Latest Drugwonks' Blog

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.  

A joke inside the FDA is that the Brief Summary is like the Holy Roman Empire: neither brief nor a summary. But it's an important jump start for a serious question—namely, how can safety information be made more user-friendly? For an answer, I turn to one of my favorite doctors, Dr. Seuss: “Sometimes the questions are complicated and the answers are simple.”

The theory behind safe use is that the most effective way to make a drug safer is to be sure it's used as directed. That means putting safety information in places and formats most accessible to patients. In 2015, that means mobile apps. According to a study from Adherent Health, nearly 75% of prescription-takers use mobile apps, including most older adults and seniors. Indeed, mobile-app adoption rates are high across all medication-taking adult age groups. Plus, new-user data from app-based safe use and outcomes support platform Mobile Health Library (MHL) confirms that, when Important Safety Information is mobile-friendly, it's regularly accessed by on-treatment patients.

Safety information is knowledge. And, in pursuit of public health, knowledge is power. 

Consider one year's worth of data for MHL's patient-support app for generic Exemestane: Of all engagement activities available to users, those concerning “side effects and safety” are most popular (at 28%), followed by “savings and refills” (16%), “about condition” (15%), “about Exemestane” (14%) and “dosing reminder” (13%). The safe-use numbers for branded medicines are even higher. For one medicine (a branded epilepsy treatment), patients are accessing the MedGuide at 90%+ rates.

When you match this with data showing the benefits that prescribing physicians (and nurse prescribers) want from patient-support apps, it's an almost-perfect fit. Ninety-four percent of primary care providers list “take Rx as directed” as their number one app priority, with “Rx and disease understanding” a close second (91%) and “conversation reinforcement” third (83%). Again, it's all about the base. 

So if the business is truly serious about giving patients what they want, then it needs to convey safety information in the ways they want it. When it comes to safety, it's time for both the FDA and Big Pharma to start saying “App-y New Year.”

In mid-January Representatives Fred Upton (R/MI) and Diana DeGette (D/CO) previewed their goals for the 21st Century Cures initiative. 

The bipartisan duo wanted to “modernize clinical trials to streamline the approval of drugs and devices,” in part by reducing paperwork and promoting adaptive trials, help FDA “better integrate the patient perspective into the regulatory process,” including using public-private partnerships to strengthen science around biomarkers and patient-reported outcomes, promote “better access to and sharing of information such as genomic and other clinical data to foster more collaboration among researchers," and to invest in programs for young scientists.

Upton -- the chair of the U.S. House's Energy & Commerce Committee -- and DeGette also planned to “incentivize new drugs and devices for unmet medical needs” by “streamlining the premarket process while establishing mechanisms to better capture real world evidence post-market." They also said they will examine incentives, including “exclusivity or simplifying the reimbursement process,” to stimulate the development of new drugs and devices for unmet medical needs.

Two weeks later the committee released a discussion draft and a Discussion Document without support from Democrats. According to Rep. Diana DeGette, “While I don’t endorse the draft document, I know that with continued engagement, we can reach a bipartisan consensus to help advance biomedical research and cures." Inside the Beltway that’s known as “playing nice.”

Not so nice was Representative Frank Pallone, Jr. (D/NJ), the ranking Democrat on the Energy & Commerce Committee. Mr. Pallone is “disappointed that the discussion document released today by Chairman Upton does not reflect true bipartisan collaboration.” Pallone added that the “nearly 400 page draft could create more problems for our health care system than it solves.” While he did not cite any specific concerns, (did he even read the report?) he did note that the draft “does not include any real dollars to fund additional basic research at the National Institutes of Health.” Real dollars -- as opposed to what? Was Senator Warren whispering in his ear? 

Per a report in BioCentury, Some provisions in the discussion draft are likely to be sticking points for Democrats, including proposals to exert more centralized control over NIH funding decisions by setting fixed, renewable four-year terms for institute directors, and making directors personally responsible for ensuring that the goals of every grant award are consistent with “a national priority and have public support.” 
FDA is likely to oppose scores of provisions in the discussion draft that would impose new mandates but do not provide additional funding. For example, the draft would require FDA and HHS to produce about 35 draft or final guidance documents, most of them on tight deadlines. 
The committee left placeholders in the draft for several topics that are potential political flash points, such as communication about off-label uses of approved products, and regulation of diagnostics.

