Ketamine – is it the new hope for depression?

Light At The End Of The Tunnel

After decades of lack of innovation in the depression field, maybe patients having tried several treatment options could see the light at the end of the tunnel.

Ketamine is a potent analgesic used in surgery. As the compound is highly soluble in lipids, it ensures a rapid onset of the effects leading to a quick relief of depression symptoms without the typical side effects of standard antidepressants like SSRI.

However, there are some health consequences of administering that drug in the long term:

  • CNS effects: as ketamine is considered to be a cerebral vasodilator that increases cerebral blood flow, it has anticonvulsant effects. However, its use could be limited as it has also unpleasant emergence reactions such as hallucinations, out-of-body experiences, and increased and distorted visual, tactile, and auditory sensitivity.
  • Cardiovascular effects: ketamine increases blood pressure, heart rate and cardiac output.
  • Respiratory effects: ketamine relaxes bronchial smooth muscles and may be helpful in patients with reactive airways and in the management of patients experiencing bronchoconstriction.

The cardiovascular effects could limit its used in depressed patients with cardiovascular conditions. Furthermore, we know that ketamine is safe when used for anesthesia but we have no idea about its long-term safety. For depression, it is given every few weeks for several months.

Another point worth to mention is the lack of reimbursement: it is not covered by any health insurance today and patients have to pay out of the pocket. Depending on the dose and the healthcare provider, it could range from USD 400 to 800 in USA.

Currently, late-stage studies are ongoing with compounds closed to ketamine developed by Johnson & Johnson and Allergan in order to fill this gap and provide patients with access to a safe and effective drug.

Thinking forward about mental health, we could maybe study psychoactive drugs more in-depth in order to discover whether they could be used in a controlled setting to ease some mental disorders.

Initiatives are launched to go into this direction. The future will tell…

 

Additional insights:

Ketamine Stirs Up Hope—and Controversy—as a Depression Drug – Wired – 2019

Ketamine Could Be the Key to Reversing America’s Rising Suicide Rate – Bloomberg Businessweek – 2019

Can we stop suicide? – NYT – 2018

Psilocybin – A long, strange trip – Because psilocybin research has been restricted, scientists actually don’t know a lot about how it does what it does; only recently has that started to change. To begin with, its chemical structure is similar to the neurotransmitter serotonin. Evidence from a 2012 study suggests that psilocybin “knocks out” serotonin receptors by occupying them, which “appears to allow information to travel more freely in the brain”; two areas in which it knocks out some activity are associated with self-awareness. – Quartz – 2018

Mind molding psychedelic drugs could treat depression, and other mental illnesses – The Conversation – 2018

The Effects of Cannabis Among Adults With Chronic Pain and an Overview of General Harms: A Systematic Review – Annals of Internal Medicine – 2017

Benefits and Harms of Plant-Based Cannabis for Posttraumatic Stress Disorder: A Systematic Review – Annals of Internal Medicine – 2017

The Ketamine Breakthrough for Suicidal Children – Scientific American – 2017

New Hope for Depression – TIME – 2017

The War on Drugs Halted Research Into the Potential Benefits of Psychedelics – Slate – 2017

Scientists and Silicon Valley want to prove psychoactive drugs are healthy – The Guardian – 2016

End the Ban on Psychoactive Drug Research – Scientific American – 2014

 

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Top 15 Pharma companies – Q1 2016 performance wrap-up

Wall Street

The Q1 2016 earnings season is now over. It is always nice to take a step back and compare the big names of the pharmaceutical industry.

Below you will find the key figures published by the most important companies in the industry.

Q1_2016.jpg

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US drug pricing is on the verge of change

MoneyPills

Drug pricing is always a topic for discussion regardless of the country where you live.

The USA have long been considered as the most expensive country when it comes to drugs. Today, several initiatives are trying to contain their price and limit the explosion of healthcare expenditures. It is not easy and several political leaders failed in front of the powerful lobby supporting the pharmaceutical industry.

Maybe, instead of price cuts, we should think of more nuanced version of price control like value-based pricing or risk-sharing agreements.

An extremely interesting article explore the future opportunity of risk-sharing agreements in the USA. It is widely used in Europe as well as in other countries but shows a slow uptake in the USA. The conclusion of the article is positive as there is room for improvement. “Most manufacturers and payers expressed interest in RSAs and see potential value in their use. Due to numerous barriers associated with outcomes-based agreements, stakeholders were more optimistic about financial-based RSAs. In the US private sector, however, there remains considerable interest—improved data systems and shifting incentives (via health reform and accountable care organizations) may generate more action.”

