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.