Friday, December 21, 2007

GiveWell’s Not Getting It Well — Medical Research Is Not Charity

FasterCures President Greg Simon responds to The New York Times piece by Stephanie Strom “2 Young Hedge-Fund Veterans Stir Up the World of Philanthropy,”

The article states, “Mr. Karnofsky and Mr. Hassenfeld, both 26, founders and sole employees of GiveWell, which studies charities in particular fields and ranks them on their effectiveness. GiveWell is supported by a charity they created, the Clear Fund, which makes grants to charities they recommend in their research.”

After reading this, the third article I’ve seen about these refugees from Wall Street, I feel moved to point out a few things. First, it’s unfortunate that what has drawn attention to their work is using blogs to flame the admittedly flawed ratings groups like Charity Navigator. Second is this obsession of equating philanthropy with “charity.” I do not know any medical research group that considers itself a charity. They are nonprofit disease research organizations developing cures for deadly and debilitating diseases. Charity has nothing to do with it – these organizations represent investments – and yes I feel silly pointing that out to people who used to do research for hedge funds.

Once you realize organizations that are trying to save lives through research are an investment, you evaluate these organizations differently. You look at their strategies, their resources, their connections, board members, partners, and risk taking, and then you can create a diversified portfolio of disease cure investments going forward. That is what FasterCures is doing with our Philanthropy Advisory Service with grants from Gates and Robert Wood Johnson – and it takes time and more than asking a hundred questions and seeing who sends you their annual report faster than others – that really only measures receptionists.

Unfortunately, GiveWell’s approach of “cost per life saved” is the equivalent of what investors call “chasing performance.” Some groups may be efficient in handing out condoms but to discuss “charities” saving lives and not mention groups like IAVI that are developing vaccines for AIDS is like focusing on iron lung distributors instead of a polio vaccine.

We are all trying to get more out of our philanthropy, but saving lives requires strategies that try to create the future – and measuring that is harder than counting dollars and cents – or condoms.

Read the "Philanthropy 2173" blog for more information at:

Wednesday, December 12, 2007

Saving Lives through Technology

On behalf of FasterCures, I attended a Capitol Hill news briefing in support of the bipartisan legislation Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007 introduced by Senate Finance Committee Members John Kerry (D-Mass.), John Ensing (R-Nev.), Debbie Stabenow (D-Mich.), Senator Mel Martinez (R-Fla.), and endorsed by former Speaker of the House Newt Gingrich (R-Ga.). The E-MEDS Act of 2007 would require physicians to use electronic prescribing (e-prescribing) in Medicare. The news briefing “Saving Lives, Saving Money: Modernizing Healthcare through Electronic Prescribing,” discussed the steps the Federal government can take to stimulate physician adopting of e-prescribing, and the potential it has to improving patient care while generating significant savings for the Federal government.

The E-MEDS Act of 2007, simply put, would save lives. Something we at FasterCures know a lot about. At FasterCures our mission is to save lives by saving time. Last year the Institute of Medicine (IOM) recommended that all physicians begin using e-prescribing by 2010 to help reduce the estimated 1.5 million preventable medication errors that occur in the United States annually. Of the 1.5 million errors, IOM studies show that over a half million of those errors occur among the Medicare population. And each year, roughly 7,000 people die from medications errors. However, less than one in ten physicians have adopted e-prescribing not because of clinical concerns, but because they do not view it as a priority. The E-MEDS Act of 2007 estimates that requiring e-prescribing in Medicare could prevent medication errors and save the Federal government billions over the next decade, even after providing physicians funds for equipment, training, and technical support.

Patient safety is an important issue and a priority among patients, providers, insurers, business, and government. E-prescribing is a system that enables prescribing clinicians to deliver prescriptions computer immediately from the point of care directly to the patient’s pharmacy of choice. It’s an efficient and accurate prescription delivery system that improves patient safety through warnings to the prescribing clinician about adverse drug interactions, allergies, and previous medication history. The technology already exist for launching a e-prescribing that will help modernize the nations healthcare system, while eliminating medical errors, injuries, hospitalizations, and even death. The E-MEDS Act of 2007 runs parallel to the work we are doing at FasterCures…saving lives…by saving time.

