Monday, February 20, 2017

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

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

Tuesday, February 14, 2017

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.




Sunday, February 12, 2017

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.


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  and , including depression,  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

Friday, February 10, 2017

How Trump’s immigration ban threatens health care, in 3 charts - Vox

But the chaos unleashed by the executive order also reveals a little-appreciated fact about our health care system: We're heavily reliant on foreigners. They're our doctors, nurses, and home care aides, and they often work in the remote places where American-born doctors don't want to go.
Chart showing that immigrants make up a significant chunk of American health careSarah Frostenson
In many ways, the health system is already stretched too thin, with scarcely enough people spread evenly across the country to do many difficult jobs. And a letter from the American Medical Association to the Secretary of Homeland Security today spelled out how Trump's immigration policy could make this worse by "creating unintended consequences."
Indeed, it’s now clear that health care is going to suffer as a result of the immigration ban, particularly if the current restrictions are broadened to include more countries or different types of visas, as is expected.

Immigrants make up 22 percent of the health workforce and 30 percent of doctors and surgeons in the US

The health care workforce in the US is a lot more international than you might think. Health care currently has the largest proportion of foreign-born and foreign-trained workers of any industry in the country.
According to 2015 data from the Migration Policy Institute, the medical profession is particularly reliant on immigrant doctors. Of the active physicians and surgeons here, 30 percent are immigrants.
"India, China, Philippines, Korea, and Pakistan are the top five origin groups for physicians and surgeons," said Jeanne Batalova, a senior policy analyst and demographer at MPI. But Iran and Syria, two of the seven countries whose citizens are no longer allowed entry to the US, are the sixth and 10th largest contributors, respectively. "So we’re talking about substantial representation from these countries [in the doctor workforce] here." The ban on these people will likely be felt at hospitals and clinics across the nation, she added.
The contributions immigrants make to medical care start early on, in residency programs, which funnel doctors through training and into jobs. A data analysis performed by the Robert Graham Center showed that residents from the seven countries made up 5.7 percent of all international medical graduates in 2015, said Stan Kozakowski, director of medical Education for the American Academy of Family Physicians. (Some data sets look at the country of origin for doctors, others at where they obtained their medical degree — and doctors who trained outside of the US are called "international medical graduates.")
That’s not a huge number right now, Kozakowski added, but it’s sizable enough. "And if you add in the countries that have been tossed in as possible expansions of the ban — Pakistan, Saudi Arabia, Lebanon, and Egypt — that number goes up to 16.7 percent."
Map showing where foreign-born doctors are from in the USSarah Frostenson
When you look at the numbers by medical specialty, foreign-trained doctors do a disproportionate amount of the work in many areas. They make up more than 50 percent of geriatric medicine doctors, almost half of nephrologists (or kidney doctors), nearly 40 percent of internal medicine doctors, and nearly a quarter of family medicine physicians, according to data from the Association of American Medical Colleges.
Compared with US-trained physicians, foreign doctors are also more likely to practice in areas where there are doctor shortages — in particular, in rural areas. (Many enter the US on visas that allowed them to stay if they work in an underserved area for three years after residency.) They’re also more likely to serve poor patients on Medicaid, the Centers for Disease Control and Prevention has found.
Chart showing medical specialities that attract foreign-born doctors in the USSarah Frostenson
"Doctors — especially in rural areas that were the key constituency that supports Trump — tend to be foreign-born," said Nicole Smith, a chief economist at the Georgetown University Center on Education and the Workforce. "The old adage that foreigners are doing the work no Americans want to do even applies to medical doctors."
new study in the BMJ revealed another twist: patients treated by foreign-trained doctors had better mortality outcomes than those treated by doctors who went through American medical schools. The study authors suggested for foreign docs' over-performance might be explained by the fact that they "represent some of the best physicians in their country of origin" and had to overcome intense competition and years of training to finally practice in the US.

Health care currently has the largest proportion of foreign-born and foreign-trained workers in the country of any industry

The foreigners in health care don't just practice medicine, though. The nursing profession is also overstretched and facing projected shortfalls in the coming years, and has come to count on immigrants. Some 20 percent of the health care support staff — including nursesand home aides — were immigrants as of 2015.
Besides work at the bedside, the research immigrants do in labs across the country is also under threat. One Syrian medical researcher told Vox he’s afraid that after working in America for more than three years at the Mayo Clinic, his application for permanent residency will now be rejected and he’ll have to leave. Other researchers on visas and green cards from Iran told us they fear leaving the US to visit family or go to conferences should they be barred from coming back home, and that this situation was untenable and had them thinking about alternative places to live.
So from the bench to the bedside, Trump’s approach isn’t just going to hurt the health system in the future — it's already hurting it now.
 




How Trump’s immigration ban threatens health care, in 3 charts - Vox

Thursday, February 9, 2017

Trump Signs Order to 'Ease the Burden of Obamacare'


 

Soon after he was sworn in, President Donald Trump signed a series of executive orders, including one to "ease the burden" of the Affordable Care Act (ACA), according to news reports.
The executive order on the White House website as of press time. But in a version posted on Twitter, the order first notes the President's intention to seek the "prompt repeal" of the ACA, and says that in the meantime, it was seeking to offer flexibility to states to create a more "free and open healthcare market."
This report from Medscape and as reported by Dan Diamond of Politico  grants authority to the heads of all federal agencies, including the Secretary of Health and Human Services to "waive, defer, grant exemptions from or delay the implementation of any provision or requirement of the Act that would impose a financial burden on individuals, families, healthcare providers, health insurers, patients, recipients of healthcare services, purchasers of health insurance, or makers of medical devices, products, or medications."
"This order doesn't in and of itself do anything tangible," Larry Levitt, vice president at the Kaiser Family Foundation, told Vox. "But it directs federal agencies to start taking steps to use their administrative authority to unwind the ACA in all sorts of ways. This is a signal that the Trump administration is not waiting for Congress to start making big changes."
The executive order also directs federal agencies to grant states maximum flexibility in implementing "healthcare programs," and to encourage the development of "a free and open market in interstate commerce for the offering of healthcare services and healthcare insurance with the goal of achieving and preserving maximum options for patients and consumers."
During the campaign, President Trump said that he wanted to make it possible for insurers to sell policies across state lines.
None of these orders state anything specific about the ACA other than giving power back to the people.
Various professional associations, such as the AMA, the American Academy of Pediatrics, American Geriatrics Society (AGS), American Medical Women's Association, The American Nurses Association are weighing in on many aspects of the intended changes or repeal of the Affordable Care Act (ACA)