We the people petition FDA Commissioner Scott Gottlieb to recuse himself from any decision making or public statements regarding the plant Kratom.

From the first announcement of Dr. Gottlieb’s nomination as Commissioner of the FDA his ability to remain impartial was called into question because of his strong ties to many of the largest pharmaceutical companies, including GlaxoSmithKline PLC and Cephalon. There is now clear evidence that casts reasonable doubt on his ability to remain unbiased on the issue of kratom.

It is a matter of public record, near the point of common knowledge within the kratom community, that Dr. Gottlieb has been a member of GlaxoSmithKline’s Product Investment board from January 2010 until present. As a member of the Product Investment board he would no doubt be aware that GlaxoSmithKline once held 2 US patents regarding isolation of the alkaloid mitragynine from Mitragyna Speciosa, the latin botanical name for kratom. [1] The patent that GlaxoSmithKline owned very clearly praises Mitragyna Speciosa (aka kratom) as “less depressant effect on blood pressure and respiration than codeine with no apparent cardiovascular liabilities. Decreased toxicity is also observed in comparison to codeine.” It also touted the compound as having “minimal side effects”. These findings have been backed by numerous studies conducted by leading pharmaceutical scientists of today including:

Dr. Jack Henningfield, Vice President of Research, Health Policy and Abuse Liability, at PinneyAssociates, and Adjunct Professor of Behavioral Biology, The Johns Hopkins University School of Medicine. Dr. Henningfield is one of the world’s leading experts on addiction and safety. [2]

University of Florida Medicinal Chemistry Professor Christopher McCurdy. [3] [4]

Scott Hemby, a professor of pharmaceutical science at North Carolina’s High Point University. [5]

Marc T. Swogger, Ph.D. Department of Psychiatry University of Rochester Medical Center Rochester, New York.

Zach Walsh, Ph.D. Department of Psychology University of British Columbia Kelowna, BC Canada.

Oliver Grundmann, Ph.D. College of Pharmacy

Department of Medicinal Chemistry University of Florida

Gainesville, Florida.

Albert Garcia-Romeu, Ph.D. Psychiatry and Behavioral Sciences

Johns Hopkins University School of Medicine Baltimore, Maryland.

Robert B. Raffa, Ph.D. Professor of Pharmacology

Temple University School of Pharmacy Research Professor

Temple University School of Medicine Philadelphia, Pennsylvania.

Roland R. Griffiths, Ph.D. Professor of Behavioral Biology Professor of Neuroscience Johns Hopkins University Baltimore, Maryland.

Paula Brown, Ph.D. Director of Applied Research, Natural Health & Food Products British Columbia Institute of Technology Vancouver, British Columbia.

Both Professor Christopher McCurdy and Professor Hemby were featured on PBS News Hour discussing their findings on kratom and it’s potential benefits in the opioid crisis. [6]

In the past months Commissioner Gottlieb has taken aim at kratom in an effort to pressure the DEA to take action against it despite the pleas of over 100,000 members of an astoundingly diverse community of veterans and civilians alike for safe access to this plant. In both statements he has completely contradicted both the patent once held by GlaxoSmithKline and the findings of the leading scientists in this field of study.

His statement in November 2017 faced backlash not only from the scientific community but from both Houses of Congress. [7] In their letter addressed to Dr. Gottlieb, Congress not only addressed and debunked the 2 main issues of his statement but they requested “that the FDA reconsider its stance and take a closer look at the facts and recent science regarding this plant.” [8]

Based on Commissioner Gottlieb’s statement released February 6, 2018, it would seem that he has declined to do as Congress requested. Rather than continued scientific study, his statement heavily references an FDA computer simulated model. His bias is readily apparent in his backing of a computer simulation that gives him the results he wants rather than the scientists who have dedicated years of research to kratom. Their research completely contradicts the computer model.

No one put it better than Dr. Hamby “They make a lot of hay of using a computer model, but it's really nice to validate the findings with actual science.” [9] Unable to validate his desired results with actual science, Commissioner Gottlieb is choosing to trust and advocate a computer simulation.

