A Shot in the Arm for Obama’s Precision Medicine Initiative

.Precision medicine is a big idea. Tailoring drugs and therapies to a patient’s individual disease, lifestyle, environment, and genes could touch off a health-care revolution, or so the thinking goes. But first there is much we need to learn about what that all means to a person’s health. That’s why the Obama administration announced Wednesday evening that it is devoting $55 million this year to the creation of a public database containing detailed health information about a million or more volunteers. It’s also why it’s trying to figure out how to better regulate the fast-growing genetic testing market.

Precision medicine is not wihout high risk, as the molecules have powerful effects, and side effects that are potentially lethal.  Hence the need for clinical trials.

Called the Precision Medicine Cohort, the database will be the “largest, most ambitious research project of this sort ever undertaken,” said Francis Collins, director of the National Institutes of Health, during a call with reporters. It will contain medical records, sequenced genomes, blood and urine tests, and even data from mobile health tracking devices and applications. Collins stressed that the database will represent people from all races, ethnicities, and socioeconomic classes, and said it will track participants over many years.

In a separate but related project, also announced Wednesday, the U.S. Food and Drug Administration published draft guidance documentson how it might police the exploding field of genetic testing. The agency is concerned that a new generation of genetic tests could risk patient safety. The technology underlying these tests can quickly and inexpensively sequence an entire genome and identify millions of genetic abnormalities at a time. But interpreting the results is still a work in progress.

Many of the tests purport to tell patients whether they have or are at risk for certain diseases and even direct them toward targeted therapies. The whole area has been largely unregulated, but the FDA aims to use its regulatory power to assess how accurate and clinically useful the tests really are.

Advanced tests like these are “pivotal to the future promise of the Precision Medicine Initiative,” said Robert Califf, the FDA’s commissioner, but that promise is only “as good as the tests that guide diagnosis and treatment.” Califf wouldn’t say when the new regulations would be finalized, but the new information should clarify some of the regulatory uncertainty facing companies that develop such tests.

                                                                     (figure 1) retina of a patient with retinitis pigmentosa:

Patients with currently untreatable neurologic diseases may benefit from novel therapies such as Retinitis Pigmentosa, Schizophrenia and Parkinson's disease.

 (figure 2) Normal retina

VC companies are investing in companies such as  Retro-sense to develop novel methods using injectables directly into the eye.

The current clinical trial is now recruiting it's initial patient cohort. To learn more about the study, it is published at Clinicaltrials.gov  

RST-001 is a gene therapy given as an injection into the eye and delivers a gene encoding a photo switch, channelrhodopsin-2, (optogenetics) to cells in the retina of the eye. When expressed, the channelrhodopsin-2 protein can depolarize in response to light thus generating a signal that is transmitted to the brain.

The study is composed of two parts. An initial dose-ranging study (part 1) is proposed whereby three dose levels of RST-001 will be studied in three separate groups of adult patients with advanced disease. This first part of the study is aimed at determining a single dose of the experimental agent which is safe and well tolerated, to further evaluate in a fourth group of patients. The second part of the study is aimed at obtaining additional safety data at the highest tolerated dose and providing important additional clinical data to guide the design of future efficacy studies.)

A Shot in the Arm for Obama’s Precision Medicine Initiative

Covered California II

Enrollment for Covered California began one month ago, and will end on January 15, 2014. The online internet enrollment worked more smoothly and was easy to access. It functions fairly well and most of the time it proceeds without a hitch.

One problem I encountered was an inability to progress from {adding members}  to where the web page for adding new members. This attempt repeated itself a number of times when 'next' was selected. After several attempts the next page did appear, and the process proceeded without further difficulty.

The people who receive the 'best benefits/premium cost' are clearly in the Medi-Cal category if their income is at or below the poverty level. The web site performed fairly well with numerous pop-ups and drop down menu selection. Because of the relatively large number of selections and fields it was difficult to scan through deductibles, and/or co pays. The site allowed users to select and compare plans by checking the plans one wanted to compare.

The plans all have deductibles and co pays. The lower the premium the higher the copay and and deductible.  In many cases the insurance appears to be 'catastrophic coverage'  Common sense would make one wonder how many people could afford a deductible of $2500 to $10,000.

