Last week the U.S. Surgeon General Vivek Murthy sent a letter to every doctor in the U.S. to warn them of the dangers of opioid addiction. While certainly well intentioned, I have to ask - in this age of technology, is this the best we can do? Why not fax or, even better, send a Western Union cable?
It has become tradition at Advera Health to look closely at the annual formulary exclusions that the large payers such as Express Scripts introduce every August. Using our safety scoring and costing algorithms we are able to quickly provide a top-line view into the effects of their decisions.
It’s been a tough few weeks for music fans with the deaths of David Bowie to liver cancer and Glen Frey to complications from rheumatoid arthritis and ulcerative colitis. These are just two of the millions of people worldwide suffering from these diseases, but I’m sure I’m not the only one who felt a sense of loss from the passing of these two men. Both profoundly influenced my adolescence and early adulthood through their music.
In the days following the news of Frey’s death, news stories emerged sourcing his longtime manager Irving Azoff and medical professionals unrelated to his treatment that assigned some degree of blame on Frey’s death to the medications he was taking to treat his conditions.
Recently a report by the U.S. Government Accountability Office (GAO), filed at the request of Representative Rosa DeLauro on December 15, 2015 was made public. The report’s focus was to better understand the rate at which drug applications were expedited using “fast track” and “breakthrough therapy” designations and if FDA was fulfilling its duty to properly track and analyze post-marketing monitoring for those drugs.
It’s often difficult to pinpoint the moment a revolution starts, but when it comes to the issue of drug pricing it’s quite possible that we’ll look back at December 6, 2013 as the day that everything changed.
That was the day that Gilead’s Sovaldi was approved for sale by the FDA. Sovaldi’s launch – and its $84,000 price tag – set off a tsunami of media attention on the issue of medication costs. Never mind that Sovaldi has an incredible cure rate, all of the attention fell squarely on it $84,000 price tag.
Monday is Patriots’ Day and its one of my favorite days of the year.
Patriots’ Day is held on the third Monday in April commemorating the anniversary of the Battles of Lexington and Concord, the first battles of the Revolutionary War. It is also Marathon Monday, the day of the Boston Marathon. It’s a day the city takes a break from normal Monday routines to cheer on runners, watch the Red Sox at 11am, and generally have a really good time.
On March 16th the Wall Street Journal’s Health & Wellness section ran an article searching for answers on why sales of the new generation of weight-loss medications are slower than expected. The general conclusion is that the “P’s” in the healthcare value chain – patients, prescribers, and payers, perceive the drugs to have major safety concerns regardless of the FDA’s enforcement of more stringent approval paths.
So why do these safety concerns persist, even with a stricter FDA?
This week we were able to answer a question that has long puzzled the healthcare industry – what are the total costs of prescribing a particular drug? Our launch of RxCost™ provides an answer by allowing a look into a group of comparator drugs to see which has the most expensive side effects and, by extension, is least safe.
I’m pleased to share the news that this week we launched RxOutcome.
RxOutcome is a powerful new dashboard on the AdverseEvents Explorer platform that allows our clients to compare drugs across an indication, class, or mechanism of action.
With RxOutcome, subscribers can now compare actual incidence rates and patient outcome rates of a group of medications to see which drug is the safest option or which drug causes particular safety issues versus others in its peer group.
Last week, pharmacovigilance news outlets announced the confirmation of one case of a serious adverse reaction from the multiple sclerosis (MS) drug Tecfidera. Reuters noted that this coincided with a 7 percent drop in Biogen Idec shares. The point of discussion here is a rare but serious brain infection called progressive multifocal leukoencephalopathy (PML). This adverse reaction led to the market withdrawal of Tysabri in 2005, and has been associated with other MS drugs as well. Tysabri was returned to the market after increased safety measures were put in place, including a risk minimization program. In 2012, the FDA posted a Drug Safety Communication stating a Boxed Warning would be added to another MS drug, Adcetris, after just 3 cases of PML were reported in patients taking this drug.
Topics: Drug Safety