Archive for the ‘Cell Medicine’ Category

14-02-2012 08:13 STEM CELLS The dance of life Recent developments in regenerative medicine and modern biology are going to have an enormous impact on our lives. Also the way itself we face the problem of sickness, aging and death changes as the hope (or the illusion?) grows that we always can fight and delay them. Stem cell research is in fact changing our knowledge of the fundamental mechanisms of life and feeding the idea that we can increasingly contrast the cruel natural selection rules which make us fall ill, grow old and die. A new frontier opens and unpredictable changes in our culture are taking place. People's hopes and fears grow at the same time. The general properties of the stem cells is presented, namely the ability to proliferate and, under certain conditions, to differentiate in other types of cells. In this way they can generate a new tissue replacing a damaged one, and also a new organ (like blood, thrachea, liver, heart, skin, cornea and very recently retina). A stamp is shown, which was emitted by the Japanese government to celebrate the discovery of a university team, which was able to regenerate a cornea and giving the opportunity to a patient to see again. Then the innovative results is presented in applications of the stem cells to orthopedy, muscular dystrophy, cardiology and dentistry. Finally the etherogeneus perspectives is presented offered by stem cell research to treat degenerative disorders, like Alzheimer, Parkinson diseases and Multiple Sclerosis. www ...

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Stem cells - ISWA project - Video

SUNRISE, Fla., Feb. 14, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (BHRT.OB) announced today that it has acquired the worldwide exclusive rights to Ageless Regenerative Institute's adipose (fat) derived therapeutic cell technology for use in the cardiac field.

"The Ageless adipose stem cell technology will allow us to broaden our portfolio of product candidates for cardiac patients," said Mike Tomas, President and CEO of Bioheart. "We have successfully treated patients in Mexico and now we are ready to expand into the US."

Adipose tissue is readily available and has been shown to be rich in microvascular, myogenic and angiogenic cells. Bioheart has recently applied to the FDA to begin trials using adipose derived stem cells or LipiCell(TM) in patients with chronic ischemic cardiomyopathy. Transplantation of LipiCell(TM) will be accomplished through endocardial implantations with the MyoStar(TM) Injection Catheter under the guidance of the NOGA(R) cardiac navigation system by Biosense Webster, Inc. -- A Johnson & Johnson Company.

Under the terms of the agreement, Bioheart will have a worldwide exclusive license to all of Ageless technology for use in the heart attack and heart failure markets. The agreement provides for upfront and milestone equity payments to Ageless.

Ageless' President and Chief Executive Officer, Dr. Sharon McQuillan, MD added, "We are excited about this collaboration with Bioheart, a leader in developing cell therapies for cardiovascular disease. Together with Bioheart, we can help to revolutionize cardiovascular medicine and improve the current standard of care for these patients."

About Bioheart, Inc.

Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients.

For more information on Bioheart, visit http://www.bioheartinc.com.

About Ageless Regenerative Institute, LLC

The Ageless Regenerative Institute (ARI) is an organization dedicated to the standardization of cell regenerative medicine. The Institute promotes the development of evidence-based standards of excellence in the therapeutic use of adipose-derived stem cells through education, advocacy, and research. ARI has a highly experienced management team with experience in setting up full scale cGMP stem cell manufacturing facilities, stem cell product development & enhancement, developing point-of-care cell production systems, developing culture expanded stem cell production systems, FDA compliance, directing clinical & preclinical studies with multiple cell types for multiple indications, and more. ARI has successfully treated hundreds of patients utilizing these cellular therapies demonstrating both safety and efficacy. For more information about regenerative medicine please visit http://www.agelessregen.com.

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.

Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management's beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

The Company is subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled "Risk Factors" in its Annual Report on Form 10-K for the year ended December 31, 2010, and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2011.

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Bioheart Acquires Exclusive Rights to Ageless Regenerative Institute's Adipose Cell Technology

13-02-2012 12:31 Sridhar Ramaswamy, MD, Tucker Gosnell Investigator and Associate Professor of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Broad Institute of Harvard and MIT, and Harvard Stem Cell Institute, discusses ongoing research into drug tolerance and resistance, specifically the roll of dormant cancer cells. If a tumor goes into remission as a result of a cancer drug and then recurs it is likely that the tumor will still respond to the initial treatment. In the dormant state the cells are resistance, in the original they are sensitive. The exact mechanism behind this has yet to be discovered. In some cases giving a course, stopping, and then continuing later on can create an additive effect, an idea that Ramaswamy calls a drug holiday. A comparison is underway between drug and non-drug induced dormant cells in order to find the mechanism that causes resistance. The ultimate goal of the research is to be able to predict and stop drug resistance.

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Dr. Ramaswamy on Dormant Tumor Cells and Resistance - Video

JERUSALEM--(BUSINESS WIRE)--

Gamida Cell announced today that the Gamida Cell-Teva Joint Venture (JV), equally held by Gamida Cell and Teva Pharmaceutical Industries, has enrolled the last of 100 patients in the international, multi-center, pivotal registration, Phase III clinical trial of StemEx, a cell therapy product in development as an alternative therapeutic treatment for adolescents and adults, with blood cancers such as leukemia and lymphoma, who cannot find a family related, matched bone marrow donor.

StemEx is a graft of an expanded population of stem/progenitor cells, derived from part of a single unit of umbilical cord blood and transplanted by IV administration along with the remaining, non-manipulated cells from the same unit.

Dr. Yael Margolin, president and chief executive officer of Gamida Cell, said, "The JV is planning to announce the safety and efficacy results of the Phase III StemEx trial in 2012 and to launch the product into the market in 2013. It is our hope that StemEx will provide the answer for the thousands of leukemia and lymphoma patients unable to find a matched, related bone marrow donor.”

Dr. Margolin continued, “StemEx may be the first allogeneic cell therapy to be brought to market. This is a source of pride for Gamida Cell, as it further confirms the company’s leadership as a pioneer in cell therapy. In addition to StemEx, Gamida Cell is developing a diverse pipeline of products for the treatment of cancer, hematological diseases such as sickle cell disease and thalassemia, as well as autoimmune and metabolic diseases and conditions helped by regenerative medicine.”

