Closer Look
In a 'tug of war,' Europe tries to revamp drug development and access
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How do you make the European pharmaceutical industry more competitive while making sure people in all 27 member countries can get the medicines they need? Those two challenges inspire draft legislation the European Commission will unveil Wednesday, an ambitious effort whose last legislative foray came 20 years ago. The proposals reflect what has changed since then: the dawn of rare disease therapies and other specialized treatments, persistent shortages, and inequitable access to medicines, among other weaknesses exposed by the Covid-19 pandemic. The goals include:
- Reworking incentives for drug development
- Preparing for drug shortages
- Altering the availability of medicines throughout the E.U.
- Streamlining the European Medicines Agency to speed drug approvals.
Resolving these issues will take time, Victor Maertans of the pharmaceutical trade group EUCOPE warned. "The European Commission is trying to address too many problems with one piece of legislation, so there is this tug of war." STAT's Andrew Joseph and Ed Silverman explain.
cancer
Vitamin D levels linked to how melanoma patients respond to checkpoint inhibitors
Vitamin D has many beneficial effects, among them helping our bodies absorb bone-building calcium and phosphorus. There's also evidence it can help the immune system. A new study published today in Cancer also links vitamin D levels to how well patients with advanced skin cancer fared when receiving immunotherapies known as checkpoint inhibitors. Researchers measured vitamin D levels in the blood of 200 patients with melanoma every three months while they got the drugs nivolumab (Opdivo) or pembolizumab (Keytruda). Just over 36% of patients with low vitamin D levels responded to the immunotherapy, but 56% of the patients with normal vitamin D did. After finishing treatment, cancers progressed after almost six months in the low-vitamin D group but it took a little over 11 months in the normal vitamin D group. Overall survival, however, was not significantly different. The researchers say vitamin D could be boosting the immune system during immunotherapy, but they call for more research.
vaccines
Opinion: How small vaccine stockpiles can keep disease outbreaks small
Equatorial Guinea and Tanzania are experiencing their first Marburg outbreaks. A safe and effective vaccine couldn't come soon enough for a disease with a mortality rate over 50%, Seth Berkley, CEO of Gavi, the Vaccine Alliance, writes in a STAT First Opinion. But Marburg could soon follow the Sudan strain of Ebola and have experimental vaccine candidates ready for testing under an emergency use listing.
While fast-tracking candidate vaccines represents a positive step forward in the race to stop these outbreaks and improve global health security, he writes it would have been better if stockpiles of vaccine were ready to go when the first cases were detected. There's no perceived market for selling these kinds of vaccines, but "this is a solvable problem," Berkeley argues. "The strategic use of relatively small vaccine stockpiles to stamp out outbreaks quickly is likely to become increasingly important." Read how that might be done.
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