn’t seen any effective tongue surgery treatments. Are any of those tongue doctors in Mexico licensed? Are you seriously going to put your entire life in the hands of a guy who has a fat wife, smokes marijuana, and moonlights in a mariachi band? Get real. Buy ProFresh, buy a tongue scraper, and move on in your pathway.
Do the supplements and the low choline diet work for TMAU?
Yes and no. Yes, with a caveat, for men and boys. No for women and post-puberty girls. For men and boys, because they don’t have menstrual cycles, it works if ALL are taken and the low choline diet is followed entirely IN FULL daily, weekly, monthly, yearly, with absolutely no cheat days. Unlike other people, TMAU patients do not have the luxury of cheat days. However, there are serious memory health problems that come from the low choline diet, and this is particularly difficult for young people still in school; students need to be at their best academically and sometimes that involves eating brain food like salmon. The supplements and low choline diet do NOT work for women and post-puberty girls the entire month; there are 9-15 days a month where it won’t work because of hormone levels. For women and girls, the current treatment options mean TMAU can be managed, but never entirely or fully: the symptoms become uncontrollable and noticeable during menstruation. It is impossible to control three days before menstruation, the entirety of menstruation, and three days after menstruation because of estrogen hormone fluctuations.
I’ve spent my life savings on supplements and am not seeing results. What gives?
First of all, don’t spend your life savings. Second, are you taking the right supplements in a disciplined and consistent manner? Third, are you doing the full 360 degree treatment plan? TMAU is basically a self-discipline disorder.
What are the right supplements?
1000 mg of activated charcoal three times daily, 1200 mg of riboflavin vitamin B2 three times daily, and 1 Nullo tablet three times daily.
What is the right 360 degree treatment plan?
Religious following of the low choline/high DMB diet. And absolutely NO low choline/high DMB diet cheat days. You don’t have the luxury of a cheat day. You have to follow the diet 100% of the time.
1000 mg of activated charcoal three times daily, 1200 mg of riboflavin vitamin B2 three times daily, and 1 Nullo tablet three times daily.
Johnson and Johnson baby wash as your shampoo and body wash; cut up Asian scrubbers to use on an individual basis. Do not use a loofah or repeat use. One and done.
ProFresh mouthwash plus a tongue scraper, twice daily.
Gratitude practice daily.
Stable on the life wheel. Read this.
Can naturopathic medicine and Traditional Chinese Medicine help?
Yes, but only in addition to the 360 degree protocol. In women, the problem is with your estrogen levels and progesterone levels, which is why it worsens around puberty and periods. Dermetel is leading a complementary and alternative medicine clinical trial to test the efficacy of options.
Should I take kombucha or drink black tea?
Absolutely not. This is a myth all over the internet. Avoid all teas, coffees, alcohol, cigarettes, and kombucha.
Should I get my tonsils and/or wisdom teeth removed?
Only if a board-certified otolaryngologist says you absolutely have tonsillitis and there is an issue with your wisdom teeth. A lot of people don’t have anything wrong with them. Don’t get sucked into the trap of unnecessary “treatments.” Don’t get your teeth or tonsils removed unless it’s for a medical reason and even then, make sure you get a second or third medical opinion. Teeth surgery and tonsillitis surgery is no joke; you have to take pain medication after and recovery hurts.
Is there a high quality, gourmet-level, low choline and high DMB cookbook you can recommend? I can’t fathom the idea of hospital type food!
Yes, we have a new cookbook coming out soon that is fantastic.
I have TMAU. Do you recommend I join the Facebook Group, the forums, and the text message group?
NO. There are a number of online groups that promote toxic negativity. The most important thing—even above the treatments Dermetel is putting on the market—is to stay positive and to surround yourself with positive people. Your words have incredible power to shape your life; the people with whom you surround yourself have incredible power to alter your mood and mindset. If you wish to talk to someone, then we recommend going to MDLive and getting an online therapist. Do not engage with negative people. Never talk about TMAU as a disease—you are getting better, stronger, healthier each and every day. Do not let negative thoughts enter your mind. If a negative thought comes in, then replace it with a positive one: “Lord, thank you for making me strong, thank you for making me tough, thank you for getting me healthy.”
Why is Dermetel doing a positive psychology trial?
The number one problem TMAU patients have is their mindset, not how the symptoms of their condition affect them on a daily basis. We think that by helping people develop a gratitude practice and practice positive psychology, then they will be in a stronger position to have the resilience to handle normal life. It can be shocking to go from mistreatment for years to being treated with respect. The treatments themselves cannot fix mindset. Inner work and resilience training is important. Dermetel’s objective is to utilize the best practices of holistic medicine from mindset to treatment itself to job readiness.
Why is Dermetel doing job readiness trials?
