’60 Minutes’ report explores fungal meningitis outbreak
ALEXANDRIA, Va. — A report on CBS’ "60 Minutes" Sunday explored the aftermath of the nationwide outbreak of fungal meningitis linked to the New England Compounding Center that, according to the Centers for Disease Control and Prevention, has sickened 720 people in 20 states and led to 48 deaths.
But "aftermath" might not necessarily be an appropriate word for the people who contracted the infection, for which there is no cure, but who must continue taking medication to treat it and suffer debilitating symptoms.
In the report, former employees of the NECC, which has since declared bankruptcy, talked about alleged means the company’s managers used to evade the scrutiny of regulators as the pharmacy, in employees’ view, had transitioned from a small operation to a manufacturing center and started ignoring safety and sanitary regulations in order to increase volume.
"This story appropriately shines a spotlight on the terrible patient suffering that occurred as a result of the irresponsible actions of NECC, and it reinforces the need to ensure proper oversight by health officials," National Community Pharmacists Association CEO B. Douglas Hoey said in a statement. "The accounts of former NECC employees that were reported in the story persuasively reinforce the views of NCPA and others that NECC was in fact evading necessary regulation in part by purporting to be a compounding pharmacy."
The report included an interview with Food and Drug Administration commissioner Margaret Hamburg, who has called for increased federal authority over compounding pharmacies. But Hoey criticized the government’s response.
"As congressional hearings and investigations have made clear, prior to the tragic meningitis outbreak, the FDA and the Massachusetts Board of Pharmacy had adequate authority to take action against NECC," Hoey said. "They could have acted to mitigate or potentially even prevent patient suffering. Sadly, they did not."
Legislation would expand Texas pharmacists’ vaccination ability
AUSTIN, Texas — Legislation proposed in Texas’ state legislature would expand the range of vaccines that pharmacists can administer to children.
Currently, pharmacists in the state can administer the flu vaccine to children older than 7 years, but they can only administer other Centers for Disease Control and Prevention-recommended vaccines for tetanus, diphtheria and pertussis to those ages 14 years and older. The new legislation, including bills introduced in the state Senate and House, would allow pharmacists to administer those vaccines to children ages 7 years and older as well.
The proposed legislation drew praise from the Texas Pharmacy Association, which noted that the state ranks below the national average when it comes to immunization rates. The TPA cited a poll of 836 Texas voters conducted last month by Baselice and Associates showed that 93% of respondents agree that children, with parental consent, should be protected against common childhood diseases, while 87% agreed that trained pharmacists should be allowed to administer vaccines.
"Pharmacists are highly qualified and trusted healthcare providers who are in the best position to help meet the growing immunization demand and reduce the number of vaccine-preventable diseases for thousands of Texas children," TPA CEO Joe DaSilva said. "Unfortunately, there are still many immunizations that Texans do not have easy access to, including the highly contagious pertussis."
PhRMA: 907 biotech drugs, vaccines under development
WASHINGTON — Nearly 1,000 biotech drugs and vaccines for more than 100 diseases are currently under development, according to a new report.
The Pharmaceutical Research and Manufacturers of America released the report Monday, highlighting a genetically modified virus-based vaccine for skin cancer; a recombinant fusion protein for treating Type 2 diabetes; a monoclonal antibody for asthma; and an antisense therapy for leukemia. These were among 907 new biologics under development that included 338 treatments for cancer; 134 vaccines for infectious diseases; 71 medicines for autoimmune disorders; and 58 treatments for cardiovascular disease.
"These medicines reflect the cutting-edge research being conducted across the country by biopharmaceutical companies in order to provide new treatment options for patients," PhRMA president and CEO John Castellani said. "In order to realize the full potential of novel biologics to improve human health, it is essential to maintain public policy and regulatory environments to support the research and development that drives biomedical innovation."