First in Class Diabetes Drug

I spent two years in the Diabetes Market- Type 2 and I can honestly say it opened my eyes to just how large the diabetes epidemic is today in America. Despite the long list of oral agents from the six different classes, there is no cure or side effect free agent, so there is room for new alternatives in pharma world.  Last week, the FDA approved a new glucose-lowering agent, canagliflozin.  It will be marketed as Invokana by Janssen Pharmaceuticals for the treatment of adult type 2 diabetes in the U.S.

Canagliflozin is the first in a new class of drug, an oral inhibitor of sodium glucose contransporter 2 that reduces the absorption of glucose in the kidney resulting in increased glucose secretion.
*English translation: It will lower sugar levels and aid in weight loss. 
The article doesn't cite the clinical studies, so it's hard to say how significant weight loss or glucose drops will be, but from a safety perspective there is no risk of hypoglycemia, which is a major selling point in the diabetes market space 

Dapafliglozin, which was approved and has been marketed in Europe for over two years now, did not receive FDA approval last year in the U.S. due to a cancer signal, or I would most likely be marketing it today. Canagliflozin does not appear to share that risk, hence its early US approval.  There are several other in class agents waiting for approval, so it will be interesting to see how successful Canafliglozin will be in it's launch mode while they have no direct competition. Let the games begin!

To read more:
First in Class Diabetes Drug

Linking risk factors to Alzheimer's Disease

The Framingham risk score was developed and has been used for years to measure cardiovascular risk factors. It factors in age, lifestyle, and health conditions like hypertension or high cholesterol levels to determine whether a patient is at risk for a cardiovascular event, such as a stroke, heart attack or myocardial infarction. 

The article suggests that two Framingham risk scores are a strong assessment for dementia and cognitive decline. The study, which was published in the Journal of Neurology, compared different elements of the Framingham score system and found that stroke score was strongly associated with 10 year cognitive decline.  If doctors start to use Framingham to identify a cognitive decline score in patients, they may be able to help patients modify lifestyle to eliminate certain risk factors of dementia. 

I think this link will be extremely beneficial to physicians and ultimately their patients.  Since doctors typically utilize the Framingham in a younger patient population when evaluating a patient's cardiovascular health, if they start to recognize deterioration in cognition in these patients and let their patients know that their brain may be at risk too, we are one step closer to closing the gap on dementia and Alzheimer's disease.



To read more about this study, please see link below.
Framingham Risk for Alzheimer's Assessment?

Primary Care Shortage

As more and more medical schools emerge, several are putting a major emphasis on primary care and for good reason.  The article discusses Quinnipiac in Connecticut and the University of California and their goal to double the amount of graduating physicians who choose to practice in primary care setting.  

JAMA published a study in December that found only 21% of third-year residents planned to enter primary care.  That is not nearly enough! There is a major shortage of primary care physicians across the United States.  Considering the Pros/Cons, it is pretty obvious why it is not the most coveted position. They work nonstop, from the office, to hospital rounds, to nursing home visits and typically are underpaid for their services.  On top of this they deal with boatloads of paperwork and kickback from insurance companies.  Sounds like fun right?



Primary care physicians of the future will more often work in multidisciplinary team settings and need to develop management and collaborative skills in addition to receiving and MD or DO. Some schools are even alluding to incentives such as scholarships and tuition reimbursement for those who do pursue primary care.

To read more at medscape: New Med Schools Aimed at Primary Care

Guided Missiles: Drug Conjugates

Drug Conjugates. A new tool for delivering medicines to microscopic targets in the body.  There are two currently being used in cancer treatments, but many more are in the works with drug makers. The article explains it best by stating, "they couple two therapies, and basically work like guided missiles. A toxic warhead is strapped to a missile that homes in on and drops its payload on a specific tumor. Such pinpoint aim has been an important goal for decades, because it could maximize a drug's impact while limiting side effects, such as the hair loss that accompanies chemotherapy's indiscriminate march through the body."

This is a huge breakthrough and could potentially be the next big breakthrough pharma and biotech has been looking for. Several heavyweights like Amgen, Pfizer, and Novartis have drug-conjugate treatments in testing for pancreative, kidney, and other cancers.  Merck is working with Endocyte on a drug-conjugate for ovarian cancer that uses a very small molecule, unlike what has been established so far.

The goal of this is to give oncologists and patients a better shot at fighting cancer.  The approach is to target the specific tumor cells rather than hitting healthy cells as well. This is easier said than done and research dates back to the mid-seventies.

