Latest Drugwonks' Blog

This week the FDA proposed cutting out the paperwork and cost required to submit a ' request' to use a medicine that hasn't approved but has demonstrated that it is relatively safe given the clinical benefit and urgency of the medical condition.   As the agency noted in a blog discussing the change: the previous request form called for 26 separate types of information and seven attachments. In fact, it was originally designed for manufacturers seeking to begin human testing, not for physicians seeking use by single patients."

This simple step could save thousands of lives and increase the number of people seeking to try a new medicine as early as possible. 

All of which begs the question of why we need compassionate use exemptions at all.  Why not turn Phase 2 and 3 into a study of people using medicines in the real world?  Joseph Cooper notes in "Regulating New Drugs that "the ultimate test of safety and efficacy is how man responds in significant numbers under diverse conditions over relatively long periods of time.  We have tended to substittue for that ultimate test one of the fads of the times -- the scientifically controlled double blind trial "

Cooper wrote that in 1972.  

We have not come very far since then.  In fact, the fad of that time has become Holy Writ.   Peter and I wrote a publication about how to use molecular markers and digitized real world data to accelerate all drug development and to turn medicine into a true learning system.   Very little of what has been written since then is more than a footnote to our original work.  And in turn, our work was shaped by the thinking of Cooper and others such as the late Nobel Laureate Josh Lederberg who wondered aloud "if innovation was possible" under the current regulatory regime.

We can learn more in less time using real world data than in a decade of clinical trials.   Kudos to the FDA.  By removing the obstacles to using new medicines in the real world and by encouraging the sharing of data from these experiences, it has given us -- and policymakers -- a look at how the agency can serve the public health in the century ahead.  And it has acknoweldged that patients should and will have more control over what medicines to use and has increased that control.  

From the pages of the Washington Examiner

Industry ties could be at issue for possible FDA pick

Respected cardiologist Dr. Robert Califf appears to be a top candidate to be the next head of the Food and Drug Administration but may face heated Senate queries over close ties to pharmaceutical companies if nominated for the post.

The Duke University cardiologist and researcher was appointed as the agency's deputy commissioner for medical products and tobacco by the FDA last month and will start in March.

At the time, several FDA and industry insiders believed the appointment signaled that Califf would be FDA Commissioner Dr. Margaret “Peggy” Hamburg's eventual successor.

Now that Hamburg officially resigned last week, insiders continue to believe Califf will be selected by President Obama to fill the position.

“I have a short list of one person, and that is Robert Califf,” Peter Pitts, president of the think tank Center for Medicine in the Public Interest, told the Washington Examiner.

Pitts, a former FDA associate commissioner, said Califf would have bipartisan appeal. He was interviewed for the top job during the Bush administration and the Obama administration.

Califf currently serves as vice chancellor of clinical and translational research at Duke University, and was founding director of the Duke Clinical Research Institute, which conducts clinical trials for several drugmakers. He will take a leave of absence from the university to fill the deputy director position.

Califf is a logical choice because he is an accomplished researcher who has more than 1,000 manuscripts to his name, which is a rare feat, Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, told the Examiner.

Nissen and Califf clashed at times while serving on FDA advisory committees, but Nissen said his colleague has a high degree of scientific integrity.

Califf was part of the Institute of Medicine committees that recommended Medicare coverage of clinical trials and the removal of the unsafe weight-loss supplement ephedra from the market, the FDA said.

While Califf has extensive research credentials, he also has extensive ties to the pharmaceutical industry.

He has received research grants from pharmaceutical giants Novartis, Johnson & Johnson, Lilly, Merck and Schering-Plough. He also consulted for Boehringer Ingelheim, Bayer, Bristol Myers Squibb, device giant Medtronic and other companies, according to a disclosure statement on the Duke institute website.

Califf was named to the board of directors for San Francisco drug manufacturer Portola Pharmaceuticals in 2012 but resigned soon after being appointed to the FDA post.

Nissen conceded that the ties could be a liability and may come up during a confirmation hearing.

The issue is “what if he is in the position to make decisions about companies with whom he has working relationships,” Nissen said. “I think his integrity makes that less of an issue, but that is in the eye of the beholder.”