However, despite hot debate launched by Hillary Clinton recently about drug pricing, the US Congress is still dominated by Republicans, who is completely supporting the pharmaceutical industry. Drug pricing and healthcare coverage will be one of the hottest debate question of the US Presidential Elections this fall.

Some articles are much less optimistic as they show that the bargaining power of private payers is far from sufficient to be able to negotiate discounts.

Drug pricing has to change in the USA because affordability and healthcare coverage will define the sales potential of the product. If the drug is so expensive that no one can afford it and no insurance will pay for it, it has no future sales opportunity. It is key to find a good balance between rewarding innovation and R&D efforts AND allowing patients to access the medicine and care they need.

 

Additional resources:

Private Sector Risk-Sharing Agreements in the United States: Trends, Barriers, and Prospects – American Journal of Managed Care – September 2015

It’s Time to Rein in Exorbitant Pharmaceutical Prices – HBR – September 2015

Why we can’t stop US drug companies from charging astronomical prices – Quartz – September 2015

Drug prices: Which companies may be the next targets? – CNBC – September 2015

Rational Drug Pricing – Huffpost Business – September 2015

Why Are Drug Costs So High in the United States? – Medscape – November 2014

High Cancer Drug Prices in the United States: Reasons and Proposed Solutions – ASCO – July 2014

Higher US Branded Drug Prices And Spending Compared To Other Countries May Stem Partly From Quick Uptake Of New Drugs – Health Affairs – April 2013

Pricing and Reimbursement in U.S. Pharmaceutical Markets – NBER – August 2010

 

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Alphabet (ex-Google) is the next big thing in Life sciences

A lot is currently written about the initiatives launched by Alphabet (Google) in the life sciences field.

I had the wonderful opportunity to have a look at the report written by the internet analyst, John Blackledge, from Cowen and I must say that he’s very smart at showing the huge potential of the life sciences at the core of Alphabet (Google).

This report is amazing as it allows you to have a better understanding of what’s happening now inside Alphabet (Google). I summarized the key points/quotes from the report below and I added other articles at the end of this blog post. Moreover, I will update it frequently as the news come in. This is a fascinating topic, I really hope Alphabet (Google) would be able to replicate the same success it has built with its search engine.

Key quotes & comments from the report:

  • Expansion into health care and related segments allows Google to leverage its core competencies in Internet communications technology, data structuring and analysis, and fundamental process reinvention.

 

  • Specific areas of focus in healthcare include:
    (1) the sequencing the human genome and the rise of precision medicine: despite the monumental significance of mapping the human genome and the implications for drug discovery, this was but one step in a long journey that continues to this day. Moreover, genes are but one factor in disease, and little is known about what role environment and lifestyle play.
    (2) the digitization of health data is exploding, with a virtually endless list of sources that can offer insight into clinical data, drug studies and more. As more data is digitized, there will be a profound impact on how patient care is administered, how therapies are researched, and how drugs are tested. EHRs (Electronic Health Records) are crucial but implementation is very challenging. Harmonization and data aggregation need to find their way. Wearables are another interesting topic in the digitization of health data. Social media and discussion boards as well as patients website are essential parts of the system that must be closely monitored as more and more patients use those communication channels in order to provide feedback and comments on treatments and daily struggles with healthcare providers.
    (3) the shift to value-based care, where payments are based on the value of care, is driving a change in how services are delivered and how much consumers engage in the process. From a provider perspective, doctors are incentivized to manage patients to the best possible health outcome at the lowest cost. From a patient perspective,
    consumers are being empowered to take a more active role in their own health care.
    These health care trends are being accommodated by technology advances in areas such as social, mobile, analytics and cloud computing, all areas of Google expertise.