Angelo Bouselli, Communications Manager, FasterCures

Angelo Bouselli joined FasterCures as the Communications Manager in April 2007. Angelo has almost ten years of marketing and communications experience in the non-profit arena. Prior to joining FasterCures, he was the Manager of Marketing and Communications at the American Society for Microbiology for the American Academy of Microbiology. He also worked in marketing and business development at The Brookings Institution for the Center for Public Policy Education. Upon moving to Washington, DC in 1998, Angelo began his career in nonprofits working for the National Hydropower Association and Steven Winter Associates. Angelo is a graduate of the University of Maryland.

Wednesday, December 5, 2007

“Diagnose Twice, Treat Once – Saving Lives by not Wasting Time”

FasterCures recently attended a briefing on Advanced Market Commitments designed to educate Capitol Hill staff on innovative financial mechanisms for tackling global disease issues. One of the issues touched upon during the discussion focused on the need for robust diagnostic tools to deliver care and treatment, not just development of the care and treatment pharmaceuticals.

FasterCures saves lives by saving time. Part of saving time is not wasting time in mis-diagnosis and therefore mis-treatment.

Addressing and finding solutions to healthcare problems in less-developed countries is often slowed by policy issues, regulations, infrastructure, access and delivery of services, and a lack of sensitive and specific diagnostic tools. And, unfortunately, in less developed countries, children, women and men really pay the price of mis-diagnosis (and with little chance of recourse). In regions with high malaria prevalence, for example, 50-80% of cases diagnosed using a syndrome approach are not validated or confirmed with laboratory-based tests, leading to significant levels of mis-diagnosis and in worst case scenarios (which happens too often) death – this is unacceptable.

These kinds of failures breed even more frustration among care-givers already working in challenging environments; further reduce a patient’s confidence in the health system; wastes human and financial resources; and, worst of all leads to unnecessary deaths. Through the FasterCures Philanthropy Advisory Service, we will examine how disease research and delivery organizations create paths from bench science to patient level solutions that include both medical treatments and the robust infrastructure necessary to deliver the medical solutions to the patient. It is clear, then, part of the infrastructure must include precise diagnosis with sensitive and specific diagnostic tools to avoid unnecessary suffering and death. With correct and contextual design, the FasterCures Philanthropy Advisory Service can serve this need by saving our most precious resource – time.

Priya Patil, Global Health Program Manager, FasterCures

Priya Patil joined FasterCures in 2007 as the Global Health Program Manager for the FasterCures Philanthropy Advisory Service. Upon joining FasterCures, Priya was a Senior Research Scientist for Futures Group, a Constella Company. As Primary Investigator of studies in sub-Saharan Africa on adherence to Anti-Retroviral Treatment (ART) and co-Investigator for an evaluation of Palliative Care programs, Priya led technical teams in design, development and data use activities. As Team Leader and Program Manager for Futures Group’s GHAIN project, Priya led the development and implementation of a patient management and monitoring system for Nigerian government facilities providing ART. She also served as Monitoring and Evaluation Technical Lead a nine (9) country project, developing a health management information system that was used to capture data for clinical, programmatic and evaluation purposes under the President’s Emergency Plan for AIDS Relief. Prior to her work at Futures Group, Priya was Co-Primary Investigator and Field Coordinator for the World Bank and Johns Hopkins University Private Willingness to Pay for AIDS Vaccine Project in Uganda.

Priya has over ten years of experience implementing programs and conducting research in sub-Saharan Africa, Asia and South America. Priya has published in several peer-reviewed journals and presented her work at both international and domestic conferences. In addition, Priya was the recipient of NIH’s National Research Service Award and a Fogarty New Investigator Award. Priya received her bachelor’s degree from the University of Chicago and her master’s degree and Ph.D. from Johns Hopkins University Bloomberg School of Public Health.

