Well, perhaps.

Six scientists in the UK and Scotland have successfully printed human stem cells with a “valve-based cell printer” that uses bio-inks to fabricate groups of viable stem cells that retain their ability to become any type of cell in your body.

Stem cells are valued by biological scientists for research because they are “pluripotent:” they can develop into almost anything a human body needs such as skin cells, muscle tissue, or internal organs. But collecting and using them has been a controversial process, as one source for stems cells has been embryonic tissue harvested after abortions. And using them inside the human body has been difficult.

This new process essentially bio-fabricates usable conglomerations of human stem cells by printing bio-ink, made up of a number of organic components including HEK293 (human embryonic kidney) via a valve-based printer with very fine nanoliter capacity (an ounce of liquid contains 29,573,529 nanoliters). The nozzle of the valve-based printer that they used is only .002 inches wide.

Between 70 and 95 percent of the cells survived past 72 hours, and three days after, the cells tested positive for pluripotency, and seemed to be growing:

Essentially, the scientists printed arrays of stem cells that could be used in future in-vitro organ regenerations. Maybe you won’t get a new motor, but you could get an on-site re-build … and surgeons won’t have to take your body apart to do it, either.

Along the same lines, the scientists speculate that “direct in-vivo cell printing for tissue regeneration” will become possible, allowing doctors of the future to heal internal injuries without surgery.

Which is a little bit cooler than 3D printed business cards, no? And better than 3D-printed guns, surely.

photo credits: Tatcher a Hainu via photopin cc, Alan Faulkner-Jones, Sebastian Greenhough, Jason A King, John Gardner, Aidan Courtney, and Wenmiao Shu, Hat tip: ExtremeTech

• BrainCells raises $30M for neuroregeneration drugs (release)
• EKR Therapeutics takes in $50M plus $95M in debt for pain, heart drugs (release)
• Wright Medical acquires Berkeley’s Inbone Tech for $24M (release)
• Argolyn Bioscience names Nixon Ellis as CEO (release)

BrainCells raises $30M for neuroregeneration drugs – San Diego’s BrainCells, a startup focused on drugs intended to stimulate the growth of new neurons, raised $30 million in a second funding round. Investors included MedImmune Ventures, Bay City Capital, Oxford Bioscience Partners, Technology Partners, Pappas Ventures and Neuro Ventures.

BrainCells set out several years ago to discover drugs that stimulate neuron growth, following pioneering discoveries at the Salk Institute that revealed mechanisms by which the brain itself regrows its primary cells under certain circumstances. The startup, which raised $17.7 million in a 2004 first round, has been screening experimental compounds against neural stem cells to identify ones that had the previously overlooked property of promoting the growth of new brain cells.

The company’s lead drug candidate, BCI-540, which it licensed from Mitsubishi Pharma, will soon be mid-stage, phase II trials as a potential treatment for depression and anxiety disorder. (Mitsubishi had previously tested as a possible Alzheimer’s therapy, so it’s already been taken by 700 patients and is considered safe.) A follow-up compound, also licensed from a Japanese company — Taisho Pharmaceutical — remains in animal testing at the moment.

EKR Therapeutics takes in $50M plus $95M in debt for pain, heart drugs – Cedar Knolls, N.J., specialty pharma EKR Therapeutics raised $50 million in a fourth funding round that also included $95 million in debt. Investors in the equity round included MPM Capital, LLR Partners, Quaker BioVentures, the Garden State Life Sciences Venture Fund, NewSpring Capital and ESP Equity Partners. GE Healthcare Financial Services provided the debt financing.

EKR, like most specialty pharmas, acquires or licenses cast-off drugs from other companies, usually in hopes of finding new uses for them. Although the release doesn’t say so specifically, this funding will likely cover the company’s recent purchase of several drugs from the rapidly disintegrating PDL BioPharma; last month, EKR said it had raised an undisclosed amount of funding for that deal, in which it agreed to pay $85 million up front and another $85 million in potential milestone payments.

The company also has the distinction of using that deal to “re-acquire” several drugs that an earlier incarnation known as ESP Pharmaceuticals handed to PDL in a 2005 acquisition, an interesting turn of events we covered here.

But there’s no shortage of reasons to treat PrimeGen’s claims with skepticism, starting with the fact that it chose to announce them at last week’s Stem Cell Summit, an investment conference in New York whose Web site already seems to be defunct. Add in the facts that PrimeGen has been making similar claims for more than two years but hasn’t ever published its findings in a scientific journal, that it only seems to present actual data at obscure overseas meetings — one organized by the Pontifical Academy for Life and the World Federation of Catholic Medical Associations, for instance, and another arranged by Serono Symposia International, a producer of continuing medical educational events — and that it appeared inordinately tickled when a pro-life U.S. Senator praised its work as “the greatest thing on the horizon” in a 2006 congressional hearing, and you have an awfully good basis for suspicion.

PrimeGen also stands out as a very odd duck in the world of stem-cell startups. The company has largely been bankrolled by two tech-industry entrepreneurs, Kingston Technology co-founder John Tu and AST Research co-founder Thomas C.K. Yuen, neither of whom have any background in biology or medicine so far as I can tell — or even a history of supporting such work. Yuen, in fact, serves as PrimeGen’s chairman and CEO, another discordant note. The company’s Web site is an amateurish mess rife with scientific vaguery of the highest order, meaningless puffery — did you know that PrimeGen is “the global leader” in stem-cell research and regenerative medicine? Me neither — and executive bios that tout routine biomedical accomplishments such as “being a Principle[sic] Investigator of NIH grants” as if they were the Nobel Prize.

That’s all shaky enough, but none of it gave much pause to mainstream publications such as the U.K. magazine New Scientist and the Philadelphia Inquirer, which played up the company’s unsubstantiated claims in recent articles (see here and here). Only the Inquirer offers a few reasons to question PrimeGen’s alleged achievement — in particular, pointing out that research now suggests it takes about two weeks to turn normal cells into what are technically callled “induced pluripotent stem cells,” whereas PrimeGen claims to do it in five to seven days.

The New Scientist piece, which goes into the most detail about PrimeGen’s technique, says the company used stretches of DNA that “code” for the same four genes used in one of last November’s gene-therapy experiments plus a fifth gene called Nanog. The company’s scientists supposedly attached the DNA to carbon nanoparticles that it mixed with the adult cells to reprogram them into iPS cells. Using the proteins coded by the genes allegedly had the same effect.

All this is certainly plausible — but so were other stem-cell “breakthroughs” that never panned out, most notably fabricated research touted by in 2005 by South Korean researcher Hwang Woo Suk, who claimed to have produced embryonic stem cells from adult tissue via cloning. Of course, it’s impossible to rule out the possibility that PrimeGen can indeed do exactly what it says here, but the signs aren’t auspicious. PrimeGen says it has submitted its latest results to a stem-cell meeting in Philadelphia this summer, and its science had better match or exceed its hype if it wants to be anything but a colossal vanity project.

• Q Thera takes in $15M for neural stem-cell treatments (release)
• Stroke clotbuster Concentric Medical withdraws IPO (IPOhome)
• Avera recaps with $9M to relaunch human tests of GI drug (VentureWire)
• Tissue repairer Nerites raises $5.7M (release)
• Semafore Pharma aims for $7.5M to launch new cancer-drug trials (VentureWire)
• Triage Wireless gets $6.7M for “cuffless” blood-pressure monitors (peHUB)
• MAKO Surgicals prices IPO, falls in first day of trading (WSJ)
• ImmunoCellular acquires assets of Molecular Antibody Technology (release)

Q Thera takes in $15M for neural stem-cell treatments – Q Therapeutics, a Salt Lake City biotech working on neural stem-cell treatments for neurological conditions, has received the first portion of a $15 million second funding round. Investors in the round included vSpring Capital, Invitrogen, Epic Ventures, Toucan Capital, University of Utah Research Foundation, Salt Lake Life Science Angels and Q management.

Q is taking aim at diseases such as multiple sclerosis and cerebral palsy that result when the protective myelin sheath that protects nerve fibers and the spinal cord deteriorates, often for little-understood reasons. The company is developing neural stem cells that can produce new glial cells, which in theory should be able to regenerate the damaged myelin. (Irritatingly enough, the company insists on calling its product “Q cells.”) The company aims to begin clinical trials in transeverse myelitis, a paralyzing form of MS, next year.

Stroke clotbuster Concentric Medical withdraws IPO – Concentric Medical, a Mountain View, Calif., developer of medical devices for removing stroke-causing blood clots, withdrew its proposed IPO. The company becomes the eighth life-science startup to abandon an IPO this year.

Concentric, of course, cited “unfavorable market conditions” as the reason for its withdrawal. The device maker, which is still unprofitable, reported working capital and cash and short-term investments of $20.3 million at the end of June and has been burning cash at a rate of about $7 million a year, so it’s not necessarily in dire straits. Concentric, in fact, today announced it had arranged a $15 million line of credit with Horizon Technology Finance, giving it an additional cushion.

The company makes and sells a catheter-based device that can be snaked through a patient’s blood vessels to the brain in order to physically “grab” and remove stroke-causing blood clots. Although Concentric won approval for the device in 2004, sales have grown more modestly — in part, perhaps, because Concentric hasn’t undertaken the clinical studies necessary to demonstrate the usefulness of its technique compared to other treatments, and has no plans to do so. (The company listed this point as a risk factor in its SEC filings.) What’s more, the Concentric device can sometimes damage blood vessels in the brain; in one of two studies, almost ten percent of patients suffered a cranial hemorrhage.

Our previous coverage of the company is here.

Avera recaps with $9M to relaunch human tests of GI drug – Avera Pharmaceuticals, a San Diego specialty pharma developing drugs against a variety of conditions, recapitalized with a $9 million “first” funding round, VentureWire reports. Such a recap usually amounts to a restart for a company, which in this case was prompted by a halted clinical trial of a drug for irritable bowel syndrome and overactive bladder.

Investors in the recap included all participants in the company’s previous funding round: Aisling Capital, SV Life Sciences, Aberdare Ventures, BioAsia Investments, H.I.G. Ventures, Montreux Equity Partners, Bay City Capital, BTG PLC, Frazier Healthcare Ventures, InterWest Partners, St. Paul Venture Capital and Windamere Venture Partners. The company declined to provide a valuation to VentureWire, but it’s almost certainly suffered a “down round,” or it wouldn’t be recapitalizing.

Avera shut down mid-stage trials of its drug, known as AV608, last year after animal testing turned up potential toxicity issues. The company has since redesigned the drug to eliminate a compound it called a “non-active metabolite,” and hopes to resume studies later this year. Avera had raised more than $72 million prior to the recap.

Details are still rather sketchy at this point. I spoke briefly with Minerva founder Cynthia Bamdad, who declined to say much about Czirr until she’d consulted her lawyers. Bamdad said Czirr was named CEO in October 2005, but “basically stopped performing any work function back in July” of 2007. “That was the reason for the recent board action.”

So far, I’ve been unable to track down Czirr for comment.

Czirr, described in this Boston Business Journal article as a former center for the University of Michigan football team, is also apparently at odds with his previous company, cancer-drug developer Pro Pharmaceuticals. Czirr stepped down as board member and executive at Pro Pharma in 2003, but still holds roughly 15 percent of the company’s outstanding shares. Czirr has been publicly critical of Pro Pharma’s financial management.