 

  • Alphabet invests in health in five different ways:
    (1) Google Life Sciences originated in Google[x], a research lab within Google that was funded by the company’s board of directors in January 2010 to pursue “moonshots”—audacious new projects that have a low probability of succeeding, but could be truly revolutionary if they do. The company views moonshots as critical in driving the true innovation required to affect revolutionary change and avoid the “incrementalism” or evolutionary change that tends to lead to corporate irrelevance over time. The Life Sciences team is responsible for such innovations as glucose monitoring smart contact lenses. With an expanding list of intellectual property, Life Sciences has begun to accelerate its collaborative efforts with third parties. The company is aggressively partnering with leading players in the health care space on a growing number of programs.
    (2) Calico’s mission is to harness advanced technologies to increase understanding of the biology that controls lifespan. Calico was originally conceived by Google Ventures President and General Partner, Bill Maris, who observed that most companies seek to find treatments for disease and associated symptoms, but that none address the root cause of disease and death. He wondered if studying the impact of aging on genetic material could lead to the discovery of drugs that could address many age-related diseases and significantly extend the human life span.
    (3) Google Ventures has provided seed, venture and growth stage funding to a host of companies in diverse fields, but its stated focus is machine learning and life science investing.
    (4) Google Capital was formed to invest in later-stage technology companies with a focus on emerging technology leaders and potential disruptors. Unlike the earlier stage companies in Google’s other investment vehicles, the later stage companies in Google Capital tend to be fairly common household names. Although the stated focus of Google Capital is on technology companies, the collision of technology and health care is blurring the lines of what a traditional “technology” company looks like.
    (5) Google Core: Over time, Google has invested in numerous health-related initiatives within its main corporate division. These have tended to be very closely linked to the company’s core businesses, such as Search. Earlier this year, the company announced that it will add health information that has been fact-checked by physicians directly to search results. The company is also talking to the FDA about using search query data to identify adverse drug reactions.

 

  • Google’s Health-Related Focus Areas: regardless of where they are housed within Google’s corporate structure, most of Google’s health-related endeavors share common characteristics.
    (1) Longevity
    (2) Genetics and Chronic Care
    (3) Diagnostics
    (4) Diabetes/Digital Health
    (5) Medical Devices
    (6) Telehealth/Digital Health
    (7) Wearables/Fitness

 

  • Google’s health endeavors fit with the company’s goals of “making the world’s information useful” and helping millions of people. Indeed, Google believes that many of the same principles, techniques and problem solving capabilities employed by its software developers can be applied to the massive inefficiencies that exist in health care to create transformational solutions and medical breakthroughs that help people live longer, healthier lives. Health care ambitions can be summarized as:
    (1) Analyze: Analytics to inform decision-making and provide business insight
    (2) Attract: Attract health care constituents to platforms and solutions that drive engagement
    (3) Aggregate: Aggregate data from disparate sources onto the Internet or GCP

 

Additional resources:

Alphabet to help researchers predict disease – Financial Times – April 2017

Google Life Sciences Exodus – STAT – March 2016

Verily, Google’s Health Gambit, Is Stacked With Scientists. Now It Needs to Build a Business – ReCode – December 2015

Google hires mental health expert to lead new life sciences unit – Financial Times – September 2015 (Subscription required)

Head of Mental Health Institute Leaving for Google Life Sciences – The New York Times – September 2015

Google Bets on Insurance Startup Oscar Health – WSJ – September 2015

Is Health Care Google’s Next Big Business After Search? This Investment Bank Thinks So – Re/Code – September 2015

Why Google Is Going All In On Diabetes – NPR – September 2015

Google’s health startup, AbbVie team up on drug research – Chicago-Sun Times – September 2015

Google Life Sciences Company Has New Deal, Official Nemesis in Diabetes – Re/Code – August 2015

Alphabet Breathes New Life, Resources Into Google’s Health Care Projects – iHealthBeat – August 2015

Google Health – Easy as ABC. Alphabet, Calico and the Aging of Humanity – What on Earth are they doing? – Digital Intervention – August 2015

 

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The dream of the universal flu vaccine might come true – Wired

Researchers found and tested a prototype of a universal flu vaccine. The first results on animals are good.

Scientists worked with a piece of viral protein so it can teach immune systems to fight groups of viruses rather than just a single strain.

As we all know, the real issue with flu comes from its mutations. It explains why the vaccine may not be so protective against seasonal flu as the virus can change.

It is probably the beginning of a new era of hope because flu kills.

Read more: Wired Article

Additional Articles:

Science Mag

WebMD

Financial Times (subscription required)

The Guardian

Bloomberg

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A Better Understanding of the US Drug Pricing Landscape and Financial Risks Associated – Health Affairs Blog

An excellent article posted on the Health Affairs blog takes a step back regarding US drug pricing and the financial risks associated with drug development well beyond the clinical trials stage.

