An FDA Golden Voucher That’s Too Good To Be True.

Posted on | October 3, 2016 | Comments Off on An FDA Golden Voucher That’s Too Good To Be True.

Mike Magee

Thirty-six years ago, as Ronald Reagan assumed the presidency, Congress cried “uncle”, in the face of America’s perceived global non-competitiveness in pharmaceuticals. They had been convinced by the persistent voices of Louis Lasagna and University of Chicago economist Sam Perltzman that there was a “drug lag” in America, and that it was the result of government regulations, inefficiencies, obstructionism, and inadequate financial inducements to encourage civic behavior. They were, after all, businesses driven by profit, and this was America.

What followed was a steady flow of enabling legislation that continues to this day including:

The Bayh-Dole Act in 1980 which freed up 28,000 Federal patents, flowing from NIH funded academic studies, released now for public use by industry, academic medical centers or both.

The Orphan Drug Act of 1983 which granted to creators of drugs treating a condition effecting fewer than 200,000 Americans a range of financial inducements including seven-year market exclusivity, liberal tax credits covering development costs, grants for drug development, and a pathway for fast-track approvals.

The Hatch-Waxman Act of 1984 which liberally extended patent lengths in return for streamlining of competitor generic approvals.

The Prescription Drug User Fee Act (PDUFA) of 1992 which helped fund the FDA with a steady flow of fees from companies submitted new drugs to them for approval in return for improved FDA efficiencies and expedited review of industry applications. (Subsequently re-issued and expanded in 1997, 2002, 2007, and 2012).

Along the way, there were other small and large actions which expanded the number of NIH Federal dollars in support of basic and applied research by academic medicals centers and industry partners, while further incentivizing the ultimate transformation of those patent protected discoveries into new pharmaceutical products. The general understanding has been that money talks, and determines loyalty, which will always be short term. Should a better deal present itself, say a merger that would allow a new address and an “inversion”, making non-taxable profits liquid again, that’s capitalism.

But even within this enabling climate of  shifting loyalties and “I’ll scratch your back, and you scratch mind”, the army of coordinated government relations specialists employed by the Medical-Industrial Complex can go one step too far.

Such is the case with the Priority Review Voucher program that is awaiting reauthorization in the 21st Century Cures Act currently before Congress. The basics of this incentive program were first proposed in a 2006 article in Health Affairs, and inserted into the Food and Drug Administration Amendment Act in 2007. The problem these incentives were intended to address was a series of diseases that disproportionately targeted poor populations around the world who often could not afford to pay for modern drugs. The initial focus was “neglected tropical disease” like malaria. In 2012, the program was expanded to also cover “rare pediatric diseases”.

Here’s how the system works. If you develop a treatment for a disease that falls under these categories, and submit your discovery for review by the FDA, they provide your company with a redeemable voucher that guarantees that one of your future submissions will receive Fast Track review (a decision within 6 months rather than the customary 10 months). That voucher can be assigned to any drug you like. Now that 4 months doesn’t sound like much, unless of course, that voucher was attached to a future block buster, like a statin drug, or if it allowed you to beat a competitor to market by one month, making your drug the first in class to arrive. 

One thing more you need to know about these “Golden Vouchers”. They are transferable. That’s right, rather than use them, you can sell them to the highest bidder; they can be applied to any drug (not just one treating rare or neglected disease); and they are good forever. How much are they worth in the open market? To date, of the nine vouchers granted, four have been sold to other companies for prices between $67 million and $350 million a piece.

Take the case of Sanofi  in 2015. They applied a voucher they paid another company $67.5 million to purchase, to their new first-in-class, statin buster, Praluent, and beat Amgen to market by just over a month. But at least the program has resulted in great innovative breakthroughs that benefited those suffering from rare and neglected disease, right? Well, not exactly.

Novartis was the first to receive this golden certificate. Their submission was for an anti-malarial called Coartem. It had been widely used elsewhere around the world for almost 10 years. Same story for Knight Therapeutics’ Impavido, a drug for leishmaniasis which had already been approved in 14 other countries at the time of its approval in 2010. In fact, six of the nine drugs that have gained vouchers were already well on their way to approval before the program was expanded to include rare pediatric disease in 2012.