Monday, November 26, 2007

Fomenting Collaborative Science

FasterCures co-hosted with Esquire magazine what has become an annual intellectual smorgasbord focused on how to foster more innovation in the conduct of medical research. The theme running throughout our afternoon’s discussion was new tools for fostering collaboration in science, and I was struck by how the medium matched the message. Once again we gathered people from all across – and outside – the disease research and therapy development spectrum; heads of nonprofit disease research foundations mixed with business innovators mixed with Internet gurus etc. The energy and synergy in these gatherings is always palpable, as people are exposed to new people and ideas that they don’t necessarily encounter in their everyday work.

The place itself encourages you to switch off your left brain for a few hours and let the right brain take over. This latest incarnation of Esquire’s “Signature Spaces” was a three-level penthouse with awe-inspiring views across New York from Central Park North. Two participants began a side meeting they’d scheduled by going head-to-head on the Indy car racing video game in the game room. Over lunch in the media room, I got an impromptu demonstration of how nonprofits are networking in Second Life by Susan Tenby (a.k.a. “Glitteractica Cookie”), the creator of the Nonprofit Commons in SL; she introduced me to several of her colleagues online, who talked persuasively and passionately about the support and resources they’ve tapped into in this online world. (The American Cancer Society raised more than $120,000 in a virtual walk-a-thon this year!)

Our conversation during the afternoon was, as usual, artfully orchestrated by Greg Simon, President of FasterCures, whose right brain is fully engaged in his work on a normal day. I found most thought-provoking our forays into two topics: how new frontiers in information technology, such as the Semantic Web and virtual worlds like Second Life, create new platforms for participation in the life sciences and the nonprofit sector; and how different models of prize philanthropy can bring the wisdom of the crowd to bear on medical research challenges, small and large.

John Wilbanks, Executive Director of Science Commons, talked about how the Semantic Web gives us the tools to create an “open source knowledge management platform for biological research” that will allow researchers to make connections between what they observe, what is known, and what data and materials are available for research much more quickly. Susan Tenby challenged us (many of whom have barely mastered instant messaging) to imagine the possibilities that a virtual world like Second Life holds for creating meaningful interactions not only among people but between people and data.

Tom Vander Ark, President of the X PRIZE Foundation, and Dwayne Spradlin, CEO of Innocentive, educated us about the power of their prize models (each very different – the former top-down, the latter bottom-up) to “crowd-source innovation” by defining a problem and then opening up the solution to the widest possible audience. In one of the most fascinating data points of the afternoon, Spradlin said that “solvers” in their system come on average from “six disciplines away” from the “seekers” who post challenges. Innocentive has posted several challenges by nonprofit groups, including a prize for ALS biomarkers, and is very excited about the promise that its model holds for nonprofits across the spectrum. X PRIZE is working with the Robert Wood Johnson and Lance Armstrong Foundations to define “grand challenges” in healthcare and in cancer that would be appropriate for prizes.

We at FasterCures believe that the scarce resources in the search for cures are neither money nor places to invest it; the scarce resources are time and information. We're thinking about how all these new technology tools and management strategies to leverage resources, promote innovation, and build collaborations can be used to shrink information gaps and the scientific research cycle.

But despite our belief in the collaborative power of information technology, it’s nice to be able to get together in a penthouse in New York every once in a while, too.

Kristin Schneeman, Project Director, FasterCures

Kristin Schneeman joined FasterCures in April 2005. She brings to the team more than fifteen years' experience in public policy, politics, academia, and the media. Kristin served for three years as a senior adviser and policy director to a gubernatorial candidate in Massachusetts, as a policy aide to a U.S. Congressman, and for four years as the front-line manager and chief-of-staff for a senior adviser to Vice President Al Gore. At Harvard University's Kennedy School of Government she directed a research project – the top priority of the Dean of the School – on future challenges facing governments, and at Harvard Business School she worked with a noted professor who specializes in analyzing and advising on complex negotiations in business, politics, and international relations. Kristin began her career as a producer of documentary films on political and social issues, for which she was the recipient of an Emmy Award in 1990.

Thursday, September 13, 2007

Be Bold

One of my favorite inspirational quotes is Basil King’s “Be bold and might forces will come to your aid,” though I have to admit I first heard it uttered by the strong and sympathetic mother Frances McDormand in Cameron Crowe’s movie Almost Famous.

