The money behind a piece of legislation can provide unique insights into the back story and this is definitely true for the REGROW Act that would reduce FDA oversight of the investigational use of stem cells in patients.
Senator Mark Kirk of Illinois, who is facing probable defeat next week in his reelection bid according to polls, has been the leading backer of the REGROW Act. Kirk has been more in the news of late due to extremely controversial Trump-like comments he made about his opponent, veteran Tammy Duckworth. Some have characterized these comments as “racist” and inflammatory.
Kirk has received campaign contributions from a number of businesses involved in stem cell product development that could stand to benefit financially if there was weaker oversight by the FDA. Data on these contributions come from research on the Center for Responsive Politics website (note that only the top 100 are listed there out of thousands of contributors, while others can be searched for manually, and the list changes over time). This money came directly or more often indirectly to him, as sometimes contributions came from second parties or employees.
Certainly, companies may contribute to Kirk just because they like him overall and with no specific interest in REGROW, but it seems to be his signature piece of legislation these days.
U.S. “Big Pharma” companies Baxter and Abbott Laboratories contributed to Kirk. A small contribution came from Astellas Pharma, a Japanese big pharma company involved in stem cell clinical research (e.g. it bought the small American stem cell biotech Ocata last year). The “drop in the bucket” donation from Astellas to Kirk is notable if nothing else symbolically because in Japan the stem cell clinical arena has recently been subject to substantially reduced regulatory oversight and proponents of REGROW often point to the Japanese stem cell regulatory system as a model for what they want to achieve in the U.S.
A $10K contribution to Kirk’s campaign came from MiMedx Group, a stem cell company with some history with the FDA. I did a post on MiMedx in 2013 here on this blog because of an FDA letter sent to the company regarding its unusual placental “stem cell magnet”. More recently, the financial website The Street also reported in May of this year that MiMedx filed suit against another stem cell company, Osiris, for “allegedly falsifying and misleading consumers with clinical data.” That’s a pretty harsh allegation, but I’m not aware if there’s any hard evidence to back it up.
MiMedx made this remarkable claim at that time about why its product doesn’t need further testing:
“Mother nature did safety and efficacy testing on the tissue,” MiMedx CEO Pete Petit told ABCNews.com, likening treatment with a placenta-based product to a kidney transplant rather than the use of a drug. Since the placenta product is made from human tissue, he said testing is unnecessary because placental cells already work in the human body.”
More broadly, according to the Center for Responsive Politics, 26 groups in all are registered to lobby on REGROW, a collection of entities including some for it and some against it. REGROW is also reportedly being promoted by Ed Bosarge, whose company Bosarge Life Sciences is on that REGROW lobbying list.
Overall, there have been hundreds of thousands of dollars spent on REGROW lobbying including from big pharma. Some of the more vocal proponents for less FDA oversight of stem cells have claimed for years that the big pharma industry has interfered with stem cell treatment development and has undue or even corrupt influence on the FDA to block patients getting access to stem cells. This always seemed like a wild conspiracy theory to me and now with these data on lobbying we can all confidently say that “Big Pharma opposing stem cells” myth is officially 100% busted.
Some might argue that some big pharma being supportive of REGROW is a sign that the bill is meritorious. Notably, however, some other groups including industry associations are opposed to REGROW as well including the Alliance for Regenerative Medicine (ARM).
REGROW has also evolved over time to be less extreme and I wonder if in yet another new incarnation the bill could be more balanced in the future so that it might garner more broad support within the stem cell community. I hope so. The goal of getting stem cell and regenerative medicine therapies to patients more efficiently is a noble one that I support as long as it doesn’t sacrifice the common sense, biomedical science-based need for rigorous data on safety and efficacy in the process.
It’s important to point out for context that certain companies lobbying on REGROW and/or contributing to Kirk also give out dozens of contributions all the time to many different lobbying and election efforts. This means that REGROW might be just one of many targets for them and in some cases the dollar amounts aren’t huge, but still REGROW is clearly on their radar screens.
What is happening now and will happen in the future? It’s interesting to speculate about whether the FDA is under political pressure and subject to lobbying to weaken or back down on its four guidances related to stem cells that are still in draft form, but to my knowledge there is no publicly accessible information on this area of lobbying. If anyone has information on that, please share it with the community.