More isotope woes forecast
The fragility of the world’s medical isotope production chain is again expected to disrupt supply this summer. Europe’s Association of Imaging Producers and Equipment Suppliers issued an “urgent update” indicating that 2 of Europe’s 3 isotope-producing nuclear reactors will undergo extended maintenance shutdowns over the course of the year, which will likely limit the availability of isotopes (http://interactive.snm.org/docs/Update_04FEB_Production_TC99.pdf).
Noting that a global workshop organized by the International Atomic Energy Agency in February indicated that Canadian suppliers are now operating beyond sustainable levels, Association President Marc Gheeraert stated in the update that Europe can expect supply shortfalls on the order of 40%–75%.
The global workshop, attended by 16 countries, forecast supply chain problems for several years, as only 5 countries — Canada, Belgium, France, the Netherlands and South Africa —produce the key isotope technetium 99m, and some 95% of world supply is created by 5 reactors, all over 40 years of age. “Participants noted that, due to the age and increasing maintenance requirements of the major production reactors, the vulnerability of the isotope supply chain is likely to persist, if not to increase, for several years,” stated Nuclear Energy Agency Director General Luis Echavarri in a summary of the workshop.
Pharma bears responsibility for labelling
The United States Supreme Court has ruled that compliance with Food and Drug Administration label warnings does not imbue pharmaceutical companies with immunity from lawsuits seeking redress for injuries caused by adverse drug reactions.
Rejecting drug giant Wyeth’s arguments (which were supported by the former George W. Bush administration) that federal oversight and regulation of drugs provides a legal shield against damages awarded by juries in any of the 50 states, the Supreme Court ruled 6–3 to uphold a state of Vermont verdict that awarded US$6.7 million to a musician whose arm was amputated after promethazine (Phenergan) was errantly injected into an artery instead of a vein (Wyeth v. Levine, No. 06-1249).
Guitarist Diana Levine was injected using the “IV push” method and when the antinausea drug entered her artery, she developed gangrene. She successfully argued in a Vermont court that Wyeth had failed to properly inform doctors about the risk of administering promethazine via IV push.
Just because a drug is approved by the FDA doesn’t mean that a state no longer has the right to regulate the conduct of businesses that harm citizens, wrote Justice John Paul Stevens, on behalf of the majority. “Failure-to-warn actions, in particular, lend force to the FDCA’s [Food, Drug, and Cosmetic Act] premise that manufacturers, not the FDA, bear primary responsibility for their drug labelling at all times.”
The ruling emboldened Democrats in Congress to introduce legislation that would allow similar lawsuits to proceed against companies that make heart devices, hip replacements, catheters and other medical devices.