Bamdad is a fascinating personality in her own right. As this 2004 Technology Review piece explains, Bamdad began her biotech career at age 36 as an artist and single mother of five with no higher degrees or scientific background. Newly divorced, she sold her Ferrari, earned an undergraduate physics degree in three years and a Harvard biophysics doctorate in five, produced a marketable biosensor from her academic work, took it to a company that was shortly acquired by Motorola, and went on to found Minerva in 1999.

Her company started life as a developer of nanoparticle-based biochips, but more recently has pushed into stem-cell science. Bamdad said Minerva scientists, in conjunction with academic researchers at UC Santa Barbara, are beginning to develop drug candidates that would attack cancer stem cells, which are primordial cells that may initiate and sustain tumors. The company has also recently taken strides toward understanding how embryonic stem cells grow and “differentiate” into the 200 or so cell types in the body. Minerva has 16 employees and has raised between $12 million and $13 million over its lifetime, all from angel investors, Bamdad told me.

I’ll likely follow up with another post when we know more about what’s actually going on with this controversy.

Featured stories:

• Stem-cell science, money and death
• Gene tests: Out of control?
• Clinical-trial data wants to be free
• Drug, biotech industries face uncertainty
• Short takes

Clones, regrown hearts, money and death — Last week, the San Diego biotech http://www.stemagen.com/ announced that it had cloned human embryos by transplanting the nuclei of adult skin cells into oocytes, or human egg cells. The cloned embryos reportedly into blastocysts, the five-day-old clumps of roughly 100 cells from which researchers can, if all goes well, extract stem cells. (The research isn’t aimed at creating cloned babies.) Although not of immediate practical use, the ability to use embryo cloning to make genetically matched stem cells would be a big step forward for the field, since the technique could be used to produce stem-cell lines specifically for the study of particular genetic disease. The Stemagen embryos, however, didn’t actually yield any stem cells, leaving some researchers skeptical that the company had actually achieved what it claimed. The NYT has more.

Another team of researchers at the University of Minnesota recently created a beating rat heart in the laboratory, although the work didn’t grow the heart from scratch and didn’t specifically use stem cells. The team used detergents to clear living cells from a dead rat heart, leaving the outer structure and valves as a scaffold that cold be “repopulated” by injected cells from newborn rats, which eventually developed into working heart muscle that pumped blood and conducted electrical signals. Eventually it may be possible to do the same with hearts taken from human cadavers and stem cells extracted from a patient’s bone marrow, potentially yielding a newly transplantable heart.

Meanwhile, stem-cell pioneer James Thomson, a University of Wisconsin biologist, argued for a major boost in state stem-cell funding, saying that Wisconsin needs to hand out $50 million a year in order to compete with California’s $3 billion program. And in sad news, a 9-year-old girl with a fatal genetic condition called Batten disease died after being treated in a clinical trial with neural stem cells intended to correct a brain-enzyme deficiency in Batten patients. Preliminary results suggested the death was a result of her disease and not the stem-cell therapy, developed by the Palo Alto, Calif., biotech Stemcells.

Test, genes and politics — A federal advisory panel raised concerns over the proliferation of genetic tests, complaining of misleading or false marketing as well as the possibility that patients could be harmed by basing medical decisions on inaccurate tests. Unsurprisingly, many tests fall through loopholes in federal regulation, partly as the result of divided responsibilities between Medicare and the FDA. No agency even knows how many such tests are currently on the market. New tests — or the prospect of them — are popping up all the time, such as a recent finding that five specific DNA variations may help predict a man’s risk of prostate cancer, a test that, predictably enough, will be commercialized within the next few months by a startup called Proactive Genomics. The panel doesn’t appear to have addressed personal-genomics services like 23andMe or deCODEme, but chances seem good that Washington will want to weigh in sooner or later.

Making the most of clinical data — Reported results of drug trials and other medical interventions tend to be heavily skewed toward “positive” trials that appear to demonstrate the effectiveness of whatever therapy is being studied. Efforts to encourage reporting of “negative” results — that is, those that show no effect, which can also yield useful information — have faced an uphill battle. Over at Fierce Biotech, the founder of Raven Biotechnologies — a company best known around here for its attempt to swallow the corpse of VaxGen — cites her personal experience to argue that neither drug companies nor scientific journals are inclined to publish negative results. “The publishing industry and pharma reinforce each other’s biases” toward positive news, Jennie Mather writes. Meanwhile, in the NYT, Memorial Sloan-Kettering Cancer Center biostatistician Andrew Vickers bemoans the culture of secrecy that discourages even academic cancer researchers from sharing their data from clinical trial more openly. Allowing others access to the data could not only improve clinical trial designs, but potentially point the way to new diagnostic tests and treatments.

Pharma, biotech under fire — Politicians are turning up the heat on the drug industry, the WSJ notes, listing efforts to allow reimportation of cheap Canadian drugs, force Medicare to negotiate drug-price discounts, permit generic forms of biotech drugs and enact healthcare reform as among the major threats to Big Pharma and Big Biotech. In California, a recent report from the California Healthcare Institute raises similar concerns about the biotech industry, arguing that increased government oversight could crimp drug development. New drug approvals are already at a 24 year low, the In Vivo blog noted recently, although research productivity at drug companies seems to be the major culprit.

Short takes:

• Pfizer last year won approval for the first drug to treat fibromyalgia, a chronic pain condition whose existence still isn’t well accepted by doctors — including the one who first defined it in 1990, but has since changed his mind. (NYT)
• California’s plan to become the first state to require electronic tracking of prescription drugs — a measure designed to thwart drug counterfeiting — may be delayed another two years, to 2011, as the drug industry upgrades its computer systems. (SF Chronicle)
• Northstar Neuroscience brain-stimulation device fails in stroke-rehabilitation trial, highlighting the hit-or-miss efforts to treat brain and nerve disorders with neuromodulation. (NYT)

• TransEnterix gets $21M for minimally invasive GI surgery (release)
• Stem-cell developer Bioheart’s IPO postponed (Forbes.com)
• Medical-practice software provider AdvancedMD acquired by Francisco Partners (release)
• Peptimmune draws $8.2M for MS drug trials (release)
• Drug-delivery co. Talima Thera names Martin Babler CEO (release)
• Alimera Sciences aims for autumn IPO to fund diabetic eye-disease drug (VentureWire, sub req’d)

TransEnterix gets $21M for minimally invasive GI surgery — TransEnterix (no Web site), a Research Triangle Park, N.C., device maker developing tools for “natural orifice” gastrointestinal surgery, raised $21 million in a first funding round. Investors included SV Life Sciences, Parish Capital Advisers and Synergy Life Science Partners.

According to the Web site for Synecor, a North Carolina incubator that founded TransEnterix, the company is at work on tools and devices for minimally invasive “trans-oral” surgery using an endoscope passed through the mouth and down the esophagus. This procedure is designed to enable surgeries through the stomach wall and other unspecified “natural entry points,” potentially in a way that could supplant minimally invasive laparoscopic procedures that require entry through the abdominal wall. Patients would be consciously sedated during the procedure.

The funding will allow TransEnterix to “deliver” its first-generation tools, presumably for use in clinical trials, and to fund development of next-generation devices.

Stem-cell developer Bioheart’s IPO postponed — Bioheart, a Sunrise, Fla., developer of a stem-cell-based heart therapy, has postponed its troubled IPO. Although the company doesn’t seem to have officially yanked it yet, odds are now good that it will.

Bioheart’s woes started last October, when it abruptly slashed its offering price and fired its underwriters. The company’s IPO has lingered on life support ever since. We gave readers some good reasons to be skeptical about Bioheart — which, notably, is backed by former football great Dan Marino, among others — as long ago as last July.

Medical-practice software provider AdvancedMD acquired by Francisco Partners — AdvancedMD, a Salt Lake City provider of Web-based medical-practice management software — now there’s a mouthful — announced that it was acquired by the private-equity firm Francisco Partners. Financial terms weren’t disclosed.

AdvancedMD, founded in 1999, sells a series of Web-based products designed to handle administration, billing and electronic medical records for physicians. The company had previously raised venture funding from Dominion Ventures, Windward Ventures and Hunter Capital. Francisco has already named a new CEO, and said that it intends to “leverage” the company’s success with “additional resources” to accelerate its growth.

Peptimmune draws $8.2M for MS drug trials — Cambridge, Mass.-based Peptimmune, a biotech at work on drugs for autoimmune and metabolic conditions, raised $8.2 million in the first stage of its fourth funding round. The company anticipates closing a second tranche in the second quarter. Investors included New Enterprise Associates, MPM Capital, Hunt Ventures, Boston Medical Investors and Silicon Valley Bank Capital.

Peptimmune is focused on using protein fragments known as peptides to disrupt or otherwise modulate immune-system reactions associated with disease. Its lead candidate, PI-2301, is a “random sequence” peptide similar in certain respects to the approved drug Copaxone, which Peptimmune is currently testing against multiple sclerosis in early-stage human tests.

Alimera Sciences aims for autumn IPO to fund diabetic eye-disease drug — Alimera Sciences, an Alpharetta, Ga., biotech focused on eye disease, is contemplating an IPO this fall, VentureWire reports (subscription required). The funds will ideally support the launch of the company’s first innovative product, a treatment for a blinding complication of diabetes known as diabetic macular edema.

Alimera, which started life as a specialty pharma that resold over-the-counter eye products, began development of its current candidate, Medidur, in 2005. The treatment, co-developed with the nanotech company pSvidia, is a tiny structure designed to be injected into the back of the eye, where it steadily emits a corticosteroid called fluocinolone acetonide. The idea is to provide the smallest possible quantity of the steroid directly to the back of the eye, where a fluid buildup in the retina steadily obscures vision. Many ophthalmologists currently treat the condition with steroid injections, although no drugs are approved for the disease.

Medidur is currently in late-stage, phase III human tests. Alimera expects data from that trial in late 2009 and could file for approval in 2010.

• Cancer stem-cell co. OncoMed strikes GSK partnership worth up to $1.4B (release)
• Kosmix pulls in $10M for health, lifestyle search (release)
• CDI Bioscience pulls in $3M for protein-production improvements (release)
• UroMedica takes in $7M for incontinence devices (VentureWire, sub req’d)
• Draths raises $2.5M for flu drugs (PE Hub)

Cancer stem-cell co. OncoMed strikes GSK partnership worth up to $1.4B – Redwood City, Calif.-based OncoMed Pharmaceuticals, a biotech founded to target and destroy the “cancer stem cells” that researchers believe may lurk at the heart of every tumor, struck a major partnership with GlaxoSmithKline to discover and commercialize new cancer drugs based on OncoMed’s technology.

The deal allows GSK to license up to four of OncoMed’s monoclonal antibody drugs that are directed at multiple cancer stem-cell targets. In turn, OncoMed gets an undisclosed initial payment, an equity investment, and milestone payments of up to $1.4 billion, plus double-digit royalties on any marketed products. The arrangement includes OncoMed’s leading product candidate, OMP-21M18, which is scheduled to begin human testing this year.

Cancer stem cells are, like most stem cells, thought to be progenitor cells that give rise to a diverse population of other cell types. In this case, however, the cancer stem cells theoretically keep tumors alive by constantly producing replacement tumor cells as they are killed off by chemotherapy, radiation or the body’s defenses. Cancer stem cells, in fact, may explain why tumors return so easily after surgery or chemotherapy, since if even a few stem cells survive, they can easily recreate the tumor.