To read more, check out Drug Conjugates

Being Fat in the Workplace

The WSJ released an article today, "When Your Boss Makes you Pay for Being Fat."  The story depicts one example from Michelin North America Inc., but with rising healthcare costs and poor results seen from voluntary company health programs, starting next year we could see a great shift in company health benefits.  Michelin is requiring employees to share their personal health information, which includes BMI, blood pressure, blood-sugar level, and cholesterol.  If employees do not wish to participate  they may face higher premiums or deductibles. 

 Because the cost of healthcare to employers is so dependent on the employees the insure, I completely understand why companies are looking for new ways to motivate their employees to adapt a healthier lifestyle. Studies have shown that people respond more so to potential losses or penalties than they do to expected gains or rewards, meaning it is actually better to ignite a bit of "tough love."  The article states that corporate spending on healthcare is expected to reach about $12,136 per employees this year, which is a big chunk of change.

Employee reward programs will shift sharing additional incentives for employees dedicated to improving their health to a none negotiable.  Some companies would motivate employees with deductibles, like the list below. According to chief medical officer for national accounts at Cigna, companies tie between 5% and 10% of employee premium costs to incentives, which will likely increase in the next few years.

Health Costs

How your shape can weigh on your wallet.

$652

Additional amount that General Electric employees who self-identify as smokers must pay for health care each year.

$1,000

Penalty that Honeywell is adding for workers who get certain types of surgery without seeking more input.

$600

Annual penalty CVS employees must pay if they fail to report their weight, body fat and cholesterol levels to the company's benefits firm.

$100

Monthly penalty that Mohawk Industries charges employees who don't participate in a health-risk assessment.

$1,000

Maximum additional amount Michelin employees with high blood pressure or large waistlines could pay for health care.

Check out article here:

Health Care Costs

Pharmacy Partnership

Sometimes generic medication isn't always a bargain.  This leads to non-compliant patients, who cut pills, do not fill prescriptions, or order their medication from Canada. Walgreen's may have the answer. Walgreens, the nation's largest pharmacy chain will now be able to use the size and scale of AmerisourceBergen and Alliance Boots to buy generic drugs at cheaper prices.  This will help the chain to "outmuscle" domestic competitors, Like CVS Caremark, and power into new markets. 

Walgreen's is confident that they will be able to lower prices through agreements with generic manufacturers on a global scale, helping them expand into Europe.  In addition to Europe, Walgreen has their eye on Asia and Africa's pharmacy market, for there is a lot of growth potential. Although a risky and aggressive move, since other companies have not partnered up to this extent before, they will have a leg-up while shifting the pharmacy/wholesaler generic pricing landscape.  
AmerisourceBergan will become the second largest distributor behind McKesson in the United States this year, as they are replacing Cardinal Health's contract with Walgreen that expires this August. I think the deal will absolutely put pressure on other companies to join forces, whether at the retail level or further down the supply chain.

This is an interesting new concept that I think is on the rise, since generics will play a very large role in the impending healthcare changes.  I think we will still have to wait to see how much actual savings are realized. Generic manufacturers can't afford to cut too many corners, since they still need to profit while continuing to create medication in line with FDA regulation. 

The real test: If Walgreen can compete with WalMart in the generic pricing arena.




Check out article at WSJ.com

The Brightside for Biotech

 If you have ever seen Monty Python, or tuned into Philly's classic rock radio station 102.9 MGK at precisely 9am, then you've heard  Eric Idle's song, "Always look on the Bright Side." It's a chipper tune, and I must admit as an avid 102.9 MGK morning listener, it definitely helps kick off my work day. Well it looks like Biotech has been singing a similar song as well, to the tune of $516 million!

It was announced today by Third Rock Ventures that $516 million has been raised to create about 15 new biotechnology companies over the next few years.  Due to economic downturn the past several years, funding had been put on pause, stifling research and development, especially for start-ups. 

Third Rock Venture's goal is to grow budding healthcare companies, advance product launches, and bring innovative life changing products to market.  This could not come at a better time, for pipelines in big pharma and biotech have run dry and everyone is after the next big thing in and willing to pay the price.


 Check out rest of article at WSJ.com:
Biotech has a rare, $516 Million Moment....

