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  • 01.12.2015

In October 2013, California Governor Jerry Brown vetoed a bill, overwhelmingly passed by state lawmakers that would limit automatic biosimilar substitution to those the FDA deems “interchangeable.” SB 598 also would have required pharmacists to notify physicians when an interchangeable is substituted for a prescribed biologic.

One of the Governor’s stated reasons for his veto was, “The FDA, which has jurisdiction for approving all drugs, has not yet determined what standards will be required for biosimilars to meet the higher threshold of ‘interchangeability.’ Given this fact, to require physician notification at this point strikes me as premature.”

Much has changed since that day – especially per physician notification. Today even the GPhA supports this public health imperative. Perhaps the biggest change in the landscape was yesterday’s ODAC meeting on a biosimilar filgrastim – and not just the overwhelming 14-0 vote in favor, but also the FDA’s strong support of the Sandoz application.

All of a sudden the issues addressed in SB 598 don’t seem so “premature.”

But the filgrastim adcomm isn’t the end of the debate. There are still many issues yet to be determined via FDA guidance  (such as nomenclature) and corporate strategy (read, “pricing”). As BIO’s Jim Greenwood said, “This week’s advisory committee meetings facilitated important discussion of the scientific approach of reviewing biosimilar applications and we encourage this positive momentum, however, we believe the appropriate way to develop policy on such a significant new approval pathway is through published guidance documents with the opportunity for public comment, rather than through single-application advisory committee meetings.”

One issue that’s taking a back seat to the approval of biosimilars is the requirement for new thinking on their post-approval safety and surveillance. Biologics aren’t the new kid on the block anymore. While it’s important to pursue ways to expedite 21st century cures (as well as the eponymous legislation), it’s equally important to focus on the details of 21st century follow-on products (both biosimilars and non-biologic complex drugs). Just as the FDA has been diligently pursuing patient-centered drug development, so too must it develop new strategies and tactics (“guidelines”) for patient-centered pharmacovigilance of biosimilars and NBCDs (such as Copaxone).

It’s also time for NORD and all the other patient and disease organizations who were so wonderfully outspoken on the urgency of expediting the FDA review process for new therapies and cures to hoist the banner of follow-on safety.

On pages 21-22 of the FDA briefing documents, an agency analysis found that, statistically, the commercial variety of EP2006 (Sandoz’ biosimilar) was lower in protein content than the comparator product (Neupogen) and was nonequivalent.  FDA dismissed this as something that could be worked out with better manufacturing controls and asked Sandoz to correct it. Okay, but isn’t this exactly the kind of thing that can cause “poor responders” to filgrastim to have suboptimal responses?  An important fact to consider when debating the value of differential nomenclature for biosimilars.

And then there’s the issue of cost. Many members of Congress have been leaning heavily on the FDA to expedite biosimilar guidances so that payers can realize cost savings.

But what will those savings be?

When ODAC member James Liebmann (assistant professor at the University of Massachusetts Department of Medicine) asked what the price of the Sandoz biosimilar would be, the answer wasn’t a resounding success for those counting their savings before they’re hatched. According to Mark McCamish (Sandoz global head of biopharmaceuticals and oncology injectables development), “We can’t say that the price would be less because in some situations the price will be at parity because of other relative terms that will come into existence that’s there. Price is a relatively complex situation.”

Indeed – as is regulatory science, which is why attention must be paid to creating ever-greater clarity for both biosimilar and NBCD pathways – and in post-approval surveillance.

It’s not just about price – it’s about safety. And it’s not about getting it done fast – it’s about getting it done right. Members of Congress should be focused on greater clarity through guidances because of patient safety issues rather than vague promises of cost-savings. As Brian Harvey (Pfizer’s VP for Regulatory Strategy -- and my former agency colleague) commented, “In lieu of a finalized guidance,” the agency has been making “very good efforts” to provide case-by-case feedback about biosimilars as companies move forward.”