About Gamida Cell

Gamida Cell is a world leader in stem cell population expansion technologies and stem cell therapy products for transplantation and regenerative medicine. The company’s pipeline of stem cell therapy products are in development to treat a wide range of conditions including blood cancers such as leukemia and lymphoma, solid tumors, non-malignant hematological diseases such as hemoglobinopathies, acute radiation syndrome, autoimmune diseases and metabolic diseases as well as conditions that can be helped by regenerative medicine. Gamida Cell’s therapeutic candidates contain populations of adult stem cells, selected from non-controversial sources such as umbilical cord blood, which are expanded in culture. Gamida Cell was successful in translating these proprietary expansion technologies into robust and validated manufacturing processes under GMP. Gamida Cell’s current shareholders include: Elbit Imaging, Clal Biotechnology Industries, Israel Healthcare Venture, Teva Pharmaceutical Industries, Amgen, Denali Ventures and Auriga Ventures. For more information, please visit: http://www.gamida-cell.com.

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The Gamida Cell-Teva Joint Venture Concludes Enrollment for the Phase III Study of StemEx®, a Cord Blood Stem Cell ...

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today the dosing of third patient in its Phase 1/2 trial for Stargardt’s macular dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The patient was treated on Monday (Feb. 6) by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA) and retina division chief at UCLA’s Jules Stein Eye Institute. The outpatient transplantation surgery was performed successfully and the patient is recovering uneventfully.

“With the treatment of this third Stargardt’s patient at Jules Stein Eye Institute, we have now completed the treatment of the first cohort of patients under our clinical protocol for phase I/II of our U.S. SMD trial,” said Gary Rabin, chairman and chief executive officer of ACT. “We will continue to regularly monitor the three SMD patients in this trial, and by early spring anticipate review of their progress and safety-related data by the Data and Safety Monitoring Board (DSMB). With approval of the DSMB, we would then advance to the next cohort of patients and administer a higher dosage of RPE cells. In the context of all three trials we have running, this patient is the fifth person worldwide to be treated with our hESC-derived RPE cells. To date, there have been no complications or side effects due to the RPE cells, and we remain cautiously optimistic that our ongoing clinical programs will demonstrate the safety and tolerability of ACT’s stem cell-derived RPE cells.”

Each of the three clinical trials being undertaken by the company in the U.S. and Europe will enroll 12 patients, with cohorts of three patients each in an ascending dosage format. These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with SMD or dry age-related macular degeneration (dry AMD) at 12 months, the study’s primary endpoint. Preliminary results relating to both early safety and biological function for the first two patients in the United States, one SMD patient and one dry AMD patient, were recently reported in The Lancet. On January 20, 2012, the first SMD patient to be enrolled in the Company’s U.K. clinical trial was treated at Moorfields Eye Hospital in London.

Further information about patient eligibility for the SMD study and the concurrent study on dry AMD is also available on www.clinicaltrials.gov; ClinicalTrials.gov Identifiers: NCT01345006 and NCT01344993.

About Stargardt's Disease

Stargardt’s disease or Stargardt’s Macular Dystrophy is a genetic disease that causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium, which is the site of damage that the company believes the hESC-derived RPE may be able to target for repair after administration.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the company’s periodic reports, including the report on Form 10-K for the year ended December 31, 2010. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Company’s clinical trials will be successful.

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ACT Announces Third Patient with Stargardt’s Disease Treated in U.S. Clinical Trial with RPE Cells Derived from ...

GAITHERSBURG, MD--(Marketwire -02/08/12)- Cytomedix, Inc. (OTC.BB: CMXI.OB - News) (the "Company"), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, announces the completion of the acquisition of Aldagen, Inc., a privately-held biopharmaceutical company developing regenerative cell therapies based on its proprietary ALDH bright cell ("ALDHbr") technology. Under the terms of the transaction as described below, Cytomedix issued preferred shares valued at $16 million based on a 10-day volume-weighted average price ("VWAP") calculated through February 2, 2012. Cytomedix will issue additional consideration to be paid in common stock upon the successful attainment of several clinical milestones. As part of the transaction, certain Aldagen investors purchased $5.0 million of Cytomedix common stock in a private placement concurrent with the closing of this acquisition.

Martin P. Rosendale, Chief Executive Officer of Cytomedix, commented, "Since joining Cytomedix as chief executive in 2008, our strategy has evolved, but the vision to transform the Company from a wound-care based technology platform into a broader regenerative medicine company has remained constant. In pursuit of this vision, we started with the successful 2010 acquisition and integration of the Angel System, a unique, best-in-class PRP platform technology that has allowed us to grow from nominal sales to $6 million per year in just over 18 months.

"This strategic acquisition of Aldagen provides Cytomedix with a novel, patent-protected cell selection technology that fits well with our existing commercial products and strengthens our long-range growth profile," he continued. "In combination, we now touch the three pillars of regenerative medicine with autologous stem cells, platelet-derived signal molecules and plasma scaffolds," he added. "We view the acquisition of Aldagen as an opportunistic transaction at an attractive valuation that will allow us to build and expand our new product development efforts with Aldagen's technology, intellectual property, people and clinical expertise. In terms of maximizing opportunity for our shareholders while managing and mitigating risk, we feel this transaction is very advantageous."

Commenting on the acquisition, Richard Kent, M.D., Chairman of the Board of Aldagen and a Partner with Intersouth Partners, Aldagen's largest shareholder, said, "We are delighted to join forces with Cytomedix as this alignment unites commercial products with a growing revenue stream with a deep pipeline of clinical opportunities. We believe these autologous technologies are complementary and hold potential to produce more therapeutics than either one could on its own. The commitment of additional capital into Cytomedix by certain Aldagen investors underscores our confidence in the very promising potential for the combination of these regenerative technologies to change how we treat a variety of large disease areas with continued unmet medical need."

Transaction Terms

At the closing, Cytomedix issued 135,398 newly designated Cytomedix Series E preferred shares to Aldagen shareholders. Pro forma for the conversion of these shares to common stock, as set forth in the designations documents for the Series E preferred stock, Aldagen shareholders will own approximately 17.3% of Cytomedix common shares outstanding after the concurrent conversion and/or redemption of all existing Cytomedix preferred shares.

There are also contingent clinical milestone payments totaling up to 20,309,723 shares, which will be issued to Aldagen shareholders upon the achievement of predetermined clinical milestones associated with an ongoing Aldagen Phase 2 trial in post-acute ischemic stroke. Notably, 80% of this contingent consideration is issuable only upon a favorable clinical efficacy signal in the above-mentioned trial. The costs of the clinical trial will be funded, in part, by the $5.0 million investment made by Aldagen shareholders, $3.0 million in proceeds from completed or committed warrant exercises by existing Cytomedix shareholders, as well as a portion of Cytomedix' cash on hand. All upfront and contingent consideration shares are subject to lockup restrictions ranging from six to 18 months.

