Science Weekly: Election special … science policy and the battle of the apes

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Science policy at the general election; how asteroids helped start life on Earth; and the response of chimps to death

Target Health Unveils Target Document® Version 1.5 – Newest version of the Company’s Internet-based Document Management and Document Sharing Software

New York, NY April 20, 2010 – Business Wire: Target Health Inc., an industry-leading eCRO, has announced the release of Target Document® version 1.5. Target Document is a cost-effective, distributable, secure, user-friendly, 21 CFR Part 11 compliant, Internet-based, document sharing, distribution, and management system that allows users in any industry, depending on their roles and permissions, to post, share, electronically sign, and archive any electronic document within a Web browser. New features include advanced user management, access to recycle bin, parallel sign off of documents, manual backup of any folder, configuration of e-Signature text, document expiration dating, email alerts to all users, etc. According to Jules Mitchel, MBA, Ph.D., President of Target Health, “Target Document eliminates the need to manage and distribute documents via email, saves paper and is ideal for vendors, CROs, clinical research sites, and Sponsors who want to transparently communicate among themselves in a secure environment. Dr. Mitchel added that in pharmaceuticals, “Target Document allows for a paperless Trial Master File (TMF) and is part of the paperless eClinical toolbox of products available from Target Health.“ The Target Health toolbox includes: Target e*CRF, Target Health’s flagship EDC software, which has been used in over 200 clinical trials, including 18 regulatory approvals; Target Encoder – which links directly into the Target e*CRF database to encode MedDRA and WHODRUG terms; Target e*CTMS™ (Clinical Trial Management System)- which allows for Internet-based project management, across studies at one website ; and Target Newsletter® – which allows for a clinical trial newsletter with real time enrollment data and comments.

For more information about Target Health and our software tools for paperless clinical trials, please contact Warren Pearlson (212-681-2100 ext 104) or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website,at: www.targethealth.com

FDA Approves Prostate Cancer Treatment

FDA has approved Provenge (sipuleucel-T), a 1) ___ for prostate cancer. It doesn’t prevent the disease, so vaccine is a bit of a misnomer, but it does do something that scientists have been trying to achieve for decades and it could be a game-changer. It offers a new way to attack the disease which could be deployed against other kinds of 2) ___. At present, however, it could help as many as 100,000 men with advanced prostate cancer. Three years ago, the FDA delayed a decision on this treatment, despite an expert panel’s recommendation for approval. According to the NY Times, WebMD and Bloomberg News, agency officials were concerned that, even though the vaccine extended 3) ___ in men with metastatic cancer who did not respond to hormone-deprivation therapy, it did not slow 4) ___ growth. The FDA also said that too few men had been studied and asked Dendreon to perform a larger trial in more than 500 men. During the trial, which involved 512 patients with advanced prostate cancer, Provenge increased overall 5) ___ by about four months, boosting median survival from 21.7 months to 25.8 months. Ongoing clinical trials are looking at whether Provenge might have more dramatic effects if given earlier in the course of prostate cancer. One of these studies is giving Provenge to men intending to undergo prostatectomy for prostate cancer that is still confined to the prostate 6) ___. Nevertheless, a full treatment will cost $93,000. Dendreon officials defended that price, saying it was in line with those of other cancer drugs in terms of cost per extra month of 7) ___ provided by the drug. The treatment will initially be available at about 50 sites used for clinical trials, and more widely distributed after four plants are cleared for use by mid-2011. The new approval is limited to the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard 8) ___ treatment.

ANSWERS: 1) vaccine; 2) cancer; 3) lifespan; 4) tumor; 5) survival; 6) gland; 7) life; 8) hormone

Stanley I. Greenspan MD, Child Psychotherapist (1941-2010)