When you have legislation ripe with loopholes like this one, you would expect it to attract bottom-feeding, hedge funders and profiteers. And in fact it has. Martin Skhreli, the former CEO of Turing Pharmaceuticals, one year before being supoenaed by Congress to testify on predatory pricing, purchased a majority stake and became CEO of KaloBios. Soon after he was arrested for Security and Exchange fraud, and the company went bankrupt. But planning documents revealed that it was the fledgling company’s plan to hit it big by obtaining a voucher for an old drug for Chagas disease that they had licensed.

Experts are now advising that any re-authorization demand that vouchers be awarded for truly novel discoveries, and that predatory pricing and limitations of access be tied to claw back provisions that allow the government to reclaim the monetary value of the voucher provided. Lesson learned: capitalism only works if you have appropriate and enforceable checks and balances.

Calling PhRMA’s Bluff: 15 Ways To Bring US Drug Costs Under Control

Posted on | September 28, 2016 | Comments Off on Calling PhRMA’s Bluff: 15 Ways To Bring US Drug Costs Under Control

Mike Magee

Historically, U.S. insurers have been relatively permissive when it comes to pharmaceuticals. Most drugs were covered and reimbursed generously. That reflected two realities: drugs were a relatively small piece of the over all health care cost, and denying certain drugs coverage on formulary lists was almost always a public relations nightmare, angering both doctors and patients. But as a recent JAMA review article so clearly delineates, evidence suggests we’re entering a new era, and PhRMA’s innovation bluff, when it comes to drug pricing, may soon be called.

Here are a few of the facts the authors shared:

• Pharmaceutical drug spending has increased approximately 20% over the past two years, compared to an 11% increase in overall health care costs. Employer costs for health care drugs now approach 1/5 of their total health care expenditures.
• A recent analysis showed per capita drug spending in the U.S. was $858 compared to an average $400 in 19 other developed nations.
• Post approval patent monopolies average 12.5 years for every day discoveries, and 14.5 years for the more novel ones.
• With patent loss, the entry of two competing generics forced price reductions of 45%. Add a third competitor, and 67% of the cost was shaved. By the time 15 generic companies competed, consumers were paying as little as 15% of the original cost. These kind of savings led to 86% of all filled prescriptions being generic by 2012.
• But, as generic prices were falling since 2008, prices on patented protected drugs increased by 164%.
• New biologics have been part of that story. And some of these high cost new entrants, like Gilead’s Hepatitis C drug, Sovaldi (vs. the cost of liver failure and liver transplant), have carried the day, and earned listing on covered drug formularies. But much of the cost has more to do with old unpatented “has-been drugs” whose prices have been manipulated by unscrupulous hedge-funders.
• The poster boy for these is 33 year old hedge-funder, Martin Shkreli, founder and CEO of Turing Pharmaceuticals. In September of 2015 he purchased the manufacturing rights to produce the off-patent anti-parasitic drug, Daraprim, which had been selling for about $13 a pill. It had originally been approved by the FDA in 1953. The purchase price from Impax Pharmaceuticals was $55 million, and included an agreement with Impax to restrict distribution of Daraprim. The drug’s major use at the time was for the treatment of toxoplasmosis in HIV patients.  Shkreli promptly raised the price to $750 a pill (a >5000% increase), and then unapologetically appeared before Congress in February, 2016, taking the Fifth Amendment repeatedly. Discovering his voice on his way out of Washington, he tweeted, “Hard to accept that these imbeciles represent the people in our government”.
• Shkreli’s Turing was not the first to invent the tactic of buying old, off-patent products, eliminating competition and then jacking up the prices. That honor likely goes to Valeant, a company that, through a dizzying array of outright purchases, mergers and acquisitions beginning in 2006, landed in front of Congress as well in 2016. Valeant’s transgressions are too numerous to count, but two 2015 cardiovascular drug price hikes, immediately following purchase, give you the idea: Nitropress up 210% and Isuprel up 520%.
• The current controversy over EpiPen pricing has nothing to do with innovation, biologics or manipulation of old generics. Rather, it is a case where control of a delivery device, which was originally designed for fast delivery of nerve gas antidotes, and approved by the FDA in 1987, has moved through the hands of multiple pharmaceutical companies over the years to ultimately land on the doorstep of Mylan in 2007. At the time, Mylan’s brand of autoinjector, the EpiPen, controlled 90% of what was a $200 million US market.
• By 2012, Mylan’s CEO, Heather Bresch, daughter of Senator Joe Manchin (D-WV), decided to go full in on an integrated public relations and government relations strategy that would greatly expand the market for auto-injectors. Hiring the same firm that managed the movement of Medtronic defibrillators into public places, Mylan worked the angles to build the case that anaphylaxis was everywhere and Americans needed to be prepared. While petitioning the FDA to broaden the indications for the device, Heather Bresch, enlisted the aid of the president of the National Association of the State Boards of Education, who just happened to be her mother, Gayle Manchin. The goal was to “help state boards of education as they develop student health policies regarding anaphylaxis and epinephrine auto-injector access and use.” It worked.
• On the federal side, legislation titled, “School Access to Emergency Epinephrine Act”, protecting all using the EpiPen on school grounds from liability, passed with Joe Manchin’s support in 2013. It included financial support for select schools to stock the product. In the meantime, one competitor dropped out of the market after some dosing problems, and the generic house TEVA’s potential entry failed to gain FDA approval in June, 2015.
• By 2015, the market was a $1.5 billion a year success story with EpiPen still controlling 90% of the market. (29) The dual pack price had been increased from $100 in 2007 to over $600 in 2016. (The online price for a pair in the UK 1s about $116 US dollars and in Canada under $200 US dollars.) When the price hiked in the summer of 2016, just as parents were getting kids ready to return to school, Bresch found herself way over her head and in full crisis management mode. The dust still hasn’t settled, and various reparative offerings by Mylan continue to be rejected by a fed-up public.

