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Petitioning Federal Drug Administration, Centers for Disease Control and Prevention

End the FDA's Discriminatory Deferral Policy - Allow Gay Men to Donate Blood!

In the days after the 2016 massacre on the Pulse nightclub in Orlando, FL, lines wove around blood donation banks with people eager to help. Gay men, however, were turned away - a stinging insult to an already grieving community. In trying to do something good, these men were publicly humiliated by a screening questionnaire that equated their sexual identity to intravenous, non-prescription drug use and prostitution.  Though it is undeniable that this original policy was critical in ensuring the safety of the national blood supply in the early days of the AIDS crisis, advancements in technology have rendered this ban unnecessary. When the first HIV-specific antibody test came out in 1987, the risk of HIV transmission from the blood supply was 1 in every 153,123 units of blood (assuming an 8-week incubation period during which HIV is undetectable). Four generations of testing later, modern HIV screening has near-perfect sensitivity, minimizing the incubation window to 9 to 14 days. Today, the risk of transmitting HIV through a blood transfusion is 1 in 1.5 million. By comparison, the odds of getting struck by lightning are 1 in 960,000.  The logic of the current deferral policy is laughably illogical: a man who is in a monogamous relationship with another man and undergoes frequent HIV testing (every three to six months) with repeatedly negative results is prohibited from donating blood. On the other hand, a straight man who has frequent unprotected sex with female partners of unknown HIV status is not barred from donating. Similarly, a woman who has unprotected anal sex with partners of unknown HIV status is similarly allowed to donate. In 2015, the policy was changed from a lifetime ban to a twelve-month deferral period - a step in the right direction, but unrealistically requiring that MSM remain celibate for an entire year. This discriminatory policy continues to perpetuate the association between gay sex, risky sex, and HIV. The FDA would better protect the blood supply by modifying their policy to defer individuals who have had unprotected sex with partners of unknown HIV status in the two weeks prior to donation - regardless of gender or sexual orientation. With this in mind, we, the members of the LGBTQ community and our allies, demand that the FDA reevaluate their outdated discriminatory blood donation policy, and instead implement one that does a better job protecting the blood supply by redefining the criteria for deferral to anyone participating in risky sexual behavior - not a blanket ban on a community eager to do their part to save lives!

Shelby Mohar
18,125 supporters
Petitioning Mark Meadows, Patrick T. McHenry, Richard Burr, Thom Tillis, Federal Drug Administration

Cross Contamination Labeling for Top 8 Allergens

I gave my two year old son a product. I had called the company that made it and verified it was safe. Within minutes he was having an anaphylactic reaction, we nearly lost him. While all foods require labeled ingredients for top 8 allergens they are not required to label for cross contamination. Meaning a company can produce almond butter, wash the equipment used to their own satisfaction then produce something else, like pasta for example then, box and sell that pasta with no disclosure or warning stating the contact with almonds. This is incredibly dangerous for people with anaphylactic reactions to these allergens. The current system we as consumers have for assuring our safety is as follows: Call the company that produced the product. Ask if any chance cross contamination occurred. Hope and pray they give you accurate information. Post on social media groups to see if anyone else has had a reaction or died from the product. Only to repeat this process on every single product, every single time. Top 8 allergens can be found in the most unexpected places, for example: gardening products, potting soil, sunscreen, cosmetics, personal care items, toilet paper, essential oils, construction supplies, glues, craft supplies, toys and sensory items and of course foods. We need a better system and we need it now. My position is that ANY product, food or not, that has been produced with a possibility of cross contamination of any Top 8 allergen should be required to carry a label. Period.

Katie Bryant
16,593 supporters
Closed
Petitioning Scott Gottlieb, Federal Drug Administration

A petition to Scott Gottlieb (FDA) to recuse himself from decisions regarding Kratom.

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 #keepkratomlegal #plantsnotpills #notanotherdrug

#KeepKratomLegal
9,348 supporters
Petitioning United States, Federal Drug Administration, United States Department of Health and Human Services

The US Federal Government should impose price controls on the pharmaceutical industry.

Traducción al español en la parte inferior de la descripción. (Spanish Translation is at the bottom of the description) Hello everyone, and thank you for viewing this petition. I am Parth, a 12 year old boy from New York, hoping to spread word of a beneficial solution to resolve a problem that people may experience in their lives.  The United States Federal Government should definitely impose price controls on the Pharmaceutical Industry. Every year, many people sadly pass away because they are unable to pay their medical bills and/or not able to buy medicine/prescription drugs. This causes a problem for lower income people who can’t afford medicines/prescription drugs that are necessary for those who need them. Imposing price controls could change people’s lives, and there would be less deaths regarding inability to afford medical care etc. According to the Harvard Gazette, a “New study finds 45,000 deaths annually linked to lack of health coverage”. One of those 45,000 deaths per year was a 26-year old boy named Alec Raeshawn Smith. He wasn’t able to afford insulin/medical care, and sadly passed away in his apartment. According to Alec’s Mother and MPR News, "He had visited the pharmacy and was kind of slapped in the face with the reality of the price tag. He didn't have that much in his bank account on that day so he left, and rumor has it that he was trying to stretch what he had left of his supply to last a couple more days to his payday so that he could pick up his prescriptions." Alec didn’t apply for health insurance. In fact, the price of insulin had tripled from 2001 to 2013. The Mother, Smith-Holt, also wants the Federal Government to impose price controls. However, this is only one story out of all the people who die from lack of medical supplies every year. Support this Petition, and sign it today so that the Federal Government/ FDA will imply price controls on Pharmaceutical Medicenes.  Traduccion al Español (Translation to Spanish) Hola a todos, y gracias por ver esta petición. Soy Parth, un niño de 12 años de Nueva York, con la esperanza de difundir una solución beneficiosa para resolver un problema que las personas pueden experimentar en sus vidas. El gobierno federal de los Estados Unidos definitivamente debería imponer controles de precios a la industria farmacéutica. Todos los años, lamentablemente, muchas personas fallecen porque no pueden pagar sus facturas médicas y / o no pueden comprar medicamentos / medicamentos recetados. Esto causa un problema para las personas de bajos ingresos que no pueden pagar los medicamentos / medicamentos recetados que son necesarios para quienes los necesitan. La imposición de controles de precios podría cambiar la vida de las personas, y habría menos muertes con respecto a la incapacidad de pagar la atención médica, etc. Según el Harvard Gazette, un "Nuevo estudio encuentra 45,000 muertes al año relacionadas con la falta de cobertura de salud". Una de esas 45,000 muertes por año fue un niño de 26 años llamado Alec Raeshawn Smith. No pudo pagar la insulina / atención médica, y lamentablemente falleció en su apartamento. Según la madre de Alec y MPR News, "visitó la farmacia y recibió una especie de bofetada por la realidad de la etiqueta de precio. No tenía mucho en su cuenta bancaria ese día, así que se fue y el rumor dice que estaba tratando de estirar lo que le quedaba de su suministro para que le durara un par de días más a su día de pago para poder recoger sus recetas ". Alec no solicitó seguro de salud. De hecho, el precio de la insulina se triplicó de 2001 a 2013. La madre, Smith-Holt, también quiere que el gobierno federal imponga controles de precios. Sin embargo, esta es solo una historia de todas las personas que mueren por falta de suministros médicos cada año. Respalde esta petición y fírmela hoy para que el gobierno federal / FDA implique controles de precios en medicamentos farmacéuticos.  

Parth Kochhar
2,957 supporters