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Politics : Formerly About Advanced Micro Devices -- Ignore unavailable to you. Want to Upgrade?


To: Alighieri who wrote (901958)11/19/2015 12:03:49 PM
From: Broken_Clock  Respond to of 1574127
 
NOVEMBER 19, 2015
Obama’s Latest FDA Nominee: No Hidden Big Pharma Links, They Are All in Plain Sight
by MARTHA ROSENBERG

The FDA has been called an arm of the drug industry because of how often it smiles on questionable new drugs and new drug approvals only to issue greater warnings or even withdraw them after the drugs made billions. Remember Vioxx, Baycol, Trovan, Meridia, Seldane, Hismanal and Darvon? They are not around anymore. Why? Remember how popular statins, brand name asthma and psychiatric drugs and GERD drugs were? Once they went off patent, the FDA “discovered” serious side effects and began to list warnings. Sorry about that.

There is a stereotype of backwoods courtroom “justice” in which prosecutors and defense attorneys who appeared to be adversarial leave arm in arm and go for a beer after a judicial decision. No hard feelings. The same collegiality oozes at FDA hearings with FDA staffers seeming to suck up to industry, perhaps for jobs in which they return to squeeze their prior colleagues. (Who remembers former Texas Governor Rick Perry’s chief of staff leaning on Perry to vaccinate all the state’s girls with the Merck vaccine Gardasil after he left for industry?)

FDA advisory panels, whose recommendations the FDA usually follows, are supposed to include “patient representatives” to see that the public’s interests are balanced against Big Pharma consultants. So many doctors and researchers now live on 5 and 6 digit drug company stipends, the FDA actually relaxed conflict of interest rules a few years ago–it could not find enough unlinked doctors!

But the “patient representatives” can be a sham. At one meeting I attended, one “patient representative” was a member of the drug industry-funded National Alliance on Mental Illness (NAMI) which was investigated by Congress for its hidden Pharma income and many consider a front group. The other so-called patient representative” had given keynote speeches at NAMI. So much for transparency.

Because of the huge amount of money to be made from a blockbuster drug like Lipitor—it was the best selling drug in the world—there is a natural tension between drug companies who want to hurry the march to Wall $treet and drug regulators who want to slow it down to protect the public.

That is why the nomination of unapologetic drug industry supporter, Robert M. Califf, for FDA Commissioner is so concerning. A disclosure statement on the website of Duke Clinical Research Institute list 25 drug companies Califf receives “research” funds from including drug giants like Johnson & Johnson, Lilly, Merck, Schering Plough and GSK.

Califf has gone on record that collaboration between industry and regulators is a good thing. He told NPR, “Many of us consult with the pharmaceutical industry, which I think is a very good thing. They need ideas and then the decision about what they do is really up to the person who is funding the study.” What?

He is known for defending Vioxx which is reported to have caused at least 50,000 heart attacks and events before its withdrawal. (Merck is said to have known about Vioxx’ cardio effects but marketed the blockbuster drug anyway.)

Califf was instrumental in the Duke drug trial of the blood thinner Xarelto and a cheerleader of the drug despite medical experts’ objections to its approval and 379 subsequent deaths. Duke, where Califf directed clinical research, is still recovering from a major research fraud scandal that resulted in terminated grants, retracted papers and a Sixty Minutes special. It is the least appropriate place from which to choose an FDA Commissioner.

If approved as FDA Commissioner, as many expect, will Califf recuse himself from decisions on the dozens of drugs whose manufacturers pay him? Or will he rule on them anyway? Either way, his nomination is a slap in the face of every honest doctor, researcher and regulator and the public that puts its trust in the FDA. In fact, if the FDA Commissioner is funded by industry, why have an FDA?



To: Alighieri who wrote (901958)11/19/2015 12:17:50 PM
From: i-node2 Recommendations

Recommended By
Bonefish
one_less

  Respond to of 1574127
 
Al, I think most everyone recognizes that Obama has created a terrible mess here through his aversion to using military power.

