UPDATE 2-Merck begins overseas recall of HDL cholesterol drug

* Merck says recalling drug from wholesalers

* Says retail supplies likely available until mid-March

* Says will discourage doctors from prescribing drug

Jan 11 (Reuters) - Merck & Co said it is recalling Tredaptive, its medicine to raise "good" HDL cholesterol levels, in overseas markets where it is sold, after it failed to prevent heart problems in a large study and raised safety concerns.

The medicine is not approved in the United States but the U.S. drugmaker sells it in about 40 countries.

Merck said it would recall stocks of Tredaptive now held by wholesalers, but that pharmacies can continue to dispense their remaining supplies. Even so, the company said it plans to discourage doctors from prescribing the pill based on negative findings from the trial which were announced last month. The study followed more than 25,000 patients in Europe and China for almost four years.

The company said it will encourage doctors to consider alternative treatments to control cholesterol, but advised patients not to discontinue Tredaptive without first speaking with their physicians.

Merck spokeswoman Pam Eisele said the company expects available retail supplies of Tredaptive to be exhausted by mid-March.

Tredaptive combines an extended-release form of niacin with another drug meant to reduce facial flushing, a side effect of niacin. The medicine has annual sales of less than $20 million. That makes it a tiny product for Merck, which has global annual revenue of about $50 billion.

Merck in December said Tredaptive did no better in the study at preventing heart attacks, deaths or strokes than traditional statin drugs that lower "bad" LDL cholesterol.

Moreover, Merck said the medicine significantly raised the incidence of some types of nonfatal but serious side effects in the study. They included blood, lymph and gastrointestinal problems, as well as respiratory and skin issues.

Tredaptive was approved in the European Union in 2008, but the U.S. Food and Drug Administration was unwilling to approve the pill until Merck conducted the costly long-term study to better assess its safety and effectiveness.

Some analysts had expected Tredaptive to capture annual global sales of more than $1 billion, if it were to win approval in the United States.

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The Project to Replace ObamaCare Begins Now

As 2013 begins, encouraging a discussion about how to replace the president’s health-care law might strike some observers as a case of particularly bad timing. After all, in the year just ended, the Supreme Court upheld most of the provisions of the law and the president won reelection. As a consequence, the best opportunities to remove the law from the books before it ever really got started are now gone. The tough reality now is that Obamacare is not going to be undone during the next four years. So why bring up an alternative plan at this point?

The answer is that replacing Obamacare is by necessity a long-term project; you have to start somewhere. Moreover, it remains essential. Like it not, health-care policy is central to the struggle over the size and scope of governmental power. Without a better approach than Obamacare, there will be no success in limiting government or in lessening the dependence of citizens on the state.

It is also going to take a lot of work and political effort to build the political coalition necessary to move health-care policy in a different direction. Indeed, one of the reasons Obamacare passed in the first place is because opponents of government-dominated health care never coalesced around a serious and workable alternative in the years prior to 2009. Moreover, those efforts that did take place to promote a real alternative, such as Senator John McCain’s proposal from the 2008 campaign, fell far short because they were not preceded by the necessary policy and political groundwork.

But all is not lost. Obamacare is flawed legislation that is already forcing employers to cut back their hiring and limit their employees’ hours. It will soon send premiums sky high for many Americans who already have insurance. Promises about the law’s coverage and cost-control effects were greatly exaggerated. There will come a time — sooner rather than later — when Americans will be ready to hear again about an alternative to Obamacare’s government-heavy approach. At that moment, which might coincide with the 2016 presidential contest, Obamacare’s opponents must be ready with a viable, center-right, market-based alternative that can win public support. And the only way to be ready for a debate on health care in 2016 is to get to work now on the alternative plan. It takes that long to develop a workable framework, get it analyzed with credible numbers, and refine it to ensure it has broad appeal.

In that spirit, I am circulating again two essays on this subject from 2012. The first, co-authored by myself and Robert Moffit of the Heritage Foundation and published in the journal National Affairs, describes what we see as the fundamental principles of an effective, market-based reform plan. The second — a sequel of sorts to the first — is my effort to provide more detail on some of the key features of a workable alternative plan. It was published last month by the American Enterprise Institute in its Health Policy Outlook series.

Advocates of expansive governmental power are always more comfortable than their limited-government opponents talking about health-care policy. It is far easier to sell “the government will take care of it” than to explain why a decentralized, market-driven approach will be better for voters anxious for certainty about their health-care needs. Nonetheless, this fight cannot be avoided. Health care is too important to fiscal policy, to the American economy, and to the concerns of voters to be set aside as an unwinnable issue.

