Media Warning about Pfizer's Tygacil Is another Example of Poor Science Reporting
When I saw one of today’s headlines, ‘FDA Warns on Increased Death Risk with Pfizer Antibiotic’ I immediately dropped what I was doing to read the article. Expecting the worse, I learned that the US Food and Drug Administration (FDA) announced today that it was modifying the label for Pfizer’s antibiotic called Tygacil.
The reason for the label changes was new clinical information that showed that patients with ventilator-associated pneumonia (VAP) and diabetic food infections that are treated with Tygacil are at increased risk of death as compared with those treated with other antibiotic treatments.
"The FDA said it looked at 13 trials with patients given Tygacil for both approved and unapproved indications by type of infection comparing the overall mortality for Tygacil with other antibiotics. Overall, the studies showed death occurred in 4% of patients receiving Tygacil, or 150 out of 3788, and 3% of patients, or 110 of 3646, receiving comparator antibiotics."
While I didn’t find the difference in the mortality rates that shocking, it is important to point out that Tygacil is not an FDA-approved treatment for either VAP or diabetic foot infections. Nevertheless, the antibiotic is routinely used by many infectious diseases physicians as a treatment for both infections. This is because many VAP and diabetic foot infections are caused my multiple drug resistant bacteria and physicians are willing to resort to unapproved treatments (like Tygacil) to treat high risk patients. Put simply, there is generally little choice; either use Tygacil or the patient may die!
Further, the 1% difference in mortality rates between Tygacil and other antibiotics may not be clinically significant because many of the treated patients are seriously ill and near death anyway. Finally, differences in the mortality were based on retrospective results from clinical studies that were designed to assess the safety and efficacy of Tygacil for indications other than VAP or diabetic foot infections. Consequently, it is difficult to conclusively say whether or not Tygacil is less safe than other antibiotics to treat patients with severe bacterial infections like VAP and diabetic foot.
Nevertheless, Tygacil's label has already been updated to warn doctors about the possible death risk. Pfizer sent a letter dated July 26 to health care professionals detailing the new label. The label change is listed below:
"Alternatives to Tygacil should be considered in patients with severe infections. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:"
The bottom line: the jury is still out on the safety and efficacy of Tygacil as a treatment for VAP and diabetic foot infections. This can only be determined when well controlled, statistically-relevant clinical trials are designed and conducted. While FDA was correct to insist that Pfizer send a note to infectious diseases physicians alerting them of possible increased risks, I don’t think that the label change was newsworthy enough to earn the headline ‘FDA Warns on Increased Death Risk with Pfizer Antibiotic’ It is a shame that journalists continue to insist on publishing sensationalistic and often times inaccurate scientific headlines. While it may garner some additional readers, it does little to instill American confidence in our public health system.
Until next time...
Good Luck and Good Job Hunting!!!!!!!.
.gif)
Despite the brouhaha surrounding the publication of an article about new South Asian strains of antibiotic resistant bacteria that carry the NDM-1 gene, some good may actually come from it. The Pharmalot Blog reported today that an article entitled 
Abbott Laboratories .jpg)
For the past decade or more multiple drug resistant strains of bacteria such as methicillin resistant Staphylococcus aureus (MRSA), enterococci and other Gram positive cocci have been highlighted and showcased in the medical and lay press. While the incidence of infections caused by MRSA and other Gram positive cocci has steadily risen, antibacterial drug discovery experts have long known that the greatest disease threat in the future will be from emerging multiple antibiotic resistant strains of Gram negative bacteria including Acinetobacter baumannii, Klebsiella pneumoniae, Serratia marcescens and Pseudomonas aeruginosa..jpg)
For many years, I taught medical students that the emergence of antibiotic resistant strains of bacteria primarily resulted from the overuse and misuse of antibiotics by physicians. While this seemed to make sense, I started chatting in the late 1990s with 
Johnson & Johnson .gif)
That methicillin resistant Staphylococcus aureus (MRSA) is in the news again is not surprising. However, to my knowledge, Nicholas Kristof‘s article in today’s New York Times may be the first Op-Ed piece written by a non-scientist about the growing threat and seriousness of MRSA infections. Mr. Kristof apparently became aware of MRSA when he was contacted by Tom Anderson, MD, a Camden, Indiana physician who was experiencing “phenomenal levels of MRSA infections" in his community.
Targanta Therapeutics, a Cambridge, MA-based biopharmaceutical company, announced that it 
(2).jpg)
Optimer, a San-Diego, CA-based biopharmaceutical company, reported 
Takeda Pharmaceutical Co., Japan’s largest pharmaceutical manufacturer, announced that it has agreed to buy Cambridge MA-based Millennium Pharmaceuticals for $8.8 billion. Millennium, founded in 1993 by high profile MIT researchers and once heralded as one the most innovative American biotechnology companies, never lived up to analyst’s expectations. That said, the company did develop and win regulatory approval for an anti-cancer drug, 
You gotta give Biogen/IDEC and Elan credit for winning regulatory approval for a product that was previously pulled from the market because of serious and potentially life-threatening side effects. 