Stanley I. Greenspan, 68, a child psychiatrist who wrote more than a dozen parenting books and developed the popular “floor time“ method for reaching children with autism and other developmental disorders, died this past April 27. In a career spanning 40 years, Dr. Greenspan drew praise for his early research on infant development and later found a wide following as an author and public speaker. At the time of his death, he was a professor at George Washington University’s medical school. In the 1970s, while working at the National Institute of Mental Health, he was at the forefront of a movement that saw human interactions and loving relationships as the foundation for a child’s emotional and intellectual growth. In books such as “First Feelings“ (1985), “The Essential Partnership“ (1989) and “Playground Politics“ (1993), Dr. Greenspan gave parents a map of the developmental stages that most children experience from birth to age 7. He said parents could best help their children by engaging in intensive, child-led play for half an hour every day. Such floor time, teaches children how to confidently take initiative and “creates the whole basis for security, trust, and self-worth that a child will need from here on.“ In 1995, Dr. Greenspan published “The Challenging Child,“ about raising difficult kids, including those who are aggressive, defiant or highly sensitive. “Engaging Autism,“ his 2006 book co-written with Serena Wieder, received positive reviews at a time when autism diagnoses were skyrocketing. The book explained how the floor time method could be tailored to address the social and emotional deficits of children with autism. Trademarked as “D.I.R./Floortime,“ Dr. Greenspan’s method focused on developing children’s underlying ability to form relationships and react to new situations. It received widespread attention as an alternative to more traditional methods that use rewards and punishments to shape specific behaviors. Dr. Greenspan thought that you don’t teach a child what to do, you let the child do and you reinforce them for what they’ve just done. That way they begin to feel more and more competent and begin to flourish right in front of your eyes. Stanley Ira Greenspan was born in New York on June 1, 1941. He struggled with reading and writing as a boy and developed methods for meeting academic requirements – scanning books for key ideas, for example, rather than reading each word closely. In adulthood, he frequently worked with co-authors who could smooth his prose. The experience of overcoming his learning difficulties taught him two things: One, that kids have different learning styles that are real and need to be paid attention to. And two, that people have an enormous capacity to use their strengths to compensate for any areas of vulnerability. Dr. Greenspan graduated from Harvard in 1962 and Yale University medical school in 1966. He began his career at the National Institute of Mental Health about 1970, a time when researchers were just beginning to understand the complex emotional lives of infants. He headed a long-term study of a group of pregnant mothers who had older children with emotional difficulties and whose families suffered from multiple risk factors, including mental illness, substance abuse and domestic violence. The idea was to see whether early intervention would help babies form emotional connections with their parents and thus avoid the trouble their older siblings had experienced. According to a 1983 report, six years after the study was begun, none of the children appeared to have developed serious emotional or psychological problems. The study led to Dr. Greenspan’s understanding of child development, a blend of psychoanalyst Sigmund Freud’s emphasis on the emotional world and psychologist Jean Piaget’s theory that children go through concrete stages of cognitive development. The emotional milestones Dr. Greenspan identified for healthy children became part of the American Academy of Pediatrics’ guidelines for doctors assessing the well-being of infants.

Comparative Effectiveness Study Confirms New Treatment for Diabetic Macular Edema

Diabetic retinopathy is the most common cause of vision loss in working-age Americans. This condition damages the small blood vessels in the eye’s light-sensitive retinal tissue. When these damaged blood vessels begin to leak fluid near the center of the retina, known as the macula, macular edema occurs. The macula provides detailed central vision used for activities such as reading, driving, and distinguishing faces. In macular edema the retinal tissue swells, which can lead to vision loss if left untreated. Laser treatment of the retina has been the standard care for diabetic macular edema since an NEI-supported study in 1985 showed it to be beneficial. However, recent small short-term studies have revealed the visual benefits of eye injections of medications that block a chemical signal that stimulates blood vessel growth, known as vascular endothelial growth factor (VEGF). These studies have indicated that repeated doses of anti-VEGF medications, such as ranibizumab, may prevent blood vessels from leaking fluid and causing macular edema. Researchers have shown that ranibizumab (Lucentis, Genentech) eye injections, often in combination with laser treatment, result in better vision than laser treatment alone for diabetes-associated swelling of the retina. While laser treatment alone has been the standard care for the past 25 years, nearly 50% of patients who received this new treatment experienced substantial visual improvement after one year, compared with 28% who received the standard laser treatment. The study involved 52 clinical sites within the Diabetic Retinopathy Clinical Research Network (DRCR.net), supported by the National Eye Institute (NEI) and the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health. The DRCR.net study, published online April 27 in Ophthalmology, confirms preliminary results and provides evidence of the treatment’s effectiveness in combination with laser therapy through at least one year of follow up. The current study included a total of 854 eyes of 691 people, who had one or both eyes treated. Participants, who were on average in their early 60s, were diagnosed with type 1 or 2 diabetes and macular edema. They were randomly assigned to one of four study groups: sham injections plus prompt laser treatment within one week; ranibizumab injections plus prompt laser treatment; ranibizumab plus deferred laser treatment after six months or more; or injections of corticosteroid medication known as triamcinolone (Trivaris) plus prompt laser treatment. Ranibizumab injections could be given as often as every four weeks, and triamcinolone injections or laser treatments could be given as often as every 16 weeks. In general, treatment was continued until a participant’s vision or retinal thickness returned to normal, or additional treatment did not improve vision or retinal swelling. After one year, nearly 50% of eyes treated with ranibizumab and prompt or deferred laser treatment showed a substantial visual improvement. People could read at least two additional lines on an eye chart with the treated eye, or letters that were at least one-third smaller than they could read before the study treatment. Fewer than 5% of eyes in these groups experienced a visual loss of two or more lines. The results were similar whether patients received prompt or deferred laser treatment with the ranibizumab injections. In contrast, about 30% of eyes that received laser treatment alone or triamcinolone plus laser showed a visual improvement of two or more lines on an eye chart, while 13 to 14% of eyes in these groups had a visual loss of two or more lines. Although participants in all three injection groups had a greater decrease in retinal thickness after one year than with laser treatment alone, patients who received triamcinolone injections had greater complication rates. About 30% of people in the triamcinolone group developed high eye pressure that required medications, and about 60% developed cataracts that required surgery. Few participants who received eye injections of ranibizumab had eye-related complications, such as an infection inside the eye likely caused by the injections, or worsening of a retinal detachment that existed prior to beginning treatment. The study found that eye injections of ranibizumab were not associated with any serious risks such as heart attack or stroke. DRCR.net researchers will continue to monitor the study participants for at least three years to obtain additional information about the safety and effectiveness of these macular edema treatments.

