Openness and Transparency | Public Health | JAMA | The EU is way ahead

The European Medicines Agency and Publication of Clinical Study Reports

A Challenge for the US FDA

Anna L. Davis, JD, MPH¹; James Dabney Miller, JD, MPH¹

The US Food and Drug Administration (FDA) has been the standard of drug regulation worldwide for decades. In 1962, in response to the thalidomide tragedy, Congress directed the FDA to evaluate the effectiveness of drugs based on “adequate and well-controlled investigations, including clinical investigations” conducted by qualified experts.

Backed by this congressional enactment, the FDA crafted groundbreaking administrative regulations (eg, the requirements of a prespecified protocol, placebo or active controls, the phasing of clinical investigations, and informed consent from patients) that have guided the global clinical trial enterprise ever since.¹ The FDA’s regulations revolutionized the evaluation of drugs in the United States and abroad.

However, the European Medicines Agency (EMA), the counterpart to the FDA in the European Union, is poised to leapfrog ahead of the FDA in an equally important drug regulatory space of transparency. In October 2016, the EMA published on its website the clinical study reports for 2 drugs (carfilzomib and lesinurad) it recently approved. In so doing, the EMA enabled access to approximately 260 000 pages of detailed clinical trial information, including the protocol, statistical analysis, and detailed clinical data. Although some information was redacted to protect patient privacy, the EMA considered only 2 pages to contain “confidential commercial information.”

he EMA adopted policy No. 0070 to achieve the goals of “better informed use of medicines” and “to make medicine development more efficient” by allowing researchers to “learn from past successes and failures.” The EMA concluded that disclosure of detailed clinical data would enable the development of “new knowledge in the interest of public health.” Whether policy No. 0070 will achieve these goals is an unproven hypothesis, but, by publishing clinical study reports, the EMA has arranged a form of natural experiment that should allow an estimate of the actual benefit, if any, from its new policy.

However, policy No. 0070 faces legal uncertainty. In July 2016, the EU General Court issued an interim injunction that has the potential to undermine or reverse that policy.⁷ In that case, PTC Therapeutics submitted to the EMA a clinical study report of a phase 2 controlled efficacy study of ataluren for the treatment of Duchenne muscular dystrophy. Based on that clinical study report, the EMA conditionally approved ataluren in July 2014. Another unidentified pharmaceutical company requested a copy of the ataluren clinical study report. The EMA offered to redact several portions of the clinical study report, but PTC Therapeutics took the position that the entire clinical study report was confidential commercial information.The challenge the FDA must confront is that the clinical study reports submitted in support of drug marketing applications in the United States are basically the same as in the European Union.⁸ The FDA currently considers clinical data to be confidential commercial information, whereas the EMA does not. The EMA’s policy No. 0070—if it survives the current legal case with PTC Therapeutics—could lead to the anomaly that the EMA proactively publishes clinical study reports online (after decisions are made regarding marketing authorization applications), whereas the FDA withholds the same or similar clinical study reports. Despite the importance of this issue to public health, in neither the United States nor the European Union is there yet clear legal authority on whether clinical study reports should be made public and, if so, under what conditions.

The European Medicines Agency and Clinical Study Reports | Public Health | JAMA | The JAMA Network

TruthinRx . Drug Costs Skyrocket

Spending on US medicine increased 20% from 2013 to 2015 – why are yours so costly? Find out. #TruthinRx

source 

A recent survey of over 3,000 brand name prescription medications found that prices have more than doubled for over 60 drugs since 2014. As the prices of prescription medications continue to rise, physicians have a responsibility to educate their patients.

TruthinRx.org allows patients to learn who controls the prices of their medications and why those prices are increasing. The interactive site provides facts, informational resources and ways that you and your patients can take action to increase drug price transparency.

Have you ever notice the difference in charges for a cash paying customer at the pharmacy ? Do you have one of those generic Rx Discount Cards ?  Does your healthplan get bulk rates ?  Why is a mailorder pharmacy less expensive, and why do some healthplans offer a no copay plan if you order through their own mail order plan ?

