Questions for a New Class of Cholesterol Drugs
By KATIE THOMAS
New guidelines governing the use of cholesterol-lowering medicines are a huge change for doctors and a vast number of patients, but the impact on the drug industry is expected to be less tumultuous.
The products that stand to gain the most from the new advice, statin drugs, are mostly sold as inexpensive generics and bring in relatively little revenue for the major pharmaceutical companies. Brand-name drugs that don’t fare as well in the guidelines, like Zetia by Merck and Vytorin, were already viewed with skepticism.
“From a Wall Street perspective, we don’t pay any attention anymore to statins,” said Mark Schoenebaum, a pharmaceutical analyst for the ISI Group. The focus instead, he said, “is on the next generation of still-unapproved drugs.”
It is those drugs — a promising new class of cholesterol-lowering drugs known as PCSK9 inhibitors — whose fate is most thrown into question by the new guidelines, released Tuesday by the two major heart associations. The recommendations place less emphasis on lowering cholesterol to a target level and do not advise using existing drugs other than statins to do so. The PCSK9 inhibitors, which are complex biological drugs that will be injected, have been shown in early trials to significantly lower cholesterol levels, but longer studies have not been completed showing that they reduce the risk of heart disease and death.
The guidelines will not determine whether the Food and Drug Administration approves these new drugs, but they could damp sales if they discourage physicians from prescribing them and insurance companies from paying for them.
“The question becomes, what happens in the medical community?” said C. Anthony Butler, an analyst for Barclays. Insurers could balk at reimbursing the cost of the drugs — or make patients contribute more — if they concluded that the guidelines from leading medical authorities did not favor their use.
Leonard S. Schleifer, the chief executive of Regeneron Pharmaceuticals, which is developing such a drug in partnership with Sanofi, said he did not think the new guidelines would delay approval, which the company is hoping will occur in 2015.
For Obama, the last campaign may be the most difficult
By Dan Balz,
Throughout his career as a national politician, President Obama often has benefited from comparisons with others. Nearing the end of the first year of his second term, he is running mostly against himself — and falling short.The disastrous rollout of his health-care law has put him on the spot in ways he has rarely been before. The cool and cerebral chief executive, whose reliance on smart people and rational analysis has been at the foundation of his often-insulated governing style, has been forced to admit that he and his team vastly underestimated the challenge of implementing the Affordable Care Act.
His appearance in the White House Briefing Room on Thursday was primarily to announce an administrative fix to quell the furor surrounding the cancellation of health insurance policies for millions of Americans in the individual market. But it also became an exercise in acknowledging error, in highlighting what he didn’t know or misjudged, and in recognizing that regaining public confidence will take much time under the best of circumstances.
Obama admitted the obvious: that his administration “fumbled” the rollout and that those missteps have changed the public’s view of him. “I think it’s legitimate for them to expect me to have to win back some credibility on this health-care law in particular and on a whole range of these issues in general,” he said of Americans. “And, you know, that’s on me.”
He said his team didn’t immediately recognize the severity of the problems on the HealthCare.gov Web site and that he did not anticipate what might happen to policies purchased on the individual market when he said people could keep their coverage if wished. He said his administration, recognizing that the information technology is not the government’s strong suit, should have thought harder two years ago about the problems it might face.
“There have been times when I thought we . . . got, you know, slapped around a little bit unjustly,” he said of past criticism of his administration. “This one’s deserved. . . . It’s on us.”
The most recent national polls tell the story of Obama’s decline in stark terms. His overall approval ratings have hit record lows and his ratings on a variety of major issues are at or near their lowest points. The health-care mess is a major contributor, but the question he must grapple with is the degree to which there are deeper doubts about his leadership.
Attributes that once helped sustain him through crises have eroded. A majority in a new Quinnipiac University poll say he is not honest and trustworthy, and more people say he is not a strong leader than say he is. In a Gallup survey, only 50 percent said he is honest. Throughout most of his presidency, that number in Gallup’s tracking hovered around 60 percent.
Obama’s approval ratings may be at record lows, but not by much. In August and September 2011, the fallout from the messy debt-ceiling negotiations that collapsed left him at a low point politically and emotionally, with poll numbers similar to today’s.
Obama’s reaction was to pivot after Labor Day that year to his reelection campaign, force the public to choose between him and Republican Mitt Romney, frame the election in terms most favorable to himself and make as much of the debate as possible about his opponent’s weaknesses and vulnerabilities. By the end of 2012, after his reelection, his approval ratings bounced back above 50 percent.