Overall, the market is beginning to signal a limit to public support for feigned innovation as employer’s costs of pharmaceuticals have approached 20% of their overall health care costs. But as the JAMA authors suggest, most of that response is falling on the shoulders of consumers in the form of rising deductibles and co-payments.  These user taxes are not only rising on everyday drugs, but now a special category is appearing for “specialty biologics”, including cancer drugs, which nail consumers with coinsurance payments that amount to 20% to 33% of cost. While this may save employers and insurers money, it’s also escalating the rates of non-adherence, and with that rates of acute hospitalization. Studies show that non-compliance generates additional health costs exceeding $100 billion annually.

The slow but steady implementation of the Affordable Care Act has moved the US one step closer to universal coverage. But at that same time, it has increasingly exposed the weaknesses of our remarkably disintegrated, inefficient, easily corrupted, and spotty health delivery system. Pharmaceuticals, as they are both measurable and trackable, as witnessed in the recent analysis of the manmade opioid epidemic, will likely be the leading edge of rationalization of health care delivery in the United States. The need for real competition, government involvement, physician restraint in prescribing, and consumer engagement is increasingly obvious to all.

To view 15 strategies to lower U.S. drug costs, derived from the JAMA article, go HERE.

 

Emancipating Pragmatism: Emerson, Ellison, Hillary, Donald, The New Museum, The ADAP Association and African American Health.

Posted on | September 24, 2016 | 4 Comments

Mike Magee

In the shadow of Monday’s Presidential debate, expected to attract close to 100 million viewers, this has been a week of remarkable highs and lows for African Americans.

Today President Obama will preside over the official opening of the National Museum of African American History and Culture on the National Mall in Washington, DC. This morning, our President said, “This museum doesn’t gauze up some bygone era or avoid uncomfortable truths. Rather, it embraces the patriotic recognition that America is a constant work in progress; that each successive generation can look upon our imperfections and decide that it is within our collective power to align this nation with the high ideals of our founding.”

This week also, in a JAMA article by Victor Fuchs titled “Black Gains in Life Expectancy”, we received positive news on the narrowing disparities in health outcomes. In the past decade, life expectancy in black Americans is now rapidly approaching that of whites in this country. The former has gained 6.0 years (69.6 to 75.6), while the latter has gained 2.5 years (76.5 to 79.0). Where did those extra years come from? .37 years from less cardiovascular deaths; .31 years from decreases in HIV mortality; .28 years from declines in traumatic injuries; and .14 years from fewer perinatal deaths. These 5 success areas alone delivered 60% of the progress.

