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Live Notes from @HarvardMed Bioethics: Authors Jerome Groopman, MD & Pamela Hartzband, MD, discuss Your Medical Mind

Writer: Stephen J. Williams, Ph.D.

As part of the Harvard Medical School Series on Bioethics: author, clinician and professor Jerome Groopman, MD and Pamel Harzband, MD gave an online discussion of their book “Your Medical Mind”, a part of Harvard Medical School Center for Bioethics Program’s Critical Reading of Contemporary Books in Bioethics Series. The Contemporary Authors in Bioethics series brings together authors and the community to discuss books that explore new and developing topics in the field. This was held as an online Zoom meeting on March 26, 2020 at 5 pm EST and could be followed on Twitter using #HarvardBioethics.  A recording of the discussion will be made available at the Harvard Med School Center for Bioethics.

 

Available at Amazon: From the Amazon book description:

An entirely new way to make the best medical decisions.

Making the right medical decisions is harder than ever. We are overwhelmed by information from all sides—whether our doctors’ recommendations, dissenting experts, confusing statistics, or testimonials on the Internet. Now Doctors Groopman and Hartzband reveal that each of us has a “medical mind,” a highly individual approach to weighing the risks and benefits of treatments.  Are you a minimalist or a maximalist, a believer or a doubter, do you look for natural healing or the latest technology?  The authors weave vivid narratives of real patients with insights from recent research to demonstrate the power of the medical mind. After reading this groundbreaking book, you will know how to arrive at choices that serve you best.

 

Doctors Groopman and Hartzband began the discussion with a recapping medical research studies and medical panels, which had reported conflicting results or reversal of recommendations, respectively.  These included studies on the benefits of statin therapy in cholesterol management, studies on whether or not Vitamin D therapy is beneficial for postmenopausal women, the ongoing controversy on the frequency with which women should get mammograms, as well as the predictive value of Prostate Specific Antigen and prostate cancer screening.  The authors singled out the research reports and medical panels reviewing the data on PSA in which the same medical panel first came out in support of using PSA levels to screen for prostate cancer and then later, after reconvening, recommended that PSA was not useful for mass screenings for prostate cancer.

In fact, both authors were

completed surprised of the diametrically opposed views within or between panels given similar data presented to those medical professionals.

The authors then asked a question:  Why would the same medical panel come to a reversal of their decision and more, importantly,  why are there such disparate conclusions from the same medical data sets, leading to varied clinical decision-making.

In general, Drs. Groopman and Hartzband asked how do physicians and patients make their decisions?

To answer this they looked at studies that Daniel Bernouli had conducted to model the economic behaviors of risk aversion in the marketplace. Bernouli’s theorem correlated market expectation with probability and outcomes

expectation = probability x utility of outcome

However, in medicine, one can measure probability (or risk) but it is very hard to measure utility (which is the value or worth of the outcome).

For example, they gave an example if a person was born blind but offered a risky to regain sight, the individual values their quality of life from their own perspective and might feel that, as their life is worthwhile as it is, they would not undergo a risky procedure. However a person who had suddenly lost their sight might value sight more, and be willing to undergo a risky procedure.

Three methods are used to put a value on utility or outcome worth with regards to medical decisions

  1. linear scale (life or death; from 0 to 1)
  2. time trade off:  e.g. how much longer do I have to live
  3. standard gamble:  let’s try it

All of these methods however are flawed because one doesn’t know their future medical condition (e.g. new information on the disease) and people values and perceptions change over time.

An example of choice of methods the medical community uses to make decisions include:

  • In the United Kingdom, their system uses a time trade off method to determine value in order to determine appropriate course of action which may inadvertently, result in rationed care
  • in the United States, the medical community uses the time trade off to determine cost effectiveness

 

Therefore Drs. Groopman and Harztband, after conducing multiple interviews with patients and physicians were able to categorize medical decision making based on groups of mindsets

  1. Maximalist: Proactive behavior, wants to stay ahead of the curve
  2. Minimalist: less intervention is more; more hesitant to try any suggested therapy
  3. Naturalist:  more prone to choose natural based therapies or home remedies
  4. Tech Oriented: wants to try the latest therapies and more apt to trust in branded and FDA approved therapeutics
  5. Believer:  trust in suggestions by physician; physician trusts medical panels suggestions
  6. Doubter: naturally inquisitive and more prone to investigate risk benefits of any suggested therapy

The authors also identified many Cognitive Traps that both physicians and patients may fall into including:

  • Relative versus Absolute Numbers: for instance putting emphasis on one number or the other without regard to context; like looking at disease numbers without taking into consideration individual risk
  • Availability: availability or lack of available information; they noticed if you fall in this trap depends on whether you are a Minimalist or Maximalist
  • Framing:  for example  when people talk to others about their conditions and hear stories about others treatments, conditions .. mainly anecdotal evidence

Stories can be helpful but they sometimes increase our overestimation of risk or benefit so framing the information is very important for both the patient as well as the physician (even doctors as patients)

Both authors have noticed a big shift in US to minimalism probably because of the rising costs of healthcare.

How do these mindsets affect the patient-physician relationship?

A University of Michigan study revealed that patients who would be characterized as maximalists pushed their physicians to do more therapy and were more prone to seek outside advice.

Physicians need to understand and listen to their patients during the patients’s first visit and determine what medical mindset that this patient has.

