Sunday, February 10, 2013

AA: Antidepressants and Arrythmias

It has been found in studies recently that high doses of certain antidepressants may leave patients at risk of developing prolongation of the QT interval, which is a marker for possible ventricular arrythmia. Investigators looked at over 38,000 electronic medical records and found a "slight but significant" association between QT prolongation and prescriptions of citalopram or escitalopram to name a few.  Others were associated with shortening the QT interval, which has been seen before in research.  The full list of medications is included in the article, so check it out.

I just found this interesting, because now certain medications both prolong and shorten, leaving a little inconsistency, and making the physician's job much more difficult.  The higher the dose, as with any drug, the side effect profile typically goes up. The antidepressant market is very different than other areas or disease states I have dealt with in the past. It is not cut and dry, there is a lot more to it and i understand that once patients find something that work for them, it's best to stick to it, but most data shows that over 40% of patients have side effects on therapy and 50% do not even respond to initial therapy.  Now arrythmias is another thing to consider and I am sure updates to the prescribing information will be occurring as more concrete evidence is found. 




Some Antidepressants cause Arrythmias

painKILLER.

This article discusses the over abuse of the painkiller hydrocodone.  The FDA is recommending this widely used drug be rescheduled.  It is currently Schedule III and under consideration for a move to schedule II.  Schedule II means it has greater potential for abuse and dependence than Schedule III. The fact is that the death rate from overdoses involving hydrocodone have tripled in the last 12 decades.  Because it is easier to get, people have found a way to abuse it.  Because it is schedule III, there is a widespread mis-perception by physicians that it safer and less dangerous, when it comes to long term abuse, which just isn't true.  There are people who do use and need samples for the appropriate reasons, especially those in rural settings.  If it is controlled, samples will no longer be available, and cost disadvantages could arise as coverage would change.

This becomes an ethical dilemma of sorts.  Can the public be trusted?  I know many companies, Shire for example, which makes ADHD medicine has incorporated time- released technology into its medications, so it cannot be abused.  I think this is the future for abused medicine, like hydrocodone. The dilemma that arises with this is that it's branded and there is probably something similar that is generic, but will not have that time released technology until it's patent expires in 16 years. The need for affordable medicine and care is at an all-time high, but what about patient safety?  I could rant about this, but my opinion is biased for several reasons, so instead I'll just let you think it over...


Check out article on Medscape

Generic Pharma- Movin' on up...

Generic pharmaceutical companies are on the rise. What used to be the "poor pharma" 5 years ago, is now a very attractive sector in the industry.  In 2013, careers in the generic sector are more attractive than ever and this is based on several factors:

  • Patent cliffs and it's effects (ie. downsizing and R&D cost cuts)
  • Improved reputation (ie. updated manufacturing, production, and logistic centers)
  • Delivering life saving medicatons that work at fraction of branded cost
  • Competing at same salary as big companies to attract quality empolyees, especially in R&D
  • Company culture of growth and development


 These four bullets are clearly the strengths and opportunities that generic companies dove in and took advantage of while big pharma was drowning in costs and trimming the fat.  One generic company employee states, "Research-focused Pharma/biotech is boom or bust whereas Generics is a more consistent and secure environment. It won’t be for everyone – the commercial realities mean that workload is high, the workforce is lean and the onus is on the individual to deliver their own work effectively."  It's definitely a big change from big pharma, but at the same time big pharma is evolving too.  The environments are changing as the workforce becomes leaner there, the workload is increasing too, but the adaptability to this change is a big part of the struggle, whereas generic companies are used to operating this way.

Generic pharma has had its negative press, most recently Ranbaxy's generic atorvatstatin fiasco, so it's great to see them thriving and growing as their business is not going anywhere.  Generics are the constant after all and their future is bright, projecting 90% of US medicine will be generic by 2016.


Check it out here:
Generic Pharma on the Rise

Saturday, February 2, 2013

Nightmare on Blockbuster Street!

Ohh, the patent cliff.  When a drug nears the end of their patent, they become fair game for generic manufacturing.  For most companies, this cliff can be as the title suggests... a nightmare.  If they have nothing to replace the product losing branded exclusivity, they are toast.




And this brings us to companies like AstraZeneca, who had a tough year in 2012, trust me, I should know.  By 2015, they could be hitting a patent cliff for what's left of their portfolio  mainly losing Crestor, a blockbuster statin.  The article discusses some of the options/alternatives for companies to better prepare for the impending cliffs.  In AZ's case it is common knowledge that they have been scrambling for the past few years to develop their pipeline, but continually have come up short in the R&D department, which has really hindered their growth.  Marketing has always been a strength, but they can only co-promote with so many companies.  They need to acquire or merge with another company yesterday, and new CEO, Soriot knows it too. 

The article states that the era of big pharma "megamergers" is over, and we may actually start to see companies dissolve into smaller, more focused entities.  As the industry has evolved with more biologics, replicating via biosimilars may not be easy, which might buy some companies a little more time as the next big patent cliff in 2015 arrives.  On the bright side, the rate of new drug approvals is on the rise, indicating the R&D drought could be ending (fingers-crossed). Analysts are suggesting that this will actually allude to overall growth in sales for the industry.  Buckle your seat belts fellow pharma friends!





Check out article @ FiercePharma:
Nightmare on Blockbuster Street

Juvenile Diabetes on the Rise



image
Diabetes is one of the fastest growing disease states in the United States, not only in adults, but also children. This article discusses the alarming rise in Type 2 Diabetes in children and the need for more aggressive treatment options.  Pediatricians are now recommending insulin shots more over oral treatments that have not been as effective as hoped in the youth.  On Monday, the American Academy of Pediatricians will issue its first ever clinical guidelines for Type 2 diabetes. Recommendations may include temporary insulin shots for children with Type 2, which would be normal regimen to treat Type 1. Another factor is that it is becoming even more difficult to differentiate,  The article states that Type 2 used to be limited to just adults, but three decades later one of every three cases of diabetes involves patients under 18 years of age.  

It's a growing epidemic and of course diet and exercise are major factors. With today's technology and lifestyle, being a kid is much different than it was when I was growing up. Kids don't meet up after school to "play" with the other neighbor kids anymore, but if they do, it usually revolves around video games, not a game of man hunt. I think having your kids involved in organized sports growing up and making sure they eat balanced/portioned meals is more important than ever.  Of course it is much easier to say than commit, and it is a lifestyle change, for not just your children but the entire family. To be six years old an diagnosed with Type 2 diabetes is just so scary to me.  

imageI am biased, as I have been professionally involved with treatments for Type 2 Diabetes and know the disease state very well.  Although I have not been tested (and I know that I should be- I'm in denial), am convinced that myself and most of my family are pre-diabetic or possibly even living with undiagnosed Type 2.  I think when you are surrounded by data and educational information, it really makes you more aware of how serious the consequences.  I will be interested to see what the pediatric guidelines recommend when they are announced on Monday.





Check out full article at WSJ: Juvenile Diabetes on the Rise