Adding Coronary Calcium Score to Traditional Risk Factors Improves Risk Assessment for Heart Disease

According to an article published in the Journal of the American Medical Association (2010;303:1610-1616), Including a coronary artery calcium score in a risk assessment for future heart disease events, such as heart attacks, provides a better estimate in some populations than a standard coronary risk factors assessment. A coronary artery calcium score was most helpful for people considered to be at intermediate risk of a heart disease – defined as those with a 3 to 10 percent chance of developing heart disease over the next five years. In the Multi-Ethnic Study of Atherosclerosis (MESA), researchers used cardiac CT scans, which detect specks of calcium in the walls of the coronary arteries. These specks, indicating calcifications, are an early sign of coronary artery disease, or heart disease. Heart disease is the leading cause of heart attacks, angina (chest pain) and death in the United States. The study drew from 5,878 MESA participants, ages 45 to 84, who initially did not have known cardiovascular disease, and included both men and women who were white, African-American, Hispanic, or of Chinese heritage. Interviewers telephoned participants or a family member at intervals of nine to 12 months to inquire about interim hospital admissions, diagnoses of cardiovascular disease, and deaths. Participants were followed for almost six years. Over the follow-up period, 209 participants experienced a heart disease event, such as heart attack, death from heart disease, or cardiac arrest. When the coronary artery calcium score was used in addition to standard risk factors, it accurately placed 77% of the overall population into the highest or lowest risk categories, compared to only 69% assessed with traditional risk factors alone. The risk assessment with the coronary calcium score reclassified a notable proportion of participants to a more accurate risk classification. An additional 23% of those who experienced events were reclassified to high risk, and an additional 13% who did not experience an event were appropriately reclassified to low risk. Risk classifications were created using risk factors from the Framingham Heart Study Risk Score and based upon the risk of having a heart attack or dying from heart disease within five years. Risk factors considered were age, gender, tobacco use, systolic blood pressure (the top number in a blood pressure reading), blood pressure medication use, blood cholesterol levels, and ethnicity. Individuals with less than a 3% chance of heart disease in the next five years were considered to be low-risk; those with a 3 to 10% chance to be intermediate-risk; and those with more than a 10 percent chance to be high-risk. The MESA findings indicated that a coronary artery calcium score may not be an efficient screening tool among low-risk individuals. It is generally accepted that patients who are at high risk should be treated regardless of their coronary artery calcium score, and as a result do not need coronary artery calcium testing for additional risk assessment. According to the authors, “We found that when we included the coronary artery calcium score to predict risk, we were better able to identify those who developed serious chest pain or heart attacks. The coronary artery calcium score was most helpful in people who would usually be thought of as intermediate risk.” “It can sometimes be hard to know whether to do things such as start patients at intermediate risk on cholesterol-lowering medicine, and so it is possible that the coronary artery calcium score may help physicians and patients decide the best way to control their risk factors.” Coronary artery calcium scanning is not generally recommended as a screening test. Whether it would improve outcomes is unknown and the scans entail additional costs and some risks, such as exposure to small amounts of radiation. One recent study provided some indication of an elevated cancer risk if a calcium score is obtained every five years. Some have suggested that a coronary artery calcium score-guided strategy may actually cost more money and prevent fewer events than simply treating all patients at intermediate risk. MESA researchers are investigating the early stages of coronary artery disease in various studies. More than 6,000 ethnically diverse men and women from six communities in the United States are participating in MESA. Participants undergo coronary tests such as CT scans, magnetic resonance imaging, ultrasounds, and electrocardiograms.

