What Endo-C Skeptics Won’t Tell You
There have been several people that have been very vocal about what Endo-C is trying to accomplish. They claim that we are a smoke and mirrors operation. Often, assertions have been made without anyone coming by our offices to see the operation or do the work of researching our company and the efforts we have done to be compliant on the Federal and State level. Sad to say, they have been irresponsible in trying to discredit both public and private citizens without fact.
In addition, understand the motivations of those involved in the subtle art of a smear. Some want to go the way of California’s approach to cannabis and think Endo-C is causing roadblock. I disagree, Endo-C is leveraging scientific methods and information to use cannabis in the most responsible way per the current laws in Utah.
I welcome the skeptics. Let’s face it this market is coming out of the shadows and it is hard to know who is credible both from a product side and a business side. Let’s break it down issue by issue.
HB130 is a vendor bill – Wrong
Doesn’t this seem very old boy network? It sounds like Endo-C has cornered the market or captured public money for their own gains. There is no monopoly nor is Endo-C obtaining any public funds. According to HB130, any institution can perform CBD studies, as long as that institution meets the requirements.
UT State Rep. Brad Daw benefits from HB130 – Another Sad Smear
Simply put: no. He has never received stock, money our any such benefits from anyone from Endo-C. He is just trying to create a reasonable safe path to understanding the benefits of cannabis for his constituents.
It is more about business than academics – We are a studies company
Our company exists to learn about the effects of CBD. So, to keep the lights on and keep our studies running, we do need income, just like a university needs tuition and grants to keep operating. Our model, under the Federal Department of Health and Human Services (HHS) guidelines, allows immediate access to CBD while gathering a large amount of data. It is a win for the consumer and a win for the doctors who need this information to feel comfortable about prescribing CBD in the future. In this study, participants provide medical history when they sign up and monthly updates online. We are creating a faster path to answers about cannabis.
One more point, both the FDA and HHS are charged with monitoring studies. Typically, one hears more about the FDA because large pharmaceutical companies are submitting their findings as part of getting approval of a new drug that they can then patent. Those studies are usually well funded and are small, usually around 60 participants, and very focused. Endo-C is trying to better understand cannabis, not to create a patented drug to sell. HHS was better match for our needs of data gathering.
Endo-C Should do Double Blind Studies – And Endo-C will
Each study type has its pros and cons. Our first study is an observational study which lends itself to gathering a wide variety of data and building further hypotheses. Observational studies are also strong on validity and in-depth understanding and accessing people in a real-world context which our primary investigator felt was important. We are not a large company like a pharmaceutical firm with a huge slush fund. Participants purchase the study and we felt it unfair to charge someone for a placebo.
In the coming months, Endo-C plans to do a double-blind study with no charge to participants. As anyone who manages studies understands, investigators need to pick the appropriate format for the type of findings to be researched.
It’s just a CBD Subscription – No, that would be easy
The inference here is that we are just sending out CBD for cash. That would certainly be easier. We have built a state of the art online infrastructure to support gathering information as we do these studies. In addition, Endo-C is Health Insurance Portability and Accountability Act compliant (HIPAA) and employees have been trained to follow protocol. Yes, the participants pay $280 which is a reasonable market rate and receive bio-available CBD gel capsules, but in addition participants get doctor monitoring and if he or she needs more CBD during the month there is no additional cost. We are interested in meeting the needs of our users when it comes to the financial aspect of the studies. With that in mind, we offer discounts to full-time students, law enforcement and a first month free trial with doctor approval.
The Institutional Review Board (IRB) is not independent – It is their reputation
Both the Food and Drug Administration (FDA) and the HHS have authorized IRBs to ensure the safety of those participating in research. The board may require modifications prior to approval of planned research or can also disapprove a study. In our case, the IRB board has provided additional requirements for our study and we have met those requirements. So, by no means are they rubber stamping our studies. IRBs consist of 5 or more members with a diverse set of backgrounds and institutional associations. At least one scientist and one non-scientist should be on the IRB. As with most boards, each member is staking their professional lives on the appropriate responsible conduct of the board members and the entities they oversee. At this time, Endo-C continues to work closely with the board to meet all the HHS requirements on each of our studies.
Lastly, an individual infers that because the IRB shares our address at this time that they are not independent. An IRB sharing a location is not unusual. We only have to look to a local Utah university to see an IRB at the same location as the on going research, but no one questions their independence.
More to come…
Endo-C is very excited to have launched its first study on the effects of CBD on pain, sleep and anxiety. We have made every effort to comply with state and federal regulations, but the most important mission is to support our participants and gather the best information that will help scientists and doctors better assist patients. Endo-C has several additional studies getting ready to launch and we cannot wait to offer them to future participants.