Stemedica is a San Diego-based stem cell company founded in the mid noughties to harness and commercialize “adult stem cell technology and therapies for the treatment of neurodegenerative diseases.” The principal movers and shakers behind the launch of this private venture were two American brothers – Roger and Maynard Howe – and their longtime Russian business partner, Nikolai Tankovich. The Brothers Howe have said they were driven to this area of medicine after a sister-in-law was severely injured in a car accident in 2004 that left her paraplegic, and after hearing of miraculous advances in cell medicine in the former Soviet Union. A compelling story, but one that neglects a few salient details…
|The Stemedica Three|
After taking their sister-in-law to Moscow for stem cell injections in 2006, the company claimed that, “Within four months, many basic life-functioning abilities began to return and [she] was able regain her independence”. By the next year the Stemedica team had announced a network of international treatment centers in places like Mexico, Italy, Switzerland and France, with others to follow in Bermuda and Korea. The plan was to use various types of “adult stem cells” (apparently including fetal-derived neural cells), in combination with lasers and other devices, to treat diseases such as “stroke, Alzheimer’s, Parkinson’s, ischemic head trauma, spinal cord injury, diseases of the eye such as age-related macular degeneration and diabetic retinopathy as well as skin, scar and bone regeneraton [sic]”.
A visitor to the Stemedica website circa 2007 was also greeted with an impressive list of institutional “strategic relationships” sporting the logos of Stanford, UC Irvine, and the Burnham Institute, among others.
By 2009, the company website had removed all mention of treatment centers and Stemedica was well on its way to amassing a collection of biotech merit badges, including state certification of a cGMP cell bank, FDA authorization for a Phase I/II clinical trial, and more recently, a patent on a cellular scaffold invented by Stemedica CTO, Alex Kharazi.
But when you’re talking about overseas treatment/profit centers, gone does not necssearily mean forgotten, and Stemedica continues to have unusually cozy relationships with a number of clinics outside the US that openly advertise stem cell injections for a thick catalog of afflictions.
The Regenerative Medicine Institute in Tijuana, Mexico (which I have blogged a bit about before) is just 30 miles south of the Stemedica office. The first clinic to be accredited by the ICMS, the RMI (which is set up within the Hospital Angeles Tijuana medical tourism operation in Mexico) offers stem cells for dozens of conditions, from cerebral palsy to frailty syndrome, under a novel business scheme in which patients are told that, for $10,000-$35,000 they can buy their way into a “clinical trial” absent many of the features like controls, randomization, or blinding that would actually make it possible to generate any scientific insights into the efficacy of the investigational product.
The institute’s StemCellMX website encourages users “To find out if our trials are right for you please contact us using the form on the right“. Essentially, they ask their customers to be subjects in medical experiments, but to pay as if they are receiving therapy. Some have begun to complain.
Stemedica’s ostensible connection is as a provider of allogeneic stem cell technology for use in one such trial for stroke. A page deeper in the StemCellMX website, however, explains how a different Howe brother, David (who has an M.D. from Ross University in the Dominican Republic), accompanied 19 patients with serious, unrelated medical conditions like autism, muscular dystrophy, spinal cord injury and hearing loss to Moscow for similar experitherapies (theraperiments?), claiming 89% improvement. The doctor in charge of these procedures was Nikolay Mironov, a member of the Stemedica Scientific Advisory Board, and the treating physician at Global Stem Cell Health (treating stroke, spinal cord injury, traumatic brain injury, Parkinson’s, Alzheimer’s, cerebral palsy, multiple sclerosis, muscular dystrophy, etc.), a company co-founded by former Stemedica director of medical services, Michael Bayer. (Bayer had previously run Bayer Stem Cells, a now-inactive site with a very similar M.O.)
The link between Hospital Angeles and Stemedica goes back at least to the 2007 list of Licensed Treatment Centers on the Stemedica website (and even today, Cesar Amescua of Grupo Angeles is Stemedica’s medical and regulatory affairs director for Latin America). Also on the 2007 list is the Brown-Darrell Clinic in Bermuda, which was slated to be launched in 2008 in collaboration with Ewart Brown, then-Premier of the island nation, and his wife Wanda. The opening had to be postposed after a local media firestorm ignited over the propriety of opening a stem cell hospital in a country in which medical regulations for cell therapy were not in place, and the Brown-Darrell clinic vanished from Stemedica’s site. Five years later, no such guidelines have materialized and the controversy simmers on.
During the 2007 hubbub, the Bermuda Sun earned itself a heartfelt hat-tip for doing background and fact checks on key players at Stemedica. They revealed that CEO Maynard Howe, Ph.D. was a “marketing expert with a Midas touch” who had made tens of millions from the sale of an anti-wrinkle laser, at a company in which Roger and David Howe and Nikolai Tankovich were also all partners (as was Roger’s son Derek, the VP of operations at Stemedica at that time). The Sun reported that Maynard was also chairman of a nutraceutical company selling something called Nanogreens (the healthy fast food!).
The Sun also cast light on CMO Nikolai Tankovich, a physicist who first struck it rich with a hair-removal laser, before setting up the company Aquaphotonics and developing a
cellular hydration bottled water product that was marketed as Penta Water; the company claimed that its structural differences from ordinary water made it better at hydration. Penta earned the rare distinction of being called out on its spurious claims on separate occasions by skeptic icons James Randi and Ben Goldacre, among others (Goldacre later wrote that he received anonymous threats after voicing his doubts about Penta.) In 2005, the UK Advertising Standards Authority upheld a number of complaints against Penta for misleading claims.