It is a great sentiment, inspiring, and hopeful. It is the belief that a dramatic act will not be in vain, that some how, somewhere the universe will not abandon you.

So when I read in the recent Boston Globe article by Liz Kowalczyk, “NIH Funds Local Teams for Daring Research,” I was heartened to learn that somebody at NIH concurred with my thinking.

NIH has recently launched a $483 million initiative “to support daring, difficult research that has the potential to solve intractable medical problems and transform patient care.” The first round of funding has gone to nine teams nationwide, with teams receiving between $21 and $25 million.

As Kowalczyk correctly points out “NIH traditionally awards most research grants - typically about $250,000 each - to individual doctors and scientists whose work has a high likelihood of success. But hoping to turn a new page on how research is done, the agency has set aside 1.7 percent of its budget in a sort of venture capital fund for large, multidisciplinary projects that are riskier but have a huge potential payoff.”

One Boston based research group intends to explore daring and difficult research as it attempts to grow heart valves, parts of a pancreas, and a tooth. Another research group hopes to improve the drug discovery process utilizing the data from genes being linked to human diseases in an effort to identify potential treatments. These projects will bring together scientists from different fields to tackle issues that have been resistant to traditional approaches. In the case of the organ project, the team includes a cardiac surgeon, two mathematicians, computer specialists, and tissue engineers.

As Dr. Alan Krensky, Director, Office of Portfolio Analysis and Strategic Initiatives NIH, which is funding the project says, “This is knock-your-socks off science.”

Who knows if the grant awardees are going to be successful? Who knows what new knowledge will be derived from their research? What is known is that we have to continue to think this way when it comes to medical research. We have to be willing to try approaches that haven’t been tried before. We need to be able to think differently about what will and won’t work. We need to be open to fail in our pursuit for cures, for with each failure more is learned

We need to be bold, and who knows what mighty forces will come to our aide.

Patrick Morris, Vice President of External Relations and Communications, FasterCures

Patrick joined the FasterCures in October of 2006. Patrick has over eighteen years of government and communication experience, at both the federal and local level. He has worked in both chambers on Capitol Hill, serving as Press Secretary to Wisconsin Senator Herb Kohl and as Communications Director to Oregon Congressman David Wu.

To read the Boston Globe please visit:

Tuesday, September 4, 2007

Information is Power

In Tara Parker-Pope’s Health Journal column, “Lessons Learned From Doctors, Patients, and My Mother,” in last Tuesday’s Wall Street Journal she talks about her mother’s experience with esophageal cancer. In this excellent piece, she writes, “Taking charge didn’t save my mother’s life, but it made the end of her life better, and gave all of us confidence in her care and the choices she made.” She goes on to write, “She believed, just as I do, in the power of information to save a life, even if it wasn’t her own.” We couldn’t agree more.

On the day her mother received her diagnosis, an estimated 1.3 million other Americans were diagnosed with cancer. Some are highly treatable. However, for others treatment eludes us. The road to treatment is paved by clinical trials. At FasterCures we focus on how we can educate more people about the central role clinical trials play in scientific advances. Clinical trials fuel the drug discovery process and ultimately lead to better treatments and cures. Nevertheless, the process remains a mystery to most. As a nation, we need to put more emphasis on helping the public understand the process of clinical research and innovation – experiment, evaluate, redesign, and experiment.

When patients enroll in trials, survey data shows that clinical trial participants feel overwhelmingly positive about their experience, believe they are treated with dignity and respect, and receive good to excellent care. And yet we know that fewer than 5 percent of adult cancer patients enroll in trials each year.

Clinical trials won’t be the right fit for everyone. My father found his way into a clinical trial after his leukemia diagnosis two years ago, and Ms. Parker-Pope’s quote about how the information didn’t save her mother’s life but it made the end of her life better resonated with my dad’s experience. His clinical trial participation gave meaning to his diagnosis. His access to a top-notch cancer center and experts in the field gave him hope that there was an infrastructure churning towards treatments. He was highly motivated at the prospect of participating in a clinical trial that might help him, but more importantly would help provide valuable information to finding treatments for others.