Key quotes from the article:

  • It may be helpful for the policy discussion to think of a drug’s value as the clinical performance and patient outcomes, while the price reflects both the value and the growing uncertainty around in-market risks of market consolidation and restricted access, branded therapeutic competition, mandatory discounts, and restrictive coverage policy.
  • As competition heats up, each sector and each entity strives to reduce input costs and maintain or improve prices — and consolidation can be an important tool to accomplish these goals. Specific to biopharma, consolidation strengthens payers’ and providers’ ability to press for drug discounts that are contractual, proprietary, and confidential.
  • Net lifetime revenues of new biopharma therapies declined from profitability in the late 1990s to slightly negative profitability by the end of the first decade of 21st century.
  • In addition to cross-sector market competition through payer and provider consolidation, there is growing intra-sectorial competition among generics, biosimilars, and branded therapeutic alternatives.
  • We should not underestimate the potential effect of mandatory price discounts on drug launch prices.
  • In-market risks for biopharma are very significant today. Because of rapid changes in the market environment, revenue expectations established when the decision is made to proceed with product development can be very different than actual revenue several years later when a product is launched.

 

Additional Resources

When Is a Virtual Business Model Suitable for Biopharmaceutical Companies? – BioProcess International – 2015

Understanding the pharmaceutical value chain – IMS Institute for Healthcare Informatics – 2014

Innovative Business Models in the Pharmaceutical Industry: A Case on Exploiting Value Networks to Stay Competitive – International Journal of Engineering Business Management – 2014

The Real Cost of “High-Priced” Drugs – Harvard Business Review – 2014

Rapid growth in biopharma: Challenges and opportunities – McKinsey – 2014

 

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Google Willingness to Help Life Sciences – Wired

Google, or Alphabet, wants biomedical research and life sciences to be more than just side projects.

Several years ago, its efforts under way in that field were probably not considered seriously by the industrial stakeholders like Big Pharma and biotech companies.

Today it is different after several investments commited lately.

Discover more in the Wired article

 

Additional Resources

4 of the biggest healthcare challenges Google is tackling – HealthcareDIVE – August 2015

Here’s why Google Ventures invests so much money in life-science companies – Business Insider – May 2015

Andrew Conrad – Google Life Sciences – The 25 most influential people in biopharma in 2015 – FierceBiotech – May 2015

Google Continues To Build Upon Its Life Sciences Ecosystem – Forbes – September 2014

Meet the Google X Life Sciences Team – WSJ – July 2014

 

 

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The difficult implementation of value-based healthcare – The Commonwealth Fund

ValueBasedCare

“A new survey from The Commonwealth Fund and The Kaiser Family Foundation asked primary care providers—physicians, nurse practitioners, and physician assistants—about their experiences with and reactions to recent changes in health care delivery and payment.

Providers’ views are generally positive regarding the impact of health information technology on quality of care, but they are more divided on the increased use of medical homes and accountable care organizations.

Overall, providers are more negative about the increased reliance on quality metrics to assess their performance and about financial penalties. Many physicians expressed frustration with the speed and administrative burden of Medicaid and Medicare payments. An earlier brief focused on providers’ experiences under the ACA’s coverage expansions and their opinions about the law.”

Probably each start of a new system is painful and requires people to adapt to it. However, it will have to be carefully monitored as adoption by healthcare providers is crucial for the success of the new system. It will validate the concept of value-based healthcare.

Read more

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US healthcare coverage increased from 85 to 90% – TIME

In a little less than 4 years, US healthcare coverage increased from 85 to 90% according to a TIME article.

“Decreasing the number of uninsured is a key goal of the Affordable Care Act (ACA), which provides Medicaid coverage to many low-income individuals in states that expand and Marketplace subsidies for individuals below 400% of the poverty line.” as stated in an article of KFF.

However, it will be difficult to have a full coverage of the population as some individuals refuse to buy healthcare insurance as they do not see how they could take advantage of the money spent in it. Some of them could simply not afford to buy coverage despite the subsidies.

Moreover, some issues arise with the methodology used to count the number of insured/uninsured people (see the Health Affairs article at the end of the post for more details).

In conclusion and despite all the issues with people not willing to adhere or counting methodology, it is a real progress to expand coverage, especially because US were lagging behind some emerging countries (have a look at the OECD Publication “Health at a Glance 2013” on page 138-139).

And what’s really interesting is the impact of more coverage on global health as a blog post pointed out.