Public advocates and some members of Congress have previously criticized the FDA for being too close to industry. The advocacy group Public Citizen noted recently that during Hamburg’s tenure the FDA grew even “more cozy with the industries that it regulates.”

Another potential focal point during confirmation could be Califf’s handling of a data fabrication scandal while at Duke. Califf was vice chancellor of Duke’s clinical research division when Dr. Anil Potti was caught in 2012 fabricating cancer research. Califf told CBS News that year he is responsible for retracting Potti’s various papers in medical journals and implementing new oversight procedures at Duke.

To be confirmed, Califf must first be vetted by the Senate Committee on Health, Education, Labor and Pensions.

The White House hasn’t announced a timeline for selecting a replacement. Press secretary Josh Earnest said during a briefing Friday the president will want someone with “impeccable medical and scientific credentials” that can also muster strong bipartisan support.

Califf did not return a request for comment as of press time. During a recent conference call with reporters on the deputy director appointment, Califf said that such a promotion “has not been a part of the discussion,” according to the Wall Street Journal.

Day after my NY Post article discussed how Arkanasa Medicaid denied 14 year Chloe Jones  a drug tailored to treat her form of CF...

State settles Medicaid suit over cystic fibrosis drug
Arkansas Times
Posted By Leslie Newell Peacock on Fri, Feb 6, 2015 at 12:05 PM

The state Medicaid office has settled a federal lawsuit brought by three cystic fibrosis patients who were denied the drug Kalydeco because of cost, the Wall Street Journal reported yesterday.

Catherine Kiger, Elizabeth West and Chloe Jones filed the suit, Kiger v. Selig et al, last year saying the state had violated their civil rights for two years by denying them the drug. The settlement was filed Thursday in federal court in Fayetteville.

Kate Luck, a spokesperson for the state Department of Human Services, said the settlement involved no monetary awards, but the state, which changed its criteria for eligibility for the drug prior to the settlement, has agreed not to change those criteria for two years. Should the state deny the drug to a Medicaid patient, it must provide the court reasons why and the court may  jurisdiction over the state's decision. ask the state "to outline the reasons for denial," Krell said.

The courts do not have jurisdiction over the decision. The only thing they can do is ask us to outline the reasons for denial.

The state previously had required the patients to prove that less expensive therapies had failed to work and,   according to the WSJ, "patients seeking to have their prescriptions reauthorized by Arkansas Medicaid were required to prove they had better lung function, weight gain and fewer hospitalizations with the drug."

The state no longer requires the patients to use the standard therapy (Pulmozyme and hypertonic saline) for 12 months before being considered for Kalydeco or to show evidence of failure on the standard therapy, Luck said. She said the studies were "made in response to more recent studies that were released on the drug. Arkansas has covered Kalydeco since 2012 and approved its first patient for coverage in 2013."

The manufacturer of Kalydeco, Vertex, of Boston, had declined to provide the drug free through its patient-assistance program. The drug targets a specific genetic cause of CF, and Luck said the state estimates that only seven CF patients in the state Medicaid program whose disease is caused by the particular gene mutation. While Luck said the denials were not "necessarily because of cost," she added that that the drug is "very expensive" and a "lifetime drug."

The annual wholesale cost of the drug is $311,000, according to the WSJ.

The FDA is not a monolithic entity. The agency is comprised of over 16,000 dedicated public servants whose areas of expertise and responsibilities range from pharmaceuticals to food, veterinary products, cosmetics, medical technology, dietary supplements, and beyond.

No one person calls all the shots – but the Commissioner is in charge and sets the tone and direction of the body that regulates more than a quarter of the American economy. A really good commissioner is measured by the impact he continues to have once she has departed. By that measure Peggy Hamburg rates an “A.”

It’s fair to say that Dr. Hamburg came to White Oak at a time when the FDA was under a cloud. Whether or not the criticism the agency was receiving was fair (most of it was not) isn’t the point. Morale was low. Moral authority amongst constituents was fading. Global leadership was ebbing. PDUFA reauthorization was pending.  Peggy did not walk into a cushy job and had a steep learning curve.