The financial algorithm was  designed by people who know little about health care or it's real expenses.  It seems the design was to fit health care into the budget process.

Jonathan Gruber, the principal economic adviser and designer is an expert in health economics at the macro level, and is no authority on patient care.  He has no medical experience or clinical credentials and is ignorant of patient-provider health process.  He had received numerous awards in healthcare economics.
Gruber has published more than 140 research articles (the majority of which were for NBER) and has edited six research volumes.^[11] He is a co-editor of the Journal of Public Economics, an associate editor of the Journal of Health Economics, and the author of Public Finance and Public Policy.^[12] In 2011, he wrote Health Care Reform: What It Is, Why It's Necessary, How It Works, a graphic novel delineating the Affordable Care Act, illustrated by Nathan Schreiber.^[2]

An allegation and video content of Gruber testifying in several resulted in an eruption of public outrage and discontent.

In January 2010, after news emerged that Gruber was under a $297,000 contract with the Department of Health and Human Services, while at the same time promoting the Obama administration's health care reform policies, some conservative commentators suggested a conflict of interest.^[18][19][20] Paul Krugman in The New York Times^[21] argued that, although Gruber didn't always disclose his HHS connections, the times when he didn't were no big deal. 

In November 2014, a series of videos emerged of Gruber speaking about the ACA at different events, from 2010 to 2013, in ways that proved to be controversial. Many of the videos show him talking about ways in which he felt the ACA was misleadingly crafted and/or marketed in order to get the bill passed, while in some of the videos he specifically refers to American voters as ill-informed or "stupid." In the first, most widely-publicized video taken at a panel discussion about the ACA at the University of Pennsylvania in October 2013, Gruber said the bill was deliberately written "in a tortured way" to disguise the fact that it creates a system by which "healthy people pay in and sick people get money." He said this obfuscation was needed due to "the stupidity of the American voter" in ensuring the bill's passage.

Writings:

Gruber's published works include:

• On February 15, 2006, the Center on Budget and Policy Priorities published an article by Gruber entitled "The Cost and Coverage Impact of the President's Health Insurance Budget Proposals"^[13]
• In a December 4, 2008, New York Times op-ed, "Medicine for the Job Market", he claimed that expanding health insurance, even in difficult financial times would stimulate the economy.^[14]
• On February 9, 2011, the Center for American Progress published an article by Gruber titled "Health Care Reform Without the Individual Mandate," analyzing the health insurance coverage impacts of alternative policy options for encouraging purchase of health insurance under the Patient Protection and Affordable Care Act, including the mandate, a late penalty, and auto-enrollment.^[15]

Covered California web site illuminates the copay/deductible inverse relationship and premium subsidy.  The working of Obamacare  obfuscates the ACA bill which was passed by the Democratic party.  Very troubling is  it did not include Republcan legislators in the design process. 

Contrary to Obama's proclamations many patients did not keep their physician,or hospital. Nancy Pelosi's uncannily accurate comment 'we won't know what is in it until we pass it'. Jonathan Gruber's "stupid" must also mean 'congress' was too stupid as well.

Portions of this article are attributable to 

New York Times, Covered California (online enrollment)

Ideologues and Unrealistic Expectations

Comments from Gary Levin MD are underlined and italicized:

Today I am amazed at an enthusiastic article about the Affordable Care Act by Eugene Robinson from Tallahassee.com.

His unbridled enthusiasm in the face of many difficulties that have nothing to do with health care exemplifies those who designed this law and passed it without reading it.

Here are some of his unsubtantiated claims and perhaps 'wishful thinking'

Eugene Robinson:  Washington Post

"Now that the fight over Obamacare is history, perhaps everyone can finally focus on making the program work the way it was designed. Or, preferably, better.

The fight is history, you realize. Done. Finito. Yesterday’s news.

Any existential threat to the Affordable Care Act ended with the popping of champagne corks as the new year arrived. That was when an estimated 6 million uninsured Americans received coverage through expanded Medicaid eligibility or the federal and state health insurance exchanges. Obamacare is now a fait accompli; nobody is going to take this coverage away."

