Because Ive become more and more interested in the Topical route I thought it would be a good opportunity to invite Dr. Yechiel, the maker of ELSOM RESEARCH Formulas and Topicals to the Topical forum.PLEASE READ THE FOLLOWING BEFORE ASKING ANY QUESTIONS:
The fact is that only two drug types (with some variations) are currently approved as treatments for hairloss, either for re-growing hair or for reduction of hairloss. Only these drugs can be associated with medicinal claims such as “my product causes hair to grow” or “my product is reduces shedding of old hair”. The reason for this is the interpretation of the law by the FDA, which is a law enforcement agency in the US and not, as some may perceive, a scientific peer-review agency. Other countries have similar regulatory agencies; because we are located in the US, we must comply with the regulations of the FDA.
The FDA’s protocol and procedures for approving a new drug are the only protocol and procedures which can result in permission to apply medicinal claims to a product. There are many other alternative protocols which are scientifically valid and can prove or disprove the usefulness of a certain ingredient or product, but it is not legal to attach medicinal claims to a product, even if found useful and valid, unless the FDA has legally approved it as a medicine. Not everything which is legally approved as “working” factually does work and not everything which has not been legally approved as “working” is factually useless. In the same way, a person with unusual abilities to present a case in court will not be allowed to practice as a lawyer, but any mediocre lawyer who is bar-certified can present a case in court and act as a lawyer. So, factually there are wonderful “lawyers” without formal education and lousy lawyers with formal education. There is one difference however:, some demagogues can persuade people that they are great lawyers and lose the case for them, while scientific evaluation is as qualified (and can be even more qualified) as a professional opinion regarding the usefulness of a certain ingredient or product.
The government tries to protect people from bad products and services, but the price for that protection is that in this process many wonderful inventions and potential cures fall victim to the regulatory process, which is a critical factor in the enormous expenditure of money and time for new drug development (in my opinion, a more important factor in making drugs expensive than even drug companies’ greed). This is also the main cause of the shockingly small inventory of potentially new and exciting medicinal candidates, and the main cause for reinventing and reshuffling old drugs instead of developing real new drugs. There are also potential patent infringement issues which also limit the spectrum of claims. Nevertheless, everyone must abide by the law. People who are not selling either of the two approved baldness drugs and who claim that their product cures baldness or reduces shedding of hair are breaking the law, even if they can show scientific evidence to support their claims. It is possible to phrase claims in a way that does not confront the law; such language may look somewhat evasive or indirect (“improves the appearance of” instead of “cures”) but the truth is that most direct language is forbidden for use by most people who sell products. However, customers and especially those concealed behind forum names can say and ask almost anything.
So, I will welcome any question which is about ingredients and products as long as people don’t ask questions I cannot legally answer, such as “Does your product cure hairloss?”
Our products are compatible with people who have hairloss issues and can improve the appearance of scalp and hair. This is the utmost extent to which I can use terms like hair, scalp, and hairloss in my answers. I can point out physical and chemical benefits which can be attached to certain ingredients on a theoretical basis “if that ingredient can actually reach a certain point in the scalp”. I expect people to speak to me with respect and I will ignore any question which is disrespectfully phrased; my expectation of respectful discourse applies not only to me but to other participants in the discussion, and I will not appreciate the use of my opinions as weapons to hurt someone else. I may need some time to answer certain questions which involve potential conflict of interest, proprietary issues, or legal status of a certain claim; other questions I can answer more quickly, but I do have a company and a life to run so my replies may not be immediate.
My goal in this exchange is primarily educational. I want to provide the people on your forum with some scientific background and with an insight that will help to sort out your expectations about hairloss issues into several categories:
Realistic and achievable goals;
Foreseeable developments and advances in understanding of hairloss;
Potential quantum-leaps with medicinal relevancy to hairloss;
Long-term, potentially-achievable, goals;
Excursions into the realm of science fiction.
I believe that as we start this we will be able to sort out more issues as they present themselves, assuming everyone wishes to participate in good fate and not to act as saboteurs. I am quite hopeful that saboteurs will be identified on their first attempt and will be prevented further access to this particular dialog.
Thank you for organizing this exchange.
Elishalom Yechiel, Ph.D.
Elsom Research Co., Inc.
paper mail: 4510 Black Hickory Woods, San Antonio, TX, USA, 78249
http://www.elsomresearch.com/ — to learn about nanotechnologies in skincare
http://www.new-equilibrium-skincare.com/cosmeceuticals/ — to order retail products
http://www.the-formulator.com/ — to order personalized products
http://www.topical-formulations.com/ — to read the Journal