As every FDA commissioner, she faced many issues. Some specifically worth noting:

·      The authority to regulate (at least after a fashion) cigarettes

·      Weathering the storm over opioid pain medications – and turning it into a public health victory

·      Advancing medical device review reform

·      Developing a regulatory pathway for biosimilars

·      Producing social media draft guidances

·      Expediting expedited review pathways

·      Expanding Expanded Access Programs

·      Identifying the need for 21st Century bioequivalence strategies

·      Facilitating adaptive clinical trial design partnerships

·      Rethinking FDA’s role in global harmonization

·      Forcing forward motion per Patient-Focused Drug Development

·      Beginning an Office of Pharmaceutical Quality

… to name only a few. That’s not to say that all of these items are tied up in a bow, that there haven’t been errors, blunders, sins of omission or that important initiatives are progressing to everyone’s satisfaction – far from it. But as Mark McClellan used to say when he sat in the Commissioner’s chair, “If some people think we’re moving too fast and others think we’re moving to slow – then we must be doing something right.”

A successful FDA Commissioner quickly realizes that a sure path to failure is to try to make everyone happy or micromanage. That ain’t the way it works. Peggy’s empowered the agency’s senior staff to follow her lead and do the right thing as they see it. The best example of this was her decision to allow Plan B (“the Morning After Pill”) to go OTC – publicly bucking political pressure from the White House to submarine the considered decision of the FDA’s professional regulatory staff – and quieting those who claim FDA decisions are “politically motivated.”

Perhaps most importantly is that faith in the FDA is stable and improving and staff morale is vibrant. Rather than the facile and ignorant drumbeat of “blame the FDA,” groups ranging from the pharmaceutical industry, to patients groups, Congress, academia, and healthcare practitioners are beginning to realize (some faster than others) that FDA is a crucial partner – indeed a senior partner -- in the innovation ecosystem.   

Peggy Hamburg is leaving the agency in a better place than she found it. She has successfully set the tone for the 21st Century FDA -- an impressive and gutsy millennial course.

And that’s as good a legacy as any commissioner could want.