The draft includes a provision allowing FDA to approve a drug with breakthrough designation on the basis of a single Phase II study, contingent on postmarket clinical trials and/or data from observational studies and registries. FDA could withdraw breakthrough approvals if sponsors failed to provide the required data, if evidence emerged showing the drug was not safe or effective, or if the sponsor disseminated false or misleading promotional material. 
The committee included provisions creating tight deadlines for FDA to assess applications for qualification of biomarkers and other surrogate endpoints.

The draft also attempts to extend and formalize FDA’s efforts to incorporate patient experiences and preferences into regulatory decisions, including using patient data in structured benefit-risk assessments. In other words, it’s time to move from a patient-centered drug development initiative to a patient-driven drug development program.

The draft also incorporates legislation on compassionate access introduced by Michael McCaul (R-Texas), as well as the Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network (MODDERN) Cures. 
The discussion draft has several provisions intended to make CMS decision-making more transparent and consistent, including a process for device and drug sponsors to appeal coverage decisions

Title IV of the draft legislation calls for “Accelerating the Discovery, Development, and Delivery Cycle and Continuing 21st Century Innovation at NIH, FDA, CDC, and CMS.” Bravo. Mr. Upton and his team at E&C understand that innovation is an eco-system. And that's precisely what 21st Century Cures is all about, creating a sustainable innovation eco-system with government players as an integral part.

One way FDA can help is to assist innovators to fail faster. Killing clinical programs earlier in the development process can save billions that can then be more fruitfully reinvested. When Thomas Edison was asked why he was so successful, he responded, “Because I fail so much faster than everyone else.” Consider the implications if FDA could help companies to fail faster. The following figures are illuminating:

• A 10% improvement in predicting failure before clinical trials could save $100 million in development costs.

• Shifting 5% of clinical failures from phase 3 to phase 1 reduces out-of-pocket costs by $15–20 million.

• Shifting failures from phase 2 to phase 1 would reduce out-of-pocket costs by $12–21 million.

One way to achieve this is for the FDA to finalize and formalize a risk/benefit grid, so that the factors behind regulatory decisions can be better understood – and future ones become more predictable. The EMA does this very successfully. Not having such a regulatory tool gives the FDA the Power of Ambiguity. But predictability is power in pursuit of the public health. Ambiguity also weighs heavily on the soul of those making investment decisions in riskier R&D propositions.

Since FDA, NIH, CDC, and CMS all fall under the purview of the Department of Health & Human Services, perhaps the 21st Century Cures legislation should be more directive relative to the co-ordination of government efforts.

How about a 21st Century Cures Czar?

I’m shocked to discover that there is gambling going on in this establishment.

From today’s New York Times:

Study Finds H.I.V. Drugs Priced Out of Reach

Drugs to treat H.I.V. and AIDS are being priced out of reach for many patients enrolled in insurance plans through the new health care exchanges, despite warnings that such practices are illegal under the Obama administration’s health care law, according to a new analysis by Harvard researchers.

The study, to be published on Wednesday in an article in The New England Journal of Medicine, looked at 48 health plans in 12 states and found that a quarter of the plans showed evidence of what researchers called “adverse tiering,” or placing all of the drugs used to treat H.I.V. in a specialty tier where consumers are required to pay at least 30 percent of the cost of the drug.

The financial impact can be drastic, the researchers found: A patient taking a common H.I.V. treatment, Atripla, would pay about $3,000 more a year in a restrictive plan compared with someone enrolled in a more generous plan, even after accounting for the fact that the more restrictive plans tended to charge lower monthly premiums.

“That’s really a large cost difference, and really is a very significant financial constraint for those with chronic conditions, particularly H.I.V.,” said Douglas B. Jacobs, the lead author of the study, who is pursuing degrees in public health at the Harvard T. H. Chan School of Public Health and medicine at the University of California, San Francisco.

The study, which did not name the insurers whose plans it analyzed, looked only at the midlevel, or silver, plans offered in the marketplaces because they are the most popular plans among consumers. More comprehensive plans, known as gold and platinum plans, are often more generous in coverage but carry higher premiums. Insurers have said that these may be a better choice for people who have serious medical conditions.