Information is power and can be empowering. My family will soon remember the two-year anniversary of my dad’s death, and we will honor his contribution to leukemia research. At FasterCures, we are working to ensure that others are offered the information about clinical trials, for everyone’s benefit. Thanks Dad.

Margaret Anderson, COO, FasterCures

Wednesday, August 29, 2007

Love isn’t all that is blind

So is cancer…but so is conviction.

I had the pleasure of attending a reception this week at the Susan G. Komen for the Cure Annual Mission Conference. Per my expectations, the bustling room was filled with brave survivors, accomplished scientists, and visionary activists fully accessorized with their pink ribbons. What I was not expecting was the diversity of participants that crossed age brackets, races, and geographies.

Based on data from the American Cancer Society, breast cancer is the most frequently diagnosed cancer among almost every racial and ethnic group. Women of African American, Hispanic, Asian American, and American Indian descent were there to reaffirm the Susan G. Komen for the Cure vision and lead their charge in advising the organization with respect to these particular populations. I also made the acquaintance of women who traveled thousands of miles from Jordan and the United Arab Emirates to represent The Middle East Partnership. This is the first partnership for breast cancer between the United States and the Middle East in efforts to build capacity, raise awareness, and increase collaborative research within the region. Finally, I was taken by the youth of some of the participants. Although less than 5 percent of all breast cancer cases occur in women under age 40, I met women as young as 21 who were cancer survivors themselves. They were energized to strengthen disease awareness and promote prevention initiatives among their peers.

Was the attendance of these groups a dismal indication of the far-reaching prevalence of the disease and cancer’s blindness to ethnicity, generation, or continental border? Perhaps to some. But to me, their participation was the manifestation of a greater conviction -- that a unified, cross-cultural, and comprehensive approach to awareness, prevention, screening, treatment, research, and empowerment could bring about great change. And that well-coordinated, global and multi-generational efforts could bring about both a stronger fight and faster cure.

Melissa Stevens, Director of Special Projects, FasterCures

Melissa Stevens joined FasterCures in June 2007 as Director of Special Projects and Interim Project Director for the Philanthropy Advisory Service initiative. She comes to FasterCures from PricewaterhouseCoopers where, as a Manager in their Health Sciences Advisory Practice, she lead large teams in providing strategic, operational, and business planning services to commercial and federal clients across the healthcare continuum.

Melissa has served academic medical centers, private research institutes, and large health systems in developing strategies for implementing clinical and translational research programs, designing conceptual models for collaboration, and assessing infrastructure to support research enterprises. Melissa received both her B.S. in Biochemistry and her M.B.A. from the Pennsylvania State University.

Tuesday, August 28, 2007

It’s about Cancer, Stupid.

Lance Armstrong’s cancer forum is putting the wrong people under the lights. Even if the presidential candidates found a cure for cancer right there on stage, with the way the media covers politics the rest of us would never know. How is it possible that after discussing their approaches to winning – dare I say it – the war on cancer -- the headlines are about which candidate is willing to take which lobbyists’ money? I thought journalists were taught not to bury the lead. Well the lead is the toll in death and suffering cancer is taking, not the campaign contributions candidates are taking.

The press continues to confuse healthcare economics with curing diseases. The benefit of Lance’s gathering is it forces candidates to go beyond the “more money” argument and into how they would change something. In a discussion about curing and surviving cancer, it is folly to debate which lobby groups are “acceptable” as donors. The last time major health players were left out of the game, they defeated a popular President by putting two actors playing man and wife sitting around a kitchen table shaking their heads. If we are going to create medical solutions for cancer, we will need everybody at the table with open minds, collaborative natures, and valuable human and financial resources. And not shaking their heads.

Lance was right to ask the field of future Presidents how they would attack cancer. Now let's start asking the press to cover the answers and not let them change the subject to pick silly fights.

Greg Simon, President, FasterCures

Wednesday, August 22, 2007

See You in September…

When Congress comes back in session this September, some heavy lifting is needed to ensure that two agencies vital to advances in biomedical research have adequate resources.

The FDA appropriations process for fiscal year 2008 continues. We appreciate the Senate’s 11% increase above the enacted 2007 budget, and see this as a first step towards a five-year effort to increase the FDA budget. We were happy to see an increase, and hope that the House will accept the Senate number. It is vital that the agency be given more funding, end of story.

