Archive for the ‘News’ Category

Article Date: 19 Mar 2009 – 5:00 PDT

USA Today on Wednesday included an editorial and an opposing opinion piece examining proposed state legislation to regulate the fertility industry. Summaries appear below.

~ USA Today: Although the case of 33-year-old Nadya Suleman, who gave birth to octuplets in January after undergoing in vitro fertilization, “points to the need for safeguards to prevent it from begin repeated,” a bill (S.B. 169) in the Georgia Legislature to define an embryo as a human being is the “wrong way to address the problem,” a USA Today editorial states. According to the editorial, “antiabortion activists hijacked the Suleman case to advance their agenda” through the legislation, which seeks to “declare an embryo to be ‘a biological human being’” and “limit the number of embryos that could be implanted.” Although the Georgia Senate went on to pass a “dialed back” version of the bill, efforts at “defining embryos as people — as activists in at least five other states are also attempting to do — represent a back-door way for abortion to be defined as murder,” the editorial says. These efforts include prohibiting fertility clinics from fertilizing more eggs than are implanted and restricting embryonic stem cell research. “More ominously, the efforts could expose doctors who discard unused embryos, and stem cell researchers who damage embryos, to prosecution,” the editorial states, adding that there is “no need to complicate the Suleman case by mixing in abortion politics.” The editorial continues that the “core issue” is the lack of regulation of the U.S. fertility industry. Although most clinics follow the American Society for Reproductive Medicine‘s IVF guidelines, “which evolve along with medical knowledge and ethical debate,” the organization’s recommendations “have no teeth,” the editorial says. According to the editorial, the “most practical way” to address the issue is a Missouri proposal that “would require doctors to follow ASRM guidelines on the number of embryos to be implanted, under penalty of losing their state medical licenses.” The proposal “has the virtues of being straightforward and simple,” and “[i]t’s about protecting health and safety,” the editorial says. It concludes, “It doesn’t play abortion politics. If other states followed suit, the sad and unusual story of Suleman would be less likely to be replicated” (USA Today, 3/18).

~ Jill Stanek, USA Today: “Now is the time for pro-lifers to introduce legislation in their states regulating IVF and, with it, the creation and care of embryos,” Stanek, a weekly columnist for World Net Daily, writes in an opinion piece responding to the USA Today editorial. According to Stanek, the original Georgia bill had “perfect model language” on limiting the number of embryos to be implanted, which she says would curtail the practice of freezing embryos and reduce the need for selective reductions. Although that language was eliminated from the bill, the measure “still importantly defines embryos outside the uterus as human beings, so court disputes must be decided in the best interest of the embryo, not either parent fighting over the embryo.” She writes that a “movement in this direction is gathering force,” citing a 1986 Louisiana law that defines embryos outside the uterus as human beings and the ongoing push for similar legislation in five other states. Stanek continues that the procedure to extract eggs for IVF “is potentially dangerous for women” and that “IVF is certainly dangerous to pre-born humans.” She writes that the “Suleman case has exposed a need to regulate the IVF industry, the sooner the better,” concluding, “Currently sea turtles in the U.S. enjoy more procreative protection than women and children” (Stanek, USA Today, 3/18).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women’s Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women’s Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2009 The Advisory Board Company. All rights reserved.

Article Date: 19 Mar 2009 – 2:00 PDT

Vyteris, Inc. (OTCBB: VYTR), manufacturer of the first FDA-approved active transdermal drug delivery system and a leader in active transdermal drug delivery technology, has announced the initiation of a Phase II clinical trial sponsored by its development partner, Ferring Pharmaceuticals Inc. The trial evaluates Vyteris’ smart patch technology for the safety and efficacy of a pulsatile delivery of a peptide hormone for the treatment of infertility in women.

