Study: Additional therapy to MS drug may reduce disease activity
SEATTLE Using a steroid drug for multiple sclerosis in addition to an MS drug may reduce the amount of disease activity more than using the MS drug alone, according to a study presented as part of the Late-breaking Science Program at the American Academy of Neurology’s 61st Annual Meeting in Seattle, April 25 to May 2.
For the study, supported by Biogen Idec, people with MS received the steroid drug methylprednisolone in monthly “pulses,” or three doses over three days, in addition to regular weekly treatment with the drug interferon beta-1a. The steroid drug has typically been used only to treat acute MS attacks, not as an ongoing treatment.
The study involved 341 people with relapsing-remitting MS. Half of the participants received both drugs; half received only the interferon drug plus a placebo. The participants were seen every three months during the three-year study for evaluation.
The participants had the disease for an average of three years and had not yet received a such disease-modifying drug as interferon.
Those who received both drugs had 38% fewer relapses, or times when the disease is active, than those receiving only the interferon drug. They also improved slightly on a test of MS disability, while the scores for the placebo group decreased slightly.
At the beginning of the study and again after three years, the researchers measured the size of lesions in the brain that are a sign of disease activity. For those receiving both drugs, the lesions stayed the same size or shrunk, while the size of the lesions grew for those taking only interferon.
“These results indicate that these two drugs may have a synergy when taken together and provide a more beneficial effect on the disease activity,” said study author Mads Ravnborg, MD, of the Danish Multiple Sclerosis Research Center at Copenhagen University Hospital in Denmark. “This is a promising finding, as the benefit from interferon is only moderate and not everyone responds fully to the treatment, so anything we can do to boost those results is positive.”
Industry leaders hail new HHS chief, but make case for role in health reform
ALEXANDRIA, Va. Senate confirmation of Kansas Gov. Kathleen Sebelius to be the next secretary of the Department of Health and Human Services drew a positive but guarded reaction from the chain and independent pharmacy industries’ top advocacy groups.
Sebelius, a highly regarded state executive with experience in health policy issues, won Senate approval as the nation’s most powerful health care official on Tuesday, despite opposition from some Republicans over her pro-choice stance on abortion and her support for a larger government role in a reorganized U.S. healthcare system.
Responding to Sebelius’ confirmation, the leaders of the National Association of Chain Drug Stores and the National Community Pharmacists Association issued statements hailing the Senate’s confirmation and congratulating the new HHS secretary. Their support, however, was mixed with a plea for Sebelius to heed pharmacy’s concerns as the Obama Administration moves ahead with its plan to overhaul the healthcare system.
“As the former governor of Kansas, we believe Secretary Sebelius is already sensitive to the health care needs of rural population centers where community pharmacies are often the sole healthcare providers in the area,” noted NCPA EVP and CEO Bruce Roberts. “We hope the Secretary addresses numerous federal policies that limit patient access to our services, whether they are onerous regulations or insufficient reimbursements. If these concerns are left unresolved patients will see their health jeopardized and the ensuing treatment costs can be far more expensive.”
In a jointly signed letter dated April 27, Roberts and Kansas Pharmacists Association executive director Michael Larkin asked Sebelius to meet with a delegation of independent pharmacists next month to discuss issues of concern to pharmacy owners. The letter, co-signed by more than 150 independent pharmacy owners in Kansas, outlined the threats posed by Medicaid reimbursement cuts, restrictions on the sale of durable medical equipment and other impediments, and pointed out that a meeting could be arranged in Washington to coincide with NCPA’s 41st Annual Conference on National Legislation and Government Affairs, slated for May 11 to 13.
NACDS president and CEO Steven Anderson also congratulated Sebelius. But he also took pains to point up the prominent role community pharmacists should play in a reorganized, more cost-effective and more patient-responsive and localized healthcare network.
“We look forward to working with Secretary Sebelius and her staff to comprehensively reform our nation’s healthcare system,” Anderson said. “As the face of neighborhood health care, pharmacy is enjoying a positive dialogue with President Obama’s administration and Congress to address healthcare affordability, accessibility and quality.
“Pharmacists are a wealth of knowledge, experience and expertise and can greatly assist the nation in the on-going debate,” Anderson added. “By counseling and educating their patients on the proper use and adherence to prescription drug medications, community pharmacists can improve patient care and quality, reduce healthcare costs and improve health outcomes.”
Sebelius, an early supporter of Obama’s bid for the presidency, filled a void as HHS cabinet nominee following the withdrawal of Tom Daschle from consideration following revelations of a delinquent tax payment problem early this year. As a two-term Democratic governor in a strongly Republican state, she won respect for her ability to reach across the aisle and form bipartisan consensus on key issues. She also has experience on health care issues: prior to her election as governor, she was Kansas’ health commissioner for eight years, and rallied support in a successful battle to prevent the sale of the state’s insurance program, operated by Blue Cross/ Blue Shield, to a private health insurer, arguing the sale would have led to higher premiums for state consumers.
Sebelius also won broad support last year for a campaign to reform state-funded health care programs by emphasizing personal responsibility for health and wellness, supporting preventive care initiatives and broadening health coverage to more of the uninsured.
One concern for community pharmacy and pharmaceutical company advocates, however, may be the governor’s pro-importation stance. According to her own website, Sebelius has pushed a program in Kansas that allows state residents to purchase drugs from some approved pharmacies in Canada and Europe.
FDA grants orphan drug designation to Antigenics
NEW YORK The Food and Drug Administration has granted orphan drug status to an investigational treatment for a rare but deadly cancer.
Antigenics announced Thursday that the FDA had given the status for its drug Oncophage (vitespen), used to treat the brain cancer glioma. The European Medicines Agency granted a similar designation to Oncophage in March.
“Glioma is such an aggressive and challenging cancer that when patients are diagnosed with recurrence of this life-threatening disease, they rarely live beyond six months,” University of California San Francisco neurological surgery associate professor Andrew Parsa said.
Parsa is the lead investigator of a phase 2 trial evaluating Oncophage as a glioma treatment.
Data from a phase 1 trial announced in November showed that vaccination with Oncophage following brain cancer surgery increased overall median survival to more than 10 months, with four patients surviving beyond a year and one patient surviving almost two-and-a-half years. By comparison, the historical median survival rate for glioma patients after surgery is six-and-a-half months.
The FDA grants orphan drug designation to drugs used to diagnose, prevent or treat medical conditions that affect fewer than 200,000 people in the United States. The designation entitles drug makers to seven years of market exclusivity, compared to the five normally given under the Hatch-Waxman Act of 1984.