“This is more like business.”

That’s what Russ Altman, MD, PhD, chair of bioengineering, said about a new endowment that was announced today. The Wallace H. Coulter Foundation gave $10 million - with Stanford then matching the gift - to create an endowment that would help translate ideas that address unmet medical needs into treatments and devices that improve human health. The program will provide seed funding for bioengineering research projects, with the goal of launching start-ups or finding corporate partners to produce and distribute the fruits of their research.

Altman explained how it differs from a grant from the National Institutes of Health:

“The projects have quarterly milestones and can be killed by the oversight committee if the milestones are not met. This is not how academic grants usually go. There is a very strong emphasis on keeping focused on what is needed for successful transfer to professional management via a start-up or a license to an existing company. Funding for this sort of work is hard to get from the NIH, so the existence of a fund in perpetuity to support this kind of work is incredibly valuable . . .”

A previous five-year grant of $5 million to Stanford’s Department of Bioengineering from the Coulter Foundation made possible the development of a blood test that could be an alternative to amniocentesis, a new type of surgical dressing that aims to prevent scarring, a drug that may improve cognition for people with Down syndrome and an ultra-cheap ventilator for hospitals in developing nations that can’t afford the current models. The foundation has recently established similar $20 million endowments at Duke University, the University of Virginia, the University of Michigan and Drexel University.

How can we better study frostbite? Why do so many patients skip their ophthalmology appointments? Does it make a difference where on the spine neural stem cells are injected when trying to treat paralysis?

Those are some of the questions that were addressed in the 28th annual Stanford Medical Student Research Symposium, as discussed in a story in today’s Inside Stanford Medicine. The event showcases some great projects, and it also underscores Stanford’s effort to address what some fear could be the declining role of physician/scientists.

Last year, Andrew Schaefer, MD, the editor of a new book, The Vanishing Physician-Scientist?, noted that while there are no precise statistics on the number of physician-scientists, there are some troubling trends indicating that a greater proportion of research is being done by PhDs. (He discussed the book in a podcast that is part of the medical school’s “1:2:1″ interview series.)

The student symposium offers compelling examples of how research can be rooted in clinical practice and how physicians have a perspective on research that must not be lost. “What we really love is seeing people doing things that make a difference,” said Laurence Baker, PhD, director of medical student scholarship and professor of health research and policy, speaking of the projects being presented at the event earlier this month.

Photo by Norbert von der Groeben: Yuri Kim (left) listens to Shah Ali’s explanation of his research project on postnatal cardiomyocyte generation in murine models of aging and cardiac injury.

The U.S. Centers for Disease Control and Prevention today released disappointing numbers about adults who had received the tetanus, diphtheria, and pertussis (Tdap) vaccine. (It’s the third item in its Oct. 14 Morbidity and Mortality Weekly Report.)

“Suboptimal” is how the agency described the 5.9 percent of adults who had reportedly received the vaccine by 2008, three years after the CDC first recommended the shot. The low numbers undoubtedly contributed to the recent spike in pertussis cases across the United States, including the death of nine infants in California because of the disease. The shot serves as a one-time substitution for the traditional 10-year booster dose of tetanus, diphtheria (Td) vaccine.

Being the first author on a paper in an esteemed journal is the objective for graduate students nationwide. Such an achievement opens the door to joining the faculty of elite institutions and has been viewed as a necessary rite of passage for academic scientists. This worthy ambition, however, has become less attainable, and that dilemma is the subject addressed by Stanford biochemistry professor Suzanne Pfeffer, PhD, the president of the American Society of Biochemistry and Molecular Biology, in her latest column in the society’s magazine.

Pfeffer lays out how multidisciplinary research increasingly is leading to papers with multiple authors and how journals, in turn, are being more demanding of the manuscripts they receive. She writes:

Why don’t more of our students publish sooner? Part of the problem is that reviewers and journals are demanding more. In the late 1970s and early 1980s, the sequence of an important gene was sufficient for publication in the flashiest of journals. I envied those manuscript reviews - what could the referees criticize when a sequence was a sequence? Now, journals quibble over whether to publish entire genomes. A referee can always ask for more experiments, another mutant, another control, and, because most journals want to maintain the highest standards, the editors agree. Such an approach may make for great papers, but it actually can be harmful to younger workers in our field because it sets the bar for publication further from their grasp.

Pfeffer doesn’t offer a simple solution, but makes several suggestions about how to ease the pain.

Here’s a small sign that things are turning around at the U.S. Food and Drug Administration.

A few days ago, my blog entry about the presentation by Jeffrey Shuren, MD, JD, director of the FDA Center for Devices and Radiologicial Health, mentioned the concerns of many in the audience from the Medtech industry and how Shuren tried to address them. The opening quote - “We’re scared. We don’t know what to expect.” - came from Connie Hoy, vice president of regulatory affairs and compliance officer, at the firm, Cutera, a maker of laser and light based medical devices, based in Brisbane, Calif.

