My open letter to the new FDA Commissioner:

Dear Robert M. Califf, MD,

Congratulations on your new role as FDA Commissioner. I wish you every success in your endeavor to safeguard the populace against dangerous and ineffective drugs.

Having said this, let me point out that your predecessor, Dr. Margaret Hamburg, was (allegedly) not as rigorously ethical as might be hoped. Please see the excerpt below. I have underlined some pertinent lines.


“… Hamburg also came under fire when she approved the highly addictive painkiller drug, Zogenix
In December 2012, an FDA advisory panel of experts voted 11 to 2 against approval of the painkiller, Zohydro ER. The panel cited concerns over that drug’s potential for overdose. Indeed, 28 law enforcement agencies and addiction experts had voiced concern that approval of a pure hydrocodone drug will lead to an increase in overdoses and deaths. Zogenix, could be used by people addicted to other opioids, including oxycodone.

Fifteen anti-addiction groups wrote a letter of complaint to the Secretary of Health and Human Services. Despite the safety concerns by the medical and law enforcement community, and despite the expert panel’s overwhelming rejection of the drug, Dr. Hamburg approved it.

The lawsuit provides documentation showing that from 2011 to May 2015, Dr. Hamburg’s husband’s hedge fund, Renaissance Technologies, “not coincidentally, held stock in Alkermes, the manufacturer of Zohydro amounting to tens of millions of dollars. Does anyone not recognize corruption?

The conflict of interest doesn’t end there. Adding even more insult to injury, Alkermes also manufactures a drug to TREAT addiction. So, both Alkermes and Renaissance Tech were given the FDA green light to rake in profits from both the sale of a highly addictive drug, then cashing in on the sale of a treatment for that drug-induced addiction!!…”

My point in posting sending you this is in no way to exhibit Schadenfreude at the Doctor Hamburg’s downfall. I think it is tragic such a talented person could have such egregiously misplaced priorities. Still, it does beg the question—could Doctor Hamburg have been  purposely sabotaging the approval of a device which could curtail the use of drugs to treat addiction, and even lower the rates of addiction!! One shudders at the thought, but have we really unearthed the depths of what the completely avaricious and selfish personality type is capable of?

So, I submit this as food for thought. I admit you don’t know me from Adam and compared to someone such as yourself, I am a mere dabbler in science, though I do make a living at it, such as it is, and have a graduate degree in Biochemistry. However, I think this email, if viewed objectively, should at least be considered as grounds for examining 510(k) file number K152432, and hopefully facilitating the approval of this drug free pain relief technology to the masses.

This technology is available in 50+ countries OTC, but not the USA. The graphic pasted below depicts results from a study published in the Journal of Rheumatology using this technology-link:

I leave you with a final thought: Someday, it will be considered barbaric that we drugged the whole body to treat the pain of one particular part.

Be well, and God bless,

PJ Kelley.

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