And yet, as this week’s events in Tulsa and Charlotte so tragically indicate, there is so much work left to be done. The Museum is part of that healing. It’s narrative power will help challenge well-entrenched perceptions, and counteract bias and prejudice, drawing them into the open where they can be managed. More concretely, we will also continue to rely on groups like the ADAP Association, who for nearly a decade have labored to assure education, testing and treatment are accessible to vulnerable populations with HIV/AIDS.

The ADAP Association is fresh on my mind since I delivered the opening keynote address at their 9th Annual Convention at the Georgetown Westin Hotel yesterday. I was honored and pleased to receive the invitation from Executive Director, Brandon Macsata, who had been responsible for my original invite nine years ago at their 1st convention. That invite, in turn, was the result of Brandon hearing me address John Kemp’s Disability group a year earlier.

Brandon suggested I might reflect on the role of “advanced professionalism” and “enlightened leadership” at this critical moment in our history, with the first Presidential debate literally upon us. To prepare, I relied heavily on a book my son, Michael, had published with the University of Alabama Press in 2004, titled, “Emancipating Pragmatism: emerson, jazz, and experimental writing”. The book derived from his PhD dissertation at the University of Pennsylvania, and extensively delved into the writings of both Ralph Waldo Ellison, author of “The Invisible Man”, and his namesake, Ralph Waldo Emerson. More on that in a moment.

In my ADAP Association speech, I began with the concept of Positive Leadership that I had developed in the early 1980’s grounded in two diametrically opposed approaches to change.

One type of leader resists change, using fear as currency to achieve short-term goals. This type of leader retrenches and divides, segregating populations as he builds walls and silos.

The other type of leader embraces change, using visioning as currency to achieve long term goals. This type of leader reaches out across the divide, congregating and integrating diverse populations as she builds islands of common stewardship.

Each style, I said yesterday, has strengths and weaknesses. The negative leader can appear, in the heat of the moment, to be strong and decisive. His weakness is that, while he may be able, with fear, to freeze a population in place for a short period of time, the world continues to evolve around him. And eventually he is revealed for what he is – a fraud.

The positive leader also has strengths and weaknesses. Her message is open and hopeful, her vision inclusive and real. The critical weakness is that, while she may be able with some accuracy to predict what will occur, it is unlikely that she will be able to predict exactly when it will occur. Her followers, therefore, must constantly be encouraged and revitalized to avoid discouragement and abandonment of the vision.

To their credit, the positive leaders of the ADAP Association, over the past 9 years have done an amazing job of revitalization and keeping hope alive. (Consider that one of the afternoon sessions was titled “Building a Focus on Healthy Aging for Older Adults Living With HIV/AIDS”.) And to the credit of African American leaders – in government and churches, schools and communities, in business and at home – they have been doing the same, over many decades. Their efforts and history are what is so vividly displayed in this new Museum.

So what did my son Michael say in his book that was so compelling that I turned to it yesterday, and return to it today to share with you?

Page 3: Quoting Emerson, “To interpret Christ, it needs a Christ…to make good the cause of freedom against slavery you must be…Declaration of Independence walking.”

Page 7: Why Words Matter, “Ultimately, Emerson came to believe that ‘America’ itself was a kind of text being read, its meaning a matter of collective decision. It followed that one’s linguistic theory, one’s view of how words generate meanings, had potentially large-scale social ramifications. In suggesting that words were ‘million-faced’, Emerson came to realize, he was suggesting that social possibility was remakeable.”

Page 18: On Change and Diversity, “Emerson writes…’the philosophy we want is one of fluxions and mobility’”.

Page 19: The American Culture, “‘Out of the democratic principles set down on paper in the Constitution and the Bill of Rights’, Ellison says, Americans ‘were improvising themselves into a nation, scraping together a conscious culture out of various dialects, idioms, lingos, and methodologies of America’s diverse peoples and regions’”.

Page 24: American Evolution, from Ralph Waldo Ellison, “We forget, conveniently sometimes, that the language we speak is not English, although it is based on English. We forget that our language is such a flexible instrument because it has had so many dissonances thrown into it ….from Africa, from Mexico, from Spain, from God knows, everywhere.”