Let's do a deepdyve into these questions.
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Your Story about Your Drug Costs
YYO . 
Prescription medications aren’t like other consumer products. Like food, shelter, and water, they can be a matter of life or death. Yet, patients are left in the dark as to why the price of medicine and their out-of-pocket costs are rising.

The costs of prescription drugs are often negotiated by drug players who aren’t required to disclose their pricing agreements. These middlemen turn a profit, while patients continue to pay a high premium.

If pharmaceutical companies aren’t required to explain their rising prescription drug prices, it could eventually make health care unaffordable for many Americans. Help us protect the future of health care.

Get Informed

Control Your Costs   Click to find out how



Share your story about your drug costs

Share your story about your drug costs

TruthinRx

Giving Patients an Active Role in Their Health Care

As payment and care delivery models shift in the United States from episodic, fee-for-service care toward population health and value-based reimbursement, health care leaders are focused more than ever on patient engagement as a key to driving down costs and improving outcomes. And yet, as so many of us know who have attempted to manage our own care or tend to sick family members, the U.S. health care system rarely feels like it’s been set up to help us succeed.

What’s needed is a fundamental redesign of the patient’s role — from that of a passive recipient of care to an active participant charged with defined responsibilities, equipped to dispatch them, and accountable for the results. In other words, we need to view the patient’s role as a job and then design that job in such a way as to drive the best health outcomes possible.

Not only is it important to define the role of the patient, it is important to teach patients their role in using health IT in a focused and limited manner, taking care to not overwhelm them with minutiae.  This will include developing a routine to examine their portal, and to inquire about devices or functionality to manage their health conditions.  Most patient already utilize search engines to educate themselves.  Health professionals already use other data bases, such as PubMed, Clinicaltrials.gov and numerous sites such as CMS.gov.

The controversy and political infighting challenges even physicians.  However patients must not be ignored in the process of revising the system..  This was a major reason for the failure of the Affordable Care Act. No one asked patients what they need. That is a failure of our system. 

Patient advocates and others who have studied the U.S. health care system have catalogued the degree of “unpaid,” and unsupported, work patients take on in service of their own care. The average, low-risk patient must follow up on referrals to specialists, fill and manage medications, and comply with physical therapy and other regimes. With legacy, pre-internet software systems still the norm in most hospital environments, patients also become unpaid couriers, shuttling critical health data from one provider to the next.

The Patient’s “Burden of Treatment”

Patient advocates and others who have studied the U.S. health care system have catalogued the degree of “unpaid,” and unsupported, work patients take on in service of their own care. The average, low-risk patient must follow up on referrals to specialists, fill and manage medications, and comply with physical therapy and other regimes. With legacy, pre-internet software systems still the norm in most hospital environments, patients also become unpaid couriers, shuttling critical health data from one provider to the next.  

It is still common for a patient to arrive at a tertiary or university medical center, expecting the referral physician to have records from the referring doctor.  Many have learned that it is mandatory for them to carry written records, MRIs, Angiography, or more to the visit.  When applying for disability, the task is even worse.  For chronic conditions it is even worse, since agencies want the complete history which may date back a decade or more. It is not uncommon for applications for SS disability benefits may take a year or more and require multiple attempt to achieve success at the process.  This is wasteful of patient and professional time and increase costs.

For patients who suffer from chronic or complex conditions, as a Mayo Clinic paper recently argued, the “burden of treatment” must be shouldered alongside the “burden of illness.” A 2012 study cited by the study’s authors estimated that the self-management of a chronic illness demands, on average, two hours of patient work each day — work that is often poorly supported, stressful, and frustrating in nature.  For all the articles advocating for “patient-centered care,” this is the change that we ultimately must be willing to make: Rather than having patients as passive recipients of care, they must be active producers of their care, in partnership and coordination with physicians and clinical staff. So what are the requirements for getting to that end state?

