January 23, 2021

The Niche

Trusted stem cell blog & resources

Right To Try (RTT)

5 min read

I’ve been concerned about a stem cell group called MD Stem Cells for many years. Now it comes under more scrutiny from a new must-read piece by Donna Young over at S&P Global. Young’s article reports a puzzling, purported right-to-try (RTT) program that MD Stem Cells appears to working on with Richard Garr. Note that Garr is the former CEO of Neuralstem (for reference, that company just renamed itself Seneca Biopharma) who now runs a CRO focused on RTT. My SCOTS concerns Two physicians …Read More

6 min read

There appears to be a big, risky loophole in the relatively new national Right To Try law. Some folks apparently anticipated this problem long ago, but I think most of us weren’t aware of it. Update: More specifically, some law and policy experts were writing about this and other potential loopholes in 2018. I recommend this piece from Beth Roxland and Elisa A. Hurley on the The PRIM&R blog. What’s the deal? It seems to be a case of what I would call piggybacking …Read More

13 min read

A new right-to-try company called Beacon of Hope is stirring some intense discussion. State and federal right-to-try laws could potentially change the fabric of how many investigational studies are conducted. That may happen through firms like Beacon of Hope. However, we don’t know much about the firm. I’m hoping to help change that. Today’s post includes a detailed interview with the leader of Beacon of Hope, Richard Garr. For background, Garr was formerly CEO at Neuralstem. During his tenure at Neuralstem it became well-known …Read More

4 min read

A new Florida bill (Bill 65 of 2019) could make the practices of stem cell clinics a felony. At the same time it would open the door to patients receiving still experimental stem cells that have at least started the clinical trial process. What’s going on? A number of states have been stepping up action related to stem cells and specifically stem cell clinics. The steps on unproven clinics range from bills, some of which have become law such as here in California and …Read More

3 min read

The year of 2018 has already been a wild one for stem cell news. There are many developments on a variety of fronts. Here are some of the most notable news bites of the last month or so. RMAT Wave. The FDA continues its warp-speed issuance of Regenerative Medicine Advanced Therapy (RMAT) designations with 20 such designations now in the public domain with Cellerant Therapeutics’ announcement and possibly a few more not yet out there. I wrote about the “carrot” of RMATs as relative …Read More

7 min read

At the request of the FDA, the DOJ is suing for permanent injunctions against two stem cell clinic firms, U.S. Stem Cell, Inc. and California Stem Cell Treatment Center (and for the latter, its parent chain of around 100 clinics, Cell Surgical Network). What does this big development mean in practical terms and how might it play out? For some discussion and potential answers, I turned again to Professor Patricia Zettler of George State University School of Law, an expert on stem cell oversight, the …Read More

3 min read

On one level a reasonable argument can be made for letting terminally ill patients have a right to try experimental as yet unproven therapies, but in the real world Right-To-Try laws have many downsides. On the whole, they are likely to be negative for patients as a group.  Raising the stakes is a push for a federal Right-To-Try law in the U.S. A bill passed the U.S. Senate so a law is a real possibility in coming months. What are the problems and risks? …Read More

2 min read

The U.S. Senate just passed a bill that if it becomes law would codify Right-To-Try as a federal law, meaning terminally patients across the U.S. could ask their physicians and drug manufacturers to be given still investigational therapies such as still unproven stem cell therapies in development. The bill’s official name is “The Trickett Wendler Frank Mongiello Jordan McLinn,and Matthew Bellina Right to Try Act of 2017.” Its goal is summarized this way, “To authorize the use of unapproved medical products by patients diagnosed …Read More

2 min read

Should patients have the Right To Try experimental therapies that could be unsafe and ineffective? What if those patients have a terminal illness and no reasonable prospects of being helpful to conventional medicine? Doesn’t it make perfect sense to let them try a risky approach if they want to do so? On the other hand, could some businesses capitalize on Right-To-Try to try to make a lot of money off of vulnerable patients? Right-To-Try sparks many tough questions like these and there is often …Read More

2 min read

My recent post on the push for National Right-To-Try (RTT) including a detailed comment from ISSCR stirred some animated feedback. In the spirit of encouraging diverse discussion, here I am posting a striking comment I received from a stem cell industry insider regarding that post on RTT as it relates to stem cells and s/he was especially focused on the controversial new Texas stem cell law: “I understand we disagree about these things, but still a little disappointed in how prominent the “snake oil” salesman scare …Read More