Driven by rising health care costs at home, nearly 1 million Californians cross the border each year to seek medical care in Mexico, according a new paper by UCLA researchers and colleagues published in the journal Medical Care.

An estimated 952,000 California adults sought medical, dental or prescription services in Mexico annually, and of these, 488,000 were Mexican immigrants, according to the research paper, “Heading South: Why Mexican Immigrants in California Seek Health Services in Mexico.”

The paper is the first large-scale population-based research ever published on U.S. residents who travel to Mexico for health services. It is based on an analysis of 2001 data from the California Health Interview Survey (CHIS), the nation’s largest state health survey.

“What the research shows is that many Californians, especially Mexican immigrants, go to Mexico for health services,” said lead author Steven P. Wallace, associate director of the UCLA Center for Health Policy Research, which conducts CHIS. “We already know that immigrants use less health care overall than people born in the U.S. Heading south of the border further reduces the demand on U.S. facilities.”

Cost and lack of insurance were primary reasons both Mexican and non-Mexican U.S. residents sought health services across the border.

Both “long-stay” Mexican immigrants (those in the U.S. for more than 15 years) and “short-stay” immigrants (less than 15 years) have high rates of uninsurance: 51.5 percent of short-stay immigrants and 29 percent of long-stay immigrants do not have medical insurance.

“This points to the importance of expanding work-based insurance in health care reform, since virtually all Mexican immigrants are in working families,” said co-author Xochitl Casteñada, director of the Health Initiative of the Americas at the University of California, Berkeley.

Both short-stay and long-stay immigrants have even higher rates of uninsurance for dental care: 77.6 percent and 51.6 percent, respectively.

Not surprisingly, dental care was the most common service obtained by immigrants.

Among non-Latino whites, prescription drugs were the most common medical service obtained in Mexico.

Long-stay immigrants used Mexican health services the most, with 15 percent reporting crossing the border during a year’s time for health services. Half of these long-stay immigrants lived far - more than 120 miles - from the border.

Long-stay immigrants are more likely to be documented than short-stay immigrants, Wallace noted, which makes it easier for them to travel back and forth to Mexico.

Short-stay immigrants - those most likely to be undocumented - were also the least likely to need medical care in all areas, with one exception: mental health.

“Undocumented immigrants tend to be younger, stronger and consequently healthier,” Wallace said. “But they are also the most stressed out, as many are struggling economically, culturally and linguistically.”

Short-stay immigrants who sought treatment in Mexico were more often women and were more likely to tell their doctor they were feeling “sad or down.”

Other findings:

• Immigrants who travel to Mexico for health services are not necessarily the poorest. One explanation: The cost of travel may offset any financial savings, creating a disincentive for the very poor to travel.

• Although cost was the primary factor in seeking health services, cultural and linguistic barriers and immigration factors were also important motivators.

How often immigrants cross the border to Mexico for health services is particularly relevant to efforts to create and expand binational health insurance plans, Wallace said.

Since 2000, several private insurance companies and at least one employer group have developed such plans, which cover an estimated 150,000 California workers who use Mexican medical facilities near the border.

These plans may be both more cost-effective for employers and more culturally relevant for participants, Wallace said.

“To the extent that binational plans encourage more people to access preventative and other health care, they should be encouraged,” he said.

Source:
Gwen Driscoll

University of California - Los Angeles

Ark Therapeutics Group plc (’Ark’ or the ‘Company’) announces that the first patient has been enrolled into the US Phase III study for Trinam®. Trinam® is Ark’s novel gene-based medicine to prevent blood vessels blocking in kidney dialysis patients who have undergone vascular access graft surgery. The product is an adenovirus-mediated VEGF D gene delivered with a novel biodegradeable local delivery device (EG001).

The Phase III study is a US multi-centre, randomised, controlled trial, in which the efficacy and safety of Trinam® will be investigated in patients with end-stage renal disease (ESRD) requiring vascular access for haemodialysis. Patients with ESRD will be randomised to receive either Trinam® in addition to standard care or standard care alone at the time of surgical placement of a synthetic PTFE graft for vascular access. Primary Unassisted Patency (time to any first intervention) will be the primary regulatory endpoint. Overall patency and a number of other important pre-defined clinical endpoints will also be measured.