Additional information

Estimating the Affordable Care Act’s Impact on Health – The Commonwealth Fund – August 2015

Meet the Health-Law Holdouts: Americans Who Prefer to Go Uninsured – WSJ – June 2015

Survey: America’s Uninsured Rate Is Down To 10% – And Falling – Forbes – June 2015

Counting The Uninsured: Are We Getting It Right? – Health Affairs – May 2015

Key Facts about the Uninsured Population – Kaiser Family Foundation – October 2014

Is the Affordable Care Act Working? – The New York Times – October 2014

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Pager is an “Uber/Amazon for Healthcare” – Forbes

Several new innovative and internet-linked services are emerging every day.

Several years ago, Amazon was selling books online, then it became a one-stop shop for many other things; Google expanded its traditional search engine business into a variety of other activities; Apple as well as other mobile phone producers launched smartphones only few years ago.., we can go on forever with examples.

Healthcare is one of the last area reached by digitalization. But the trend is now more than settled.

Recently a new startup named Pager raised USD 14 million for making your medical appointments instant and for a flat fee during extended hours (from 8:00am to 10:00pm).

A Forbes article drew some parallel with Uber for taxi ordering:  “The service finds and verifies doctors for its network and bills you automatically over a linked credit card”. However the CEO, Gaspard de Dreuzy, compared the company with Amazon instead: “Pager is focused on delivering a broader range of care options on demand than exist today. It could be a tele-consult via phone or messaging, or an in-person visit in the home, or a referral to the right specialist. We like to think of ourselves as the Amazon for healthcare.”

The service is only currently available in New York, but the company will soon expand its operations with the funds raised.

Other companies like ZocDoc or Doctors on Demand are also facilitating life for patients or people looking for health services quickly.

Below an pic from WSJ (see the related article in the Additional material section):

OnDemandDoctors-WSJ2015

Additional material:

Startups Vie to Build an Uber for Health Care – WSJ – August 2015

The Best Digital Business Models Put Evolution Before Revolution – Harvard Business Review – January 2015

There’s Now A Seamless For When You’re Feeling Sick – Huffington Post – December 2014

9 Healthcare Tech Startups To Watch – InformationWeek Healthcare – December 2014

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Addressing the Financial Burden of Cancer Treatment – From Copay to Can’t Pay – JAMA Oncology

anguish

Cancer care is not only about individual health but also financial health

A new article in JAMA Oncology is raising awareness of the disastrous consequences cancer treatment could have on the financial health of patients.

There is substantial evidence that high financial burden could lead to decreased clinical benefits due to poor treatment adherence and deteriorating quality of life. This is a challenge for oncologists as they are looking to provide the best care for each patient. But what happen if she or he cannot afford it?

The authors suggest several measures to improve patients’financial health:

Restructure cost sharing and insurance design. Due to the current US insurance system designed with deductibles, copays and tiering, cancer patients could face extreme financial burden and, consequently poor health outcomes. Deteriorating health is tied to unaffordable treatments involving lack of adherence.

Eliminate low-value prescribing practices. Common high-cost practices that do not improve clinical outcomes should be excluded in order to preserve patients’financial health.

Create tools to evaluate patient risk regarding financial distress. The routine assessment of financial health should be done early and, if necessary, patient could be addressed to dedicated programs to facilitate care access like patient assistance programs offered by charities.

Improve cost transparency. Providing this information as well as out-of-the-pocket cost information are valuable and allow patients to choose healthcare providers to minimize the impact on their personal budget.

Provide financial counseling as part of cancer care. Patients need to understand what impact(s) their cancer diagnosis could have on their private life (employment, future income, family financial security,…). It is crucial in order to avoid financial pressure and improve planning for the patient’s family and relatives.

Express Scripts is also concerned about the price of cancer drugs as shown in a recent article. As a payer, it would like to really focus on value-based reimbursement and implement indication-based formularies. They will allow to better decide on which treatment/drug works best for which patient. Today, several tools are available to improve treatment decision like tumor testing, genetic analysis, predictive analytics,… Integrated care along with better claims management will complement the measures discussed above in order to provide real solutions and benefits for the patients.