Other important work on drug safety will need action in September. The Prescription Drug User Fee Act (PDUFA) reauthorization needs to be addressed since it expires at the end of September. The PDUFA reauthorization contains some key initiatives to move us forward on drug safety and address some of the concerns outlined in the IOM’s report on the topic released almost a year ago. Two areas covered in PDUFA that we are paying close attention to are the FDA Critical Path Initiative which needs more resources, and the proposed Reagan-Udall Foundation which needs to be launched immediately. We believe this Foundation can serve as the research arm of the FDA. There is a wealth of information that resides within the FDA that can be brought to bear on drug safety analysis and drug development issues.

Finally, bills for NIH appropriations will also be considered when Congress returns to session in September. The House and Senate numbers offer slight increases, and there is great concern that NIH will continue cost-cutting if more funds aren’t appropriated.

We certainly need to continue investing in medical research now, in order to accelerate medical solutions for later.

Margaret Anderson, COO, FasterCures

Thursday, July 19, 2007

What Has Five Hats and a Hundred Thousand Hands?

So I’m with my family and 50,000 of our closest friends at the Live Earth concert near New York City when these five college aged guys with backward hats start whooping and hollering like they had found gold or were giving birth to those little creatures in Alien. I was hesitant to turn around and inquire “Are you ok? Have you been invaded?” Soon I noticed that the noise level was way beyond five guys, in fact it had started to spread in a pattern. Great, I thought, we’re all being invaded.

Soon the noise was way away from us and we could see it and it was…The Wave…

Let’s just say those five guys were pretty proud of themselves for moving 50,000 people to follow their lead. Five hats moved 100,000 hands. Go figure. We understand that challenge at FasterCures. We have been trying to move a $100 billion research enterprise in this country on a budget of only a few million dollars a year. Now, with our grant from Sumner Redstone of $35 million, we have a chance to start a real wave. But, it is still a huge challenge for even $35 million to move $100 billion. And, that is why we are gathering our “five hats” -- smart friends and advisors to help us determine how to create a wave that will move $100 billion to accelerate the discovery of cures. Seems impossible, but then again…I was at a concert the other day and there were these five guys with backward hats…


Thursday, June 14, 2007

The FDA and You

You might be shocked to hear that the Superintendent of the Montgomery County schools has a budget akin to what FDA Commissioner von Eschenbach has to run an agency that regulates a whopping 25% of American consumer spending. Think about how you use FDA-regulated products each day -- when shampooing, brushing our teeth, taking aspirin or prescription drugs, applying makeup, putting on sunscreen, talking on a cell phone, cooking food in a microwave, and even watching TV. It starts to seem like there is little in our daily lives that isn't affected.

In recent weeks, I've been participating in hill visits with the FDA Alliance (I also sit on their Board) to talk to Congressional staff about FDA's resources. We've been making headway to increase awareness about the need for increased appropriations for FDA. We have yet to meet with anyone who disagrees with the argument that the agency needs more money. How much of an increase we'll see remains to be seen, but the next few weeks will be critical.

The FDA budget has been going backwards not forwards because of inflation, increasing costs, expanded missions, and scientific advancement. The current budget levels are far from adequate. We're asking for $2 billion for fiscal year 2008 (plus user fees on top of that).

I think we'd all agree we look to the FDA to be at the ready as scientific innovation flows through the pipeline. Otherwise what's the point of investing in innovation in the first place? We're expecting cures, and we'd like them sooner than later. The agency needs to be a cutting-edge regulator, one that is a "Gold Standard" worldwide. We need to be maximizing the potential of things like large datasets of electronic health records. This will aid in monitoring drug safety.

The list of things that FDA staff are thinking about now is no doubt long, but they can't scratch the surface without adequate funding. We are all either patients now, or will be one at some point. We need a strong and robust FDA. The 111 members of the FDA Alliance representing consumers, patients, professional societies, and industry all uniformly agree on that point. Increasing FDA's budget is a win-win for public health and the economy. Wouldn't you agree?

Margaret Anderson, COO, FasterCures

Saturday, June 9, 2007

Working For You?

