August 18, 2010

The FDA and Avastin: ObamaCare’s Death Panels Precursor?

Filed under: Economy,Health Care,Life-Based News,Taxes & Government — Tom @ 3:13 pm

Just to be clear, I don’t think an FDA panel’s preliminary Avastin revocation decision is Exhibit A demonstrating the imminent arrival of ObamaCare’s death panels, as discussed in an e-mail I sent on the topic a couple of days ago:

I think it’s an unclear and borderline call at this point, and while making the accused political connection is convenient, it isn’t yet proven.

The FDA turndown recommendation for Avastin occurred on July 20, according to WaPo. Berwick was appointed on July 7.

I’m not clear on when CMS (the Center for Medicare and Medicaid Services) suggested that Medicare not cover it. If it’s later than July 20 and there’s no collusion, CMS is just following normal procedure saying it won’t cover something FDA doesn’t approve. One of the Hot Air posts indicates that it’s July 22 for the Provenge and August 13 for Avastin. Don’t know when or even if Provenge got the FDA un-approval recommendation. …

But I DO think that the FDA’s by its decision has arrogated to itself the power to serve as a de facto death panel.

In an editorial today, the Wall Street Journal elaborated (bolds are mine):

The FDA allowed the use of Avastin for metastatic breast cancer in 2008, under the “accelerated approval” program for drugs that show promising evidence against life-threatening diseases. Avastin’s dispensation came in spite of a negative 5-4 ruling in 2007 by the board known as the Oncology Drug Advisory Committee, or ODAC.

ODAC decided that Avastin did not meet what the FDA considers its acid test: Patients did not live longer—that is, the overall survival rate did not improve in a statistically significant way. Yet a clinical trial showed a 52% median improvement in “progression-free survival,” which measures the time women live without their disease spreading or worsening. In practice, this means delaying the growth of tumors by about 11 months in combination with chemotherapy—five and a half months longer than chemo alone.

ODAC met again in July to consider Genentech’s request for conversion from accelerated to full approval, with new data at its disposal. Astonishingly, it ruled again, this time 12-1, that Avastin’s progression-free survival advantages are not clinically meaningful.

… The median overall survival benefit for one subgroup of 496 patients between the ages of 40 and 64 was an additional 5.7 months of life. Some individuals gain years. At any rate, even the 31% reduction in the risk of disease progression or death is better than the status quo.

So here we have government-anointed medical patriarchs substituting their own subjective view of Avastin’s risks and costs for the value that doctors and patients recognize. If Avastin is rescinded, thousands of dying women will lose more than proverbial false hope in the time they have left. They will lose a genuinely useful medicine.

The Avastin mugging is really an attempt to undermine regulatory modernization like accelerated approval that offends the FDA’s institutional culture of control and delay. It is also meant to discourage innovations like Avastin that the political and medical left has decided are too costly, with damaging implications for the next generation of cancer drugs.

… ODAC’s advice is not binding, and the FDA will deliver its final judgment in September. It would be a hideous injustice if the agency came down once more on the wrong side of a life-and-death question.

Ann Althouse is correct in calling out FDA’s approach for what it is: “They don’t want to be seen as death panels, because to be seen as death panels will undermine their relentless, bureaucratic work.”

But that’s what this is.

In terms of ObamaCare, the Avastin decision may be a precursor to how decisions to deny patients the benefit of life-saving or (in the case of Avastin) life-extending drugs will be made under ObamaCare. The FDA will serve as the “bad cop” denying approval while Donald “About 8% of GDP is plenty (for all health care–it’s currently about 17%)” Berwick gets plausible deniability. In that sense, how this works out could be a dry run for a more habitual death-panel approach.

NYT Scrubs GZM Imam’s ‘Iconic’ Paragraph From Original Online Report

GZMprotestSign0810On December 8 of last year, at some point before hitting the “print” button, someone at the New York Times decided that a story about what has since become known as the Ground Zero Mosque needed to be reworked.

Earlier that day, the Times published an online powder-puff piece by reporters Ralph Blumenthal and Sharaf Mowjood about Imam Feisal Abdul Rauf’s GZM plans. The pair’s story was revised before it went to print, and the online version was changed (“Muslim Prayers and Renewal Near Ground Zero,” with a web page title bar that reads “Muslim Prayers Fuel Spiritual Rebuilding Project Near Ground Zero”) to mirror it. It’s even puffier.