“The initiation of this Phase II clinical trial is an important milestone for Vyteris in developing an effective peptide transdermal delivery system. We look forward to continuing our strong partnership with Ferring to achieve success with this project for the benefit of infertility patients,” said Dr. Haro Hartounian, chief executive officer of Vyteris. “Ferring’s confidence in moving forward with this trial further demonstrates the commercial potential of our smart patch technology to deliver peptides and other biopharmaceuticals using Vyteris’ transdermal delivery system.”

“This Phase II clinical trial will provide guidance on the roles that the smart patch technology may play in treating women with infertility problems,” said Wayne Anderson, chief executive officer of Ferring. “The non-invasive nature of this product and increased patient comfort will create a new standard of care for infertility treatment.”

The trial will be a multi-center clinical trial conducted at approximately 35 centers throughout the U.S. and will enroll approximately 500 female patients between the ages of 18 and 38 years with anovulatory / oligoovulatory infertility. In this clinical trial, the safety and tolerability of Vyteris’ transdermal delivery system will be evaluated over the trial period. The trial is currently enrolling subjects and is expected to be fully enrolled by July 2009.

With the initiation of the Phase II clinical trial, Vyteris earned a $2.5 million milestone payment from Ferring, which had been previously advanced in July 2008 in the form of an interest bearing loan, the principal amount of which has now been satisfied through application of this milestone payment.

About Vyteris

Vyteris, Inc. is a specialty pharmaceutical company developing and commercializing innovative technology for controlled delivery of peptide and small molecule therapeutics. Vyteris’ first product, LidoSite(R), which provides dermal analgesia prior to venipuncture (IV catheter insertions, blood draws, etc.) and superficial dermatological procedures, was the first FDA-approved active patch. Vyteris’ proprietary transdermal drug delivery technology delivers drugs comfortably through the skin using low-level electrical energy. This active patch technology allows precise dosing, giving physicians and patients control in the rate, dosage and pattern of drug delivery that can result in considerable therapeutic, economical, and lifestyle advantages over existing methods of drug administration.

About Ferring Pharmaceuticals Inc.

Ferring Pharmaceuticals Inc. is a subsidiary of Ferring Pharmaceuticals, a privately owned, international pharmaceutical company. Ferring Pharmaceuticals offers a line of urology, orthopaedic and infertility products in the U.S. markets. They include: EUFLEXXA(R), (1% sodium hyaluronic acid), BRAVELLE(R) ( urofollitropin for injection, purified), MENOPUR(R) and REPRONEX(R) (menotropins for injection, USP), NOVAREL(R) (chorionic gonadotropin for injection, USP), ENDOMETRIN(R) (progesterone) Vaginal Insert, ACHTREL(R) (corticorelin ovine triflutate for injection), PROSED(R) DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate), and DESMOPRESSIN.

Ferring Pharmaceuticals specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, orthopaedics, gastroenterology, obstetrics/gynecology and infertility.

Vyteris Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Words such as “expect,” “estimate,” “project,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “would,” “should,” “believes,” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements in this press release include, without limitation, statements concerning the potential impact of the new marketing agreement and other matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to differ materially from results expressed or implied by this press release. Such risk factors include, among others, the competitive environment and competitive responses to the new marketing arrangement. The Company has described other important risks and uncertainties under the caption “Risk Factors” in its most recent Annual Report on Form 10-KSB and in various filings made with the SEC. Actual results may differ materially from those contained in the forward-looking statements in this press release.

Source
Ferring Pharmaceuticals Inc.

Article Date: 19 Mar 2009 – 0:00 PDT

New treatments for infertility could be closer to reality, thanks to a discovery from scientists at the Université de Montréal and Maisonneuve-Rosemont Hospital Research Centre. According to a study published in the journal Molecular Human Reproduction, the researchers have become the first to clone, produce and purify a protein important for sperm maturation, termed Binder of Sperm (BSP), which may have implications for both fertility treatments and new methods of male contraception.

