Biotech/Pharmaceutical – Bubble or Bust

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In the last few years, the US is trying to bounce back from unbelievable unemployment and almost zero growth in the economy. Although, at the height of the US recession and very bad economic times, it seemed like the Biotech/Pharma industry was not as negatively impacted as other sectors. Advancing to 2015, Pharmaceutical Companies have announced $102.3 billion in biotech stocks were the market’s hottest investment.

The “S&P Biotech Select Industry Index has grown 34.31%, while the DJIA and the S&P 500 have only appreciated 2.97% and 6.7% respectively, meaning that in 2014, biotech has outperformed the market by an even larger margin than in 2013. This conveys the strength of the life science/Healthcare sector and shows that a stable framework is in place for further expansion”. However, it is important to point out that “rough estimate shows that only 30% of the 150 companies that make up the biotech index are profitable. Only 30% High-potential, no-profit biotech stocks are the most likely to come down as investors become less willing to pay up for growth”. Top Biotech Stocks to watch in 2015 are, Gilead Sciences, Inc. (NYSE/GILD), Alexion Pharmaceuticals, Inc. (NASDAQ/ALXN, Grifols, S.A. (NASDAQ/GRFS) and Biogen Idec (NASDAQ/BIIB).  “There are always challenges bringing drugs to the market. Additionally, if you look at the cost of getting a new drug to the market, depending on the methodology of how you evaluate it, it can be anywhere from $500 million to $2 billion to get a drug candidate through the incredibly arduous pre-clinical, clinical and regulatory process just to demonstrate safety efficacy and tolerability to the satisfaction of the FDA”, in the opinion of the market the above mentioned biotech companies were successful in meeting the FDA demands. “Even when a drug gets to the phase 3 development stage, the probability of failure can be as high as 50 percent (depending on the therapeutic category.). Biotech companies tend to be highly resilient, able to reinvent themselves—they tough-out these disappointments. The passion, intellect and determination of committed scientists and clinicians remain undaunted, even emboldened by the challenges of drug development”

Recently, Biotech/Pharma companies have managed staffing challenges by implementing reorganizing/restructuring which has resulted in layoffs. Companies must identify staffing vulnerabilities and design in order to reduce layoffs. “Many of the people working in biotech companies hold advanced degrees and have highly specialized technical and nontechnical expertise. They are typically strongly value human life and hold a deep commitment to creating new therapeutics, medical devices or diagnostics that improve medical treatments or meet unmet medical needs”, because of this, it can be very difficult for individuals in the biotech/Pharma industry laid off to find another job in a timely manner (~6 months).

Biotech/Pharmaceutical – Bubble or Bust

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In the last few years, the US is trying to bounce back from unpresented unemployment and almost zero growth in the economy. Although, at the height of the US recession and very bad economic times, it seemed like the Biotech/Pharma industry was not as negatively impacted as other sectors. Advancing to 2015, Pharmaceutical Companies have announced $102.3 billion in biotech stocks were the market’s hottest investment.

The “S&P Biotech Select Industry Index has grown 34.31%, while the DJIA and the S&P 500 have only appreciated 2.97% and 6.7% respectively, meaning that in 2014, biotech has outperformed the market by an even larger margin than in 2013. This conveys the strength of the life science/Healthcare sector and shows that a stable framework is in place for further expansion”. However, it is important to point out that “rough estimate shows that only 30% of the 150 companies that make up the biotech index are profitable. Only 30% High-potential, no-profit biotech stocks are the most likely to come down as investors become less willing to pay up for growth”. Top Biotech Stocks to watch in 2015 are, Gilead Sciences, Inc. (NYSE/GILD), Alexion Pharmaceuticals, Inc. (NASDAQ/ALXN, Grifols, S.A. (NASDAQ/GRFS) and Biogen Idec (NASDAQ/BIIB).  “There are always challenges bringing drugs to the market. Additionally, if you look at the cost of getting a new drug to the market, depending on the methodology of how you evaluate it, it can be anywhere from $500 million to $2 billion to get a drug candidate through the incredibly arduous pre-clinical, clinical and regulatory process just to demonstrate safety efficacy and tolerability to the satisfaction of the FDA”, in the opinion of the market the above mentioned biotech companies were successful in meeting the FDA demands. “Even when a drug gets to the phase 3 development stage, the probability of failure can be as high as 50 percent (depending on the therapeutic category.). Biotech companies tend to be highly resilient, able to reinvent themselves—they tough-out these disappointments. The passion, intellect and determination of committed scientists and clinicians remain undaunted, even emboldened by the challenges of drug development”

Recently, Biotech/Pharma companies have managed staffing challenges by implementing reorganizing/restructuring which has resulted in layoffs. Companies must identify staffing vulnerabilities and design in order to reduce layoffs. “Many of the people working in biotech companies hold advanced degrees and have highly specialized technical and nontechnical expertise. They are typically strongly value human life and hold a deep commitment to creating new therapeutics, medical devices or diagnostics that improve medical treatments or meet unmet medical needs”, because of this, it can be very difficult for individuals in the biotech/Pharma industry laid off to find another job in a timely manner (~6 months).