Page 25 and 28: Creating Our History, “The jazz musician—who, Ellison says, always plays both ‘within and against the group’ — constantly reflects and redefines the ensemble in which he plays. Likewise the ensemble reflects and redefines the larger community to which it belongs….that ‘anticipatory arena where actuality and possibility, past and present, are allowed to collaborate on a history of the future.’”

This has been a momentous week. We have made progress. But there is much left to be done. This should neither surprise nor discourage. On the final page of Michael’s book, he writes, “An emancipated pragmatism happens whenever and wherever a creative mind or community of creative minds engages in democratic symbolic action.”

Our future is being written now. VOTE.

Islands of Common Stewardship – TLC/Dartmouth/ReThink Health UCRV/Schweitzer Fellowship/RCP

Posted on | September 12, 2016 | 2 Comments

VIDEO

Mike Magee

A little over a year ago, I made a quick trip to Washington – one day, back and forth, from Hartford, CT. I was there to seek advice from an old friend, Fitzhugh Mullins, as we completed planning for the second decade of the Rocking Chair Project. This early childhood intervention program targets young, economically disadvantaged, expectant mothers, supporting them with a health professional-led home visit which includes the gift of a upholstered glider rocking chair and ottoman as a “gift of nurturing” for both mother and child. The visits, repeated over 1000 times in the past 10 years, include reinforcement of healthy messages, nurturing, and emphasize long term continuity with the health care system.

We had been relying on individual 2nd year Family Medicine residents around the country to identify the target moms, and to follow through with these “high-touch” visits. The challenge now was how best to scale up to the general population of economically disadvantaged families.

Our lead adviser, Yale Professor Emeritus, Ed Zigler (Father of Head Start), told us a long time ago that the intervention was so low cost and powerful, tapping into two critical social networks (Medicine and Family), that it should be offered to entire populations, not just a lucky few individual patients.

Fitz summed up the challenge immediately. He said we were seeking a vertically integrated network with existing distribution channels. In other words, a well organized, efficient, and financially sustainable system that had the ability to identify the target population prenatally, and already was accustomed to making home visits in the immediate postnatal period.

Our next stop was Hanover, NH, to garner the advise from another old friend from the Chick Koop days, Joe O’Donnell, Senior Advising Dean and Director of Community Programs at the Dartmouth Geisel School of Medicine. Joe is a brilliant and empathetic clinician, and within weeks we were introduced to Steve Voight, Executive Director of ReThink Health – Upper Connecticut River Valley. ReThink Health focuses on healthy collaboration and meaningful disruption. In their words, “We spur big-picture thinking that allows leaders to step outside their own frames of reference. This lets them better see how the various parts of the system interact in unexpected ways and determine how and where they can exert influence. We do this by deeply understanding their challenges, listening to diverse voices, and working together to harness the information, insights, and actions needed to overcome entrenched beliefs and disrupt the status quo.”

Steve’s regional organization has focused on two counties in New Hampshire and two counties in Vermont. Through their active and inclusive planning process, they have identified many of the challenges and opportunities, and the key personalities and health service organizations. One of those organizations was the TLC Family Resource Center in Claremont, NH. Joe and Steve introduced us to Executive Director, Maggie Monroe-Cassel, and Clinical Supervisor, Melony Williams. Several meetings later, we committed to working with each other.

We defined four separate goals for the collaboration:

1. To expand the recruitment of eligible expectant moms (with a special focus on teens) into existing TLC comprehensive health programs. The primary strategy is to offer the high quality RCP glider chair and ottoman, assembled in a home visit, to eligible moms, who agree to a comprehensive pre-natal TLC intake interview and to one follow-up home visit.

2. To create a high impact experience, through the RCP visit, which will enhance the relationship between the moms and families and the TLC health professionals, and aid therefore in long-term retention.

3. To include highly motivated, and well-trained, carefully selected medical students from Dartmouth Geisel School of Medicine, and positively impact the formative training of humanistic medical students with a focus on empathy and community service.

4. To reinforce inclusiveness of mothers and family as part of the team and positively impact the future trajectory of family members and child.

The collaboration, launched on Mother’s Day, May 8, 2016, received an immediate boost when two Dartmouth Medical Students, Emily Johnson and Kristen Delwiche, who Joe had been mentoring, applied for and were granted a Schweitzer Fellowship focused on supporting our new home visit collaborative.

