User talk:Ljamesh/Afamelanotide

Illegal?

The UK's MHRA has clearly stated that it is neither illegal to buy or use melanotan peptides. This is also true in the United States. In the United States it is only illegal to sell the peptides as drugs. There is no prohibition for their sales as molecular substances. This isn't entirely the case in the UK where it is generally illegal to sell them without prior government authorization. Rather than use a blanket term of "illegal" to describe the peptides this delineation should be made. If this isn't done the article will lose credibility. I'm reviewing your other edits Ljamesh and I'll voice other suggestion and/or concerns in the next day or so. Sometime-science-editor (talk) 08:37, 11 March 2009 (UTC)

The sale of the peptide afamelanotide may not be illegal for research purposes, however I still dispute that these products are afamelanotide. Furthermore, this section focuses on "Warnings on illegal "melanotan" products".

I'm unsure of where it is written that these products are legal for sale; could you provide a link to where the MHRA has said this? I can provide links to where regulators have said the product is illegal:

• The IMB states that the products are "illegal on the Irish market"
• The MHRA's press release (notes to the editor) states "The MHRA has currently contacted 18 different companies explaining that any supplying or advertising of Melanotan is illegal and any websites etc should be taken down"
• The 2009 Norwegian Medicines Agency warning claims that "melanotan" is "farlig og ulovlig" (dangerous and illegal)
• The most recent FDA warning letter lists several breaches of the Federal Food, Drug, and Cosmetic Act, including that the products sold by the vendor are new drugs "because they are not generally recognized as safe and effective for its labeled uses" and that "a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it". As a result, the vendor is informed "Your sale of these products without approved applications violates these provisions of the Act". I think it is reasonable to say that this could be termed "illegal" activity.
• Whilst not issued for "melanotan", the FDA's warning letter to Melanocorp in 2007 was issued for "the illegal sale and marketing of the product Melanotan II".
• Recent US press coverage has referred to "illicit supplies" and products being "sold illegally".

I think the term illegal is valid in the context, in this instance, unless there is evidence to suggest otherwise. Please provide more feedback as you get the chance. Ljamesh (talk) 21:33, 11 March 2009 (UTC)

Either you've failed to understand the heart of what I am saying or you're purposefully ignoring it. There is a big difference between selling the peptides and buying/possessing them. It is not sufficient to blanket label the peptides as "illegal" in all respects when they aren't. Possession and usage in both the United Kingdom and the United States is not illegal. Relative to the UK even Claire Tilstone of the MHRA explained this on video (the link escapes me but I can track it down and provide it if need be). In the U.S. anyone can order the peptides from manufacturing labs so long as the labs are not selling them as drugs. Are you not aware of this? Sometime-science-editor (talk) 06:01, 12 March 2009 (UTC)

I felt that I understood the thrust of your argument, I'm not trying to mislead.

The subsection is titled "Warnings on illegal "melanotan" products" in a section titled ""Melanotan" products sold online". The warnings relate to illegal products, sold online for human purposes. Agencies have not warned about afamelanotide, but the sale of products called 'melanotan' for the use in humans, which is illegal and poses a threat to public health. The regulatory releases have stated the products are "illegal" as stated above, but I think you need to provide evidence if you feel this is contrary. Perhaps the MHRA video will clear up the issue, but I'm not familiar with the one you are referencing.

If you feel it necessary to discuss the sales of these products for research purposes, please add some referenced text on the matter on the page. I feel, however, there is a risk that it may give the impression to a casual reader that all products sold as "melanotan" are legitimately for in vivo and in vitro research or that the sales of these products for human use is legal.Ljamesh (talk) 06:32, 12 March 2009 (UTC)

This video has the quote, "Now, as a user she's not breaking any laws but the companies [presumably UK companies] selling it are..." Again to label the peptides in blanket fashion as illegal is false. I understand your concerns about giving casual readers false impressions but if legalities of the peptides are going to be brought into the article then the full picture of those legalities needs to be addressed not just half of the story. Sometime-science-editor (talk) 07:12, 12 March 2009 (UTC)

The quote is not from the MHRA (their public stance is that the products sold online are illegal), but from a journalist. Again, the warnings are against the illegal peptides being sold online under the name 'melanotan', hence the title. Can you propose alternatives for us to discuss? If not, I feel that the wording is representative of the situation and not misleading. A line on the legal sales of the peptide may be valid, but I feel that this is not something to be dwelled on as this is an issue that only affects such a small audience (scientific researchers), who would be aware of the situation. You are a scientist, but you are also acutely aware of the situation here, I suspect most of your peers would be too?Ljamesh (talk) 08:12, 12 March 2009 (UTC)

You're only half-right. Uk law is that sales and marketing of the peptides is illegal, not possession or usage. Would you kindly inform yourself better? You as a representative of your company should know these facts. You're wasting our time here. this video has Claire Tilstone of the MHRA directly stating, "it's not illegal to use it". Again if the legalities of the peptides are going to be introduced into the article then the full picture needs to be given not some sanitized "for the public's good" version. Readers have a right to know the full picture about the peptides. Your company's position is understood relative to the peptides and doubting that what people are being sold is in fact NDP-MSH or melanotan II but given the latest BMJ article it is clear that authorities are generally discussing usage of "melanotan I and II" not usage of "substances other than melanotan I and II". So unless you disagree with that let's move on shall we? Sometime-science-editor (talk) 08:36, 12 March 2009 (UTC)

The latest BMJ article does not make a clear link between afamelanotide and "melanotan" (rather it states that the "melanotan 1" has the generic name afamelanotide and is in clinical trials) and makes some generalisations about the peptides and the risks they pose. The author presents no clinical results showing a link between the "melanotan" products and afamelanotide. I ask for a little time in addressing this fully, but can address your specific concerns here if you believe this not to be the case. Other articles have not made this link (including the original Langdon BMJ article). Again, I have not seen (and thus far we have not been provided here) solid proof that afamelanotide is being sold illicitly as "melanotan". Authorities have addressed substances "sold" as "melanotan I and II", but the warnings have not been about afamelanotide, which is being tested in most jurisdictions under regulated trials.

I have made alterations based on your comments and ask that you provide references or alterations for us to discuss. I maintain that these products are illegal to supply for human use and the term "illegal" (which has been widely used in official releases and media coverage) is apt. I appreciate, however, that no ground has been made on other, more important issues related to afamelanotide. If you are uncomfortable with the new wording, let us leave this section for the moment and address and implement the rest until an accurate, agreeable version for the "melanotan" section can be reached. Ljamesh (talk) 05:40, 17 March 2009 (UTC)