As Brian Harvey (Pfizer’s VP for Regulatory Strategy -- and my former agency colleague) commented, Pfizer has been “very pleased” with the frequency of its interactions with FDA regarding biosimilars and “the granularity of the feedback” the company is receiving.”

For those in the know, that’s great, but it leaves the rest of us guessing. Official guidance would be even better.

This past summer Qasim Rashid  wrote an article entitled: "When Will the Muslim Honor It's First Nobel Laureate?"  It's a moving piece  about the failure of Islam to honor science and indeed how scientists who's research deviates from or challenges Islamic dogma are treated as infidels.  

Rashid writes: "Muslims today boast, rightfully, about Islam's Golden Age and its unprecedented contributions to the sciences. Muslim leaders worldwide implore Muslims to rise up to that greatness once more. But in doing so, too many ignore the 20th century's most prominent Muslim scientist--one who once again rekindled the brilliance of the countless Muslim scientists who created the Golden Age of Islam."

The source of extremistism is the insistence upon doctrinal certainty and the enforcement of that world view through defilment, descration and death.   The refusal to engage in fact-based discussions about the origins of the Universe and the evolution of man means that much of physics and biology is off limits.   

In his book "The Ascent of Man"  Jacob Bronowski wrote: “There is no absolute knowledge. And those who claim it, whether they are scientists or dogmatists, open the door to tragedy.”

The massacre of this week, the killing of 122 children in Pakistan, the rise in attacks on Jews in Europe are the result of this monstraous centainty.  Islamic leaders will be hard put to undermine this aspect of it's epistemoilogy but they must do so to save their religion.  

We have not faced a similar assault on freedom since Nazi Germany.  And no surpise, the Third Reich rose to power by subsuming science to it's Aryan vision. 

Back then the West rose up to defend freedom in the "hour of maximum danger."  It must do so now. without apology or resort to the usual relativistic excuses that hamstring the actions and intellectual honesty necessary to that defense.  And it can begin by pointing that the gap betweeen Islam and the rest of the world that opens wider with every savage act of violence can be bridged only when the scientific impulse -- the challenge of past dogmas and theories and the dedication to critical thinking -- is wovem into the fabric of education and institutions.  Honoring the scientists of today is a good way to demonstrate that necessary shift in outlook. 

You can read his article by going to this link: When Will The Muslim World Honor Its First Muslim Scientist Nobel Laureate?


Today, as the FDA’s Oncologic Drug Advisory Committee (ODAC) adcomm debates and discusses whether to recommend approval of a Sandoz filgrastim biosimilar, (supported by the agency in their meeting materials), a few interesting items of note.

On pages 21-22 of the FDA briefing documents, an agency analysis found that, statistically, the commercial variety of EP2006 (Sandoz’ biosimilar) was lower in protein content than the comparator product (Neupogen) and was nonequivalent.  FDA dismissed this as something that could be worked out with better manufacturing controls and asked Sandoz to correct it. Okay, but isn’t this  exactly the kind of thing that can cause “poor responders” to filgrastim to have suboptimal responses?  An important fact to consider when debating the value of differential nomenclature for biosimilars.

Here’s what the FDA had to say …

 More concerning was that Sandoz was apparently confused in providing multiple lots of the biosimilar to the FDA for the protein testing.  As a result, they thought they had provided 6 lots for testing that turned out to be only 4.  Page 4 of the Addendum states:

“On November 25, 2014, Sandoz responded to the Agency request. In the response, Sandoz clarified that the actual number of EP2006 commercial drug product lots used in the statistical analysis referred to above is four lots instead of six lots. The six EP2006 commercial drug product lots initially considered were determined to be not independent because four of those six EP2006 commercial drug product lots were split-fill lots from two EP2006 bulk drug product batches, resulting in only four independent EP2006 commercial drug product lots.”

If Sandoz, a world-class company with a stellar record for cGMPs, in their highly reviewed and internally scrutinized licensing application confuses batches of their biosimilar, what can we expect in the real world after marketing?  If Sandoz can’t track different lots of their experimental drug, what will the reality be in the real world? Another cry for sanity in the debate over nomenclature.