Hoy was kind enough to email me a couple days after the event, and her response gives a sense of the impression Shuren left. Here’s what she said:

Several take aways from the meeting:

I very much liked Dr. Shuren He seemed down to earth and clearly wants to communicate. That in itself is reassuring.

I liked that he took some responsibility for the problems in the FDA
review process. I actually think he was a little hard the reviewers,
for example, when he stated that he thought the agency lacks technical
expertise. That is not the case in the laser side of the business.

I also appreciated that he was able to point out shortcomings on
industry side with out being accusative. He is right, quality of
submissions is critical to a smooth process and it is industries
responsibility to prepare quality submissions.

I also liked the fact that he wants to build a clinical group at FDA.
BUT, that also scares me a bit. One of the things that is important is
that industry can dictate the protocols in their trials. FDA can’t be
too prescriptive or it will damage industry by possibly adding too much
cost and/ or time.

Overall, I was comforted and encouraged by what I hear.

The Stanford Biodesign Round Table, at which Shuren talked with panelists and answered questions from the audience, is now available as a video on the Web.

“We’re scared. We don’t know what to expect.”

That’s what one medical device company executive told me about the U.S. Food and Drug Administration’s plans to revamp the way it approves new technologies for market, as we were milling about before the start of a roundtable event here yesterday. Her worries were shared by many in the medtech industry who made up the audience of some 500-plus.

It was the mission of the guest of honor, Jeffrey Shuren, MD, JD, director of the FDA Center for Devices and Radiologicial Health, to assuage their fears, and explain how he and his colleagues are trying to fix what virtually everyone agrees is a troubled system: Industry officials say the approval process for devices seems to be dragging on longer than ever; they complain that the CDRH is being swayed by complaints from consumer groups that devices are being rushed onto market before they are fully checked out as safe.

Shuren didn’t candycoat the situation. He said that the medical device industry is caught in a “perfect storm,” as a result of the weakened economy, changing health-care reimbursements, new emphasis on medical cost control, declining research and development effectivenesss - “and declining predictability, consistency and transparency in FDA pre-market decision making.” That last one was the focus of his remarks, and he was optimistic. “The problems are many and the causes lie both with FDA and with industry, but I believe they are solvable,” said Shuren.

Since officially taking the helm of the CDRH in January, Shuren has helped to oversee the production of two reports: one on the 510(K) program that the CDRH uses to review applications, the other on the use of scientific evidence. Together, they offer dozens of recommendations for improving CDRH’s operations. They extend from making certain terms in the regulations less ambiguous to tapping outside scientific expertise when evaluating leading-edge innovations. Shuren said that such changes would lead to a more transparent, consistent and predictable system, making it easier for device companies to plan for the future.

And Shuren tried to dispel the notion - voiced by some at the event - that the CDRH was placing a greater emphasis on safety at the expense of innovation. “You’re right that some folks have raised safety concerns about devices coming on the market, but actually one of the bigger drivers is industry [officials] who were telling us that they were not happy with the way things were going. ” He added that he starts off his cover letter for the reports with the credo, “Foster innovation.”

“That’s one of the goals of the 510(K) program, and we take it very seriously,” he said.

The devil is, of course, in the details, and a panel of industry leaders grilled Shuren about the proposals. It’s not clear that they were satisfied with all that they heard, but Shuren’s effort to communicate (this is one in a series of meetings he has held) was appreciated. One panelist, Josh Makower, MD, a successful medtech entrepreneur and a consulting associate professor at Stanford, remarked. “You have been the most open center director we’ve seen in the history of the device industry, which is great because we are in crisis now.”

The event lasted more than two hours and a webcast is to be made available later this week on the home page of the Stanford Biodesign progam, which hosted the event with Stanford Health Policy and the Program in Health-Care Innovation at the School of Business.

The H1N1 influenza did not cause the devastating pandemic that many feared, but it did draw attention to how our nation lacks the ability to quickly produce sufficient quantities of a vaccine against the flu. A report issued this morning from the President’s Council of Advisors on Science and Technology outlines steps that the federal government can take both in the short term and over the long run to speed up the making and delivery of vaccines, potentially saving thousands of lives in the process.

Ann Arvin, MD, Stanford’s vice provost and dean of research and a founder of the Stanford-LPCH Vaccine Program, is one of the eight committee members responsible for the report.

Among the suggestions: accelerate identification of newly emerging pandemic viruses (so vaccine production can start sooner), develop a collection of stock viral “backbones” to allow faster production of specific vaccine strains, and develop faster and more reliable tests to document vaccine potency. The report also recommends steps to dramatically alter the way vaccines are produced, most notably by “moving away from the current practice of growing influenza viruses in fertilized chicken eggs, which is an inefficient method, and using modern cell-culture systems instead.”