My oped in the NY Post:  How President Obama Can Spur Precision Medicine

President Obama is calling on Congress to improve the nation’s health by increasing the development of precision medicines — treatments that target the underlying cause of life-threatening diseases.
He says he wants to ensure everyone has access to the right drugs at the right time, because it can reduce the cost of health care and save lives.
That’s great. Too bad that, under ObamaCare, people are getting fewer targeted treatments and paying more for them.
In his State of the Union, the president mentioned Bill Elder, a 27-year-old medical student being treated for a rare form of cystic fibrosis with Kalydeco — which, the president noted, “has reversed a disease once thought unstoppable” by turning off the genetic mutation causing his disease.
Yet Kalydeco isn’t easily available under most health plans. Ask Chloe Jones, a 14-year-old Arkansan with the same type of cystic-fibrosis mutation.
Her state Medicaid agency has refused to give her Kalydeco, insisting that she first fail to respond to older, cheaper therapies that treat the symptoms but not the underlying cause. (Kalydeco costs about $200,000 a year.)
That is, she has to get sicker before getting the medicine that shuts off her disease.
Chloe’s not alone. Nearly 70 new treatments precisely target the underlying causes of disease; many, like Kalydeco for CF or Herceptin for breast cancer, target specific disease paths or benefit specific groups of patients.
Compared to trial-and-error or wait-and-see care, matching the right treatment to patients is much more cost-effective, especially for the person who’s sick.
Yet health plans are covering fewer new precision medicines, instead forcing patients with CF, cancer, multiple sclerosis, psoriasis and HIV to get sicker before they can use them.
And when they do allow access, they’re forcing patients to pay up to half the new medicines’ cost.
Yet ObamaCare is exacerbating this pre-existing problem with our system — by accelerating the transformation of prescription-drug coverage to a vast pyramid scheme.
Thanks to the ObamaCare law, health plans now enroll people under the promise of covering anyone with a pre-existing condition — but those same plans make it increasingly difficult, if not impossible, for these people to get the medicines they signed up to receive.
At the center of the scam are pharmacy benefit managers, or PBMs. These are the firms that actually develop and run the drug benefits for health plans.
PBMs bargain with drug makers to get discounts or rebates for including their pharmaceuticals on “formularies” — the list of drugs your health plan covers.
ObamaCare has already accelerated consolidation in this obscure industry, to the point that just two PBMs now control the drug benefits of nearly 200 million Americans.
The two firms are using their vast market power to extract big rebates from drug companies in exchange for including precision medicines on their formularies.
Increasingly, PBMs are only covering one precision medicine for a given condition — the drug made by the company that offers them the biggest rebate.
That’s what happened with the new drugs for Hepatitis C. One big PBM, Express Scripts, is only covering the drug Viekira Pak; the other, CVS/Caremark, has made two other new medicines, Sovaldi and Harvoni, the exclusive “precision” options for patients with hepatitis C.
Left-leaning health-care “reformers” hail these pay-for-play schemes as ways to reduce health-care costs and make new medicines more affordable. But the discounts don’t help patients.
Instead, the PBMs will pocket about $3 billion in rebates from these drugs this year. And you can expect them to apply the same protection racket to medicines for cancer, MS and psoriasis.
Even then, more than 60 percent of health plans require patients to “fail first” on less precise drugs for HIV, multiple sclerosis, cancer, psoriasis and other illnesses.
The outrages don’t stop there. When the PBMs and plans finally stop excluding access to a precision drug, they often still force people to pay thousands out of pocket for the medicines — up to 40 percent of the cost.
Insurers and PBMs profit from all this, but it’s a waste of health-care dollars even though precision drugs are so costly.
Indeed, studies by Columbia University economist Frank Lichtenberg show that access by patients and their health-care providers to new medicines promotes longer, higher-quality life and better health care at a lower total cost.
And health-outcomes expert Dr. Susan Horn has found that when you’re “failing first” on a cheaper drug, you’re not only more likely to miss work, but also to run up other medical bills related to your illness. And even the cheaper drug still costs.
Precision medicines, while expensive, save money by eliminating guesswork, use of ineffective treatment and costly health services. Lichtenberg notes that every $1 spent on new medicines saves about $6 in other medical costs.
If Obama wants to usher in an era of precision medicine, he should work to replace “fail first” or “step therapy” approaches with value-based precision therapy, and to end the practice of forcing patients to pay the highest prices for the most effective medicines.
Precision medicine is the best remedy for PBMs and insurers who get richer by making people like Chloe Jones sicker.

Come steppin' down the stairs pretty Peggy-O.

News today that FDA Commissioner Hamburg will resign tomorrow.

More on this to be sure – but for now let’s just say that she’s leaving the agency in a better place than she found it. She set the tone for the 21st Century FDA -- an impressive and gutsy millennial course.

Here’s the New York Times report.

Much on the horizon for her successor, beginning with working to shape PDUFA VI.

And who better to do this than … Rob Califf.

Today is World Cancer Day.   The goal of this annual event is to generate support and awareness to ensure "all people have the right to access quality, effective cancer treatment and services on equal terms,regardless of geography and without suffering economic hardship as a consequence."

The way to do so: high prices for medicines. 

As Tomas Philipson points out in his op-ed today in Forbes,  the doctors who are only able to pass themselves off as economists because they refuse to debate real economists with real evidence, claim a 'just price' is a price that is... well, less than what they think is 'fair.'   Or a price that is set by government.  Which is one and the same to these faux financial experts.   

But a just price is, as Philipson notes, ithe price that brings better medicines to market that leading to lower prices for health and staying aive.  Which includes eliminating the use of the high priced and much more costly surgical and  hospital based services that enrich the institutions of the would-be economists:

"The current pricing debate is misguided because it is the price of health, and not healthcare, that is the key to patient health. Before a new innovation, the price of better health is effectively infinite for some patients who do not respond to existing treatments because they cannot buy better health. Thus, regardless of price charged for a new treatment it always lowers the marginal price of health for some patient populations. For example, before the breakthrough therapies for HIV in 1996, infected patients could not buy a longer life at any price.  Regardless of the price of the new HIV drugs that came on the market, the price of buying a longer life thus fell. When generics come in, the price of health falls even further but is not captured as returns to the innovators ultimately responsible for it.