Most patients with TMAU have been bullied, ostracized, and humiliated by others on a daily basis for the entirety of their lives. Getting their condition under control means people start treating them better, and many patients have absolutely no idea how to make sense of their “new normal.” There are social skills that need to be refined, communication skills that need to be polished, and job training that may have been missing for years due to the condition. As both of Dermetel’s treatments work and work well, Dermetel thinks it is incredibly important to help patients transition to the next stage of life—a normal life—with tools and skills that will help them excel.
Can I eat whatever I want after the trials?
Yes. Even eggs benedict with hollandaise, the greatest food in the world.
When will Dermetel register its clinical trials?
We’ve submitted our paperwork for several trials already.
Why hasn’t Dermetel registered the clinical trials yet?
We have; they’re not live yet. It took us several months to solidify funding. We didn’t want to send in our protocol paperwork or file our final patent registration documents until we had funding secured because it would put the timer on our patents and expose us to even more competition.
Getting full funding upfront this is such a novel strategy…why take this pathway?
Look around in the case studies—so many other small pharmas get eaten alive due to lack of resources, researchers get desperate, it’s a bad situation all around. This strategy may be new but it will work and pretty soon there’ll be case studies about the Dermetel Way of getting things done. We asked for a bold number and we got it. This cushion also means we’re able to acquire a few inventions in cash and it also means we can get to market that much faster. We have very smart people advising us; we know exactly what we’re doing.
Has Dermetel started recruiting for clinical trials?
Only informally. No medical information has been collected; Dermetel is only adding people to its email list-serv. Only Formstack offers GDPR and HIPAA approved form service, which is why Dermetel uses it. Dermetel’s advice is to be cautious about giving out any private medical information without signing a GDPR and HIPAA consent form in advance.
Why is Dermetel fundraising via GiveButter?
Like a lot of non-profits, Dermetel lacks a substantial endowment fund as it was founded by students. Dermetel is now fundraising via GiveButter to increase its endowment for its other projects: its highly well received children’s summer camp and its free telemedical clinic. We’re taking action steps to develop an endowment via corporate sponsors in the pharmaceutical industry. Dermetel’s objective by 2021 is to have a substantial endowment in place via the acquisition of its TMAU treatments and any further corporate donations.
Are you guys certain you can get the treatments acquired after passing Phase 3?
Dermetel has a close relationship with Pfizer. The father of the founder of Dermetel is a physician who has won numerous awards from Pfizer; the two know all of Pfizer’s senior management and Dermetel is using Pfizer for all of its contract manufacturing at a significant discount. Pfizer will absolutely give a strong offer and Dermetel will shop around amongst different options for the best end deal. We have absolutely no doubt that Dermetel’s treatments will get acquired at or above the number our donor-investors expect us to achieve. Passing phase 3 makes us extremely attractive to acquirers and the fact that we’re a nonprofit distinguishes us from all the other players in the rare disease pharmaceutical space. When the time comes, there will be buyers. Our focus right now is meeting the standards our donor-investors have set. They are holding us to the same standards to which they’ve held all the for-profit pharma companies they acquired, so we have a high bar to reach and exceed.
Why is Dermetel running phases 1 to 3 in-house?
Dermetel doesn’t trust any of the other pharmaceutical companies to follow through after rare disease phase 1 trials because of the high costs the companies face. A lot of these huge pharmaceutical M&A deals for rare diseases rarely result in getting drugs to market because people misjudge the potential profitability level. Dermetel studied all the McKinsey reports and all the HBS cases: it is WAY too risky to sell until we have certification that we passed phase 3 in both areas. As well, the big companies don’t have the same hunger, the same determination to get to market fast. You can’t teach hunger. You either have it or you don’t. Big companies can’t innovate on the ground as fast; there is WAY too much bureaucracy. Our approach is to do it all in house for phases 1 to 3 and then, when we have everything needed, then we present a finished and polished approval package—medical research, marketing, and the pharmaceutical products themselves—to the big pharmaceutical companies. We want to be in a strong position to set the deal terms so we have enough to fund trials for all of the other rare dermatogenetic diseases and then get those drugs on the market too. This is a lifelong project; this is not a one-time thing for Dermetel. It is a commitment.
Can’t Dermetel do phase 4 itself?
Theoretically, yes, but distribution is time consuming and nobody on our team finds it even remotely interesting. It’s more exciting to be in drug discovery and run the trials themselves than to have to deal with the distribution side. Other companies have distribution networks and pharmaceutical sales reps in place; no need to reinvent the wheel. Their procedures, their sales people, and their marketing people are really strong. Phase 4 pharmaceutical marketing people are generally the smartest in any MBA class and they know what they’re doing. Inventors and managers are a different breed from marketers. Marketers have their own way of doing things; they know how to get distribution deals done, motivate the sales people to get doctors to prescribe, convince academic doctors to support the treatment at research conferences and in academic journals, and get all the key player insurance companies on board. Pharmaceutical marketing is the most difficult subject. It’s quite different from marketing in other industries due to regulation. We aren’t experienced enough yet to be at that level. In business and in life, you have to play to your strengths.