Accelerate Progress

Blog : Welcome, from the Director of Accelerate Progress

2008-09-17T16:09:46-06:00

A welcome and introduction to our organization and our website, dedicated to accelerating progress for patients fighting life-threatening illnessesWelcome to Accelerate Progress Accelerate Progress is devoted to bringing about faster access to promising and potentially life-saving new therapies for patients fighting cancer and other diseases (a good page for first-time visitors on the Whats, Hows, Whos, and Whys is here). We use the tagline, Accelerating Access Through Better Science to describe the core of our approach. Tremendous work has been done to advance our understanding of the diseases we call cancer, not to mention many other life-threatening diseases. Progress in understanding the biological causes and genetic pathways that can lead to cancer and other life-threatening diseases has been substantial. Where we have fallen short is in translating those gains in knowledge into meaningful patient benefits. Failures and inefficiencies in our approaches to developing and using new medical treatments contribute to the needless suffering and death of hundreds of thousands of patients each year. With that as background, then, Accelerate Progress seeks to identify and then implement improvements to those research & development, regulatory, and treatment systems that show the most promise to accelerate our progress against cancer and other such diseases. To further our mission, in addition to identifying and implementing systems improvements noted above, Accelerate Progress will also fund direct research efforts, particularly in the areas of adaptive trial design, Bayesian and other modern statistical analyses, biomarker identification and validation, and other related diagnostics research, focusing on areas not currently well served by for-profit organizations or other non-profits. We measure progress in terms of quality and duration of patients’ lives, reductions in total time from discovery to patient bedside for new therapies, and an increase in the number of meaningful therapeutic options available to patients fighting cancer and other life-threatening diseases. We expect improvements in these areas to produce other benefits including significant reductions in costs of treatment as well as increases in participation rates for clinical trials, both of which will help support a virtuous circle and further accelerate progress. We believe strongly that many constituencies must come together in sharing productive ideas, becoming active parts of a coalition to accelerate progress, and that we can help bring those voices together, being beholden to none of them ourselves. We will provide expertise, direction, communication, and passion for both patients and progress. As Israel Gaither, national commander of the Salvation Army once said: “We are apolitical, but all of the issues that face society are impacted by politics. It’s about being a voice for the voiceless.” We recognize that meaningful and positive change must be brought about in many areas. These changes will not happen without focused efforts and openness from within industry, from academia, from treating physicians, researchers, advocates, patients, regulators, NCI/NIH, and other key stakeholders. If we as a society want progress to be accelerated, we must be willing to take a hard look at every contributor to a lack of progress and take ownership of all the areas ripe for improvement, not just a single one or two that might receive the most media attention. Accelerate Progress is focused on accelerating access to promising and potentially lifesaving new therapeutics through the broad adoption and use of better science. Better science to Accelerate Progress means better trial designs, more use of advanced statistical analysis methods, better communication and collaboration between stakeholders, greater transparency in all aspects of the development and regulatory review processes, validation and increased use of biomarkers and related diagnostics within the development process, and other similar improvements. We hope our passion for both patients and progress is plain to see. We also hope you will join us, lend your voice and talents to our cause, and help us accelerate progress. As Director, I hope that those of you reading this Welcome and visiting our pages or talking with our advisors at external events will take the time to reach out, to offer a contribution of time, energy, idea, finance, or other, in recognition of the need to accelerate progress against these terrible diseases. I welcome you to reach out to me directly at with your insights and contributions. As many with whom I speak often remind me, the tasks ahead of us are daunting, often likened to a ‘mountain’ before us. As I often reply, the mountain is getting higher with each passing day and if we do not begin this work now, it will only be more daunting for those who follow. Welcome again to Accelerate Progress. Work is already underway, so please, lend a hand however you can. Together, we truly can Accelerate Progress and save lives.

Links : Foundational Pieces

2008-09-17T15:21:53-06:00

Core readings that provide core support for the mission and work of Accelerate ProgressThe ‘Foundational Pieces’ area of our Accelerate Progress website pulls together those pieces written, presented, and/or published by either members of our organization or that we find so fundamental to a robust understanding of salient issues as to require inclusion here. We welcome additional comment and suggestions for future foundational piece inclusions though reserve the right to post the link elsewhere should we find it more appropriate for another section. To begin, the following two pieces by our Chief Scientific Advisor, Dr. Phil Schein and by Dr. Schein with Barbara Scheffler are definitely foundational to the work of Accelerate Progress. They are: The Case for a New National Program for the Development of Cancer Therapeutics by Dr. Schein which provides an excellent starting point for understanding the many issues and constituencies involved in the systems we address and Barriers to Efficient Development of Cancer Therapeutics by Dr. Schein and Barbara Scheffler which serves well as an excellent follow-on reading, thought it stands on its own merits as well. Additionally, for focused insights on our approach to the use and development of advanced trial designs and statistical analysis methods within regulatory development, this recent piece by Dr. Scott Gottlieb, former Deputy Commissioner at the FDA, and also a member of our Scientific Advisory Board, as presented at the Food and Drug Law Institute Colloquium on Access to Unapproved Drugs. Improving Access to Life-Saving Medicines through Modernization of the Regulatory Review Process As Dr. Gottlieb notes, it’s all about “Accelerating Access Through Better Science”. We have the tools and our understanding of the science has advanced significantly enough to allow us to design better trials, to use better statistical analysis tools, and to learn more in shorter periods of time, but we need to focus on using those tools and science to full advantage. Accelerate Progress will be leading the way in this area by forming appropriate academic, industry, and governmental collaborations and funding direct research efforts to improve our knowledge of and use of advanced trial designs and analytical tools.