“We have previously isolated and characterized BSPs from many species, such as bulls and boars,” says Dr. Puttaswamy Manjunath, senior author and a professor in the departments of medicine and of biochemistry at the Université de Montréal and a member of the Maisonneuve-Rosemont Hospital Research Centre.

“We know from these studies that if this protein is missing or defective in these species, fertility is compromised. We believe that BSP is equally important in humans.”

An elusive protein

Dr. Manjunath and colleagues have tried to isolate human BSPs for more than 10 years. In most mammals, these proteins are typically produced by the seminal vesicles and added to sperm at ejaculation. Yet this is not the case for humans, primates and rodents. According to Dr.Manjunath and his team, these species produce small amounts of BSPs only in the epididymis, a duct that connects the testes to the urethra.

“For a few years, we were looking in the wrong place,” says Dr. Manjunath. “In addition, the minute quantities of BSP produced in humans has made it impossible to isolate and characterize.”

Cloning leads to purification

Dr. Manjunath and his team went back to the basics. Using molecular biology technique they cloned the gene (DNA) that encodes human BSP. Through cloning, they were able to produce and purify this protein.

“After considerable troubleshooting, we were able to produce functional human BSP. Our next steps are to confirm its biological role in human fertility,” says Dr. Manjunath.

Role of BSPs in other animals

Following ejaculation, sperm undergo a complex series of modifications inside the female reproductive tract. The changes sperm undergo during this process include redistribution of surface proteins, loss of sperm membrane lipids and increased sperm movement. A family of sperm-binding proteins (BSPs) secreted by the seminal vesicles has been shown to be essential for sperm maturation in female reproductive tracts of cows, sheep, pigs and other hoofed animals.

Notes:

This release is available in French.

About the study:

The article, “Recombinant expression and affinity purification of a novel epididymal human sperm-binding proteins, BSPH1,” was authored by Université of Montreal and Maisonneuve-Rosemont Hospital Research Center researchers Jasmine Lefebvre, Guy Boileau and Puttaswamy Manjunath.

Partners in research:

This study was funded by the Canadian Institutes of Health Research and Le Fonds de la Recherche en Santé du Québec.

On the Web:

About the Université de Montréal: http://www.umontreal.ca/english/index.htm

About the Maisonneuve-Rosemont Hospital Research Centre http://recherche.maisonneuve-rosemont.org

About the Department of Biochemistry http://www.bcm.umontreal.ca

About the Molecular Human Reproduction: http://www.oxfordjournals.org/our_journals/molehr/for_authors/index.html

Source: Sylvain-Jacques Desjardins
University of Montreal

Article Date: 12 Mar 2009 – 5:00 PDT

 

The Atlanta Journal-Constitution on Tuesday published an editorial and opposing opinion piece about a Georgia bill (S.B. 169) that would grant personhood status to embryos and regulate the number of embryos that can be implanted during in vitro fertilization procedures. The state Senate Health and Human Services Committee approved the bill on Monday by a 7-6 vote. Summaries of the editorial and opposing opinion piece appear below.

~ Maureen Downey, Atlanta Journal-Constitution: If Georgia’s bill granting personhood to embryos becomes law, “it will halt the embryonic stem cell research” and “will so complicate legal questions around frozen embryos that it could drive in vitro fertilization clinics out of the state, forcing desperate Georgia couples to go out of state as well,” Downey, a member of the Journal-Constitution‘s editorial board, writes. The “real intent” of the bill is “to outlaw abortion, a goal its proponents acknowledge,” Downey writes, adding that “[w]hile stem cell research may potentially save many lives, those opponents argu[e] it deals a death blow to the embryo itself, which they see as an unconscionable trade-off.” Downey continues that although opponents are “entitled to that belief, … the conviction that pinpoint-sized cells have the same rights as children battling leukemia or teenagers paralyzed from a driving accident is a minority opinion, according to most national polls.” According to Downey, Gov. Sonny Perdue (R) “has attempted to make Georgia a leader in life sciences and biomedicine,” and the state is expecting 20,000 members of the biotech industry to attend the 2009 BIO International Convention in May. “Passage of S.B. 169 would undo those efforts to court the biomedical industry, end major research projects at Georgia universities and cast the state as an anti-science backwater,” Downey writes (Downey, Atlanta Journal-Constitution, 3/10).

