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Washington, D.C. – The Office of the United States Trade Representative (USTR) has released its annual “Special 301” Report on the adequacy and effectiveness of U.S. trading partners’ protection and enforcement of intellectual property rights (IPR). Significant elements of the 2014 Special 301 Report include the following:
• USTR highlights growing concerns with respect to the environment for IPR protection and enforcement in India and other markets.
• The Report expresses ongoing, serious concerns about the protection and enforcement of trade secrets with respect to China, and emerging concerns in other markets.
• USTR announces that it will conduct Out-of-Cycle reviews to promote engagement and progress on IPR challenges identified in this year’s reviews of India, Kuwait, Paraguay and Spain.
“The United States is an innovation economy. We are the global leader in research and development. We have given rise to some of the most creative, inventive and entrepreneurial businesses in the world, contributing significantly to advances in global health, the development of the digital economy and the education and entertainment of billions of people worldwide. More than 30 million Americans owe their jobs directly to these and other innovative industries. USTR is fully committed to unlocking opportunity for those Americans to share their inventions and creations with people all over the world without their work being infringed or misappropriated,” said Ambassador Michael Froman.
“Release of the 2014 Special 301 Report marks 25 years since USTR published the first Special 301 ‘Fact Sheet.’ In that time, we have achieved dramatic changes in the international intellectual property landscape. The Obama Administration is committed to meaningful and sustained engagement with trading partners -- from China to India to Canada -- with the goal of resolving intellectual property-related concerns so that Americans and American firms can compete on a level playing field in those markets.”
“I would like to congratulate the Governments of Italy and the Philippines on their removal from the Watch List. Both were named in the first Special 301 Fact Sheet and in many annual reports since, but today we acknowledge their accomplishments and encourage them to continue their progress,” Ambassador Froman concluded. “Likewise, we congratulate Israel on its removal from the Watch List earlier this year.”
The Times of India quotes Pfizer's senior vice-president for global policy and international public affairs, Justin McCarthy, that "a series of regulatory initiatives and legal challenges have frayed relations between the Indian government and global pharmaceutical firms,” and urged the government to "shift from using destructive IP policy as an access strategy.”
Mr. McCarthy and Pfizer ought to be applauded for bringing to light this important policy issue where the Indian government wants to bury the truth. However, I would add one nuance to the policy discussion. India’s IP grabs aren’t an access strategy – it’s a doomed effort at domestic industrial policy.
A wolf in sheep’s clothing shouldn’t be called a sheep.
California may be the poster child for the Medical Home but, when it comes to pharmacy synchronization, it’s a healthcare house divided: the House of hospital pharmacists on the one side, patients, physicians, and community pharmacists on the other.
Currently pending in front of the State Assembly is AB2418, legislation that would promote “promotes policies designed to improve patient medication adherence.”
Specifically the bill addresses pharmacy synchronization, a tried and true methodology for significantly improving compliance and adherence. The bill is being opposed by hospital pharmacists or better known as the “anti-adherence” organization.
Adherence is a problem of behemoth proportions. According to a report in the report conducted by the New England Healthcare Institute, not taking medications as prescribed leads to poorer health, more frequent hospitalization, a higher risk of death and as much as $290 billion annually in increased medical costs. There isn’t any one way to solve the problem. Education? Sure, but that only gets you so far. Apps and other social media interventions? Yes. Phone call reminders from physicians and pharmacists? Absolutely. But, alas, there is no one magic bullet.
Pharmacy programs seem to be the best way forward, and there’s hard data to back that up. Case in point – the successful Appointment-Based Model program being used at Thrifty White, a Midwest chain of pharmacies. (For more information on the Thrifty White program, see the article, Adherence and persistence associated with an appointment-based medication synchronization program, from the December 2013 edition of the Journal of the American Pharmacists Association.) Patients enrolled in the program have experienced 3.4 to 6.1 times greater adherence
Medication synchronization is a pharmacy service that improves patient adherence to prescribed medications by coordinating the refill dates for all of a patient’s chronic prescription medications so these can be picked up on the same date each month. It is estimated that 76 percent of Americans aged 60 and over use two or more medicines and 37 percent take five or more medicines. Patient and caregiver lives are simplified by eliminating multiple trips to the pharmacy each month. It also minimizes confusion over when a prescription is due to be refilled, and minimizes disrupting treatment through delayed or missed refills.
The Appointment-Based Model (ABM) is a voluntary medication synchronization prescription refill program that aims to improve patient adherence as well as the efficiency of the pharmacy operation. The ABM provides enhanced patient access through a streamlined process, opportunity for patient education on medication use, and greater pharmacist oversight to address potential contraindications, duplicate drug therapy, and errors.