It is of course true that full replacement of Obamacare with a workable, market-based alternative will be an extremely difficult undertaking. But it is also true that a new direction in health care is crucially important for the country. And so, that being the case, it’s far better to get started on the effort now than to delay and thereby handicap the possibility of future success.

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As 2013 Begins, Get Ready For An ObamaCare Tax Onslaught

 (Photo credit: 401(K) 2012)

The third wave of ObamaCare taxes began on January 1, the latest blitz before the tsunami of changes from the health overhaul law hit in 2014.  These new and higher taxes are being levied to partially pay for ObamaCare’s massive new subsidies for private health insurance and expansion of Medicaid.

The most controversial of the latest ObamaCare taxes is the Medical Device Tax that hits entrepreneurial firms making equipment such as heart valves and hip replacement parts. They face a 2.3% profit on gross sales – a tax they must pay even if they have no profit at all.  Many firms say this tax – slated to collect $29 billion over 10 years – will soak up virtually all of their research budgets.

The medical device industry employs more than 400,000 people in 12,000 factories across the country, often small, entrepreneurial firms with a small product line.  Many say that to survive, they will have no choice but to relocate abroad – taking much-needed, high-tech jobs with them.  These lost jobs will be more casualties of ObamaCare.  And the tax means that medical devices will be more expensive, driving up health cost even further.

A new Surtax on Investment Income impacts individuals making more than $200,000 a year or couples with $250,000 or more.  They must pay a new 3.8% levy on income from investments, possibly including profits from the sale of a home.

A new Medicare Tax adds to ObamaCare’s pain.  These same high-earners must pay an additional .9% Medicare payroll tax on wages above $200,000 for individuals and $250,000 for couples.  This means the current 2.9% Medicare payroll tax will be increased to a total of 3.8% — a big hit especially for the self-employed.

Together, these new Medicare taxes are expected to raise $318 billion to help fund ObamaCare.

The new Flexible Spending Account Tax limits the amount of money that workers can set aside tax-free for medical costs.  ObamaCare sets the cap at $2,500 in order to collect another $13 billion from taxpayers.  (Previously there was no cap; however some employers limited the amount worker could set aside.)

Those who find the accounts most valuable are those with the greatest health needs – parents of special needs children, people who have had organ transplants and who must take maintenance drugs, and others facing major medical expenses.

Beginning January 1, ObamaCare also tightens the screws on Itemized Medical Deductions.   The law raises the threshold for allowed deductions from 7.5% of adjusted gross income to 10%, further burdening those with the largest medical expenses by limiting how much of these costs they can deduct on their taxes.  Hit to these taxpayers:  $19 billion.

Many more taxes are coming, including a “tax penalties” for individuals and businesses who don’t comply with ObamaCare’s mandate that they purchase government-approved health insurance.  The Congressional Budget Office expects these penalties for non-compliance to bring in $160 billion in the first decade they are in effect.

ObamaCare’s $1 trillion in total tax increase hit everything from health insurers, drug companies, and tanning salons to Health Saving Accounts and – eventually – high-cost employer-based health insurance.

All of this will prove that the more people learn about what is actually in the health overhaul law, the more unpopular it will become.

The 2012 elections were not a referendum on ObamaCare:  President Obama avoided talking about everything except the early candy that the law tosses out.  And Gov. Mitt Romney was unable to persecute the law’s most unpopular provisions – the individual and employer mandates, Medicaid expansion, and health insurance Exchanges — because they all are part of the health reform law he passed in Massachusetts.

But the drip-drip-drip of the law’s taxes, mandates, and dislocations will continue, and 2013 likely will see a new attempt to delay, divert, defund, and dismantle the law.

More on Forbes:

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Washington Post Story On Romney Begins To Unravel

Dispatches from the Meme Wars.

So this morning the Washington Post runs a story detailing what kind of a jerk Mitt Romney was in high school. This is a surprise, right? A high school kid being a jerk. This has never ever happened before. Why, you might well ask, would the Washington Post devote valuable time and space to writing about this event? And why, you might well follow up, is this worth posting about when everyone should be talking about the environment?

The answer is easy. It builds a meme and it translates Obama’s endorsement of gay marriage from a liability into a perceived strength.

