The FDA: Still Not The Government You Hoped For

Well I’m sure those 47,000 people, especially the dead ones, would vote with their wallets and would stop buying that nasty drug. So there’s the case for eliminating the FDA all together… and eliminate their reports and testing and statistics on harmful drug effects. The market takes care of itself when fewer living people show up at the pharmacies. It’s the best way to identify corporate malfeasance. Ain’t that right Mr. Paul…

And they worried their pretty little heads about drugs being sold to Americans from Canada, Ireland or Austrailia. Imagine that!!
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Thank you Obama, Pelosi, and Reid!! DORKS!

Professional left?

If politicians from both parties keep repeating that government can’t do anything right then pretty soon it becomes a self-fulfilling prophecy.

As long as politicians from both parties keep being paid by multi-national corporations to prevent government from doing what’s right, then pretty soon it becomes a government that only works for multi-national corporations.

As ever, follow the money.

Michael Scherer:
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they worried their pretty little heads about drugs being sold to Americans from Canada
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That brings up an important point, one that TIME’s Massimo Calabresi predictably fails to examine:
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How did the rest of the developed world handle the availability of the drug “Avandia?”
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When did Canada, for example, do about the risks to diabetes patients, and, importantly, when?
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Fortunately for news consumers, where TIME’s Massimo Calabresi predictably fails, the net-neutral internet delivers:

http://www.pharmalot.com/2007/11/canada-severely-restricts-avandia-over-heart-risks/
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Canada Severely Restricts Avandia Over Heart Risks
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By Ed Silverman // November 11th, 2007 // 8:13 am
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With little fanfare, Health Canada is telling doctors and other health care workers that Glaxo’s diabetes pill can only be used only in rare circumstances, and is no longer approved for use with other common diabetes meds, such as insulin or sulfonylureas. Another caveat – Avandia can’t be used in patients with any stage of heart failure, according to info posted on the health agency’s web site on Nov. 6.
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The move comes as the FDA has yet to complete its own review. An agency advisory committee met in July and suggested Avandia carry new safety warnings about heart risks. The panel was convened after a controversial study published in The New England Journal of Medicine contended the pill causes a 43 percent increased risk of heart attack and the FDA is reportedly considering placing a Black Box warning on the label.
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The restrictions vindicate the position advocated by Steve Nissen, the Cleveland Clinic cardiologist who co-authored the New England Journal meta-analysis. “The Canadian decision seems very thoughtful. Essentially, they are withdrawing approval of the drug for most previous indications,” he writes. “It will still be available for the occasional patient who might benefit, but most usage will cease. I think it is a reasonable compromise short of complete withdrawal.”
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For its part, Glaxo gave this statement to Bloomberg News: “Patient safety in the use of our medicines is very important to us, and this updated information will assist Canadian physicians in making individualized treatment decisions when managing the chronic and life-threatening disease of diabetes,” says Rav Kumar, Glaxo’s vice president of regulatory and development operations.

So, how does that work?
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How does the Canadian government do the right thing immediately, as in three whole years ago, while our FDA does not?
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And how does Calabresi manage not to include the relatively successful experience of our neighboring first-world country in the process of reporting this story?
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Not to suggest that there’s some sort of deliberate conspiracy afoot, but does Robert Gibbs’ recent claim about the “professional left” and its fixation with “Canadian healthcare” correlate in any significant way with establishment national publications’ apparent, willful ignorance when it comes to how other wealthy nations’ systems work –while ours does not?
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Is there some other reason why Massimo Calabresi would leave out one of the most important parts of the story –Canada’s FDA didn’t “Have a Drug Problem”– that you can imagine, Michael Scherer?
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Those two things –the blackout of other OECD nations’ comparative health care advantages, and the disdain in which the Beltway political class, both Democratic and Republican, holds activists who point out those successes– are they somehow related, do you think?

Thank you, stuart, for connecting the dots.

Four years ago or so the VA changed all prescriptions for Actos to Avandia. I complained, and they tried to tell me that it was the same stuff, so much for their opinions. Needless to say I stop getting my prescription filled with the VA.

To bend over backwards to be fair to Calabresi, he does manage to sneak in this:

Unlike the FDA, European regulators had insisted on a long-term cardiac-safety study, called RECORD, when they approved the drug. So GSK argued that the only prudent approach would be to let the RECORD trial run to completion in 2009 to reach a definitive answer on cardiovascular risk. To top agency officials, it seemed like a reasonable solution at the time. But three years and hundreds of millions of dollars in Avandia sales later, it turns out the RECORD trial may not be as reliable a study of cardiac risk as agency officials had hoped.