CDI Bioscience pulls in $3M for protein-production improvements – CDI Bioscience, a Madison, Wisc., biotech aiming to improve the efficiency of genetically engineered cells in the production of biotech drugs, raised $3 million in a first funding round. Battelle Ventures and Innovation Valley Partners provided the funding.

CDI has developed a process that forces bioengineered cells into a “senescent” state, which CDI claims is characterized by greater energy production (in terms of increased numbers of mitochondria) and increased protein synthesis and output. The company claims that cells “shifted” into senescence routinely produce three to seven times the amount of engineered protein — the output that biotechs purify into drugs — than their unshifted counterparts.

UPDATED: Expanded items on Fate Therapeutics and Medgenics. The Satoris item is now a standalone post here.

Fate Therapeutics launches regenerative-medicine quest with $12M — In one of the splashiest launches in recent memory, Seattle’s Fate Therapeutics launched a new regenerative-medicine quest and raised $12 million to help it along. The company aims to develop drugs that redirect fundamental cell biology in ways that mimic the regenerative powers of stem cells, either by “reprogramming” normal cells into stem cells or by directing existing “adult” stem cells in the body to activate their regenerative powers.

I mentioned the hype, right? Fate’s release — and its Web site — prominently quotes one of its scientific advisors saying the company’s approach amounts to “the dawn of a new day in medicine,” so it seems safe to say that the company doesn’t lack for self-confidence. Fate also arranged a slew of positive press coverage timed to its announcement, including this story in Forbes.

Fate has assembled a team of scientific stem-cell luminaries — see the release for details — and the potential of this sort of approach is certainly huge. At the moment, most stem-cell companies are trying to use transplanted cells themselves to regenerate damaged or diseased tissues, still an unproven approach with a number of shortcomings — among them, the likelihood that patients receiving cell transplants will have to take immunosuppressive drugs to prevent transplant rejection.

By contrast, targeted drugs that can push existing cells back into a primordial, regenerative state could open up entirely new forms of medical treatment. Assuming, that is, that everything works — and that’s a big if at this point. Understanding of cells’ natural regenerative mechanisms remains in its infancy, so it’s probably worth taking Fate’s grander claims with a grain of salt until the company proves that it can do what it claims it can.

Here’s Forbes on what Fate has in store for us:

Already, Fate Therapeutics has treatments in clinical trials to improve the potency of cord-blood stem cells and to treat myelodysplastic syndromes, anemias that strike 10,000 Americans a year. Another drug program might help reduce the impact of the genetic disorder that causes Down syndrome. Other treatments could affect the same litany of diseases touted as targets for stem cell therapy: Alzheimer’s, osteoporosis and Parkinson’s, to name a few. Because tumors are caused by stem cells run amok, drugs to turn down their activity might be potent cancer medicines.

Fate, of course, isn’t alone in this quest. Plasticell, a fairly new U.K. biotech with a much lower profile than Fate, is also looking for non-invasive ways to tap cellular regeneration; see our coverage here.

Investors in the funding include Arch Venture Partners, Polaris Venture Partners, Venrock and OVP.

Medgenics raises £3.3M in London IPO — Vienna, Va.-based Medgenics, a biotech that aims to help patients produce genetically modified protein drugs within their own bodies, raised £3.3 million ($6.8 million) in an initial offering associated with its listing on the AIM market of the London Stock Exchange, VentureWire reports (subscription required). The company is developing “Biopumps,” which are tiny protein “factories” made from a patients’ own tissue that are designed to provide lasting drug treatment for chronic conditions such as anemia or hepatitis.

UPDATED: Expanded items on SpinalMotion and Plasticell. Previous items on Evalve and Excaliard have been expanded into standalone posts here and here.

Spinal-disc maker SpinalMotion arranges $14M loan facility — SpinalMotion, a Mountain View, Calif., developer of artificial spinal discs, arranged a $14 million “loan facility” — sort of a line of credit — with GE Healthcare Financial Services. The company last raised $20 million in a third round in September 2006, and to date has raised a total of $44.2 million in venture funding, according to VentureWire (subscription required).

SpinalMotion’s artificial cervical and and lumbar discs are designed to provide alternatives to spinal-fusion surgery or an approved artificial disc (J&J’s Charite) for degenerative-disc conditions. Both are being tested in large clinical trials, and the company said in June that both trials are now fully enrolled.

I wasn’t able to reach anyone at the company — the release itself was issued by GE Healthcare — and so haven’t had a chance to ask why SpinalMotion decided to take on debt rather than pursuing another venture-financing round. The obvious answer would be that management believes the company can get better terms from either VCs, IPO investors or potential acquirers following the release of those clinical-trial results, and is willing to take on debt to tide the company over until the data is in.

The obvious risk, meanwhile, is that if either or both trials go sour, the company will be in much more of a hole if it plans to raise new funds. It’s a calculated gamble, one whose outcome will be interesting to observe.

Plasticell takes in £690K for stem-cell work — Plasticell, a U.K. biotech hoping to develop new drugs that mimic the regenerative effects of stem cells, has pulled in £690,000 ($1.4 million) in the company’s first institutional funding round.

The Capital Fund, a London-based VC outfit, provided £250,000 of that funding, while unidentified existing invested accounted for another £440,000. Plasticell also received a £1.1 million grant from the U.K. government in January to develop robotic systems for culturing stem cells.

Plasticell hasn’t yet made much of a splash, although its scientific advisors include some heavy hitters in the U.K. stem-cell research community, including Sir Martin Evans, who shared the Nobel Prize last month. The company is pursuing two complementary objectives: Culturing stem cells in order to identify the various biochemical signals that cause them to “differentiate” into various types of body tissue, and searching for drugs that might mimic or alter those signals in both stem cells and normal cells.

Such work could have a variety of applications, such as cancer treatments or “regenerative medicine” that restores tissues damaged by disease or injury. In a way, the company’s efforts parallel work by other research teams that recently reported a way of “reprogramming” normal cells to convert them into stem cells (see our coverage).

OTHER HEADLINES OF NOTE:

• Exiqon to buy cancer-diagnostics startup Oncotech for $45M (GenomeWeb, reg req’d)
• Australia’s Xenome raises $10M for new peptide drugs (release)
• Nanoparticle-drug maker Bind Biosciences receives $16M (release)
• Yaupon takes in $16M for cancer, CNS drugs (release)
• Hormone-drug maker Clarus draws $8M (release)
• Israel’s HealOr receives $8M for skin-care drugs (release)
• HistoRx names Rana Gupta as CEO (release)

Two research groups have just reported ways to “reprogram” ordinary cells in ways that cause them to revert into a primordial state resembling that of embryonic stem cells. Those embryonic cells have long been controversial because they’re derived from five-day-old embryos in a destructive process, but also hold the promise of unlocking the body’s ability to regenerate damaged or diseased organs because they’re capable of transforming themselves into any type of tissue.

The new techniques — more specifically, improvements on this early work, which essentially functions as a proof of principle in humans — could potentially break the political logjam over stem-cell research. For more than six years, anti-abortion politics have held back the field, thanks to a presidential order that blocks funding for any work that doesn’t involve a handful of stem-cell lines that existed in 2001. Although states like California, which has just begun spending $3 billion that voters authorized for stem-cell work three years ago, have picked up the slack, the federal restrictions have clearly held scientists back and forced some to relocate overseas. (For our previous coverage of stem-cell issues, see the end of this post or click here.)

If it’s possible to produce embryonic-like stem cells (technically, “pluripotent” cells) without destroying embryos, however, moral objections to the research should fall away. “My personal barometer of optimism has gone up a bit,” says James Thomson, the University of Wisconsin researcher who first isolated human embryonic stem cells almost a decade ago and who led one of the teams reporting results today. “This will remove the restrictions [on stem-cell work]… and the research will accelerate.” Thomson believes that the federal limitations may have cost the field three to four years of lost time.

In its current state, however, the new technique isn’t yet a panacea. The two teams — Thomson’s in Wisconsin, which published its findings in the journal Science, and a separate group at Kyoto University in Japan, which published in Cell — both achieved their feat by transplanting four genes known to be active in embryonic stem cells into ordinary “somatic” cells, the non-reproductive cells that compose almost almost all of the body’s organs. (Thomson’s team used fetal skin and a newborn’s foreskin, whereas the Japanese group used skin and connective-tissue cells from adults.) The Japanese team, led by Shinya Yamanaka, a stem-cell scientist who recently accepted an appointment at the UCSF-affiliated Gladstone Institute (see our coverage here), laid the groundwork for this approach when they successfully reprogrammed mouse skin cells into stem cells back in June (our coverage here).

That technique, however, involves the use of retroviruses that integrate new genes into the cells’ genomes — a risky process that can inadvertantly make the cells cancerous. The two teams also use different sets of genes, one of which — the c-MYC gene used by Yamanaka’s group — is also linked to cancer.

Scientists still have to figure out what these genes are doing and whether there are other simpler and less dangerous ways of achieving the same effect. It’s also still not clear whether the reprogrammed cells are identical to the embryonic cells, although Yamanaka’s group has reportedly already coaxed the reprogrammed cells to transform into heart and nerve cells.

Still, the reports represent a giant step forward for stem-cell research, although Thomson and other experts caution that it’s far too soon to abandon work on the original embryonic stem cells. After all, it was a decade of research into those cells that made the reprogramming technique possible in the first place. The reprogrammed cells may already be useful in searching for new drugs and in unraveling the genetic components of disease, since for the first time it should now be possible to produce pluripotent cells with a known genotype — at least without using the also-controversial cloning process known as somatic-cell nuclear transfer (SCNT), which is sometimes called “research cloning.”

The reprogramming experiments come just a week after Oregon scientists reported obtaining embryonic stem cells from cloned rhesus-macaque embryos. Primates had never been successfully cloned before. The primate results will serve as a useful backstop for the reprogramming work, since it should be possible to compare the resulting pluripotent cells to determine how different they are. If both methods produce equally potent cells, “the whole field is going to completely change,” Jose Cibelli, a primate stem-cell researcher at Michigan State University, told Science. “People working on ethics will have to find something new to worry about.”

The mainstream press is all over the story, of course. For more, see the NYT, the WaPo, and the LA Times for starters. The Science piece linked above has more technical detail. Also, the Center for Genetics and Society has a timely, albeit opinionated, release about the work.

UPDATED: Expanded considerably from original version.

Further reading:

• Chinks in the stem-cell monopoly
• Is Big Pharma tiptoeing into stem cells?
• Brazil’s great stem-cell experiment
• Massachusetts jumps on the stem-cell bandwagon
• Legal cloud lifts from California stem-cell effort
• Guilt-free stem cells (first item)
• Novocell: With diabetes study pending, investors pony up another $25M
• Stem cell “brain drain” or “brain gain”?
• California’s stem-cell management disarray
• Stem-cell institute gets a new president, but its management challenges haven’t gone away

Hopes are obviously high that the widely respected Australian scientist, pictured at left, can bring some stability to the institute, formally known as the California Institute for Regenerative Medicine. A string of CIRM staffers, including former president Zach Hall and chief scientist Arlene Chiu, have departed or announced their resignations in the past several months, despite the fact that the agency is finally starting to get rolling with major grant programs for stem-cell science and research facilities. Although CIRM insists that these departures are individual decisions unrelated to any larger issue, it sure looks like the agency’s heavy responsibilities, lean staffing and Byzantine management structure are simply burning out its employees. (CIRM insiders have since confirmed that assessment in confidence. See my previous coverage here.)