Those numbers began moving down early in his second term and have dropped sharply since September. But Obama has no campaign left to run, at least not against another politician. The campaign ahead is one to restore credibility to his presidency. Without it, his second-term agenda remains at risk.
Why Doctors Don’t Take Sick Days
By DANIELLE OFRI
NEW YORK — The bottle of Maalox sat perched on the triage desk in the emergency room. It was mint flavor, or maybe lemon — I don’t recall exactly — but it shimmered temptingly. I had just finished with a new admission, and my stomach had been groaning ominously for hours. It was after midnight, the whole night was still ahead of me, and I was getting desperate. I scribbled the last of my medication orders and snagged the Maalox bottle, popping the top and chugging two revolting capfuls on my way to the elevator.
As I rode upstairs, I could feel the intestinal protestations growing. There was going to be an apocalyptic resolution to this. The elevator opened and I burst into the restroom, just in time to disgorge the Maalox and everything else into the toilet, conscientiously keeping my white coat and stethoscope clear of the fray.
I staggered into the call room and flopped onto the couch. My fellow resident listened to my tale of gastrointestinal woe and did what any residency buddy would do: he slid an 18-gauge IV into my antecubital vein and strung up a bag of IV saline. I spent the pre-dawn hours prostrate on the couch doing phone work — renewing medications, answering calls from nurses, ordering labs — while my colleagues did the foot work on the wards and in the emergency room. Together we kept everything running.
After morning rounds, I caught a few hours of sleep at home, showered, and then reported back to the hospital at 10 p.m. for my next shift.
What I didn’t do was call in sick.
It has long been known that doctors make the worst patients. From day one in medical training, the unspoken message is that calling in sick is for wimps. Much of this is logistics. The staff has to scramble to reschedule patients — many of whom have been waiting weeks or months for their appointments. Patients who need medical attention that day are crammed into someone else’s schedule or sent to the emergency room. Your already overworked colleagues are saddled with extra work, and patients usually get the short end of the stick.
So most doctors ignore their symptoms and resist taking the day off unless they are sick enough to be hospitalized in the next bed over.
Health Care in the US as Seen From Down Under: "Mens Sana in Insanus Patriae"
Thursday, 14 November 2013 00:00By Niall McLaren, Truthout | Op-E
Australia's national health service, Medicare, treats health care as a human right for all, including illegal immigrants - and it costs less and delivers better outcomes than US health care, according to McLaren.
Article 25 (1) of the Universal Declaration of Human Rights, adopted by the UN in 1948, states: "Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including . . . medical care . . . and the right to security in the event of . . . sickness, disability . . . "
These days, most people would say that an adequate standard of living includes readily available health care of a proper standard, that "health care delayed is health care denied." Most people would also expect that citizens of a wealthy country should be able to expect better health care than the benighted citizenry of a poor country. So it comes as something of a shock to learn that the United States, which spends almost 50 percent of the world's total health expenditure, ranks way down on most health statistics. Let's start with the World Bank Health Indicators, which show that, in 2009 (latest available figures), Germany, for example, spent $4,724 per capita, some 11.7 percent of GDP, for which citizens received 8 hospital beds per thousand people and a princely four doctors per thousand. Germans are generally pretty healthy, but they pay for it. My tightwad country, Australia, spent $4,118 per capita, 9.0 percent of GDP, to get four beds and one doctor per thousand patients for slightly better standards of health than the Germans. Since then, our government has committed to spending 8.0 percent of GDP on health, and we are on course to get that (now down to 8.4%).
However, when we look across the Atlantic, we find that the United States spends $7,990 per person, an astounding 17.7 percent of GDP, to get only three beds and two physicians per thousand population. To make things worse, US figures are rising rapidly, now thought to be over 18.0 percent of GDP, but where are the standards of health? In a word, they're nowhere. In fact, they're worse than that, as the statistics conceal a grossly inequitable distribution of health expenditure. A Hollywood starlet's boob job, at $65,000, crowds out any number of poor people from even a look at a clinic, as Joe Bageant's biting reportage shows. Health costs are the biggest single cause of bankruptcy in the United States, while disabled veterans can be seen on street corners in any city, begging for money, not to mention all the mentally ill people crammed in prisons, the new asylums.