1. The fight is not history, we are barely through round one and all the points go to the opponents of the ACA.

2. Six million Americans have not received coverage from the ACA. Registering is only the first step. It took me over ten hours of fumbling on the web site, and on hold via telephone. How many will be able to pay premiums by deadlines, or negotiate the difficult process of acquiring a provider. 

"There may be more huffing, puffing and symbolic attempts at repeal by Republicans in Congress. There may be continued resistance and sabotage by Republican governors and GOP-controlled state legislatures. But the whole context has changed."

The upside of the ACA is that all previously uninsurable patients now are enrolled no matter what pre-existing condition they have A+++++.

Can the ACA be improved?  Most definitely. The argument should not be Republican against Democrat.  Political party does not immunize one against illness.

I wholly agree with Mr. Robinson's analysis regarding the eventual goal of a uniform health system.  To call it universal care is a misnomer.

"The real problem with the ACA, and let’s be honest, is that it doesn’t go far enough. The decision to work within the existing framework of private, for-profit insurance companies meant building a tremendously complicated new system that still doesn’t quite get the job done: Even if all the states were fully participating, only about 30 million of the 48 million uninsured would be covered.

Yes Obamacare does not go far enough, however that is not the principle flaw. There is no one principle flaw, if there are any that is the poor analysis  and proposed implementation of a major expenditure that will effect most businesses,  all patients, and our national budget, and come up short.  If we are intent, committed and dedicated to these goals then let's get it right (or mostly right the first time)

Obamacare does establish the principle that health care is a right, not a privilege — and that this is true not just for children, the elderly and the poor but for all Americans.

Throughout the nation’s history, it has taken long, hard work to win universal recognition of what we consider our basic rights

This is a political and philosophical statement, not about health care. We need to keep these issues separate.  I agree with him about the tenet that all people should have health care financing.

Our first step should be to put on hold further mandates while the act is re-evaluated. Repeal is not an option, however amendment is a reality and not an 'existential' argument.

Mr Robinson's  article is not objective, nor unbiased. He totally neglects the weaknesses of the law which will require amendments.  Placing the issue in terms of a 'battle' between political parties does disservice to dedicated professionals who have  been in the system,  and who were neglected during the planning process.

To ignored the flaws would be a fatal mistake, health care costs will soar and there will still be large gaps in the insured population

Contact Eugene Robinson ateugenerobinson@washpost.com.

Contact Gary Levin MD at gmlevinmd@digitalhealthspace.com

ObamaCare: We Did Not Know What was In It Until It Passed

It did pass, and we still don't know what  is in it.  Each day we learn of waivers, modifications, amendments to 'fix' fatal flaws in the law.  This is the simple part.....getting people to sign on for health coverage....the doorway to health and wellness.

Dates have been set, mandates have been put on hold, insurance policies were cancelled, no wait..Obama says "Kings X", I take that back. Sebelius smiles and goes before congress, non-plussed.  She must be close to retirement so no problem and undoubtedly she will be through with her public service.  I wonder if she has health coverage?

Many of us have tried to take the high road and plan health reform logically analyzing each step as we proceed.  This is almost a futile endeavour, because the landscape is constantly changing.




Secretary of Health and Human Services Kathleen Sebelius testifies at a Congressional panel last week. The White House has outlined a new exemption under the Affordable Care Act

n a last-minute policy change, the Obama administration waived the so-called individual mandate under the Affordable Care Act for people whose individual health insurance policy is being canceled.

The act requires most Americans to have qualified health insurance starting in 2014 or pay a tax penalty, unless they meet one of myriad exemptions. One is if qualifying coverage would cost more than 8 percent of household income (the affordability exemption). Another is they can prove a hardship such as homelessness, bankruptcy, domestic violence, large medical debts, utility shutoff notice or death in the family.

Under new guidance issued late Thursday, the Centers for Medicare and Medicaid Services (CMS) said that having an individual insurance policy canceled now qualifies for the hardship exemption.

The process is not really that simple:

People who qualify for the cancellation hardship exemption have two options:

-- Don't buy coverage and don't pay a fine.