Where are we now? We are 5 months into the program. TLC recruitment of new moms into their programs has increased. They have already completed four Rocking Chair Project home visits, and have four new arrivals scheduled for births in the immediate future. The TLC professionals and medical students have blended well professionally. All say the experience has been rewarding. They have gained fresh insights into the home-based needs of economically disadvantaged families, and see important benefits of participation in team based approaches to care.

On every level, we are capturing insights to share and communicate with others in the future. For example, TLCs Melony Williams is presenting our program this October at the Healthy Families America (HFA) 2016 National Conference For America’s Families.  Our two Schweitzer Fellows post monthly updates and will be preparing a summary paper in the future. ReTHINK HEALTH: UCRV is preparing a blog post of our progress together, which in turn will be shared with the national ReTHINK HEALTH program. And Dartmouth is planning a Grand Rounds on our collaboration.

For a health care system which has been historically silo’d, segmented and professionally segregated, the disruptive work of collaboration doesn’t just happen. We need projects and challenges that bring us together and simultaneously unite us with patients and families in their settings and on their terms. Judging at least from this one project so far, our gliding rocking chair is much more than a piece of furniture. It is a vehicle capable of bringing us together; strong enough to support the weight of widely differing professional points of view; and comforting enough to calm and encourage beleaguered families while reinforcing empathetic professionalism which is so often in short supply.

Will this model – uniting the Rocking Chair Project with regional home visitation family services, regional health promoters, health professional schools and students – be scalable? Only time will tell. But this much is already clear, when communities collaborate in caring ventures, those who give gain at least as much as those who receive.

9/11 Is Still Fresh.

Posted on | September 9, 2016 | Comments Off on 9/11 Is Still Fresh.

Mike Magee

Fifteen years ago, I had the honor to recount the stories of 10 boat captains and 10 passengers who participated in the maritime evacuation of Manhattan Island on 9/11 (the largest maritime rescue operation since Dunkirk in WWII). The experience continues to remind me that America is a great country, and part of our “goodness” is not giving in to fear and prejudice. Fear is never a currency that should be supported or rewarded.

Here are some reviews of ALL AVAILABLE BOATS. If you don’t have a copy, I encourage you to purchase one HERE.

The America it portrays deserves a place in your home.

_______________________________________________________

4.0 out of 5 stars
9/11 Still is Fresh
By Ouisie on July 18, 2016
Having just seen the 9/11 monument, this book was interesting.

5.0 out of 5 stars
Good people doing what they can for each other on 9/11
By Manhattan on April 27, 2015
I consider this material the best of all that has been produced about 9/11. It’s about people coming together to help each other in an extreme situation. They hadn’t prepared for it yet they couldn’t have done better if they’d planned for it for years. Leaders rose to the situation. In the weeks after 9/11 the material in this book was on display with audio of interviews of these people and still photos of them. I visited the show several times. It was displayed in two different locations in lower Manhattan.

5.0 out of 5 stars
A much overlooked yet critical segment of 9/11 rescue.
By Maria Pagano on August 6, 2013
I had no idea of all the effort that went into the water rescue- 450,000 people were picked up all along the shoreline of lower Manhattan and taken out of harms way by these fearless mariners. The photographs and stories were startlingly new, fresh, even for me, another volunteer on that awful day.
BklynMom

5.0 out of 5 stars
New insight into a familiar tragedy
By Camilla W. Von Bergen on January 19, 2012
This book is heartening, and provides a lot of insight into one aspect of the 9/11 tragedy with which most of us have no experience. Although most of us saw television or still photos taken from offshore, I do not think many of us focused on the boats, and mariners, heading towards the devastation. I have always had a great admiration for those who, “…go down to the sea in ships.” My admiration is if anything greater now.

5.0 out of 5 stars
All Available Boats!
By John Curran on October 29, 2011
This @mims Twitter post: ‘Moving documentary of 9/11 evacuation by boat shows #resilience of cities[…]reminded me of how humbled and impressed I was after reading how successfuly the evacuation was conducted by literally ‘All Hands’ who came together and made a difference during this crisis!