The safety of the trial will be assessed by an independent Data and Safety Monitoring Board (DSMB) against a pre-specified set of stopping rules defined during the Special Protocol Assessment (SPA). The DSMB will also undertake a blinded ’sizing’ analysis after 150 patients have been enrolled to determine the final trial size. This type of adaptive design assists groundbreaking drugs to ensure robust efficacy data are available to satisfy regulatory requirements as approval standards evolve.

Results from a Phase II open-label, non-randomised, standard-care controlled trial of Trinam®, reported in March 2007, indicated that the access grafts of patients given Trinam® remained functional for dialysis, on average, up to three times longer than in untreated controls. Trinam® was well tolerated with no quantifiable systemic distribution of the product found and no serious side effects were exhibited other than those consistent with the nature of the operation and underlying condition.

Trinam® was awarded Fast Track Status by the FDA earlier this month and has been granted Orphan Drug Status in both the US and Europe. US regulatory review for the product comes under the responsibility of the Centre for Biologics Evaluation and Research (CBER), the specialist biologics division of the FDA.

Dr David Eckland, Research and Development Director of Ark, commented: “We are very pleased to commence enrolment into the Phase III study for Trinam® which follows the Fast Track Status gained from the FDA earlier this month. There is a significant unmet therapeutic need in this indication and today’s news brings us a step closer to gaining approval for a product which we believe will transform the prognosis for many patients suffering from kidney failure.”

Dr Nigel Parker, CEO of Ark, added: “First patient enrolment is a significant milestone for this very important gene-based medicine and reflects the good progress we continue to make at Ark. Our whole portfolio is growing in strength and we look forward to announcing details of Trinam®’s continued progress in due course.”

Trinam®

Trinam® is a combination of a vascular endothelial growth factor gene in an adenoviral vector (Ad-VEGF-D) and Ark’s biodegradable local delivery collagen collar device (EG001). At the end of the access graft surgery procedure, the collar is fitted around the outside of the vein/graft join. The Ad-VEGF-D solution, which reduces the likelihood of blood clots and intimal hyperplasia, is then injected into the space between the wall of the collar and the blood vessel. This unique method of administration of the gene localises its delivery to the target tissue site, maximising efficacy, avoiding systemic distribution and thus minimising the potential for side effects.

Source
Ark Therapeutics Group plc

WASHINGTON, May 28 — The FDA has approved a system for replacing ankle joints deformed by arthritis that may preserve a greater range of motion than fusion surgery.

The Scandinavian Total Ankle Replacement (STAR) system, manufactured by Small Bone Innovations, is a mobile-bearing device consisting of two metal plates with bars that fit into the bone and a polyethylene spacer that moves between the plates like a ball bearing.

It is the “first of its type,” according to the FDA, which has approved several fixed-bearing devices in which “the articulating surface is molded, locked, or attached to one of its metallic components.”

The STAR system “more closely imitates the function of a natural ankle,” according to Daniel Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health.

It represents an alternative to fusion surgery, which involves cementing the tibia to the talus bone in the ankle, reducing the ability to move the foot up and down.

The approval was based, at least in part, on a study of 224 patients who were followed for at least two years. Those who were fitted with the STAR system had rates of adverse events, surgical interventions, and major complications similar to those in patients who had fusion surgery, according to the FDA.

As a condition of the approval, the device maker must evaluate the safety and effectiveness of the device over the next eight years.

‘Maximising Health Gain Through Community Pharmacy’ is the title of two jointly badged publications from pharmacy organisations CCA, NPA, RPSGB, PSNC and AIMp. The documents, which were produced in collaboration with the NHS Alliance, were launched to the NHS this week, as part of a strategy to promote the role of pharmacists to commissioners, managers, general practitioners and others in primary care. The documents also seek to influence the commissioning of pharmacy services by PCTs under World Class Commissioning and the integration of pharmacy into Practice Based Commissioning (PBC).

The guides - ‘10 High Impact Changes in PCT Commissioning Practice’ and ‘5 High Impact Changes for SHAs’ - have been produced as a provider perspective on commissioning. They provide PCTs and SHAs with suggestions of how to work with pharmacists in order to maximise their contribution to the development of PBC and commissioning.

The pharmacy bodies believe that the vision for delivering high quality care to patients will only succeed if all primary care professionals - including community pharmacists - are fully involved in the planning, redesign and delivery of new services. Commissioners want high quality providers: community pharmacy is already delivering a multitude of cost-effective services that benefit patients; it is ready and eager to further develop this service provision within a World Class Commissioning environment.

