Providing information or promoting drugs?

On 12 January, US Food and Drug Administration (FDA) officials released finalized recommendations for drug makers that wish to provide medical literature to doctors about unapproved uses of their products. It’s no small matter, since over 20% of US prescriptions are written for ‘off-label uses’.

Earlier guidelines required companies to commit to submitting an application to the FDA for the unapproved use before sharing peer-reviewed journal articles or reference publications about it. However, the new recommendations permit sales representatives to share data about uses that companies don’t plan to submit for FDA review.

Additionally, the finalized version of the new guidelines does not require that drug companies provide peer-reviewed materials that reach different conclusions about the unapproved use.

The revised policy recommends that that peer-reviewed materials given to doctors are not “marked, highlighted, summarized, or characterized by the [company] in any way”. Such actions could be considered ‘off-label promotion’ of drugs, which is what US pharmaceutical giant Eli Lilly did when it used catchy slogans to persuade doctors to prescribe the antipsychotic Zyprexa for unauthorized use in elderly patients (Lilly pleaded guilty to violating US law on 15 January). This practice is still illegal. However, I doubt the relaxed guidelines will help companies provide an unbiased view of their drug’s safety and clinical effectiveness—something that certain companies apparently need help with.

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Photo by zimpenfish

Defrosting Cold War restrictions

Now that the US is no longer the undisputed world technology leader, rules devised during the Cold War to prohibit the export of certain technologies and restrict foreign scientists from immigrating to the US are outdated and harmful to economic competitiveness, the US National Research Council (NRC) reported last Thursday.

Back in 2003, the scientific community protested the strict post-9/11 visa rules, citing that many students and scholars could not obtain visas. While it is now comparatively easier for students to obtain visas, professional researchers applying for US work visas still face many regulatory obstacles, the NRC report notes.

The report urges the president to issue an immediate executive order that—in addition to easing high-tech export restrictions—would also expedite the visa process for foreign scientists and engineers. The report also suggests new rules that would automatically allow foreign students to remain in the US for a year after obtaining advanced scientific or technical degrees.

An executive order to fix these visa woes might help foster innovation in the US. However, in addition to the executive order that the NRC suggests, I think the next US Congress should devise permanent legislation—that will stay in place during future presidential administrations—that eases export and visa restrictions, in order to promote US-foreign collaboration in the long-term. Do you think it’s time the US rework its visa rules for biomedical researchers?

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Photo by Elaron

Using antibiotics as a bandage

A recently released Dutch study involving nearly 6,000 adult subjects found that giving antibiotics to patients in intensive care units (ICUs) to prevent infections increases the chance these patients will survive. The article reports that after four weeks, patients who received oral antibiotic had an absolute reduction of mortality of 2.9% compared to those who did not receive this preventative treatment. Moreover, those who received both oral and intravenous antibiotics had an absolute reduction of mortality of 2.9% compared with the control group.

These results add a new twist to the debate over the use—or overuse—of antibiotics by medical professionals: Drug-resistant bacteria are a growing problem in health care centers worldwide. To reduce deaths from these ‘superbug’ infections, experts have urged doctors to use antibiotics judiciously instead of prescribing them willy-nilly.

So is prophylactic administration of antibiotics the best solution for preventing ICU patient deaths from hospital-acquired bacterial infections? While this may be a good short-term solution, I think that it merely puts a temporary bandage on underlying problems with hospital protocols. Better cleaning and testing for drug-resistant infections should be the first actions we take, rather than pumping patients with antibiotics as a precaution.

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Photo by markhillary