It would not have required nearly the intervention if he'd taken care of it up front. But today it is going to require someone to sort this out. You've got King Abdullah of Jordan saying it is WWIII, and that is my belief, as well.

You will try to point out that GWB started it, and that is a popular view but one which is historically just not correct. Obama's repeated failures to act have created a problem that is very unlikely to just go away.

When this is over the entire region will likely be a new and different geopolitical landscape and it is hard to say what it will look like. But it is difficult to envision the kind of relative stability in the region on the day Obama took office. If it makes you feel better to say it is all Bush's fault then so be it.



To: Alighieri who wrote (901958)11/19/2015 12:32:21 PM
From: jlallen4 Recommendations

Recommended By
FJB
locogringo
THE WATSONYOUTH
TideGlider

  Read Replies (2) | Respond to of 1574127
 
Can you believe there are morons still calling this mess a success???

Nation's largest insurer may exit Obamacare due to losses

By PHILIP KLEIN ( @PHILIPAKLEIN)
11/19/15 8:04 AM
washingtonexaminer.com

UnitedHealth Group, the largest insurance company in the U.S., on Thursday slashed its earnings outlook, citing new problems related to Obamacare, and told investors it may exit the program's exchanges.

"In recent weeks, growth expectations for individual exchange participation have tempered industrywide, co-operatives have failed, and market data has signaled higher risks and more difficulties while our own claims experience has deteriorated," Stephen J. Hemsley, chief executive officer of UnitedHealth Group, said in a press release.

The release added that, "UnitedHealthcare has pulled back on its marketing efforts for individual exchange products in 2016. The company is evaluating the viability of the insurance exchange product segment and will determine during the first half of 2016 to what extent it can continue to serve the public exchange markets in 2017."

The company said it expects "earnings pressure" of $425 million, which "is driven by projected losses on individual exchange-compliant products related to the 2015 and 2016 policy years."

Insurers have had trouble signing up young and healthy individuals on the Obamacare exchanges, which is necessary to offset the costs of covering older and sicker enrollees. This has forced insurers to hike premiums, raise deductibles, and slash the number of doctors and hospitals offered on its plans. Meanwhile, the Obama administration has cut its enrollment expectations for 2016 to about half of what they were when the the legislation became law.

In a conference call with investors, Hemsley offered a sober assessment of the exchanges' future viability. He said that claims data have been getting worse as time has gone on, and there's no evidence pointing toward improvement.

Asked about whether the company could sustain losses past 2016, he was blunt: "No. We cannot sustain these losses. We can't really subsidize a marketplace that doesn't appear at the moment to be sustaining itself."

The year 2017 is significant for insurers, because that's the year when several programs designed to mitigate risk for insurers through federal backstops go away. The hope was that those programs would act as training wheels for Obamacare in its first few years of implementation, but after that, the insurers were supposed to be able to thrive on their own. UnitedHealth's statement suggests otherwise.

If UnitedHealth and other insurers decide to exit, remaining insurers will be forced to take on even more high-risk enrollees, prompting them to either raise rates further or exit themselves. That in turn would deprive individuals of choices and remove competition, a key purpose of the exchanges.



To: Alighieri who wrote (901958)11/19/2015 1:32:09 PM
From: Tenchusatsu2 Recommendations

Recommended By
jlallen
THE WATSONYOUTH

  Read Replies (1) | Respond to of 1574127
 
Al,
I definitely get it..."bomb the shit out of them"...optics are important....brains not so much.
I don't consider Obama's current "strategy" with regard to ISIS to be all that smart. Do you?

If he doesn't want to be involved in a quagmire, he should stop his limited campaign against ISIS and just let Hollande and Putin have free reign in the region.

Otherwise, Obama should be in it to win it.

This "nuanced" shit only works if Obama knows WTF he's doing, and it's clear he doesn't, especially when he's been wrong about ISIS at every step.

Tenchusatsu