What these misperceptions make clear is drug pricing is more complicated than self-interested buyers (Memorial Sloak Kettering, MD Anderson) will have you believe. Although their misguided policy proposals are of course well-intended, if taken seriously they could have very harmful impacts on patients who have no existing options to limit the impact of  their diseases."

These misperceptions persist in large part because their purveyors duck and dodge when asked to debate or discuss in pubiic, one on one.   Rather, they retreat to the security of publications, forums and programs that allow them to manufacturer serious sounding statements that are factually inaccurate and misleading. 

If I didn't know better, I'd say that these pretend economists are afraid to engage directly with Philipson, Frank Lichtenberg,  Tufts's Josh Cohen or anyone else that would challenge their version of the truth.

The danger is that if these opinions become the foundation for pricing policy here, it will reduce investment and ensure that onlly the very rich get access to life saving drugs.   

Today, senior FDA officials and representatives from leading patient and health policy organizations are meeting in Washington, DC to discuss the urgent and contentious issues surrounding expanded access to investigational drugs.  Yesterday I keynoted the “Expanded Access Programs: New Models for Stakeholder Collaboration, Program Design, Supply Equity and Access for Investigation Drugs” conference. I was pleased to share the day with colleagues such as Richard Klein (Patient Liaison Program Director, FDA’s Office of Health and Constituent Affairs) and Diane Dorman (Vice President for Public Policy at NORD).

The full program can be found at

Some points from the conference worth mentioning:

There is “therapeutic misinterpretation” of early scientific data resulting in some patients asking for access to investigational products based on mouse data! Patients see reporting of promising early data in places like USA Today and immediately call the FDA.

Better “expanded access IQ” isn’t just reserved for patients – but is also needed for physicians. Many doctors are unsure of just what there roles and responsibilities are relative to expanded access protocols. Is this even taught in medical school? And then there's the issue of physicans being concerned (and rightfully so given our litigious society)) about liability issues.

The urban myth that adverse events reported through expanded access programs derail the success of FDA approval is not supported by facts. Richard Klein repeatedly told the conference that (to his knowledge) there were no examples of this – and he’s contacted his FDA colleagues in search of such circumstances. Perhaps it’s time for industry to gather examples – if they, in fact, exist – and share them with the FDA as a tool to correct the problem.

Is “expanded access” even the right term to use? It means one thing in the US, and completely unrelated things in other countries. In the UK, for example, “expanded access” is a reimbursement strategy for approved products.

How can IRBs be restructured to expedite review rather than being a bottleneck?

In the words of the great health policy guru, Buffalo Springfield, There's something happening here / What it is ain't exactly clear.

Perhaps, as part of the FDA’s current initiatives to enhance both the timeliness and weight of the patient voice, expanded access plan development and execution should involve patient organizations. Maybe it’s time to harness that power to make the process both more-inclusive and better.

Another issue that remains at-large is who pays for access to these unapproved drugs? What a company can charge is regulated (via draft guidance), but sometimes the drug company will bare all costs, other times some costs, and just as often it’s the patient who writes the check. And IRB and other related costs are often borne by the patient. Perhaps there’s a role for the Federal government.

How about a fund that pays for access for any approved FDA expanded access IND or protocol? I propose that this issue should be a key part of the pending 21st Century Cures legislation being drafted by Representative Fred Upton, the Chair of the House Energy & Commerce Committee and by Senator Lamar Alexander in the Senate.

All sides want the same thing -- expedited expanded access programs. But name-calling and bridge burning doesn't bring anyone closer together or experimental drugs to dying patients any faster.

Let’s expedite access by enlarging the Expanded Access Ecosystem.

My complete keynote remarks (including commentary on Abigail Alliance v. von Eschenbach and the Right-to-Try debate can be found here.

When it comes to myths about healthcare, one of the great shibboleths is that Big Pharma profits from innovation “that comes primarily from the NIH.” It’s never been true – and now a new study confirms it.