As part of the transaction, as of the closing date three Aldagen Board members have joined the Cytomedix Board, which has been expanded to nine seats. They are Richard Kent, M.D., Chairman of the Board of Aldagen; Lyle Hohnke, Ph.D., Aldagen's former CEO; and Joseph Del Guercio, Managing Director of CNF Investments and a current Board Observer for Aldagen. Concurrent with these additions, Craig Mendelsohn has stepped down from the Cytomedix Board.

In addition, Edward L. Field, Aldagen's Chief Operating Officer, has been appointed as Chief Operating Officer of Cytomedix.

Aldagen is now a wholly-owned subsidiary of Cytomedix and will retain manufacturing and product development facilities in Durham, N.C.

For additional information about this transaction, please refer to the Company's Report on Form 8-K, filed with the Securities and Exchange Commission on or about February 8, 2012.

About Aldagen

Aldagen is a clinical-stage biopharmaceutical company developing patent-protected autologous cell-based therapeutics for tissue repair and regeneration. Aldagen's clinical development efforts are led by a team of leading researchers and experienced clinicians. All product candidates target conditions with significant unmet medical needs. Aldagen has a deep product pipeline and data generated in a number of disease states including:

ALD-301 for the treatment of peripheral arterial disease ("PAD") and critical limb ischemia ("CLI") ALD-201 for the treatment of ischemic heart failure ALD-401 for the treatment of ischemic stroke

Safety has been demonstrated in more than 70 patient treatments across all clinical trials of ALDHbr cells and positive study results in CLI and cardiac ischemia have been published and presented at major medical meetings. A growing body of scientific data validates Aldagen's proprietary technology, including approximately 250 peer-reviewed publications and presentations. Aldagen has the only stem cell selection technology utilizing an intracellular enzyme marker to fractionate essential regenerative cells from bone marrow.

Aldagen's proprietary bone marrow fractionation process identifies and isolates metabolically active cells expressing high levels of the enzyme aldehyde dehydrogenase, or ALDH, which is a key enzyme involved in the regulation of gene activities associated with cell proliferation and differentiation. The selected biologically instructive cells, ALDHbr cells, have the potential to promote the repair and regeneration of multiple types of cells and tissues, including the growth of new blood vessels, which is critical to the generation of healthy tissue. Preclinical research suggests that ALDHbr cells specifically migrate to sites of ischemic damage and induce the formation of new blood vessels at those sites. In human clinical trials utilizing ALDHbr cells, evidence of improved perfusion in ischemic tissue has been observed. Other stem cell therapies require expansion of cells that increase manufacturing and regulatory risk, increase processing costs and may delay treatment of the patient up to several weeks. Aldagen produces well-characterized cell populations with a high level of purity without the need for these additional steps, thereby enabling a rapid turnaround time -- typically 36 hours once the bone marrow is received.

Opus National Capital Markets served as financial advisor and Cozen O'Connor served as legal counsel to Cytomedix on the acquisition. The Merchant Banking Group of Burrill & Company served as financial advisor and Hutchison Law Group served as legal counsel to Aldagen, Inc. on the transaction.

Conference Call

Cytomedix and Aldagen management will hold a conference call to discuss the acquisition and to answer questions beginning at 10:00 a.m. Eastern time on Thursday, February 9, 2012. Shareholders and other interested parties may participate in the call by dialing 888-713-4214 (domestic) or 617-213-4866 (international) and entering passcode 15132911. The call will also be broadcast live on the Internet at http://www.streetevents.com, http://www.fulldisclosure.com and http://www.cytomedix.com. A slide presentation will accompany the conference call and will be posted at 8:00 a.m. Eastern time on Thursday, February 9, 2012, to the home page of the Company's website at http://www.cytomedix.com.

A replay of the conference call will be available beginning two hours after its completion through February 16, 2012, by dialing 888-286-8010 (domestic) or 617-801-6888 (international) and entering passcode 48593244. The call will also be archived for 90 days at http://www.streetevents.com, http://www.fulldisclosure.com and http://www.cytomedix.com.

About Cytomedix, Inc.

Cytomedix develops, sells and licenses regenerative biological therapies primarily for wound care, inflammation and angiogenesis. The Company markets the AutoloGel™ System, a device for the production of autologous platelet rich plasma ("PRP") gel for use on a variety of exuding wounds; the Angel® Whole Blood Separation System, a blood processing device and disposable products used for the separation of whole blood into red cells, platelet poor plasma ("PPP") and PRP in surgical settings; and the activAT® Autologous Thrombin Processing Kit, which produces autologous thrombin serum from PPP. The activAT® kit is sold exclusively in Europe and Canada, where it provides a completely autologous, safe alternative to bovine-derived products. The Company is pursuing a multi-faceted strategy to penetrate the chronic wound market with its products, as well as opportunities for the application of AutoloGel™ and PRP technology into other markets such as hair transplantation and orthopedics while actively seeking complementary products for the wound care market. Additional information regarding Cytomedix is available at http://www.cytomedix.com.

Safe Harbor Statement
Statements contained in this communication not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix' actual results may differ materially due to a number of factors, many of which are beyond Cytomedix' ability to predict or control, including many among others, risks and uncertainties related to the Company's ability to successfully integrate this acquisition, to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company's sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel™ System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as "believes", "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2010, filed with the SEC and other subsequent filings. These filings are available at http://www.sec.gov.

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Cytomedix Expands Commitment to Regenerative Medicine With Acquisition of Aldagen

06-02-2012 16:47 Salk scientists use an old theory to discover new targets in the fight against breast cancer Similarities between genetic signatures in developing organs and breast cancer could predict and personalize cancer therapies Reviving a theory first proposed in the late 1800s that the development of organs in the normal embryo and the development of cancers are related, scientists at the Salk Institute for Biological Studies have studied organ development in mice to unravel how breast cancers, and perhaps other cancers, develop in people. Their findings provide new ways to predict and personalize the diagnosis and treatment of cancer. In a paper published February 3 in Cell Stem Cell, the scientists report striking similarities between genetic signatures found in certain types of human breast cancer and those of stem cells in breast tissue in mouse embryos. These findings suggest that cancer cells subvert key genetic programs that guide immature cells to build organs during normal growth. "Stem cells in a healthy developing embryo have a GPS system to alert them about their position in the organ," says Geoffrey Wahl, a professor in Salk's Gene Expression Laboratory, who led the research. "The system depends on internal instructions and external signals from the environment to tell the stem cell what to do and where to go in the body. It stimulates the stem cells to grow and form more stem cells, or to change into different cells that form complex organs, such as the breast. Our ...