About the authors:

Jerome Groopman, M.D. is the Dina and Raphael Recanati Professor of Medicine at Harvard Medical School, Chief of Experimental Medicine at Beth Israel Deaconess Medical Center, and one of the world’s leading researchers in cancer and AIDS. He is a staff writer for The New Yorker and has written for The New York TimesThe Wall Street Journal,The Washington Post and The New Republic. He is author of The Measure of Our Days (1997), Second Opinions (2000), Anatomy of Hope (2004), How Doctors Think (2007), and the recently released, Your Medical Mind.

Dr. Pamela Hartzband is an Assistant Professor at the Harvard Medical School and Attending Physician in the Division of Endocrinology at the Beth Israel Deaconess Medical Center in Boston. She specializes in disorders of the thyroid and pituitary glands. A magna cum laude graduate of Radcliffe College, Harvard University, she received her M.D. from Harvard Medical School. She served her internship and residency in internal medicine at the Massachusetts General Hospital, and her specialty fellowships in endocrinology and metabolism at UCLA.

More articles on BioEthics and Patient experiences in this Online Open Access Journal Include:

Ethics Behind Genetic Testing in Breast Cancer: A Webinar by Laura Carfang of survivingbreastcancer.org

Tweets and Re-Tweets by @Pharma_BI ‏and @AVIVA1950 at 2019 Petrie-Flom Center Annual Conference: Consuming Genetics: Ethical and Legal Considerations of New Technologies, Friday, May 17, 2019 from 8:00 AM to 5:00 PM EDT @Harvard_Law

Innovation + Technology = Good Patient Experience

Drivers of Patient Experience

Factors in Patient Experience

Patient Experience Survey

Please also see our offering on Amazon at https://www.amazon.com/dp/B076HGB6MZ

“The VOICES of Patients, Hospital CEOs, Health Care Providers, Caregivers and Families: Personal Experience with Critical Care and Invasive Medical Procedures,”

 

 

 

 

 

 

 

 

 

 

 

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Real Time Coverage @BIOConvention #BIO2019: After Trump’s Drug Pricing Blueprint: What Happens Next? A View from Washington; June 3 2019 1:00 PM Philadelphia PA

Reporter: Stephen J. Williams, PhD @StephenJWillia2

 

Speaker: Dan Todd, JD

Dan Todd is the Principal of Todd Strategy, LLC, a consulting firm founded in 2014 and based in Washington, DC. He provides legislative and regulatory strategic guidance and advocacy for healthcare stakeholders impacted by federal healthcare programs.

Prior to Todd Strategy, Mr. Todd was a Senior Healthcare Counsel for the Republican staff of the Senate Finance Committee, the Committee of jurisdiction for the Medicare and Medicaid programs. His areas of responsibility for the committee included the Medicare Part B and Part D programs, which includes physician, medical device, diagnostic and biopharmaceutical issues.

Before joining the Finance Committee, Mr. Todd spent several years in the biotechnology industry, where he led policy development and government affairs strategy. He also represented his companies’ interests with major trade associations such as PhRMA and BIO before federal and state representatives, as well as with key stakeholders such as physician and patient advocacy organizations.

Dan also served as a Special Assistant in the Office of the Administrator at the Centers for Medicare & Medicaid Services (CMS), the federal agency charged with the operation of the Medicare and Medicaid programs. While at CMS, Dan worked on Medicare Part B and Part D issues during the implementation of the Medicare Modernization Act from 2003 to 2005.

Cost efficiencies were never measured.

Removing drug rebates would cost 180 billion over 10 years. CBO came up with similar estimate.  Not sure what Congress will do. It appears they will keep the rebates in.

  • House  Dems are really going after PBMs; anytime the Administration makes a proposal goes right into CBO baseline estimates;  negotiations appear to be in very early stages and estimates are up in the air
  • WH close to meet a budget cap but then broke down in next day; total confusion in DC on budget; healthcare is now held up, especially the REBATE rule; : is a shame as panel agrees cost savings would be huge
  • they had initiated a study to tie the costs of PartB to international drug prices; meant to get at disparity on international drug prices; they currently are only mulling the international price index; other option is to reform Part B;  the proposed models were brought out near 2016 elections so not much done; unified agenda;
  • most of the response of Congress relatively publicly muted; a flat fee program on biologics will have big effect on how physicians and health systems paid; very cat and mouse game in DC around drug pricing
  • administration is thinking of a PartB “inflation cap”;  committees are looking at it seriously; not a rebate;  discussion of tiering of physician payments
  • Ways and Means Cmmtte:  proposing in budget to alleve some stresses on PartB deductable amounts;
  • PartD: looking at ways to shore it up; insurers 80% taxpayers 20% responsible; insurers think it will increase premiums but others think will reduce catastrophic costs; big part of shift in spending in Part D has been this increase in catastrophic costs
  • this week they may actually move through committees on this issue; Administration trying to use the budgetary process to drive this bargain;  however there will have to be offsets so there may be delays in process

Follow or Tweet on Twitter using the following @ and # (hashtags)

@pharma_BI

@AVIVA1950

@BIOConvention

@PCPCC

#BIO2019

#patientcost

#PrimaryCare

 

Other articles on this Open Access Journal on Healthcare Costs, Payers, and Patient Care Include:

The Arnold Relman Challenge: US HealthCare Costs vs US HealthCare Outcomes

Centers for Medicare & Medicaid Services announced that the federal healthcare program will cover the costs of cancer gene tests that have been approved by the Food and Drug Administration

Trends in HealthCare Economics: Average Out-of-Pocket Costs, non-Generics and Value-Based Pricing, Amgen’s Repatha and AstraZeneca’s Access to Healthcare Policies

Can Blockchain Technology and Artificial Intelligence Cure What Ails Biomedical Research and Healthcare

Live Conference Coverage @Medcity Converge 2018 Philadelphia: Oncology Value Based Care and Patient Management

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Live Conference Coverage @Medcity Converge 2018 Philadelphia: Oncology Value Based Care and Patient Management

Reporter: Stephen J. Williams, Ph.D.