Trounson certainly has a glittering resume and experience in both academia and business, having founded several fertility clinics and at least one biotech company, Singapore’s ES Cell International. (He’s currently director of the stem-cell and immunology laboratories at Monash University in Victoria, Australia.) With luck, his background will stand him in good stead in dealing with Robert Klein II, the strong-willed real-estate magnate who heads CIRM’s powerful oversight board, and who clashed with Hall several times during his tenure as president — even squabbling over who had the right to assign office space, according to a piece by David Jensen over at Wired News. Trounson, who will earn $475,000 a year, has already released a statement touting his intention to forge a “partnership” with Klein and the oversight board.

That said, the challenges CIRM still faces are significant, and it doesn’t help that Trounson apparently won’t even start his new job until the end of the year — and even then will likely work part-time while he winds down his involvement with his Monash laboratory. With all due respect to acting president Richard Murphy, it’s still likely to be a while before CIRM gets the steady hand on the tiller it appears to need so badly.

For more information, see the comprehensive coverage at Dave Jensen’s California Stem Cell Report, which also includes links to a number of mainstream-media stories.

Spinal-implant maker LDR raises $25M — Austin, Texas-based LDR, a maker of spinal implants, raised $25 million in a third funding round. Investors included Telegraph Hill Partners, Austin Ventures, Rothschild Private Equity and PTV Sciences.

LDR sells spinal-fusion devices, artificial disks and other spine-related devices in more than 30 countries, and plans to use the funds for further expansion.

Aldagen adds $9M for adult stem-cell work — Aldagen, a Durham, N.C., biotech developing regenerative therapies with “adult” stem cells, raised an additional $9 million (PDF link), bringing its third funding round to a total of $23 million. Investors in the additional financing include Tullis-Dickerson, CNF Investments, Harbert Venture Partners and Intersouth Partners.

The company’s most advanced experimental treatment uses stem cells derived from umbilical-cord blood to somehow improve the speed and effectiveness of cord-blood transplants in children, although the company doesn’t explain how. Nor has it revealed the results of an early-stage human test. Other treatments now entering clinical trials use stem or related progenitor cells isolated from a patient’s own bone marrow to treat heart failure or clot-related oxygen deprivation in the limbs.

The Triangle Business Journal has more.

ThromboVision raises $4M for personalized-medicine diagnostics — The Houston, Texas, biotech ThromboVision said it raised $4 million in a first funding round. Investors included the private-equity firm National Healthcare Services and private investors.

ThromboVision is developing new tests of platelet activity that may help doctors determine which patients are most likely to respond to low doses of blood thinners such as aspirin or Plavix, which are used to prevent clots that can cause heart attacks or strokes. This is similar — in concept, at least — to the FDA’s recent push to require the use of genomic tests to determine the proper dosing of warfarin, another blood thinner. (See our coverage here.)

MachLabs launches two device companies — MachLabs, a Redwood City, Calif., investor partnership founded by entrepreneurs Michael Laufer and John Lonergan, recently launched two medical-device startups, VentureWire reports (subscription required). Lyten is developing a minimally invasive treatment for obesity, while Permatox hopes to introduce a non-invasive alternative to Botox.

TeleMedicine Clinic receives €7M for radiology services — Barcelona-based TeleMedicine Clinic, a center for the outsourced analysis of medical images such as X-rays and MRIs, raised €7 million ($9.7 million), VentureWire reports. Investors included Kennet Partners, Active Capital Partners and an undisclosed European seed investor.

These should be the best of times for California’s $3 billion stem-cell program. Lawsuits that barred the institute from spending its vast sums have been dismissed, serious money has started to flow to scientists, and a $227 million capital-spending project that will build new laboratories across the state is gearing up.

For all its successes, however, the stem-cell organization — formally known as the California Institute for Regenerative Medicine — can’t seem to keep its top officials on board. First, there was the abrupt resignation of the institute’s first president, Zach Hall, who departed CIRM at the end of April, months earlier than his original plan, amid internal tensions over that capital-spending project. By mid-summer, the stem-cell body had made little progress finding a replacement and instead tapped Richard Murphy, the recently retired head of the Salk Institute and a former member of the stem-cell institute’s powerful oversight committee, to take the reins on a temporary basis (PDF link).

Then came the news last week that the institute’s top scientific official, Arlene Chiu, is also leaving unexpectedly. Chiu, who joined CIRM with great fanfare in mid-2005, ended up shouldering additional responsibility when Hall left. Last week, she said simply that she would be returning to her home in Los Angeles to “pursue new professional directions” — a statement that carries more than a whiff of burnout. (At least she’s not leaving to spend more time with her family.) Chiu doesn’t leave until October, and will remain a consultant to the institute after that.

CIRM spokesman Dale Carlson says these and other recent staff departures noted by David Jensen over at the California Stem Cell Report were all for individual reasons, that they’re unrelated to one another and that “[t]he timing is coincidental and nothing more should be read into them.” Maybe that’s true, and absent calling them all up, there’s really no way to know for sure, although CIRM certainly has an incentive to put out the message that all is well.

That said, it seems safe to say that the stem-cell agency is probably one of the most grueling places to work in all of biomedicine. Structurally, CIRM is a Rube Goldberg-inspired contraption in which a panel of 26 appointed academic luminaries, business types and patient advocates oversees a professional staff of no more than 50. The powerful oversight committee chairman, Robert Klein II, essentially runs the show, which undoubtedly complicates the job of finding a prominent biologist — not usually the shyest and most self-effacing people around — willing to give up their laboratory in order to butt heads with Klein over the institute’s management and direction.

What’s more, CIRM itself was deliberately designed to function on a shoestring. That hard cap of 50 staffers was initially intended to reassure California voters that the agency wouldn’t waste taxpayer money on a hiring binge, and in that sense, it’s clearly worked. On the other hand, add the fact that the agency hasn’t even come close to filling all 50 positions to the string of departures, and it begins to look a lot like the institute is paying the price by burning through its human resources at an accelerated rate. (See also this related comment from Christopher Thomas Scott of Stanford’s Stem Cells in Society program over on Dave Jensen’s blog.)

This is certainly one way to run an organization, and it’s probably helped the stem-cell organization avoid criticism of how it’s managing taxpayer funds. (It also would have been unseemly to staff up too much when the agency was living primarily off of charitable donations, as it was before the courts dismissed the lawsuits.) On the other hand, there are other risks to running so lean. Last spring, CIRM approved a $2.6 million grant to a Los Angeles outfit called the CHA Regenerative Medicine Institute, a nonprofit subsidiary of a for-profit South Korean company, and one whose founding president appeared to be embroiled in plagiarism allegations. The resulting mini-scandal appears to have since fizzled out, particularly once the plagiarism allegations were retracted, but it’s an early cautionary tale for CIRM, which surely doesn’t want to face future scandals that could have been prevented with a bit of additional staff oversight.

Read More:
* On CIRM and stem cells, see this item on whether the U.S. “brain drain” is reversing or not, and this item on whether Big Pharma is tiptoeing into embryonic stem-cell investments (with a followup here).
* For other biotech-related pieces, check out this item on Koronis and its unique anti-HIV strategy, these looks at recent baby steps toward “personalized medicine,” a take on the ridiculously large IPO envisioned by Talecris Biotherapeutics, and two items on startups that aim to pioneer the dawning age of “personal genetics.”
* On more general medical subjects, see my admittedly opinionated takes on healthcare reform, evidence-based medicine, the nascent push for electronic health records and Andy Grove’s quixotic healthcare-reform crusade.

CORRECTION: This item originally stated that CIRM “handed out” a $2.6 million grant to the CHA Regenerative Medicine Institute. That grant is still in administrative review, so I’ve corrected the wording.

Stem-cell proponents have long told anyone who will listen that U.S. restrictions on the research will lead to a “brain drain” of scientists emigrating to other countries where the work can proceed without limits.

The prospect of the brain drain, though, was always somewhat overblown, as only a handful of scientists have emigrated specifically to escape federal limits on stem-cell research. Among them were Roger Pedersen, the UCSF biologist who in 2001 decamped to the University of Cambridge in the U.K. and two husband-and-wife scientists — Neal Copeland and Nancy Jenkins of the NIH and Edward Holmes and Judith Swain of UCSD — who left for Singapore last year. (Holmes’ decision to move is especially hard to paint as a “brain drain,” since he sat on the powerful committee that oversees California’s $3 billion stem-cell program.)

These days, it’s equally tempting to suggest that the brain drain — to the extent that it ever existed — has been reversed into a “brain gain.” Several California universities have boosted their hiring of stem-cell researchers and administrators from elsewhere in the U.S., and now some foreign scientists seem willing to pull up roots for the Golden State as well.

Yesterday, for instance, the Gladstone Institute of Cardiovascular Disease, a research organization affiliated with UCSF, announced that it had hired Shinya Yamanaka, a Japanese researcher who recently demonstrated a way to revert ordinary skin cells back into a stem-cell like state. (See our coverage here (first item); Yamanaka is pictured to the left.) It’s a homecoming of sorts for Yamanaka, a Kobe University researcher who was a postdoc and then a staff research investigator at Gladstone in the mid-1990s. Arlene Chiu, interim chief scientific officer for the California stem-cell program, called the move “a great coup for Gladstone and for California.” Gladstone, apparently hoping to maximize the publicity effect, has already put up a bio page for Yamanaka.

The move is certainly a coup for California’s still-nascent stem-cell effort, especially since as recently as two months ago, Yamanaka had disavowed any desire to leave his native Japan. As a harbinger of a reverse brain drain, however, it’s still pretty weak beer. That’s particularly true since Yamanaka is only going to be spending one week a month in San Francisco for the next year or two, according to the WSJ health blog, although the institute’s head said he hopes to bring the Japanese scientist on full-time in two years.

For more background on Yamanaka, try this WSJ column by Peter Landers.

UPDATE: David Jensen over at the California Stem Cell Report runs with a list of the nearly 50 stem-cell researchers who have come to California since the state’s stem-cell program was approved by voters. Two caveats: The list was produced by the stem-cell agency itself, and it doesn’t include names of scientists who have moved out of the state, so it’s a fairly one-sided perspective on the question. Still, it’s worth a look if this sort of thing interests you.

Featured companies: VistaGen Therapeutics, MindWeavers, Cutanea Life Sciences, Heptares Therapeutics

VistaGen raises $3.75M for stem-cell based drug discovery — South San Francisco, Calif.-based VistaGen Therapeutics, a biotech that uses human embryonic stem cells to discover new drugs, raised $3.75 million in a bridge financing as it prepares to raise up to $20 million in a fourth round, VentureWire reports (subscription required). Montaur Capital Partners provided the funding.

VistaGen, founded in 1998, isn’t your typical stem-cell company. Where companies ranging from Geron and Advanced Cell Technology to Novocell aim to use the controversial cells — which must be derived from five-day-old embryos in a destructive process — directly as therapies to help regenerate damaged organs, VistaGen merely grows stem-cell cultures in its labs and uses those cultures to discover and run preliminary safety tests on drug candidates.

The embryonic cells are capable of “differentiating” into any type of cell in the body, which VistaGen says makes them valuable for determining how an experimental drug molecule will interact with living human tissue. The company uses its stem-cell “screens” to identify promising small-molecule drugs (that is, compounds that can be swallowed rather than injected) and to determine what side effects they might cause once ingested. Over time, VistaGen suggests, it might develop screens for drugs that trigger stem cells’ regenerative powers, potentially inducing cellular repair in conditions such as heart disease or diabetes.