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Stem Cell Study Finds New Treatments For Breast Cancer - Video

08-02-2012 23:17 NicholasAnderson.info Nicholas Anderson, Author of "NOC British Secret Operations" interviewed by Joseph Dowdy. stem cell transplantation... can't say diseases to get hopes up. oversaw exfiltration of doctor who is an expert at stem cell transplantation. not an expert or doctor, but can speak from experience. much of this may bother others. there is an assumption one belief is correct and others are wrong. stem cells are human and animal organisms derived from embryos. they can renew themselves in others bodys/cells/tissues. they are not factory assembled. they are coming from aborted tissue that would be thrown away. in the soviet union, they experimented on them. again, author does not know all about stem cells. speak to your doctor and do your own research. for most basic info on the doctor from the soviet union, see the book. was this post cold war debriefing? was he a scientist who knew a lot? no. he defected in mid-70s. the west/us/uk milked him for info. they did nothing with that info. he returned to the new russia after the collapse and started again. what has he been doing since? is the russian medicine better?? yes, it's more advanced or the west has simply got their advancements from russia. this is like a replacement battery for tissue/cells/body; it must be recharged. it does offer terminally ill chance to live longer; not a medical diagnosis. if people know enough about stem cells, they probably know what it is... it's good for regenerating tissue without ...

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Insights Into MI6: Stem Cell Transplantation - Video

09-02-2012 16:10 Dr. Madan Jagasia, hematology and stem cell transplant section chief at Vanderbilt-Ingram Cancer Center, describes the stem cell transplant process. He explains the various parties involved in treatment and decision-making. Learn more about our Blood and Marrow Transplant Program: http://www.vanderbilthealth.com

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Stem Cell Transplants - Video

09-02-2012 15:59 Sherry Ray, community nurse practitioner, shares her experience of being a caregiver to her husband during his stem cell transplant. She describes the quality of care her husband received. Learn more about our Blood and Marrow Transplant Program: http://www.vanderbilthealth.com

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Stem Cell Transplant Patient Care: A Caregiver's Point of View - Video

09-02-2012 15:56 Sonny Ray shares his experience about Vanderbilt-Ingram Cancer Center's Blood and Marrow Transplant Program. Learn more about our Blood and Marrow Transplant Program: http://www.vanderbilthealth.com

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Stem Cell Transplant: Sonny's Story - Video

01-02-2012 13:37 Meet founders of Cord Blood Registry, Tom and Wendy. Hear why they started CBR -- a family business dedicated to helping people live healthier lives through cord blood stem cell medicine. Today, CBR has grown, but the attention to healthy families is the same. For more than 15 years, Cord Blood Registry has led the umbilical cord banking industry in technical innovations and provided families with peace of mind and hope. CBR's experience and dedication to quality has enabled CBR to help more clients use their cord blood stem cells in treatments than any other family bank. Our research and development efforts are focused on helping leading clinical researchers advance stem cell regenerative medicine that may help families in the future. Ultimate use of cord blood stem cells will be determined by the treating physician who will consider if they are applicable for the condition and should come from the patient or a suitable donor (like an HLA matched sibling). There is no guarantee that treatments being studied in the laboratory or in clinical trials will be available in the future. CBR is the preferred choice of OB/Gyns. © 2011 Cord Blood Registry. All rights reserved. Privacy Policy.

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Meet the Founders of Cord Blood Registry - Video

01-02-2012 21:36 Notes from the interview: Nicholas Anderson - Author, NOC: British Secret Operations Big Pharma... must be careful in discussing reason for writing books is in part because of something along these lines medical doctor helped to exfiltrate from soviet union end of 1991 doctor wanted to meet... nicholas anderson flew to meet in moscow... bottom line: he claimed to have number of effective treatments and cures... MIND YOU... he's not trying to get your hopes up, but you should look into alternate treatments natural remedies. stem cell, energetic medicine is more detail in the book? when the book was written, it was non-fiction. but it didn't last to be a non-fiction novel. former secret operations must be cleared. large majority that was redacted or cleared from the fiction novel was about big pharma. certain things -are- in the book. also know that nicholas anderson was skeptical about these items first. even so, he wondered why aren't these alternative cures more widely known? the doctor appeared on a primetime show and the media prevented him from saying what he wanted to say... in a couple examples, they removed things he had said. they said the -opposite- of what he actually said. it was then that he realized he was on to something and he saw that happening. did this doctor have access to this medicine in the soviet union or was it secretive? in the beginning of communism, they did come up with things in medicine that the west never did come up with. this doctor had ...

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Insights Into MI6: Big Pharma - Video

08-02-2012 11:12 Stem Cell Treatment of Pro/Am dancer and orthodontist, Dr. Janet Vaughan. In attempt to get her dancing career back on track, Dr. Vaughan decided to undergo stem cell therapy at the Stem Cell Institute in Panama City, Panama. Dr. Jorge Paz, Medical Director at the Stem Cell Institute presents Dr. Vaughan's case discussing her injuries and subsequent recovery. After being unable to compete for 2 years, Dr. Vaughan is once again slated to compete on the professional dance circuit with her current professional partner, Mr. Eddie Stutts (Professional 10-Dance World Champion). From 2007-2009, Dr. Vaughan partnered with World Champion Tony Dovolani and competed extensively in the US, winning a National Reserve Pro/Am Rhythm title. Tony Dovolani is best known for his appearances on ABC's hit reality series, "Dancing with the Stars", and has teamed up with Chynna Phillips, Wendy Williams, Audrina Partridge, Kate Gosselin, Kathy Ireland, Susan Lucci, Jane Seymour and other celebrities on the show.

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Stem Cell Therapy for Osteoarthritis and Sports Injuries: A Case Study - Video

19-09-2011 13:52 Learn more at http://www.cordblood.com Learn how newborn stem cells are being researched as treatment for patients with hearing loss. An innovative study held at Children's Memorial Hermann Hospital in Houston will be evaluating the effects of a child's own cord blood as treatment for acquired hearing loss. Only CBR offers your family exclusive access to several groundbreaking clinical trials such as this one. CBR was chosen as the only bank to provide cord blood because these studies require consistent processing and storage methods to reduce any possible variables. To learn more about this study, please visit clinicaltrials.gov To learn more about the lifesaving potential of cord blood, order your free information kit here http://www.cordblood.com Disclaimer: Ultimate use of cord blood stem cells will be determined by the treating physician who will consider if they are applicable for the condition and should come from the patient or a suitable donor (like an HLA matched sibling). There is no guarantee that treatments being studied in the laboratory or in clinical trials will be available in the future. CBR is the preferred choice of OB/Gyns. Source: blind survey, GfK Market Measures, 04/07, funded by CBR. © 2011 Cord Blood Registry. All rights reserved. Privacy Policy

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(Captioned) Hearing Loss Research : CBR Exclusive! Stem Cells Explored as Cure for Hearing Loss - Video

NEW YORK--(BUSINESS WIRE)--

IntelliCell BioSciences, Inc. (OTCQB: SVFC.PK) (PINKSHEETS: SVFC.PK); (“IntelliCell”) or the (“Company”), was invited to demonstrate its stromal vascular fraction technology at the recent Baseball Injuries Symposium at the Andrews Sports Medicine Institute in Alabama held and sponsored by USA Baseball. The course Chairman is Dr. James Andrews, and moderated by PT Kevin Wilk, and Dr. Jeff Dugas. One of the courses presented during the three day event was on stem cell technology presented by Dr. Joshua Hackel. Dr. Hackel presented the state of regenerative medicine technology in the role of treating sports injuries. The link is http://www.mediafire.com/?u7bfa662e3r1sdp.