, but do you understand exactly what happened?
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Does it sound like countries like Germany, Switzerland, France, Italy or Denmark had the same problem as the United States in knowing what do do about the risky drug, or not?
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So Massimo implies that the European regulators similarly failed, basically, because “the trial may not be as reliable a study of cardiac risk,” but did they? Or did they simply follow the example of Canada, which essentially de-approved the drug in 2007? Massimo doesn’t manage to say.
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One could get the impression that we’re not supposed to know about such things as goes on in other wealthy countries…

Continuing the theme; Saudi Arabia banned it back in March.
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http://arabnews.com/saudiarabia/article33556.ece

“And they worried their pretty little heads about drugs being sold to Americans from Canada, Ireland or Austrailia. Imagine that!!
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Thank you Obama, Pelosi, and Reid!! DORKS!”
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And where was the GOP on this issue?
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See my post # 6 for what happened under Bush.
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This is not a political issue, this is regulation issue, and it seems to me it is all about money, not health.

“And where was the GOP on this issue?”

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Well let’s see. How about we breakdown the vote on the Dorgan Amendment which was the Amendment proposed to open up our Drug business in this country to allow the import of prescription drugs.
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Voting for the Dorgan Amendment

28 Dems and 23 Republicans for a 51 vote total (Total number needed for passage however was 60)

33 Dems and 15 Repubs voted “nay”. A 48 vote total.
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Now I know there is fuzzy math, but in my calculation, had more of the dems per percentage voted for rather than against the Dorgan Amendment, we would now be able to purchase our prescription drugs from Canada if we wanted. We just might have seen a dramatic drop in prices due to this Amendment which would have allowed the free market to determine prices, not the government through regulations.
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How’s that for ya ??? Anymore stupid questions??

Oh and here is the link to the actual vote.
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http://www.senate.gov/legislative/LIS/roll_call_lists/roll_call_vote_cfm.cfm?congress=111&session=1&vote=00377#position

GlaxoSmithKline, the manufacturers of Avandia does not contribute to campaigns. Their Political Action Committee – GSX-PAC – is very active.
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http://www.campaignmoney.com/political/committees/smithkline-beecham-corporation-political-action-committee-glaxosmithkline-pac.asp?cycle=08

Whatever else this guy says, whatever his reasons for admitting it, he’s absolutely correct:

…had more of the dems per percentage voted for rather than against the Dorgan Amendment, we would now be able to purchase our prescription drugs from Canada if we wanted.
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We just might have seen a dramatic drop in prices due to this Amendment which would have allowed the free market to determine prices, not the government through regulations.

Can any liberal argue in good faith against this proposition?
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The only question for Rustydog would be why he wasn’t screaming at his Republican politicians to vote drug importation into the Medicare Part D program they passed, the way some of us liberals were just yelling at our legislators, if he knew that the preferred regulation of the pharmaceutical industry was the biggest rip-off for Americans.
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That said, Democrats defeated the Dorgan Amendment, with strong support from the above discredited Obama FDA:

http://thehill.com/homenews/senate/71307-fda-opposes-senate-drug-importation-amendmen
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FDA opposes Senate drug importation amendment offered to healthcare bill
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By Jeffrey Young – 12/08/09 08:05 PM ET
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A proposal to enable the importation of cheaper prescription drugs could endanger the U.S. medicine supply and would be difficult to implement, the Food and Drug Administration said Tuesday
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These criticisms from Margaret Hamburg, President Barack Obama’s FDA commissioner, could prove damaging to an effort by a broad coalition to enact the longstanding goal of easing consumers’ access to prescription drugs from countries such as Canada, where the prices are generally lower than in the United States.

Wait, “Margaret” who? Wasn’t that person featured in Calabresi’s piece somewhere?

The Senate Finance Committee concluded in January 2010, after a two-year review, that GSK failed to promptly alert the FDA about Avandia’s drug risks. In response, FDA commissioner Dr. Margaret Hamburg initiated another review of whether to keep Avandia on the market.

Oh, that Margaret Hamburg…the one who was so concerned about the safety of imported Canadian drugs.
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Right…Safety first.
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Always.

newf@2,6`
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Thanx for the statistics and your analysis. I really wished you had left out the “Any more stupid questions?” part. Kinda distracts from the educational value.

m0mentom0ri, thanks for the link.
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That’s quite a list-if I were a Congressman I’d feel left out if I didn’t get any scratch.

Well Rusty you made my point didn’t you? Rep and Dem both voted against it, and for the Drug companies. It is all about money, not health.
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Did I call you stupid? Or did I call you out for making it a party issue?
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This is one area where we should agree, but I see that even on positions you support, you don’t.

I agree that the FDA has not, if ever, been doing its job well (That is, its alleged job of protecting the safety of food nad drugs on the market. It seems to have done its actual job of helping manufacturers make huge profits via preferential positioning and the rubber-stamping of industry-conducted safety studies that fool the populace into thinking they are being protected by Big Brother).
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But do you really mean to suggest that a better mechanism would be to let “the market” kill people in order to discover that they might want to make adjustments in order to improve their bottom lines?

