Obama Reverses Bush Policy on Stem Cell Funding
Please read the following story in the San Diego Union-Tribune about the Obama administration removing Federal restrictions on embryonic stem cell research.
Researchers praise lifting of restrictions
By Terri Somers
San Diego Union-Tribune Staff Writer
March 10, 2009
Related news:
From San Diego to Boston, scientists celebrated yesterday when President Barack Obama signed an executive order clearing the way for more federal funding to human embryonic stem cell research, once again elevating scientific research to a national priority.
Obama reversed eight years of federal funding restrictions implemented by President George W. Bush, who was morally opposed to embryonic stem cell research. Many scientists say those restrictions have hampered research that could hold the secret to cures for diseases such as diabetes, Alzheimer's and cancer.
Obama directed the National Institutes of Health to establish rigorous scientific and ethical guidelines for the research. He also pledged renewed support of scientific research, swiping at his predecessor by saying that the nation's scientific policy will now be “based on fact, not ideology.”
On policy decisions from health care to protecting endangered species, experts have complained that the Bush administration squashed scientific data that did not jibe with White House policy.
“Promoting science isn't just about providing resources, it is also about protecting free and open inquiry,” Obama said to a group of scientists and patient advocates who packed the East Room of the White House. “It is about letting scientists like those here today do their jobs, free from manipulation or coercion, and listening to what they tell us, even when it's inconvenient – especially when it's inconvenient.”
Embryonic stem cells are the master cells that give rise to the more than 200 cell types in the body. To separate and grow them, a days-old embryo must be destroyed.
Until now, researchers seeking federal funds had to limit themselves to using 21 stem cell lines created before August 2001, when Bush restricted funding.
Now scientists using cells created after that date can apply for federal grants from the NIH, the biggest source of basic research funding in the country. Obama's stimulus package included an additional $10billion for the NIH, which had not seen its funding increase commensurate with inflation for years.
Robert Klein, who wrote California's Proposition 71 to fund stem cell research and circumvent the federal restrictions, was in the East Room yesterday.
“It was a historic moment for science and Americans,” said Klein, chairman of the California Institute for Regenerative Medicine. “Whether youhave Alzheimer's in the family, or diabetes or cancer, to have the president elevate medical science and his commitment to advance it, and specifically stem cell research, it was tremendously exciting and encouraging and gives great faith in the future to all of our families.”
At a “Free the Stem Cells” breakfast at the home of researcher Jeanne Loring of The Scripps Research Institute, scientists gathered to watch the event and toast Obama. Some were moved to tears, Loring said, because the president's actions validated research to which they have dedicated their careers.
Some scientists, while thrilled with the executive order, think it is mostly incremental because it does not allow federal funds to be used to create new stem cell lines.
A 1996 law, known as the Dickey-Wicker amendment, prohibits the creationof embryos for research purposes, said Evan Snyder, head of the stem cell program at the Burnham Institute for Medical Research. That is important to scientists who want to make stem cell lines that model aparticular disease so that they can study its progression and test therapies, Snyder said.
Congress is now expected to workout the details, including passing laws that guarantee the protection of stem cell research in the future.
Twice during the Bush administration, bipartisan measures were approved to ease the restrictions, but Bush vetoed both bills.
Rep. Diana DeGette, D-Colo., who sponsored the two bills with Rep. Michael Castle, R-Del., said she wants to prevent stem cells from becoming a “ping-pong issue.” DeGette said she thinks the measure now has even more congressional support.
The debate over stem cells has divided the country more along religious lines than political ones, with groups such as the Jewish Council for Public Affairs supporting the research and the Catholic Church opposing it.
“There are a lot of things I can disagree with the president on, but this is not one of them,” said Rep. Brian Bilbray, R-Carlsbad. “If an embryo has already been created but is going to be destroyed, then you want the maximum benefit that can be derived from that loss. That's what hits home to me. Any parent who has lost a child understands how precious life is, but that works both ways,” said Bilbray, whose infantson died from crib death.
But Tony Perkins, president of the conservative Family Research Council, said the order “shows disrespect for the deeply held moral convictions of tens of millions of Americans by compelling taxpayers to fund this deadly experimentation.”
The moral divide over stem cell research for the past eight years has prevented the passage of any national guidelines on the research, including a ban on reproductive cloning. Obama said yesterday that the stem cell policy is designed so that it “never opens the door to the use of cloning for human reproduction.”