Dr. Hackel compared the IntelliCell SVF technology to several other methods of regenerative medicine being considered to be used by the leading orthopedic sports medicine doctors. Dr. Steven Victor, CEO of IntelliCell stated, "We are extremely excited that IntelliCell’s technology compares very favorably to all the other technologies, for procedures common to all major sports industries. We are extremely grateful to have the opportunity to present to over 200 leading doctors and trainers looking to treat major league, collegiate and amateur baseball players with regenerative medicine. IntelliCell Biosciences believes that its technology will be utilized by such experts this year."

About IntelliCell BioSciences, Inc.

IntelliCell is a pioneering regenerative medicine company focused on the expanding regenerative medical markets using stromal vascular fraction derived from adult adipose tissue. IntelliCell intends to initially focus on selling laboratory suites and licensing its technology to doctors for use in their offices for their patients. The company is also setting up Centers of Excellence where doctors can treat their patients. In addition, IntelliCell BioSciences is exploring storing the stromal vascular fraction in cryo-storage for future uses. The company is also starting FDA IND clinical trials at major medical centers for clinical indication approval. IntelliCell intends to pursue expansion to secondary markets and beyond the U.S. through a combination of company-owned and licensed clinical facilities.

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IntelliCell Demonstrates at the American Sports Medicine Institute Held in Conjunction with and at the Andrews Sports ...

RED BANK, NJ--(Marketwire -02/07/12)- American CryoStem Corporation (OTCQB: CRYO.OB - News) announced today that it has completed providing stem cell processing services for Personal Cell Sciences Corp., a cutting edge manufacturer of anti-aging skin care products.

The study involves researching the regenerative function of a conditioned medium obtained from each participant's adipose (fat tissue) derived mesenchymal stem cells and their ability to promote the production or secretion of collagen, elastin and fibronectin related to skin wound healing.

John Arnone, CEO of American CryoStem and Founder of Personal Cell Sciences, commented, "CRYO's patented tissue culture media and its proprietary, aseptic adipose tissue processing methodology allows, as an added benefit for PCS customers to store a clinical grade sample of their own stem cells for future use in regenerative medicine. We are pleased to provide comprehensive Bio-Insurance storage solutions at our clinical facility."

The adipose tissue samples were acquired utilizing a mini-liposuction procedure. A total of sixty milliliters (approximately 2 fluid ounces) of adipose tissue was collected in the physician's office and sent to CRYO's laboratory for processing. Once processed, the resulting stromal vascular fraction (SVF) was forwarded to the Personal Cell Sciences laboratory for proprietary formulation for patient specific products.

"We are very excited to announce our service agreement and participation in this clinical study for Personal Cell Sciences. This contractual manufacturing agreement reinforces our capabilities to provide CRYO's exceptional clinical processing for relevant adult stem cell related products," said Anthony Dudzinski, COO of American CryoStem. "We look forward to our continued business relationship with PCS and expanding these services to other developers to speed their product's time to market."

About American CryoStem: American CryoStem Corporation (OTCQB: CRYO.OB - News) markets clinical processing products and services for Adipose (fat) Tissue and Adipose Derived Adult Stem Cells. CRYO's clinical processing and preservation platform supports the science and applications being discovered globally by providing the highest quality, clinically processed cells and assuring their sterility, viability and growth cap abilities, while at the same time developing cutting edge application, therapies and laboratory products and services for consumers and physicians.

The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Certain of the statements contained herein, which are not historical facts, are forward-looking statements with respect to events, the occurrence of which involve risks and uncertainties. These forward-looking statements may be impacted, either positively or negatively, by various factors. Information concerning potential factors that could affect the Company is detailed from time to time in the Company's reports filed with the Securities and Exchange Commission.

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American CryoStem Completes Cell Processing for Clinical Study

02-09-2011 03:47 metromd.net Stem Cells to Treat Acne Scarring | An overview by Alex Martin, MD of how he combines stem cell therapy and the CO2 fractional laser to effectively treat facial scars caused by acne. Offices near Hollywood, Beverly Hills, Los Angeles and Orange County. Questions? Please call the MetroMD Institute of Regenerative Medicine at (323) 285-5300 or email us at info@MetroMD.net.

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Stem Cells to Treat Acne Scarring | Los Angeles | Hollywood | Beverly Hills - Video

Editor's Choice
Academic Journal
Main Category: Neurology / Neuroscience
Also Included In: Stem Cell Research;  Rehabilitation / Physical Therapy
Article Date: 04 Feb 2012 - 10:00 PST

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The February edition of Neurosurgery reports that animal experiments in brain-injured rats have shown that stem cells injected via the carotid artery travel directly to the brain, greatly enhancing functional recovery. The study demonstrates, according to leading researcher Dr Toshiya Osanai, of Hokkaido University Graduate School of Medicine in Sapporo, Japan, that the carotid artery injection technique could, together with some form of in-vivo optical imaging to track the stem cells after transplantation, potentially be part of a new approach for stem cell transplantation in human brain trauma injuries (TBI).

Dr. Osanai and team assessed a new "intra-arterial" technique of stem cell transplantation in rats, with the aim of delivering the stem cells directly to the brain without having to go through the general circulation. They induced TBI in the animals before injecting stem cells into the carotid artery seven days later.

The stem cells were obtained from the rats' bone marrow and were labeled with "quantum dots" prior to being injected. Quantom dots are a biocompatible, fluorescent semiconductor created with nanotechnology that emit near-infrared light with much longer wavelengths that penetrate bone and skin, enabling a non-invasive method of monitoring the stem cells for a period of four weeks following transplantation.

This in vivo optical imaging technique enabled the scientists to observe that the injected stem cells entered the brain on the first attempt, without entering the general circulation. They observed that the stem cells started migrating from the capillaries into the injured part of the brain within three hours.

