J.R.’s Zaphne Blog News for 08-26-2018


AMP #153 – Ryan Moran on Compassion and Capitalism | Aubrey Marcus Podcast

What experimental drug? Most companies don’t post compassionate use policies

A. s patients clamor for greater access to experimental medicines, a survey released Tuesday finds that just 19 percent of 100 drug makers publicly post policies about their programs for obtaining these drugs, which are known as compassionate use. Only one of those companies posted information about specific procedures for making requests, and this company did not list any contact information. More specifically 52 percent of the 25 companies with a market capitalization of greater than $10 billion analyzed by consulting firm Avalere Health disclosed policies on their web sites. By contrast, 14 percent of medium-sized companies – those with market caps between $1.5 billion and $10 billion – posted details and only 4 percent of smaller companies, with market caps of less than $1.5 billion, did the same. 

The findings underscore arguments by a growing number of patient advocacy groups and lawmakers that the process for gaining access to experimental medicines is difficult, a complaint that has generated criticism of the US Food and Drug Administration and sparked social media shaming campaigns of some companies. Currently, under federal law, if terminally ill patients are not eligible to obtain an experimental drug through a clinical trial, they can apply to the FDA for its expanded access program, which is also known as compassionate use. Although drug makers must agree to make their medicines available, patient groups and their supporters maintain the FDA program is arbitrary and cumbersome, and so have focused much of their criticism at the FDA. As a result, 33 states have passed so-called Right to Try Laws that are designed to circumvent the FDA. Federal legislation is also pending. 

A company may lack sufficient supplies of their drug. As a result, the Avalere findings should be seen as a reason to pressure the pharmaceutical industry to do more to disclose policies toward compassionate use, even if a company’s official position is not to agree to make medicines available, according to Art Caplan, who heads the division of bioethics at the New York University Langone Medical Center. The House passed what is known as the 21st Century Cures legislation, which would require drug makers to disclose various details about a compassionate use policy. The House bill would require companies to provide procedures and contact information for making requests, the general criteria the drug maker will consider or use to approve requests, and the length of time a company anticipates will be needed to acknowledge a request has been received. Just three of the 19 companies that have posted their policies included information about the length of time needed before compassionate use requests are likely to be acknowledged. 

Keywords: [“company”,”drug”,”FDA”]
Source: https://www.statnews.com/pharmalot/2016/10/11/experimental-drugs…

Compassionate Capitalism: Resolving the Ethics of Business and Medicine

US physicians are becoming more entrepreneurial to cope with the seismic shifts happening since the passage of legislation creating Obamacare. Physician entrepreneurs are challenged by how to reconcile the ethos of business with the ethos of medicine. Many physicians have been entrepreneurs for decades and have played various roles in the innovation pipeline as inventors, market perceivers, social entrepreneurs, educational entrepreneurs, business leaders or investors. Now there is a convergence of forces that is forcing physicians to be even more entrepreneurial and innovative to not just serve their patients better, but to survive an increasingly turbulent landscape. Physicians need to embrace an innovative and entrepreneurial mindset, lead , manage operations to achieve maximal effectiveness and efficiency and use digital health technologies to leverage their value and create new business models. 

The challenge to most physicians is to how to do that while balancing the conflicts between how business is done and how medicine is practiced. A new series of books by Laurie Bassi, et al, titled, Good Company: Business Success in the Worthiness Era, John Mackey and Raj Sisordia, titled, Conscious Capitalism, Seth Godin, titled, The Icarus Deception, and Richard Branson, titled, Screw Business As Usual, are all making the claim that it is those companies and those entrepreneurs who do good for the world who will win the game of capitalism. Physicians are uniquely positioned, and are starting to be trained, to take advantage of this trend as they are constantly improving the state of the art in their fields and now gaining MBA’s, graduate level certificates in one or more areas of biomedicine, and are reaching out to the investment community to fund the research and development, the intellectual property designations they need, the team for their companies, the strategic alliances they will need for their supply chain, and their distribution chain, as well as the marketing necessary to launch a successful biomedicine product or service. The physicians will also have a new look and demeanor, with their iPADs in hand, talking to early stage investors and venture capitalists about funding their idea from the start through to international patents and business arrangements that will change the medical landscape around the world. The medical consumer, the patient, will benefit greatly from this expansion of entrepreneurism through physicians practicing compassionate capitalism. 

This is all possible not just because physicians today want to become entrepreneurs. It is now inevitable that innovation will grow by leaps and bounds and it will be driven by physicians and other entrepreneurs putting their ideas to the ultimate test, the market test. 

Keywords: [“Physician”,”more”,”business”]
Source: http://www.cliexa.com/2016/11/compass-cap-resolving-medicine

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.