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Tag Archives: public policy
The EPA is now considering a proposal to regulate the ubiquitous antibacterial compound triclosan. That’s the stuff manufacturers have been pouring into everything from soap to toothpaste in order to market it to a germophobic public. As the EPA documents … Continue reading
The Obama administration has announced the launch of a new website with troves of freely accessible data from across the government. The site includes major releases of several new datasets that agencies used to charge money for, as well as … Continue reading
In research bound to haunt the nightmares of certain trial lawyers and state legislators, scientists at the University of South Florida have found that long-term cell phone use might actually be good medicine: “It surprised us to find that cell … Continue reading
The FDA has just launched a new web page about medication disposal, focusing on the tricky problem of drugs that are too hazardous to throw in the trash. The page highlights the danger of Junior or Fluffy getting into a … Continue reading
A couple of posts ago, I referred to the “echo chamber” problem in emergency communications. If you doubted the existence of that phenomenon, this news should settle the issue: A Coast Guard training exercise in the Potomac River near the … Continue reading
Gerald Weissmann, editor-in-chief of the FASEB Journal, has a good editorial in the journal’s current issue. While it doesn’t break any new ground, it does provide an excellent history of the vast “dietary supplement” industry: If our economy tanked because … Continue reading
This is pretty amusing. A few days ago, I got a press release from an Institutional Review Board (IRB) contractor called Coast IRB. IRBs are the organizations that monitor human clinical research to make sure everything is done in accordance … Continue reading
A new paper in the journal CHEST presents the case of a toddler who went into respiratory distress after receiving a smear of Vicks VapoRub under her nose. To figure out what happened, the researchers replicated the treatment in ferrets, … Continue reading
Yesterday’s Chicago Sun-Times brings news that should keep some biotech investors up at night:
Lake Forest-based hospital products maker Hospira Inc. said today it landed European authorization to market the biogeneric anemia drug Retacrit in Europe, making the medicine its first marketed biogeneric medicine.
Hospira said it will launch the product, used to treat anemia in cancer and dialysis patients, in Europe beginning with Germany in early 2008, but Hospira executives said earlier that the drug won’t have an impact on Hospira’s bottom line in the next few years.
Retacrit will compete with Amgen’s cash cow Epogen, which has been off patent for awhile now. Unlike conventional drugs, protein-based therapies like Epogen (recombinant human erythropoietin) haven’t had to face generic competition when their patents end. Biotechnology companies have acted accordingly, keeping the prices of protein-based drugs very high. This loophole exists because biological products have historically been things like plant extracts, which are virtually impossible to quantify and standardize, so regulators in most countries hadn’t contemplated anyone making biologically equivalent copies of these medicines. In Europe, at least, those regulations have now been revised to allow the introduction of “biogenerics,” and Hospira is taking advantage of that.
The US FDA is still debating the issue of biogenerics, and of course the makers of brand-name protein therapies have been lobbying hard to maintain the status quo. If Retacrit takes off in Europe next year, it will give biogenerics proponents more ammunition. I wouldn’t place bets on the final outcome of this fight, but I’m pretty sure it will be a boon to civil litigators in either case.
The BBC is reporting another depressing development in the World Health Organization (WHO) campaign to eradicate polio:
Nigeria is fighting a rare outbreak of a vaccine-derived form of polio, says the UN’s World Health Organization. It says 69 children in the north have caught the paralysing disease from others who had already been immunised. The WHO says such rare outbreaks have occurred where immunisation campaigns did not reach enough of the population.
If you’re just tuning in, Nigeria is the same country that had a disastrous polio vaccine boycott in 2003, spurred by extremists who claimed the vaccine was part of a Western plot to eradicate Muslims. The rumor managed to shut down vaccination campaigns across wide swaths of territory, causing a predictable spike in polio infection rates shortly therafter. Now that there’s an outbreak of vaccine-derived polio, we can be sure the same scare-mongers will be claiming vindication. Would this be happening if we took a more integrated approach to poor countries’ public health problems, rather than focusing our energy and money on ego-driven eradication campaigns against individual diseases? Continue reading