Blog : Accelerate Progress Comments on Today’s Provenge Data Release

2009-04-28T17:10:39-06:00

Comments on data released today from landmark study of new immunotherapy against prostate cancerAccelerate Progress Comments on Provenge Data Released at Annual Meeting of American Urological Association April 28, 2009 A significant advance for men with advanced prostate cancer was announced today with the release of data from a milestone study on a new immunotherapy called Provenge. The data from the study, known as IMPACT, supported and confirmed data from two previous Phase III studies and numerous earlier stage trials of the therapy. “This data is compelling, exciting, and represents a true paradigm shift in how we think about fighting prostate cancer, “said Scott Riccio, Executive Director of Accelerate Progress. “For the first time, we have real clinical validation that cancer can be fought by stimulating the body’s immune system and that this approach leads to significant improvements in patient survival, the most meaningful of all measurements. Hundreds of thousands of men fighting prostate cancer will now have real hope that a safe and effective new option will be available to them in their fight for life.” “The excitement generated by this data is tinged by sadness, however, in memory of the more than 60,000 men who have already passed away during the two years since the FDA had the opportunity to take the advice of its independent expert panel and approve this new therapy. Our frustration only increases when we consider that even though this therapy has now exceeded the additional hurdle for approval set for it by the FDA, it will still be another year, another 30,000 deaths, before our system see the therapy approved and broadly available. This is just one more tragic example of why our drug-to-patient system must be overhauled and modernized, to prevent further unnecessary suffering and death. Prostate cancer is the most common cancer, other than skin cancers, in American men is the second leading cause of cancer death in men, behind only lung cancer. The American Cancer Society estimates that during 2008 about 186,320 new cases of prostate cancer were diagnosed in the United States. About 1 man in 6 will be diagnosed with prostate cancer during his lifetime and African-American men are more than twice as likely to die from this disease, for reasons not yet well understood. Proponents of earlier access to therapies like Provenge point out they are not advocating a ‘lowering of the scientific bar’ by the FDA, but rather an embrace by the Agency of the science and tools that are available to it for reviewing and approving these therapies, many of which are already shown safe and effective and yet are delayed time and again on technicalities, contributing to tens of thousands of patient deaths each year and significant unnecessary suffering. Scott Riccio is founder and executive director of Accelerate Progress, the nonprofit Center to Accelerate Progress Against Cancer and Other Life-Threatening Diseases. Accelerate Progress works with others to make medical research work better right now for researchers, patients, and clinicians, and to modernize this complex system in the next five years. Together we find, validate and implement technologies, processes and policies that remove current roadblocks and create new incentives that quickly and safely move new treatments to patients. Collaboration ~ Design ~ Advocacy ~ Implementation ~ Impact Contact Information: Scott Riccio, Executive Director, (312) 420-3296 Website: http://www.accelerateprogress.org