At week 4, the researchers noted that the rats in the stem cell transplant group achieved a substantial recovery of motor function, compared with the untreated animals that had no signs of recovery.

The team learnt, after examining the treated brains, that the stem cells had transformed into different brain cell types and aided in healing the injured brain area.

Over the last few years, the potential of stem cell therapy for curing and treating illnesses and conditions has been growing rapidly. Below is a list of some of its possible uses.

Stem cells represent a potential, new important method of treatment for those who suffered brain injuries, TBI and stroke. But even though bone marrow stem cells, similar to the ones used in the new study, are a promising source of donor cells, many questions remain open regarding the optimal timing, dose and route of stem cell delivery.

In the new animal study, the rats were injected with the stem cells one week after TBI. This is a "clinically relevant" time, given that this is the minimum time it takes to develop stem cells from bone marrow.

Transplanting the stem cells into the carotid artery is a fairly simple procedure that delivers the cells directly to the brain.

The experiments have also provided key evidence that stem cell treatment can promote healing after TBI with a substantial recovery of function.

Dr. Osanai and team write that by using in vivo optical imaging:

"The present study was the first to successfully track donor cells that were intra-arterially transplanted into the brain of living animals over four weeks."

A similar form of imaging technology could also prove beneficial for monitoring the effects of stem cell transplantation in humans, although the tracking will pose challenges, due to the human skull and scalp being much thicker than in rats.

The researchers conclude:

"Further studies are warranted to apply in vivo
optical imaging clinically."

Written by Petra Rattue
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

Visit our neurology / neuroscience section for the latest news on this subject. "Therapeutic Effects of Intra-Arterial Delivery of Bone Marrow Stromal Cells in Traumatic Brain Injury of Rats—In Vivo Cell Tracking Study by Near-Infrared Fluorescence Imaging"
Osanai, Toshiya; Kuroda, Satoshi; Sugiyama, Taku; Kawabori, Masahito; Ito, Masaki; Shichinohe, Hideo; Kuge, Yuji; Houkin, Kiyohiro; Tamaki, Nagara; Iwasaki, Yoshinobu
Neurosurgery. 70(2):435-444, February 2012. doi: 10.1227/NEU.0b013e318230a795 Please use one of the following formats to cite this article in your essay, paper or report:

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Petra Rattue. "Treating Brain Injuries With Stem Cell Transplants - Promising Results." Medical News Today. MediLexicon, Intl., 4 Feb. 2012. Web.
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Treating Brain Injuries With Stem Cell Transplants - Promising Results

28-07-2009 18:23 Researchers at the University of California, Irvine have reversed Alzheimers-like symptoms in mouse models of the disease with injections of neural stem cells. The first author, Mathew Blurton-Jones, has a Training grant from the California Institute for Regenerative Medicine. The lead author, Frank LaFerla, has a SEED grant and an Early Translational grant from CIRM.

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Neural Stem Cells Reverse Alzheimer's-Like Symptoms - Video

(SACRAMENTO, Calif.) - Experts from UC Davis Health System will share the latest research about regenerative medicine, with a focus on chronic pain and the promise of stem cell therapies, during a community forum on the university's Sacramento campus. The discussion takes place on Tuesday, Feb. 7, from 6- 7:30 p.m. at the UC Davis Education Building, 4610 X Street, in Sacramento.

The event features Jan Nolta, director of the UC Davis Institute for Regenerative Cures; Scott Fishman, chief of the UC Davis Division of Pain Medicine; and Kee Kim, chief of spinal neurosurgery at UC Davis Medical Center. The three specialists will discuss the challenges of treating chronic pain, especially back and neck pain, and the clinical research now under way to use stem cell therapies to overcome it.

The forum is free and open to the public. It is part of "Stem Cell Dialogues," UC Davis Health System's discussion series about regenerative medicine and the goal of turning stem cells into cures. Each speaker will provide a short presentation followed by a panel discussion and question and answer period. The event will be moderated by Fred Meyers, professor of medicine and pathology, and executive associate dean of UC Davis School of Medicine.

Seating is limited. Those interested in attending must reserve a seat by contacting Kate Rodrigues at 916-734-9404 or e-mail kathleen.rodrigues@ucdmc.ucdavis.edu. Doors open at 5:30 p.m.  Free parking will be available in Lots 12 and 14, just south of the Education Building, near 45th Street and 2nd Avenue.

UC Davis is playing a leading role in regenerative medicine, with nearly 150 scientists working on a variety of stem cell-related research projects at campus locations in both Davis and Sacramento. The UC Davis Institute for Regenerative Cures, a facility supported by the California Institute for Regenerative Medicine (CIRM), opened in 2010 on the Sacramento campus. This $62 million facility is the university's hub for stem cell science. It includes Northern California's largest academic Good Manufacturing Practice laboratory, with state-of-the-art equipment and manufacturing rooms for cellular and gene therapies. UC Davis also has a Translational Human Embryonic Stem Cell Shared Research Facility in Davis and a collaborative partnership with the Institute for Pediatric Regenerative Medicine at Shriners Hospital for Children Northern California. All of the programs and facilities complement the university's Clinical and Translational Science Center, and focus on turning stem cells into cures. For more information, visit http://www.ucdmc.ucdavis.edu/stemcellresearch.

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The promise of stem cell therapies forum

14-10-2011 11:58 Moving America Forward's Doug Llewelyn interviews Dr. Ed Park about the revolutionary technology of Telomerase Activation, which was the subject of the Nobel Prize in Medicine in 2009. Using natural nutraceuticals, telomerase can be safely activated, allowing stem cells to prevent and reverse aging's harmful effects. http://www.rechargebiomedical.com

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Moving America Forward with William Shatner honors Dr. Ed Park of Recharge Biomedical - Video

Morning After The Morning's Trash

In my last post, I focused on flaws in the medical device approval process. The Union of Concerned Scientists’ “FDA at a Crossroads” meeting also covered problems with drug approval. This is perhaps no better illustrated than by the disappointing decision by Secretary of Health Kathleen Sebelius’ to deny the emergency contraceptive, Plan B, over-the-counter status for women under the age of 17. This was a particular disappointment to many because President Obama had promised that decisions at the FDA would be made based on science, rather than politics. Some of us, naively, hoped that “change we can believe in” was real, having forgotten that the Tooth Fairy wasn’t.

Two of the speakers at the recent FDA at a Crossroads meeting were formerly at the FDA; both left because of political pressures. Dr. David Ross, was an FDA reviewer for Ketek (an antibiotic). In a Congressional hearing, Dr. Ross testified that he had been pressured to soften his findings about liver toxicity due to the drug and threatened by FDA Commissioner von Eschenbach, who said, “If you don’t follow the team, if you don’t do what you’re supposed to do, the first time you’ll be spoken to, the second time you’ll be benched, and the third time, you’ll be traded,” according to Ross.

