Statin dilemma: heart & maybe prostate cancer benefits, but big bump in Diabetes risk

statinsStatins have been hailed as some of the best drugs ever.

Given the massive, deadly prevalence of cardiovascular disease, some have even semi-jokingly talked about putting statins in the water supply for public health.

The growing evidence (e.g. this story) that statins might significantly aid in prevention, delayed progression, or even post-treatment delay of recurrence o cancer seemed to add to the glowing rep of statins. As a prostate cancer survivor, the news on statins and prostate cancer seemed particularly notable.

But then another narrative has been developing that is not all statin peaches and cream. Statins impair glucose metabolism and very strongly increase the risk of developing Diabetes. This connection seems like the real deal. The higher the dose of statins taken, the greater the risk.

The link between statins and Diabetes is not some small increased risk either, but a rather huge effect.

Dang, I knew the statin story was too good to be true.

It’s not clear how statins throw a monkey wrench into some patients’ systems to trigger Diabetes either so that may make it harder to say engineer a new statin that doesn’t pose the Diabetes risk any time soon.

I guess we’ll all have to stay tuned on this one and this dualism reinforces the idea that there is no “free lunch” when it comes to medication. There will always be potential for side effects. Always. Whether we are talking about chemical drugs or biological drugs like stem cells. Frustrating, but true.

Stem cells on Mother’s Day, clinical trials, and more

One of the many interesting ways in which “stem cells” are named in different languages around the world is “mother cells”. For example, in Spanish, you can learn more about these “mother cells” here in ¿Qué son las células madre?Stem Cell Symbol

On Mother’s Day it is worth thinking about where the stem cell field stands at this time.

There has never been a more exciting time than today for stem cell research and the related area of regenerative medicine. There is good reason for hope that stem cells may translate into real, proven safe and effective treatments for a many conditions in coming years and decades.

The total number of stem cell trials continues to grow. While not an exact measure and as we’ve seen some minority of “trials” are really more about making money than anything else, the number listed in clinicaltrials.gov is pushing 5,000 when I search for “stem cells”. All around the world there are much-loved moms who are facing difficult health issues and perhaps the “mother cells” of stem cells in the future can be the answer to help.stem cell clinical trials map

I get contacted by patients almost every day now and probably at least half of the patients I communicate with are women. Some are mothers inquiring about stem cells for their children who might face various conditions such as autism or cerebral palsy. Others are asking about treatments for themselves or their moms, in particular for multiple sclerosis (MS) the last few years.Today we should be careful if our moms are considering stem cells to advise them to use caution, as there are many challenges out there in the for-profit stem cell world. But it is important too to talk about real hope as the stem cell field continues to develop.

Happy Mother’s Day!

Apple getting into the genomics biz?

iPhone7In March, I was thinking it’d be fun to do an April Fool’s Day post.

I wrote the following as a possible satire spoof piece title but never had a chance to do an actual post:

iPhone 7 To Come With iPhone 7ATGC Version with Personal DNA Sequencer

Now perhaps my idea for an April Fool’s Day prank piece might not be so far off the mark from reality.

Antonio Regalado just reported on rumors that Apple might be seriously considering getting into the genomics business. Apparently some kind of personal genomics analysis tool or app could come as part of the much-discussed ResearchKit. Then again this is just a rumor and even if true, the program could be killed or delay.

This genomics program at Apple could be very exciting. With the advent of Oxford Nanopore DNA sequencing on a USB thumb drive kind of technology, it’s not difficult to imagine a future where computing and genomics join forces in a direct-to-consumer kind of way.

At the same time, Apple could well find itself tangling with the FDA as its ResearchKit program evolves and especially if it dives into personal genomics given 23andMe’s experience.

I expect there would in the future be a social media kind of platform for sharing one’s DNA data and interacting with others interested in doing the same, comparing data, etc. Apple, 23andMe, Ancestry.com, and others are likely to compete in this area. Of course issues such as privacy, genetic discrimination, etc. would come along with such developments.

Hold onto your A’s, C’s, G’s, and T’s…along with your hat.

Bioheart on the edge in 2015?

Bioheart logoStem cell biotech company Bioheart ($BHRT) has had a rough 2015 so far.

Could this year be a decisive, negative tipping point for the company?

It has a number of clinical trials going, but from my view things seem increasingly uncertain.

An oddity amongst stem cell biotechs, Bioheart and its leadership have at times seemed to toy with what some might view as controversial projects. Kristin Comella, CSO of Bioheart, has played a major role in other ventures including in the past with the Ageless Institute, a stem cell clinic. Earlier this year, investors reportedly including Brenda Leonhardt (ex-wife of Bioheart founder, Howard Leonhardt) filed a lawsuit against Bioheart for millions in alleged unpaid debt.

Comella and Bioheart are also involved in what I view as concerning training of physicians in the use of a fat-based stem cell product that might be an unapproved biological drug from the FDA’s perspective. Comella provided some insights on Bioheart and the doctor stem cell training in a recent interview I did with her. She didn’t seem concerned with the FDA.

Bioheart has another puzzling venture, US Stem Cell Clinic, LLC, (“SCC”), which it describes in this way:

“a partially owned investment of Bioheart, Inc., is a physician run regenerative medicine / cell therapy clinic providing cellular treatments for patients afflicted with neurological, autoimmune, orthopedic and degenerative diseases. SCC is operating in compliance with the FDA 1271s which allow for same day medical procedures to be considered the practice of medicine. We isolate stem cells from bone marrow and adipose tissue and also utilize platelet rich plasma.”

Recent FDA draft guidances at the very least call into some doubt the compliance of some of the offerings of US Stem Cell Clinic, LLC. The FDA could back down on the requirement for the fat-based stem cell product SVF to be approved in advance as a biological drug, but then again it might not.

Investors seemed worried. Bioheart stock has taken a beating recently, down almost 60% in the last 3 months and almost 7% just today. Overall it seems that something has got to give soon.

Disclosure: I own no stock in Bioheart or its direct competitors. This piece is not financial advice.

GMO: Why 3 Such Difficult Little Letters?

GMOI realized a few years ago that I really should know a lot more about the whole debate over genetically modified (GM) organisms (GMOs). What are the facts on GMOs?

As a scientist who has for many years done amongst other things genetics research including making and studying so-called “knockout mice” that are in a sense GMOs and also as a parent, a gardener, and a vegetarian (actually pescetarian), I should already know GMOs inside and out, right? Well, yes and no. On the GM animal and technology side, yes, but I realized I need to bone up on GMO plants and foods that contain ingredients from them.

GMOs can be any GM living thing, but when people refer to GMOs they usually are talking about GM plants and foods that might contain ingredients from them. I’m not a plant researcher myself, but I find the topic of genetic modification more generally to be very intriguing. There’s a lot of information and “information” out there though. How to tell the difference? One thing that is clear is that there doesn’t seem to be much room on this for discussion as it usually ends up turning into at best a debate and at worst a diatribe.

The “wrong” opinion about GMOs depends upon where one finds oneself and often such “wrong” statements could lead you to being subject to a hefty dose of righteous indignation from, for example, a friend-turned-lecturer.

On the one side we have the “GMO OMG” folks who view anything GMO as coming from the devil. On the other we have some folks who will not tolerate any slight concern over or question about GMOs at all, which they characterize as being akin to anti-vaccine rhetoric or the memes of the Dr. Oz-Gwyneth Paltrow crowd.

Why do GMOs incite such intense reactions with usually no room for middle ground?

I’d be especially interested in hearing from people who might have “middle ground” views on this not entirely on one side or the other.

I suppose by even doing this post I am asking for trouble, huh?