~ Daniel Becker, Atlanta Journal-Constitution: It is “true medical science” that the “human embryo is one of us, fully human with great potential,” Becker, president of Georgia Right to Life, writes in an opposing opinion piece. He adds that S.B. 169 “will ensure that Georgia taxpayers only fund ethical and fiscally responsible research into the future.” Becker says that GRTL has “always supported adult stem cell research, which to date has 70 known cures to its credit.” However, the group is opposed to human embryonic stem cell research “that requires the killing of human embryos,” he writes, adding, “Our opponents seem to be far more committed to unbridled science than to human dignity and ethics.” President Obama’s removal of certain federal funding restrictions on embryonic stem cell research “places our society on a very steep and very slippery slope,” Becker continues. “Since many researchers will not be content to use only so-called ‘surplus’ embryos, they will demand support for the creation and destruction of human embryos just for research, through human cloning and other methods,” he writes, adding that “[w]e in Georgia are going to uphold the view that human beings are more precious than money, biotech conventions or economic development.” Becker concludes that Obama “has sealed his confirmation as the ‘abortion president’ with his executive order Monday. We in Georgia, with the passing of S.B. 169, will seal our confirmation as pro-life people” (Becker, Atlanta Journal-Constitution, 3/10).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women’s Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women’s Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2009 The Advisory Board Company. All rights reserved.

Article Date: 10 Mar 2009 – 6:00 PDT

A new study to be published in an upcoming issue of the prestigious medical journalHuman Reproduction [1] shows that Anecova’s in vivo embryo culture system significantly improves the number of good quality embryos produced in the context of Assisted Reproductive Technology (ART). Embryo quality is widely recognized as a factor directly influencing the ultimate success rate of ART.

“These preliminary results are very encouraging,” commented, in a joint statement, the 3 authors of the study: Dr Christophe Blockeel (CRG, UZ Brussel), Dr Pascal Mock (Inventor of this novel concept, IVF Specialist, Geneva) and Dr Greta Verheyen (CRG, UZ Brussel). “Not only this procedure appears to be feasible and safe, but it also led to improvements in terms of embryo quality”. “If confirmed by larger studies which are currently ongoing in several European Centers, this system could initiate a paradigm shift in the entire field of Reproductive Medicine” added Dr Carlos Simon (IVI Valencia), Chairman of the Scientific Advisory Board for Anecova.

Currently, the in vitro Fertilisations (IVF) procedure involves retrieving eggs from the ovaries and fertilising them in vitro, followed by a culture period in the IVF laboratory for 2-5 days. One or more embryos, selected on the basis of their morphological quality, are afterwards transferred in the maternal womb for the completion of gestation. As nearly one in ten couples, or more than 70 million people throughout the world, are affected by fertility issues, improving assisted reproductive technology is a major challenge.

The study reports that eggs collected from 13 patients undergoing IVF treatment were randomly assigned to either in vivo or conventional in vitro culture. In the in vivo arm, fertilization and embryo development led to improved embryo quality with a significantly higher proportion of normal embryos than in the conventional in vitro culture. Three healthy children were born; two with an embryo from the in vivo arm, and one with an embryo from the in vitro arm.

A major advantage of the leading-edge technique developed by the Swiss biotech company Anecova, within a partnership with the Ecole Polytechnique Fédérale de Lausanne (EPFL) is that it constitutes a return to a procedure which is much closer to the natural process. Anecova’s system involves the introduction of microinjected human eggs into a retrievable and permeable capsule which allows optimal exchange between the uterine maternal environment and the developing embryo.