If you missed this is the graf that has the left exercised:

BLOOMFIELD HILLS, Mich. — Mitt Romney returned from a three-week spring break in 1965 to resume his studies as a high school senior at the prestigious Cranbrook School. Back on the handsome campus, studded with Tudor brick buildings and manicured fields, he spotted something he thought did not belong at a school where the boys wore ties and carried briefcases. John Lauber, a soft-spoken new student one year behind Romney, was perpetually teased for his nonconformity and presumed homosexuality. Now he was walking around the all-boys school with bleached-blond hair that draped over one eye, and Romney wasn’t having it.

“He can’t look like that. That’s wrong. Just look at him!” an incensed Romney told Matthew Friedemann, his close friend in the Stevens Hall dorm, according to Friedemann’s recollection. Mitt, the teenaged son of Michigan Gov. George Romney, kept complaining about Lauber’s look, Friedemann recalled.

A few days later, Friedemann entered Stevens Hall off the school’s collegiate quad to find Romney marching out of his own room ahead of a prep school posse shouting about their plan to cut Lauber’s hair. Friedemann followed them to a nearby room where they came upon Lauber, tackled him and pinned him to the ground. As Lauber, his eyes filling with tears, screamed for help, Romney repeatedly clipped his hair with a pair of scissors.

Of course the story gets much sadder with Romney presumably responsible for the guy’s failed life and death from cancer.

He came out as gay to his family and close friends and led a vagabond life, taking dressage lessons in England and touring with the Royal Lipizzaner Stallion riders. After an extreme fit of temper in front of his mother and sister at home in South Bend, he checked into the Menninger Clinic psychiatric hospital in Topeka, Kan. Later he received his embalmer’s license, worked as a chef aboard big freighters and fishing trawlers, and cooked for civilian contractors during the war in Bosnia and then, a decade later, in Iraq. His hair thinned as he aged, and in the winter of 2004 he returned to Seattle, the closest thing he had to a base. He died there of liver cancer that December.

He kept his hair blond until he died, said his sister Chris. “He never stopped bleaching it.”

There are unanswered questions here, like what this has to do with anything, how a high school dropout bummed around Europe taking dressage lessons and, my favorite, how getting an “embalmer’s license” led to a culinary career? But the Post doesn’t address them.

The main source for this vignette is a former classmate of Romney’s named Stu White. According to the Washington Post:

“I always enjoyed his pranks,” said Stu White, a popular friend of Romney’s who went on to a career as a public school teacher and has long been bothered by the Lauber incident.”

But ABC News reports

“White was not present for the prank, in which Romney is said to have forcefully cut a student’s long hair and was not aware of it until this year when he was contacted by the Washington Post.”

From this it is pretty clear that the Lauber incident did not unfold in the way the Washington Post describes, if, indeed, it happened at all. (h/t to the Daily Caller)

Why this and why now?

As we’ve mentioned before this is all part of a process to brand Romney as a vicious, thoughtless, out-of-touch rich guy. It is really Obama’s only hope as he can’t possibly win if he runs on his objective accomplishments.

This story has obviously been in the works for a while but the news value of it is questionable. It is the basic oppo dump material that the Washington Post obediently churns out on Republicans. As Major Garrett reports in National Journal, the whole Biden-evolving postion idea was a scam to allow Obama to support gay marriage:

Did Obama sacrifice huge swaths of swing voters? Probably not. The polls have shifted to net favorable on the question of same-sex marriage and independents are unlikely to punish Obama for a policy position consistent with everything else he’s done on gay issues. Social conservatives will, of course, be aggrieved. But they were already.

Also, consider this on the gay-marriage pronouncements: Biden was first, Obama second. That the two happily reversed the common order of things ought to tell you something about their relationship (solid), their understanding of tactics (advanced), and how they can play Washington’s chattering class for fools (easily).

But suddenly, the nothingburger story developed by the Post had a hook. In fact it had a hook that could effectively frame the entire story to fit into the overarching Obama campaign. Obama was against gay marriage, but then he met parents of friends of his daughters who were gay and the subject was discussed at family dinners and he changed his mind. Another “gutsy call” in which he took an unpopular position after carefully weighing everything, and, of course, consulting his deeply held Christian faith.

Romney, on the other hand, when he went to an elite private school for elite rich kids relentlessly bullied a kid who was gay and continues his bullying and homophobia to this day by not supporting homosexual marriage. It all fit. And the Post was able to make good on its investment.

The ABC story makes it clear that there are other Romney classmates lining up to dish on him, presumably after they sign with a literary agent:

One former classmate and old friend of Romney’s – who refused to be identified by name – said there are “a lot of guys” who went to Cranbrook who have “really negative memories” of Romney’s behavior in the dorms, behavior this classmate describes as “evil” and “like Lord of the Flies.”