What outcomes of medication synchronization?
· Improved adherence and time on therapy.
· Enhanced patient quality of care resulting from better adherence and understanding of medication therapy.
· Increased patient and pharmacist engagement allowing for greater monitoring and oversight of patient multiple-medication regiments.
· More efficient pharmacy operations. Medication synchronization has the potential to reduce administrative costs incurred by pharmacists and physicians long term as it streamlines medicine refill processes and helps pharmacies manage their inventories.
The American Medical Association adopted Resolution 801(I-12) in 2013, which encouraged relevant organizations, including insurance companies, to implement prescription refill strategies for patients with multiple prescriptions to reduce travel barriers to access to medicines.
The National Community Pharmacists Association (NCPA) and National Association of Chain Drug Stores (NACDS) have endorsed medication synchronization language for states to use when considering legislation. The American Pharmacists Association (APhA), American Cancer Society, Stroke Foundation, Epilepsy Foundation, American Academy of Pain Managemet and State Pain Policy Network are also educating their members on the benefits of medication synchronization.
According to CMS, The estimated cost to Part D sponsors is $0.5million and the savings to Part D sponsors and beneficiaries is $1.8 billion. And there will be an overwhelming reduction in overall health care costs because of improved patient outcomes due to enhanced medication adherence, which should lead to higher quality ratings for a health insurance plan.
AB 2418 should be a no-brainer.
The other evening I attended a dinner hosted by National Journal and AstraZeneca on the topic of “patient centricity.” Those around the table were payers, patient advocates, providers, pharmaceutical executives, IT geeks, and policy wonks.
Patient Centricity is a phrase we hear a lot and it’s lost a lot of it’s meaning – kind of like “personalized medicine.” But (in the immortal words of Jim Croce) “It doesn’t have to be that way.” "PC" is the new Healthcare.
In fact, when you think about it, both phrases really mean the same thing – driving positive therapeutic outcomes and, not surprisingly, the assembled diners agreed. After all, payers want (and are willing – mostly) to pay for treatments that work, physicians want treatments that provide the maximum therapeutic benefit, pharmaceutical companies want their products to work as well as they possibly can (so that physicians want to prescribe them to more patients and payers want to pay for them), and patients (last but not least) want to get well as swiftly and completely as possible.
(And, it’s no accident that many in Pharmaland have found religion in the wake of the intense focus on the prices of certain specialty medicines. It is now more urgent than ever to protect “sustainable innovation.”)
The point to remember is that a patient who is diagnosed earlier and treated with the most efficacious treatment as soon as possible is the least expensive over time. Alas, this means we must think long-term – not a trait the healthcare system is known for.
Patient Centricity = Driving Outcomes. Personalized Medicine, the right medicine in the right dose for the right patient at the right time, drives outcomes. Patient Centricity is Personalized Medicine.
QED.
One day before her resignation, HHS Secretary Kathleen Sebelius sent a letter to Congressman Bill Cassidy (R, LA). One of the subjects was academic detailing.
According to Secretary Sebelius:
AHRQ no longer conducts an academic detailing program as of September 2013.
But what happened to tax dollars already spent?
In October 2010, AHRQ awarded five grants for a program on academic detailing and the “communication of CER results to physicians”. This program to disseminate CER findings is supported by $29.5 million from the American Recovery and Reinvestment Act (aka, “the stimulus package”).
* One contract, for $11.7 million, went to Total Therapeutic Management (TTM) and is specifically intended for physician outreach and education
The goal of this contract was to integrate AHRQ’s comparative effectiveness research, products, and tools into clinical practice through 9,000 on-site, face-to-face visits with clinicians, nurses, health plan formularies, benefit managers, and other healthcare professionals.
According to TTM’s Barry Patel, “the AHRQ AD project to disseminate CER findings was a 3 year program that was scheduled to end in September 30th. The project has been over since Sept 30th 2013 as scheduled.”
Other recipient’s of the $29.5 million were:
* Ogilvy Public Relations Worldwide, Healthcare Division: $18 million to create a publicity center and another contract for $8.6 to create regional dissemination centers.
* Prime Education (an educational design and accreditation company focused on continuing medical education programs): $4 million as a “continuing education award.”
* IMPAQ International (a social science research and consulting firm that specializes in impact evaluations for a client base of predominantly U.S. government agencies): $2.4 million to evaluate the impact of the other four contracts.