3:15 – 4:00 PM Breakout: What’s A Good Model for Value-Based Care in Oncology?

How do you implement a value-based care model in oncology? Medicare has created a bundled payment model in oncology and there are lessons to be learned from that and other programs. Listen to two presentations from experts in the field.

Moderator: Mahek Shah, M.D., Senior Researcher, Harvard Business School @Mahek_MD
Speakers:
Charles Saunders M.D., CEO, Integra Connect
Mari Vandenburgh, Director of Value-Based Reimbursement Operations, Highmark @Highmark

 

Mari: Building strategic partnerships with partners focused on population based health and evidence based outcomes. they provide data analytics and consultative services.  Incorporate risk based systems.  also looking at ancillary segments because they see cost savings.  True Performance is their flagship performance program and 11% lower ED (saving $18 million) rates and 16% lower readmissions ($200 million cost savings).  Also launched the Highmark Cancer care Program with Johns Hopkins.  They monitor the adherence pathways and if clinician shows good adherence they give reimbursements.

Charles:  Integra is a cloud based care platform focused on oncology and urology and allow clinicians to practice value based care. Providers must now focus on total cost including ER visits, end of life and therapies (which is half of total cost in US).  The actionable ways to reduce costs is by reducing ER visits.  What is working? Data on reimbursements models is very accurate so practices can dig into data and find effieciencies.  However most practices do not have the analytics to do this.

  • care navigation
  • care path based treatment choices
  • enhanced patient access and experience

What is not working

  • data not structured so someone has to do manual curation of records
  • flawed logic based on plurality of visits but physician doesn’t know who else they saw
  • target pricing not taking into account high prices of new therapies
  • lack of timely reporting either by patient or physician
  • insufficient reimbursements
  • technology limitations

 

4:10- 4:55 Breakout: What Patients Want and Need On Their Journey

Cancer patients are living with an existential threat every day. A panel of patients and experts in oncology care management will discuss what’s needed to make the journey for oncology patients a bit more bearable.

sponsored by CEO Council for Growth

Moderator: Amanda Woodworth, M.D., Director of Breast Health, Drexel University College of Medicine
Speakers:
Kezia Fitzgerald, Chief Innovation Officer & Co-Founder, CareAline® Products, LLC
Sara Hayes, Senior Director of Community Development, Health Union @SaraHayes_HU
Katrece Nolen, Cancer Survivor and Founder, Find Cancer Help @KatreceNolen
John Simpkins, Administrative DirectorService Line Director of the Cancer Center, Children’s Hospital of Philadelphia @ChildrensPhila

 

Kezia: was a cancer patient as well as her child getting treated at two different places and tough part was coordinating everything including treatments and schedules, working schedules

Katrece: had problem scheduling with oncologists because misdiagnosis and her imaging records were on CD and surgeon could not use the CD

John:  the above are a common frustration among patients at a time when they don’t need the confusion. He feels cancer centers need to coordinate these services better

Sara:  trying to assist people with this type of coordination is very tough even with all the resources

Kazia:  she needed to do all the research on her own because big dichotomy being an adult and a pediatric patient where pediatrics get more information and patient centered care. She felt she felt burdening the physicians if she asked the same questions.  How can we get more interaction with primary care physicians and feel comfortable with their interaction?

John: there is this dichotomy especially on wait times for adults is usually longer.  We can also improve patient experience with counseling patients

Katrece: Just working with a patient navigator is not enough.  The patient needs to take charge of their disease.

Sara: Patient communities can help as sometimes patients learn from other patients.

Amanda:  in breast cancer , navigators are common but must take care they are not only people patients see after a while

John:  at CHOP they also have a financial navigator.  On the adult side there are on call financial navigators.  Recent change of the high deductible plans are a major problem.  Although new families are starting to become comfortable with the financial navigator

Katrece:  guiding your children through your experience is important.  It was also important for her to advocate for herself as she had three different sites of cancer care to coordinate and multiple teams to coordinate with each other

Amanda:  A common theme seems to be hard trying to find the resources you need.  Why is that?

Kazia:  Sometimes it is hard to talk about your disease because it can be emotionally draining comforting other people who you told about the disease and they are being empathetic.  Sometimes they want to keep their ‘journey’ to themselves

John:  A relative kept her disease secret because she didn’t want to burden others…. a common cancer patient concern

Sara: Moderation of a social group is necessary to keep it a safe space and prevent trollers (like in Facebook support groups).