I had all of 4 minutes on CNBC this week – which I shared with Merrill Goozner -- to answer the question, “Should the FDA be speeding cancer drugs to market?” What a question.
Answer: YES -- if they work, NO -- if they don’t! (Merrill agreed. that left 3 minutes of dead space.)
But there’s the rub. What does it mean for a drug to “work?” Is extending life three months at a cost of ten to twenty thousand dollars per patient “working?” Is a drug that has a 92% chance of not being a placebo effect “working” compared to a drug that has a 95% chance?
This issue came to a head at the recent meeting of the American Society of Clinical Oncologists – otherwise known as “cancer doctors.” According to the New York Times, several people who had spoken out against a particular cancer drug received threats, even death threats. Apparently some patients felt they had the right to have this drug approved as a last resort even if many scientists felt it did not “work.” And if those scientists didn’t support “saving their lives”, these angry patients felt comfortable threatening them. This is an example of a system that is not working.
Or rather, the system is working just as we set it up to work. We have a $100 billion research enterprise feeding products into a $1 billion drug review system, funded to an ever growing degree by industry user fees. At the front end, we have some pretty strict rules for what constitutes “working.” And anything less than a high “non-randomness” score (i.e. 95% chance of not being random) won’t “work.” Try telling that to terminally ill patients who want to take a drug that has a score of 90 or 85.
Meanwhile, those user fees have been restricted for years from being applied to post market surveillance of newly approved drugs. If you can’t do post market surveillance, you don’t know how a drug is working in the real world until someone reviews random adverse event reports from doctors and starts comparing them to previously obtained clinical trial data that may or may not have tested for the reported effect. And then when deadly effects are discovered in some people, all hell breaks loose because nobody was monitoring whether the drug “worked.”
Avandia. Vioxx. Accutane. Thalidomide. All these drugs work for some people in some very important ways. For other people, they don’t just not work, they’re deadly. Until we have a system that works, it will be hard to tell whether the drugs are working ….or wasting both money …and lives.

Wednesday, May 23, 2007

Why We Won the War

Welcome to this, my inaugural post, on the new Fastercures blog. I hope you'll check in with us early and often and bring your friends. Comments are welcome and ideas even more so.

So maybe you heard the news that FasterCures received a $35 million (It feels really good when you put your little finger in your cheek and turn it when you say $35 million dollars) grant from Sumner Redstone. I sat with him the day of the announcement and asked a question that had been on my mind for a long time -- or ever since I finished reading "Cryptonomicon" by Neal Stephenson a month ago.

"So, Mr. Redstone, " I asked, "When you were breaking codes in the Pacific in WWII, (Gentle Reader, you probably didn't know that Redstone was a code breaker in the War, stick with us for more surprises) how did you act on what you learned without giving away to the Japanese that you had broken their codes?"

"Not a problem," said he. "They didn't believe it was possible to break their codes so nothing we did looked suspicious to them. The Chicago Tribune even published that we had broken their codes and the government was going to indict them for treason until we learned the Japanese didn't believe it."

Glad I asked.

You see, people get confused with this "seeing is believing" business. I have always felt it was the other way around. You can't see what you don't believe in. People who believe in something the rest of us can't see and then make it visible to us, we call magicians, or inventors, or visionaries. People who can't believe in something until they see it, we call "objective, " or "realists," or "practical." (Some historians argue that the Native Americans couldn't see, much less grok (look it up, Stranger in a Strange Land, by Robert Heinlein) the pilgrims approaching their shores because they had no mental concept of ships and people crossing the water.)

You see (sorry), here at FasterCures we believe in something we can't see -- that we can cure many of the diseases that cripple and kill us in this generation. Say that at a science convention and see what happens. A group of very objective practical people will guffaw and turn away. Ignore them. Find the one or two people who come up to you and say "yes, I know." They are the ones who believe it and will make it happen.

We won WWII because our enemies could not believe that we could break their codes and they couldn't see what we were doing as a result. The war on disease is one we can win, but you have to believe it first in order to see it later....or sooner.

That's it for now.
This is Greg Simon at FasterBlogs for FasterCures