But do you really mean to suggest that a better mechanism would be to let “the market” kill people in order to discover that they might want to make adjustments in order to improve their bottom lines?
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No.
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This has been yet another fun-filled edition of “Simple Answers to Simple Questions.”
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centfan is no fan of my commentary, but I’d be remiss if I didn’t mention that the referenced piece was probably a bit of heavy snarkasm.
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I don’t think that centfan was being serious in that proposal, but was illustrating the obvious faults of the “glibertarian” perspective.

When Congress backed the government’s position on not allowing consumers to import drugs, the Democrats should have taken the position that no finished drugs, in bulk or final packaging, could be imported by a company to be sold on the American market. A large number of drugs are produced in Ireland, England, Isreal and other countries and imported into this country in bulk containers or even finished products. Look at the generic Prilosec from various retailers and no matter what the final trade dress says on the 42-tablet package, the individual 14-tablet packages inside were made in Isreal by the same company.

The American pharmaceutical companies have very large investments in countries all around the world and transfer or trade products between local companies.

Great point.

Well allthings, perhaps you need to go back and re-read your comment initially. You seemed to be making the case it was the usual liberal banter that the Republicans being the “party of No” where at fault for not passing the Dorgan Amendment. When in fact it was clearly the Democrats who did nothing, and voted “NO”.
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I wasn’t calling you stupid, I was calling your question stupid. Clearly a different story all together.

That’s an excellent link. Political journalists should provide links like these with every report.

Yes, stuart hit the nail… snark, all snark… but it will be considered seriously by our more conservative shadows.
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And stu-z, I am always a fan of your detailed and considered responses to anything. More of that can only help expose and answer all issues that we collectively face.
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I think (I think) we’ve only disagreed on the use of “centrism” as a dirty word. In an ideal world one man’s centrism is another man’s pragmatism… and centrism can include right or left thinking as long as there is enough concensus to get the best solution for a problem actually done.
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I mean done as in it’s started and it’s finished and the problem is fixed to some practical degree in a complex society.
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On that score my only problem with Obama in terms of practical execution has been the dive into healthcare (obviously necessary at some point) rather than creating a blow-out renewable energy policy. He could have killed more birds with that one and had plenty of ammo to burn the naysayers. Unfortunately, even on that count, unless gasoline hits $5.00 a gallon again there is no momentum to change our energy economy.

stu~
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thanks for pointing out to me what I had missed. Even though I am unfamiliar with cen, I missed the reference to (I assume) Ron Paul at the end of the comment — the obvious clue to sarcasm.

A 2.11~
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Thanks for clarifying that you meant not to call allthings stupid, but, while there is a difference between calling a question or the questioner stupid, if anyone had typed to you “stupid question”, I suspect you, too, would have heard “stupid you”. In other words, the difference was not clear without you having made it so. So, again, thanks for doing so.
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No matter its value to allthings, I suspect it is valuable as part of changing the tone with many onlookers who, at other times, will be engaged with you.

Thanks for the compliments, centfan.
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Ahh…wait a second…
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“I think (I think) we’ve only disagreed on the use of “centrism” as a dirty word.”
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I think that we have a disagreement over what “centrism” means.
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I make a distinction between centrism as defined and promoted by Third Way ideologues and pragmatism, a distinction which you elide when you say:
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“In an ideal world one man’s centrism is another man’s pragmatism…centrism can include right or left thinking as long as there is enough concensus to get the best solution for a problem actually done”
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If you mean “pragmatism,” you should say “pragmatism.” Pragmatic behavior has nothing to do with including left and right thinking or consensus. Often, the most pragmatic course of action isn’t amenable to consensus at all.
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Also, you are somewhat obscuring the difference between political pragmatism and pragmatic policy.
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What can get done in a particular political environment, in other words, isn’t necessarily the most practical policy solution to a given problem.
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Despite all of their claims to “pragmatism,” Third Way advocates are centrists in the most ideological meaning of the term, not endowed of practical solutions to anything, as we’ve seen from so many episodes in which they’ve had the power to implement their deranged policies –Gramm-Leach-Bliley being the example that immediately comes to mind.

I think you need to reread your post! Calling them Dorks. I pointed out to you in a Rhetorical question that the GOP didn’t support it either.
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If you read my last line: “This is not a political issue, this is regulation issue, and it seems to me it is all about money, not health;”, makes it clear that I was not blaming the GOP for this problem.
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I mean three lines Rusty, I would think you would read them all.
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Seems to me that you are just trigger happy, don’t care about the issues, just the politics, typical of your posts.