Account for Patient Work Across the Full Care Journey

First, we need to acknowledge and account for all the patient work that now goes unrecognized and unsupported. This means grappling with the complexity of tasks patients take on as they seek care across an ever-expanding number of settings — work that varies widely depending on acuity level, disease state, demographics, insurance type, socioeconomic conditions, and so on.

But the way we access and experience care has changed. Where we used to have a lifelong relationship with a family doctor, we now switch doctors frequently due to scheduling issues, changes in insurance coverage, and other factors. We’re also more likely to seek care outside the walls of health systems or the boundaries of specific networks — whether it be through urgent care visits, virtual consults, or alternative therapies. And we know that much of what affects our health, for better or worse, happens between visits. Who is accountable for measuring the patient experience over time and across all of these disparate care settings?

As we shift toward population health, with provider reimbursements tied directly to improved outcomes, we need to move from managing episodes of care to managing the entire patient journey across the full ecosystem of care. The patient journey becomes the operational backdrop against which patients, physicians, and other staff and caregivers must play their respective parts.

Intentionally Design the Patient’s Job into the System

If the patient is to have a job in the care-delivery process, we must apply the same principles of intentional work design to their jobs as we do to those of physicians and clinical staff. In a recent Physician Leadership and Engagement Survey conducted by athenahealth with 2,000 doctors, we found that only 20% of doctors surveyed reported high levels of engagement in their jobs. Those who were highly engaged, however, pointed to a few key drivers: trust in leadership and the system, open communication and feedback, and an operationally effective work environment that allows them to deliver high-quality patient care. It’s not a stretch to that patients would be engaged and motivated by the same drivers.

The Hidden Reasons Why Obama Care (ACA) is Failing

The true measure of how well the ACA is working should not be measured by how many uninsured people sign up for it.  The press fails to report the deep financial flaws brought about by a congress that passed the ACA for political gain.

One of the most litigated questions under the Affordable Care Act (ACA) is whether the United States government owes health insurers that offered qualified health plans (QHPs) through the ACA’s marketplaces the full amount that would be due them under the formula found in the ACA’s risk corridor statute and regulation. At least 17 cases brought by insurers are now pending in the Court of Federal Claims, one of which has been certified as a class action. An additional case is pending on appeal in the United States Court of Appeals for the Federal Circuit.

Background

The risk corridor program is, along with the risk adjustment and reinsurance programs, one of the Affordable Care Act’s three premium stabilization programs. It was designed to attract normally risk-averse insurers into offering a new product to a new population with uncertain prospects during the first three years of the health insurance marketplaces. It collects contributions from participating insurers that made profits that exceed certain “risk corridors” and makes payments to insurers whose losses fall outside those corridors. It was only in force for 2014, 2015, and 2016.

Nothing in the statutory provision creating the ACA program required it to be revenue neutral. Insurers entered the marketplaces in 2014 believing that risk corridor payments would be made if they were due under the statutory formula regardless of the level of collections. In 2014, however, nine months after health plans had submitted their rates for 2014 and three months after they had begun marketing qualified health plans (QHPs), CMS began to describe the program as budget neutral.

Regardless of HHS assurances and CBO projections, the potential magnitude of risk corridor receipts and payments and the effects on particular insurers and markets is highly uncertain.  The substantial uncertainty facing insurers participating in the exchanges in 2014 has only been partially resolved as they develop rates for 2015.  There remains a real possibility that promised risk corridor payments could significantly exceed receipts for 2014 or later.  If so, payment reductions could be problematic for some insurers, especially for smaller companies and/or new entrants.As it turns out, several insurers are now in court suing CMS for losses.  

Flash forward to 2016-2017.  The final accounting for evaluation of 2016 risk corridor adjustments does not occur until July 2017. The original final notice included budget neutrality while recent comments from HHS avoid that issue in it's forward looking plan for reimbursing insurance companies for their losses.  The scheme is a game of chairs.