Blog : No More Death By Federal Red Tape

2009-04-18T20:18:55-06:00

A recent opinion piece by the Executive Director of Accelerate Progress. The following Op-Ed was published in both the San Francisco and DC Examiners on March 25, 2009. For clarity purposes, the blog below includes the original language (pre-editing for publication) and suggestions vis-a-vis NCI and the Comprehensive Cancer Centers. No More Death By Federal Red Tape Here’s hoping that as Dr. Margaret Hamburg takes over the Food and Drug Administration FDA, she will remember Anna Tomalis, a seventh-grader from Maryland who died last August from cancer. Archaic FDA rules prevented Tomalis from getting a new drug in the late stages of development that doctors believed would have meaningfully extended her life. And despite considerable scientific advances in understanding cancers, the FDA is presiding over a period of plummeting approvals. The result is that other drugs that could help patients like Anna never make it from the lab to the medicine cabinet. To prevent the FDA from blocking medical progress and innovation, the new commissioner must reform and modernize the review process so 21st-century science can be turned into valuable new medicines. Despite progress in research, 2008 was a dark year for actually fighting cancer. Only 10 cancer drugs got market approval from the FDA but only three of those were actually new, the rest being approved drugs receiving further approval to treat additional cancers. This mirrors a wider decline: Only 19 new medicines of any kind were approved in 2007, the lowest figure for 24 years. That was a bad blip, but averages are steadily falling. This decline is inversely proportional to the high levels of scientific discovery and investment. Between 1990 and 2007, the private sector tripled research and development budgets to $45 billion. According to Tufts University research, the number of drugs entering clinical development more than doubled between 2000 and 2005, but only 8 percent of these candidates finally won market approval from the FDA, down from 20 percent for the period 1993-97. Something is clearly wrong with the way we regulate drug development. Huge financial and intellectual resources are being poured into one end of the pipeline but very little comes out the other. The FDA’s methods are now almost five decades old and far behind current science. There are also problems with the way the FDA reviews and approves clinical trials. A recent study by Vanderbilt University showed that some cancer trials take more than 800 days before they are even allowed to begin, with more than half of all process steps adding nothing to the assessment. Between 1999 and 2006, the average length of a clinical trial increased by 70 percent but delivered little for patients. As Dr. Vincent DeVita, one of the country’s leading oncologists, wrote in Nature journal in December: “At my own institution I reside on many committees involved in protocol review, and I can say with authority that we are hopelessly over-regulated.” As a result, bringing a new drug to market now takes between 12 and 15 years and costs around $1.2 billion, effectively excluding all but huge companies. This makes it uneconomic to develop new treatments for many less common afflictions such as rare cancers. The increasing regulatory burden now stifles research, forcing it overseas to countries such as China and India. One easy reform for the new leaders at the Department of Health and Human Services and the FDA would be to speed up access to the most promising new therapies when their benefit to a patient outweighs the risk from the disease. Currently, the system considers a drug unsafe and ineffective until the day it is approved, when in reality its effects are known long beforehand. The FDA thus arbitrarily denies terminal patients access to experimental drugs that could extend their lives. As a large, centralized bureaucracy, the FDA should recognize it cannot keep pace with science to the degree necessary to assess new drugs and diagnostics promptly and efficiently. The FDA should therefore restrict itself to what it does best, such as advising on best practice and monitoring new drugs as they become widely used. Actual drug approval must be delegated to those closer to the science and the patients. Well positioned structures such as the National Cancer Institute’s Comprehensive Cancer Centers, at the forefront of research and treatment and with experience of partnership with the FDA on training, could easily take over review and approval of new trial protocols, bringing significant efficiency there. Dr. Hamburg must sweep away bureaucratic inertia and commit herself to bringing the FDA into the 21st century. Reform of drug approval and regulation is not just a dry subject for academics and bureaucrats, nor is it pro- or anti-industry: It is pro-patients — and life or death for many. Scott Riccio is founder and executive director of Accelerate Progress, the nonprofit Center to Accelerate Progress Against Cancer and Other Life-Threatening Diseases.

Press : No more death by red tape

2009-03-26T12:46:17-06:00

An Opinion piece by the Director of Accelerate ProgressThe article can be found in the March 26th editions of the DC and SF Examiners and on their websites at: No more death by red tape (DC Examiner) No more death by red tape (SF Examiner)

Press : Medicare Expands Options for Off-Label Use

2009-02-24T20:58:28-06:00

Oncology News International Story on Medicare's decision to expand sources to support off-label use of new drugsA portion of the quote below, provided to Ron Piana at Oncology News International, was used in this story and can be found here at Medicare Expands Options for Off-Label Use The CMS action has garnered plaudits not only from major cancer organizations but also from watch-dog groups like Accelerate Progress, who view FDA’s ultraconservative drug approval process as a barrier to cancer care for desperately ill people, according to Scott Riccio, Accelerate Progress executive director. Mr. Riccio told Oncology News International that “we believe that expanding the meaningful and effective use of off -label drugs is driven, in part, by appropriate reimbursement from CMS. Appropriate off -label use of cancer drugs will be fostered by more, not less, communication of clear actionable information.” For additional context, the full quote provided read as follows: “Accelerate Progress believes that expanding the meaningful and effective use of off-labels drugs is driven, in part, by appropriate reimbursement from CMS. A great deal of our learning about what drugs work for which patients and which dosing schedule and multi-drug combinations are most effective for each individual takes place after drugs are approved by FDA and available to oncologists. These oncologists are a well-networked group and, as health IT improves, they are increasingly effective at communicating their learnings to colleagues to help quickly inform new treatment paradigms for particular patients or patient groups. Appropriate off-label use that informs improvements in individual patient care will be fostered by more, not less, communication of clear, truthful, and actionable information. Our analysis of the entire drug-to-patient system indicates that accelerating this post-approval learning while enhancing the IT infrastructure and tissue-banking initiatives necessary to support sharing of learning and communication of both safety and efficacy data is one key component of driving meaningful progress to patients more quickly and effectively. This important step, however, is limited in its effectiveness by the number of safe and effective options available to oncologists for use which means that we also need to be addressing the poor output (the so-called “Valley of Death") from the development and regulatory pipeline that delivers such limited options to oncologists.”