Dollars for Docs

 It's common knowledge that pharmaceutical companies pay large amounts to physicians whom participate and are trained to lecture on their specific products in a non-biased format.  All this information is available to public now via the Sunshine Act.   It was just released through journalism group ProPublica, that 22 physicians have received over $500,000 since 2009 based on speaking and consulting feeds.  This is an annual report by ProPublica called "Dollars for Docs"  which has revealed one major trend: Psychiatrists were most commonly listed, with the top 5 all working in psychiatry. The top paid doctor is Jon Draud, MD, who is a medical director at of a psychiatric and addiction medicine program in Tennessee.  According to the article, Dr. Draud has received a total of $1,009,213 from AstraZeneca, Cephalon, Lilly, Forest, Merck, Novartis, and Pfizer- all the major players in CNS.

This is an issue that you either side with or are against; typically, if you are an academic you disagree.  It's perfectly legal for physicians to consult or speak for pharmaceutical companies.  I think the hope is that their is honest communication and clear, set guidleines, so there is no confusion in what each parties intent is for the agreement.  Pharmaceutical companies utilize thought leaders, because they are typically innovative in their medical approach and not afraid to try new products, if the data and mechanism of action warrants it, of course!  But of course there is that underlying question whether they are only using the product (or as much of the product) because they are being paid.

To read more, check out this article on medscape.
Dollars for Docs

Curbing Health Tests

Amid a growing effort to curb unnecessary health care, a consortium of medical groups is issuing a sweeping set of recommendations to limit commonly overused tests and treatments.  Working in a patient focused setting, I see these tests occur daily... but I also over hear how overused or unnecessary certain tests are according to some healthcare professionals.

The article discusses a list compiled of 90 recommendations designed reduce costs and protect patients from potential harm.  These overused tests range anywhere from electrocardiograms to mammograms. They suggest against doing routine imaging for lower-back pain within the first six weeks unless certain warning signs are present, and don't order annual electrocardiograms, or EKGs, for low-risk patients without symptoms.

The recommendations, spearheaded by the nonprofit ABIM Foundation, part of the American Board of Internal Medicine, were based on the individual medical groups' assessment of existing scientific evidence, according to the foundation. "Our goal is really to get the scientific information out there, the same information in front of the doctor and the patient, so they can have that conversation, particularly so the patient can realize that more is not better," said Christine Cassel, an internist and chief executive of the ABIM Foundation.

The full set of recommendations can be viewed here

This is a great example of more not always being better.  Just because it is offered, it doesn't mean patients always need it, or need it as consistently. I think that as we see the healthcare platform continue to change, less will be offered on a  reoccuring basis in an effort to cut costs.  And that is the argument to this list of recommendations... Is it really about the patients safety, or more so about the cost reductions in an ever changing environment. From a patient persective, I think it would nice to always have the option for the specific test.

Read full article here

Good Stress?

It turns out stress isn't always a bad thing, it's more about how one reacts and views the nature of stress.  This article discusses research regarding stress and the changes in body chemistry and behaviour when coping with stressful situations.  The study is expected to be published in March via the Journal of Personality and Social Psychology. 

Stress is usually portrayed as having negative health consequences, but it also can aid in boosting the immune system and in the speed of brain processing or even improving memory.  "You could have tons of stress, but it's the mindset about stress that matters," said Alia Crum, a post-doctoral researcher at Columbia and an author of the study. When people see stress as debilitating, the body does not react as well as when one views it as having positive side effects, so it really depends on a persons attitude.

I found this interesting, because I stress-out easily and often, sometimes for good and othertimes for bad.  Now knowing this information, at least stress is healthy and could potentially have positive health benefits if I keep an open mind set and work through the stress?

Check out article at WSJ.com

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

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

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.  

I 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

Drumroll...

At a time when R&D is more important than ever in Big Pharma, it's hard to believe that at the end of the day, there is one person behind it at each company. I think this could possibly be the most difficult job to have within Pharma. Can you imagine the pressure? Merck spent over $50 billion in six years and of that only 5 products were approved!

If you get a chance, take a look at the metric breakdown of 5 big pharmaceutical companies and the amount invested in R&D. Elliot Sigel of Bristol-Meyer came out on top for smartest spending putting $28 billion into R&D and having 7 new products approved in that six year time frame. Product pipeline can make it or break it, hence why the R&D chief could be the most powerful person while having the most complicated job in the entire company.







Check this out at WSJ.com!
The Best R&D Chief in Pharma World

What's in a Name?

Apparently, X and Z are the trendiest new letters in drug names. There are some crazy names out there and it really makes you wonder, "How do they come up with these?"  I know this is a question many doctors ask themselves, as they are responsible to for learning not only the names, but being able to link it to the proper disease state, indications and safety information.