Thus, fertilization and embryonic development take place in vivo (within the in vivo culture system in the future mother’s uterus) rather than in vitro (in a test tube in a laboratory). The early stage embryos start their life in close communication with the maternal environment, recreating the two-way exchange of fluids and factors found in the natural development of embryos, improving the overall quality of the embryos.

“Anecova will strive to improve the overall quality of care in ART by enabling the use of more physiologic and natural medical solutions for couples with conception difficulties”, said Martin Velasco, Chairman of the Board at Anecova and CEO.

[1] An in vivo culture system for human embryos using an encapsulation technology: a pilot study. Human Reproduction. Published online on March 10 under advance access. doi:10.1093/humrep/dep005.

About the Brussels’ Centre for Reproductive Medicine

The ‘Centrum voor Reproductieve Geneeskunde’ (CRG) from the Universitair Ziekenhuis Brussel (UZ Brussel, Belgium) is a specialized centre in Reproductive Health. Since 1983 it has led groundbreaking work in the development of assisted reproductive techniques and novel clinical practices.

Brussels’ Centre for Reproductive Medicine

About IVI

The Instituto Valenciano de Infertilidad (IVI) came into being in 1990 as the first medical institution in Spain wholly specialized in human reproduction. IVI is at the forefront of Reproductive Medicine, and has opened several centers in Spain, Europe and South America.

http://www.ivi.es

About EPFL (Ecole Polytechnique Fédérale de Lausanne)

EPFL is one of Switzerland’s two Federal Institutes of Technology. It offers complete study courses in Engineering, Basic Sciences, Architecture, Life science and Management. In addition to excellence in education and research, EPFL has a strong commitment to technology transfer and the Science Park on campus is home to more than 100 enterprises and numerous investors. With its three missions – education, research and technology transfer at the highest international level – EPFL stimulates collaboration between students, professors, researchers and entrepreneurs.

http://www.epfl.ch

About Human Reproduction journal

Human Reproduction is a monthly journal of the European Society of Human Reproduction and Embryology (ESHRE), and is published by Oxford Journals, a division of Oxford University Press.

http://www.eshre.com

About Anecova

Anecova was created in 2004 by Martin Velasco and Dr Pascal Mock. Anecova is working with world leading scientists and clinicians in the area of ART with the objective of developing more natural approaches. The company is ISO certified (9001 and 13485), obtained the European Certification (CE Mark) in 2007 for the Anecova-d1 device and expects to start commercialization in Europe by the first half of 2010. Anecova was granted the Technology Pioneer award in 2008 at the World Economic Forum.

Anecova

Article Date: 06 Mar 2009 – 5:00 PST

The birth of 33-year-old Los Angeles resident Nadya Suleman’s octuplets, who were conceived through in vitro fertilization, has created concern among reproductive endocrinologists about “how a profession that has highly refined the art and science of helping women who have struggled to get pregnant could be so misused,” the Washington Times reports. Suheil Muasher, medical director of the Muasher Center for Fertility and IVF in Fairfax, Va., said that Suleman’s doctor “reflects badly” on fertility specialists, adding, “While we don’t really know the exact facts of the case, whatever was done here was outside the guidelines” of the American Society for Reproductive Medicine. ASRM’s guidelines limit the number of embryos implanted in a woman depending on her age and health history. Muasher said the guidelines are recommendations, rather than requirements, because each case must take into account several factors, including age, fertility problems and previous pregnancies. For a woman younger than age 35 “with a favorable prognosis,” ASRM recommends the transfer of no more than one embryo; for women the same age with a “more complicated case,” ASRM calls for the transfer of no more than two embryos, the Times reports. For women ages 38 to 40, the society recommends no more than three embryos, and for women older than age 40, no more than five embryos.

