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High Court Hopes
(Page 3 of 7)
By NRO Symposium
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JOHN FUND
One of the least-noticed mistakes made by the Obama administration in its arguments for its health-care law this week was the claim by Solicitor General Donald Verrilli that Congress had passed Obamacare to deal with a pressing national problem only “after long study and careful deliberation.” I’m told that even liberal lawyers in the courtroom had pained looks on their faces at that preposterous assertion.
Certainly the general public doesn’t buy that argument, as indicated by the polls. I doubt many lawyers do either. Congressional leaders bullied members into voting for the measure in the dead of night, blatant payoffs such as Nebraska’s “Cornhusker Kickback” and Florida’s “Gatoraid” were handed out, and members were given almost no time to absorb the bill’s 2,700 pages (leading House speaker Nancy Pelosi to say, candidly, “we have to pass the [health-care] bill so that you can find out what is in it.”) At least one Supreme Court justice is said to be astonished that process was so sloppy that Congress left out the traditional “severability” section, which routinely allows that should the courts strike down part of a law the rest would stand.
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Indeed, the third day of oral arguments in the Supreme Court brought a mild surprise: At least five of the justices are considering repealing all of Obamacare, either because the task of figuring out which parts can work absent an individual mandate is too onerous or they don’t believe Congress would have passed the bill without the mandate. In other words, the Court just might take the extraordinary step of sending Congress a stiff rebuke: that its recklessness and sloppiness in lawmaking should have some limits.
Randy Barnett, the Georgetown law professor who has bravely pushed the legal arguments against Obamacare with bulldog tenacity for two years, summed up what has been a good week for the law’s critics: “After these arguments, if the Court strikes down the Affordable Care Act, no one in the country will be surprised.” Indeed, if it happens, a majority of Americans will be relieved. And the battle over putting back some serious curbs on Congress’s ability to run roughshod over the Constitution will then begin in earnest.
— John Fund, a New York writer, is author of Stealing Elections: How Voter Fraud Threatens Our Democracy.
This is my contribution to today's http://www.nationalreview.com on-line discussion about how the Court should rule and what should the political response to it's decision (or the decision we hope for) be.
I hope the Court rules Obamacare unconstitutional. The fact that Congress had many other ways to expand insurance pools has undermined the necessary and proper claim for the mandate. As Roger Vinson noted in his district court ruling, “While the individual mandate was clearly ‘necessary and essential’ to the Act as drafted, it is not ‘necessary and essential’ to health care reform in general.” The mandate is a way to redistribute premium revenue from the young and healthy to other groups. Under Obamacare, it is possible to pay the penalty and use the free emergency care that must still be provided under current law. I think all the judges regard Obamacare as unconstitutional and a failure.
If the Court overturns the law, Obamacare again becomes an issue. Supporters will warn that young people will lose coverage under their parents’ plan and that this will undo community rating. Opponents will be able to say the ruling stops a tax increase, blocks the indirect tax Obamacare imposed on people forced to buy the amount of health-care coverage deemed necessary by government, and pulls the plug on rationing. I hope legislators introduce a market-based reform plan that makes low-cost coverage available. If Obamacare supporters want to reintroduce the law with higher taxes and more regulation, let them.
Two important news items courtesy of BioCentury:
The first concerns the necessary and timely updating of how the FDA determines risk/benefit for medical devices.
Final FDA guidance on risk-benefit determinations for devices
FDA released final guidance that seeks to clarify how the agency determines the risk-benefit profile of a medical device during a premarket review. The guidance, which is in line with a draft released last August, says that in addition to safety and efficacy, FDA reviewers will consider criteria such as the novelty of the technology, the characterization of the disease and the availability of alternative treatments or diagnostics.
The guidance includes a worksheet that reviewers will use to make risk-benefit determinations during a review. FDA said it is developing training modules to help industry and sponsors understand how the Center for Devices and Radiological Health (CDRH) will apply the guidance. Reviewers will begin applying it to incoming submissions and to submissions already under review beginning May 1.
Of particular interest to those following the agency’s arduous journey in search of a risk/benefit “grid” is how CDRH will both develop and use its “worksheet” and whether or not that document will be public information after a regulatory decision is reached. Transparency would certainly go a long way towards holding the Center’s feet to the fire vis-à-vis regulatory predictability and consistency.
