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Drugs and Profits: Pharmaceutical Companies Should First Do No Harm

Last year the Food and Drug Administration rescinded approval of the drug Avastin for treating breast cancer patients, prompting a firestorm of criticism. The decision was denounced by some politicians as health care rationing, and by breast cancer patients who feared that they would be deprived of a drug that they felt had helped them immensely.

But these criticisms ignore the facts: Avastin was rejected simply because it didn’t work as it was supposed to, and the F.D.A. should resist the aggressive campaign by Genentech, the drug’s maker, to get that ruling reconsidered at a hearing in late June.

Avastin has been on the market for seven years, and combined with other drugs it is effective in treating, but not curing, some colon, lung, kidney and brain cancers. It inhibits the development of new blood vessels and in so doing can starve a growing tumor.

Treating a breast cancer patient with Avastin costs about $90,000 a year, and Genentech could lose $500 million to $1 billion a year in revenue if the F.D.A. upholds the ban.

A clinical trial published in 2007 demonstrated that Avastin, when paired with the chemotherapy drug Taxol, halts the growth of metastatic breast cancer for about six months longer than chemotherapy alone. Genentech then asked the F.D.A. for approval of Avastin, combined with Taxol, for use against metastatic breast cancer.

This halt in tumor growth is known as progression-free survival. But delaying the worsening of cancer does not necessarily prolong life, and Avastin was not shown to lengthen patients’ overall survival time. So Genentech argued that the drug led not to longer life, but to improved quality of life.

In 2007, an F.D.A. advisory committee rejected the application, deciding that the toxic side effects of Avastin outweighed its ability to slow tumor growth. The F.D.A., however, overrode the committee and granted what is called accelerated approval, allowing Avastin to be used pending further study. The criteria for full approval was that Avastin not worsen overall survival and that the drug provide clinically meaningful progression-free survival.

To support its case Genentech submitted data from two additional clinical trials in which Avastin was paired with chemotherapy drugs other than Taxol. Like the first trial, neither showed a survival benefit. Both showed an improvement in progression-free survival, though this outcome was much less impressive than in the original study. In addition to seeking full approval for the Avastin-Taxol combination, Genentech also asked the F.D.A. to approve the use of Avastin with the drugs used in these follow-up studies.

Genentech presented progression-free survival as a surrogate for better quality of life, but the quality-of-life data were incomplete, sketchy and, in some cases, non-existent. The best that one Genentech spokesman could say was that “health-related quality of life was not worsened when Avastin was added.” Patients didn’t live longer, and they didn’t live better.

It was this lack of demonstrated clinical benefit, combined with the potentially severe side effects of the drug, that led the F.D.A. last year to reject the use of Avastin with Taxol or with the other chemotherapies for breast cancer.

In its appeal Genentech is changing its interpretation of its own data to pursue the case. Last year Genentech argued that the decrease in progression-free survival in its supplementary studies was not due to the pairing of Avastin with drugs other than Taxol. This year, however, in its brief supporting the appeal, Genentech argues that the degree of benefit may indeed vary with “the particular chemotherapy used with Avastin.” In other words, different chemotherapies suddenly do yield different results, with Taxol being superior. The same data now generate the opposite conclusion.

Perhaps more troubling is the resort to anecdote in the brief to the F.D.A. and in the news media.  Oncologists recounted their successes, and patients who were doing well on Avastin argued for its continued approval. But anecdote is not science. Such testimonials may represent the human voices behind the statistics, but the sad fact is that there are too many patients who have been treated with Avastin but are not here to tell their stories.

Avastin will not disappear because of the F.D.A. decision. It remains available for treating other cancers, and research to find its appropriate role in breast cancer treatment continues. In the meantime, the F.D.A., which is expected to make its decision in September, needs to resist Genentech’s attempt to have it ignore scientific evidence.

Serious progress in the treatment of cancer will not be the result of polemics, lobbying or marketing. Genentech’s money and efforts would be better spent on research for more meaningful treatments for breast cancer.

By: Frederick C. Tucker, Jr., Oncologist and Op Ed Contributor, The New York Times Opinion Pages, May 24, 2011

May 25, 2011 Posted by | Big Pharma, Capitalism, Consumers, Corporations, Government, Health Care, Health Care Costs, Health Reform, Pharmaceutical Companies, Politics, Public Health, Regulations, U.S. Chamber of Commerce, Women, Women's Health, Womens Rights | , , , , , , , , , , , , , , , , , | Leave a comment

Privatization: The Road To Hell

Billionaires are different from you and me, for obvious reasons, including the fact that they buy much pricier baubles than we do.