Dale McClure, president of ASRM, said he is pleased that the California Medical Board is investigating the Suleman case. Suleman has said that her procedure involved six embryos. McClure said, “Physicians have known for many years about the dangers of multiple pregnancies,” adding, “ASRM and its affiliate, the Society for Assisted Reproductive Medicine, have worked steadily to formulate evidence-based guidelines for the number of embryos to transfer in assisted reproductive technology cycles.” He noted that the percentage of triplet births from ART procedures has declined, with 2% reported in 2005, down from 7% in 1996. The success rate for fertility doctors improved from 28% to 34% during the same period. Stephen Lincoln, a reproductive endocrinologist with the Genetics and IVF Institute in Fairfax, said that aside from Suleman’s case of octuplets, “we have seen a significant reduction in higher-order births of triplets or more. We can do better and we are trying.” He added, “There are a lot of factors that pressure people to transfer more.” Muasher said he is concerned that the publicity surrounding Suleman’s case will lead some infertile couples to fear conceiving high-order multiples if they undergo IVF. In reality, the majority of reproductive endocrinologists follow ASRM guidelines, he said.

Another concern among fertility doctors is that an increased scrutiny of the field will lead to regulations, similar to those in some European countries, that regulate the number of embryos that can be implanted. Lincoln said that regulations on the number of embryos that could be implanted would affect the success rate for many doctors and patients. He explained, “We have to be careful that we don’t make laws that hurt success rates and deter patients from getting the best treatment possible,” adding, “We are always cautious when the government wants to impose restrictions. Technology is outpacing our ability to morally look at things, and we may make laws that three or four years down the road may be obsolete” (Goff, Washington Times, 3/4).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women’s Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women’s Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2009 The Advisory Board Company. All rights reserved.

 

Article Date: 06 Mar 2009 – 5:00 PST

Parents Via Egg Donation (PVED), a global non-profit organization that has served over 5000 individuals over the past year celebrates its first year of operation. Marna Gatlin founder of Parents via Egg Donation couldn’t be more pleased at the positive reception and rapid growth of this much needed organization. “Our organization is growing by leaps and bounds! And we couldn’t be happier.” Commented Gatlin, in regards to her first year of business.

Fertility treatment is often complex, difficult, and often a painstakingly private journey – even more so when couples or singles are not able to have children using their own eggs. However, PVED is helping change all that. PVED is offering information, resources, and a sense of community to those considering or attempting to create or grow their family using donor eggs.

PVED’s members are made up of couples and singles of various religions, races and sexual orientations. “Many of these individuals didn’t feel like they had any means of receiving support, getting educated, becoming empowered, or had a voice,” said Founder Marna Gatlin, who conceived her son with egg donation. “Often they felt isolated.”

“I decided to create an organization that would embrace every parent who had chosen egg donation to grow their family,” said Gatlin. “And I took the idea a step further: this resource would be a global resource for unbiased, timely, and accurate information about egg donation, eliminating the need to search far and wide for piecemeal information and answers.”

The organization offers “how to” information: How to select a donor; how to select an egg donor agency; how to select an infertility clinic; as well as information on the step-by-step egg donation process, information about disclosure, and resources and links where readers can learn more. Gatlin also offers information regarding agencies, legal and medical professionals, treatment centers, mental health therapists, pharmaceutical companies, and other resources.

For more information about Parents via Egg Donation, please visit their website at: http://www.pved.org .

The Parents via Egg Donation Organization was created to provide an informational and supportive environment where parents and parents-to-be can come together to exchange information about all facets of the egg donation process. Our mission and purpose is to educate, support, and empower families and individuals at any stage of the process who choose to use egg donation to build a family.

“Wherever you are in the process, there is a place in our community for you.”

Marna Gatlin
Founder
Parents via Egg Donation
http://www.pved.org
marna@pved.org
503.987.1433

 

Article Date: 06 Mar 2009 – 0:00 PST

A new Utah Department of Health (UDOH) report explores health issues among the state’s Asian population. Utah Asians are healthier than the statewide population in several areas:

- 7.3% of Utah Asians are obese. At 21.3%, the state obesity rate is nearly triple that.
- Fewer Utah Asians die of coronary heart disease than other Utahns.
- Fewer Utah Asian teenagers give birth than other Utah teenagers.

