California companies are developing new medicines for diabetes: Report

Pharmaceutical research and biotechnology companies based in California are researching and developing 58 new medicines for diabetes, a chronic disease that afflicts 220 million patients worldwide, including 23.6 million Americans, a new report shows.

“New medicines for this condition are important considering that more than 50 million Americans have it”

The 58 medications being worked on by California companies make up a fourth of the record 235 treatments for the disease and its closely related conditions that are being developed by all of America's pharmaceutical research and biotechnology companies.

The new medications are listed in the report "Medicines in Development for Diabetes: 2010," which is published by the Pharmaceutical Research and Manufacturers of America (PhRMA).

"Clearly, there is an urgent need for our companies to focus on diabetes, the nation's fifth deadliest disease," said PhRMA Vice President Ed Belkin. "Since 1987, the diabetes death rate has increased by 45 percent even as the death rates for heart disease, stroke and cancer have declined."

Belkin stressed that nearly eight percent of the U.S. population had diabetes in 2007 "and the price tag for the disease that year exceeded $170 billion. In California, a report last year showed diabetes had doubled over the last decade and the state had the 11^th worst ratio of people in the nation with the disease."

The development of new medicines is particularly important for minorities, including Latino residents. "According to the California Diabetes program, slightly more than 10 percent of all Latinos living in the United States have diabetes and, on average, Latinos are nearly two times more likely to have this long-term chronic disease than non-Hispanic whites of similar age," said Dr. Aliza A. Lifshitz, former four-term president of the California Hispanic Medical Association and a physician in internal medicine at Cedars-Sinai Medical Center in Los Angeles.

Dr. Lifshitz, a popular Spanish language media columnist and commentator, stressed the urgent need for new medicines for a disease "that has affected so many patients in Latino communities throughout California and, for that matter, the nation. In Los Angeles County alone, at least 600,000 adults suffer from diabetes. We still have a very long road to travel before we can claim a victory, but with more than 200 medicines in development, we have new treatment options to look forward to."

Nearly 50 of the 235 new medicines for diabetes and its related conditions are in the final phase of clinical testing and for eight of the drugs, applications have been submitted to the U.S. Food and Drug Administration for review. The development of these new diabetic treatments requires billions of dollars. The average cost of developing a new drug today is $1.3 billion and it often takes 10 to 15 years to create a new medicine and get it approved.

The 58 medicines being developed by California companies are mainly for Type 2 diabetes, which accounts for 90 to 95 percent of diabetes cases "and it is nearing epidemic proportions," Belkin said. "While lifestyle changes such as weight loss, combined with exercise, can reduce the risk of developing the Type 2 disease, medicines have been critical to improving and lengthening the lives of those suffering from it."

California's pharmaceutical and biotechnology companies are also working on medicines for diabetic neuropathy, which causes nerve damage in the arms, hands, legs and feet. "It's important to have treatments for this condition because it often worsens over time and the loss of sensation and other problems associated with serious nerve damage make a patient prone to developing open sores that can become infected and may not heal," Belkin said. "This serious complication can lead to the loss of a foot, leg or even a life."

Metabolic syndrome and macular edema are the other diabetic targets of California companies. Patients who have metabolic syndrome are at increased risk of developing coronary heart disease, other diseases caused by plaque buildup in artery walls and Type 2 diabetes. "New medicines for this condition are important considering that more than 50 million Americans have it," Belkin noted.

Macular edema is a condition that features fluid leaking into the part of the eye where "sharp, straight-ahead vision occurs," he said. "The fluid causes swelling and blurred vision. Macular edema can occur at any stage of diabetic retinopathy, which is the most common diabetic eye disease and a leading cause of blindness in American adults."

A key challenge in California and many other states is making sure diabetics and other chronic disease sufferers who are uninsured or struggling financially are able to obtain the medicines they need consistently. Last year, 21 percent of Californians were uninsured. And through May, the unemployment rate in the state was 12.4 percent.

The insurance problem is particularly acute among Latinos: though they represent about a third of California's population, they account for 54 percent of the uninsured, according to a 2005 research brief compiled by the Latino Coalition for a Healthy California.

"It is important to provide assistance programs that offer needed medicines for free or nearly free," Belkin said. "That's why America's pharmaceutical research and biotechnology companies sponsor the Partnership for Prescription Assistance (PPA)."

The PPA is a single point of access to more than 475 assistance programs that provide free or heavily discounted medicines to eligible patients. Nearly 200 of the programs are offered by the pharmaceutical companies themselves, including firms in California.

"Two months ago, the PPA celebrated its five-year anniversary," PhRMA's Belkin said. "And so far, more than 6.5 million Americans, including well over 350,000 Californians, have been connected to patient assistance programs that might help them."

Patients seeking assistance can call 1-888-477-2669 or access a Web site (www.pparx.org). "Those who need help obtaining their medicines should not hesitate to call the toll-free number if they want to talk to someone," said Dr. Lifshitz, the former head of the California Hispanic Medical Association. "The operators who man the toll-free call centers speak 150 languages, including Spanish."

The PPA also offers information on more than 10,000 free health care clinics in America and more than 40 of its patient assistance programs address the special health needs of children.