A sleek car costing $100,000? Why, for them, that’s just an easy impulse purchase. A few million bucks for a Matisse original? Go ahead — it’ll liven up the hallway. How about throwing a fat wad of cash at a university to get an academic chair named for you? Sure, it’s all part of the fun of living in BillionaireLand.

Then there is the top crust of the upper-crust — such megalomaniacal megabillionaires as the Koch brothers. Using money from their industrial conglomerate, their foundation and their personal fortunes, these two far-out, laissez-faire extremists are literally buying public policy. Their purchases of everything from politicians to the tea party help them push the privatization of all things public and the elimination of pesky regulations and taxes that crimp their style.

To advance their plutocratic privatization cause, brother Charles has even gone on a shopping spree for an invaluable bauble that most of us didn’t even know was for sale: academic freedom. And it’s surprisingly cheap!

For only $1.5 million, Koch bought a big chunk of the economics department of Florida State University a couple of years ago. His donation gives him control of a new “academic” program at this public institution to indoctrinate students in his self-serving political theories.

The billionaire gets to screen all applicants, veto any he deems insufficiently ideological, and sign off on all new hires. Also, the department head must submit yearly reports to Koch about the faculty’s speeches, publications and classes, and he evaluates the faculty based on “objectives” that he sets.

Charles has made similar purchases of academic freedom at two other state universities, Clemson and West Virginia. Also, in a May 20 piece at Alternet.org, investigative researcher Lee Fang reveals that Koch has paid $419,000 to buy into Brown University’s “political theory project,” $3.6 million to establish Troy University’s “center for political economy” and $700,000 for a piece of Utah State’s Huntsman School of Business, which now has the “Charles G.
Koch Professor of Political Economy.”

Imagine the screams of outrage we’d hear from the Kochs if a labor union were doing this.

A recent article in The Onion, the satirical newsweekly, printed a downsize-big-government spoof that Charles and David would love to turn into reality. The parody disclosed that President Obama had come up with a surefire plan to balance the federal budget: Rob Fort Knox! “I’ve got the blueprints,” Obama is quoted as saying, “and I think I found a way out through a drainage pipe.”

Unfortunately, with today’s political climate dominated by howling winds from the far-right fringe, there’s no longer any room in American culture for satire. Sure enough, some laissez-faire extremists at such Koch-funded corporate fronts as Cato Institute and Heritage Foundation are presently howling for the government to sell all of America’s gold stored in Fort Knox. Noting that we have billions worth of bullion in the vaults, a fellow from Heritage made this keen observation: “It’s just sort of sitting there.”

Uh, yeah, professor. Like Mount Rushmore, the Grand Canyon, the Lincoln Memorial and other national assets — being there is the point.

Yet these ivory tower ideologues are using the current brouhaha over the budget deficit as an opening to push their loopiest fantasies of selling off all of America’s public properties, facilities, systems and treasures to create a no-government, plutocratic paradise. Just spread our public goods out on tables, like a flea market from hell, and invite the global rich to buy it all.

For example, a fellow from another Koch-funded front, the American Enterprise Institute, observes that the government could raise billions of dollars to retire that pesky deficit simply by selling our interstate highway system. Americans would then have to pay tolls forever to the corporate owners, but hey, he exclaims, remember that tolls “work for the River Styx, why not the Beltway?”

What a perfect metaphor for privatization! In ancient mythology, dead souls must pay a toll to be ferried across the River Styx and enter the depths of hell.

By: Jim Hightower, CommonDreams.org/Creators.com, May 25, 2011

May 25, 2011 Posted by | Democracy, Government, Ideologues, Ideology, Koch Brothers, Politics, Regulations, Republicans, Right Wing, Taxes, Tea Party, Unions, Wealthy | , , , , , , , , , , , , , , | Leave a comment

A Straight-Talking, Truth-Telling Machine?: Tim Pawlenty’s Version Of The “Truth”

Former Minnesota Gov. Tim Pawlenty formally kicked off his Republican presidential campaign yesterday, and after struggling to come up with a rationale for his candidacy, he’s apparently settled on a theme. Pawlenty, we’re told, will be a straight-talking, truth-telling machine.

As rationales go, I suppose this isn’t bad. Indeed, Pawlenty took steps to back this up, telling Iowans he wants a gradual phasing out of federal ethanol subsidies, and noting that he’s headed to Florida to endorse overhauling Medicare and Social Security. Pawlenty has spent many years saying the exact opposite, but why quibble? This is the new Pawlenty, speaking truth to power, and adopting the mantle of the last honest man in American politics — or so we’re supposed to believe.

But for a man who used the word “truth” 16 times in his campaign kick-off speech, Pawlenty is already undercutting his message with all kinds of falsehoods.