In a collective statement, the pharmacy organisations comment:

“It is important that PCTs and SHAs appreciate that pharmacy must be positioned within clinical frameworks to contribute effectively, strategically and authoritatively.

The objectives of our guides are threefold: to nurture collaborative approaches between PCT and practice based commissioners and local pharmacies; to robustly promote the role of community pharmacists as frontline NHS clinicians, and to highlight the valuable input pharmacists can make to both the commissioning and the provision of services through successful integration into primary care.

Community pharmacists are already introducing innovation in service re-design in areas such as prescribing, NHS Health Checks and sexual health, and with their increased involvement in PBC, the benefits to patients will continue to develop.

Our two publications provide up-to-date case studies and examples of best practice in how to work with pharmacy. We hope they will provide commissioners with more ideas about the health gain that community pharmacy can deliver, with simple practical suggestions for making it happen.”

Source
National Pharmacy Association

People with type 1 here.

According to the JDRF study, using CGM devices enables people who have achieved excellent control (with HbA1c levels below 7 percent) to continue to tightly manage their diabetes while cutting down on the frequency of low blood sugars, called hypoglycemia. Research has shown that good blood sugar control is a key factor in reducing the risk of the devastating long-term complications of the disease, such as blindness and kidney disease — but that the fear of low blood sugar emergencies often prevents many people from achieving tight control, and remains a constant concern for those who manage their diabetes well. The landmark Diabetes Control and Complications Trial (DCCT) showed that with intensive insulin therapy, excellent blood glucose control was obtained, but at the expense of a considerable increase in hypoglycemia. Today, the JDRF study has shown that, with CGM, hypoglycemia can be reduced while maintaining excellent blood sugar control.

The CGM study was a randomized and controlled trial involving 129 adults and children ranging in age from 8 to 69 years old at 10 sites, including the Atlanta Diabetes Associates, the Joslin Diabetes Center, Kaiser Permanente Southern California, Nemours Children’s Clinic - Jacksonville, FL, the Lucile Packard Children’s Hospital at Stanford University, the Barbara Davis Center for Childhood Diabetes at the University of Colorado Denver, the University of Iowa, the University of Washington, and Yale University, and coordinated by the Jaeb Center for Health Research in Tampa, Florida. Participants all had good diabetes control when they enrolled in the trial, and were randomly assigned to either a group that used CGM devices or one using standard finger-stick glucose testing for 26 weeks.

“The research suggests that CGM devices helped people who were already doing an excellent job of managing their diabetes continue to do so, while lowering the risk of pushing their blood sugar so low it causes hypoglycemia, which can be life threatening,” said Dr. Bruce Bode, Atlanta Diabetes Associates and one of the lead authors of the Diabetes Care paper. “These trials are showing that CGM not only helps people get into control, which can have a significant positive impact on lowering the risk of complications, but it enables them to stay in control without increasing the near-term risk of hypoglycemia. That’s terrific news for people with diabetes and their families.”

(People with diabetes try to maintain their blood sugar levels between 70 mg/dL and 180 mg/dL. When blood sugar becomes very low, people can become confused, lethargic, and even slip into a coma or die. Very high blood sugars can also be dangerous. And long term, lack of control increases the risk of developing devastating complications, including eye, kidney, nerve, and heart disease. HbA1c is a measure of long term blood sugar control; standards of good control are generally below 7% for adults, and below 7.5% to 8% for children, depending on age. According to the DCCT findings, every one point reduction in HbA1c reduces the risk of long-term complications by approximately 40%.)

According to the study, for the people using CGM devices the time the blood sugar level was below 70 mg/dL decreased by 37 minutes a day. This compared with a decrease in the control group of only 5 minutes a day. In other words, people in the CGM group spent almost two hours more time per day in the target blood sugar range of 71 to 180 mg/dL compared with the control group, and about half an hour less time per day with glucose values in the potentially dangerous hypoglycemia range. The authors demonstrated a number of other significant benefits in this population including:

• more people in the CGM group had an improvement in HbA1c of more than 0.3% (31% versus 5% in the control group)

• fewer had a worsening of HbA1c greater than 0.3% (28% versus 52%)
• more CGM users had a HbA1c level below 7% at 26 weeks (88% versus 63%)
• more people in the CGM group than the control group had a decrease in HbA1c of more than 0.3% without experiencing a severe hypoglycemic event (28% versus 5%).