Press : Speeding Up Translation of New Cancer Therapeutics

2009-01-26T13:47:59-06:00

Dr. Phil Schein, Chief Scientific Advisor, and Scott Riccio, Executive Director, are interviewed for "Future Medicine" segment on ReachMDProgram Description Translation for cancer therapeutics is taking too long and costing too much, according to Dr. Philip Schein, visiting professor in cancer pharmacology at the University of Oxford in England and leading international authority in the treatment of cancer. How can we improve in the future? Join host Dr. Bruce Bloom’s conversation with Dr. Schein and Scott Riccio, founder and director for Accelerate Progress, a not-for-profit “action-tank” focused on bringing new promising and potentially lifesaving therapies to cancer patients, about why and how we should truncate the lengthy approval process and decrease the costs of bringing new therapeutics to market. Series Focus on Future Medicine and Genetics Guests Scott Riccio Phil Schein, MD Hosted by Bruce Bloom, DDS, JD Listen to the Podcast here at ReachMD’s site

Blog : What if Santa Got Cancer?

2009-01-14T21:23:03-06:00

A recent Letter To The Editor published in the Cedar Creek Pilot, a Texas newspaperThis ran as two Letters to the Editor in the Cedar Creek Pilot on January 13, 2009. http://www.cedarcreekpilot.com/letters/local_story_013145354.html http://www.cedarcreekpilot.com/letters/local_story_013145215.html What if Santa got cancer? By Scott Riccio Executive Director Accelerate Progress “What if Santa got cancer?” Now, of course, I don’t mean the Santa, that magical jolly old soul who’s been delivering cheer to children around the world since long before I was born and will assuredly be doing so long after I’m gone, thanks to some very powerful old magic. No, I’m talking about the other Santas, those helpers of the Big Man himself, who dutifully chip in to bring some extra good cheer to family, friends, kids at the mall, and a great many patients in the hospital fighting cancer during this time of year. What if those Santas got cancer? In 2008 nearly 1.5 million people in the United States will be newly diagnosed with cancer. Almost one in two men and one in three women will be diagnosed with cancer in their lifetime. The National Institutes of Health estimate overall costs of cancer (including costs of the treatments, costs of hospital care, costs of support and fighting side effects, etc.) in 2007 at a staggering $219.2 billion. The very real costs to a family of losing ‘their’ Santa is not broken out by NIH, but ask anyone who’s lost one and their faces alone will tell how costly it was. Our inefficient systems contribute to development times for these promising and potentially lifesaving new options that regularly exceed twelve years per drug and often require spending of more than $1 billion per drug developed. How many Santas have to die before we recognize that the system must be changed? Bruce Tower, a member of the Board of Directors of Accelerate Progress, is one of those Santas still fighting for his life, and a testament to the strength and impact on others that one man can have. Bruce has spent the last 28 years of his life coaching soccer teams in a small town in Texas. He’s been far more than just a coach, though, as he’s been a mentor and father figure to many of the children he’s inspired, even as he coached through this chemo treatments and other care that often sapped his strength, but never his spirit. “Never give up!! You don’t know what you can do until you’ve tried!!” These have been Bruce’s mottos for his many teams of impressionable youngsters and, it’s safe to say, Bruce has made a lasting impression. Unfortunately, Bruce will need more help against his advanced stage prostate cancer. There has only been one treatment approved for this late stage of prostate cancer in the last 45 years, and this treatment, a chemotherapy, is so harsh that almost half of the eligible men choose not to take it. Now, Bruce was one of the ‘lucky’ ones who got enrolled in a clinical trial of an investigational therapy and received the active drug, the side effects of which were mild flu-like symptoms. Bruce benefited from this treatment and his having gotten it may be a big part of the reason he’s still with us to play Santa again this year and hear his youngest grandchild say, “I yuv you Paw Paw” for the first time. Click here to see Bruce talk about what this therapy has given him and what is denied to 27,000 men this year alone. Unfortunately, because this therapy has not yet made its way through the 12-15 year development, review, and approval maze, (despite the fact that an independent, expert panel of leading scientists determined it was both safe AND effective and voted overwhelmingly to approve it) Bruce is not allowed to receive even a booster shot! Instead, the FDA chose to delay access to the treatment for at least two more years, during which time more than 54,000 men will die. Yes, we lose 27,000 men a year to advanced prostate cancer and more than 475,000 Americans to other cancers each year. We must act now to change the system before any more lives are needlessly lost! Click here to find out how you can help. You can read another story about Bruce and his impact here. Unfortunately, the story is incorrect in one key area. In spite of an overwhelming vote of support from an independent panel of experts, the FDA did not approve the therapy.