5.0 out of 5 stars
All Available Boats
By Mary on August 31, 2011
Short read with lots of pictures. Good book on September 11th and very touching story on what happened that day in New York City. A real eye opener that is sad but shows the hero’s on that terrible day. I would recommend it if you want some inside stories on what happened on that day that will always be remembered by all of us. Mary

5.0 out of 5 stars
WOW!
By A customer on June 24, 2003
I HATE READING BUT I SAW AN ARTICLE IN MY BOATING MAGIZINE ABOUT THIS BOOK SO I HAD TO GET. I READ THE WHOLE THING IN 2 DAYS. THIS IS FULL OF INFO THE NEWS STATIONS NEVER TOLD YOU ON THIS DAY WE WILL NEVER FORGET. THIS IS A MUST FOR ANYONE. NEVER FORGET 9/11

 

Precision Medicine vs. Public Health $$$ – NIH Funding Priorities Not A New Debate.

Posted on | August 29, 2016 | Comments Off on Precision Medicine vs. Public Health $$$ – NIH Funding Priorities Not A New Debate.

Paul Starr, Princeton

Paul Starr’s observations (The Social Transformation of American Medicine, p.370) in 1982:

“In 1964 a Presidential Commission on Heart Disease, Cancer, and Stroke (the DeBakey Commission) which had been appointed at the behest of the Lasker lobby, recommended a massive commitment of federal funds to establish ‘a national network of regional centers, local diagnostic and treatment stations, and medical complexes designed to unite the worlds of scientific research, medical education and medical care.’ The report paid no attention to any environmental, nutritional, or other public health and preventive concerns. Like the report of the Hospital Commission of the 1940s, the DeBakey Commission report was a classic of the kind of myopia that the medical establishment of the mid 20th century confused with visionary ideas. No one, as Elizabeth Drew later pointed out, ever asked whether other diseases such as those affecting children or diseases that could actually be cured might be more worthy of federal effort. The commissions conclusions in favor of a medical assault on heart disease, cancer and stroke were foreordained by the commissions name and its composition (the Lasker lobby as one of its representatives said had a quorum.) The aim was to make medical services more available, but there was little thought as to whether such an investment might actually make a difference in health.”

Eli Ginzberg, Columbia U. Health Economist

And from Eli Ginzberg in 1992:

“I learned several important lessons from my term on the Advisory Committee to the National Institutes of Mental Health(1959-1963): that most bureaucrats measure their success by the amount of money they are able to extract from Congress…; that there was a cozy relationship between the senior officials of NIMH and the academic medical leadership, much like the relationship of senior procurement officers in the Pentagon and the aerospace companies; (and) that fashion and enthusiasm dominate the world of medical ideas and policy as they do other fields.” (from The Eye of Illusion, p.82.)

Mylan EpiPen? What About Medicare Part D?

Posted on | August 25, 2016 | Comments Off on Mylan EpiPen? What About Medicare Part D?

Mike Magee

Pediatric drug prices have led the news recently with the fantastic and purposeful price escalation of Mylan’s EpiPen. With all that going on, it would have been easy to miss the analysis of the complete Medicare Part D year over year costs (2014 vs. 2013) that were recently released. 70% of Medicare patients carry Part D policies. The others are enrolled in Medicare Advantage plans or “stand-alone prescription drug plans”.

Here’s a summary:

1. Total billing tic’d up a bit over 17%, with total health care claims up 3.3% by way of comparison. 12.6% of this was from prescription drugs. CMS delivered $121 billion in 2014 compared to $103 billion in 2013.

2. Nine of the top ten drug contenders (by numbers of claims, not total cost) were unchanged from 2013, and all ten were generics. #1 generated a spend of $748 million. #10 a mere $136 million.

3. If you look at cost, however, the top ten in 2014 were all brand name. In the lead, as you might guess was the Solvaldi Hep C star with a $3.1 billion spend. Then came Nexium (antacid), Crestor (cholesterol), Abilify (depression), Advair (bronchitis/asthma), Spiriva (COPD), Lantus SoloSTAR(insulin pen), Januvia(Type 2 Diabetes), Lantus (insulin pen), Revlimid (anemia). Each of these drew more than $1 billion.

4. There were over 1 million prescribing health professionals.

5. Medicare patients who chose brand name over generics on average pay co-pays that are 10 times higher than they need to. 

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