Encouragingly, similar beneficial results were seen in children, adolescents, and adults spanning the ages of 8 to 69 years.

Dr. Aaron Kowalski, Program Director for Metabolic Control at JDRF, explained that in planning this study, the change in HbA1c was not selected as the primary outcome measure because the researchers did not anticipate being able to lower HbA1c levels in the CGM group, given their already exquisite level of control. He noted that the study group expected that there might even be small and clinically insignificant increases in HbA1c values in the CGM group if the devices were able to help them reduce the frequency of glucose levels below 70 mg/dL. Instead, the CGM group was able to maintain HbA1c levels with less biochemical hypoglycemia, whereas HbA1c levels rose over time in the control group. He noted that all the HbA1c outcomes favored the CGM over the control group.

Major eligibility criteria for the study included people over the age of 8 who had type 1 diabetes for at least one year, who either used an insulin pump or took at least three daily insulin injections, and had HbA1c levels below 7.0%. Subjects in the control group were given blood glucose meters and test strips and asked to perform blood glucose monitoring at least four times daily, and met with study personnel as often as the CGM group.

The study is the second major publication resulting from JDRF’s groundbreaking CGM trials, established to clinically document the benefits of CGM devices in helping people with type 1 diabetes manage their disease more effectively. In results published last fall in The New England Journal of Medicine, the JDRF Continuous Glucose Monitoring Study Group reported that CGM substantially improved blood sugar levels without increasing the frequency of hypoglycemia in adults over 25 years of age in a randomized trial of 322 adults and children with type 1 diabetes and HbA1c levels above 7 percent. (Like virtually every other study of a new drug or device in the treatment of type 1 diabetes, because lowering of HbA1c was the primary outcome of interest, that study excluded individuals already reaching target HbA1c levels lower than 7 percent. As a result, the study group also conducted a separate, concurrent randomized trial to evaluate the efficacy and safety of CGM in adults and children with type 1 diabetes who already had successfully achieved HbA1c levels less than 7 percent with intensive insulin therapy.) More information on the initial results of JDRF’s CGM trials and on the Artificial Pancreas Project is available online at http://www.artificialpancreas.org/.

Dr. Kowalski noted that over the past 15 years, the use of rapid and long-acting insulin analogs, improvements in insulin pumps, and more frequent home blood glucose monitoring have had a positive impact on the ability of people with type 1 diabetes to achieve blood sugar control targets. However, the rates of severe hypoglycemia remain too high and the occurrence of such events is often followed by a decline in glycemic control due to fears of further hypoglycemic episodes. Hypoglycemia remains the major limiting factor for people with type 1 diabetes in trying to achieve and maintain good blood sugar control. These study results are extremely encouraging in showing that hypoglycemia can be reduced without sacrificing glycemic control.

About Type 1 Diabetes

Type 1 diabetes is an autoimmune disease that affects children, adolescents, and adults, in which the immune system attacks cells in the pancreas that produce insulin, a hormone that enables people to convert food into energy. People with type 1 diabetes are dependent on insulin for the rest of their life. But insulin is not a cure, and people with diabetes are at significant risk for a wide range of serious complications, including heart disease, blindness and kidney disease. As many as 3 million people in the U.S. have type 1 diabetes.

About CGM Devices

CGM devices, manufactured by several companies and approved by the FDA as an adjunctive therapeutic for diabetes, provide both a real-time snapshot of the glucose levels of a person with diabetes, as well as trend information on whether glucose is moving upwards or downwards, and how fast. Devices also provide warnings when the glucose is becoming too high or too low.

Source:
Jillian Lubarsky

Juvenile Diabetes Research Foundation International

MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) announced that the efficacy portion of its first Phase 3 clinical trial evaluating its novel LEVADEX™ orally inhaled migraine therapy met all four primary endpoints. Additional endpoints showed that LEVADEX provided rapid and sustained pain relief for up to 48 hours after dosing.