GENETICS

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Patient’s Whole Genome Reveals Risk of Diseases and Adverse Drug Responses

According to a study published in the Lancet (2010;375:1525-1535), scientists at Stanford and Harvard Universities collaborated to assess the clinical usefulness of analyzing a patient’s full genome for disease risks and unusual drug responses. The work brings closer to reality the concept that whole-genome sequencing might one day play a clinical role. The authors evaluated the entire genome of a 40-year old man and compared it to several databases of disease-related gene variants. They also factored in the patient’s medical and family history and statistical disease risks. As part of the work, the researchers provided the patient with genetic counseling and clinical tests relevant to his family history. The genome analysis revealed variants associated with diseases in the man’s family (osteoarthritis, vascular disease and early sudden death). It also uncovered variants linked to conditions not in his family (iron overload and thyroid and parathyroid diseases). Some variants suggested that he might have unusual responses to certain heart medications, which is meaningful in light of his risk for cardiovascular disorders. The authors view their work as a proof of concept that whole-genome sequencing can yield clinically useful information for individual patients. They acknowledge that many challenges remain, including the effect of the environment, which is difficult to quantify and often changes throughout a person’s life. The paper concludes that the transition to genome-informed medical care will require an integrated team including medical and genetics professionals, ethicists and health-care delivery organizations.

TARGET HEALTH excels in Regulatory Affairs and works closely with many of its clients performing all FDA submissions. TARGET HEALTH receives daily updates of new developments at FDA. Each week, highlights of what is going on at FDA are shared to assure that new information is expeditiously made available.

The Industry-Physician Relationship

Like the patient-physician relationship, the industry-physician relationship is complex, important, and subject to conflicts.  Efforts to regulate, monitor, and ultimately manage this relationship are very much evident in both government health care reform initiatives and evolving professional codes of conduct. An editorial, published in The New York Times (1 May 2010), criticizes a new effort by the Council of Medical Specialty Societies to establish a code of conduct regulating the interactions between its members and industry. While the Council takes a collaborative approach, attempting to assure that industry funding does not compromise professional independence and establishing guidelines intended to assure the independence of industry supported CME (Continuing Medical Education), the Times seems to favor “divorce.“ The recently passed health care law takes a slightly different tack on provider-industry relations, focusing on transparency through mandated disclosure of any support provided by companies to physicians and teaching hospitals. The disclosed support would then be made available to the broad public by HHS. Target Health continues to monitor this debate closely. While not directly involved in support of providers or hospitals, we do care about preserving an environment where our clients, the companies that discover and develop new medicines and devices, have access to critical experts and expertise. It is in the public interest that innovator companies be able to access the best Academic Centers, Medical Societies, individual practitioners, and public agencies that have valuable, even critical insights to offer innovative companies. The public interest is best served by striking the proper balance, managing conflicts of interest while defining and encouraging constructive dialogue and productive interaction.  By Mark L. Horn, MD, MPH – Chief Medical Officer, Target Health Inc.

Target Health Inc. (www.targethealth.com) is a full service eCRO with full-time staff dedicated to all aspects of drug and device development.

Areas of expertise include Regulatory Affairs, comprising, but not limited to, IND (eCTD), IDE, NDA (eCTD), BLA (eCTD), PMA (eCopy) and 510(k) submissions, Management of Clinical Trials, Biostatistics, Data Management, EDC utilizing Target e*CRF®, Project Management, and Medical Writing.

Target Health has developed a full suite of eClinical Trial software including 1) Target e*CRF® (EDC plus randomization and batch edit checks), 2) Target e*CTMS™, 3) Target Document®, 4) Target Encoder®, 5) Target Newsletter®, 6) Target e*CTR™ (electronic medical record for clinical trials). Target Health ‘s Pharmaceutical Advisory Dream Team assists companies in strategic planning from Discovery to Market Launch. Let us help you on your next project.

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