Biosimilars are here to stay -- and we need a nomenclature safety net.

 


A recent article in Biocentury by Roger Longman and Jane Borne of Real Endpoints has some undiluted advice about the challenge drug companies will face getting customers for the record number of new medicines approved in 2014

"HCV has taught payers they can in fact limit access to valuable drugs even when there’s no competition at all. Five years ago, it would 
have been unthinkable to deny a relatively healthy but HCV-infected patient a curative drug. Today it’s routine."

Ditto for HIV, MS, psoriasis, various cancers.  


"They are willing to challenge head-on, as far as we can see for the first time in a major, potentially fatal disease, the resistance of physicians and patients in order to provide their customers with a mechanism for bending the cost curve in specialty drugs. And that means that we will see similar deals in all significant competitive specialty categories — including in some areas of cancer."

RIght now companies are responding by offering the big pharmacy benefit networks discounts in exchange for being the only drug of it's kind covered.  And since the first movers are likely to cut such deals to limit competition,  what will happen to other medicines that may have significant benefits for patients or to other medicines that need to be used in combination.  When price is the only thing that matters, outcomes take a backseat.  And pharmacy plans are doing because, under Obamacare, they can.  

Isn't that a restrictive formulary?  Won't that kill the other speciality pharmacies and small drug stores that sell on service and not just margin?  Isn't that bad for patients?

There's only one right answer: Yes.

There are three things companies must do to get their products to patients.  I am not sanguine about the ability or desire of  most companies to take these steps.

1.  Identify groups of patients that benefit most from a new medicine, especially groups that will benefit and require a combination of treatments to improve health.

2.  Demonstrate the benefit of such treatments to patients and their families in terms of a return to or continuation of life free for disease.   Estimate the value of this state of wellness and estimate the cost -- in terms of out of pocket spending, lost productivity and even death -- of forcing people to use a drug that's cheaper for a health plan but not best for a patient.  

3.  Demonstrate the benefit of such treatments to employers, universities, retirement funds, life and disability insurers, Medicare, Social Security.   And share this information widely and with Congress.  Otherwise valuable Obamacare reforms to eliminate discrimination against chronically ill people through restrictive formularies will fail.  

As Longman and Borne note:  It’s crucial that biopharma provide (these other stakeholders) the appropriate measurement tools. If they don’t, buyers will settle on the easiest point of comparison: price.










 
Exhibit-14
From 

And Ivan Ackerman. Always the wrong answer. Always.


 

It seems that some folks at the AMA think that 7+3=9.

According to Inside Health Policy, an American Medical Association internal council report reveals the group is leaning toward a naming scheme where biosimilars and their reference products would share the same International Nonproprietary Names (INN). The report says that unique names may suggest different active ingredients within the products and go against standard nomenclature. This stance differs from that of the innovator biologics industry and a handful of specialty physician groups, which argue that shared naming would improperly imply interchangeability.

Wrong.

Assigning differential naming to biosimilar products will certainly prove challenging to the various constituents of the drug compendia community — but it will be crucial for pharmacovigilance. In the real world, how can we not have separate names when there are going to be four categories of products?

Based on comparative analytical data, FDA will characterize its assessment of biosimilarity into one of four levels -- not similar, similar, highly similar or highly similar with a fingerprint-like similarity — depending on the type, nature and extent of any structural and functional differences revealed.

Additional pharmacologic studies would be required to show that the identified difference is “within an acceptable range to consider the proposed biosimilar product to be highly similar to the reference product.”

FDA said only products in the top two tiers would meet the statutory requirement for analytical similarity under the Biologics Price Competition and Innovation Act of 2009. Products in the top two tiers would then only require “targeted and selective animal and/or clinical studies to resolve residual uncertainties” to demonstrate biosimilarity. In addition, these data could be used to extrapolate clinical data for additional indications.