Now it may all be moot, since President Trump and the GOP congress are about to repeal/amend the Affordable Care Act.

Dear Dr. Price: 5 suggestions for the new Health and Human Services secretary

Congratulations on your confirmation ! That was easy, and now comes the hard part.

If I could speak with the new head of HHS I would tell him many things, however this writer covers most of it .

Suneel Dhand writes his message to Tom Price. on KevinMD's blog.

 "As a physician myself, it’s great to know that a fellow physician will head up the agency. I’m sure you understand too, having been a practicing orthopedic surgeon, how disheartening and frustrating it is to have non-clinical “experts” making key decisions about health care.

I’m sure you’ve also seen the news about how your nomination has divided the physician community. Nevertheless, you have the full support of many of our nation’s top physician organizations, including the American Medical Association.

I am all for physicians taking leadership positions in health care, industry and — yes — politics. Your resume is hugely impressive. I’m aware of many of your viewpoints. And in the interests of being completely honest, I am not in agreement with all of them — as I’m sure is the case for a large percentage of the over 800,000 physicians in the United States.

Especially if you ever propose changes that risk any of our long-suffering patients losing access or have the result of making health care more unaffordable for them. Having said that, I am glad about your consistent wish to put the “doctor-patient relationship” first. Nobody needs to tell you what has gone on over the last decade and how the practice of medicine has changed for the worse. We need to consider the following five points to make American Health Care Great Again:

1. The cost of our health care system is just unsustainable, as we’ve known for a very long time. 2. The frontline of medicine has been decimated by excessively onerous regulations.   3. Let’s keep our independent physicians.  4. Let’s foster a health care system that favors doctors (or nurses, or indeed any other health care professionals) in positions of leadership.  5. As you’ve already said time and again, we must always remember that it’s all about the patient and their doctor. This paradigm is central to all health care systems — true patient-centered care.   

As much as we need to improve, let’s also not forget all of the great things about American health care. We have the most amazing doctors and nurses and lead the world in innovation and research. We can maintain our high standards, while still giving our patients the best possible deal at much lower costs. We can also make our system a great one to work in for our hard-working doctors. This health care ship can still be reversed — especially by the collective efforts of those physicians who all started off with the same call to service and altruistic intentions that you probably did too.

Author:  Heath Train Express took several liberties in quoting his article for the sake of brevity.  The entire article is linked below.

Dear Dr. Price: 5 suggestions for the new Health and Human Services secretary

Consumers want telehealth—what does that mean for health systems? | Healthcare IT News

Today, 50 million U.S. consumers would switch providers to one that offers telehealth, compared to 17 million in 2015.

60 percent of adults willing to have a video visit with a doctor want to see a doctor online regularly to help manage a chronic condition. The perception of what a visit to the doctor or clinic has shifted measurably during the past two or three years/ . It has become more accepted as an accepted mode of practice by physicians and patients alike.

Many clinics are struggling as to how to implement this function to their practice. 

Consumers want to see their PCPs

65 percent of consumers are interested in seeing their PCP over video

Consumers want to see the PCP they trust and know through tele-health. Twenty percent of consumers said they were willing to switch to a PCP that offered video visits. For health systems looking to retain current patients, as well as bring new patients into the system, making tele-health part of the primary care offering can produce big results.

What is driving this change?

Consumers are more likely to avoid an ER if telehealth is an option

20 percent of Americans would use a video visit for middle-of-the-night care

That’s not to say that consumers have abandoned the emergency room but they are open to alternative options of care. This consumer sentiment is driven largely by long wait times and high costs. Health systems can use telehealth to divert resources and costs away from the ER and urgent care facilities and into lower cost options like telehealth.

Southwest Medical Associates, a health system based in Las Vegas, Nevada, deploys an in-clinic marketing strategy for its telehealth service, SMA NowClinic. One marketing tactic involves the use of TV screens to post the wait times at all SMA Urgent Care locations—sometimes showing as high as 90 minutes—while another screen reads “Need to speak to someone right away” and promotes the telehealth service. To date, Southwest Medical has enrolled more than 30,000 patients in telehealth and conducted more than 20,000 telehealth visits.