Kazia:  most group members will get together and force those trollers out of the group

Katrece: alot of anxiety after treatment ends, patient feels like being dropped on the floor like they don’t get support after treatment.  If there were survivorship navigators might be helpful

Amanda: for breast cancer they do a Survivor Care Package but just a paper packet, patients do appreciate it but a human coordinator would be a great idea

 

 

 

 

Please follow on Twitter using the following #hashtags and @pharma_BI

#MCConverge

#cancertreatment

#healthIT

#innovation

#precisionmedicine

#healthcaremodels

#personalizedmedicine

#healthcaredata

And at the following handles:

@pharma_BI

@medcitynews

 

Please see related articles on Live Coverage of Previous Meetings on this Open Access Journal

LIVE – Real Time – 16th Annual Cancer Research Symposium, Koch Institute, Friday, June 16, 9AM – 5PM, Kresge Auditorium, MIT

Real Time Coverage and eProceedings of Presentations on 11/16 – 11/17, 2016, The 12th Annual Personalized Medicine Conference, HARVARD MEDICAL SCHOOL, Joseph B. Martin Conference Center, 77 Avenue Louis Pasteur, Boston

Tweets Impression Analytics, Re-Tweets, Tweets and Likes by @AVIVA1950 and @pharma_BI for 2018 BioIT, Boston, 5/15 – 5/17, 2018

BIO 2018! June 4-7, 2018 at Boston Convention & Exhibition Center

https://pharmaceuticalintelligence.com/press-coverage/

 

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Measuring generic medicine performance

Larry H. Bernstein, MD, FCAP, Curator

LPBI

 

Measuring performance in off-patent drug markets

Category: Abstracted Scientific Content
Author(s):
GaBi 2015; 4(4).   http://gabi-journal.net/issues/vol-4-2015-issue-4

 

Generic medicines can play a role in curbing rising pharmaceutical costs, and therefore the cornerstone of key policies within Organisation for Economic Co-operation and Development (OECD) countries has been to promote the wider use of generics after patent expiry or loss of market exclusivity of originator drugs. At patent expiry however, prices and market share of different generics in different countries vary significantly [1, 2] compared with branded originator drugs. Studies examining the effect of generics entry on originator prices and market share have produced contradictory results [3, 4].

In an attempt to address the key concerns of decision makers about the performance of generic policies, Kanavos [5] has developed a methodological framework comprising five indicators (independent of policy mix) that can be used as a benchmark for evaluating generic policy in non-tendering settings once originators lose exclusivity. These indicators are: (1) generic drug availability after patent expiry; (2) delay in time to generic entry; (3) number of generic competitors; (4) price development of originators and generics after loss of exclusivity; and (5) evolution of generic volume market share.

Kanavos [5] proposes a number of metrics to assess the performance of each of the indicators over time. For generic drug availability, the metrics include: (1) the share of total molecules studied in each country, with generic entry within the first 12 and 24 months after patent expiry; (2) the proportion of total sales facing generic entry within the same time-frame; and (3) the proportion of sales facing generic entry in the top and bottom decile of each market by sales, 12 and 24 months after patent expiry.

Intercontinental Medical Statistics data (last quarter of 1998 to the last quarter of 2010) for 101 molecules that had lost patent protection in 12 EU countries were analysed to test and measure the performance of the indicators. Countries were divided into three tiers according to perceived strength of their generic policies. The aim was to understand the drivers behind generic entry and competition in each country, and to identify any associated changes in prices, sales and market share over time after the originator patent had expired.

The empirical analysis carried out by Kanavos [5] confirms the hypothesis that different regulatory policies produce diverse outcomes. Some general predictions were confirmed, and the expected effects of individual policies were questioned.

Tier 1 countries (Denmark, Germany, The Netherlands and the UK), for example, had high levels of generic prescribing and substitution, consistently less time delay to generic entry, higher numbers of generic competitors, faster price declines and higher generic volume shares compared with Tier III countries (Greece, Italy and Portugal), which showed opposite trends; these countries implemented price capping on generics and had fewer incentives for generic prescribing. Tier II countries (Austria, Finland, France, Spain and Sweden) had moderate levels of generic prescribing and used price reduction strategies.

Price reductions in some countries implementing supply-side measures, such as price capping or linking generic price to the originator price as done in Greece, Italy and France, were significantly slower over time than seen in countries that did not have these controls, such as Denmark, Germany, The Netherlands and the UK; countries with no such controls had the shortest delay in time to generic entry and the highest rate of generic penetration.

Kanavos [5] questions the extent to which reference pricing facilitates faster and more extensive generic competition after patent expiry. In Sweden and the UK, which do not have international reference pricing (IRP), delays to generics entry are shorter compared with countries that have IRP. The UK’s open-market pricing system for post-patent drugs allows price competition to be achieved quickly after patent expiry, and the decreases in the price of both generic and originator drugs 12 and 24 months after patient expiry are relatively large. Other reasons accounting for the speed of competition in the UK include implementation of attempts to teach medical students the cost-saving benefits of generic products, and implementation of mandatory International Nonproprietary Names (INN) prescribing.

Germany, in contrast, has an established IRP system but a more competitive market compared with the UK. An association, however, was identified between the use of reference pricing and a pattern of high prices for originator drugs and continually decreasing prices for originator drugs after patent expiry. The volume share for generics 24 months after originator patent expiry is large in Germany. Greece is an outlier; although it has implemented a reference pricing system, this has not been reinforced with INN prescribing or mandatory generic substitution that could increase generic uptake.

Another question addressed by Kanavos [5] is the effect of the introduction of generic drugs on the prices of originators whose patents have expired. In most cases, prices of originator drugs were found to decline in response to generic entry. Paradoxically, in Germany and Denmark, prices of originator drugs in fact increased [6, 7]. The opposite has been observed in Greece, where prices of off-patent originators that do not face generic entry generally decreased although in some cases they increased. This suggests that generic competition and availability of generics are important determinants of price reductions of off-patient originator brands, since in their absence the price of these products can increase.