Of course, the obvious flaw in a computer simulation is the results are only as good the information programmed into them. If that information is biased, the results will also be biased. It can logically be concluded that based on how contradictory the computer model is to the actual science that has been conducted that it is probable that the data the model is based on is biased.

All the scientists listed above have spoke out against Commissioner Gottlieb's unfounded attacks on Kratom. [10] On February 8, 2018, just days after the FDA's statement 9 of the above scientists wrote to the White House directly to address this matter. Not only do they refute the claims of the FDA, they refer to kratom twice as a "lifeline away from ...opioids". They spoke out strongly opposed to any action from the DEA and FDA. As creditable scientists, they offered a number of studies published studies to reinforce their belief. [10 a - e]

Even if, by some small possibility the computer model is in fact accurate, since when does the FDA, or any branch of government, rely on computer simulations to drive policy?

Commissioner Gottlieb has said that he is committed to ending the opioid crisis which is commendable, especially since in 2008 he seemed to take a favorable stance toward synthetic opioids when he gave expert testimony on behalf of Cephelon, one of the largest fentanyl manufactures in the country. This fact was one of the key questions that congress had for Dr. Gottlieb when he was first nominated as Commissioner of the FDA. [11] Incidentally, in the case that Dr. Gottlieb was paid to defend their actions, Cephelon pled guilty to criminal charges that they promoted their fentanyl products for off-label uses other than what the FDA approved and paid a $425 million dollar fine for their actions.

This case demonstrates that at least at one point in history, Commissioner Gottlieb not only favored synthetic and harmful opioids, but his willingness to put his name and reputation on the line for financial gain.

In August 2016 the DEA announced it’s intent to classify kratom as a schedule 1 drug, however due to scientific research, public outcry and calls by Congress to overrule the decision they withdrew their intent in October 2016. They decided to allow the scientific community the space and time necessary to continue studying kratom and it’s possible benefits to society. [12] As Professor McCurdy states "We must be able to do the research, if (kratom) goes Schedule I, this will make it nearly impossible to do so.” Commissioner Gottlieb must follow the example set by the DEA and allow further actual scientific study to be conducted on kratom without constant pressure, threat of actions or attempts to discredit findings from the head of a government organization.

Given Commissioner Gottlieb’s past financial ties to big pharmaceutical companies like GlaxoSmithKline and Cephelon, his willingness to accept computer models over actual science and his being a member of the product investment board of the only pharmaceutical company that has held patents on kratom, it is clear he can’t approach this topic with true impartiality and he must recuse himself from any further decisions involving kratom.

[1] US Patent 3,256,149 (Expired) http://bit.ly/2nORi9O, US Patent 3,324,111 http://bit.ly/2EsDsnW

[2] http://216.30.191.148/HL-AKA-Eight_Factor_and_Recommendations_by_PinneyAssoc.pdf

[3] http://pharmacy.ufl.edu/faculty/christopher-mccurdy/

[4] https://www.youtube.com/watch?time_continue=1&v=ieItgEbKpsU

[5] http://www.highpoint.edu/blog/2017/02/faculty-recognized-for-research-and-innovation/

[6] https://www.pbs.org/newshour/show/kratom-help-treat-opioid-addiction

[7] https://polis.house.gov/uploadedfiles/kratom_fda_health_advisory_letter.pdf

[8] https://polis.house.gov/uploadedfiles/kratom_fda_health_advisory_letter.pdf

[9] https://www.cnn.com/2018/02/06/health/fda-kratom-opioid-bn/index.html

[10] http://bit.ly/2nUP0pF

[10 a] http://bit.ly/2nMRszm

[10 b] http://bit.ly/2BOOG5i

[10 c] http://bit.ly/2nTRogs

[10 d] http://bit.ly/2Ee9YuR

[10 e] http://bit.ly/2EaFv0o

[11] http://bit.ly/2E88Jgt

[12] https://www.uspharmacist.com/article/the-dea-changes-its-mind-on-kratom

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