Patients taking LEVADEX therapy (formerly referred to as MAP0004) had statistically significant improvement at two hours compared to patients on placebo for each of the primary endpoints:

- Pain relief: 58.7 percent of patients who received LEVADEX compared with 34.5 percent for placebo (p< 0.0001);
- Phonophobia free: 52.9 percent of patients who received LEVADEX compared with 33.8 percent for placebo (p< 0.0001);
- Photophobia free: 46.6 percent of patients who received LEVADEX compared with 27.2 percent for placebo (p< 0.0001); and
- Nausea free: 67.1 percent of patients who received LEVADEX compared with 58.7 percent for placebo (p=0.02).

A total of 792 patients were included in the primary data analysis as specified in the protocol of the FREEDOM-301 study, which was conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA). The patient population studied had more severe migraine pain than expected, with 46 percent reporting severe pain and 54 percent reporting moderate pain prior to administration of the study drug.

Results from additional pre-defined analyses include:

- LEVADEX therapy achieved statistically significant onset of pain relief at 30 minutes after dosing (p=0.03);
- While not statistically significant, 50% more of the patients receiving LEVADEX therapy than the patients receiving placebo reported pain relief at 10 minutes;
- LEVADEX therapy achieved statistically significant sustained pain relief from two to 24 hours (p<0.0001), as well as two to 48 hours (p<0.0001, when unadjusted for multiplicity);
- LEVADEX therapy achieved statistically significant pain freedom (pain symptom score = 0) as early as 30 minutes (p=0.002, when unadjusted for multiplicity); and
- LEVADEX therapy achieved sustained pain freedom from two to 24 hours, as well as two to 48 hours (p<0.0001 for both time points, when unadjusted for multiplicity).

There were no drug-related serious adverse events reported in the trial. LEVADEX was well tolerated, with the most common adverse event reported being medication aftertaste at six percent, with two percent of patients receiving placebo also reporting medication aftertaste. The next most common adverse event was nausea at five percent, compared with two percent for placebo. Symptoms or sensitivities typically associated with commonly used triptan migraine treatments, such as chest discomfort (one percent) or chest pain (0 percent), were rare and comparable to placebo. There were no changes in lung function, as measured by spirometry, between the active and placebo groups.

“These results show the potential of LEVADEX to provide both rapid and sustained relief of all migraine symptoms to patients who suffer from migraine,” said Sheena Aurora, M.D., a FREEDOM-301 clinical study investigator, director of the Swedish Headache Center and assistant professor of neurology at the University of Washington School of Medicine. “Migraines are painful and can also be incapacitating, and current treatments serve only a minority of migraine sufferers. Patients continue to seek new migraine therapies that offer both fast and long-lasting relief from pain and migraine associated symptoms so that they can resume daily activities as quickly as possible. LEVADEX has the potential to address this unmet need and to be a first-line therapy for migraine.”

Migraine is a common, debilitating neurological disorder that affects approximately 30 million people in the United States, according to the National Headache Foundation. Limitations of oral triptans, the class of prescription drugs widely used for migraines, include slow onset of significant pain relief between 45 and 90 minutes, substantial variability in patient response and side effects such as heightened blood pressure.

“We are very pleased with these results and look forward to continuing development of LEVADEX with the goal of bringing this differentiated therapy to the many patients who suffer from the debilitating effects of migraine,” said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals. “Market research has shown that migraine patients want medications that can treat all symptoms of their migraine rapidly and that are long-lasting as well as convenient to take. Unlike currently available migraine therapies, we believe that LEVADEX has the potential to address all these patient needs and to offer a significant advancement in migraine therapy for this underserved patient population.”

“Importantly, LEVADEX showed sustained pain relief for up to two days in this trial with fewer of the side effects generally seen with commonly used migraine treatments. We believe that, if these findings are confirmed in a second Phase 3 trial and LEVADEX is approved for marketing, LEVADEX could offer significant benefit to many of the 30 million migraine sufferers in the U.S., including many who are not helped by currently available migraine medications,” said Shashidhar H. Kori, M.D., vice president of clinical development and medical affairs of MAP Pharmaceuticals.

The company plans to present further data from this trial at an upcoming medical conference.

FREEDOM-301 Trial Design

FREEDOM-301 is a multi-center, randomized, double-blind, placebo-controlled Phase 3 trial designed to evaluate the safety and efficacy of LEVADEX as a potential treatment for acute migraine. Primary efficacy measures include pain relief, and being phonophobia, photophobia and nausea free at two hours after dosing. FREEDOM-301, the first Phase 3 study of LEVADEX therapy, was conducted pursuant to a Special Protocol Assessment with the U.S. Food and Drug Administration .