Countries that have strong demand-side policies, e.g. mandatory or strongly encouraged INN prescribing, have a higher degree of generic penetration after patent expiry and lower time delays to generic entry compared with countries that do not encourage these policies. The effect of generic pricing and substitution, however, may be related to the specific components of the policies, i.e. whether physicians or patients are permitted to overrule generic substitution and whether pharmacists are offered incentives or disincentives to dispense generic over branded products, as well as the price difference between originator brand and generic.

Although the author acknowledges some limitations to the study, he suggests that the broad conclusions and specific findings have important policy implications. He believes that further research is needed to identify the most effective policy mix that will maximize generic entry and penetrations and lead to greater expenditure optimization by health insurers.

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Victoria Hale: Pharmaceutical Pioneer

Larry H. Bernstein, MD, FCAP, Curator

LPBI

 

Bringing Life-Saving Medicine to Those Who Can Least Afford It

http://www.genengnews.com/insight-and-intelligence/victoria-hale-pharmaceutical-pioneer/77900545/

The quest for innovative, affordable, and sustainable medical solutions for women has driven Victoria Hale, Ph.D., to start multiple companies. [iStock/© zodebala]

http://www.genengnews.com/media/images/AnalysisAndInsight/Oct27_2015_iStock_22080713_FamilyPoverty1381802542.jpg

http://www.genengnews.com/Media/images/AnalysisAndInsight/oct27_2015_VictoriaHale_Headshot5521815813.jpg

  • Three years into working for Genentech, Victoria Hale, Ph.D., faced a pivotal moment. Her career was on track to becoming a high-ranking, well-paid executive in one of the major pharmaceutical companies. Instead, she quit her job to create a whole new model for the way pharmaceuticals are developed.

Prior to Genentech, while working at the FDA, she witnessed an example of what happens to medicines for unprofitable markets. A pharmaceutical company was developing one new drug for two promising indications, one a potential blockbuster and the other an orphan disease. Corporate executives decided to focus on the blockbuster and abandon the orphan disease because it distracted the team from the more profitable indication.

Dr. Hale saw this as a glaring injustice.

“I felt that it was important to make drugs for everyone who needs them, regardless of whatever level they can pay,” she says. “People cannot develop medicines themselves. Experienced, trained professionals are the only ones who know how to do this. There are people who have medicines for any disease here, while 5,000 miles away babies are dying for lack of simple medications.”

Observing the inequities in how drugs were distributed, she asked a fundamental question: “What if we removed the profit requirement? What if we created a nonprofit model for developing pharmaceuticals?”

As someone with a Ph.D. in pharmaceutical chemistry from the University of California San Francisco, Dr. Hale was well aware that bringing a new drug to market can cost in the billions. Her strategy, with a future nonprofit, was to find drugs with patents that had expired or which were not being used because of low profit margins. Even so, getting governmental approval for a new use for an existing drug can cost $50 million.

  • Struck a Chord

Nevertheless her vision of creating a nonprofit model for addressing injustices in how drugs are distributed began attracting donors. Her first major fundraising success came when the Gates Foundation provided her with a $4.7 million check for seed money. In the years since, she has been granted $150 million in total for several programs. Other philanthropic organizations have continued to fund her efforts, and, surprisingly, if not amazingly, Dr. Hale was able to find an anonymous donor who provided an $82 million grant to fund low-cost highly effective contraception efforts.

Dr. Hale can point to many examples of how this nonprofit approach has successfully played out in practice. One example is the work that the company she founded in 2000, OneWorld Health, is doing in providing a cure for black fever. This is a disease that has historically infected a million people a year in India leading to 300,000 death annually.

Black fever, or visceral leishmaniasis, is a disease of the poor. A malnourished person may have a compromised immune system, making him or her vulnerable to the parasite that causes leishmaniasis.

“When I was first looking into black fever,” remembers Dr. Hale, “there was a treatment available, but the cost was more than $100, and families faced the choice of going into debt for three generations or allowing the family member to die.”

Dr. Hale learned of an injectable antibiotic, paromomycin, that was apparently effective against the parasite in the laboratory setting. It hadn’t been formally studied in people for use against black fever, and there was no money to continue further research on it, so although a cure existed, it hadn’t been proven and it wasn’t available for those who needed it. However, using her nonprofit approach, Dr. Hale and her colleagues were able to raise the $50 million from the Gates Foundation for clinical trials in India, and succeeded in demonstrating efficacy and safety.

Today, Dr. Hale, who was awarded the 2015 Award for Leadership in Women’s Health Worldwide at the 23rd Annual Congress of the Academy of Women’s Health, and her colleagues are able to produce paromomycin for $10 per treatment. As a result, and combined with other public health interventions, India may soon be free of this scourge.

Another of Dr. Hale’s concerns is unwanted pregnancy. Her organization Medicines360 is able to provide an IUD that has a 40-fold greater success rate than the pill, it lasts for three years, and is sold for $50 each to women who lack adequate insurance. Medicines360 makes it available to family planning clinics that provide services to low-income women. The consequences for women and for society are incalculable.

Like OneWorld Health, Medicines360 is also a new approach to pharmaceuticals. Medicines360 is particularly aimed at pharmaceuticals for women, and it has a unique operating model: it reinvests profits generated through commercial sales revenue and puts these profits into advocacy, education, research, and development. The goal is to provide innovative, affordable, and sustainable medical solutions for women.

For Medicines360, profits aren’t the motive; they’re the means to a mission. Dr. Hale believes that her nonprofit can be a model for other nonprofit pharmaceutical companies and also for hybrid companies that could get part of their funding from philanthropists and part from traditional sources. She already knows that there are young idealistic people who will carry the model forward and who are pushing this agenda.