Additional resources

1,495 Americans Describe the Financial Reality of Being Really Sick – NYT – 2018

Out-of-Pocket Costs, Financial Distress, and Underinsurance in Cancer Care – JAMA Network – 2017

Cancer patients skipping medicines or delaying treatment due to high drug prices – STAT News – 2017

Financial toxicity: 1 in 3 cancer patients have to turn to friends or family to pay for care – STAT News – 2016

Drug Abacus – Interactive Exploration of Drug Pricing – 2015 – Memorial Sloan Kettering

How Much Should Cancer Drugs Cost? – 2015 – WSJ

New Cancer Drugs are Expensive, but Price Controls are Misguided – 2015 – Forbes

Cost of Cancer Drugs Should Be Part of Treatment Decisions – 2015 – ASCO

Pricing in the Market for Anticancer Drugs – 2015 – Journal of Economic Perspectives

The High Cost of Cancer Drugs and What We Can Do About It – 2012 – Mayo Clinic Proceedings

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Hacking the Human OS – IEEE

health_keyboard

A mind-blowing report from IEEE about the human body’s operating system

Can we harvest digital health data from trackers and sensors to improve our health and well-being? I summarized below what you will find on the IEEE dedicated web page. I was amazed by the variety and depth of all the innovations presented in these pages. Some of them have certainly the power to be game changers in the health care world. I’m looking forward to seeing all the advances coming to life!

Reading the Code

Several technologies are close to the market and will help us monitor our health. A very good example is the biostamps developed by John Rogers from the University of Illinois. These tiny, stretchable and skin-like sensors are able to send information and data to our smartphone alerting us whether something is happening in our body. More and more complex data could be sensed such as blood oxygen, blood glucose and even muscle weakness or sleep patterns.

Another fascinating example that could change the life of Type 1 diabetes patients is the artificial pancreas. It links “data from an implanted blood-sugar sensor to a computer, which then controls how a pump worn on the hip dribbles insulin under the skin through a pipette. In its fully realized form, the machine would take the patient out of the decision-making loop”. Advanced versions of the system are currently in clinical trials. Continuous monitoring is a huge advance in the field of disease management. It could strongly lighten the daily burden of each patient.

Another field where wearable are very popular: athletes. They are always eager to test the last innovation in the wearables arena. Physiological measurements can be extremely useful to optimize training and rest periods, improve performance and avoid injuries. Sleeves, wristbands, sensors equipped with highest technology can really make a difference in the way we monitor and track performance.

A device rapidly diagnosing any medical condition or disorder… Sounds like science fiction, right? Like in Star Trek… Some of you may recall the tricorder. And guess what? It’s about to become reality thank to a competition launched by Qualcomm. 300 teams registered, 10 finalists which are about to deliver their prototypes very soon. Once the winner has been chosen, real life clinical trials will start and we will know if it’s really working as expected. It’s a huge step forward as it will allow the diagnosis (and maybe the start of a treatment) for a lot of people, not only in US or Europe but also in emerging countries where the lack of medical infrastructure is killing human beings…

 

Analyzing the Code

Technology companies showed their interest in healthcare only recently… It’s welcomed because without technology you cannot do anything with data sets. However, some people are afraid of their data becoming public and being hacked. I think that between these two extreme opinions, we can take the good from both sides and see what this can bring us. “Apple, Google, Microsoft, and Samsung, have all launched e-health initiatives, mostly based around smartphones and wearables. Indeed, the fast-growing health care business would seem a natural next step for the tech giants”. A lot of deals have been signed between pharmaceutical companies and technology firms: Google and Novartis; IBM, Apple, Medtronic & JNJ… These are deals to follow in order to analyze the outcomes. Great initiatives could really emerge and I think we are at the beginning of a new era!

Long term analysis could help us understand in a more detailed way how we get sick, how the disease develop and how we could have anticipated it by looking at biomarkers trends.

The new era of precision medicine is making a big difference for patients. An open-source platform has transformed the way patients are being treated. Surgery is not always the best option in oncology for example and sometimes drug treatment is much more effective. A thorough and careful analysis of all the parameters will help doctors taking the right decision for the right patient at the right time.

Real-time epidemics modelling could have saved lives. Building treatment centers at the right locations, anticipating the spread of the disease (in this case, Ebola) and how to limit the contagion were several of the criteria used to run the model. We will never know what would have happen without such a model but globally we can say that modelling is critical in disease management. Additionally, it is not the use of a single model that will be helpful but the customized and accurate modelling for each and every epidemic, according to its characteristics.

 

Changing the Code

Performing surgical interventions at very small scales is becoming a reality. “Thanks to developments in microfabrication and other areas, researchers are pushing the limits on the size and capabilities of objects small enough to move through the human body”. “With the right design, researchers say, a microrobot—or a swarm of them—could deliver a highly targeted dose of drugs or radioactive seeds, clear a blood clot, perform a tissue biopsy, or even build a scaffold on which new cells could grow”. For the time being, tests have only been run in animals.