None of this comes without some spending, and the report calls for investing $1 billion or more annually for the next several years to accomplish these objectives. It notes that the funds can be justified on a cost-benefit basis, as the advances in these areas would improve our nation’s defenses against a variety of other deadly pathogens, in addition to the savings they would provide in preventing deaths from influenza.

Indeed, some work relevant to these initiatives is already under way by researchers at Stanford, as outlined in a medical school release last year. In addition, grants from the stimulus fund are supporting a Stanford research effort to explore why vaccines against influenza prompt different responses in different people and why some people are more vulnerable to flu than others to begin with.

What if scientists who benefit from grants from the National Institutes of Health had to devote some small portion of their time explaining to the public what their work is about? That’s the idea being floated by Suzanne Pfeffer, PhD, Stanford biochemistry professor and the new president of the American Society for Biochemistry and Molecular Biology.

In her column in the August issue of the society’s magazine, Pfeffer estimates that if every NIH investigator donated 60 minutes of their time, that could amount to 10,000 hours of educational activities such as talks to elementary school students, public forums and tours of scientists’ laboratories.

The idea is well within the realm of the possible, and indeed a similar measure is already in place for recipients of grants from the National Science Foundation. Pfeffer offers detail on how such an effort could work, and she offers, in a nutshell, why it makes sense:

Explaining science to the public is very important. First, we owe it to them. Taxpayers support a large proportion of biomedical research in the U.S. and in other countries around the world. At a time when public understanding of science could use a major boost, who better to explain the excitement and importance of scientific discoveries than highly trained biomedical researchers?

The White House announcement that President Barack Obama was doing an end run around the U.S. Senate and doing a recess appointment of a new head of the Center for Medicare and Medicaid Services, or CMS, has, not surprisingly, caused something of a kerfuffle.

Donald Berwick, MD, a Harvard medical school professor and president and CEO of the nonprofit Institute for Healthcare Improvement, just become the agency’s first permanent chief since 2006. He was nominated for the job months ago, but his appointment was being held up by Republicans, who said that he would impose government rationing - and that he favors socialized medicine. By officially making the appointment while the Senate is in recess, Obama moves past the effort to pillory Berwick and lets him get started on the job.

Still, it’s worth noting that despite the efforts to pigeonhole Berwick as some sort of leftwing radical, he doesn’t fit that caricature. As noted in an editorial in the Washington Post, he was endorsed by the two previous heads of the agency under President George W. Bush, as well as their counterpart under President George H.W. Bush. The Kaiser Health News Service has created a resource guide page about Berwick that offers a balanced view: It shows that while Berwick has ambitions to overhaul our health-care system, his ambitions are guided by initiatives that are as noncontroversial as apple pie - such as changing medical practices so as to eliminate unnecessary infections in hospitals and prescription errors that cause thousands of deaths each year.

My article in the latest issue of Stanford Medicine magazine may help put what Berwick wants to do in some context. What he and other health reformers are essentially saying is this: Let’s get more health care for less money. At first blush, it sounds like a real estate agent offering some beachfront propery in Nevada, but the premise actually embodies what has made our nation so vibrant. Through innovation, we can achieve - and we have done so in the past - greater productivity. The nation’s leading hospitals and health-care organizations are all now trying to implement quality improvement campaigns that will deliver better care while reducing costs.

Of course, for every Model T, there’s also an Edsel, and so it’s certainly not a given that whoever is in charge of the CMS is going to be able to realize such savings. As the agency overseeing Medicare and Medicaid spending, it has the ability to reward certain practices and penalize others, but figuring out how best to do that is no small feat.

Amid all the debate in the United States about whether vaccines are safe, people sometimes lose sight of what happens when children miss their measles shots. A failure to provide widespread immunizations for this disease in eastern and southern Africa over the past year is a painful reminder of the results of such lapses. According to a brief item posted today by the International Society for Infectious Diseases,

A steep increase in cases of measles in eastern and southern Africa
has put recent gains in reducing mortality due to this highly
contagious disease at risk of being reversed. As of mid-June 2010,
the outbreak has affected more than 47,907 children in 14 countries,
resulting in 731 deaths. The most recent confirmed measles outbreaks
were reported from Malawi, Mozambique and Zambia.

The outbreak is attributed to failure to achieve sufficient vaccination coverage due to lack of funding for immunization from governments and other partners to the anti-measles initiative conducted by the World Health Organization and UNICEF. The outbreak is also the result of certain groups refusing to be vaccinated. UNICEF Regional Director for Eastern and Southern Africa, Elhadj As Sy, said:

Measles IS easily preventable. In order to sustain our efforts and
successes in combating the disease, we urgently need to fill the
funding gaps. Otherwise, we will again see more measles deaths in the
near future.