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Doubts about Valeant’s Activity in California

Larry H. Bernstein, MD, FCAP, Curator

LPBI

 

Documents Raise New Questions About Valeant’s Pharmacy Relationships in California

A key Valeant pharmacy was denied a license in California for making false statements. Months later, people affiliated with it gained an ownership stake in a licensed pharmacy.

Charles Ornstein  ProPublica, Oct. 22, 2015

Over the last week, Valeant Pharmaceuticals International, a large drug maker, has seen its stock price plunge amid allegations of questionable dealings with pharmacies.

Now ProPublica has obtained documents showing how people affiliated with Valeant’s main pharmacy used a backdoor approach to gain an ownership stake in California after the pharmacy, Philidor Rx Services, was denied a permit to operate in the state.

Philidor’s license application was denied in May 2014 after the California Board of Pharmacy accused the company and its representatives of making “false statements of fact.” Specifically, the board said Philidor lied when listing the pharmacy’s owners, its accountant and its authorized signatories for financial transactions.

Several months later, a holding company whose chief executive identifies herself onlineas Philidor’s director of pharmacy operations purchased a 10 percent stake in West Wilshire Pharmacy in Los Angeles.

Since last Friday, Valeant’s stock has plummeted almost 40 percent as investors have raised as-yet-unanswered questions about its accounting and business practices, particularly its relationship with so-called specialty pharmacies that generally charge patients lower co-payments than retail pharmacies.

Disclosure of the West Wilshire transaction seems likely to intensify those questions. It’s unclear how it enables Philidor or Valeant to distribute drugs any more easily than a contractual relationship with a California pharmacy would. Calls to Philidor, Valeant and West Wilshire were not returned.

Virginia Herold, the executive officer of California’s Board of Pharmacy, said it’s vital that pharmacies and their owners provide truthful information to the board.

“The board spends a lot of time investigating applications to ensure the individuals are who they say they are,” Herold said, though she declined to discuss Philidor specifically because the pharmacy has appealed its license denial. “It is a concern to us when someone misrepresents that.”

Valeant rose to prominence through acquisitions of drugs and companies, including Bausch & Lomb and skin-care company Medicis. It specializes in taking over companies with portfolios of small, sleepy drugs, slashing research and development spending, and raising drug prices aggressively. A bevy of high-profile hedge funds, most prominently Bill Ackman’s Pershing Square Capital Management, have taken big stakes in Valeant.

Increasingly, Valeant and other drug companies are encouraging patients to use specialty pharmacies. They are essentially mail-order pharmacies that help patients and doctors navigate insurance company requirements.

Specialty pharmacies are seen as a reliable distribution channel for expensive drugs, offering patients convenience and lower costs while maximizing insurance reimbursements from those companies that cover the drug. Patients typically pay the same co-payments whether or not their insurers cover the drug.

But investors are concerned that Quebec-based Valeant has not disclosed the full extent of its relationship with Philidor and its network of other pharmacies. They also are concerned about the convoluted ownership structure of the network, which has only grown more confusing with Valeant’s recent disclosures.

Camarillo, Calif.-based R&O Pharmacy filed a lawsuit in federal court against Valeant earlier this month, contending Valeant demanded it pay $69 million for drugs even though “it seems that Valeant has no evidence whatsoever to back up its claims.”

R&O’s complaint postulated two theories to explain Valeant’s actions: “1. Valeant and R&O are victims of a massive fraud perpetuated by third parties; or 2. Valeant is conspiring with other persons or entities to perpetuate a massive fraud against R&O and others.”

The lawsuit was first reported on Monday by a group called the Southern Investigative Reporting Foundation.

During a conference call with analysts on Monday, Valeant said that R&O is one of the specialty pharmacies in its network. Valeant said it shipped approximately $69 million worth of drugs to R&O, which was worth about $25 million to Valeant’s bottom line.

“R&O is improperly holding amounts it received from payers,” Valeant said in a slide presentation.

Valeant also disclosed for the first time Monday that it had a “contractual relationship with Philidor and late last year we purchased an option to acquire Philidor.” Philidor is based in Hatboro, Penn., outside Philadelphia.

Then, on Wednesday, Philidor issued its own statement shedding a little more light on its network. Philidor said it is licensed in 46 states and the District of Columbia. “Philidor has contractual relationships with the affiliated pharmacies, such as R&O Pharmacy, under which we provide those services. Philidor does not currently have a direct equity ownership in R&O Pharmacy or the affiliated pharmacies, but does have a contractual right to acquire the pharmacies now or in the future subject to regulatory approval.”

Neither Valeant nor Philidor made reference to West Wilshire Pharmacy.

ProPublica pieced together some details about what’s gone on in California using documents requested under the state’s Public Records Act and other documents on the state pharmacy board’s website.

Philidor applied for a California license in August 2013, listing Matthew S. Davenport as its chief executive. The board denied the application on May 16, 2014, citing “false statements of fact” and failure to comply with pharmacy laws, among other things.

In a Philidor filing with the federal government in July 2013, it lists Andrew Davenport as its CEO. Andrew Davenport, who is reported to be Matthew Davenport’s brother, also was featured as the pharmacy’s chief executive in an interview posted recently on theFacebook page of a Pennsylvania state senator.

Matthew Davenport is listed as the chief innovation officer of BQ6 Media Group, which bills itself as a “privately held marketing firm specializing in pharmaceutical communications.”