The argument that differential naming is bad for patient safety is pure Orwellian Newspeak — specifically “blackwhite, ” The ability to accept whatever “truth” the party puts out, no matter how absurd it may be — no matter the lack of supporting data. When it comes to biosimilar nomenclature, it’s urgent that we keep our priorities straight. And that means keeping patient safety, not interoperability challenges, at the top of the agenda. Fortunately, White Oak trumps blackwhite.

The good news is that a handful of specialty physician groups disagree with the AMA and are siding with the innovator biologics industry in urging FDA to adopt a biosimilar naming scheme under which products have distinguishable names, pushing back against arguments made by an American Medical Association council and generic drug makers for shared International Nonproprietary Names (INNs). The groups, like innovator companies, argue that distinct names are needed to track adverse events and to protect against improper pharmacy substitution.

The specialty physician groups wrote to FDA on December 18th that a shared name would imply interchangeability, referencing statements made by the agency in past about how INNs should not be used to "imply pharmacologic interchangeability of products with the same active ingredient(s)."

Signers of a the letter include: Alliance for Patient Access; American Academy of Allergy, Asthma & Immunology; American Association of Clinical Endocrinologists; American College of Rheumatology; American Gastroenterological Association; Association of Black Cardiologists; American Urological Association; Clinical Immunology Society; Coalition of State Rheumatology Organizations; physician co-conveners Biologics Prescribers Collaborative; and members of the National Physicians Biologics Working Group of the Alliance for Patient Access.

For a more complete debunking of the AMA’s position, see the recent FDLI paper, Biosimilar Nomenclature: Can we Achieve the Truth, the Whole Truth, and Nothing but the Truth?

Claude Debussy said, ‘‘Music is between the notes.’’ And the same can be said for biosimilarity and the practice of medicine. We now have many thoughtful guidance documents but, in many respects, it’s just theory. And just as the case with music theory, the words on the page are one thing—but when talented performers sit down at different pianos in disparate venues the results are both similar and unique.

Lot's of high-fives about the record number of approvals coming out of FDA.   Not to be a buzz kill but who cares unless patients are nickled and dimed to death by the intellectually empty barking of health plan and pharmacy benefit management firms that to use new treatments is simply allowing drug companies to rake in unjust profits that will bankrupt America and drive premiums sky high.  

In particular AHIP, the AHIP funded sock puppet called the National Coalition on Health Care and Express Scripts have been feeding the media beasts scare stories of greedy Big Pharma and their high prices forcing health systems to ration care.   In the wake of all the new drug approvals (and the FDA is still too damn slow) anticipate the next wave of articles about "How Can We Afford All These Drugs?"

The fact is, new medicines are developed not to save health plans money.  They do by replacing sick hospitalizaed patients with healthy productive comsumers and premium payers.  But new medicines -- especially this generation of drugs and the next -- are developed to predict, and prevent diseases from progressing by using what Eric Topol and Stephen Quake called molecluar stethoscopes:  chips and high powered computers that can detect and sequence the gene expression networks impllicated in disease or disease risk in real time.  That will lead to more precise answers about how to prevent and how to treat disease.  And it will lead to an acceleration of drug development and to determining with nearly 100 percent accuracy what works.

The AHIPs and Express Scripts of the world, as well as most hospitals (at least in the US) are seeing their business model crumble.  They don't know it yet, anymore than the record companies and movie chains and department stores had the foresight to anticipate how digitization of information would force them to the brink of extinction.   It's happening to the big box approach to health care.   And the rent seekers and businesses that will be destroyed are panicking.  

The only ways they have left to defend the status quo is lobbying, regulations and scaring the public.  And they will fight like hell to limit access to new, targeted treatments that deliver most of the economic and social benefits to indivudals.   WIth a willing and biased media behind them, they will have some initial success.  But soon the winds of change will sweep them and their pre-industrial approach to managing care will away.  

We are on the edge of the Cure Century and they hate it.  

In case you missed this story over the holidays.

