Is Kratom The New Marijuana?

While the war against opioids rages on, chronic pain patients are struggling to find a suitable alternative to manage their condition. As a chronic pain sufferer myself, I am always concerned about any action taken by state governments and the FDA to limit access to medication. 

Kratom is a tree from Southeast Asia, with leaves that contain compounds that have psychotropic effects. Two compounds in kratom leaves, mitragynine and 7-α-hydroxymitragynine, interact with opioid receptors in the brain, producing sedation, pleasure, and decreased pain, especially when users consume large amounts of the plant. The FDA has identified Kratom as an opioid like substance with similar properties, creating a wave of regulatory actions that impact both industry and patients.

Some states are banning Kratom by classifying it as a Schedule I controlled substance, like in Ohio. Unfortunately, it may be years or even decades before enough research is conducted to prove the medical benefits of Kratom for chronic pain. Ideally, the FDA would hear the patient voice about the potential clinical benefits and investigate further. Unfortunately, as we have seen with cannabis, this is not the case.

Actions to ban Kratom and limit research initiatives hurts patients. Congress passed major opioid legislation this week that was signed into law, again showing that our government knows we desperately need to do something about the opioid crisis in our country. Limiting access to alternatives like Marijuana and Kratom is counter productive. Instead, we should be actively researching the medicinal benefits to help pain patients. They do not deserve to suffer and have their medication taken from them.

Until the FDA recognizes the potential benefits, Kratom will end up in the same battle as marijuana.

FDA APPROVES ETEPLIRSEN FOR PATIENTS WITH DUCHENNE MUSCULAR DYSTROPHY

We want to share with you the video of the late Ricky Tsang who passed away recently after suffering with Ducenne Muscular Dystrophy (DMD) for over 30 years.  This is a You Tube video that Ricky did to Janet Woodcock, FDA director of the Center for Drug Evaluation and Research, concerning accelerated approval for Eteplirsen, a new drug that treats DMD, after the FDA Advisory Committee voted not to accelerate approval. 

While this video is heartbreaking, it is also an education about rare diseases and how rare disease patients suffer.  Ricky discusses the devastation caused by DMD which causes its victims to progressively lose their muscular abilities and results in life-threatening heart and respiratory conditions. Most DMD patients die in their 20's or 30's.   Here is a link to Ricky's video https://www.youtube.com/watch?v=NUjJEHmkEUg

Etepliren is made by Sarepta Therapeutics in Cambridge, Massachusetts. The Lerman Law Firm is proud to join with thousands of rare disease patients and advocates in aggressively promoting both the use of orphan drugs and the plight of rare disease patients who need those drugs NOW.  By working with Congress, the NIH, the FDA, and the pharma and biotech industry, we can accelerate the time to market of life-saving and life-changing drugs such as Eteplirsen. 

Candace Lerman, who is the Lerman Law Firm's Director of Advocacy for rare disease patients and our liaison with the biotech and pharma industry, is also a rare disease patient who used an Orphan drug to put her disease into remission.  While Candace still has multiple other health issues, her experience has convinced us that all patients deserve that opportunity.  For more information about Candace Lerman and our legislative advocacy on behalf of rare disease patients and the promotion of Orphan drugs see her blog at RareCandace.com.

We thank Director Woodcock for her accelerated approval of Eteplirsen and we look forward to similar approvals for other Orphan drugs in the pipeline.