While the United States wrangled with morality, governments in the United Kingdom, Sweden, Israel, China and Singapore poured money into the research.
States developed their own patchwork of laws. California voters agreed in 2004 to invest $3 billion of taxpayer money into funding stem cell research over the next decade. California now provides the most government funding of the science worldwide.
That didn't erase bureaucratic hurdles in the laboratory. Research institutes and universities, already strapped for cash, had to buy duplicate sets of equipment and tools. Bush's restrictions meant scientists could not conduct stem cell research using microscopes bought with federal dollars. Stickers were put on equipment in most laboratories to designate what was paid for with federal money.
“It was horribly expensive and a waste of precious taxpayer resources not to beable to use them for research,” said Larry Goldstein, a Howard Hughes Institute researcher at the University of California San Diego.
“Now, the stickers can come off.”
California scientists who had to look abroad for government-supported collaborators will now see more opportunities to partner with colleagues in other states, Klein said.
More research money for stem cell scientists is also bound to fuel more innovation in San Diego's biotechnology community, said Joseph Panetta, who headsBiocom, the local biotechnology industry trade group. As the research in universities and academic institutes begins to bring discoveries, those discoveries will be spun out into companies, Panetta said.
Cash-strapped biotechnology companies also can apply for NIH funding, said E. EdwardBaetge, chief scientific officer at San Diego-based Novocell, which is using stem cells to develop a diabetes therapy. The state stem cell institute now can shift its focus from basic research to helping companies, Klein said.
“There's a huge lack of capital post-basic-discovery,” Klein said. “With (state) grants, we have anopportunity to really move therapies forward.”
The Associated Press contributed to this report.
Please click here to read the story online.
Promise of Stem Cell Research
Lifting restrictions should boost research in San Diego
SAN DIEGO UNION-TRIBUNE EDITORIAL:
March 10, 2009
PresidentBarack Obama's long-expected lifting of federal restrictions on stemcell research was big news in Washington, but in medical researchcenters such as San Diego and the San Francisco Bay Area, it was evenbigger news.
Specifically, Obama's executive orderreverses an August 2001 order by President George W. Bush thatrestricted federal funding to research involving 70 stem cell lines inexistence at that time. Bush's order was an attempt to reach acompromise between those who wanted to prohibit all embryonic stem cellresearch and those who did not want restrictions on the research.
Scientistsconsider embryonic stem cell research the most promising because thosestem cells are believed to have the ability to grow into many differentcells for regenerative medicine. Opponents believe research onembryonic stem cells is immoral because human embryos are killed in theprocess.
Obama's order is expected to have a morefar-reaching impact on California, including San Diego, because thestate and the region have begun to build research infrastructure underProposition 71, which established the California Center forRegenerative Medicine and is providing $3 billion over 10 years forstem cell research.
Four prominent local institutions –UCSD, the Burnham Institute for Medical Research, the Salk Institutefor Biological Studies and The Scripps Research Institute – have formedthe San Diego Stem Cell Consortium. The collaborative organization hasreceived tens of millions in state grants to conduct life-saving workin human embryonic stem cell research.
The consortium hasplanned a $115 million stem cell research center on Torrey Pines Mesa,but the credit crunch, coupled with California's budget crisis, haveprevented the institution from securing the needed loans. Privatecompanies, including Cytori Therapeutics, International Stem CellCorp., Life Technologies (formerly Invitrogen), Novocell and MediStem,also do stem cell research in San Diego.
Under the federalrestrictions, researchers in California and elsewhere were not able touse federal funds for buildings or research equipment. In many labsaround the state, researchers had duplicate equipment, with differentcolor-coded labels. This was expensive and impractical. Now researchersshould be able to use the same buildings and the same equipment forboth state and federally funded research.
Obama's orderdoes not remove all federal restrictions on stem cell research. TheDickey-Wicker ban, first passed in 1996 and renewed each yearafterward, prohibits researchers from creating their own stem celllines with federal money. That will stay in place, at least for thenear future.
Still, with the release of funds from theNational Institutes of Health's $28 billion annual budget and withmoney expected from the economic stimulus package, stem cellresearchers may be able to speed up their potentially life-saving work.
Please click here to read the opinion piece online.
Spotlight on Heart Disease
With this issue of the Biocommunique, BIOCOM will look at member companies with drugs and devices in development to treat heart disease. Following our 2009 "Art of Research" Calendar, each month, we'll look at a new disease and our member companies’ efforts in it, with the information also posted to the "About Southern California" section of our Web site.