An hour after his official launch, Pawlenty talked to Rush Limbaugh, who noted in 2006 that Pawlenty said that “the era of small government is over” and that “government has to be more proactive, more aggressive.” Pawlenty responded that the newspaper article that published those remarks was wrong; the paper ran a correction; and that he was only quoting someone else.

Dana Milbank looked into this and discovered that Pawlenty “had taken some liberties with the facts.”

The article is all about Pawlenty’s efforts as governor to take on drug and oil companies and other practitioners of “excessive corporate power.” It includes his boast that many ideological Republicans “don’t even talk to me anymore” because of his support for things such as the minimum wage.

“The era of small government is over,” Pawlenty told the newspaper. “I’m a market person, but there are certain circumstances where you’ve got to have government put up the guardrails or bust up entrenched interests before they become too powerful…. Government has to be more proactive, more aggressive.”

The newspaper did issue a “clarification,” but only to say that Pawlenty’s quote about small government was “in reference to a point” made by the conservative writer David Brooks — one that Pawlenty, from his other comments, obviously agreed with.

Of course he did. In 2006, Pawlenty wasn’t well liked by the far-right, as he defended big government, endorsed cap-and-trade, wanted to reimport prescription medication from Canada, and wanted officials to be more effective and aggressive in fighting the oil industry.

Everything he told Limbaugh yesterday, just like the new persona he’s struggling to adopt, just isn’t true.

And really, that’s just scratching the surface. Wonk Room ran a fact-check piece yesterday, noting seven obvious lies Pawlenty told yesterday, on issues ranging from health care on the nation’s finances. Similarly , the AP ran a similar piece, highlighting several more of the candidate’s falsehoods from yesterday.

Pawlenty needs to realize that those who base their entire message on offering candor and uncomfortable truths face an even tougher burden — they’re inviting even tougher scrutiny. By lying repeatedly on his first day as a national candidate, Pawlenty is off to an ignominious start.

By: Steve Benen, Contributing Writer, Washington Monthly, Political Animal, May 24, 2011

May 24, 2011 Posted by | Big Government, Conservatives, Corporations, Elections, GOP, Government, Health Care, Ideologues, Ideology, Medicare, Politics, Republicans, Social Security | , , , , , , , | Leave a comment

The Dick Cheney Of Israel: It’s What Netanyahu Is Doing To Israel Now

Three points about Obama’s recent speeches on the Arab world and the Middle East — the one at the State Department, and the one today at AIPAC. Jeffrey Goldberghas been responding to these in detail.

1) It’s complicated. We should no longer be surprised that a major Obama speech on an important topic is characterized mainly by its embrace of complexity.  Here’s why this matters:

Traditionally the role of a Presidential speech is to say, in bald terms, which side of an issue the Administration is coming down on. Are we going to war, or not? Is the president going to sign a bill, or veto it? People outside the government underestimate how important big presidential speeches are in resolving policy arguments and deciding what an administration’s approach will be.

Obama’s big speeches have been unusual, because the side they come down on is that of complexity. In his classic Philadelphia “race in America” speech: the recognition that every part of our racial mix has its insecurities and blind spots. In his Nobel prize address: that military force is not the answer but is an answer. In his West Point speech a year and a half ago: that the U.S. can’t stay in Afghanistan forever but should stay for a while. You can apply this analysis to almost every major address.

Including these latest speeches. He argued that the United States has “interests” in the Middle East — oil, stability, anti-terrorism — and it also has ideals. So it will try harder to advance its ideals, without pretending it has no (often contradictory) interests. He presented Israel-Palestine in this same perspective. As a meta-point, he said that Israel-Palestine is only part of the larger Arab-world evolution, but is a crucial part. On the merits, he emphasized that Israel has to be secure, that Hamas must accept that reality, that Israel must be able to defend itself — but that it cannot stand pat, wait too long to strike a deal, or forever occupy the West Bank.

My point here is about Obama rather than about the Middle East. From some politicians, for instance those otherwise dissimilar Georgians Jimmy Carter and Newt Gingrich, a collection of “complex” ideas often comes across as just a list. Obama, most of the time, has pulled off the trick of making his balance-of-contradictions seem a policy in itself. Rather than seeming just “contradictory” or “indecisive.” This is unusual enough that it’s worth noting. (And for another time: the vulnerabilities this approach creates.)

2) Israel’s Cheney. By “a Cheney” I refer to the vice presidential version of Dick Cheney, who (in my view) mistook short-term intransigence for long-term strategic wisdom, seemed blind and tone-deaf to the “moral” and “soft power” components of influence, profited from a polarized and fearful political climate, and attempted to command rather than earn support from allies and potential adversaries.