The classmate believes Romney is lying when he claims to not remember it.

“It makes these fellows [who have owned up to it] very remorseful.  For [Romney] not to remember it? It doesn’t ring true.  How could the fellow with the scissors forget it?” the former classmate said.

View the original article here

And So The Campaign Begins

I don’t think any accomplishment Obama can tout will save him from the backlash he’ll reap from having forced Obamacare down our throats.

Even if SCOTUS strikes it down in its entirety (thereby presumably taking it off the table as a campaign issue), everyone will still know what Obama is capable of, and what he and his Democrat colleagues are willing to do to achieve it. That genie is out of the bottle, and I’m betting most voters will want no more of it, Bin Laden or no Bin Laden.

In any event, killing Bin Laden does not appear to have been very successful in fostering a general perception that Democrats are turning over a new leaf to become hawks. I doubt he’ll get very much mileage out of this.

View the original article here

The Budgetmania Begins

Late last night, the House began voting on the substitute budget amendments to the Ryan budget.  Here is a quick rundown.

Simpson-Bowles

Every single Republican in Washington is committed to doing everything in his or her power to terminate Obamacare, right?  Wrong!

Last night, 16 Republicans from the ‘pale-pastel caucus’ voted for the Simpson-Bowles budget alternative in the form of the Cooper-LaTourette amendment.  This budget fully funds Obamacare. Period.  There would have been more supporters if not for the fact that Heritage Action and other organizations scored against the vote.

Over the next few months, we will hear many self-ingratiating protestations over our conservative choices for Congress, particularly our Senate candidates.  They will claim that we must elect any Republican that they deem to be electable, as the only means of garnering 51 votes to repeal Obamacare through reconciliation.  Anyone who thinks that “just any Republican” would have the courage to seek full repeal through expedited parliamentary measures (especially if the Supreme Court strikes down only part of the law) is not grounded in reality.

As an aside, the Simpson-Bowles budget also raises $1.2 trillion in taxes to feed the voracious bureaucracy, fails to deal with the major drivers of the deficit, cuts the military, and fails to close one agency or abolish a single program.  The amendment was defeated 38-382; 22 Democrats and 16 Republicans voted for it.  The list of Republican supporters is below the fold.**  And no, they’re not all from swing districts.

In addition to the Simpson-Bowles budget, the House held votes on several other proposals.  The final vote on the underlying bill – the Ryan budget – and the RSC alternative will take place later on Thursday.  Here are the roll call results for those budget alternatives:

Obama’s Budget

Mick Malvaney offered an amendment in the form of Obama’s budget proposal to see how many votes it would attract.  Well, it didn’t attract any.  It was defeated 0-414.  What a bunch of cowards.

CBC Budget

The annual Congressional Black Caucus budget, which proposed $595 billion more in spending than Obama and raised $4 trillion in taxes, was defeated 107-314.  Yes, there are that many inviolate kooks in the House.  If only we had 107 unvarnished conservatives on our side in the most conservative districts like they have in the most liberal districts.

Tomorrow, the House will vote on the RSC budget and the Democrat Budget Committee amendment before voting on final passage of the Ryan budget.

Here is one cautionary note about the vote tally on the RSC budget.  While a yay vote on the annual RSC budget is often a good litmus test for where the member is holding, there are some wolves in sheep’s skin that muddle the tally with unprincipled yay votes.  Confident that the budget will ultimately fail to win passage, they cast a yay vote as a means of protecting their identity.  Last year, Democrats exposed these imposters by voting present on the RSC budget.  Fearing that the present votes would give conservatives the low-threshold majority to pass the bill, many of the pale-pastel Republicans changed their yay votes back to nay in order to ensure that Democrats wouldn’t “saddle” them with the RSC budget.  It will be interesting to see what happens this time around.

**GOP yay votes for Simpson-Bowles

Bass, C. (NH-02)

Buerkle (NY-25)

Dent (PA-15)

Dold (IL-10)

Gibson, C. (NY-20)

Johnson, Timothy (IL-15)

LaTourette (OH-14)

Lummis (WY-AL)

Meehan (PA-07)

Petri (WI-06)

Platts (PA-19)

Reed, T. (NY-29)

Shimkus (IL-19)

Simpson, M. (ID-02)

Wolf (VA-10)

Young, D. (AK-AL)

Cross-posted from The Madison Project

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