A total of 792 patients (ages 18 to 65) were included in the modified intent to treat population used for primary data analysis, as specified in the protocol. Patients enrolled in the trial were evaluated for the treatment of a single moderate or severe migraine, and then were given the option to continue in an open label, long-term safety arm. This safety arm is targeting 300 patients for six months and 150 patients for 12 months, and over 500 patients are continuing in this arm of the trial.

About LEVADEX™

LEVADEX orally inhaled migraine therapy is a novel migraine therapy in Phase 3 development. Patients administer LEVADEX themselves using the company’s proprietary TEMPO® inhaler. LEVADEX has been designed to be differentiated from existing migraine treatments. It is a novel formulation of dihydroergotamine (DHE), a drug used intravenously in clinical settings to effectively and safely treat migraines. Based on clinical results, the company believes that LEVADEX has the potential to provide both fast onset of action and sustained pain relief and other migraine symptom relief in an easy-to-use and non-invasive at-home therapy.

LEVADEX is designed to incorporate the multiple beneficial mechanisms of action that allow DHE to block initiation of migraine, limit pain, reduce inflammation and stop a migraine at any point in the migraine cycle. Based on research to date, including the FREEDOM-301 trial, the company believes the unique pharmacokinetic profile of LEVADEX has the potential to effectively treat migraines, while minimizing the side effects commonly seen with DHE and other currently available medicines.

About Migraine

Common symptoms of migraine include recurrent headaches, nausea, vomiting, photophobia (sensitivity to light) and phonophobia (sensitivity to sound). According to the National Headache Foundation, most migraines last between four and 24 hours, but some last as long as three days. On average, migraine sufferers experience 1.5 migraine attacks monthly, although 25 percent of them experience one or more attacks weekly, according to published studies. Migraine patients report that currently approved drugs do not fully meet their needs due to slow onset of action, short duration of effect, inconsistent response and unacceptable side effect profiles. The economic burden of migraine remains substantial despite existing treatments, with the direct and indirect costs of migraine in the United States estimated at over $20 billion annually.

Source
MAP Pharmaceuticals

Boston Scientific Corporation (NYSE: BSX) announced it has received approval from the U.S. Food and Drug Administration (FDA) to market its TAXUS(R) Liberte(R) Atom(TM) Paclitaxel-Eluting Coronary Stent System, a highly deliverable, next-generation drug-eluting stent (DES) specifically designed for treating small coronary vessels. It was approved for use in vessels as small as 2.25 mm in diameter and joins the TAXUS(R) Express(R) Atom(TM) Stent as the only drug-eluting stents approved for small vessel use in the U.S. The Company plans to begin a full U.S. launch of TAXUS Liberte Atom next month.

“The rapid adoption of the TAXUS Express Atom Stent has confirmed the need for this type of stenting option in the treatment of small-vessel coronary artery disease,” said Mark Turco, M.D., F.A.C.C., F.S.C.A.I., Director of the Center for Cardiac and Vascular Research at Washington Adventist Hospital, Takoma Park, Maryland. “The TAXUS Liberte Atom Stent provides clear design and deliverability advantages. Additionally, in the TAXUS Atlas Small Vessel clinical trial, the TAXUS Liberte Atom Stent yielded a two-year target lesion revascularization rate that was 60 percent less than the TAXUS Express Atom Stent. I am pleased to be able to offer this option to my patients.”

Data from numerous clinical studies have shown that an estimated 10 percent of patients undergoing percutaneous coronary interventions have small vessels (<2.5 mm). Until recently, many physicians were inclined to implant bare-metal stents in these patients since they were the only approved stenting option for small vessels. Last year's launch of the TAXUS Express Atom Stent offered an alternative treatment choice for patients with small vessels who will now have the additional option of the TAXUS Liberte Atom Stent.

The TAXUS Liberte Stent features design improvements over the Company’s first-generation TAXUS Express Stent, including thinner struts to allow better stent deliverability and conformability, as well as uniform stent geometry for consistent lesion coverage and drug distribution.

Boston Scientific offers the industry’s widest range of coronary stent sizes. The Company expects to expand its stent portfolio later this year with the first 38 mm long DES, the TAXUS(R) Liberte(R) Long Stent, which is currently under review with the FDA.