Outside Editorials : Framework for Experimental Drug Use in Terminally Ill Patients

2009-01-12T19:46:21-06:00

Medscape Today Article by Roxanne Nelson covering structural issues relating to increasing patient access to experimental drugsMs. Nelson’s recent article starts by framing the debate this way: A terminally ill cancer patient has the right to refuse treatment, but does that same patient have the right to demand access to investigational therapies? That question has spurred emotional debate from both sides of the issue, ranging from advocates who believe that experimental drugs should be made readily available, to those who argue for restrictions. An article in the December 17 issue of JAMA attempts to provide a framework for a workable and effective balance of access and oversight. She follows with a summary of the JAMA piece, quotes from its authors, and some quotes from others working to change (or defend) the system. This quote from our Executive Director follows the table of potential issues and solutions from the JAMA piece: Scott Riccio, executive director of Accelerate Progress, a public charity created to increase the speed and efficiency of the systems that most directly affect patients fighting cancer and other life-threatening diseases, believes that the authors have raised important issues and proposed reasonable solutions. “It is well worth further discussion,” he commented to Medscape Oncology. “I think that the current system should be revamped to speed access to the most promising new therapies by recognizing that our learning about these therapies is not a ‘binary’ event, as it’s essentially now treated. In other words, right now the system essentially says the drug is unsafe and ineffective right up until the point at which it’s approved, when we ‘suddenly’ know it to be safe and effective.” In reality, information is continuously accumulated over time, he added. “When the benefit-to-risk profile of the therapy can be said to have a reasonable likelihood of outweighing the risk to the patient from their disease, the system ought to begin to expand access to the therapy to those patients that fit the analysis, and begin to expand or restrict access as further data emerge.” To be clear, when we speak of “expanding access to the therapy to those patients that fit the analysis...” we mean that at this point, the system should be approving these options for use by those patients and their doctors. We believe that meaningful access would be provided by and should be measured in new therapeutic approvals (be they conditional/provisional, accelerated, or other similarly named constructs). The full article should be read here (opens in new window).

Press : Modernizing Drug Evaluation

2009-01-12T16:21:30-06:00

Dr. Bruce Bloom interviews Dr. Scott Gottlieb, Scientific Advisory Board Member, and Scott Riccio, our Executive DirectorProgram Description While new science continues to evolve the development of drugs and cures, the scientific principals we use to evaluate the drugs is arguably obsolete. Host Dr. Bruce Bloom is joined in this segment by Scott Riccio, founder and director for Accelerate Progress, a not-for-profit “action-tank” focused on bringing new promising and potentially lifesaving therapies to cancer patients, and Dr. Scott Gottlieb, a practicing physician and resident fellow at the American Enterprise Institute (AEI). Listen in to learn how clinical trial models might be changed to better evaluate the success of new drugs that target subsets of the population with certain cancers, and expedite translatable cures. Series Focus on Future Medicine and Genetics Guests Scott Riccio Scott Gottlieb, MD Hosted by Bruce Bloom, DDS, JD Click Here to Listen to the Interview On-Demand or Download the Podcast (Opens in a new window)

Press : Accelerate Progress Remembers the 500,000 Americans Who Died of Cancer in 2008

2009-01-06T14:36:21-06:00

An introduction to the Why, the How, the Who, and the When for Accelerate ProgressClick here to view this press release in your browser. AP_PR_One.pdf

Current Issues : Health 2.0, Patients as Partners

2009-01-05T17:23:56-06:00

Can empowering patients change the nature of drug research and accelerate progress?This story by Catherine Arnst examines some recent efforts to engage patients in the research and development process as active participants as opposed to just data points to be enrolled, followed, and reported on. It’s an intruiging idea, explored by companies like PatientsLikeMe, to create social networking sites to foster information sharing and patient activism in order to potentially accelerate the pace of research and learning about new drugs and treatment regimens. The story can be read here. It is certainly becoming more and more clear that patients want to take charge of their health and play a more active role in identifying and incorporating new treatments and options to match their own personal profiles, both psychological and biological.