WASHINGTON (AP) -- The Food and Drug Administration approved 41 first-of-a-kind drugs in 2014, including a record number of medicines for rare diseases, pushing the agency's annual tally of drug approvals to its highest level in 18 years. FDA drug approvals are considered a barometer of industry innovation and the federal government's efficiency in reviewing new therapies. Last year's total was the most since the all-time high of 53 drugs approved in 1996.

The 2014 approval list includes 15 drugs for so-called orphan diseases, which are rare conditions and disorders that affect fewer than 200,000 people in the U.S. Last year's tally, which included drugs for rare cancer and metabolic disorders, exceeded the 13 orphan drugs approved in 2012.

Nine drug approvals in 2014 benefited from the FDA's "breakthrough" designation, a recent program designed to speed up development of promising drugs by providing companies with extra meetings and earlier communication with FDA scientists. Milne said these meetings provide more predictability and transparency about the FDA review process, a boon to both companies and investors.

The complete AP story can be found here.

12 Years a Slave

  • 01.04.2015
It's been a dozen years since the nefarious Andrew Wakefield article. Will the truth really set us free.

Have a look at this video and please pass it on.
A plaque at the entrance of the American Civilization Center at Brandeis University proclaims:  “To speak freely, to question openly, to differ without fear.”

That plaque has been tarnished by the unwillingness of Brandeis University to live up to that credo.   Rather than immediately defend Brandeis student Daniel Mael’s right to republish a fellow student's call for intifada in America and her lack of remorse over  of the death of the two NYPD officers, Brandeis has let radical forces threaten Mael’s safety. 

As Lori Lowenthal Marcus wrote: “There’s an ugly tempest brewing at Brandeis University and it’s based, at least in part, on free speech, tolerance and student safety. The storm grew out of a more generalized anger with the state of public discourse and of the safety of individuals in our society at large.

But at this point, one black self-described revolutionary and one Jewish conservative journalist, both Brandeis students, are the figureheads in a battle for the soul of an institution.”

That battle was lost long ago.  Brandeis, like many other universities now limit the actions and speech of anyone who differ with those groups who define themselves as oppressed or as defending the oppressed.   

Like many other students, Kadijah Lynch is embracing a radical, wholesale attack on America’s democratic capitalism that begins with limiting the freedom of those who disagree with you or dare to criticize you and ends with those that are ‘oppressed’ deciding what the oppressors can do.    

To the radical, suppression of free speech is necessary if the society is unjust and unequal.   The ruling classes and its apologists will use political freedoms and civil liberties to stay in power.   And anyone who disagrees with any aspect of the program or worldview is regarded as a threat to revolution.  Hell, freedom is simply a bourgeois prejudice, as Lenin put it.

So attacking Daniel Mael for reposting ugly Tweets from a fellow student and self-styled revolutionary is not wrong, it’s moral.  

And Brandeis University – or at least a significant share of the administrators, professors and students feel the same way.

Some would point to the University’s invitation to have Jimmy Carter speak about the evils of Israel and dis-honoring Ali Al-Hirsi because she had spoken about the evils of radical Islam as examples of this allegiance to a radical form of egalitarianism.   Indeed, bashing Israel and defending Islam is the most common way to demonstrate support for ‘the oppressed.’   That explains why the anti-police forces have drawn the attention of ISIS, Al Qaeda and why the social media mob attacking Mael is led by the Hamas campus organization, Students for Justice in Palestine

Brandeis not only practices a form of ‘free speech’ that encourages such groups, it is the fountainhead of what Herbert Marcuse – one of its former professors – called repressive tolerance. 

Marcuse believed that in America freedom perpetuates injustice.  In 1965, while still at Brandeis, he wrote a highly influential article entitled, "Repressive Tolerance“ As a Wikipedia article on Marcuse argues that “genuine tolerance does not permit support for "repression", since doing so ensures that marginalized voices will remain unheard. He characterizes tolerance of repressive speech as "inauthentic." Instead, he advocates a form of tolerance that is intolerant of right wing political movements.  That is, the liberation of the oppressed requires silencing those who oppose them.  As Marcuse asserts:

“This means that the ways should not be blocked on which a subversive majority could develop, and if they are blocked by organized repression and indoctrination, their reopening may require apparently undemocratic means. They would include the withdrawal of toleration of speech and assembly from groups and movements which promote aggressive policies, armament, chauvinism, discrimination on the grounds of race and religion, or which oppose the extension of public services, social security, medical care, etc.