TAXUS Stents have been evaluated by the industry’s most extensive randomized, controlled clinical trial program, with follow-up to five years in some cases. These trial results have been supplemented by data on more than 35,000 patients enrolled in post-approval registries. To date, approximately 11 million Boston Scientific stents have been implanted globally, making them the world’s most frequently used stents.

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties

TAXUS Stents have been evaluated by the industry’s most extensive randomized, controlled clinical trial program, with follow-up to five years in some cases. These trial results have been supplemented by data on more than 35,000 patients enrolled in post-approval registries. To date, approximately 11 million Boston Scientific stents have been implanted globally, making them the world’s most frequently used stents.

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding clinical trials, product performance, competitive offerings, procedural volume, overall market size and our market position. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.

Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and, future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A - Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A - Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file thereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.

Source: Boston Scientific Corporation

PAREXEL International Corporation (Nasdaq: PRXL), a leading global biopharmaceutical services provider, announced it has reached a milestone in managing oncology-based clinical trials over the last five years, which have involved over 175,000 patients in hundreds of programs across 80 countries. PAREXEL will be marking this milestone during the American Society of Clinical Oncology (ASCO) Annual Meeting, to be held May 29 - June 2, 2009 in Orlando, Florida. PAREXEL’s hematology and oncology experts will be available during the ASCO meeting at Booth #1980 to discuss their capabilities to support the successful development of novel cancer treatments.

“Significant advances in targeted therapies for cancer have generated more competition for patient populations. To meet industry demand for conducting cancer trials across a broad range of indications, PAREXEL continues to leverage our global footprint and ability to manage complex programs on a worldwide scale to help biopharmaceutical companies access diverse patient populations, navigate regulatory issues, and identify effective investigators,” said Mark A. Goldberg, M.D., Chief Operating Officer, PAREXEL International.

“With approximately 10 million people diagnosed with cancer each year worldwide, PAREXEL works with biopharmaceutical companies toward the goals of improving the development success rate for oncology drugs and getting treatments to patients sooner,” said Denis R. Miller, M.D., Senior Medical Director, Clinical Research Services, PAREXEL. “Our global team of hematology and oncology experts helps clients advance important innovations through our understanding of unmet medical needs, the standards of available cancer care worldwide, and how new anticancer agents will be positioned in the treatment of patients, from the earliest phases of clinical development through the approval process and into post-marketing.”

PAREXEL has experience across a broad range of cancer indications as well as all classes of therapeutics including cytotoxics, biologics, targeted therapies, immunotherapies, vaccine therapies, and supportive treatments, such as blood products, growth factors, antiemetics, and analgesics. PAREXEL’s Hematology/Oncology Therapeutic Area Team offers expertise to help clients with every facet of drug development, including protocol review, safety assessment, clinical development, medical imaging, technology integration, regulatory affairs, and product lifecycle management. Comprehensive services provided by the team include the planning, design, and management of feasibility studies, Phase I - IV trials, and post-marketing studies as well as site selection, patient recruitment, data analysis, non-clinical evaluation, and IND/NDA submissions. PAREXEL leverages the experience and relationships its experts have with leading cancer centers and key opinion leaders in its ongoing collaborative efforts.

PAREXEL applies a proven, therapeutically focused expertise methodology to clinical development programs across a broad range of areas. For more information about PAREXEL’s in-depth expertise in the oncology, central nervous system (CNS), cardiovascular, infectious disease therapeutic areas, as well as a broad range of other therapeutic areas, visit: http://www.parexel.com/clinical_research/therapeutic_expertise.html.

About PAREXEL International

PAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, medical communications and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