And, speaking of consistency, some news from our Regulatory Cousins across the pond.
EMA finalizes guidance on MAA transparency
The EMA and the Heads of Medicines Agencies (HMA) adopted a joint guidance for a Europe-wide approach to identify which information included in an MAA can be publicly released after approval, should a request for access to information be submitted. The guidance is part of EMA's policy to increase transparency and access to documents, which came into effect in 2010.
According to the guidance, sections of an MAA dossier that would not be released include detailed information on manufacturing processes and synthesis of the active ingredient, as well as contractual agreements. In general, reports on non-clinical and clinical trials, including efficacy and safety trials, would be made available, although exceptions may be considered when innovative study designs or analytical methods have been used. Identifiable patient information would be redacted. Scientific advice received by a sponsor on an agreed indication would be available, while advice related to new developments and formulations would remain confidential.
(For you Yanks, “MAA” = “Marketing Authorization Application.”)
This is interesting for a number of reasons, let me mention two. First, it points to the ability to harmonize across borders. Need an ocean separate us from this concept? And, second, is this at all predictive of where the FDA might go relative to “going public” with redacted Complete Response Letters?
Inquiring minds want to know.
Indeed, the FDA proposal recognizes that individuals, armed with increasingly individualized information on what’s best for them, can make better decisions than a system where what is spent on health care is determined by bureaucrats. More consumers want more personal responsibility and freedom in making health care decisions, not less. They want to spend less time and money on medical care. So why would some groups oppose making more medications that have been widely used for years - for such conditions as high cholesterol, migraines, and hypertension - more accessible?
Groups such as the Center for Science in the Public Interest and Public Citizen claim the FDA proposal will “permit” people to use more medicines without solid information. On the contrary, the explosion of diagnostics, applications and online communities has increased our ability to responsibly take control of our health and well-being. In today’s digital world, we can use our smartphones to obtain test results and access information tailored to our diagnosis, genetics, health goals and lifestyle. Making drugs for osteoporosis prevention, birth control, migraines, cholesterol and erectile dysfunction available without a prescription would, with appropriate safeguards and new health-information tools, empower people to look after themselves. In fact, evidence shows that moving prescription drugs over the counter (OTC) helps people stay on track with their treatment regimen.
Critics often point to what they claim is misuse of cough medicines as an argument for more FDA regulation of OTC products, not less. But a recent survey I conducted on how American families treat coughs and colds underscores the opportunity self-care can offer to improve health. Over the past year, 61 million consumers avoided missing work, school or other scheduled appointments due to illness because they had access to OTC cough medicines to alleviate their symptoms. And nearly 75 percent of all consumers surveyed complemented cough and cold medicine use with rest, fluids (including chicken soup) and other “home” remedies.
The nearly a third of patients who see a physician for a cold wind up spending $7 billion on office visits and another $2 billion on antibiotics a year even though antibiotics don’t work for such ailments. If we were all forced to run to the doctor and get a prescription every time we coughed or were stuffed up, we would be spending a lot more money treating symptoms that can be alleviated effectively by OTC medicines in our pharmacy or supermarket and, more often than not, resolve on their own.
So why do some groups want to keep Americans shackled to our current system of care? As Eric Topol notes in “The Creative Destruction of Medicine,” access to our “own data and information - whether it be DNA sequence or biosensor remote monitoring - will soon be unprecedented, and surely each individual has more at stake about his or her health than the busy physician who is looking after hundreds to thousands of patients … But change cannot take place unless consumers are the driving force.” Without the ability to conveniently access and use more medicines we know and trust in tandem with such valuable personal health information, the paternalism of the present health care system will prevail. Opponents of the FDA proposal are afraid of losing control over our lives.
There is wisdom in the crowd. The benefits of consumer empowerment outweigh the risks that, in fact, can be managed mostly by we the people by educating each other. Turning more prescription medicines into OTC products not only saves time and money. It enhances our ability to sustain health rather than just treat disease.
Illustration: Dangerous drugs by John Camejo for The Washington Times
2. the fact that CER standards and information is not only controlled by government but used in 'academic detailing' of doctors while private companies are banned to discuss new treatments..
UK elderly "being denied cancer treatment"
LYNNE TAYLOR
Under-treatment is one of a number of factors contributing to around 14,000 avoidable cancer deaths in patients aged over 75 in the UK every year, according to a new report.