As to the scope of this tolerance and intolerance: ... it would extend to the stage of action as well as of discussion and propaganda, of deed as well as of word.”

While teaching at Brandeis, Marcuse was afforded every opportunity to speak his mind.  True his worldview, Marcuse took every chance to criticize those who disagreed with him.   Abraham Sachar, the President of Brandeis who hired Marcuse in 1954 said that Marcuse was “the most relevant symbol in my experience of the cynical radical who demands independence as a right for himself but considers it ‘hypocrisy’ when it is expected of him.”   Sachar goes on to note that Marcuse was not fired for his views but rather quit to accept a longer contract from another university.   Sachar writes that Marcuse never sought to the set the record straight.  Rather, he remained silent. 

Today Brandeis has endorsed the ‘narrative’ of a radical professor being fired for his views.  It recently celebrated Marcuse with a one-day conference entitled: “The Many Dimensions of Herbert Marcuse.”  An ironic title since the event was an intellectual love fest that skated over the discussion of repressive tolerance.  The International Herbert Marcuse Society largely organized the event.  The group consists of diehard radicals who view the organization as an engine of repressive tolerance.  So for instance, the next Society conference focuses on the following question: “ Given Marcuse’s emphasis on praxis, critical pedagogy cannot be limited to classroom space in universities - how can a critical rationality translate into programs of activism, agitation, and organization?”  In other words, how can universities be turned into factories of radicalization and repression?

Marcuse dedicated “Repressive Tolerance” to his students at Brandeis including Angela Davis and Abbie Hoffman.   Davis became closely associated with the Black Panthers, the Communist party and most notoriously, with providing her sawed-off shotgun to kill a judge who had sent her lover, George Jackson, to prison.  She was acquitted and later received the International Lenin Peace Prize (formerly named the International Stalin Peace Prize) by East Germany.  These events have been scrubbed from the official Brandeis University biography of Davis.  

The failure to defend Daniel Mael’s right to republish the vile and violent comments of Ms. Lynch is the result of Brandeis University’s passive acceptance of repressive tolerance.   It is a sad decline.

Sachar recalls that Marcuse and other leftist professors organized a rally at Brandeis during the Cuban Missile Crisis.  They called the Khrushchev-Castro decision to based misses in Cuba as a legitimate response to “American imperialism.”   One speaker, anthropology professor Katherine Gough, declared to wild applause, that if war broke out she hoped America would be defeated. 

When Sachar found out about her comments, her met with her to find out first hand what she said.  Hough repeated her statements.  Sachar told her that he did not “quarrel with her right to denounce American foreign policy. The freedom of platform gave her no warrant for an irresponsible attack.” 

Gough’s husband David Abele (head of the anthropology department) claimed that Sachar’s criticism was illegitimate.  Sachar replied “apparently freedom of speech means that you can dish it out but you don’t have to take it.”  To which Abele said: when I speak it’s my right.  When you speak its intimidation.  Incredibly, Abele then requested a bonus for his wife.  Sachar said no.  Abele and Gough left for another university, but not before suing Brandeis for ‘unfair treatment.’

Sachar did not reward Gough or Abele for their behavior.  His determination to uphold the credo “to speak freely, to question openly, to differ without fear” caused those that attacked that principle to leave Brandeis.

Up till now, the Brandeis community and its president, Fred Lawrence, have failed to defend Daniel Mael and speak out against repressive tolerance.   Next week, when Mael and his parents meet with Lawrence, who is considered to be the front runner to head the Anti-Defamation League.  The president will have a choice:  the valor of Abraham Sachar or Marcuse’ radical program of suppression. 