The other was Dr. Susan Wood, former assistant FDA commissioner for women’s health and director of the Office of Women’s Health, who resigned from the FDA after Plan B’s approval was initially denied.

The Tradition of Politics at the FDA

Before we delve into the specific discussion of Plan B, let’s look at the context of the politicization of the FDA, under the recent Bush administration in particular, which led to the characterization of the “broken FDA.” During that period access to healthcare information, health services, and medical research became limited by two growing trends: the infusion of increasingly restrictive religious doctrines and the implementation of ideology-driven—rather than scientific, evidence-based—public policies. Initially, access to science-based information was limited through censorship and even distortion in government sources (e.g., data regarding the efficacy of condoms in preventing HIV infections and STDs were removed from the CDC’s Web site). This neither helped reduce the teen birthrate nor STDs. They used the same misinformation tactic with the now discredited breast cancer-abortion link.

Ideologic shifts were also demonstrated by resource allocations. For example, HIV prevention programs at the CDC were reduced by $4 million while funding for abstinence-only programs rose from $20 million to $167 million, despite the lack of evidence of effectiveness, in contrast to the previous peer-review, scientific-merit-based process of NIH grant funding. No federal money is spent on comprehensive sex education. Even worse, since 1982, “Over $1 billion in government funding has been granted to abstinence-only programs…[which] are expressly forbidden from discussing contraception…and often contain factually inaccurate and distorted information. Those who design and operate these programs are often inexperienced, religiously-motivated and frequently have close ties to the anti-abortion movement.”

The trend away from evidence-based medicine affects healthcare practitioners in numerous areas, ranging from patient education and disturbingly eroding standards of medical care to selection of research topics, grant writing, and the research funding process. Upon her dismissal from the President’s Council on Bioethics in 2004 for disagreeing with the administration’s stance on stem cell research, Dr. Elizabeth Blackburn, a prominent cancer researcher and one of only three full-time biomedical researchers on the council, wrote, “When prominent scientists must fear that descriptions of their research will be misrepresented and misused by their government to advance political ends, something is deeply wrong.” Among her many honors, incidentally, is the 2009 Nobel Prize in Medicine.

A brief history of the FDA commissioners and other key persons over the past 20 years illustrates politics at work in the FDA.

David Kessler (commissioner,1990–1997) took a great deal of heat for trying to have the FDA regulate tobacco products and for trying to gain approval for RU-486 (mifepristone).(He lost on both counts.) He was also notable for being appointed by President George H. W. Bush and retained by President Clinton.

Jane Henney (commissioner, 1998–2001), also appointed by Clinton, authorized FDA approval of RU-486. She was, not surprisingly, ousted when George W. Bush took office. She also tried to change business as usual by filling positions with career appointees rather than political ones, actively demonstrating her goal of “leading policy and making enforcement decisions based on science, not on political whims.”

An infamous nominee for chairing Bush’s FDA advisory panel on women’s health policy was Dr. W. David Hager, an obstetrician-gynecologist. He had helped prepare a “citizens’ petition” calling for the FDA to reverse its approval of RU-486. He was perhaps more widely known for his reported refusal to prescribe contraceptives to married women and as author of a book that “recommends specific Scripture readings and prayers for such ailments as headaches and premenstrual syndrome.” After the outcry of critics, he was not appointed chair of the advisory panel but did serve on it in 2002–2005, despite bipartisan opposition.

Mark McClellan (commissioner, 2002–2004) was an economist appointed by George W. Bush. McClellan reportedly had decided against approving Plan B for emergency contraception even before his staff completed its analysis.

Lester Crawford (commissioner, July–September 2005) was a veterinarian also appointed by George W. Bush. His term is perhaps best remembered for three features: the audacity of a veterinarian making decisions about women’s health and reproduction, his vehement opposition to Plan B’s approval, and the criminal charges against him for false reporting about holdings relevant to his appointment (that he and his wife owned stocks in food, beverage, and medical device companies that he was in charge of regulating). He got off with probation and a fine.

Susan F. Wood was another casualty of Crawford’s brief and divisive tenure at the FDA. As noted, she resigned because of the politicization of the agency—specifically, having the approval of Plan B emergency contraception denied, despite scientific evidence of the pill’s safety and recommendations from the FDA’s own advisory committee.

Andrew C. von Eschenbach (commissioner, 2005–2009) had been the head of the National Cancer Institute before being appointed as FDA commissioner. He was also tied to the decision of the FDA to deny emergency contraceptives over-the-counter status, despite the recommendation of the FDA’s advisory group and its own staff members, as well as that of many medical organizations.17 The FDA had followed advisory committee recommendations in every other case in the past decade. He is also known for reportedly threatening FDA reviewers who disagreed with him. Von Eschenbach’s ideologic, rather than evidence- based, decisions were so egregious that on March 23, 2009, the U.S. District Court (Tummino v. Torti) ordered the FDA to reconsider its decision blocking access to Plan B. It also ordered the FDA to act within 30 days to extend over-the-counter access to 17-year-olds. The court’s conclusions about the FDA’s behavior were damning.

The FDA’s ability to function and its reputation have been seriously hurt in the past decade. In a 2006 survey of FDA scientists, about 18 percent responded that they had been asked to exclude or alter information or their report’s conclusions for nonscientific reasons. A further 60 percent were aware of cases where industry “inappropriately induced or attempted to induce the reversal, withdrawal or modification of FDA determinations or actions.” One-fifth (20 percent) said they had been “asked explicitly by FDA decision makers to provide incomplete, inaccurate or misleading information to the public, regulated industry, media, or elected/senior government officials.” Lest you think this survey was markedly biased, even Senator Chuck Grassley, a staunch Republican, commented on the survey report, “The responses of these scientists reinforce the findings of the independent Government Accountability Office, which said the process for reviewing drugs on the market is deeply flawed.”

As a result of the politicization, the FDA staff has reportedly become greatly demoralized, interfering with its ability to function and protect the public. FDA whistle-blowers have testified that the agency considers the drug companies its clients, and its decision-making furthers the interests of those clients.

Many experienced and valuable clinicians have left the agency, leaving a void. Equally importantly, the FDA has lost considerable respect and authority in the eyes of both the public and important members of Congress.

From 2001 to 2009, the most obvious politicization at the FDA was related to women’s health issues, and especially access to contraception.