A study in Health Affairs by Bhaven N. Sampat and Frank R. Lichtenberg (What Are The Respective Roles Of The Public And Private Sectors In Pharmaceutical Innovation?) puts the issue in a data-driven perspective that gives the NIH its due – but in the proper frame of reference.

For example, according to Sampat and Lichtenberg, fewer than 10 percent of drugs had a public sector patent, and drugs with public-sector patents accounted for 2.5 percent of sales, but that the indirect impact was higher for drugs granted priority review by the FDA. (Priority review is “given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists.)

478 drugs in our sample were associated with $132.7 billion in prescription drug sales in 2006. Drugs with public-sector patents accounted for 2.5 percent of these sales, while drugs whose applications cited federally funded research and development or government publications accounted for 27 percent.

This is an important article that contains much data analysis worthy of careful consideration by the healthcare policy community.

Specific consideration should be given by Senator Elizabeth Warren, whose new draft legislation, the so-called “Medical Innovation Act,” would result in less R&D investment by the true drivers of progress – the private sector – resulting in less innovation. Senator Warren’s suggestion that a percentage of private sector profits be used as a “fee” would have a chilling effect on future investments in R&D by biopharmaceutical companies subject to the legislation. 

Senator Warren’s proposal inaccurately argues that because the proposed fee would only be coming from net profits – after business and R&D expenses have been accounted for – it will not impact investment in drug development. Given the lengthy R&D process to develop new medicines – an average of at least 10 years for one new drug – biopharmaceutical R&D is characterized by long-term R&D investment strategies across R&D portfolios. Thus, a portion of profits earned by innovative biopharmaceutical companies today are used to fund future research. If a percentage of those profits are used for the proposed fee, then there may be a chilling effect on future investments in R&D by biopharmaceutical companies subject to the rule.  Facts are pesky things.

The National Institutes of Health plays a vital role in basic research and early discovery, but is robbing Productive Peter to pay Government Paul the best bang for the buck when it comes to advancing public health?

As Sampat and Lichtenberg show, the engine of innovation is the biopharmaceutical industry, which spends in excess of $50 billion annually on research and development. It's not a competition; the NIH and industry complement each other's efforts. But context matters.

The NIH focuses on basic research, the study of fundamental aspects of phenomena without specific applications. The biopharmaceutical industry addresses most of its R&D toward clinical research, science focused on the actual development of new medicines. The NIH provides grants to academic institutions. Industry employs the scientists who do the work and, increasingly, funds academic research.

Alas, headlines for hyped and misleading "NIH-funded cures" are far sexier than those for "more money for drug regulation." Pursuing misguided policies that siphon funding from the groundbreaking medical research happening in the biopharmaceutical industry will have devastating consequences for patients and society. The proposed legislation would result in fewer medicines for patients and lost jobs at a time when our economy can least afford it. Senator Warren and others should pay heed to the facts and avoid the fiction. They are inversely important to advancing 21st-century healthcare.

I think everyone who is running to paint any Republican candidate as a climate denying, Creationist, anti-vaccine Neanderthal would agree that records matter.  That is, what you do is more important than a curveball question during a press mashup thrown by a reporter seeking a ‘gotcha.’

As a proud citizen of the Garden State, I am obligated to respond to the implication that Chris Christie is a anti-science wingnut who thinks parents can choose to have their kids infect others with measles and other communicable diseases.

Turns out New Jersey’s childhood immunization rates are some of the highest in the United States.

It is number 1 compared to all other states for measles-mumps-rubella (MMR) vaccination rates.

New Jersey’s immunization rates are above the national average for major childhood vaccines.

It’s immunization rates are higher than California.  And Kentucky.

Source: CDC

With regard to Governor Christie’s alleged support of vaccine choice, his statement to “take a hard look” at legislation introduced by a Democrat in the NJ legislature to weaken vaccine requirements stands in valiant comparison to the pandering of then candidates Obama and McCain on vaccines causing autism, the do as you please stance of Rand Paul and the outright lunacy of Michelle Bachman.

Do people forget that Christie was attacked for requiring a hospital worker returning from Africa to be quarantined?   The idea that the governor of a state that has aggressively and successfully pushed to raise immunization rates – along with other public health metrics  – is absurd.  


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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