A new emerging medical field: electrical therapy. Vagus nerve stimulation has the potential to treat several conditions from migraine to asthma, even immune diseases. Progress is very slow and several failures have made history… but new startups are created and renew the interest in this type of technology.

W like Watson, the digital MD. Watson is based on machine learning: “bringing together computer scientists and clinicians to assemble a reference database, enter case studies, and ask thousands of questions. When the program makes mistakes, it self-adjusts. Researchers also evaluate the answers and manually tweak Watson’s underlying algorithms to generate better output. Here there’s a gulf between medicine as something that can be extrapolated in a straightforward manner from textbooks, journal articles, and clinical guidelines, and the much more complicated challenge of also codifying how a good doctor thinks.” Progress is under way.

 

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Analysis of Clinical Trial Length – Nature Drug Discovery

clinical_tags

How can we explain the duration of clinical trials?

A recent Nature Drug Discovery article written by L. Pregelj & her colleagues from the University of Queensland (Australia) found a solution with a multiple-regression model partially explaining the variation in clinical trial length. The controlling factors included trial primary purpose, end point classification, trial size, therapeutic class, geographic location, type of sponsoring organization.

Sample characteristics: trials started between 2005 and 2009, registered at ClinicalTrial.gov by February 2013. Total number of trials analyzed: 14’319 (Phase I, II or III)

A first view on the trials shows that:

– the numbers of individual trials registered each year rose;

– the length of these trials initially decreased across all phases.

But more details are needed to have better view of the real factors impacting the duration of clinical trials.

The authors built a model to assess whether the changes in clinical trial length depend on trial design specificities (primary purpose, phase, size, allocation,…), therapeutic class (anti-infectives, cancer drugs, cardiovascular medicines, CNS products, metabolics,…), geographic location, type of sponsoring organization (Government vs. Industry) or a combination of some of these factors

The results:

– overall mean length (unweighted): 21.6 months.

2 key factors influencing clinical trial length: type of sponsoring organization and therapeutic class. The trend for length is flat for the pharma industry meaning greater experience and knowledge enabled the companies to build efficiencies but further improvements will be difficult to achieve with standard trial design. The trend is decreasing for US Federal sponsored trials suggesting that best practices began to diffuse beyond the industry itself.

– despite the fact that the stage of the trial (Phase I, II or III) was not one of the two major factors contribution to the length of a clinical trial, the influence of this factor increased significantly in the recent years.

These results are surprising somehow as you would anticipate to have the stage of the trial as a major contributor to its length but the therapeutic class and the sponsor are far more important.

Nature Drug Discovery Article (Subscription required)

Nature Drug Discovery Supplementary Material

More resources:

Better Clinical Trial Designs Could Lower Development Costs And Yield More New Drugs – 2014- Forbes

Understanding Clinical Trials – 2013- An overview provided by Roche

An Overview of Bayesian Adaptive Clinical Trial Design – 2012 – Berry Consultants

Adaptive design clinical trials: Methodology, challenges and prospect – 2010 – Indian Journal of Pharmacology

 

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New genetic testing will be inexpensive and democratized – NYT

DNAextraction

New Genetic Tests Hold Promise

A new article published in the New York Times is really fascinating. A Silicon Valley start-up, Color Genomics, found a simple way to test for genetic mutations responsible for breast and ovarian cancers. They used saliva samples and full automation together with medical doctors interpreting the results for USD 250 per test, a tenth of the competitors’price. As women will be able to pay out-of-the-pocket themselves, the company will not even bother to negotiate with insurance companies. For women not able to finance the cost themselves, Color Genomics will give it for free.

It is only the starting point of a new trend. New diagnostics companies are emerging and finding new ways to deliver the same results but cheaper than the big firms. Illumina is one of the major companies understanding and capturing this trend with the launch of a low cost machine.

Another compelling example in the start-up world is Theranos, a firm able to perform a lot of lab tests on a single blood drop at very low prices; or Counsly, a company that develop low-cost genetic test for parents planning to have children.

However, some questions remain about the impact on healthcare costs, who should be tested,… Below are some recent resources bringing elements of response to these points.

Will lowering the price of genetic testing raise the cost of medical care? (Forbes Article)

What patients need to know about cancer genetic testing (American Cancer Society)

NYT Article

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Improvement in US doctors’s adoption of EHR (Electronic Health Records) – Accenture

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A survey of US doctors created by Accenture shows improvement in EHR use. Good news!