Baby, it’s cold outside – if you’re suffering from Hep C.

A recent article in the Washington Post, “One company’s battle to stop the wave of high priced drugs,” could more accurately have been titled, “One company’s battle to stop innovation.”

The Post reports:

This week, the country's biggest drug plan manager Express Scripts said it will drop Gilead's drugs Sovaldi and Harvoni from a list of preferred drugs covering 25 million patients and instead will only put Viekira Pak on its list. Express Scripts said it has negotiated a significant discount with AbbVie — perhaps between $20,000 and $30,000 per course of treatment — in return for expanding access to patients and allowing primary care doctors to prescribe the drug … Until recently, Express Scripts didn't exclude any drugs from its list of preferred medications. But the exclusion list grew from 44 drugs two years ago to 66 in this past year.

Until recently, Express Scripts didn't exclude any drugs from its list of preferred medications. But the exclusion list grew from 44 drugs two years ago to 66 in this past year. The company's chief medical officer, Steven Miller, said he's been telegraphing a move like the AbbVie deal all year.

"We need innovation, and affordability has to be part of that innovation," Miller said in an interview. The companies aren't disclosing the discount, but he said the deal helps close the gap between prices in the U.S. and western Europe. Sovaldi is priced at $57,000 in the United Kingdom and $66,000 in Germany.

That’s the party line – for payers. But you have to read on to get the rest of the story -- about the chilling impact the Express Scripts strategy will have on patient care and pharmaceutical innovation.

"The only way you do exclusions," Miller said, "is you have to do drugs that clinically have identical outcomes."

But Dana Goldman, director of the Schaeffer Center for Health Policy and Economics at the University of Southern California, warns this could come at the expense of the patient since not all will respond to the same treatment. Express Scripts says it won't limit access for hepatitis C patients who need Gilead's drugs, but drug exclusions could still be problematic for patients, Goldman said.

"The reality is if you put up barriers for physicians and patients, we know that people won't have as good access," said Goldman, whose own research found that limits on what drug availability lead to worse outcomes for psychosis patients.

What’s really happening is insurers want someone else to pay for their failure to adequately price demand for highly effective, potentially lifesaving drugs. If the critics had their way and new regulations required price slashing, inevitably patients would lose access to lifesaving therapies, both directly and as a result of reduced research and development expenditures on what could be the next Sovaldi, or Ebola-fighting ZMapp.

Insurers also are hardly powerless, which is evident in their ability to shift drug costs to patients. While critics lambaste the American health system as free enterprise run amok, in reality the U.S. health insurance sector is more like a regulated monopoly – with a mandated customer base that will keep growing as Obamacare expands its reach and as America continues to age.

Prescription drugs currently make up just over 11 percent of the nation’s nearly $3 trillion health care tab; simple math indicates pharmaceuticals are not the major driver of runaway U.S. health expenditures.

And Express Scripts is not what anyone would call a disinterested party.

Consider the 2010 comment of George Paz, chairman and chief executive of Express Scripts, “The cheapest drugs is (sic) where we make our profits.” And just who is “cheaper” better for? "Our whole model is switching people to lower-cost drugs. The more money my shareholders make, the more money I make."

Paz ranked sixth on the 2012 Forbes CEO compensation list, with $51.5 million in total compensation the preceding year, and $100.2 million over a five-year period.

More money for George and Co., but less choice and no savings for patients. This has been the case with brand vs. generic medicines for years. But at least these often resulted in lower out-of-pocket co-pay expenses for patients. Today, the same fatten-George’s Wallet schemes are being used for drugs for evermore serious and life-threatening conditions – such as Hep C. Express Scripts enjoys enormous leverage in the marketplace. What Express Script’s Dr. Miller didn't’ say about drug exclusions, is that his employer told investors earlier in the year that company planned to save $1 billion in 2015 by excluding 66 medicines from its list of covered drugs.

And they did.

Brr. That’s the sound of chilling innovation.

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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