Until last year, West Wilshire was owned entirely by Shahrokh Makhani, a licensed pharmacist. He sold a 10 percent stake in August to a company called Lucena Holdings LLC., which was formed in Delaware but has an address in Ambler, Penn.

Lucena lists Sherri Leon as its chief executive officer. Leon’s LinkedIn page lists her as director of pharmacy operations for Philidor since August 2013.

Also listed as an ownerof Lucena is Gregory W. Blaszczynski. He was Philidor’s bookkeeper, accountant and a signatory on its financial transactions, according to the pharmacy board’s denial of Philidor’s license. Blaszczynski is also listed as chief financial officer of BQ6 Media Group, where Matthew Davenport works.

There are other indications that Philidor and West Wilshire are closely tied. West Wilshire’s online privacy policy mentions Philidor directly. In addition, both companies direct questions to the same toll-free number. West Wilshire’s website is also hosted on an online network that belongs to Philidor.

On Thursday afternoon, Valeant announced that it would hold a conference call Monday to “lay out the facts including allegations made against our company regarding our relationship with Philidor and R&O.”

It said many of the reports to date “contain numerous errors, unsupported speculation and incorrect interpretations of facts and circumstances to the detriment of the shareholders of the company.”

ProPublica reporter Jesse Eisinger contributed to this report.

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Protecting Your Biotech IP and Market Strategy: Notes from Life Sciences Collaborative 2015 Meeting


 

Protecting Your Biotech IP and Market Strategy: Notes from Life Sciences Collaborative 2015 Meeting

Achievement Beyond Regulatory Approval – Design for Commercial Success

philly2nightStephen J. Williams, Ph.D.: Reporter

The Mid-Atlantic group Life Sciences Collaborative, a select group of industry veterans and executives from the pharmaceutical, biotechnology, and medical device sectors whose mission is to increase the success of emerging life sciences businesses in the Mid-Atlantic region through networking, education, training and mentorship, met Tuesday March 3, 2015 at the University of the Sciences in Philadelphia (USP) to discuss post-approval regulatory issues and concerns such as designing strong patent protection, developing strategies for insurance reimbursement, and securing financing for any stage of a business.

The meeting was divided into three panel discussions and keynote speech:

  1. Panel 1: Design for Market Protection– Intellectual Property Strategy Planning
  2. Panel 2: Design for Market Success– Commercial Strategy Planning
  3. Panel 3: Design for Investment– Financing Each Stage
  4. Keynote Speaker: Robert Radie, President & CEO Egalet Corporation

Below are Notes from each PANEL Discussion:

For more information about the Life Sciences Collaborative SEE

Website: http://www.lifesciencescollaborative.org/

Or On Facebook

Or On Twitter @LSCollaborative

Panel 1: Design for Market Protection; Intellectual Property Strategy Planning

Take-home Message: Developing a very strong Intellectual Property (IP) portfolio and strategy for a startup is CRITICALLY IMPORTANT for its long-term success. Potential investors, partners, and acquirers will focus on the strength of a startup’s IP so important to take advantage of the legal services available. Do your DUE DIGILENCE.

Panelists:

John F. Ritter, J.D.., MBA; Director Office Tech. Licensing Princeton University

Cozette McAvoy; Senior Attorney Novartis Oncology Pharma Patents

Ryan O’Donnell; Partner Volpe & Koenig

Panel Moderator: Dipanjan “DJ” Nag, PhD, MBA, CLP, RTTP; President CEO IP Shaktl, LLC

Notes:

Dr. Nag:

  • Sometimes IP can be a double edged sword; e.g. Herbert Boyer with Paul Berg and Stanley Cohen credited with developing recombinant technology but they did not keep the IP strict and opened the door for a biotech revolution (see nice review from Chemical Heritage Foundation).
  • Naked patent licenses are most profitable when try to sell IP

John Ritter: Mr. Ritter gave Princeton University’s perspective on developing and promoting a university-based IP portfolio.

  • 30-40% of Princeton’s IP portfolio is related to life sciences
  • Universities will prefer to seek provisional patent status as a quicker process and allows for publication
  • Princeton will work closely with investigators to walk them through process – Very Important to have support system in place INCLUDING helping investigators and early startups establish a STRONG startup MANAGEMENT TEAM, and making important introductions to and DEVELOPING RELATIONSHIOPS with investors, angels
  • Good to cast a wide net when looking at early development partners like pharma
  • Good example of university which takes active role in developing startups is University of Pennsylvania’s Penn UPstart program.
  • Last 2 years many universities filing patents for startups as a micro-entity

Comment from attendee: Universities are not using enough of their endowments for purpose of startups. Princeton only using $500,00 for accelerator program.

Cozette McAvoy: Mrs. McAvoy talked about monetizing your IP from an industry perspective

  • Industry now is looking at “indirect monetization” of their and others IP portfolio. Indirect monetization refers to unlocking the “indirect value” of intellectual property; for example research tools, processes, which may or may not be related to a tangible product.
  • Good to make a contractual bundle of IP – “days of the $million check is gone”
  • Big companies like big pharma looks to PR (press relation) buzz surrounding new technology, products SO IMPORTANT FOR STARTUP TO FOCUS ON YOUR PR

Ryan O’Donnell: talked about how life science IP has changed especially due to America Invests Act

  • Need to develop a GLOBAL IP strategy so whether drug or device can market in multiple countries
  • Diagnostics and genes not patentable now – Major shift in patent strategy
  • Companies like Unified Patents can protect you against the patent trolls – if patent threatened by patent troll (patent assertion entity) will file a petition with the USPTO (US Patent Office) requesting institution of inter partes review (IPR); this may cost $40,000 BUT WELL WORTH the money – BE PROACTIVE about your patents and IP

Panel 2: Design for Market Success; Commercial Strategy Planning

Take-home Message: Commercial strategy development is defined market facing data, reimbursement strategies and commercial planning that inform labeling requirements, clinical study designs, healthcare economic outcomes and pricing targets. Clarity from payers is extremely important to develop any market strategy. Develop this strategy early and seek advice from payers.