But the most bizarre fact is, alone among the world's hundred or so wealthiest countries, the United States does not provide health care for its most vulnerable citizens. Oh sure, the wealthy can book into some very fancy, ultra-high-tech institutes to have a total body rebuild, but that's the sort of stunt that got Prince Grigory Potemkin a bad name: Behind the facades, the poor are warehoused in the charity wards, if at all. Anybody with an interest in the health game (and that's all of us) knows perfectly well that the true measure of a nation's health is not the tiny heads of rich old people getting heart transplants, whose expenditure drags the national average up, but the very large tail of poor children who drag the health statistics down, because their untreated throat infections end up as rheumatic heart disease, perforated eardrums, chronic bronchitis etc. What counts is not expenditure, but what that money achieves. Now the interesting thing is that, if we look at the very large, naturalistic experiment going on around the world, the one called "health care delivery and funding," it would seem that providing treatment for all those poor people does two things: it actually lowers the total cost to the country and it yields improved health standards.
Health Law Rollout’s Stumbles Draw Parallels to Bush’s Hurricane Response
By MICHAEL D. SHEAR
WASHINGTON — Barack Obama won the presidency by exploiting a political environment that devoured George W. Bush in a second term plagued by sinking credibility, failed legislative battles, fractured world relations and revolts inside his own party.
President Obama is now threatened by a similar toxic mix. The disastrous rollout of his health care law not only threatens the rest of his agenda but also raises questions about his competence in the same way that the Bush administration’s botched response to Hurricane Katrina undermined any semblance of Republican efficiency.
But unlike Mr. Bush, who faced confrontational but occasionally cooperative Democrats, Mr. Obama is battling a Republican opposition that has refused to open the door to any legislative fixes to the health care law and has blocked him at virtually every turn. A contrite-sounding Mr. Obama repeatedly blamed himself on Thursday for the failed health care rollout, which he acknowledged had thrust difficult burdens on his political allies and hurt Americans’ trust in him.
“It’s legitimate for them to expect me to have to win back some credibility on this health care law in particular and on a whole range of these issues in general,” Mr. Obama said. The president did not admit to misleading people about whether they could keep their insurance, but again expressed regret that his assurances turned out to be wrong.
“To those Americans, I hear you loud and clear,” Mr. Obama said as he announced changes intended to allow some people to keep their insurance.
But earning back the confidence of Americans, as he pledged to do, will require Mr. Obama to right more than just the health care law. At home, his immigration overhaul is headed for indefinite delay, and new budget and debt fights loom. Overseas, revelations of spying by the National Security Agency have infuriated American allies, and negotiations over Iran’s nuclear arsenal have set off bipartisan criticism.
For the first time in Mr. Obama’s presidency, surveys suggest that his reserve of good will among the public is running dry. Two polls in recent weeks have reported that a majority of Americans no longer trust the president or believe that he is being honest with them.
Obama Proposal Worries Insurers and Regulators
By REED ABELSON and ABBY GOODNOUGH
President Obama’s effort to quiet a political uproar by suggesting on Thursday that consumers should be allowed to keep their current health plans met significant resistance from many insurers and state regulators, who said they had not been consulted in advance about the proposal, doubted it could work and feared it might seriously damage the new insurance marketplace.
After the president announced the proposed changes, insurance regulators participated in a heated conference call, according to one regulator, where many expressed deep unhappiness about the proposal.
Some on the call felt “the president kind of threw us under the bus today,” the regulator said on the condition of anonymity because the discussion was supposed to be private.
What emerged from the call was a strongly worded statement warning of the possible effects of the president’s proposal.
“This decision continues different rules for different policies and threatens to undermine the new market, and may lead to higher premiums and market disruptions in 2014 and beyond,” said Jim Donelon, Louisiana’s insurance regulator and the president of the National Association of Insurance Commissioners.
In Washington State, where the new state-run exchange has been a success, Mike Kreidler, the insurance commissioner, issued a harsh response, saying he would not do as Mr. Obama had urged and allow the state’s insurers to extend policies into 2014.
“I do not believe his proposal is a good deal for the State of Washington,” he said. “In the interest of keeping the consumer protections we have enacted and ensuring that we keep health insurance costs down for all consumers, we are staying the course.”
Under the new policy, the White House said insurers would no longer be required under the Affordable Care Act to upgrade existing coverage for people who were now enrolled. People would be allowed to keep their policies even if they did not provide all the benefits and protections required by the 2010 health care law.
How insurers would sell these existing policies, and at what prices, will have to be determined by insurance regulators and insurance companies. Many insurers did not ask that rates for existing policies be approved by state regulators because the policies were supposed to be discontinued at the end of the year.
A Health Care Fix
By THE EDITORIAL BOARD
President Obama has come up with a modest fix for a self-inflicted political wound: his repeated — and wrong — assertions that Americans would be able to keep their health insurance plans if they wanted to under the health care reform law.
The fix, which deals with the cancellations of individual policies, is far preferable to a destructive Republican bill that is expected to come up for a vote in the House on Friday and to a Senate bill sponsored by some Democrats. But it raises a few troubling questions, most of which cannot be answered quickly.