Consumers want to use video visits for follow-up care

52 percent of adults willing to have a video visit to see a doctor are interested in using video visits for post-surgical or hospital stay follow-ups.

It’s estimated that between 15 percent and 25 percent of people discharged from the hospital will be readmitted within 30 days, with many of these readmissions being preventable. Consumers are open to the idea that follow-up care can be done via telehealth. Physicians that offer follow-up care via video may find that patients are more likely to adhere to recommendations since they feel more in control of their treatment.

In addition to offering urgent care services with its telehealth service NYP On Demand, New York-Presbyterian also offers follow-up visits so that patients can see their own physicians for appointments that do not require coming in to a clinic or hospital.

Consumers want to manager chronic conditions via video

60 percent of adults willing to have a video visit with a doctor are interested in seeing a doctor online to manage chronic conditions

Today, 1 in 2 U.S. adults have a chronic condition. Treating chronic conditions comes at a high costs for both consumers and health systems, making it equally beneficial to move these reoccurring visits to video. Building specialty programs for conditions such as diabetes, hypertension and congestive health failure—and making consumers aware of the programs—can drive better patient outcomes.

Marshfield Clinic, a health system based in Wisconsin, is expanding its virtual care services and envisions providing support to its diabetic population by monitoring blood sugar and offering medication counseling.

Consumer thoughts and perspectives on telehealth are becoming increasingly important to health systems, and forward-thinking health systems are using telehealth to determine the services they offer in the future. 

Numerous companies have sprung up to fill this need.

World Wide Telemedicine Directory of Providers

Consumers want telehealth—what does that mean for health systems? | Healthcare IT News

Early marijuana use associated with abnormal brain function, study reveals

The legalization becoming common due to recent referendums and state legislative actions.

A dried flower bud of the Cannabis plant. Credit: Public Domain

Does legalization make it safe? Has the Food and Drug Administration any jurisdiction over it's production or sale.

Marijuana is a mood altering molecule derived from a plant.  It has been popular as an underground treatment that reduces anxiety and creates distortions of sensory input (particularly visual). It increases appetite, and alters pain perception.  In the past regulation consisted of an outright ban on growing and usage.  During the past several years many states have legalized it's use for medicinal purposes by requiring a physician's signature.

Marijuana is the most commonly used illegal substance in the world. Previous studies have suggested that frequent marijuana users, especially those who begin at a young age, are at a higher risk for cognitive dysfunction and psychiatric illness, including depression, bipolar disorder and schizophrenia.

Dr. Osuch and her team recruited youth in four groups: those with depression who were not marijuana users; those with depression who were frequent marijuana users; frequent marijuana users without depression; and healthy individuals who were not marijuana users. In addition, participants were later divided into youth who started using marijuana before the age of 17 and those who began using it later or not at all.

Participants underwent psychiatric, cognitive and IQ testing as well as brain scanning. The study found no evidence that marijuana use improved depressive symptoms; there was no difference in psychiatric symptoms between those with depression who used marijuana and those with depression who did not use marijuana.

In addition, results showed differences in brain function among the four groups in areas of the brain that relate to reward-processing and motor control. The use of marijuana did not correct the brain function deficits of depression, and in some regions made them worse.

Of additional interest, those participants who used marijuana from a young age had highly abnormal brain function in areas related to visuo-spatial processing, memory, self-referential activity and reward processing. The study found that early marijuana use was also associated with lower IQ scores.

"These findings suggest that using marijuana does not correct the brain abnormalities or symptoms of depression and using it from an early age may have an abnormal effect not only on brain function, but also on IQ," said Dr. Osuch.

Read more at: https://medicalxpress.com/news/2016-10-early-marijuana-abnormal-brain-function.html#jCp
Early marijuana use associated with abnormal brain function, study reveals