Commentary by Josh Remick MD, NYU Senior Chief Resident
Well, it’s been quite a week! First there was Obama’s VP buzz putting the world in a frenzy, which finally culminated with his 3am “phone call” telling the world that it would be Senator Biden. Then there was the final week of the 2008 Summer Olympics and what an Olympics it was! We witnessed Phelps and Bolt shatter the record books, we reveled in the “Redeem Team’s” triumph and we thrilled in the amazing display of gymnastics by both the US and the Chinese teams. However, now it seems that the female Chinese gymnasts’ age has come under scrutiny.
Speaking of 12-year old girls, an excellent article in the NY Times examined the marketing campaigns for the new cervical cancer vaccines Gardasil (manufacturer Merck) and Cervarix (manufacturer GlaxoSmithKline) and its possible implications. It discussed the fact that the vaccines were approved by the FDA in only 6 months (typically this can take onwards of 3 years), were recommended for universal implementation (almost never done) and have legislation pending in over 20 states for mandates requiring school-age females to become vaccinated (Virginia will be the first state requiring this in October, 2009). The article discusses the intense marketing campaign that resulted in these accomplishments, not just to public but to lawmakers and physicians as well. It also raises many of the arguments against the vaccine that critics have been voicing, from the fact that Cervical Cancer is not one of the top-10 most deadly cancers in the US, unlike in the developing world where it is a lethal disease. Nevertheless, the vaccine is too expensive for the developing world to mass distribute it. Side effects of the vaccine are also mentioned, as is the unresolved issue of how long immunity from the vaccine will persist. Lastly, critics point out that the vaccine only immunizes against 70% of cervical cancer causing strains of HPV, leading many to worry that a false sense of security will result in decreased rates of PAP smears which are incredibly effective at reducing the rate of cervical cancer in the US. Personally, I find this article so interesting because Gardasil/Cervarix have revolutionized the vaccine industry and made it profitable on the order of blockbuster drugs, meaning that the controversies expressed in this article are only going to become more prevalent as we move forward.
Staying with Merck for a bit, the news was not all rosy for the Pharmaceutical Company this week. The FDA, in response to the early results of the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) study, issued a statement that it was investigating the findings of increased cancer risk and cancer death in the study group. While spurious results are not uncommon in clinical trials (and many are calling this finding in SEAS a spurious result by pointing to other Ezetimibe studies, SHARP and IMPROVE-IT, whose interm results do not show an increase in cancer risk); however, a NY Times article from last month, points out that a) SHARP and IMPROVE-IT have only 1-2 years of data compared to 4 for SEAS and b) the rates of cancer death do appear to be increased in these trials. While definitive conclusions about Ezitimibe are still several years away, data proving the benefits do not yet exist to justify use of Ezitimibe as a front-line cholesterol-lowering medication.
Okay, now for the speed round:
More data was published showing the increased risk of osteoporotic fractures in patients chronically using PPIs. I believe a certain handsome Senior Chief Resident may have mentioned this once before…
For the first time, pharmacotherapy has been shown to slow the progression of disease in patients with COPD. Researchers for the TORCH study (which failed to show a statistically significant mortality benefit) conducted a post-hoc analysis and showed that the combination of Fluticasone proprionate and Salmeterol (Advair) reduced the rate of FEV-1 decline by approximately 16 mL per year compared to placebo (55 mL vs. 39 mL). A similar benefit was also shown with Fluticasone and Salmeterol when used as monotherapy…
If you missed it last week, check out the report in the NEJM about performing pediatric cardiac transplantation from donors who died of circulatory arrest. Just as fascinating were the accompanying perspective articles that discussed the ethical issues related to transplanting a heart from a donor who died from circulatory death rather than brain death….
Lastly, we may be hearing not just from 4 out of 5 dentists who recommend Trident chewing gum, as researchers out of London showed this week that sugarless chewing gum 3 times daily for approximately 30 minutes can speed up bowel recovery time after surgery!
That’s all for this week. See you all soon!
Image courtesy of Wikimedia Commons