Panelists:

David Blaszczak; Founder, Precipio Health Strategies

Terri Bernacchi, PharmD, MBA; Founder & President Cambria Health Advisory Professionals

Paul Firuta; President US Commercial Operations, NPS Pharma

 

Panel Moderator: Matt Cabrey; Executive Director, Select Greater Philadelphia

 

Notes:

David Blaszczak:

  • Commercial payers are bundling payment: most important to get clarity from these payers
  • Payers are using clinical trials to alter marketing (labeling) so IMPORTANT to BUILD LABEL in early clinical trial phases (phase I or II)
  • When in early phases of small company best now to team or partner with a Medicare or PBM (pharmacy benefit manager) and payers to help develop and spot tier1 and tier 2 companies in their area

Terri Bernacchi:

  • Building relationship with the payer is very important but firms like hers will also look to patients and advocacy groups to see how they respond to a given therapy and decrease the price risk by bundling
  • Value-based contracting with manufacturers can save patient and payer $$
  • As most PBMs formularies are 80% generics goal is how to make money off of generics
  • Patent extension would have greatest impact on price, value

Paul Firuta:

  • NPS Pharma developing a pharmacy benefit program for orphan diseases
  • How you pay depends on mix of Medicare, private payers now
  • Most important change which could affect price is change in compliance regulations

Panel 3: Design for Investment; Financing Each Stage

Take-home Message: VC is a personal relationship so spend time making those relationships. Do your preparation on your value and your market. Look to non-VC avenues: they are out there.

Panelists:

Ting Pau Oei; Managing Director, Easton Capital (NYC)

Manya Deehr; CEO & Founder, Pediva Therapeutics

Sanjoy Dutta, PhD; Assistant VP, Translational Devel. & Intl. Res., Juvenile Diabetes Research Foundation

 

Panel Moderator: Shahram Hejazi, PhD; Venture Partner, BioAdvance

  • In 2000 his experience finding 1st capital was what are your assets; now has changed to value

Notes:

Ting Pau Oei:

  • Your very 1st capital is all about VALUE– so plan where you add value
  • Venture Capital is a PERSONAL RELATIONSHIP
  • 1) you need the management team, 2) be able to communicate effectively                  (Powerpoint, elevator pitch, business plan) and #1 and #2 will get you important 2nd Venture Capital meeting; VC’s don’t decide anything in 1st meeting
  • VC’s don’t normally do a good job of premarket valuation or premarket due diligence but know post market valuation well
  • Best advice: show some phase 2 milestones and VC will knock on your door

Manya Deehr:

  • Investment is more niche oriented so find your niche investors
  • Define your product first and then match the investors
  • Biggest failure she has experienced: companies that go out too early looking for capital

Dr. Dutta: funding from a non-profit patient advocacy group perspective

  • Your First Capital: find alliances which can help you get out of “valley of death
  • Develop a targeted product and patient treatment profile
  • Non-profit groups ask three questions:

1) what is the value to patients (non-profits want to partner)

2) what is your timeline (we can wait longer than VC; for example Cystic Fibrosis Foundation waited long time but got great returns for their patients with Kalydeco™)

3) when can we see return

  • Long-term market projections are the knowledge gaps that startups have (the landscape) and startups don’t have all the competitive intelligence
  • Have a plan B every step of the way

Other posts on this site related to Philadelphia Biotech, Startup Funding, Payer Issues, and Intellectual Property Issues include:

PCCI’s 7th Annual Roundtable “Crowdfunding for Life Sciences: A Bridge Over Troubled Waters?” May 12 2014 Embassy Suites Hotel, Chesterbrook PA 6:00-9:30 PM
The Vibrant Philly Biotech Scene: Focus on KannaLife Sciences and the Discipline and Potential of Pharmacognosy
The Vibrant Philly Biotech Scene: Focus on Computer-Aided Drug Design and Gfree Bio, LLC
The Vibrant Philly Biotech Scene: Focus on Vaccines and Philimmune, LLC
The Bioscience Crowdfunding Environment: The Bigger Better VC?
Foundations as a Funding Source
Venture Capital Funding in the Life Sciences: Phase4 Ventures – A Case Study
10 heart-focused apps & devices are crowdfunding for American Heart Association’s open innovation challenge
Funding, Deals & Partnerships
Medicare Panel Punts on Best Tx for Carotid Plaque
9:15AM–2:00PM, January 27, 2015 – Regulatory & Reimbursement Frameworks for Molecular Testing, LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA
FDA Commissioner, Dr. Margaret A. Hamburg on HealthCare for 310Million Americans and the Role of Personalized Medicine
Biosimilars: Intellectual Property Creation and Protection by Pioneer and by Biosimilar Manufacturers
Litigation on the Way: Broad Institute Gets Patent on Revolutionary Gene-Editing Method
The Patents for CRISPR, the DNA editing technology as the Biggest Biotech Discovery of the Century

 

 

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