Families rush to save their children after trial shows MS drug risks

A new report from Nationwide Children’s Hospital in Columbus, Ohio, is particularly disturbing for parents.

The hospital’s Pediatric Outcomes Surveillance Consortium analyzed data from the 12-week pediatric clinical trial COVID-19, in which participants received an otherwise available therapy called interferon beta for relapsing multiple sclerosis (MS).

The study found that the number of newly diagnosed cases of the neurodegenerative disease rocketed from 35 patients in the first two weeks to 66 patients in the sixth week.

“These numbers are dramatic,” said Dr. Bennett Weinbaum, a neurologist at Nationwide Children’s and the study’s lead author. “We do not have very good data yet on the long-term health effects of interferon beta, so what this really tells us is a huge problem.”

Interferon beta is not a medication per se, but a form of treatment that stimulates the immune system’s T cells, a group of white blood cells that help defend the body against infection. Interferon beta has been used to treat autoimmune diseases, such as multiple sclerosis, since its discovery in 1950.

The researchers looked at information from patients who were in the clinical trial between September 14 and November 21, 2016. They estimated that 596 newly diagnosed cases of MS were reported by pediatric neurologists between October 22 and February 1, 2017.

“This study demonstrates the worrisome nature of an over-the-counter, inexpensive drug that has been used routinely for decades in the community, when the major researchers in the field were not looking,” said Dr. David Misrahi, a neurologist at Fox Chase Children’s Hospital in Philadelphia, in a news release. Misrahi was not involved in the study.

There were no deaths or deaths related to stroke in the trial. For children and adults taking the drug, the rate of serious adverse effects was 0.44 per 1,000 days. So far, this rate hasn’t dramatically changed from two weeks ago, Weinbaum said.

Relying on the clinical trial’s results, MS treatment may soon be curtailed.

The Centers for Medicare and Medicaid Services’ Payment Advisory Commission is considering lowering the MS drug discount rate, which insurers use to pay for the medicine.

The panel will consider lowering the discount from between 25% and 35% to between 15% and 25%, after a previous decision was reversed by the agency’s commissioners. If the figure is lowered, then there is potential that CMS will continue to allow the current discount rate in its decision for 2019. CMS plans to make a final decision in the fall of 2019.

For some, this development is seen as a victory. Dr. Sidney Wolfe, of Public Citizen, a consumer advocacy group in Washington, had petitioned CMS to review the use of MS drugs on Medicaid patients and started the Pay for Results program in 2015 to encourage lowering of their discount rate.

In July, the Physicians Committee for Responsible Medicine, a Virginia-based anti-meat group, also petitioned CMS to lower MS discount rates, urging the agency to put “the needs of sick children first.”

For other people, the news is not as good.

For Todd Barker, 47, of Falls Church, Virginia, the news is “devastating,” he told CNN affiliate WTVR. His son Tyler, 9, was diagnosed with MS at 3 years old.

Doctors suggested Tyler receive a new drug, Ocrevus, after hearing how helpful interferon beta was for “my son’s ailing joints,” Barker said.

But according to Meier, who knew of MS patients benefiting from interferon beta, this drug “should not be prescribed to children and adolescents.” In order to recruit people in COVID-19, Meier said, there were dosages given that were 100 times higher than what a doctor would give to a patient.

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