Vaccinations

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The need to be vaccinated against the measles virus has been in the news for weeks. It is hard to believe we are having this discussion in 2015; if I did not know better, I would think that the USA was a third world country; believe it or not the measles was declared eliminated in the United States in 2000 which means, the virus is usually brought into the USA by international travelers and we only had sporadic outbreaks; now we are dealing with a resurgence of the disease in the United States primarily because of the lack of vaccination. I am obviously in the “get vaccinated” camp. As you are probably aware, the measles outbreak has been linked to Disneyland in California in mid-December 2014 and the outbreak has now been reported in 14 States. Besides California, Arizona is the next hardest hit State.

I do understand some parents are of the opinion that vaccines cause Autism. However, to date “many studies that have looked at whether there is a relationship between vaccines and the autism spectrum disorder (ASD) and to date, the studies continue to show that vaccines are not associated with ASD”. Please review the Center for Disease Control and Prevention (CDC) Website http://alturl.com/t2fm7 . I have also heard from parents that the vaccine has peanut oil and my child is highly allergic. Please note, that vaccines do not contain either corn or peanut oils. Additionally, you can view vaccine ingredients via the CDC website http://alturl.com/bik68

There is a relatively small group of parents in a big country who have decided not to vaccinate their children however, their decision not to vaccinate their children can have a profound impact on public health. Interesting information,” Most parents who do not vaccinate do believe vaccines are necessary to protect the health of their children but also believe their children could suffer from the vaccines themselves”.

Approximately 25 states allow philosophical exemptions or religious exemption. Of course, because of health complications, some children should not be vaccinated and it is because of these children why vaccination is so important. In 2013-2014 in the entire US there were approximately 1000 medical exemptions but over 17,000 philosophical exemptions. Mississippi and West Virginia do not allow religious or philosophical exemptions, and they reported only about 50 medical exemptions.

The measles disease is extremely contagious for the following reasons:

  • “An infected person can spread it four days before developing a rash.
  • 90% of people who are not immune and are close to someone with measles will also get infected.
  • The virus is airborne.
  • It can also live on infected surfaces for up to two hours”.

As I stated previously , I am in favor of immunization coverage in the United States and I hope that many parents who are not in favor of having their children being vaccinated will change their mind.

 

 

Infectious Disease – 2015

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The Ebola outbreak was in the headlines in 2014 and it is in the news as we begin 2015. No virus strikes as much fear and thus, lack of compassion for individuals infected with Ebola. A nurse in the UK is in critical condition infected with the Ebola virus http://alturl.com/euj2t An American Health worker exposed to Ebola is headed to Nebraska for observation. “The World Health Organization (WHO) reports more than 20,000 confirmed or suspected cases of Ebola, mostly in the countries of Guinea, Liberia, and Sierra Leone, as of Dec. 27 (Dec. 24 for Liberia). More than 7,800 people have died in the largest Ebola outbreak ever recorded”. Unfortunately, we will probably read about many more cases throughout 2015. However, scientists are currently working to develop a vaccine. http://alturl.com/dfb3v

The CDC declares Influenza an epidemic because of the high incident of the flu in various regions of the US. That being the case, the flu high incident rate was in the news in 2014 and continues to be discussed in January of 2015 http://abcnews.go.com/Health/15-children-dead-cdc-declares-flu-epidemic/story?id=27895739 The flu has not yet peaked thus, the reason for the concern, as well as, the deaths that have occurred to date.

The Norovirus outbreaks on cruise ships was in the news in 2014. There were so many cases in 2014 that I thought twice about cruising. http://alturl.com/3rs3g However, did you know that the” Norovirus is second to the common cold in reported illnesses, impacting millions of people around the world each year. Norovirus, previously known as Norwalk Virus, was actually named for a land-based outbreak in Norwalk, Ohio, that originally occurred some 30 years ago. It can break out at any time of the year.” We will probably see this virus in the news in 2015. The CDC implemented a Vessel Sanitation Program http://alturl.com/vbtzp ; notification is required when the GI illness count exceeds 2% of the total number of passengers or crew onboard.

Enterovirus has been attributed to at least 3 deaths in 2014; these deaths were in children; the infection most often occurs in the summer\ fall and is most prevalent in children. Enterovirus enters the body through the gastrointestinal tract and thrives there, often moving on to attack the nervous system. “Enteroviruses can be found in the respiratory secretions (for example, saliva, sputum, or nasal mucus) and stool of an infected person. Other people may become infected by direct contact with secretions from an infected person or by contact with contaminated surfaces or objects, such as a drinking glass or telephone. Parents, teachers, and child-care-center workers may also become infected by contamination of the hands with stool from an infected infant or toddler during diaper changes”.

In 2014 there was an outbreak of Mumps in Columbus, Ohio. Columbus reported over 250 cases which is quite an increase from previous years. The outbreak started on the campus of Ohio State University, outbreaks are infrequent, it is unlikely that Mumps will be in the news in 2015. Mumps is a vaccine preventable illness.