Maybe it’s time for Congressman Paul Ryan to call a hearing to discuss the, um, outcomes of that $25.9 million.
Many of the claims about Zohydro are incorrect, and efforts to trump FDA's approval threaten the integrity of science-based regulation, FDA Commissioner Margaret Hamburg said in an interview with Steve Usdin of BioCentury This Week television. Edited excerpts follow.
BCTV: Why did FDA approve the drug?
Margaret Hamburg: I certainly understand the broader concerns that are motivating some of this in terms of the terrible public health burden of opiate addiction, abuse, misuse and overdose. But there is a need for adequate pain treatment of patients. And Zohydro, in fact, does represent an important pain medicine for people that respond better to hydrocodone - or if you need to rotate pain medicines because of chronic use - who don't want to be exposed to acetaminophen, which is a leading cause of liver toxicity, often even fatal liver toxicity.
And all of the other hydrocodone products currently in the marketplace are combined with acetaminophen.
BCTV: The governor of Massachusetts and several members of Congress have said Zohydro is superpotent and more addictive than other opioids.
MH: One of the common misperceptions is that this is the most potent opiate out there. And that simply isn't true. The second is that the other opiates out there have abuse deterrent formulations. And we wish that that were so. But in fact, almost without exception, the abuse deterrent claims of some of the products really don't hold water when tested.
And the one abuse deterrent formulation that has met the FDA criteria for labeling as abuse deterrent actually only provides deterrence against immediate injection or nasal intake - snorting. But it does not prevent oral abuse. And the majority of opiate overdose and abuse is through the oral route, not injection.
BCTV: Is there any deterrent now or even conceivable that's going to prevent somebody who's determined to abuse an opioid from doing that?
MH: Certainly not in terms of the formulation of the drug. There is nothing that can, at the present time, deter a determined abuser.
BCTV: Massachusetts and Vermont have tried to ban Zohydro. Other states are talking about it. What are the consequences of having states take that unprecedented action of overruling FDA approval?
MH: I do think that it's quite troubling. And I understand the motivation behind some of these actions in terms of the pressing need to reduce the burden of opiate addiction and preventable disease and death. But I think people should step back and really think very carefully about what it means for states or the Congress to start dictating what drugs should be approved and which ones should be withdrawn from the marketplace.
You can easily look at scenarios that are increasingly worrisome where, because of ideological beliefs or dislike for certain patient categories or other criteria, drugs that could make a difference in people's lives get banned.
BCTV: Some members of Congress have written to the HHS secretary and asked her to overrule FDA's decision. What happens if we have a political system where political appointees can overrule FDA on decisions that members of Congress don't like?
MH: I think it's very worrisome. FDA has a very carefully defined legal regulatory framework for our decision-making. Most importantly, we are driven by the science, and there is a set of scientific database standards for product review and approval. When individuals who have very different backgrounds and are in the political environment, not the scientific environment, start making the decisions for the public, you can end up in some very worrisome places.
The full video interview is available at www.BioCenturytv.com.
By now you’ve surely seen the news (the good news) about Sarepta Therapeutics and it’s investigational drug for Duchenne muscular dystrophthe. The FDA (in a reversal of it’s original position) has indicated a willingness to consider the treatment for accelerated approval.
Much made of the high-pressure tactics employed by patient groups. But, if this decision is viewed as “the uncaring FDA caving in to desperate patients,” we’re being unfair to the agency, misrepresenting the intellectual potency of the patient voice, and missing a very important nuance.
In it’s Page One coverage of this story the Washington Post, after much FDA bashing (and towards the very end of the article), writes,
Not everyone faults the FDA for taking so long to decide how to proceed. Eric Hoffman, director of the Center for Genetic Medicine Research at Children’s National Medical Center and a longtime Duchenne researcher, said valid questions remain about eteplirsen’s dystrophin-producing abilities and how effective Sarepta’s drug really is.
“I’ve personally been very impressed with the FDA,” he said. “There’s every indication they are taking this extremely seriously.”
Hoffman said he understands the families’ sense of urgency, and he shares optimism about exon skipping. But he said the public campaign to pressure the FDA has divided the community more than united it.
“It becomes this form of bullying that puts everybody between a rock and hard place,” he said. “Unless you’re supporting kicking out the head of the FDA and granting accelerated approval as quickly as possible, then you’re supporting killing Duchenne kids.”
He said that the reality is more nuanced and that FDA reviewers do want to help patients but are wary about setting a precedent by approving high-priced drugs they aren’t yet convinced will work.
Precisely.