Blog : 2008 Year in Review

2009-01-02T02:07:27-06:00

A reflection on the milestones reached by Accelerate Progress in 2008Thank you for your help in accelerating progress in 2008 As I look back at 2008 and our accomplishments at Accelerate Progress, it is important for me to give thanks to all of you who have helped make everything possible. You are our donors, partners, researchers, volunteers, friends, and trusted advisors. You are the passion, the insights, the foundation upon which our progress is forged and I thank you for being an integral part of our organization. This is a difficult review for me to write because I have always focused on the milestones that show direct benefit for patients and you can see those reflected in our 2018 plan which lays out our organization’s purpose and some of our important ‘measurables’ that will drive our goal to improve the rate at which we deliver access to new safe and effective therapeutics for patients fighting cancer and other life-threatening diseases . Unfortunately, 2008 brought precious little in the way of that sort of direct impact. However, we recognize that in order to have the sort of impact we desire on national policy, we need to significantly expand awareness of Accelerate Progress among national policymakers and continue to build our repuation as the leading independent, credible expert body to inform health policy as it relates to cancer and other life-threatening diseases. In that vein, we made important strides in 2008, but be assured, for Accelerate Progress, this is only a necessary means to achieve our goal of systemic reforms and we continue to chomp at the bit for faster progress. I hold myself and our organization accountable for doing more to accelerate progress each day. With that in mind, 2008 was a challenging but productive year for Accelerate Progress. It was challenging because the pace of systemic change remains slow, the barriers to progress remain many, and the opposition to change remains steadfast. It was also challenging as I continue to strive for the day when Accelerate Progress can get the undivided attention from me it so deserves. 2008 was productive for Accelerate Progress because our voice was heard by many more policy leaders than in 2007 and we built upon our position as a leading, independent expert voice for the voiceless, the patients suffering and dying needlessly within an inefficient system. I’ve listed a few of our 2008 accomplishments below, while recognizing that much, much more must be done to create meaningful change and a better system that will more quickly deliver the promising and potentially lifesaving new therapies from our research clinics into the hands of patients and their doctors. Before moving to those, though, I must note that I continue to be blessed with an amazing wife and my perfect partner whose passion and dedication to our family and Accelerate Progress enabled all of the accomplishments listed here (as well as providing the inspiration for our new First Time Visitors page here), so I thank her from the bottom of my heart while also giving thanks to my two beautiful children who bless me with their health and love and share me with Accelerate Progress. Milestones for 2008 included: Holding briefings and policy sessions with staffers of more than 35 members of Congress, both House and Senate, Democrat and Republican Filing for and, in November, ultimately receiving (after almost 8 long months!) our official 501(c)3 recognition from the IRS Participating in a meeting in February with senior members of FDA to help support expanded access to potentially lifesaving new therapies for patients who have exhausted all current options (this meeting included Anna Tomalis’ mother, Liz, and began our brief but inspiring time with Anna referenced in my blog piece here) Presenting as invited speaker at the press conference in April held by Senator Sam Brownback (R-KS) and Congresswoman Dianne Watson (D-CA) to introduce the bi-partisan sponsored Access, Care, Compassion, and Ethics for Seriously Ill Patients Act (the “ACCESS Act”) Launching our “Cause page on Facebook to increase awareness of our efforts and drive expansion of our grassroots support Developing and launching our new website to expand awareness of Accelerate Progress (special thanks to Matt Jurmann of Chromatic Sites for donating so much of his time to this effort!) Recruiting additional world-class leaders in their field to Scientific and Policy Advisory Boards for Accelerate Progress Initiating discussion and holding meeting with senior FDA officials (Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research and Dr. John Jenkins, Director of the Office of New Drugs) to discuss the state of Accelerated Approval and Fast Track iniatives as well as other systemic barriers to faster progress for patients Being approved and activated within Guidestar charity database, exposing our organization to many more potential institutional and individual donors. Also approved as giving option within Schwab’s Donor Advised Fund, the JustGive charity website, iGive’s shopping for charity site, and other related sites After initiating contact with President-Elect Obama’s Health Transition Team, we were requested to provide a written summary document of our recommendations for changes to be reviewed and vetted by the transition team focusing on Health and FDA issues. We provided the document which can be viewed here Creating first “Acceleration Engine” collaboration with research-oriented foundation to help drive faster progress for patients Launching Coalition for Faster Progress and signed on initial Foundation partners Being interviewed, along with our Chief Scientific Advisor Dr. Phil Schein and another of our scientific advisors, Dr. Scott Gottlieb, for the ReachMD radio show on XM Satellite radio, discussing the need for systemic improvements to drive faster progress. I will send out an update when I get an air date for the show Holding one-on-one call with head of Obama Health Transition Team to discuss broad issues and Accelerate Progress’ systemic views, goals, and history Beginning the planning for first community-wide awareness building and fundraising events to be held in 2009 In summary, our takeaway from 2008 is that we are being heard, we are making progress, we are beginning to make a difference by expanding the number of national policymakers who are better informed of the pivotal issues that slow progress. We have brought attention to the lack of transparency throughout the regulatory development and review systems and we have raised awareness of the ongoing critical needs of patients fighting cancer and other life-threatening diseases caused by our inefficient and ineffective systems. We have done all of this on a shoestring budget, bringing fiscal discipline to every effort, effectively using Priceline, Hotwire, and Expedia to minimize travel costs, piggybacking on other meetings when possible, and keeping ad and other spending to minimal levels. Most importantly, we could not have done this without all of you. We expect 2009 to be a transformational year for Accelerate Progress as we move further onto the national policy stage and increase our effectiveness and the strength of our voice for patients through advocacy for better policy and better science. We’ll continue to work to humanize these systems, to remember who the progress is supposed to be for and recognize and bring attention to the failures and consequences of inefficiency. We’ll also continue to be part of the solution, remembering what I was taught as a child, that it’s not appropriate to criticize if you aren’t willing to put the time and effort in to help create a solution and help make it happen. We will put in the time and efort and we will help make it happen. I will be providing our 2009 outlook in a separate email in the next few days. From the bottom of my heart, thank you all. Sincerely, Scott Riccio Executive Director Accelerate Progress

