Why does gottlieb favor organ sales

Others outside of the FDA raised questions with how that agency has attempted to restrict access to kratom. Jack E. Henningfield , PhD, is an adjunct professor at Johns Hopkins University and vice president for research, health policy and abuse liability at Pinney Associates. He is currently a consultant to the American Kratom Association and had previously provided pro bono support to the same group in their efforts to prevent the Drug Enforcement Administration from banning kratom.

Henningfield also worked on dietary supplement notifications for kratom products in an effort to get FDA to regulate kratom as a dietary supplement.

For example, Narcan, which is used to treat opioid poisoning binds to opioid receptors, but no one calls Narcan an opioid. Prozialeck was one of the first to recognize that interest in kratom was growing. He co-authored a paper in the Journal of the American Osteopathic Association on kratom. The article also provided an overview of usage for the substance such as fatigue, diarrhea and cough.

He also provided information on its legal status and additional potential medical uses of kratom including fighting off fatigue and managing coughs. In so doing, kratom would be put in the same category as substances such as marijuana, LSD and heroin. However, The Washington Post reported that the DEA yielded to protests from the public and lawmakers and withdrew the plan. Griffin added he was not in favor of placing kratom in Schedule 1, saying that doing so would effectively ends research into the substance.

All but one of those kratom deaths had other factors such as existing diseases or conditions like CVD, epilepsy or multiple drug use such as stimulants and alcohol. Though those are only anecdotal, it is difficult to ignore that volume of information.

Secondly, there are animal studies that show the chemicals isolated from kratom can alleviate pain and the symptoms of opioid withdrawal. Those studies, even though there are not a lot of them, should not be completely ignored. Other clinicians and professionals who have researched kratom told Healio Family Medicine the polar opposite views being expressed in the debate pose their own set of dangers to people, and that a common ground must be found.

This is madness. This is also dangerous because it denies a therapy that many people are currently using for opioid maintenance therapy or chronic pain that they rely on or to which they are addicted. Making it illegal or shutting off the legal supply by forcing recalls will push some law abiding citizens to use illegally smuggled kratom or even worse, use heroin or illicit fentanyl. White authored a paper that appeared in the American Journal of Health System Pharmacy that underscored the need for more research on kratom, saying the existing clinical, pharmacokinetic, and pharmacologic data is inadequate.

There has to be a middle road that allows kratom to be available while the serious research that needs to be done can be completed. Access should be restricted for recreational use and to children but allowed for chronic pain and opioid addicted people.

Others, such as Kirk L. A FDA official told Healio Family Medicine established federal and scientific processes mean the door has not completely closed on kratom use. Before it can be legally marketed for therapeutic uses in the U. Both mitragynine and 7-hydroxymitraginine are substances with opioid effects whose use may result in serious negative outcomes and accordingly, DEA would advise anyone against using this substance for its psychoactive properties.

The FDA spokesperson said patients needing treatment for opioid use disorder already have viable legal options , and more such therapies could be forthcoming. We understand that patients suffering from opioid addiction need access to effective treatment options.

Creating an efficient pathway for the development of these treatments is a very high priority for Commissioner Gottlieb. Primary care providers must help their patients make informed decisions when it comes to kratom, Cumpston said, and even then, may want to encourage patients to think twice about recommending it, especially when it comes to opioid addiction. In my opinion, the combination of FDA-approved drugs to treat addiction and therapy from addiction specialists is known to be safe and effective, so kratom users are taking unnecessary risks.

White said that despite the benefits of kratom, there are many things to be considered before suggesting it to patients. If a person has had bad experiences with prescription opioids before and its either opioids or kratom as treatment options, then I would bring kratom into the discussion. He and his colleagues found all of the products contained the stimulant mitragynine on their label, but the narcotic 7-hydroxymitraginine was not found.

However, these authors also pointed out that previous studies have shown the small quantities of this chemical in kratom can make it difficult to identify. There is a lack of standardization and quality control surrounding the manufacturing these items. Aggarwal G, et al. J Intensive Care Soc , ;doi: Anwar M, et al. Brown PN, et al. J Ethnopharmacol.

Epub Mar Accessed April 13, Accessed March 7, Dizon D. The Oncologist. Drago JZ, et al. The O ncologist. Drug Enforcement Administration. Accessed Feb. Accessed April 3, Griffith OH et al. J Psychoactive Drugs. Prozialeck WC, et al. Each year, about 9, people are removed from the kidney transplant waiting list because they die before they are matched with a donor or become too sick to undergo the operation.

The United States currently prohibits the sale of kidneys, and a major concern about changing the law is that people with low incomes would be more likely to sell their organs. Some ethicists worry that with compensation for kidneys, poor people would donate kidneys in disproportionate numbers and affluent people would receive them disproportionately. The researchers also calculated that the number of transplants per year would increase from 17, to 31, — enough to supply kidneys for yearly additions to the wait list.

With the increased supply, the proportion of transplant recipients who are poor — defined in this study as adults without a high school diploma — would rise from 6 percent to 30 percent.

Currently, poor people are less likely to be added to the transplant waiting list, in part because they tend to be less healthy and have worse prospects for a successful transplant.

It is also more difficult for poor people to find living donors because their friends and relatives would struggle more with lost wages and other issues associated with organ donation.