In March 2009, President Obama issued a memorandum on scientific integrity. A further encouraging sign of change was the May 2009 appointment of two well-respected physicians to lead the FDA, Drs. Margaret Hamburg and Joshua Sharfstein. Dr. Sharfstein has since left. Dr. Hamburg, the opening speaker at the UCS conference, noted that it was imperative to build trust in FDA’s integrity, and that it is science-based. Dr. Hamburg concluded that “I agree with the Center [for Drug Evaluation and Research (CDER)] that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.”

Unfortunately, Dr. Hamburg—and all women—just had the rug pulled out from them by Sebelius’ overtly political, evidence-be-damned stance.

Plan B Perspective

The irrational decision to overrule the recommendation of numerous experts appears based on the idea that young girls would be buying the pill without parental consent, and that such girls could not do so safely. They ignore that kids can readily buy Tylenol, which has significant liver toxicity and is often a component of deadly drug overdoses. Plan B is far safer—and also unlikely to be used routinely because, at ~$50, it is relatively expensive.

Even the conservative American Academy of Pediatrics urged approval of the morning-after pill for young teens, recognizing Plan B as being a safer alternative to abortions or unwanted pregnancies.

Plan B has the same hormone found in birth control pills, progestin, but in a larger dose. It works primarily by preventing ovulation. In contrast, mifepristone, or RU-486, is used to induce a medical abortion in a process similar to a miscarriage.

What were the arguments against Plan B this time? President Obama expressed his concern as a parent, that his daughters must not have access to such a medicine without adult guidance. His personal preferences are not “evidence-based science”. And he is deluding himself. We can guide our children, but we cannot control their behavior. My hope has been to educate my kids and offer them counsel knowing that, for better or worse, they will make many mistakes along the way. Prevention of pregnancy through ready access to contraceptives is far safer than an abortion or unwanted pregnancy. . .which may doom a teen to a lifetime of poverty and misery. There is a superb cartoon capturing the debate, Matt Davies,’ “Which of these responsibilities is a 15 year old too young to be handed?”—a screaming baby or Plan B pill.

Even the digital world seems to be biased, as now even Siri is getting into the act. Siri conveniently can direct you where to buy Viagra, but feigns ignorance when asked to direct to a reproductive health center offering abortion counseling or services.

The Plan B Decision has been characterized as “Sacrificing ‘Change We Can Believe In’ for Expediency?” “Only half of the nation’s teen moms ever earn a diploma; more than half go on welfare; and more than half of the families started by teens live in poverty.” The Ft. Wayne paper has it right stating, “Plan B politics ignore human toll.” I have never understood how many conservatives can demand censorship, restriction of contraceptives, and control of women’s bodies, all in the name of being “pro-life.” Fetal rights trump a woman’s…but then these people take no responsibility for the care, feeding, and education of these unwanted children. The sanctity of life ends at the womb. A life sentence is a huge price for a moment’s mistake.

Mechai Viravaidya

Even Thailand, which many US citizens likely would (erroneously) consider to be a third-world country, is more enlightened in some health-related ways. For example, Mechai Viravaidya, a former Thai senator and founder of the Population and Community Development Association (PDA), and enormously successful family planning NGO, made a brilliant educational campaign focused on reducing both the birthrate and the AIDS epidemic, by making sex education fun and promoting condoms to be as readily available as cabbages. He even has a restaurant and resort known as “Cabbages and Condoms.” It was a wonderful place to visit. (insert pic)

So why did Obama and Sebelius kill OTC Plan B—the first time that the Health and Human Services Commission has ever overruled the FDA? Only two reasons come to mind. The first is that Obama is overtly campaigning for the conservative vote. The second is similar, but a bit less overt—that OTC Plan B was sacrificed to take a firmer stance on having contraceptive coverage as part of all insurance plans.

And Plan B’s got it right, too, in their ad: “I chose a condom but it broke. Now I Have A Second Chance.”

Why don’t the politicians get it?

~~~

Images: Morning After The Morning’s Trash, from waltarrrrr on Flickr; pictures of condom bouqets and t-shirt by the author; Mechai Viravaidya holding a t-shirt, from Gates Foundation on Flickr;

Previously in this series:

Molecules to Medicine: Clinical Trials for Beginners
Molecules to Medicine: From Test-Tube to Medicine Chest
Lilly’s Shocker, or the Post-Marketing Blues
Molecules to Medicine: Pharma Trumps HIPAA?
Molecules to Medicine: Should pepper spray be put on (clinical) trial?
Molecules to Medicine: FDA at a Crossroads—a Tough Place to Be

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Molecules to Medicine: Plan B: The Tradition of Politics at the FDA

31-01-2012 18:50 http://www.singularityweblog.com This morning I interviewed Daniel Kraft for Singularity 1 on 1. I met Dr. Kraft at Singularity University where he is the Medicine and Neuroscience Chair and executive director of the FutureMed Program. Daniel is one of those people with an incredibly diverse spectrum of talents and interests for he is not only a medical doctor and oncologist but also an inventor, a technology and space enthusiast, an entrepreneur and an F-16 flight surgeon. During our conversation we discuss a variety of topics such as: Daniel's early interest and talent in technology and science; his original fascination with the Apollo Space program and eventual participation in International Space University; his passion for flying and being a pilot; his medical education and personal journey to becoming a faculty member at Singularity University; his desire to be an instigator, connector and motivator of innovation; the story behind as well as the purpose and structure of the FutureMed program; bone marrow harvesting, regenerative medicine and stem cell research; longevity and the future of medicine and health care; his greatest inspiration and concerns about the field of medicine and his belief that one doesn't have to be a doctor to improve health care.

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Daniel Kraft on Singularity 1 on 1 (part 1) - Video

31-01-2012 20:35 http://www.singularityweblog.com This morning I interviewed Daniel Kraft for Singularity 1 on 1. I met Dr. Kraft at Singularity University where he is the Medicine and Neuroscience Chair and executive director of the FutureMed Program. Daniel is one of those people with an incredibly diverse spectrum of talents and interests for he is not only a medical doctor and oncologist but also an inventor, a technology and space enthusiast, an entrepreneur and an F-16 flight surgeon. During our conversation we discuss a variety of topics such as: Daniel's early interest and talent in technology and science; his original fascination with the Apollo Space program and eventual participation in International Space University; his passion for flying and being a pilot; his medical education and personal journey to becoming a faculty member at Singularity University; his desire to be an instigator, connector and motivator of innovation; the story behind as well as the purpose and structure of the FutureMed program; bone marrow harvesting, regenerative medicine and stem cell research; longevity and the future of medicine and health care; his greatest inspiration and concerns about the field of medicine and his belief that one doesn't have to be a doctor to improve health care.

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Daniel Kraft on Singularity 1 on 1 (part 3) - Video