 

 

The Future of Healthcare – Robotics

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“The term robotics means the use of a robot to perform various functions. A robot has movable physical structure, a power source, a sensor system, and a computerized ‘brain’ to control activities”. In an effort to make certain we are all aware of my definition of what robotics is in medicine, I define a robotic technique as a mechanical device controlled using a computer system through computer control or human intervention. The most common use of robotics is in surgery specifically, the most common is in Orthopedic and Urologic surgery. Robotics in surgery is not a new technology but the technology is always evolving. In my opinion, the important advantage of robotic a system is, that it is minimally invasive however, robotic systems are very expensive and there is a perceived steep learning curve for the surgeon.
The use of Robotics in surgery still requires the expertise of the surgeon, but the instruments used by robotics may improve the control and the precision of the surgeon. “Patients with robotic surgery have smaller incisions, shorter hospital stays, and normally faster recovery time. This reduces costs for the patient and gives the patient the ability to return to their normal activities in a much shorter time span”.

Beyond surgery

Just imagine, at one time robots were considered science fiction, what we watched on television or read about, but the future is here and we need to embrace it. The partnership between engineers and clinicians including all healthcare workers will be critical as we include robotic technology into clinical practice from the lab to the bedside. I hope is that medical robotics in the next decade will be the norm in many aspects of medicine particularly, in patient care. In addition, it is my hope that this technology will also aid in improving quality of care and reducing the shortages recognized in healthcare; thus, in caring for the patient.

The Future of Healthcare – Electronic Medical Records

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It is almost unheard of to go to a doctor with symptoms and not have gone to a medical information website beforehand and self diagnose. Of course, self diagnosing is quite disturbing to a doctor and many times we are incorrect about our disease/illness. Equally amazing, is to walk into a doctor’s office today and see a paper medical record; often in place of paper is a electronic medical record.

Electronic Medical Records (EMR) is a digital version of a paper medical chart that contains all of a patient’s medical history.  At its best, EMR allows your primary care doctor and your medical team to better manage your medical information, ultimately delivering better care and having a better outcome.  In 2009 the Obama administration gave incentives to push for the implementation of electronic medical records however, “the scope and pace of the implementation has been far beyond the capacity of many medical institutions”.

Benefits of Electronic Medical Records

“An EMR is more beneficial than paper records because it allows providers to:

  • Track data over time
  • Identify patients who are due for preventive visits and screenings
  • Monitor how patients measure up to certain parameters, such as vaccinations and blood pressure readings
  • Improve overall quality of care in a practice”

At its worse,  doctors complain that EMR is time-consuming because implementation to a electronic system is slow and often times two different systems, paper and digital are maintained for awhile, electronic systems are expensive to implement, safety oversight is minimal, a complex medical picture is challenging and extra effort has to be made to avoid errors, computer crashes can cause medical notes to vanish, and there is a potential for mix-ups which can be dangerous and thus, deadly. Recently outlined in  local newspapers are testaments of EMR at its worse. A hospital stated that they had two different systems, paper and electronic and essentially, human error occurred which was deadly. At another hospital incorrect information due to a typing error was entered into a digital system which resulted in the death of an infant. A complex and seriously sick individual created a confusing EMR which resulted in human error.

Although, there has been many peaks and valleys with regard to Electronic Medical Records, in my opinion EMR does improve the quality of medical care by making a patient’s medical history easily available to the treating Physician(s)/medical team. It is my hope that in the next 10 years  the struggles and challenges we are facing today will be behind us and medicine will catch up with the rest of the electronic future.

Communication in the workplace

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Working as a consultant I have had the opportunity to experience many workplace cultures and I have found the common thread in all workplaces that makes the workplace a challenge is the lack of effective communication. Is communication a part of workplace ethics? Yes, it is in my opinion. I would say that workplace ethics goes beyond business ethics. Most companies focus on business ethics because senior management feels as a company, ethical principles and moral or ethical problems constantly arise in a business environment and a set of standards are established and hopefully followed. Business ethics is indeed very important for a company to focus on; understanding and complying with the laws and regulations as it pertains to business conduct keeps a company out of trouble. Business ethics has also lead to the development of corporate policies that govern ethical conduct.

Some companies still do not realize that their most valuable asset is there employee and thus, effective communication in the workplace plays an important role in maintaining good work relations and ultimately having a successful and financially stable company. What is effective communication in the workplace? Effective communication is being clear and transparent. It is communicating negative or difficult information while still maintaining trust and not creating conflict. Effective communication is encouraging attentive listening, two-way communication, trust building, confidence between management and employees, team work and constructive problem solving.
“Communication is an art” both verbal and non-verbal, it does come naturally to some and not so naturally to others. If done poorly it can create misunderstanding, frustration, questioning trust, reducing respect. Unfortunately, I have witnessed workplace communication performed poorly; hiding behind an inappropriate e-mail message or a non-verbal message thus, causing employee de-motivation and high turnover. What is most unfortunate is that most companies – senior management have no idea that they are communicating poorly and feel their lack of effective communication is justified.