Alkhass (Amni), Schuller (Stemedica Intl., Amni)
Meanwhile, in the Rest of the World, Stemedica has continued its empire-building and regulatory arbitrage overseas. In recent years, they have inked a deal with Jordanian Stem Cell Company, chaired by Prince Asem Bin Nayef of Jordan, and partnered with Amni BioScience, a Middle East regional biz headed by fellow San Diego citizen Sam Alkhass (who also brokered the Jordan alliance), and counting Tankovich and David Howe, as well as Stemedica International chief Frank Schuller, and Mark Tager, Stemedica executive for dermatological operations, and another ‘nother Howe brother, Bruce, on its team.
Stemedica is popping up all over Asia, entering a joint venture with AnC Bio in Korea, and launching Stemedica Asia in Singapore. In China, Maynard and David held an Educational Forum with W.A. Stem Cell Technologies, a company recently exposed in a Nature article that detailed how its medical tourism arm offers a double dose of stem cells (adipose, cord blood) for autism for 250,000 RMB (around $40,000), in apparent violation of the Chinese Ministry of Health’s efforts to rein in over-the-top claims of stem cell efficacy. W.A. is headed by Shu Li, a former engineer who also goes by the name of Taichi Tzu, holds a patent on negative gravity therapeutic methods, and has “been practicing Taoist alchemy for over 15 years.”
Maynard and David go to Shanghai
Stemedica also shows up in the logo roll on the website for Beijing’s IPM Group (also known as Beijing Damcell Bio-Medical Technology), alongside the heraldry for Harvard, Oxford, and Cambridge and STEM-CELL.KZ (website archived here), a seemingly now-defunct company in Kazakhstan, the country where Daniyar Jumaniyazov has been injecting heart patients with Stemedica cells as part of a trial at the National Medical Research Center in Astana, in collaboration with Nikolai Tankovich. (Jumaniyazov is also a member of the Amni team).
Some people might see Kazakhstan as a less than obvious choice for a Phase II clinical trial, but at least two U.S. cardiologists, Nabil Dib and Jackie See, called the announced results “promising” and “impressive” in a recent press release. What the Stemedica release fails to mention is the direct ties between the company and these commentators; Jackie See is on the Stemedica scientific advisory board, and that Nabil Dib is a special advisor to the board.
The release also fails to mention that Jackie See, himself a member of the physician team at California Stem Cell Treatment Center (which offers stem cells for (among others) asthma, hair loss, incontinence, MS, kidney failure and Peyronie’s disease), has been in trouble in the past for scientific fraud. In 1999, the LA Times reported how Harvard Scientific, a company at which he was director for research, got into trouble with the FDA for submitting “misleading and erroneous information about a clinical study” for an agent being tested for treatment of sexual impotence. Predictably, this hurt Harvard Scientific’s share price, triggering an investor suit against See (RK Company v See). According to the circuit court ruling, the court “repeatedly described Dr. See’s testimony as not credible,” and the plaintiff (who was himself in prison at the time on bribery and racketeering charges) won.
The press release also neglects to disclose that Nabil Dib is the director of cardiovascular research at Mercy Gilbert Medical Center in Arizona, one of the sites where Stemedica is conducting its stroke clinical trial. It further omits Dib’s former role as chief of staff in the stem cell transplant clinic at Stowe Biotherapy. The proprietor of that business, Larry Stowe, surrendered to authorities this January after 60 Minutes caught him and his then-partner Frank Morales offering stem cells and tall tales to an ALS patient, on camera.
Neglecting the inconvenient seems to be the norm at Stemedica. When the Brothers Three and Tankovich co-authored a book (The Miracle of Stem Cells), the company neglected to mention that the president of their publisher (ChangeWell Publishing) is Stemedica’s dermatology exec, Mark Tager. When the radio show In Our Life Time interviewed Maynard Howe about his life, his company, and “the miracle of stem cells” the show’s host, Dave McGuigan, neglected to mention that he also serves as Stemedica’s VP for Marketing and Business Development, despite having an hour to do so. And when Stemedica announced that company president Nikolai Tankovich had been named legate at the obscure Centre for Science and Society in Oxford, they neglected to mention that the director of that centre, Frank C. Schuller, is also head of Switzerland-based Stemedica International.
We’re in the business of miracles
Stemedica even almost entirely neglects to mention that some of its “adult, allogeneic stem cells” are actually fetal in origin (the mincing code for this apparently being “taken from donated brain tissue“). Fetal cell injections have a history of being ethically problematic and potentially dangerous, when used outside the a well-regulated, scientifically controlled context. (Readers interested in a disturbing, long-form exposition of a fetal cell treatment gone haywire should check out this chapter from the book, When Science Goes Wrong.)
Riccardo Nisato, Director of Manufacturing and Clinical Business Development at Stemedica International, did in fact drop the F (for “fetal”) bomb in a single comment announcing his appointment back in 2009, which Stemedica’s neglecters seem to have neglected to neglect but, to be fair, he was still new back then and may have missed the memo.
The sister-in-law whose accidental paralysis kicked off this latest family venture died back in 2009. But while she was still living, a local magazine reported that, despite the hype, “an MRI performed in June revealed that the stem cells had not repaired her spinal cord.” In the end, she attributed her perceived progress “to God.”