-- Buy a bare-bones catastrophic policy on an exchange. These catastrophic policies do not meet the requirements of the Affordable Care Act, but people who buy them won't owe a fine. Before Thursday's rule change, to buy this policy a person had to be younger than 30 or meet the affordability exemption.

To qualify for the new policy-cancellation exemption, consumers must complete a hardship application, which will let them purchase a catastrophic plan or receive a penalty waiver, according to Centers for Medicare and Medicaid Services. (For the application, see http://1.usa.gov/19YrBnK.)

To purchase the catastrophic policy, they must submit the form, and evidence of a canceled policy, to a company selling such policies in their area.

The announcement came just days before the Monday deadline for enrolling in coverage to start Jan. 1, and insurance companies are not happy.

When Obama announced another policy reversal in November - saying insurance companies could temporarily renew certain policies that were to be canceled because they did not comply with the act - he gave states the option of allowing that or not.

Covered California did not. As a result, most individual health policies in California that are not grandfathered will be canceled Dec. 31.

Some customers of Anthem Blue Cross and Blue Shield of California will be able to keep their non compliant policies until the end of February or March, respectively, under a settlement with the state insurance commissioner.

People with individual plans that are grandfathered, meaning they had them before the act was signed in March 2010, may keep them until the insurance company decides to cancel them.

It appears that nothing is guaranteed as to the roll out. Insurers, providers, hospitals are all nervously watching and waiting. 

Affordable Care Act "It ain't over until it's Over"

If you are reading this blog and waiting for me to tell you what is going to happen in health reform, you have come to the right place.  I know as much about this as Kathleen Sebelius or Barak Obama.

I am certain that makes you all feel better.

I know that is reassuring to my readers, because Obama and Sebelius had access to and heard many learned opinions on developing the affordable care act. However they were not listening and the elephant in the room was political intrigue, and 'what's in it for me ?"

Today my spouse received the magic letter from Covered  California stating that she has qualified, and now all she has to do is go to the website  log-in and pick her (Silver plan) That is no small task.

Among many other things, the subsidies make no logical sense to me (or others)  I need all of my funds to support myself and my disabled wife who has been unable to work for over ten years.  $250 USD would help pay for the pain medication she takes as a result of a bad wrist injury in 2002. After that she was uninsurable, so I am grateful that the ACA now affords her the ability to become insured until she reaches age 65 and  will be eligible for Medicare.

 It seems that my user id and/or password is incorrect, and I do not remember any of the questions, or answers for the security questions. Small wonder....their selection of Q&As is quite a mystery to me. I am so old I don't remember who my best friend in high school was, no the color of my first car, nor my favorite food (I like them all). Whatever happened to my mother's maiden name?

I called the telephone numbers listed on Covered California for lost user ids/passwords, and was either greeted with a busy signal or a 'we are busy right now, go to our web site, coveredca.com. Now would anyone call them if they had not already tried to use the web site.  The live on line chat room brings up a blank white screen.

The ACA has created stress for all of us, not knowing the eventual outcome...success or failure or some point in between  For those whose former policies  have been cancelled I say let's let them get to the front of the line.

It makes a lot of sense......they are already paying customers and the system needs their premium dollars now.

Everyone else should wait several weeks. Another month won't make much difference to those who have not been insured for the past decade or so.

Although I have never liked insurance companies, I do feel empathy for the mess the affordable care act has produced on top of the measly 15% margin they must operate upon now, and all those pre-existing condition patients waiting in the wings.

As Yogi Berra (byname of Lawrence Peter Berra) once told me, "It ain't over, until it's all over"  (Yes, he did tell me that personally when I was a sprite living in Connecticut.)  My Dad took me to at least a hundred Yankee games in the Bronx. I also have a signed Mickey Mantle original photo of the "Bronx Bomber"

So what does that have to do with the ACA? Let's listen and take seriously what Yogi had to say. I trust him, after all he was a Yankee on a team that broke all records winning  7 world series' back to back.

Would you rather trust President Obama, our Congress, or Secretary Sebelius?  After all Yogi batted left handed and threw right handed. (source Wikipedia)/