For now, however, VistaGen’s lead drug candidate is a relatively prosaic compound called AV-101 that the company plans to begin testing against epilepsy later this year. AV-101 is a “prodrug” — a molecule that’s converted into an active form by the body’s natural metabolism — that turns into a neuroinhibitor once it reaches the brain. In addition to epilepsy, VistaGen suggests that the drug may also have uses in stroke, neuropathic pain and neurodegenerative diseases such as Alzheimer’s disease. For more detailed info, see the company’s Web site here and here.

Oxford’s MindWeavers raises $1.1M for mind-altering software — MindWeavers, an Oxford, England-based software company that develops software designed to improve mental function, raised $1.1 million (£558,000) through City and Merchant Group. Next year, the company hopes to raise up to £1 million with a listing on London’s Plus Markets electronic exchange.

MindWeavers develops its programs based on neuroscience research from Oxford University, which spun out the company in 2000. Its first product was Phonomena, a interactive game for children that the company says builds auditory discrimination and language skills. Several other programs are designed to improve “neuroplasticity” and to stimulate brain activity in middle-aged and elderly people in order to ward off age-related cognitive decline. VentureWire has more.

Skin-care firm Cutanea raises “millions” in convertible debt — Cutanea Life Sciences, a Cambridge, Mass., specialty pharmaceutical company focused on dermatology, raised a “multi-million” dollar round of convertible debt, VentureWire reports. Institutional investors such as Nexus Medical Partners provided the funding. Cutanea licenses neglected or cast-off experimental drugs from universities or other companies and runs them through human tests.

Heptares Therapeutics spins out of Britain’s MRC — The MRC Laboratory of Molecular Biology has spun out a new company, Heptares Therapeutics, with undisclosed seed funding from MVM Life Sciences Partners. The company will focus on drugs for diseases of the nervous system and metabolism. (Hat tip: PE Hub.)

CORRECTION: Due to incorrect information supplied by VentureWire, the VistaGen Therapeutics item originally stated that Montreux Equity Partners provided funding. In fact, Montaur Capital Partners led the funding. The VentureWire correction is here.

The round was led by Johnson & Johnson Development, the venture arm of J&J itself, joined by Sanderling Ventures, Asset Management Company and Pacific Horizon Ventures.

In my earlier piece, I explored whether J&J’s involvement marked the first time that Big Pharma had directly funded an embryonic stem-cell company. It turns out that’s probably true, although J&J’s investment in Novocell dates back to at least 2005, a fact I didn’t learn until a few days after I wrote that post. (I had updated the previous item with that acknowledgement, but the update somehow got lost in WordPress, so I’ll just make the point again here.)

I’ve also heard from some sources that J&J’s interest isn’t so much in stem cells as in a separate Novocell technology for “encapsulating” cells to protect them from immune-system rejection after a transplant. Although that sort of technology might be useful for protecting stem-cell transplants, it’s also got potential utility outside the stem-cell field. For instance, if transplants of insulin-producing pancreatic islet cells ever became feasible as a diabetes treatment, encapsulation might be one way to ensure that the cell transplants “take” without forcing patients onto immunosuppressive drugs for the rest of their lives. (Exactly how to procure a reliable supply of islet cells is a separate problem, since donors and cadavers tend to be in short supply — and that’s where stem cells are likely to enter the picture.)

Novocell, in fact, is currently performing early-stage trials of exactly that sort of therapy, using islet cells procured from cadavers. The encapsulated cells are injected into “tissue pockets” just under the skin of the thighs or the lower abdomen. Last year, the company presented preliminary data from the study in which the cells transplanted into the first two treated diabetics appeared to show early signs of functioning without triggering an immune-rejection response.

Since the study was supposed to include 12 patients who would be monitored for 12 months, new data from that study might not be too far off, which probably helps explain J&J’s interest in leading this new round.

The catch is that biogenerics supporters want to attach this langauge to a reauthorization of the FDA’s user-fees act, the awkwardly named PDUFA, which has to pass by September to keep the FDA operating smoothly. The Senate’s version passed in May, whereas the House just approved its version yesterday — but didn’t include a biogenerics pathway. The senators want to add it to their version of the bill, which has to be reconciled with the House version in a conference committee. But key House members, including Energy and Commerce Chairman John Dingell, a Michigan Democrat, appear likely to object, since they haven’t had a chance to weigh in on the provision.

The upshot: Turf wars between the houses of Congress may cost us our best shot at biogenerics legislation in some time. Tying the measure to PDUFA would be one of the best ways to sidestep legislative roadblocks that opponents and their biotech/pharma backers are likely to throw up — but the window is closing rapidly. The WSJ has more here.

Digital medical records are good for your health — or are they? One of the strongest arguements for digitizing medical records is that they’ll help prevent medical errors and improve medical care. A recent review of other studies in the journal Health Services Research gave digitized records a strong vote of confidence when it found that hospitals that switched to electronic drug-ordering systems saw a 66 percent drop in medication errors. (Such mistakes apparently kill 500,000 U.S. hospital patients every year.) Similarly, a report from the Pharmaceutical Care Management Association predicts that electronic prescribing could save Medicare as much as $29 billion over the next two years while preventing two million medication errors.

As with any technology, however, electronic records are no panacea. Another study of walk-in doctor visits found no improvement in treatment quality among practices that used electronic medical records versus those that still relied on paper. The study’s conclusion: Implementing digitized records is just the first step — doctors and medical groups still need to do a lot of work to get the most out of them.

On a related note, a Senate committee recently passed legislation that would offer subsidies to convince doctors to install digital health-record systems.

RNAi is hot, hot, HOT — Once again, it’s boom times for a new drug technology, and this time the spotlight is on RNA interference — a fascinating but largely unproven method for turning off individual genes by using a short stretch of double-stranded RNA to activate ancient gene-silencing machinery inside cells.

The party really got started last year, when Merck paid $1.1 billion to acquire Sirna Therapeutics, a fledgling RNAi company that had barely managed to move a single drug into an early-stage trial. Now things have heated up even further. Last Friday, AstraZeneca struck a $400 million deal with Silence Therapeutics. Then on Tuesday, Roche stepped up to forge a $1 billion deal with Alnylam, an early pioneer in the area.

What’s worth remembering is that no matter how promising a technology like RNAi seems, putting it to practical use almost always takes far longer and costs more than people expect in the early stages. Just take a look at the roll call of other drug technologies that have undergone similar cycles of hype and disappointment — gene therapy, antisense, therapeutic vaccines. All remain promising — but none of them worked the first time out of the gate. Even monoclonal antibodies took close to two decades before anyone could make a reasonable drug with them. Maybe RNAi will be different — but I wouldn’t bet my wallet on it.

Have cancer vaccines gotten a raw deal? A paper in Clinical Cancer Research (described here) argues that regulators and companies may be too quick to dismiss clinical-trial results if they focus on tumor shrinkage rather than long-term outcomes like survival. That may well be true, as tumor shrinkage is a notoriously bad measure of whether drugs work or not, although it’s also worth noting that a reconsideration still wouldn’t have helped Dendreon’s Provenge vaccine, since its survival data was so statistically equivocal. (Separately, the SEC has now opened an informal inquiry into Dendreon’s public disclosures about Provenge this year.)

DNA transplant “transforms” microbial species – J. Craig Venter’s group at his eponymous institute takes the honors, described here in the WaPo. Next up: Transferring an entirely synthetic genome into a DNA-less microbe to create “artificial life,” something Venter says may happen within months. Similarly, here’s the NYT on the new science of “synthetic biology.” Brace yourselves.

Does “pay for performance” improve medical care? A few weeks ago, the WSJ said no, citing a Medicare experiment. Today, the NYT says yes, citing… a Medicare experiment! I’ll have more to say once my head stops hurting.

Pre-implantation genetic diagnosis may harm fertility – Or so say the authors of a Dutch study described by the WSJ here. Several researchers seem to think the results need to be verified elsewhere before abandoning the procedure, in which a single cell is extracted from an IVF embryo for genetic analysis.

Stem cells tailor their own environments — At least according to Canadian researchers, who explored the specifics of how embryonic stem cells communicate with the cells around them. The Globe and Mail has the story.

Simple enzyme short-circuits bacterial drug resistance – Basically, it prevents bacteria from swapping the genes that confer resistance to antibiotics.

High-throughput output –

• Vermont sets up a Web site comparing pharmacy drug prices (Kaiser)
• Researchers discover molecule that may promote food allergies (BBC)
• Breast-cancer risk genes may not influence survival (WSJ)
• Congressional Democrats want to know who muzzled the former surgeon general (Bloomberg)
• Scientists identify gene linked to autism (BBC)
• Robotics help stroke patients regain function (NYT)

(NOTE: This item originally incorrectly stated that J. Craig Venter’s company, Synthetic Genomics, was involved in the research that transplanted one microbe’s genome into another. In fact, it was Venter’s own research institute, the J. Craig Venter Institute.)

Sunrise, Fla.-based Bioheart thinks enough of its stem-cell treatment for heart disease that it has just boosted its expected IPO take by $10 million, to $45 million. A close reading of its latest SEC filing, however, raises a fair number of questions for would-be investors.

Bioheart’s leading therapy candidate is MyoCell, a treatment designed to reverse heart-attack damage. MyoCell consists of myoblasts — a kind of muscle stem cell — that are removed from a patient’s own thigh muscles, cultured for roughly 21 days, and then injected into the scar tissue surrounding the individual’s heart in a minimally invasive procedure. If all goes well, these myoblasts then engraft into the scar tissue, transform into normal skeletal-muscle cells and then, in some still-mysterious fashion, restore some muscular activity to damaged portions of the heart.

So far, so good, even if Bioheart can’t explain why the transformed cells might bolster the heart, since they don’t appear to “link up” with chemical signals that direct the heart’s cells to beat in unison. The company does offer several theories, including the possibility that the injected cells somehow “stretch,” channel electrical currents, fuse with or otherwise “acquire” properties of existing heart-muscle cells, or release proteins that inhibit scar formation.

Unfortunately, two early clinical trials so far haven’t demonstrated that MyoCell significantly improves heart function, and some data suggest the therapy might even be dangerous. The first test, a 20-patient safety trial called Myoheart, provided no statistically significant evidence that the treatment helped patients walk farther, improved their quality of life or bolstered their hearts’ efficiency (as measured by a parameter called left ventricular ejection fraction). To be fair, Myoheart wasn’t designed to provide proof of efficacy. Still, two of the 20 patients died, possibly because of MyoCell, and four experienced irregular heartbeats thought to be related to the cell therapy.

A larger 40-patient trial in Europe called Seismic also turned up cause for concern. Although this trial compared heart patients who received MyoCell with others who didn’t, it still hasn’t generated any statistically significant data suggesting the stem-cell treatment helps patients. (Only interim data is available, although the company says it doesn’t expect to see significant data for several months.) More disturbing, however, is the fact that the MyoCell patients actually saw their heart efficiency decline, on average, almost four times faster than the untreated group in the six months following the procedure. One patient died from multiple organ failure, possibly attributable to MyoCell, and eight others had irregular heartbeats possibly linked to the therapy.

The Seismic data also aren’t statistically significant and may well be skewed if, by chance, the MyoCell group included especially sick patients or if healthier people dominated the control group. Still, it’s not exactly an encouraging sign, so it beats me why the company thinks its IPO chances have greatly improved all of a sudden, particularly in a market environment that has recently been fairly dismissive of biotech offerings.