The political danger Mr. Obama is trying to head off is widespread defection from the reform law by Democrats worried about their re-election chances in states where Mr. Obama is unpopular. The fix he offers gives them an alternative that we hope keeps Democrats united in defense of reforms that will be of immense benefit to tens of millions of uninsured or poorly insured Americans.
“There is no doubt that the way I put that forward unequivocally ended up not being accurate,” Mr. Obama said on Thursday of his earlier erroneous statements. He said he was thinking of the 95 percent of insured Americans who are covered by group insurance provided by employers, unions, Medicare or Medicaid. And he said he believed the remaining 5 percent covered by plans bought in the individual market would be able to keep their current policies under a “grandfather clause” in the law (the clause applied only to policies obtained before the law was signed in March 2010), even if those policies were not as good as what is available on the health insurance exchanges.
That explanation is not likely to satisfy his critics or even his supporters, who are dismayed by the administration’s failures in rolling out health care reform. He has damaged his credibility, and it is uncertain how he can earn back the public’s confidence.
The following article demonstrates one of the effects of "corporatism-run-amok" on people in the developing world.
-SPC
A Haitian Boy’s Needless Death From Diabetes
By PALAV BABARIA and AISLING O’RIORDAN
JEAN-PAUL was 12 when he died. A diabetic, he might well have lived if not for a tragically simple problem, common in rural Haiti: the glucose test strips available did not match the only glucometer we had access to in our rudimentary district hospital.
We are doctors — one American, one Irish — who worked as volunteers at the town hospital in Haiti’s desperately poor central plateau last spring. On the storm-drenched night that Jean-Paul arrived at the emergency room, we rushed to him through corridors clattering as if glass were breaking, as rain pelted down and leaked through the tin roof, forming puddles and muddy rivulets on the floor.
Jean-Paul was lying on a gurney. He looked much younger than 12, his growth stunted by Type 1 diabetes and malnutrition. He was unconscious and breathing in grunts. His sticklike wrists barely had a pulse.
In any emergency room in the United States, doctors would have immediately inserted a breathing tube in his throat, resuscitated him and admitted him to intensive care. In rural Haiti, we had no such options.
His father, gripping the gurney, told us Jean-Paul had been sick for a few days; he hadn’t known Jean-Paul’s infection could drive his sugars dangerously high; if he’d had a glucometer, as most American diabetics do, he could have seen it for himself. The small devices measure blood sugar by reading a drop of blood on a test strip.
But while the local health center had a glucometer, it was out of test strips. And our district hospital didn’t have enough glucometers to give one to every patient. In any event, Jean-Paul’s family waited to make the expensive and time-consuming trip to our hospital, hoping their son’s illness would pass. They waited until he was so sick that they had no choice.
Jean-Paul’s first blood-sugar sample was too high to be read on the glucometer. He was already in diabetic ketoacidosis — a life-threatening complication of diabetes. The initial steps for treating it are simple: fluid and insulin. We injected him with insulin and flooded him with liter after liter of fluids, trying to pump life back into him.
In Maine, Obamacare shift could affect many
About 15,000 facing canceled or altered policies might be able to keep their plans, but it’s uncertain.
By Kevin Miller kmiller@pressherald.com
Washington Bureau Chief
Washington Bureau Chief
WASHINGTON — The Obama administration’s abrupt policy shift Thursday on a key component of the Affordable Care Act could affect 15,000-plus Mainers whose policies were set to be canceled or modified next year.
But it remained unclear Thursday whether the majority of those policy holders will be able to keep their current insurance plans, and how their premiums will be affected if they do. Those decisions rest with Maine regulators and the insurance companies.
“The (Maine) Bureau of Insurance is reviewing today’s announcement,” said Doug Dunbar, spokesman for the state agency. He declined further comment on how the bureau might respond to the policy shift.
Facing intense pressure from the public and Democrats in Congress, President Obama agreed Thursday to allow insurance companies to continue offering plans that do not meet minimum standards set by the Affordable Care Act.
The standards had prompted insurance carriers across the country to issue notices that non-compliant plans would be canceled. The result was a powerful backlash against Obama, who had promised Americans that they could keep their existing plans, and against Democrats in Congress who supported the law.
Maine health plans canceled as Obama unveils fix
As President Obama reached out Thursday to millions of Americans receiving cancellation notices from their health insurers, Pam Pultz waited to see what the latest twist in the health reform law will mean for her.