It's the job of pharmaceutical consultants to create a name that isn't already taken or will lead to medical mix-ups because of other products on the market with similar sounding names.  Finding a unique name can be very difficult when there are more than 30,000 trademarked prescription drugs in the United States alone and 150,000 in Europe.  The people in marketing spend more time and money in focus groups and market research than one could imagine to come up with a name such as Pfizer's Xeljanz. Then, once they have found suitable options, it must pass regulatory approval. It's like a never ending game of Scrabble! 10 points for the letter Z!

This article talked about recent studies showing drug names starting with X and Z are more memorable and evoke some positive relationship with doctors or patients, which led me to consider what does make a good name? I started searching the web as I was curious to learn more and happened to come across a second article from USA Today referencing William Trombetta, who happens to be a past professor of mine from the pharmaceutical marketing program at St. Joseph's University, what are the odds!

Dr. Trombetta states: "A lot of it is more art than science. There are certain letters that express power and control, like Z, M or P. Other letters, like S, are more passive. Depending on what the drug does, you want to give the name certain features."

It also mentioned the X's and Z's are "high-tech" triggers. That article was written in 2007.  Fast forward six years to 2013 and what once seemed high-tech is now commonplace and the most popular names seeking approval or launch currently. I wonder what would be considered a high-tech trigger letter today? 

Read more at Fierce Pharma: Xs and Zs become popular in drug names 

Click here for: USA Today Article

Off-Label Marketing

As a pharma rep who has been through several sales product trainings, off-label marketing is a big no-no! It can cause a great deal of trouble for the company and employee, resulting in major lawsuits and expenses.   Although the pharmaceutical industry does self-govern via PhRMA, setting industry standards and guidelines to uphold, it does not mean everyone follows them.  Unfortunately, off-label marketing probably happens more often than I'd like to admit as a member of the industry.

Well in a recent case, U.S. v. Caronia, the court has called one pharma rep's off-label marketing a form of protected speech. Touche. This left legal experts and the FDA in search of SOME kind of response, but unfortunately they came up short.  The FDA did respond saying it "does not believe that the Caronia decision wil significantly affect the agency's enforcement of the drug misbranding provisions of the Food, Drug, and Cosmetic Act (FiercePharma)." This makes sense, as one trial in a specific region is probably not enough, drugs are marketed on a global level, through many different channels.

So one way to look at this is that another off-label-promotion-is-free-speech claim is making its way through the courts.  This isn't "new" news. There may not have been an FDA appeal this time, but I guarantee it is not the last we hear of it.

Read more: FDA won't appeal free-speech ruling on off-label marketing - FiercePharma 

Novartis CEO- Not Just Pushing a Pill

And another rep bites the dust. Novartis just completed it's 4th major layoff in the last two years, all under new CEO Joseph Jimenez. Novartis is going through the same challenges many other pharmaceutical companies are facing. Losing patent protection to a cash cow, a product that keeps the lights on at HQ, and pays for new product launches is a difficult transition, especially when there isn't anything promising in the pipeline.

If you take a look at the video embedded in the link below, Jimenez offers his outlook on sales strategy. These days it goes far beyond the pill itself, and focuses more on selling effectiveness, and finding the opportunities for growth and global expansion.

He is a big believer that the industry needs to spend less money on sales and marketing and more on research and development, which I think is something almost everyone in industry can agree on. Right now big pharma companies are battling bids on small start-ups with promise.

He also alludes to Novartis and many other companies moving away from physically selling products to companies being paid on positive patient outcomes. This is an interesting concept, that I think we will be hearing more about in the near future and I'm sure I will be blogging on the subject again!




Check out this article here at WSJ.com.  There is a great video link that I reference.
At Novartis, The Pill is Just Part of the Pitch

United Health Weighs In...

United Health is just one of the many insurance companies affected by Health Care Reform.  As a professional in the pharmaceutical industry, agreements with insurers are critical to getting branded products on plans leading to widespread patient use.  There has been a great deal of buildup regarding this topic and now that it is to become a reality, insurers, such as United Health, are taking the necessary precautions and planning ahead for a new market landscape with great uncertainty. 

I was interested to learn that they will be focusing in on limited markets.  Only taking on 10-25 in an arena of 100 or more, is a major cut back.  Of course this will vary by state, but I think we are likely to see more individual plans, which means more exchanges depending on the level of interest on local levels.  One major concern as mentioned in the article is that this could push up premiums, which could deter many people.

Well, there is still much to unfold as other insurance companies weigh in between now and the fall and legislation gets ready to take full effect in 2014.  I'm sure we will hear plenty more on this topic to come, so stay tuned!

Check out article here at WSJ.com: 
United Health Weighs In