The Duchenne muscular dystrophthe case also serves as an important example as to why the FDA’s nascent Special Medical Use program shouldn’t be limited to anti-biotics/anti-infectives. There’s much work to be done – and the more options that are open to bring important new therapies to patients the better.
Accelerated Approval is good – but, as a recent blog from Context Matters points out, the FDA’s previously established programs to expedite therapies (including Fast Track, Accelerated Approval, and Priority Review) have not produced lasting improvements in approval time. “Based on our preliminary analysis, in 2008 the average cycle time for ‘Priority’ was 10.1 months, versus the ‘Standard’ which was 21.2 months. In 2011, the average cycle time for ‘Priority’ was 19.5 months, versus ‘Standard’ which was 17.5 months,” the blog authors wrote. “What’s interesting here is that over time the fast lane has apparently become just another standard lane; in 2011 it was actually even slower.”
What’s standing in the way of the FDA Special Medical Use Super Highway?
The FDA needs to have the proper infrastructure and support to successfully reduce approval times. Clearly, when you’re looking at products that have less data behind them, you need more senior people who can devote greater resources to studying them, and that also takes time away from other programs that the agent needs to review. It’s one thing to give the FDA more authority, it’s another thing to give the FDA greater responsibility, but if you don’t give them the resources to get it done, to a large degree it is just rhetoric.
And there’s more than enough of that to go around.
Dr. Michael Weber, hotshot cardiologist, Chairman of the Center for Medicine in the Public Interest, and all-around good guy weighs in on medication adherence and the value of apps.
The AP reports:
Medicine only helps if you take it properly. And adhering to an exact schedule of what to take, and when, can be challenging for patients who are forgetful or need to take several medications.
Doctors warn about the consequences and urge patients to use various techniques, such as using divided pill boxes or putting their pill bottles beside their toothbrush as a reminder to take their morning and bedtime medicines.
Still, only about half of patients take medication as prescribed, resulting in unnecessary hospital admissions and ER visits that cost the U.S. health care system an estimated $290 billion a year.
To help combat the problem, many doctors are trying a more high-tech approach: They're recommending smartphone apps that send reminders to patients to take their medications and record when they take each one.
"I think it's going to become pretty standard" for doctors to recommend them, said Dr. Michael A. Weber, a cardiologist at SUNY Downstate Medical Center. Weber began recommending apps to patients a few months ago and already has seen better lab results from a few using them.
"Some people say, 'That's a great idea,'" Weber said. "Even ones who claim they're conscientious, like the reminders."
He said the apps are particularly helpful for patients with symptomless conditions, such as high blood pressure or high cholesterol. Those patients are less likely to regularly take their medications than someone with pain or an infection.
"I don't think they're going to change the world," Weber said, though he recognizes benefit of apps. Even so, he said smartphone apps won't do much to help people who simply don't like taking medicine, fear side effects or can't afford their prescriptions.
The full AP story can be found here.
In a March 25, 2014 tweet and blog post, I inaccurately referred to Gabriel Levitt as an “admitted felon” and to his business, PharmacyChecker.com, as having “felonious business interests.” Mr. Levitt’s attorney has assured me that Mr. Levitt has never been charged with or convicted of a felony, nor has PharmacyChecker.com. Per Mr. Levitt’s attorney, PharmacyChecker.com provides pharmacy verification and drug price comparisons.
In today’s New York Times, Andrew Pollack reports:
Saying they can no longer ignore the rising prices of health care, some of the most influential medical groups in the nation are recommending that doctors weigh the costs, not just the effectiveness of treatments, as they make decisions about patient care.
And further:
In practical terms, new guidelines being developed by the medical groups could result in doctors choosing one drug over another for cost reasons or even deciding that a particular treatment — at the end of life, for example — is too expensive. In the extreme, some critics have said that making treatment decisions based on cost is a form of rationing.
This is an urgent discussion that has been going on for a while minus any real imput from providers. It’s good to have them join the conversation. But here’s the bad news:
The cardiology societies, for instance … plan to rate the value of treatments based on the cost per quality-adjusted life-year, or QALY — a method used in Britain and by many health economists.
It’s important to point out that NICE in England (not Britain – that’s an important distinction) has publicly stated that it is moving away from using QALY-based reimbursement decisions, moving to a value-based insurance design (VBID) strategy.
Here’s the important difference – QALY is based on cost, VBID is based on outcomes.
Everyone should welcome physicians to the crucial discussion over reimbursement. But the focus should be on paying for what works, not for what’s cheapest.
As for an open and honest debate over the costs/benefit of end-of-life care – it’s important, but politically problematic.
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.