Pultz, who owns an Agway store in Dover-Foxcroft, buys her own health insurance through Anthem. The plan suits her needs and she wants to keep it, but she said she has been told to expect a cancellation notice by the end of the month because her $14,000 deductible is too high to comply with the Affordable Care Act.
“My fear is I’m going to lose something that I bought and paid for and shopped for,” Pultz said. “I’m not doing anything wrong, and I’m being penalized.”
On Thursday, Obama announced that insurers will be allowed for another year to offer plans that fall short of the requirements set forth under his landmark health reform law. The move came after consumers across the country received cancellation notices for noncompliant plans, despite Obama’s promises that Americans could keep their plans if they liked them.
The administration’s proposed “fix” affects the individual market, made up of consumers who buy their own insurance rather than obtain coverage through an employer or government programs such as Medicaid and Medicare.
In Maine, about 32,000 people currently have an individual health plan. Some can choose to keep their plan, provided the coverage is “grandfathered,” or already in place before the health reform law passed in 2010, and exempt from many of its provisions.
Tens of thousands of other Mainers will see their coverage changed or cancelled. Anthem, the largest insurer in Maine’s individual market, has notified about 8,500 Maine policyholders that their plan will be canceled and replaced with the most comparable ACA-compliant plan, according to the state insurance bureau. The new plans would take effect Jan. 1, 2014, unless the policyholder chooses different coverage.
http://bangordailynews.com/2013/11/14/health/maine-health-plans-canceled-as-obama-unveils-fix/print/
House Passes Bill Letting People Keep Their Health Plans
By ROBERT PEAR and ASHLEY PARKER
WASHINGTON — Defying a veto threat from President Obama, the House on Friday approved legislation that would allow health insurance companies to renew individual insurance policies and sell similar policies to new customers next year even if the coverage does not provide all the benefits and consumer protections required by the new health care law.
The vote was 261 to 157, with 39 Democrats bucking their party leadership to vote in favor of the bill.
The legislation would go further than the fix announced on Thursday by Mr. Obama, who said he would temporarily waive some requirements of the law and allow insurers to renew “current policies for current enrollees.”
Representative Fred Upton, Republican of Michigan and the chief sponsor of the House bill, said his legislation would fulfill a promise that Mr. Obama had made to the American people and then broken.
“In the last three years,” Mr. Upton said, “the president personally promised that if people liked their current health care plan, they could keep it ‘no matter what.’ But cancellation notices are now arriving in millions of mailboxes across the country. It’s cancellation today, sticker shock tomorrow.”
Mr. Upton, the chairman of the Energy and Commerce Committee, belittled Mr. Obama’s proposal, saying it was offered at the last minute, “as the administration’s allies in Congress panicked.”
Senior Democrats criticized the Upton legislation as a ploy that could unravel the entire health care law.
“Don’t pretend you care about the American people’s health care here,” said Representative Mike Doyle, Democrat of Pennsylvania. “You just want to repeal the Affordable Care Act. Democrats are not going to let you do that.”
With 39 Dems behind it, House passes Obamacare fix
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| Thirty-nine House Democrats on Friday broke ranks to support a Republican bill that would allow health insurers to continue selling plans canceled under Obamacare through 2014, the first test of support on Capitol Hill since the law’s disastrous rollout. The House voted, 261-157, to pass the bill by Rep. Fred Upton (R-Mich.). It’s a significant show of disloyalty to the White House, but House Democrats had expected the defections to be far higher before the Obama administration said Thursday that it would pursue an administrative fix to the cancellation problem. Obama’s White House vowed to veto the bill, saying it “threatens the health security of hard working, middle class families.” The bill is headed nowhere in the Democratic-led Senate, where a number of Senate Democrats have also proposed their own changes to the health care law. (IN 90 SECONDS: Obamacare puts Democrats’ credibility on the line) Four Republicans opposed the bill — Reps. Jim Bridenstine of Oklahoma, Paul Broun of Georgia, Ralph Hall of Texas and Thomas Massie of Kentucky. Some conservatives had feared the bill could be viewed as making Obamacare “better.” The Democratic defections largely came from members from the most moderate districts, including Reps. Bill Braley of Iowa, Ron Kind of Wisconsin, Ami Bera of California, Nick Rahall of West Virgnia. Also voting in support was Rep. Patrick Murphy of Florida, where the local Blue Cross plan got significant attention for sending out 300,000 cancellation notices. But other Democrats voted for the bill, too, including Reps. Peter DeFazio of Oregon and John Garamendi of California. Democrats had feared mass defections earlier in the week, but Obama’s mea culpa speech on Thursday — along with persuasion from White House officials who came to the Hill to meet with House and Senate Democrats — stanched the blow somewhat.
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