Clare Krusing, a spokeswoman for America’s Health Insurance Plans, an industry trade group, said that a crucial component of the marketplace was consumer choice, and that the study should have included an analysis of the gold and platinum plans. “Individuals have diverse health and financial needs, and health plans have designed a wide range of coverage options, including those with lower cost-sharing, so individuals can pick the policy that is best for them,” she said.

Health insurers are prohibited from discriminating against people with specific medical conditions under the new federal health care law, and the law contains some provisions that help prevent such practices. Patient advocates and others, however, have said that some companies appear to be skirting the law by restricting access to all drugs that treat certain conditions.

In May, two consumer groups filed a federal complaint asserting that four insurers in Florida had discriminated against people with H.I.V. by making their drugs more costly and difficult to obtain. All of the companies have since agreed to make changes that would lower the cost of the drugs in 2015, although the federal complaint is still pending.

The latest study is “more confirmation that this is happening, not only in Florida, but in other states as well,” said Carl Schmid, deputy executive director of the AIDS Institute, one of the groups that filed the federal complaint.

In December, the Obama administration said that it would investigate insurers’ prescription drug coverage, and told insurers that companies that place most or all drugs that treat a condition on the highest-cost tiers are effectively discriminating against people with those conditions.

In an effort to contain the rising cost of prescription drugs, many insurers are requiring extra steps for people who need the drugs or raising out-of-pocket amounts that patients must pay. The insurers say such practices are necessary to keep premiums low and to encourage patients and their doctors to make cost-effective decisions, like choosing a cheaper generic over an expensive brand-name drug.

But what makes these cases different, the researchers said, is that the insurers restricted access to all drugs that treat H.I.V., even less costly generics, leaving patients who have the virus with few options.

Limiting access to H.I.V. drugs could benefit insurers because it might discourage people with such conditions from signing up for coverage. But the study’s authors warned that if left unchecked, a small number of insurers — those offering the most generous coverage — could end up shouldering the burden of caring for the sickest patients.

If the more generous plans end up with a disproportionate share of sicker members, they could, in turn, adopt more restrictive practices. “It could, in essence, be a race to the bottom on drug benefit designs,” Mr. Jacobs said.

A new poster presentation at the European Crohn’s and Colitis Organisation, titled, “Biosimilar but not the same,” offers some timely and important real-world data on the differences between originator biologics and their biosimilar cousins.

The study, from Mercy University Hospital, University College Cork, Centre for Gastroenterology, Mercy University Hospital, Cork, Ireland, studied the clinical impact of both the innovator product (Remicade) and it’s EMA-approved biosimilar (Inflectra). The findings are important. Specifically, the rates of surgery in Infliximab and Inflectra groups were significantly different.

80% of the Inflectra group required hospital readmission versus 5% of the infliximab (Remicade) group. (p=0.00004). 60% of patients in the Inflectra group needed steroid augmentation of standard steroid tapering protocol with 50% requiring multiple increases in steroid dose versus 8% of patients in the Infliximab (p-value = 0.0007). Over the course of 8 weeks, 93% of patients in the Inflectra group had an increase in CRP with 7% remaining unchanged whereas 100% of patients in the infliximab group had a decrease in CRP (p=<0.001).

The conclusion is not ambiguous, “Our results suggest that biosimilars may not be as efficacious as the reference medicine. The results found reflect the ECCO statement position that the use of most biosimilars in IBD will require testing in this particular patient population and cannot be extrapolated from other disease populations."

The complete poster can be found here.

These First World data points about a product from a respected manufacturer (Hospira) cannot be ignored and must be used to inform the policy debate over nomenclature, interchangeability, label extrapolations, and overall pharmacovigilance practices.

Attention must be paid.


The Patient Centered Outcomes Research Institute (PCORI) has given nearly $300 million away to groups that are conducting research that is less then, shall we say, transformational..   Most of the money is going to comparaative effectiveness research that pays lip service to differences in individuals when in fact it is just coming up with one size fits all comparisions with a bit of control for age, gender, ethnicity, disease stage.  For instance, PCORI is funding a study http://Which Medicine Is Best for Children with Epilepsy?   Really?  Drug A over Drug B or Drug C?   