For our March disease spotlight, we'll take a look at companies with products and devices in development to treat heart disease. There are more than 30 companies in Southern California addressing this disease. This year about 1.2 million Americans will have a first or recurrent coronary attack. About 452,000 of these people will die. The most common heart condition in the United States is coronary heart disease, which can lead to heart attack and other serious conditions. Coronary heart disease is the nation’s single leading cause of death.
The following companies responded to our request for summaries of their heart disease efforts. If your company not on the list, please email Michelle Wright and we'll update you on our site. And please contact us if your company is doing anything in multiple sclerosis, which will be our next diseaseindication.
Special thanks to Mentus Life Science for helping produce this report. Please visit www.mentus.com for more information.
Southern California life science companies working in heart disease include:
Accumetrics, Acon Labs, ActiveSight, Arena Pharmaceuticals, AvivaBio, BeneChill, Biosite, BioVascular, BioTechPlex Corp. Celladon, Cytori Therapeutics, CytRx, Digirad, Epitope Diagnostics, Isis Pharmaceuticals, Kalypsys, Lpath, Nanogen, Micell Technologies, Phillips Respironics, Protein Polymer Technologies, Orexigen Therapeutics, ResMed, Reva Medical, Sangart, TargeGen, Theregen and Volcano Corp.
Accumetrics works to advance medical understanding of platelet response and enhancing quality of care for patients receiving antiplatelet therapies by providing industry-leading and widely accessible diagnostic tests for rapid platelet function assessment. The VerifyNow System is the first, simple and accurate system for measuring the individual response to multiple antiplatelet agents, the company says.
ACON Laboratories, Inc. provides a broad range of high quality and competitively priced lateral flow rapid diagnostic tests. The five key groups in our rapid test product line are: Fertility, Infectious Diseases, Drugs of Abuse, Tumor Markers and Cardiac Markers available for sale in Asia, Middle East, Africa, Russia and Latin America.
Arena Pharmaceuticals is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Its lead anti-thrombotic drug candidate, APD791, has completed Phase 1a and Phase 1b clinical trials.
AvivaBio develops enabling drug discovery and development technologies by combining biochips with cell biology. Medicinal chemists and toxicologists using the Aviva service can efficiently test compounds for potential cardiac liability. Aviva's screening services can efficiently support medicinal chemistry programs by testing hundreds of molecules per week.
BeneChill is developing novel cooling technologies to improve patient outcome safter acute ischemic events such as cardiac arrest, stroke, and traumatic brain injury. The RhinoChill System is a battery-operated, non-invasive, portable, and easy-to-use medical device for rapid therapeutic patient cooling.
Biosite is a leading provider of rapid diagnostics products and antibody development technologies. Biosite makes a range of diagnostic tests to identify and aid in the diagnosis of heart attacks and diagnose the severity assessment of heart failure.
BioVascular works to develop and commercialize novel cardiovascular therapeuticsfor significant unmet medical needs. BioVascular's lead product, saratin, is a polypeptide produced by recombinant means in yeast. This product was licensed from Merck, KGaA in 2005.
BioTechPlex provides enabling products for the discovery and development of respiratory and cardiac drugs as well as the evaluation of respiratory, cardiac and autonomic function. CardioDataPad differentiates itself by providing physiologically relevant moment-by-moment time-frequency spectral analysis of ECG signals along with their non-linear chaotic behavior with numerics and graphics updated every 30 seconds.
Celladon is a privately held biotechnology company founded with the goal of becoming the leader in developing molecular therapies for the treatment of heart failure. Our products target the key enzyme deficiency in advanced heart failure, SERCA2a, which regulates calcium cycling and contractility in heart muscle cells. Our first product candidate, Mydicar, delivers the gene for the SERCA2a enzyme and is currently being tested in Phase 1 and 2 clinical trials.
Cytori Therapeutics goal is to be the global leader in regenerative medicine. The companyis dedicated to providing patients with new options for reconstructive surgery, developing treatments for cardiovascular disease, and banking patients' adult stem and regenerative cells. Adipose-derived stem and regenerative cells (ADRCs) may be ideally suited for treatment of heart attacks, an acute condition, and coronary artery disease, a chronic condition.
CytRx Corporation is a biopharmaceutical research and development company engaged indeveloping high-value human therapeutic products based upon its small-molecule molecular “chaperone” regbulation technology. Iroxanadine is an orally available molecular chaperone amplifier currently being developed to repair damage to end othelial cells that line the interior of blood vessels.