One other interesting fact that would-be investors might want to consider: Bioheart’s primary patent on MyoCell expires in 2009, which is when the company is expecting to see final data from a pivotal U.S. trial. That could crimp commercialization of the treatment even if it is approved, to say the very least. (The company does say it thinks it can win a five-year extension of the patent, but even that isn’t very much.)

Bioheart’s original SEC filing, in case you’re curious, is here. (Hat tip: VentureWire, subscription required)

UPDATE (10/12/07): Bioheart slashes its offering price, effectively halving the company’s value. I gloat about it here.

Teams from Kyoto University, MIT and a Harvard-UCLA collaboration all confirmed a report last year out of Kyoto that skin cells could be reprogrammed by implanting four genes that produce proteins called transcription factors, which control the effects of other genes. Adding those four factors kicked off an intracellular chain reaction that reverted the skin cells to a primordial, “pluripotent” state characteristic of embryonic cells.

There are, of course, a number of caveats, the most significant of which is that the work so far has only succeeded in mouse cells. Extending it to human cells may be tricky, in part because they will likely require additional transcription factors. What’s more, at least one of the transcription factors used in the mouse experiments appears to contribute to cancer; so may the type of virus used to transfer the transcription-factor genes into skin cells. As a result, it’s not yet clear whether the embryonic stem cells produced this way could be used to help regenerate damaged tissue or organs in humans, such as dopamine-producing neurons for Parkinson’s patients or insulin-secreting pancreatic cells for diabetics. All that said, it’s a very encouraging step forward, both in terms of advancing understanding of stem-cell biology and the potential for altering the ethical landscape for the work.

For more, see the WSJ and the NYT.

The trials of Avandia, continued — The fracas over the controversial diabetes drug continued to throw shrapnel in all directions, leaving almost no one unscathed. Avandia’s maker, GlaxoSmithKline, published interim data from a large trial of the drug in the New England Journal of Medicine and touted it as evidence of the drug’s safety — only to find it accompanied by three editorials nitpicking the data and arguing that the data did little to allay doctors’ concerns. In congressional hearings today, a diabetes expert said he was berated by a company official and threatened with a lawsuit for raising questions about Avandia’s safety several years ago. Then the FDA commissioner told Congress that the agency would require strict new warning labels on Avandia and a similar drug.

The FDA, meanwhile, faced charges that one of its drug-safety officials was reprimanded after earlier recommending exactly those warnings for Avandia. And congressional Republicans went after Cleveland Clinic cardiologist Steven Nissen, who first raised the alarm about Avandia almost three weeks ago, suggesting that he had colluded with Democrats to embarrass the FDA and to enhance his chances of one day becoming FDA commissioner himself. As if all that weren’t enough, the NYT also asked if GSK’s efforts to promote Avandia to African-Americans may be backfiring.

Whew.

In research, where you stand depends on who’s paying the bills – An unusual report in the journal PLoS Medicine found that research studies sponsored by drugmakers were 20 times more likely to favor the companies’ products than trials with no disclosed funding source. Conclusions drawn by the research scientists involved — apart from the data itself, that is — were 35 times more likely to favor a sponsor’s drug, the PLoS Medicine study found.

The study looked at nearly 200 published trials of the cholesterol-lowering drugs known as statins to gauge what effect the source of funding had on the results. The research team noted that several factors could account for the tremendous slant in favor of sponsors’ products, including the fact that drug companies might squelch negative studies instead of publishing them and the possibility that trials might be deliberately designed in order to skew the results. For more, check out this San Francisco Chronicle story.

Cancer drug news – The year’s biggest cancer meeting, the annual gathering of the American Society for Clinical Oncology, took place in Chicago over the weekend. Here are a few highlights you might have missed:

• Meeting focus shifts from new drugs to new applications for old drugs (Business Week)
• New drugs show promise for liver cancer (WSJ)
• Biotech Telik reveals that its ovarian-cancer drug Telcyta not only didn’t work, it apparently killed women five months sooner than those receiving standard treatment; FDA orders halt to current Telcyta studies (Bloomberg, TheStreet.com)

California pension fund, private-equity money chase healthcare “cost-cutting” – Calpers, the largest pension fund in the U.S., invested $700 million in Health Evolution Partners, a private-equity fund run by a former Bush administration health official that aims to find ways to reduce the cost of healthcare. According to the NYT, the fund will focus on new ideas such as remote monitoring of elderly or demented patients in order to keep them out of nursing homes longer, telemedicine, chronic-disease management and genomics-based “personalized medicine” that tailors treatments to individual genetic profiles. One thing the fund will not be looking at, though, is electronic health records, which HEP founder David Brailer championed for two years in the Bush administration without much impact; he terms the field “a saturated market.” (See also this story in the SF Chronicle.)

I laid out some early thoughts on high-tech approaches to the healthcare crisis in this piece on Andy Grove’s reform crusade. In general, many of the things Brailer is interested in strike me much the same way Grove’s ideas did — that is, as worthy but woefully insufficient efforts if you expect them to actually reduce healthcare costs. Truly tackling the problem of costs means addressing structural failures of the system, including the current fee-for-service system that rewards doctors financially for doing more procedures or prescribing more drugs regardless of whether or not they help patients. In addition, it wouldn’t hurt to find out more about which medical treatments help patients most — which the NYT’s David Leonhardt addressed here and which I wrote about here — which probably also ultimately means restricting the use of the treatments deemed less effective.

Viewed against that backdrop, Health Evolution Partners and Calpers may be doing little more than spitting into the wind.

Speaking of healthcare reform – The WSJ weighed in with this piece on why the subject of healthcare reform doesn’t send politicians fleeing anymore. The usual suspects — rising health-insurance premiums and out-of-pocket costs, the growing numbers of uninsured Americans — make their obligatory appearance, but the really interesting nugget is how the insurance industry is angling to co-opt reform rather than opposing it outright as it did with the Clinton plan in 1993-94. That alone speaks volumes as to how thoroughly fed up many Americans have become with the ramshackle mess we call a healthcare system.

And while we’re on the subject – One of the major Bush administration healthcare-reform initiatives — besides the smashing success of electronic medical records, that is — was to push Medicare to institute financial incentives that would reward doctors for providing better care. Such “pay for performance,” however, seems to be falling short, according to a pilot study published in the Journal of the American Medical Association and described by the WSJ. In that study, 54 hospitals in the “pay for performance” plan did no better at improving medical practices than 446 hospitals that weren’t offered the incentives.

Gates to measure global public-health performance – No, not all by himself. The Bill and Melinda Gates Foundation, however, gave the University of Washington a $105 million grant to track the impact of public-health programs on a worldwide basis. From the WSJ article:

The new institute will be headed by Christopher Murray, a professor at the University of Washington, who previously served as director of a public-health program at Harvard University and as an official at the World Health Organization. The institute’s missions will include collecting and analyzing data on health trends, such as the prevalence of major diseases and the availability of health services, as well as conducting independent evaluations of the effectiveness of health programs.

The plan reflects the Gates foundation’s strategy of using statistical measures to determine the effectiveness of its grant-giving. The institute will disseminate the information it gathers about global health issues, programs and giving, officials said.

Institute officials pointed to the dearth of available statistics in global health, contrasting that to business, which runs on clear results. “It would seem strange that we would need an institute like this,” Dr. Murray said. But in public health, “we’re so far behind the norm in other sectors.”

The grant is the foundation’s second aimed at gathering better global public-health information.

Ideological foes of the state’s stem-cell effort, which voters approved by a large margin in a 2004 ballot initiative, have waged a two-year battle in the courts to shut it down. The opponents — a coalition of anti-tax and limited-government conservatives and anti-abortion activists — argued that the California Institute for Regenerative Medicine is rife with conflicts of interest and that its establishment violated the state constitution because CIRM wasn’t fully under control of the state government. (The initiative text shields CIRM from legislative interference for three years, and beyond that point requires legislative supermajorities to enact any changes.)

The suits effectively froze CIRM’s ability to dole out research funds, since the uncertainty over entire effort’s constitutionality made it impossible to sell the state bonds that will fund research proposals and laboratory construction at universities across the state.

The court’s decision was largely foreshadowed by a district court ruling in CIRM’s favor more than a year ago. The institute’s opponents, however, insisted on pressing their case through two levels of appeal, to no avail.

Yesterday’s ruling occasioned the overheated rhetoric we’ve become accustomed to whenever the subject of stem cells comes up. Robert Klein II, chairman of CIRM’s powerful advisory board and effectively head honcho of the entire effort, called the ruling “a great victory” and said “our $3 billion is free from these restrictions put on by the ideological right.” Meanwhile, Terry Thompson, a lawyer for two of the plaintiffs, declared that the ruling “establishes a precedent for well-meaning but misdirected rich people to invade the public treasury for projects of their own and parlay a few million dollars [of campaign expenses] into a few billion dollars of wasted taxpayer money.”

CIRM has already managed to issue $158.8 million in research grants, thanks to some creative financing that included a $150 million state loan approved by Gov. Arnold Schwarzenegger and the sale of $45 million in “bond anticipation notes” to mostly wealthy individuals whose money would have been lost had the court decision gone the other way. The first $250 million in state bonds, likely to be issued in July or August, will mostly go to repay the loan and notes.

With California’s stem-cell program in the clear, the big question now is whether activists will mobilize against similar but smaller scale efforts in New York and Massachusetts — not to mention, of course, whether their luck will be any better if they do.

For more, see the SF Chronicle, the San Jose Mercury News and the LAT.

New restrictions, which the panel didn’t spell out, could put a serious crimp in ESA sales, which currently amount to billions of dollars for Amgen and Johnson & Johnson. The two companies have also been taking a public-relations battering in terms of how they promote the drugs. Yesterday, the NYT ran a front-page piece that detailed how rebates offered by Amgen and J&J encourage doctors to overuse the drugs, and today the WSJ followed with a look at whistleblower allegations that J&J boosted EPO sales by pushing higher-than-approved doses.

It’s worth remembering that while the storm is currently walloping industry giants like Amgen and J&J, plenty of smaller biotechs that have staked their hopes on getting into the anemia-treatment game could eventually be affected as well. These companies include Affymax, FibroGen and Neose. Only Affymax is public; another potential ESA competitor, GlycoFi, was acquired by Merck last year.

First embryonic stem-cell trial edges forward – By early next year, Geron plans to be injecting recent spinal-injury patients with nerve cells grown from embryonic stem cells, in hopes of regenerating damaged nerve pathways. This trial was supposed to be underway already, but last year the FDA requested more animal data for safety purposes. Geron CEO Thomas Okarma says the treatment will have been tested in 2,000 animals before it ever reaches humans. The FT’s Clive Cookson has the story.

Aggressive treatment leads to worse “quality of death” in cancer patients – File this one under things you already knew but didn’t want to think about. A study of 243 advanced cancer patients revealed that a greater number of aggressive treatments — including the use of ventilators and non-palliative chemotherapy — in the last week of life was associated with greater physical and psychological distress and a lower chance of dying in a preferred location (often home). Money quotes:

[Said study lead author Gabriel Silverman:] “These results suggest that when patients are actively dying, the use of aggressive treatments should be considered with caution and only pursued with the full understanding of patients or their surrogate decision makers.

[...]

“As a doctor, if I had a patient or family who wanted aggressive, life-sustaining care toward the end of their life, I would view it as a red flag warning of patient or caregiver distress,” Dr. [Robert] Arnold [of the University of Pittsburgh] concluded. “Often patients and their families are suffering, sad, or distressed at the end of life, and when dying occurs in medical settings they may hope that aggressive treatment will help the suffering, but often it doesn’t.”