PCORI is funding mainframe medicine when cloud=based, crowd sourced technologies that integrate genomics, systems biology and patient provided data to match people to treatments.  It is investing heavily in PROMIS and it's own CER research network.. both are based on technologies and natural language processing algorithms that are old, clunky and barely accessible to patients.   

The new Congress has just launched a 21st century cures initiative.  A close look at the legislation and it's goals suggest that PCORI is ill-suited to the goal of using 21st century bioinformatics to increase the role and power patients have over access to new treatments.  PCORI is funding yesterday's research methods.

Congress should hold oversight hearing on PCORI and ask some hard questions about it's research focus.   It doesn't have to exist at all or in it's current form.  Indeed,  the money from PCORI and other stand alone pots of money could be integrated into a public-private venture to support biomarker development and precisiono medicine that the legislation calls for.  

PCORI had better show it's ready to shift it's gears and mission if it wants to survive.
The Energy and Commerce committee 21st Centure Cures Initiative has produced an important piece of legislation designed to accelerate the adoption of precision medicine.  The way to tell if it will pass is how much time and effort AHIP and the PBMs spend trying to gut the recommendations to advance personalized or precision medicine.  If they cared about the cost of medicines, they would propose ways to reduce the time and money needed to develop and adopt precision medicine.   The same goes for critics who say nothing about the value of medicines and are not an advocates for 21st century cures.

Here is the committee's press release and the legislation itself.

A real-world step towards both helping patients now and gathering useful data to advance better care.

PFF Adds 12 Sites, Bringing Total to 21 Centers Across the Country

CHICAGO, January 27, 2015 – The Pulmonary Fibrosis Foundation (PFF) today announced the expansion of its PFF Care Center Network with the selection of 12 additional sites, bringing the total number of medical centers to 21 in 20 states. Launched in 2013, the PFF Care Center Network is comprised of leading medical centers with specific expertise in treating pulmonary fibrosis (PF), a group of lung disorders including idiopathic pulmonary fibrosis (IPF) that are often difficult to diagnose and manage and that are associated with survival rates of less than five years following diagnosis in certain diseases.  

“As the leading advocate for the pulmonary fibrosis community, we are dedicated to advancing the care of people living with this deadly disease, and this starts with providing greater access to experienced care teams,” said Gregory P. Cosgrove, M.D., chief medical officer of the PFF. “Working together, institutions within the Network will identify and share best practices, which foster better care and ultimately enable more institutions that embrace these practices to be certified as a PFF Care Center site.”

As part of the selection process, a panel of peer reviewers, comprised of current members of the PFF Board of Directors, Medical Advisory Board, PFF Care Center Network and PFF Patient Registry Steering Committee, reviewed and scored applications.

“When selecting sites to add to the PFF Care Center Network, we consider a center’s specific programs and its geographic location in order to best serve the needs of the broader pulmonary fibrosis community,” said Kevin Flaherty, M.D., M.S., chairman of the Steering Committee of the PFF Care Center Network. “The new centers selected provide the highest quality patient care and an individualized approach to treatment in accordance with best evidence-based recommendations. We welcome these new centers and look forward to continuing to expand the Network in the coming year.”

The Pulmonary Fibrosis Foundation Care Center Network

The PFF Care Center Network uses a multidisciplinary approach to deliver comprehensive patient care, forming specialized care teams comprised of experts in interstitial lung disease in pulmonary medicine, rheumatology, radiology and pathology. This multidisciplinary approach is critical to managing a complex disease like PF and ensuring people with PF receive an accurate diagnosis, obtain quality clinical care, and acquire important support services.

The institutions newly certified as PFF Care Center Network sites include:

  • Inova Fairfax Medical Campus
  • Mayo Clinic in Rochester, Minn.
  • Medical University of South Carolina
  • New York-Presbyterian/Columbia University Medical Center and New York-Presbyterian/Weill Cornell Medical Center
  • Piedmont Healthcare
  • The University of Arizona Interstitial Lung Disease Program at the University of Arizona Medical Center-University Campus in Tucson
  • The University of Kansas Hospital
  • Tulane University School of Medicine
  • University of Alabama at Birmingham
  • University of Miami Miller School of Medicine
  • University of Pennsylvania
Washington University School of Medicine in St. Louis

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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