That was bad for the U.S. when Cheney was around. It’s what Netanyahu is doing to Israel now, and Israel has less margin for strategic error than America does.

Right after Obama made his big speech, it was welcomed in most of the world and by most major U.S. Jewish organizations. The immediate critics were Mitt “throw Israel under the bus” Romney, Sarah Palin, Tim Pawlenty, Mike Huckabee, and Binyamin Netanyahu. Explain to me the universe in which this is a wise strategic choice for a nation highly dependent on stable relations with the United States — and on ultimately making an agreement in the region that allows it to survive as a Jewish democratic state.

Think of this contrast: when China’s Hu Jintao came to Washington for a state visit, each of the countries had profound disagreements with the other. (Chinese leaders hate the U.S. policy of continued arms sales to Taiwan, much more so than Netanyahu could sanely disagree with any part of Obama’s speech.) Neither China nor America is remotely as dependent on the other as Israel is on the United States. Yet Obama and Hu were careful to be as respectful as possible, especially in public, while addressing the disagreements. High-handed and openly contemptuous behavior like Netanyahu’s would have seemed hostile and idiotic from either side. As it is from him.

The real service Netanyahu may have done is allowing easier U.S. discussion of the difference between Israel’s long-term interests and his own.

3) God bless this speech. President Obama showed that it is possible to end a speech with … a real ending! The usual one might have sounded odd in a speech largely addressed to the Islamic world. So the release text of his speech concluded in this admirable way:

“We hold these truths to be self evident, that all men are created equal.”

Those words must guide our response to the change that is transforming the Middle East and North Africa — words which tell us that repression will fail, that tyrants will fall, and that every man and woman is endowed with certain inalienable rights. It will not be easy. There is no straight line to progress, and hardship always accompanies a season of hope. But the United States of America was founded on the belief that people should govern themselves. Now, we cannot hesitate to stand squarely on the side of those who are reaching for their rights, knowing that their success will bring about a world that is more peaceful, more stable, and more just.

By: James Fallows, National Correspondent, The Atlantic, May 22, 2011

May 23, 2011 Posted by | Conservatives, Foreign Governments, Foreign Policy, Freedom, GOP, Government, Ideology, Middle East, National Security, Politics, President Obama, Republicans, Right Wing, Terrorism | , , , , , , , , , , , , , , , , , , | Leave a comment

Why Don’t Men Like Schwarzenegger, John Edwards Use Condoms?

The revelation that former California Gov. Arnold Schwarzenegger fathered a  child a decade ago with a woman who was not his wife—a disclosure that comes  just a couple of years after we learned that onetime Democratic presidential  candidate John Edwards had done the same thing—begs an important question:

Exactly what century are we in?

The issue here isn’t even why a married person would have sex outside his or  her marriage, which is not an infrequent occurrence now or at previous points  in history. It’s not even about how a public person thinks he or she could  behave that way without anyone finding out. Edwards, after all, was castigated  for doing something so reckless and foolish during a time when he was under  intense media scrutiny. But the fact that Schwarzenegger was able to keep this  a secret for the entire time he was in the governor’s mansion is astounding,  and suggests maybe Edwards wasn’t as delusional as some people thought.

But has it not occurred to these men to use a condom? Birth control is readily  available. It’s legal. It’s simple to use. And it limits the fallout from an  affair. Learning of a past sexual dalliance would understandably be very  upsetting to a spouse. Learning that a child was produced from the union is  devastating and adds a living, breathing reminder of the episode, a pain  compounded by the fact that it is not the child’s fault that he or she is a  walking symbol of marital betrayal.

But seriously, if a woman approaches  a man and says, “you are so hot,” as Rielle Hunter reportedly said to  Edwards, does it not occur to the man that she might not mind having a  permanent connection to the candidate a child would secure? And what was  Schwarzenegger thinking when he had sex with someone who actually worked for  the family? Did he not consider the possibility of pregnancy?

Perhaps the use of birth control  adds to any guilt the men might feel; if the episode is planned, it is more  difficult to convince oneself that passion was to blame. It’s sort of the  counter-argument to those who believe that providing birth control to sexually  active young people will give them ideas about sex they wouldn’t otherwise  have. More likely, they are thinking about sex, and while it may not be wise to  engage in sex at a young age because of the emotional implications, the  physical consequences of sex without birth control are far more serious. One  would think adult men would know that by now.

By: Susan Milligan, U.S. News and World Report, May 18, 2011

May 19, 2011 Posted by | Politics | , , , , , , , , , , , | Leave a comment