“The rest of us could learn a lot from Utah Asians about the advantages of maintaining a healthy weight,” said April Young Bennett of the UDOH Center for Multicultural Health (CMH). “Utah Asians are the only Utah racial group that is meeting the state goal for a low obesity rate and that may explain why, as a group, they have fewer chronic health problems than other Utahns.”

Bennett clarified that it can’t be assumed that all Utah Asians are healthy. “Overall, Utah Asians seem to suffer from fewer health disparities than other Utah racial and ethnic minorities,” she explained. “But Asians are also more diverse than other Utah racial and ethnic groups. Their diversity may mask important health differences between national origins and other socio-demographic factors.” Less than twenty percent of Asian immigrants to Utah have come from the same country of origin.

Health leaders are concerned that Utah Asians are unequally affected by poor pregnancy outcomes.

- 6.2% of Asian pregnant women in Utah experience gestational diabetes, compared with 3.2% of all pregnant women in Utah.

- 9.6% of Asian babies in Utah are born at a low birth weight, compared to 6.8% of all Utah babies.

Like other Utahns, Asians would also benefit from improved access to health care, better nutrition and more physical activity.

Kumar Shah, Chair of the Ethnic Health Advisory Committee, emphasized that people of all races should work together to eliminate these shared problems. “We should focus on these common problems first,” he said. “Poverty and lack of access to health care affect all races and national origins. We can all benefit from living healthier lifestyles by not smoking, eating the right foods, and exercising, even though genetics makes some races more susceptible to certain health problems than others.”

The report is fourth in a series on the health of racial and ethnic minorities in Utah. The final report about the health of Utah American Indians will be issued on March 11, 2009.

See the complete report here.

The mission of the Utah Department of Health is to protect the public’s health through preventing avoidable illness, injury, disability and premature death, assuring access to affordable, quality health care, and promoting healthy lifestyles.

Utah Dept of Health

Article Date: 18 Feb 2009 – 6:00 PST

The New York Times on Tuesday examined how epidemiological studies and new methods for testing embryonic genes are beginning to provide “tentative answers” about whether subtle differences in embryos grown in petri dishes for in vitro fertilization procedures lead to any lasting health effects. Researchers are exploring whether changes in gene expression or developmental patterns in IVF embryos cause defects, some of which are apparent at birth and some of which do not appear until later in life. Some studies show that some rare disorders appear to be directly linked to abnormal patterns of gene expression associated with IVF. A November 2008 Centers for Disease Control and Prevention study found that infants conceived through IVF or artificial insemination had an increased risk of several birth defects, including a cleft lip palate and a malformed rectum. The study found that of the 4,792 infants without birth defects, 1.1% were conceived through IVF or related methods, compared with 2.4% of the 9,584 infants with birth defects. However, the findings were considered preliminary, and researchers do not believe that IVF carries an excessive risk for birth defects, as the risk for birth defects among all infants is about 3%, the Times reports. Although the CDC findings show insight into comparative risks, they do not provide answers about absolute risks, according to the Times. The Times reports that “the real question — what is the chance that an IVF baby will have a birth defect? — has not been definitively answered.”

Richard Schultz, associate dean for natural sciences at the University of Pennsylvania, said that there is a “growing consensus” in the field that the procedure does carry risks. He added, “It is now incumbent on us to figure out what are the risks and whether we can do things to minimize the risks.” George Daley, a researcher at Harvard Medical School who is studying human embryonic stem cells, said while he has seen changes in embryonic stem cells related to which genes are activated, he is not certain what is behind the changes. The process of controlling whether genes are active or inactive is known as epigenetics. Daley added, “My major concern is that we don’t have enough information, or the tools to measure epigenetic stability.”