Outside Editorials : “The FDA is Killing Crohn’s Patients” by Gideon J. Sofer

2008-12-30T04:35:57-06:00

A young man's story of his fight for life against Crohn's diseaseGideon’s story describes his experience with a lack of approved options to fight his disease and what he went through in hopes of finding another option to fight for his life. You can read Gideon’s story here at the WSJ (may require subscription)

Current Issues : The Role of Investigational Therapy…

2008-12-23T18:10:00-06:00

An article on the choice, and the chance, to hope, by Dr. Emil J. Freireich and Dr. Razelle KurzrockWhat does it mean to discuss palliative care with a patient instead of searching for additional investigational options? Whose choice should it be to end the search and give up hope? Those questions, and more, are discussed by Drs. Freireich and Kurzrock in this article. From the article: When patients receive hopeless diagnoses, it is important for the physician to discuss palliative care, but it is equally important—and perhaps more so—for the physician to be knowledgeable about, and to discuss frankly and positively with the patient, the options for participating in clinical research at major research centers where new therapies are being developed. [Dr. Freireich] has been a physician involved in caring for cancer patients with diagnoses of terminal illnesses for more than 50 years and has personally cared for hundreds of patients who have had dramatic, life-altering benefits from investigational therapies. [He] has assisted in caring for the first patient with metastatic choriocarcinoma to be treated with high-dose methotrexate, a patient who is still alive today 50 years after her initial diagnosis, and has cared for children with acute lymphoblastic leukemia who, rather than going to palliative care, engaged in clinical trials that have not only benefited them, but have transformed a uniformly fatal illness 70 years ago to one that is now 85% curable. The important point to be made is that one must be cautious in discarding the possibility of investigational therapy. An important note relating to both the individual good and the public good follows: In the case of investigational therapeutics, the patient is willing to participate in a process that offers not only hope for the patient as an individual, but makes a substantial contribution to the body of knowledge that will benefit patients in the future. The full article can be read here.

Tributes : Tributes to Carol Ann Thomas

2008-12-13T02:43:43-06:00

"You Light Up My Life" by Rawley Thomas and fellow Celebrants “You Light Up My Life” A Celebration of Carol Ann Thomas’ Life September 27, 1944 - November 21, 2008 Given November 29 and December 6, 2008 By Rawley Thomas Carol Ann Thomas, 64, of St. Charles, Illinois and formerly of Oskaloosa, died November 21, 2008, in her family room in St. Charles after a brief though courageous battle with brain cancer. She was born September 27, 1944, in Oskaloosa the daughter of Forrest Harrison and Wilma Verle Ver Steegh Fortney. She touched so many people, including me that I am trying to provide you a tiny inkling of her character and her “light.” In Minnesota, she graduated from Montgomery High School in 1962 and Mankato Commercial College in 1964. On May 27, 1978, Carol Ann and I united in marriage in the Little Brown Church at Nashua. I vividly recall the beaming smiles on the faces of my two existing children, John and Alexis, during that marriage day. Before and after our marriage she worked at SuperValu Stores in Hopkins, MN, where we had met. My children would come each weekend to live with Carol Ann and me. I cautioned Carol Ann that they might eventually live with us full time. About two years later, my first wife, Lois, thoughtfully decided that two parents were much better than one to raise her children. Carol Ann easily slipped into that role of full time Mother. As so often seems to happen, Carol Ann became pregnant with Kimberly Ann, shortly after John and Alexis joined us to live. As was her strong character, she insisted on continuing to play softball in the spring – pitching and running the bases, when six months along in her pregnancy – much to the aghast of her fellow players – But I knew that there was little I could do to change her behavior – I could only keep score. She was always her own woman. One month after having Kim, we all moved to St. Charles for me to accept a new job. New child, new house, new school, new city, new job – our family always seemed to adjust to the major milestones in life together. Carol Ann always proved to be the “rock” for our family. Carol Ann loved golf – a sport she never successfully got her reluctant husband to adopt. She did, however, impart her father’s Montgomery greens keeper skill to rotate cutting our lawn in every possible direction. On April 12, 2002, she called to inform me that she would be late coming home. Seems she had to attend a luncheon after golf. She and her golf buddies had had trouble finding her ball on an elevated par three green – until she discovered it in that 17th hole. Despite her extraordinary golf skill, even beginners loved playing with her – as long as they kept a reasonable pace. As Kim finished fifth grade, Carol Ann decided to encourage her to attend private school. Kim chose Fox Valley Lutheran Academy (FVLA) and blossomed for three years of Middle School under the extraordinary teaching of Jan Zimdahl. As Kim became a sophomore, FVLA asked Carol Ann to pick up a freshmen boy, Robert Harston, from Glenwood School for Boys to attend FVLA. The local public school refused to admit Robert. Glenwood boys were supposed to spend the weekend with their families, but Robert’s Mother left him with his week day house parents. So, Kim and Carol Ann volunteered to take Robert on the weekends. I was fine with their decision, but cautioned that this weekend step was most likely to be the first step of many. By early spring, Robert lived with us full time. By the summer, we attended court to obtain custody, where, with Robert’s help, Carol Ann convinced his mother and sister that we only wished to take care of Robert legally, not break any bonds with them. As a side note, 6’4” Robert thought he could beat an old, slow, over-weight, smaller white custodial father at one-on-one basketball. He finally achieved his goal as a senior – about 50% of the time. Carol Ann was so proud of all the children she raised. Eventually, Carol Ann volunteered to work for FVLA as their bookkeeper. She successfully converted from a DOS accounting package to QuickBooks, while offering much help in streamlining many office processes. She always wanted to feel needed and respected for her “common sense” approach to people relationships and associated business processes. Carol Ann joined the Board of Directors of the Elgin Symphony Youth Orchestra (EYSO). Eventually, she became the full time Director of Finance. She always loved music and being with those who shared her love. EYSO honored Carol Ann by dedicating “Sinfonica: the Sound of Latin America” on November 9, 2008. Two days later, she was able to view and listen to the two concert DVDs from her wheel chair at home – what a treat! Three years ago in 2005, during Carol Ann’s first bout with breast cancer, her greatest concern was going to Disneyworld with her two grandchildren, Cassandra and Cody. Her Oncologist, Bob Bayer, thoughtfully adjusted her chemo schedule to accommodate her most important need. Carol Ann drove herself home from EYSO on September 5th with a horrible headache. An MRI confirmed that the breast cancer has spread throughout her brain. She was so very dedicated that she insisted that I drive her to EYSO throughout her illness. She demanded a smooth transition. During the last week, her cancer took away her ability to speak. Despite this, she mustered enough energy to say two sentences. To her mother, she said, “Who drove you here?” Two days later, after giving her water through an eye dropper, she said to me, “Thank You” in her clearest strong voice. I’m sure her “thank you” was both for the water and our life together. So, I pass along from Carol Ann to all of you who have come here today to celebrate the “light” of her life – “Thank You” for being here. Click here to find out how you can help celebrate the light and the life of Carol Ann, honor her memory, and help us to create a better health system and policy for the rest of the Carol Anns out there. Click below for a beautiful set of eulogies to Carol Ann from Rawley and other celebrants of her life; family and friends alike. You_Light_Up_My_Life_-_A_Celebration_of_Carol_Ann_Thomas_Life_12_12_08.doc