Digirad provides medical diagnostic imaging systems and personnel and equipment leasing services to physicians' offices, hospitals and imaging centers for cardiac, vascular, and general imaging applications. Digirad’s new Cardius 3 XPO imaging system is the only dedicated camera for nuclear cardiology SPECT applications to feature three detectors.
Epitope Diagnostics Inc. develops, manufactures and markets innovative rapid tests and niche ELISA kits for the worldwide diagnostic community.
Isis Pharmaceuticals, Inc. is a leading drug discovery and development company, focused exclusively on the therapeutic target, RNA. Isis' drug development programs are focused on treating cardiovascular and metabolic diseases.
Kalypsys is a San Diego based biopharmaceutical company with clinical stage pharmaceutical products. Central to our pipeline expansion is epiK – a proprietary and highly automated small molecule drug discovery platform. Our rapidly advancing pipeline is focused on two therapeutic areas that target some of the world’s most widespread diseases and unmet medical needs: pain/inflammation and metabolic disease.
Lpath, Inc., headquartered in San Diego, California, works inbioactive-lipid-targeted therapeutics, an emerging field of medical science whereby bioactive signaling lipids are targeted for treating important human diseases.
Nanogen has developed a strong product and proprietary technology base inadvanced diagnostic solutions for two of the fastest growing in vitro diagnostic (IVD) markets – molecular diagnostics and rapidpoint-of-care testing. Its Point-of-Care Diagnostics Division has developed a rapid quantitative test for NT-proBNP as an aid in diagnosis of Congestive Heart Failure (CHF).
Micell Technologies, Inc.,a privately-held, early-stage biomedical company dedicated to advancing combination product therapies in the cardiovascular, orthopedic, and drug-delivery areas. Its Supercritical Fluid Technology consists of patented processes and methods for surface modifications of medical devices with specific focus on improvements to current polymerbased drug-eluting technologies.
Minnow Medical, Inc., headquartered in San Diego, California, develops products to treat artery disease throughout the body, including the heart, leg, neck and head. The Minnow Medical Peripheral Vascular System uses a unique catheter and a energy generator to open stenoses and reduces plaque deposits during a brief endovascular procedure.
Philips Respironics is the leading provider of innovative solutions for the global sleepand respiratory markets. Respironics is organized into three primary groups: the Sleep and Home Respiratory Group, the Hospital Group, and the International Group.
Protein Polymer Technologies, Inc. is a biotechnology company that discovers and develops innovative therapeutic devices to improve medical and surgical outcomes. The Company focuses on developing technology and products to be used for soft tissue augmentation, tissue adhesives and sealants, wound healing support and drug delivery devices.
Orexigen Therapeutics, Inc.is a biopharmaceutical company focused on the treatment of obesity. The Company's lead combination product candidates targeted for obesity are Contrave, which is in Phase 3 clinical trials, and Empatic™, which is in the later stages of Phase 2 clinical development.
ResMed is a leading developer, manufacturer and marketer of products for the screening, treatment and long-term management of sleep-disorderedbreathing (SDB) and other respiratory disorders.
REVA Medical, Inc. is a private medical device company developing a bioresorbable drug-eluting stent to treat coronary artery disease.
Sangart, Inc. is a privately held biopharmaceutical company focused on being the global scientific, clinical and commercial leader in oxygen-therapeuticagents, providing innovative products to patients in need. Sangart’s lead product, MP4OX, is designed to effectively target oxygen delivery to tissues that are insufficiently oxygenated.
TargeGen, Inc. is a privately held vascular biology-focused biopharmaceutical company based in San Diego, CA. TargeGen primarily develops small moleculekinase inhibitors that target vascular leakage (edema), vascular proliferation (angiogenesis) and inflammation.
Theregen, Inc. is a regenerative medicine company that is developing cell-based therapies for cardiovascular indications. Anginera, Theregen's lead product, is an epicardial patch designed to improve cardiac function in patients.
Volcano Corporation develops, manufactures and commercializes a broad suite of devices designed to facilitate endovascular procedures, enhance the diagnosis of vascular and structural heart disease and guide optimal therapies. The company's intravascular ultrasound (IVUS) product line includes ultrasound consoles that can be Integrated directly intovirtually any modern cath lab and single use disposable imaging catheters unique to our system.