The Times reports that researchers hope to first determine why growing embryos in petri dishes leads to changes in gene expression. Secondly, if there are changes, researchers would like to determine if altering the laboratory conditions could eliminate such changes. One possible explanation is related to the broth, known as the culture medium, in which the embryos are grown, the Times reports. However, studying possible effects of the culture medium is difficult because IVF centers use multiple media and often switch from one media to another, according to Elizabeth Ginsburg, medical director of the IVF at Brigham and Women’s Hospital.

Ginsburg also noted that the discussion of potential risks of IVF largely has been confined to scientists. Although the consent forms at Ginsburg’s center mentioned the possibility of increased risk of certain genetic disorders, no patients have opted out of the procedure because of it. Richard Rawlins, director of the IVF and assisted reproduction laboratories at the Rush Centers for Advanced Reproductive Care, said, “I have never had a patient ask me anything” about it, adding, “For that matter, not many doctors have ever asked, either.” Following changes in infants conceived through IVF also presents challenges, as health issues or disorders might not become apparent until adulthood, the Times reports. Alistair Sutcliffe of University College London said there is a strong need for more information on the risks associated with IVF. He added, “Obviously more knowledge is required. The perfect study hasn’t been done” (Kolata, New York Times, 2/17).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women’s Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women’s Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2009 The Advisory Board Company. All rights reserved.

 

Article Date: 18 Feb 2009 – 6:00 PST

Vitrolife (STO:VITR) has received approval from the American Food and Drug Administration, so-called 510(k) clearance, for its new needle for the collection of human oocytes, Swemed Sense™ (patent pending), which reduces the risk of tissue damage and pain. The needle, which has previously received European approval, a so-called CE mark, and which was launched at ESHRE in 2008, has received a very positive response and publicity. Swemed Sense™ will now be launched in the USA.

Swemed Sense™ combines the good properties of Vitrolife’s previous needles with a new way of designing the front part and tip, so that the patient will experience less discomfort and so that the risk of bleeding is reduced. “This is the first product that applies a new technical principle for oocyte collection needles. We believe in this principle very much,” says Anette Jäderberg, Marketing Director at Vitrolife.

The Swemed Sense™ oocyte aspiration needle is designed with a thinner front part and tip so as to minimize tissue damage, bleeding and pain. However, the rear part of the needle has a larger diameter. This makes the needle stable and therefore does not reduce the handling ability. Furthermore, the procedure is just as fast as when a thicker needle is used, which is not the case with uniformly thin needles. A patent application has been submitted for Swemed Sense™ in all major markets.

The response after the launch of Swemed Sense™ in Europe has been incredibly positive.

It is estimated that the market for Swemed Sense™, which is used in the collection of oocytes for IVF, amounts to approximately 50 million Euros worldwide.

February 16, 2009 Göteborg, Sweden

Magnus Nilsson CEO

Vitrolife is a global biotechnology/medical device Group that works with developing, manufacturing and selling advanced products and systems for the preparation, cultivation and storage of human cells, tissue and organs. The company has business activities within three product areas: Fertility, Transplantation and Stem Cell Cultivation.

The Fertility product area works with nutrient solutions (media), cryopreservation products and advanced consumable instruments such as needles and pipettes, for the treatment of human infertility. The Transplantation product area works with solutions and systems to evaluate and maintain organs outside the body order to select usable organs and keeping them in optimal condition while waiting for transplantation. The Stem Cell Cultivation product area works with media and instruments to enable the use and handling of stem cells for therapeutic purposes.

Vitrolife today has approximately 150 employees and the company’s products are sold in more than 80 markets. The company is headquartered in Gothenburg, Sweden, and there are subsidiaries in USA, Australia, France and Italy. Production facilities are housed in Sweden and USA.

The Vitrolife share is listed on NASDAQ OMX Stockholm, Small Cap.

Vitrolife AB (publ), Box 9080, SE-400 92 Göteborg, Sweden. Corporate identity number 556354-3452.

Vitrolife