An insightful survey has been conducted by Accenture on the use of EHR by US doctors. Have a look at the infographic!

5 take-home messages:

1. 79% of US doctors are more proficient using EHR. They use EHR to enter patient notes electronically, e-prescribe and receive clinical results

2. They communicate with their patient electronically more frequently and regularly use software-based clinical decision support systems

3. Patients are also engaged with these new tools for requesting prescription refills, email their doctors and access their medical information online

4. EHR lead to a lot of benefits: better patient engagement and satisfaction; improved understanding of their medical condition; more valuable communication with their GP; records accuracy

5. EHR challenges: more user-friendly EHR softwares need to be implemented as doctors complain about the use of EHR; doctors do not always think of accessing EHR of a new patient (seen by another doctor)

Conclusion: the progress shown by the report are good news but there is still work to do and improvements to implement.

Accenture Report

More resources on EHR:

My blog posts on digital health

Intro to EHR: Introduction_to_EHR_McGrawHill_2011

Implementing Electronic Health Records in Hospitals – 2014 – Albert Boonstra & al. – BioMedCentral

Integrating Electronic Health Records Into Clinical Workflow – 2014 – Svetlana Lowry & al. – US Department of Commerce

Using Electronic Health Records to Improve Quality & Efficiency – 2012 – Sharon Sillow-Carroll & al. – 2012 – Commonwealth Fund

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Big biopharma deals we might see in 2015 – BioPharmaDive

Merger mania is alive and well – what could we expect in the coming months?

HandshakeA very interesting article from BioPharmaDive is analyzing the last trends in M&A. 2014 as well as the start of the year have been exciting as we mentioned in a dedicated post. For more on what happened in 2014, have a look at the Evaluate Pharma 2014 Year in Review below.

Some speculation and trends have been deduced from the past by the editor of BPD. He thinks that there is more to come and here what he’s anticipating:

1. Merck & Jazz Pharma backed by a very nice business fit with complementary franchises and products.

2. Shire & BioMarin would be the perfect combo between rare diseases and orphan drugs.

3. Gilead & Seattle Genetics to make a great use of the mountain of cash accumulated by Gilead.

4. Pfizer & Celgene to help Pfizer grab some market shares in oncology.

BioPharmaDive Article

EvaluatePharma2014inReview

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How Big Pharma GlaxoSmithKline is managing its R&D Collaborations – Xconomy

SanDiego

Being close to scientific innovators is key

Cambridge and San Diego are two main centers for innovation in life sciences, according to GlaxoSmithKline. Actually the big pharma established a “first-of-its-kind collaboration” with San Diego’s Avalon Ventures in 2013; lastly it has opened a small office in San Diego to manage its R&D partnerships and to prospect for more deals on the West Coast. GSK also set up a similar outpost in 2014 in Kendall Square, the Cambridge, MA, neighborhood that has become the pharmaceutical industry’s East Coast hub and is close to Harvard, MIT, and the Broad Institute.

Xconomy article

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Don’t kill Obamacare – The Economist

Despite all the critics against Obamacare, the initiative seems to be good for both patients and costs

clever2 key achievements:

  • First, despite the incompetent rollout of healthcare.gov (the website that allows people to use the federal exchanges), the proportion of Americans who lack cover has fallen from 16.2% to 12.3% since 2009.
  • Second, the previously terrifying pace of medical inflation has slowed. The amount that America spends on health care grew by 3.9% a year in nominal terms between 2009 and 2011—having grown by 7.3% a year in 2000-08.

Read the article in The Economist

Tougher laws a likely legacy of the Disneyland measles outbreak – Reuters

One undeniable fact: Most of the recent measles cases have been in people not vaccinated

child_in_a_raincoatThe proposed laws have been introduced in statehouses by both Democrats and Republicans and include a range of approaches, from requiring schools to post immunization rates to entirely eliminating religious and philosophical exemptions.

The year’s largest measles outbreak has been traced to Disneyland in Anaheim, California where visitors were exposed to the disease in mid-December. The vast majority of cases have been in that state, which allows both philosophical and religious exemptions.

In all, 10 of the 17 states with reported measles cases have allowed parents to opt out of vaccines on philosophical grounds, creating a far easier way out of immunizations than states that only exempt families with extensively documented religious objections or health conditions that preclude vaccinations. Read more  What is measle?