Press : We are now Guidestar certified, Schwab DAF approved, and set up on iGive for shoppers

2008-12-12T22:11:29-06:00

See our latest additions and new ways to Accelerate ProgressMore to come, but this now allows potential supporters to find us and do due diligence via the Guidestar.org website. Additionally, now that we have been approved as a qualified organization to receive donations from individuals who have invested in the Schwab Donor-Advised Fund, we have that extra layer of validation to communicate to potential contributors. Do your shopping at iGive and help support Accelerate Progress! iGive brings together a lot of leading retailers, including Amazon, Coldwater Creek, Land’s End, Patagonia, Lane Bryant, Overstock.com, and so many more, and if you shop from their iGive website to these retailers, Accelerate Progress receives a small percentage (from about 2-20%, averages around 3%) of your purchase and you don’t have to do anything special, just shop! Just register at iGive and shop away! Click the link below and it will start you on your way, knowing that Accelerate Progress sent you! http://www.iGive.com/AccelerateProgress

Outside Editorials : “Mr. President-elect, strengthen fight against cancer” by Lance Armstrong

2008-11-20T18:18:43-06:00

A recent commentary piece by Lance Armstrong, cycling champion and founder of LiveStrongThe opener from Lance Armstrong’s recent Commentary piece on CNN is certain to get some attention: Here’s something that should outrage you: Every day, more than 1,500 Americans die of cancer. Our federal government knows how to prevent many of these losses. Tragically, its attention has simply been elsewhere. The rest of his piece and the priorities he lays out as prescriptive advice for the incoming President is here.

Outside Editorials : “FDA Overhaul Overdue” by Henry Miller

2008-11-20T18:13:31-06:00

Dr. Miller, who headed the Food and Drug Administration's Office of Biotechnology from 1989 to 1993, calls for reformDr. Miller precedes his list of desirable qualities of a new FDA commissioner with this entry: The FDA is desperately in need of renewal: It is dysfunctional, suffering from cultural, organizational and management problems that have been exacerbated by congressional mandates and meddling. As a result, drug development by major U.S.-based drug companies is in dire straits, with costs up and regulatory approvals down. Read the rest of Dr. Miller’s piece here.

Press : Press release updates coming soon

2008-09-22T00:43:25-06:00

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