This release contains “forward-looking” statements regarding future results and events. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects,” “intends,” “appears,” “estimates,” “projects,” “targets,” and similar expressions are also intended to identify forward-looking statements. The forward-looking statements in this release involve a number of risks and uncertainties. The Company’s actual future results may differ significantly from the results discussed in the forward-looking statements contained in this release. Important factors that might cause such a difference include, but are not limited to, risks associated with: actual operating performance; actual expense savings and other operating improvements resulting from recent restructurings; the loss, modification, or delay of contracts which would, among other things, adversely impact the Company’s recognition of revenue included in backlog; the Company’s dependence on certain industries and clients; the Company’s ability to win new business, manage growth and costs, and attract and retain employees; the Company’s ability to complete additional acquisitions and to integrate newly acquired businesses or enter into new lines of business, including, but not limited to, the successful business integration and anticipated synergy achievements in connection with the ClinPhone acquisition; the impact on the Company’s business of government regulation of the drug, medical device and biotechnology industry; consolidation within the pharmaceutical industry and competition within the biopharmaceutical services industry; the potential for significant liability to clients and third parties; the potential adverse impact of health care reform; and the effects of exchange rate fluctuations and other international economic, political, and other risks. Such factors and others are discussed more fully in the section entitled “Risk Factors” of the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2009 as filed with the SEC on May 8, 2009, which “Risk Factors” discussion is incorporated by reference in this press release. The forward-looking statements included in this press release represent the Company’s estimates as of the date of this release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company’s estimates or views as of any date subsequent to the date of this press release.

PAREXEL is a registered trademark of PAREXEL International Corporation, and Perceptive Informatics is a trademark of Perceptive Informatics, Inc. All other names or marks may be registered trademarks or trademarks of PAREXEL International Corporation, Perceptive Informatics, Inc. or their respective owners and are hereby acknowledged.

Source: PAREXEL International Corporation

Could a holiday in the sun reduce the risk of developing multiple sclerosis? In a recent review for F1000 Medicine Reports, Bridget Bagert and Dennis Bourdette highlight recent advances in potential treatments.

Multiple sclerosis (MS) results from a failure of the body to recognize itself. The immune system attacks and destroys the sheath that protects nerve fibres, as if it were a foreign body or infection. Vitamin D, which is produced in the skin in response to natural sunlight, is an immune system regulator. This might explain why MS is less common in sunnier countries.

Giving MS sufferers vitamin D pills - or encouraging them to spend more time in the sun - might be a cheap and easy treatment. Bagert and Bourdette point out that oral vitamin D therapy is now in phase II clinical trials, to see how well it works and how much would be needed.

They say “The arrival of effective oral agents will give MS patients more therapeutic options and will be a major advance in the global effort to alter the natural history of this chronic disease”.

Dennis Bourdette, Faculty Member for F1000 Medicine, is chairman of the Department of Neurology and director of the Multiple Sclerosis and Neuroimmunology Center at Oregon Health and Science University, USA.

Bridget A Bagert is a member of the Department of Neurology, Louisiana State University Health Sciences Center, USA

The full text of this article is available at http://www.f1000medicine.com/reports/10.3410/m1-34/.

Source:
Kathleen Wets

Faculty of 1000: Biology and Medicine

Couples are being asked to replace their usual form of birth control with a new male contraceptive in a study to test its effectiveness.

Researchers at The University of Manchester, working in collaboration with nine other centres across the world, will ask men in stable relationships to take part in the trial of the hormonal contraceptive.

The research, which follows a similar trial in China published earlier this month involving testosterone injections, will involve male volunteers aged 18 to 45 being given injections of testosterone along with a second hormone that has been shown to reversibly suppress sperm production.

The combination of two hormones means the trial will require half the frequency of injections as the Chinese study. The two hormones - Norethisterone enantate and Testosterone undecanoate - have already undergone trials to test their safety and were shown to have only mild side-effects in a small number of individuals.

The trial will initially involve up to four courses of injections over six months, during which time the men’s sperm count will be measured to ensure it is below fertility levels.

The couples - 60 in Manchester and a further 340 internationally - will then be asked to rely solely on the hormonal method for 12 months while the male partner continues to receive the injections every eight weeks.

At the end of the trial period, the men’s sperm count will continue to be monitored to assess how quickly fertility levels return to normal.

Lead researcher Frederick Wu, Professor of Medicine and Endocrinology, said: “There is currently a great imbalance of contraceptive methods between men and women with almost 20 different female methods compared to only condoms and vasectomy for men.

“The World Health Organisation wants to provide more male contraceptive choices - especially reversible methods - to allow couples to better plan their families.

“We know from previous studies that any side-effects are minor, while the risk of pregnancy with this hormonal treatment is similar to that of the female pill and far less than the risks posed by using barrier methods alone.

“Couples taking part in the trial are likely to be married or in long-term relationships and may be looking for alternatives to their existing methods of contraception.”

Source
The University of Manchester

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