Where do we go from here?

Anatomy of a black market drug -Part Three.

Please read Part One and Part Two of “Anatomy of a Black Market Drug” before reading Part Three, “Where do we go from here?” to see the sum of all parts of the story.

As it is, the FIP community has become quite a mess. Who would have imagined that we would ever have to discuss the black market of an illegally manufactured substance that claims to replicate a patented formula? That there would be professional entities and researchers somehow attempting to normalize outlaw activities, encouraging rogue dealers to openly set up shop and sell a black-market substitute for GS-441524 as "the cure for FIP?"

And yet, here we are in the twilight zone, where people and businesses who stand for legal, regulated drugs are criticized for refusing to embrace illegal, unsafe, unregulated and unauthorized substances, while those who should speak adamantly against it (universities, researchers, research foundations, professional organizations, licensed veterinarians, etc.) instead encourage and promote what they should have unequivocally condemned. The black market spoofs of the GS-441524 substance are ILLEGAL. They are manufactured in China, without any safety or quality control, are not regulated by the FDA and are STOLEN from the patent holders Gilead Science, Inc. and the Regents of the University of California.The original patent was amended to add The Regents of the University of California as co-applicant and the change was recorded by WIPO on 09/17/2019. Is it that hard to understand? And yet, both members of the academic field and black market peddlers show unity and believe they are above laws, rules, and regulations.

So, what happens next? Does the black market ultimately stifle the approved, regulated options, and becomes the go-to treatment for FIP? Do the Chinese sellers and their network of dealers keep on raking in profits from unregulated by the FDA, stolen IP (intellectual property)? Do they keep on laughing at the FDA, while openly flaunting their illegal activities as a badge of impunity? Do sick cats continue to be the new frontier for unbridled street research experiments based on a limited, single field trial with an experimental chemical? Does the absurdly unethical and woefully outlaw become the new normal?

It seems unlikely.

1- MESSING WITH THE FDA IS A BAD IDEA
The US Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. It is the quintessential regulatory agency.

The FDA’s position is that counterfeiting drugs is a particularly heinous crime (their words) and is a significant patient safety and health issue.

By now, it would be childish to think the FDA is not aware of the black market GS-441524. Mrs. Susan Gingrich’s letter to Gilead Sciences, Inc., dated June 17, 2019, has made its way through the relevant government agencies. Additionally, the participants in this illegal trade have not been exactly discreet in advertising and promoting their products, so the proverbial cat, pun intended, has been out of the bag and in plain sight for months now.

What the FDA decides to do is largely not public. The agency does not publicize its action when looking into criminal activity – selling illegal, unsafe substances is a crime – until after the facts. What is happening beyond the scenes is anybody’s guess.

However, the assumption that the FDA can let anyone defy its authority is hard to imagine. Think of the precedent it would set. Look at it from the FDA’s perspective. What do they see?

• A well-known university (UC Davis) and its professor (Dr. Pedersen) gleefully endorsing black market unregulated substances, recommending sellers, support groups, and directly assisting users. [1, 2]

• Professional publications acknowledging the black market, making unfounded claims that  GS-441524 is “a cure for FIP.”  [2]

• A flurry of Facebook groups, pages, and websites pushing sales of bootleg, misbranded chemicals of questionable quality and origin at the detriment of basic public safety.[3, 4]

• The development of an entire network of illicit sellers showing absolute contempt for the FDA and other federal agencies and their functions. [3, 4]

Notes and References
1 – See “Anatomy of a Black Market Drug, Part One” and “Anatomy of a Black Market Drug, Part Two: Crafting the Near Perfect Infomercial” for full story, links, and references.

2 – The FDA has authority to regulate drugs under Title 21 U.S.C. 321 (g)(1) – Source: Cornell Law – generally under the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 321-393). Only the FDA can make a claim that a drug is treating or curing a disease. Professionals who defy the terms of the FDCA are subject to punishment (See United States vs Burzynski Cancer Research Institute).

3 – A drug is “misbranded” if its labeling contains unfounded claims or inadequate directions for use, inadequate warnings of potential dangers, or inaccurate information about the contents of the product. The misbranding is addressed by FTC under the Federal Trade Commission Act (FTCA) (15 U.S.C. 41 et seq.), which authorizes FTC to regulate advertising claims, contains both a general prohibition of unfair or deceptive acts or practices in or affecting commerce (15 U.S.C. 45 (a)) and a provision that specifically prohibits the false or deceptive advertising of foods, drugs, devices, or cosmetics (15 U.S.C. 52). 

4 – The Federal smuggling statute (18 U.S.C. 545) prohibits unlawful introduction of products into the United States. Possession of such products alone is sufficient for conviction under this statute; in addition, any such products are confiscated by the Government. Penalties for violating this statute include fines, imprisonment for up to five years, or both. In one case, U.S. v. Richardson, John Richardson, M.D., and three co-defendants (Ralph Bowman, his office manager, and Robert Bradford and Frank Salaman, two members of the Committee for Freedom of Choice in Cancer Therapy) were convicted of several crimes including conspiracy to smuggle Laetrile from a clinic in Mexico into the United States. The defendants argued that FDA’s classification of the drug, which prohibited its being brought into the country, was an act of governmental misconduct; they claimed their actions were justified because Laetrile was unavailable but necessary in the United States. Their conviction was upheld on appeal. Bradford was fined $40,000, Richardson $20,000, and Salaman and Bowman $10,000 each.