Tau gets a little respect – For the past decade or so, Alzheimer’s researchers have concentrated their attention on beta amyloid, the protein that clumps around neurons in “tangles” visible in the autopsied brains of many — though not all — Alzheimer’s patients. Now comes evidence that a dark-horse protein called tau may also bear some responsibility for the disease. Researchers reported last week in Science that they reversed memory loss in mice by tinkering with their genes to produce lower levels of the tau protein. It’s heartening to see competing theories getting some attention in the Alzheimer’s community, which has had an unfortunate tendency to shun researchers who strayed from the majority opinion, but don’t expect beta-amyloid supporters to give much ground until they have to. That might be soon, as a new batch of drugs designed to block formation of beta-amyloid tangles should begin reporting data from human trials later this year.

New genetic heart-disease link – Another whole-genome association study has identified a new genetic variation that appears to increase heart-attack risk by 60 percent in European populations. The catch is that the variation doesn’t appear to be associated with any known gene, and instead exists in the long stretches of non-coding, or “junk,” DNA, meaning that no one has any idea why it should have any effect on heart-attack rates. The NYT has more.

Stem-cell researchers make like Willie Sutton – Near the end of this otherwise unremarkable account of a talk by James Thomson, the Wisconsin researcher who first isolated and grew human embryonic stem cells, comes this interesting nugget: Thomson will open a “satellite laboratory” on the UC Santa Barbara campus for stem-cell collaborations with UCSB researchers. Coincidentally enough, having a presence in the state might also qualify Thomson for funding by California’s $3 billion stem-cell program. Willie Sutton, you’ll recall, is the outlaw who once proclaimed that he robbed banks “because that’s where the money is.” Some sentiments, it seems, are universal.

Hypocrisy in the generic-biologics fight? – The prospect of legislation that clears a path for “generic” versions of expensive biotech drugs appears to have dimmed significantly. But biotech consultant and blogger David Williams — no fan himself of the push for “biogenerics” — notes that biotech companies and their lobbyists may be shooting themselves in the foot when they argue that biogenerics could never be “identical” to branded products now on the market. It’s worth reading his entire post — it’s not long — but the gist is that changing the manufacturing process for name-brand biotech drugs, which happens all the time, opens up the same “equivalence” issues that BIO and its allies find insurmountable where biogenerics are concerned. The main difference is that name-brand manufacturers can handle the issue with short, inexpensive “bioequivalence” trials — but they insist that biogenerics must undergo expensive, full-blown clinical testing to assure their efficacy and safety. If the biogenerics issue heats up again, don’t be surprised to see this argument make a comeback.

Surgical robots in space, stem cells in rodent eyes – These are just two interesting stories from the San Jose Mercury News I haven’t yet had a chance to mention. Last Sunday, the Merc ran this piece on efforts to automate surgery, with the ultimate goal of building robots that could operate on astronauts in space or soldiers on the battlefield. Far off and far out stuff. Similarly, this piece outlined the possibility of growing new blood vessels using an early and highly regenerative stem cell called a hemangioblast. Ultimately, these fast-growing cells could one day regrow blood vessels in the heart, eyes or limbs that were damaged by injury or disease.

Although Patrick’s plan is similar in some respects to California’s enormous $3 billion stem-cell effort and New York’s proposed $1 billion investment in stem-cell and related research, it differs in key respects. The most significant may be that Patrick isn’t billing the effort primarily as a stem-cell plan, even though it’s clear that the state initiative would give the stem-cell field a major boost.

The Massachusetts plan would devote roughly half its total funding to capital investment in research facilities across the state — in part, simply to ensure the wide availability of expensive research equipment for use in stem-cell work. (In California, by contrast, only about 10 percent of the $3 billion can be directed to “bricks and mortar.”) Currently, instruments purchased under a federal grant can only be used in studies involving a limited number of stem-cell lines, a restriction that has hampered the work outside of privately-funded laboratories.

According to this piece in the Boston Globe, another $250 million in the Massachusetts plan will be devoted to direct research grants — a much smaller amount than in other states. The remainder of the $1 billion will consist of tax subsidies designed to draw biotechnology firms to the state. Among the individual projects the plan may subsidize are a tissue bank for housing newly created lines of stem cells and a center for the exploration of a gene-silencing technique called RNA interference that earned a University of Massachusetts scientist the Nobel Prize last year.

Also unlike proponents of the similar plans in California and New York, Patrick isn’t promoting this initiative specifically as a way to cure deadly diseases or to boost economic development in the state. Instead, he casts it as an effort to meet competitive challenges from foreign nations and other states, as well as a way to counter a recent flattening in biomedical research funding through the National Institutes of Health, which has disproportionately affected states like Massachusetts.

The NYT has more here, and notes that the plan also includes $250 million in hoped-for private-sector “matching funds” that will pay for grants, fellowships and capital investment. You can also check out the state’s official press release, a more detailed outline and five-point plan, and even the video of the governor’s announcement.

Now it appears that Congress may weigh in: The WSJ quotes Rep. Fortney “Pete” Stark, a California Democrat, calling for changes in Medicare reimbursement to eliminate any incentive to overuse the drugs, which stimulate production of the red blood cells that carry oxygen.

More on “generic” biologics — Here are two takes on the move to allow copycat versions of biotech drugs that I neglected to mention in yesterday’s post on the subject. Writing at Forbes.com, Scott Gottlieb — former FDA deputy commissioner for medical and scientific affairs, now a pundit at the neoconservative American Enterprise Institute — makes the counterintuitive argument that copycat biotech drugs will speed the development of new drugs, even if they’re just simply improved versions of older ones.

Meanwhile, pharma/biotech consultant David E. Williams dismisses the biogenerics push as “a bad bill that deserves to die” on his Health Business Blog, but suggests that Congress could adopt a more straightforward solution: Simply mandate price cuts on biotech drugs once their patents expire. It’s such a wacky but weirdly intriguing idea that I can’t even tell if it makes sense, but I certainly doubt that Congress could muster the political will for such a naked exercise of government power — it simply violates too many current assumptions about the usefulness and necessity of markets.

Stem cell divisions — The president of California’s $3 billion stem-cell research program resigned abruptly on Tuesday, citing both health concerns (a recent diagnosis of prostate cancer) and tensions between patient advocates and biomedical academics over plans to spend up to $300 million on new research facilities. Zach Hall’s departure will now come earlier than expected — he’ll depart at the end of April instead of the end of June — but plans to name a successor are already underway. Despite his title, Hall wasn’t the head honcho of the California institute; that honor is reserved for Robert Klein II, chairman of the inaptly named Independent Citizens Oversight Committee, who is also rumored to have clashed with Hall more than once. David Jensen of the estimable California Stem Cell Report has all the details.

Dollars for doctors (and everyone else) — Why does U.S. healthcare cost so much? The economics blog Marginal Revolution hosted a fascinating debate on the subject earlier this week, prompted by Tyler Cowen’s capsule review of a new book by Maggie Mahar titled Money Driven Medicine. The argument is too complex to do it much justice here; the best summary I can make without writing an essay myself is that the entrepreneurial instincts of doctors and medical-technology suppliers (including drug companies), combined with weak resistance from desperate patients, leads to market failure, including drastic overuse — and misuse — of medical services. Don’t miss Mahar’s contribution to the Marginal Revolution debate in comments. Two other takes on the book are here and here.

In a similar vein, this post from the group blog Health Care Renewal aims to explain why so many academic researchers seek out funding from pharmaceutical and biotech companies these days. Turns out it’s not just the greed of companies eager to co-opt paragons of the ivory tower; instead, blogger Roy Poses suggests that university incentives similar to the ones that motivate car salesmen are at fault. Definitely worth a read if the question has ever crossed your mind.

Research odds and ends from the week that was:
• Scientists discovered a gene that appears to be key to “self-renewal” in both embryonic and adult stem cells.

• Surgeons are exploring ways of conducting minimally invasive procedures using “natural openings” in the body such as the mouth, the rectum or the vagina.

• Take that, white supremacists: Physical anthropologists now believe that European skin only lightened up 6,000 to 12,000 years ago, suggesting that “our European ancestors were brown-skinned for tens of thousands of years” prior to that. The link is subscription-only, so here’s a brief snippet of the Science news article:

Researchers have disagreed for decades about an issue that is only skin-deep: How quickly did the first modern humans who swept into Europe acquire pale skin? Now a new report on the evolution of a gene for skin color suggests that Europeans lightened up quite recently, perhaps only 6000 to 12,000 years ago. This contradicts a long-standing hypothesis that modern humans in Europe grew paler about 40,000 years ago, as soon as they migrated into northern latitudes. Under darker skies, pale skin absorbs more sunlight than dark skin, allowing ultraviolet rays to produce more vitamin D for bone growth and calcium absorption. “The [evolution of] light skin occurred long after the arrival of modern humans in Europe,” molecular anthropologist Heather Norton of the University of Arizona, Tucson, said in her talk.

Now it appears that Congress may weigh in: The WSJ quotes Rep. Fortney “Pete” Stark, a California Democrat, calling for changes in Medicare reimbursement to eliminate any incentive to overuse the drugs, which stimulate production of the red blood cells that carry oxygen.

More on “generic” biologics — Here are two takes on the move to allow copycat versions of biotech drugs that I neglected to mention in yesterday’s post on the subject. Writing at Forbes.com, Scott Gottlieb — former FDA deputy commissioner for medical and scientific affairs, now a pundit at the neoconservative American Enterprise Institute — makes the counterintuitive argument that copycat biotech drugs will speed the development of new drugs, even if they’re just simply improved versions of older ones.

Meanwhile, pharma/biotech consultant David E. Williams dismisses the biogenerics push as “a bad bill that deserves to die” on his Health Business Blog, but suggests that Congress could adopt a more straightforward solution: Simply mandate price cuts on biotech drugs once their patents expire. It’s such a wacky but weirdly intriguing idea that I can’t even tell if it makes sense, but I certainly doubt that Congress could muster the political will for such a naked exercise of government power — it simply violates too many current assumptions about the usefulness and necessity of markets.

Stem cell divisions — The president of California’s $3 billion stem-cell research program resigned abruptly on Tuesday, citing both health concerns (a recent diagnosis of prostate cancer) and tensions between patient advocates and biomedical academics over plans to spend up to $300 million on new research facilities. Zach Hall’s departure will now come earlier than expected — he’ll depart at the end of April instead of the end of June — but plans to name a successor are already underway. Despite his title, Hall wasn’t the head honcho of the California institute; that honor is reserved for Robert Klein II, chairman of the inaptly named Independent Citizens Oversight Committee, who is also rumored to have clashed with Hall more than once. David Jensen of the estimable California Stem Cell Report has all the details.

Dollars for doctors (and everyone else) — Why does U.S. healthcare cost so much? The economics blog Marginal Revolution hosted a fascinating debate on the subject earlier this week, prompted by Tyler Cowen’s capsule review of a new book by Maggie Mahar titled Money Driven Medicine. The argument is too complex to do it much justice here; the best summary I can make without writing an essay myself is that the entrepreneurial instincts of doctors and medical-technology suppliers (including drug companies), combined with weak resistance from desperate patients, leads to market failure, including drastic overuse — and misuse — of medical services. Don’t miss Mahar’s contribution to the Marginal Revolution debate in comments. Two other takes on the book are here and here.