Several bloggers posted about the pair’s online original when it appeared. A few, including Pamela Geller at Atlas Shrugs and Ben Muessig at The Gothamist, excerpted some or all of the key paragraphs shown on the left below (bold in the third paragraph is mine). On the right is how that segment went to print on December 9 (link is to hard-to-read enlarged scan of that day’s front page, where the story’s opening paragraphs appeared near its bottom right), and how it currently appears online:

NYTsideBySideGZM120909

Putting aside the issue of whether previous online versions of subsequently revised stories should be retained and kept available to readers for future reference (I think they should; the Times, the Associated Press, and others clearly disagree), and even giving the paper the benefit of the doubt on the need to fit available print edition space, there’s plenty of reason to question the paper’s editing choices. The most important one is: “Why did the third paragraph disappear?” That disappearance raises at least these points:

  • The imam describes the location as being “close to 9/11,” as if the fallen towers represent some kind of event and not an actual place. Is this imperfect English, or a slip of the tongue? Readers who know more about Rauf’s full background might be tempted to think he’s referring to something positive, especially given that he describes being so close to them as being “iconic.”
  • Expanding on the Rauf’s use of “iconic,” the word “icon” in context means: “a person or thing regarded as a symbol of a belief, nation, community, or cultural movement.” So if the GZM’s proposed location is indeed “iconic,” it’s far, far more than a nice community center, isn’t it? Readers who know more about Rauf’s full background have legitimate cause for wondering what he believes the GZM really symbolizes.
  • It’s also interesting how the phrase “a longtime critic of radical Islamists” fell off. It’s not like “Islamists” is a forbidden word at the Old Grey Lady — or even (though much more rare) “radical Islamists.” Perhaps Blumenthal or Mowjood found some contradictory information, like that 60 Minutes interview where Rauf told Ed Bradley less than three weeks after the 9/11 attacks that “the United States policies were an accessory to the crime that happened,” and that “in the most direct sense, Osama bin Laden is made in the USA.” It seems a bit more likely, at least before the GZM idea sprung up, that Rauf, based on his own words, had really been a longtime sympathizer with radical Islamists.
  • Finally, it’s more than a little odd that the Times denied itself the opportunity, after originally claiming it, to brag about getting a scoop. Did the paper back away from seemingly valid bragging rights because of nervousness about being accused of proactively helping the project move along?

Given the facts and attitude clues washed out, the Times made some interesting editorial decisions indeed. When done, the presentation of Rauf is on balance became much more favorable, and there were no direct alerts that something might be amiss. Imagine that.

Cross-posted at NewsBusters.org.

Latest Pajamas Media Column (‘The Ruling Class Takes Care of Its Own’) Is Up

Filed under: Business Moves,Economy,Taxes & Government — Tom @ 9:03 am

http://i739.photobucket.com/albums/xx40/mmatters/ManWithMoneyBagIt’s here.

It will appear here at BizzyBlog on Friday morning (link won’t work until then) after the blackout expires.

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UPDATE: Found this item yesterday (HT GovernmentExecutive.com) –

Many news organizations have reported that the average federal employee earns more than the average private-sector worker.[1] Is higher federal pay justified given that the federal government employs a more skilled workforce than the private sector? Detailed analysis shows that the size of the wage discrepancies is not warranted:

  • The federal pay system gives the average federal employee hourly cash earnings 22 percent above the average private worker’s, controlling for observable skills and characteristics.
  • Including non-cash benefits adds to this disparity. The average private-sector employer pays $9,882 per employee in annual benefits, while the federal government pays an average of $32,115 per employee.
  • Overall, controlling for other factors, federal employees earn approximately 30 percent to 40 percent more in total compensation (wages and benefits) than comparable private-sector workers.
  • Federal employees enjoy job security irrespective of the state of the economy. Since the recession began, federal employment has risen by 240,000—12 percent. The unemployment rate for federal employees has only slightly risen from 2.0 percent to 2.9 percent between 2007 and 2009.
  • Federal employees demonstrate with their actions that they receive better compensation in the public sector than in the private sector: They quit their jobs at one-third the rate of the private employees.
  • Bringing federal compensation in line with private-sector compensation would save taxpayers approximately $47 billion in 2011.

That’s even before eliminating positions that are redundant, unnecessary, counterproductive, and/or better off privatized.

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UPDATE 2: More from Matt Welch at Reason.com.

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RELATED: Via ABC (HT Dr. Helen) — “Civil Servants Find Themselves Cast in Unlikely Role — Fat Cats”