Cancer mortality rates are getting significantly better for the under-75s, but they are improving at a much slower rate in those aged 74-84 and actually getting worse for people aged 85 and over, says the study, from Macmillan Cancer Support.
PREDICT charter underlines trial bias against older people
The number of people living with a cancer diagnosis is set to rise from two to four million in the next 20 years, and, with half of all new cancer cases in the UK diagnosed in people aged 70 or over, this is an issue which must be addressed as a matter of urgency, says Macmillan.
According to the report, some of the reasons why older patients are less likely to receive treatment than those who are younger include:
- recommendations on treatment are too often being made on the basis of age, regardless of how fit patients may be;
- assessments do not adequately measure an older person's fitness for treatment, and co-existing health problems are often not identified or effectively managed;
- many patients do not take up treatment because they have inadequate practical support to help them at home, with transport, or with care for dependent spouses and other family;
- older people are not represented on enough clinical trials, reducing the amount of evidence available to clinicians on the benefits and risks of cancer treatment and its impact on quality of life: and
- oncologists and cancer surgeons need more support to manage issues specific to older people such as falls, incontinence and multi-drug use. In a survey of 98 oncology trainees, 60% reported that they have never received any training in the particular needs of older people with cancer, despite them making up half of numbers getting cancer each year, the study reports.
"To deny older patients treatment that could cure them based on ill-founded assumptions is an unacceptable act of discrimination," said Ciaran Devane, chief executive of Macmillan Cancer Support.
"We have a moral duty to treat people as individuals and give them the best chance of beating cancer, regardless of their age," he stressed.
"Efforts are begin made to increase early diagnosis and promote healthier lifestyles, but much more needs to be done to tackle under-treatment. The NHS and social care providers must wake up to the specific issues older people face and ensure treatment decisions are based on their overall health, not just their date of birth," said Mr Devane, adding: "writing people off as too old for treatment is utterly shameful."
Added Professor Riccardo Audisio, consultant surgical oncologist at St Helen's Hospital: " it is despicable to neglect, not to offer, not to even go near to the best treatment option only on the simple basis of the patient's age. This has been a horrible mistake that, particularly in the UK, we have suffered from."
Macmillan has, in partnership with Age UK and the Department of Health, set up five pilots to test new models of older people's care. They will report in December this year.
- Meantime, the National Cancer Intelligence Network (NCIN) reported yesterday that almost 10% of bowel cancer patients die within a month of being diagnosed, and of these 56% are over 80% years old, while 60% have been diagnosed following an emergency admission to hospital
A new study by CVS Caremark shows that Massachusetts residents with chronic conditions are more likely than residents of all other states to take generic medication.
Alaska ranks last in terms of patients who obtain the maximum allowable amount of medicine with each refill, New Jersey ranks last with just 57.8 percent of prescriptions filled with generic drugs, and New Mexico ranks last when measuring patients who refill their prescriptions as directed.
According to CVS Caremark, the failure of patients to adhere to their prescriptions layers $290 billion in unnecessary health costs onto a health care system that is crushing federal and state budgets with little sign of abating.
Per CVS Caremark, use of generics is a critical component in determining whether patients are sticking to their prescription regimen because the cost of brand-name drugs can be a deterrent. Patients also tend to stick to mail-order prescriptions more closely than they do to prescriptions they need to pick up at retail outlets.
More than half of Americans suffer from a chronic disease, contributing to 75 percent of the country’s health care costs.
(The complete discussion can be found here.)
The lead commentary was written by Alan B. Cohen, professor of health policy and management at Boston University School of Management and executive director of its Health Policy Institute.
Cohen writes, “The specter of rationing has also been invoked by those seeking to repeal the Independent Payment Advisory Board — a panel that would recommend ways to lower Medicare costs — so that Congress and special interests may retain firm control over Medicare spending cuts. By delegating responsibility to independent experts, such a board would help depoliticize the existing process.”
My response?
“Professor Cohen criticizes those who want to repeal the Independent Payment Advisory Board for invoking “the specter of rationing.” That ignores an immediate and crucial concern.
The board will be composed of 15 presidential appointees, unaccountable to the public. It will be given the task of cutting billions in Medicare expenditures — largely by denying government reimbursement for new and innovative medicines.