In a similar vein, this post from the group blog Health Care Renewal aims to explain why so many academic researchers seek out funding from pharmaceutical and biotech companies these days. Turns out it’s not just the greed of companies eager to co-opt paragons of the ivory tower; instead, blogger Roy Poses suggests that university incentives similar to the ones that motivate car salesmen are at fault. Definitely worth a read if the question has ever crossed your mind.

Research odds and ends from the week that was:
• Scientists discovered a gene that appears to be key to “self-renewal” in both embryonic and adult stem cells.

• Surgeons are exploring ways of conducting minimally invasive procedures using “natural openings” in the body such as the mouth, the rectum or the vagina.

• Take that, white supremacists: Physical anthropologists now believe that European skin only lightened up 6,000 to 12,000 years ago, suggesting that “our European ancestors were brown-skinned for tens of thousands of years” prior to that. The link is subscription-only, so here’s a brief snippet of the Science news article:

Researchers have disagreed for decades about an issue that is only skin-deep: How quickly did the first modern humans who swept into Europe acquire pale skin? Now a new report on the evolution of a gene for skin color suggests that Europeans lightened up quite recently, perhaps only 6000 to 12,000 years ago. This contradicts a long-standing hypothesis that modern humans in Europe grew paler about 40,000 years ago, as soon as they migrated into northern latitudes. Under darker skies, pale skin absorbs more sunlight than dark skin, allowing ultraviolet rays to produce more vitamin D for bone growth and calcium absorption. “The [evolution of] light skin occurred long after the arrival of modern humans in Europe,” molecular anthropologist Heather Norton of the University of Arizona, Tucson, said in her talk.

The world’s biggest clinical trial of stem cells is underway in Brazil, the WSJ reports, an effort that could shake up scientific and commercial expectations for regenerative medicine.

The Brazilian trial involves so-called “adult” stem cells that can be harvested from a mature individual’s own tissue — in this case, bone marrow. (By contrast, controversial but more potent embryonic stem cells must be extracted from a days-old embryo that is usually destroyed in the process.) According to Antonio Regalado’s story, the 1,200 person test aims to see if those bone-marrow cells can reverse a dangerous swelling of the heart that frequently results from a common parasitic infection called Chagas disease. The disease is spread by barbeiros, or “kissing bugs” (see image), which are rife in poorer regions of the country.

Work on adult stem cells has long had a shaky reputation among scientists because the field is rife with unverified claims, often peddled by shady clinics eager to sign up desperate patients. The Brazilian effort is significant both in its scale and its rigor, since the test is specifically designed to ensure that any successful results aren’t simply due to random chance, researcher bias or placebo effect. (Similar but far smaller trials are under way in Poland, Austria, Finland and Denmark.)

Researchers will inject 600 Chagas patients with an “espresso cup’s worth” of their own bone marrow in hopes that the stem cells it contains will regenerate damaged heart tissue. (Another 600 will get placebo saline injections.) The treatment, however, remains controversial, especially in light of recent research that suggests bone-marrow stem cells have little, if any, ability to transform themselves into muscle tissue. The journal Nature, in fact, recently called for a moratorium on tests of adult stem cells in heart disease until their properties are better understood.

The trial, however, also offers a cautionary note to the biotechnology industry, since the Brazilian government is explicitly interested in developing a cost-effective treatment — what one involved researcher calls “a poor man’s cell therapy.” Cells derived directly from a patient can’t be patented, which could greatly limit their commercial attractiveness.

In related news, researchers today reported using bone-marrow stem cells to halt, and possibly even reverse, the course of “type one” diabetes in 14 of 15 recently diagnosed patients. In this trial — which, coincidentally enough, also took place in Brazil — researchers effectively “reset” the immune systems of patients by using their own marrow cells, a process similar to the way physicians treat leukemia with bone-marrow transplants. In all but one patient, the treatment appeared to halt the immune system’s attack on insulin-producing cells in the pancreas. The results were published today in the Journal of the American Medical Association.

[Editor's note: David Hamilton, a former Wall Street Journal reporter, has covered the biotech sector for years and we're delighted to have him as a contributor on news and trends in biotech, health and science (we've already run a few of his pieces). Biotech and health start-ups haven't been a VentureBeat focus, but they're important. We plan to create a separate forum for his work, and point to his more important stuff from VentureBeat.]

The world’s biggest clinical trial of stem cells is underway in Brazil, the WSJ reports, an effort that could shake up scientific and commercial expectations for regenerative medicine.

The Brazilian trial involves so-called “adult” stem cells that can be harvested from a mature individual’s own tissue — in this case, bone marrow. (By contrast, controversial but more potent embryonic stem cells must be extracted from a days-old embryo that is usually destroyed in the process.) According to Antonio Regalado’s story, the 1,200 person test aims to see if those bone-marrow cells can reverse a dangerous swelling of the heart that frequently results from a common parasitic infection called Chagas disease. The disease is spread by barbeiros, or “kissing bugs” (see image), which are rife in poorer regions of the country.

Work on adult stem cells has long had a shaky reputation among scientists because the field is rife with unverified claims, often peddled by shady clinics eager to sign up desperate patients. The Brazilian effort is significant both in its scale and its rigor, since the test is specifically designed to ensure that any successful results aren’t simply due to random chance, researcher bias or placebo effect. (Similar but far smaller trials are under way in Poland, Austria, Finland and Denmark.)

Researchers will inject 600 Chagas patients with an “espresso cup’s worth” of their own bone marrow in hopes that the stem cells it contains will regenerate damaged heart tissue. (Another 600 will get placebo saline injections.) The treatment, however, remains controversial, especially in light of recent research that suggests bone-marrow stem cells have little, if any, ability to transform themselves into muscle tissue. The journal Nature, in fact, recently called for a moratorium on tests of adult stem cells in heart disease until their properties are better understood.

The trial, however, also offers a cautionary note to the biotechnology industry, since the Brazilian government is explicitly interested in developing a cost-effective treatment — what one involved researcher calls “a poor man’s cell therapy.” Cells derived directly from a patient can’t be patented, which could greatly limit their commercial attractiveness.

In related news, researchers today reported using bone-marrow stem cells to halt, and possibly even reverse, the course of “type one” diabetes in 14 of 15 recently diagnosed patients. In this trial — which, coincidentally enough, also took place in Brazil — researchers effectively “reset” the immune systems of patients by using their own marrow cells, a process similar to the way physicians treat leukemia with bone-marrow transplants. In all but one patient, the treatment appeared to halt the immune system’s attack on insulin-producing cells in the pancreas. The results were published today in the Journal of the American Medical Association.

Earlier today, VentureWire reported (sub required) that Novocell, an early-stage San Diego biotech that aims to treat diabetes with the embryonic cells, is hoping to raise $35 million in a third round of funding. The interesting thing, however, isn’t so much the money as the identity of the lead investor: Johnson & Johnson Development Corp., the venture arm of pharmaceutical giant J&J.

The news grabbed my attention because to date, Big Pharma has shown relatively little interest in the smaller biotechs working on embryonic stem-cell therapeutics, with the standard explanation that the field is too young and in need of some solid clinical success before the big guys can get involved. Political controversy over the destruction of embryos — necessary to derive the stem cells — probably also inclines the naturally cautious pharmas to move even more carefully. (Novacell intends to make new insulin-producing islet cells from embryonic cells, then transplant them into diabetics.)

Here are some snippets from the VentureWire piece:

The funding, which the company revealed in a Form D filing with the Securities and Exchange commission, came into the company last month. Johnson & Johnson Development Corp. led the funding, alongside the participation of Asset Management Partners and Sanderling Venture Partners. [...]

The investment from Johnson & Johnson’s venture capital arm brings the company on as a strategic investor, [Novocell Chief Executive Alan] Lewis said, giving them “a major ownership in the company.”

As it turns out, I’m not aware of any other Big Pharma equity investment or development partnership involving embryonic stem cells. Jennifer Van Brunt, a biotech-data maven and editor of Recombinant Capital‘s Signals Magazine, says her databases don’t show any, either. The only remotely similar deal I was able to turn up after some searching was another J&J venture investment in Tengion, a Pennsylvania biotech that wants to grow new organs such as bladders. Tengion’s technology, however, would use a patient’s own stem cells, not ones derived from embryos.

Stem-cell proponents have long complained that Big Pharma and venture capitalists alike have failed to step up to the plate with support for embryonic stem-cell work, effectively slowing scientific and commercial progress in the field. If J&J’s investment is a sign that regenerative medicine is quickening pulses in at the big drug companies, things could get interesting.

Unfortunately, that’s mostly just speculation at this point. A J&J spokesman confirmed the investment, which is part of $20 million Novocell has raised so far in this round, but had no comment about the company’s strategic plans. If anyone knows of other pharmas who have dipped their toes into the embryonic stem-cell field in a similar fashion, I’m all ears. Tell us about it in comments and I’ll update as necessary.

[Editor's note: David Hamilton is a contributing author on VentureBeat. If you have a biotech story tip for him, let us know via the "story tip" link above.]

Earlier today, VentureWire reported (sub required) that Novocell, an early-stage San Diego biotech that aims to treat diabetes with the embryonic cells, is hoping to raise $35 million in a third round of funding. The interesting thing, however, isn’t so much the money as the identity of the lead investor: Johnson & Johnson Development Corp., the venture arm of pharmaceutical giant J&J.

The news grabbed my attention because to date, Big Pharma has shown relatively little interest in the smaller biotechs working on embryonic stem-cell therapeutics, with the standard explanation that the field is too young and in need of some solid clinical success before the big guys can get involved. Political controversy over the destruction of embryos — necessary to derive the stem cells — probably also inclines the naturally cautious pharmas to move even more carefully. (Novacell intends to make new insulin-producing islet cells from embryonic cells, then transplant them into diabetics.)

Here are some snippets from the VentureWire piece:

The funding, which the company revealed in a Form D filing with the Securities and Exchange commission, came into the company last month. Johnson & Johnson Development Corp. led the funding, alongside the participation of Asset Management Partners and Sanderling Venture Partners. [...]

The investment from Johnson & Johnson’s venture capital arm brings the company on as a strategic investor, [Novocell Chief Executive Alan] Lewis said, giving them “a major ownership in the company.”

As it turns out, I’m not aware of any other Big Pharma equity investment or development partnership involving embryonic stem cells. Jennifer Van Brunt, a biotech-data maven and editor of Recombinant Capital‘s Signals Magazine, says her databases don’t show any, either. The only remotely similar deal I was able to turn up after some searching was another J&J venture investment in Tengion, a Pennsylvania biotech that wants to grow new organs such as bladders. Tengion’s technology, however, would use a patient’s own stem cells, not ones derived from embryos.

Stem-cell proponents have long complained that Big Pharma and venture capitalists alike have failed to step up to the plate with support for embryonic stem-cell work, effectively slowing scientific and commercial progress in the field. If J&J’s investment is a sign that regenerative medicine is quickening pulses in at the big drug companies, things could get interesting.

Unfortunately, that’s mostly just speculation at this point. A J&J spokesman confirmed the investment, which is part of $20 million Novocell has raised so far in this round, but had no comment about the company’s strategic plans. If anyone knows of other pharmas who have dipped their toes into the embryonic stem-cell field in a similar fashion, I’m all ears. Tell us about it in comments and I’ll update as necessary.

[Editor's note: David Hamilton is a contributing author on VentureBeat. If you have a biotech story tip for him, let us know via the "story tip" link above.]