In other words, its only viable option will be to further ratchet down reimbursement rates for providers, especially doctors, who are already losing money on Medicare patients. Indeed, according to the American Medical Association, the financial burden of too-low payments under Medicare has driven 17 percent of doctors and 31 percent of primary care doctors out of the Medicare program altogether.
If rates fall any lower, seniors will have an increasingly difficult time securing doctor appointments. Visits will be cut short to squeeze in patients and care compromised. The board is even more insidious because it deflects policy makers’ attention from innovative reform efforts with real cost-saving potential.”
To which Cohen retorts:
“Mr. Pitts’s attack on the Independent Payment Advisory Board, on the other hand, contains an apocalyptic vision of stifled innovation and compromised patient care wrought by “insidious” board decisions. This is what reform opponents and industry groups want the public to believe.”
Apocalyptic? Just what does that mean?
Here are some synonyms for “apocalyptic” from www.thesaurus.com:
- Important
- Prophetic
If my comments are apocalyptic, what are the antonyms that might represent those of Dr. Cohen?
- Insignificant
- Unimportant
Perhaps a more straightforward way to say it (IMHO) is that I’m right and he’s mistaken.
And a big “thank you” to the Gray Lady for providing the forum.
Immaturity is the incapacity to use one's intelligence without the guidance of another. -- Immanuel Kant
Is "Kant" in the FDA vocabulary?
Here’s the latest House PDUFA discussion draft being circulated by the House Energy and Commerce Committee.
As pointed out in the Pink Sheet, guidance development would take on a much larger and likely more extensive role at FDA if provisions in the draft are ultimately approved. The draft, would require FDA to give at least three months’ notice before it intends to issue a certain type of draft guidance and solicit public comment.
New, more rigid guidelines for public participation prior to issuing some draft guidance documents, as well as a requirement that they be finalized within a year, likely would require an increase in agency resources devoted to those efforts.
The more predictable schedule also would favor industry by ensuring the waiting period for FDA thinking on a subject would not be potentially unending. Industry typically complains about the uncertainty of FDA policy on many subjects.
The rule would apply to a guidance that “sets forth initial interpretations of a statute or regulation, sets forth changes in interpretation or policy that are of more than a minor nature, includes complex scientific issues, or covers highly controversial issues,” according to the draft.
A clause in the proposal allows the agency to skip the advance notice if it is impracticable, unnecessary or contrary to public interest, but it would still be required to meet with stakeholders during a three-month period beginning the day the guidance is issued.
Once a draft guidance is released, FDA would be required to finalize it no more than 12 months later or it would be considered null and void, according to the discussion draft.
Comprehensive reviews of final guidances also would be required every five years under the bill to ensure they are not “outmoded, ineffective, insufficient or exceedingly burdensome.”
The provision would subject FDA to a much more formal schedule of guidance development. While the intention appears to exclude routine guidance updates from the rule, it would be easy to place most, if not all, new agency guidance, into one of those categories, especially “highly controversial” and “more than a minor nature.”
The schedule would create more pressure on the agency to finalize guidances before the one-year deadline, which could leave them incomplete or rapidly outdated. A more structured guidance development process ideally would prevent situations where industry has been penalized for violations of FDA policy, yet still waited for years to receive formal agency thinking on the subject.
Sponsors have complained the agency changed its guidance on clinical trial endpoints in the midst of a development program, making continuation more complicated.
FDA is clearly being forced to battle against congressional efforts to adjust its mission to focus more on issues of innovation … and PDUFA’s first principle of predictability.
A provision would add to FDA’s mission that it would strive to establish a regulatory system that “protects the public health and enables patients to access novel products while promoting economic growth, innovation, competitiveness, and job creation among the industries regulated by this Act,” according to the draft.
The package includes reauthorizations of the prescription drug and medical device user fees, as well as new programs for generic drugs and biosimilars.
The four user fee cycles would run from FY 2013 through FY 2017.
The user fee package is expected to be ready for passage soon. Health Subcommittee Chairman Joe Pitts, R-Pa., already has stated he wants the bill signed by President Obama by June.
He alone is free who lives with free consent under the entire guidance of reason. -- Baruch Spinoza
Abbott Laboratories’ pharmaceutical spinoff will be called AbbVie and will debut by the end of the year.
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.
