NYT tackles some of the big pharma questions

The New York Times > Business > Dangerous Data: Despite Warnings, Drug Giant Took Long Path to Vioxx Recall

But a detailed reconstruction of Merck's handling of Vioxx, based on interviews and internal company documents, suggests that actions the company took - and did not take - soon after the drug's safety was questioned may have affected the health of potentially thousands of patients, as well as the company's financial health and reputation.

The review also raises broader questions about an entire class of relatively new painkillers, called COX-2 inhibitors; about how drugs are tested; and about how aggressively the federal Food and Drug Administration monitors the safety of medications once they are in the marketplace...

...Five times as many patients taking Vioxx had heart attacks as those taking naproxen.

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In a separate NYT article there's a discussion about lowering the cost of drug development by changing how innovation is funded in the US.

These are big questions, the NYT deserves credit for tackling them. Is it just my imagination, or are they doing more of these research-intensive pieces lately?

The most interesting question is how intimate the relationship between the FDA and manufacturers has become. How many key people move between the FDA and manufacturing? How do key donations affect legislators? Eliott Spitzer must be watching closely.

PS. A fivefold relative increase in MI risk is an enormous increase. It's curious that such a large effect didn't emerge earlier. Is there something about patients who can't tolerate NSAIDS (and thus end up on Vioxx) that makes them also prone to MI?

Insider trading in the US Senate

Marginal Revolution: Senatorial Privilege

Yes, apparently everyone does do it. Senators cheat.

In February we reported on a new study showing that the stock picks of Senators, as revealed in their financial disclosure forms, outperformed the market by a whopping 12 percent.  Insider trading anyone?  Although it's not clear whether any laws have been broken, Alan Ziobrowski, one of the study's authors says 'there is cheating going on, at a 99 percent level of confidence.'

The SEC looked at the study but, surprise, surprise, it seems that they are too busy going after Martha Stewart to have the time to look into evidence that our leaders are using their political power and influence for personal gain.  An article in the Philadelphia Inquirer notes slyly, 'the SEC may have little incentive to tangle with the Senate, given their relationship. Senators approve members of the SEC's governing body, as well as the agency's budget.'

Unfortunately the article is not yet published, it is forthcoming in the Journal of Financial and Quantiative Analysis...

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I wonder if they'll break this down by party. Shades of Hillary's pork bellies. Good thing no-one cares about this any more.

The end of the PAP smear?

Technology News: Health : Vaccines May Nearly End Cervical Cancer

If approved in a few years, as expected, the vaccine likely would be recommended for girls ages 10 to 12 in the United States and elsewhere. The study, to be reported Saturday in the journal The Lancet, is the second this month showing a vaccine's success against the sexually transmitted human papillomavirus, believed to cause most cervical cancers.

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There have been several trials, all promising.

We may have to wait for the current cohort to die off, but sometime in the nex 60 years we may see the end of the PAP smear. If we eliminate HPV cervical cancer there are better ways to spend health care energies than PAP smears.

A Feed aggregator for medical topics - Reider and Ross

Medlogs.com - The News Aggregator for Medical Topics

My esteemed colleague Jacob Reider has put together this news aggregator for medical topics. Jacob is quite brilliant and a hacker besides, so I ought to have expected this. I found it by accident though when I was testing Google's indexing of blogger. Google hadn't indexed my blog entry from November, but they did index this aggregator -- which in turn referenced the terms I was testing on.

Jacob has categorized my "Faughnan's Notes" blog as a medical blog. I'll have to try to put more healthcare related entries in it! In fact ithis blog largely politics and economics; Jacob probably stuck it in his collection because he has peculiar tastes.

I shall have to see if I can add this aggregator to my bloglines feeds.

PS. Google does seem to have done something major to their indices. They are now only a few weeks behind on indexing blogger and their "pages indexed" count has doubled. So maybe we SHOULDN'T think of shorting their stock!

Floresians: Homo erectus or homo sapiens?

The New York Times > Science > Miniature People Add Extra Pieces to Evolutionary Puzzle

There has been little evidence until now that Homo erectus long survived its younger cousins' arrival in the region. Modern humans probably exterminated the world's other archaic humans, the Neanderthals in Europe. Yet the little Floresians survived some 30,000 years into modern times, the only archaic human species known to have done so.

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First of all, I think Stepen Baxter should get special mention for making the Floresians seem inevitable.

Secondly, this article mentions in a rather off-handed way, that our ancestors slaughtered both Homo erectus and Neanderthal. I'd long assumed that was true (presumably we ate them), but I'd not realized it was now common wisdom. It's scary to think that, as nasty as we are now, we might once have been even worse.

Lastly, this is a great article. If the Floresians were Homo sapiens they are at once both less exotic and more fantastic. As to those who doubt that such odd looking creatures could be of the same species as us ... they need to compare a chihuahua to a Great Dane.

Life extension through supplements -- not likely to work

CNN.com - Study: Vitamin E may do more harm than good - Nov 10, 2004

People take large doses of vitamin E in the belief that it helps counter oxidation by unstable 'free radical' molecules, which damages cells and can accelerate aging and lead to heart disease and cancer.

Miller, who was surprised by the findings of the study, said there could be several ways the vitamin supplementation is damaging the body.

While vitamin E in low doses is a powerful antioxidant, in higher doses its effects may promote oxidative damage, and may also overwhelm the body's natural antioxidants, he said.

Dr. Raymond Gibbons of the Mayo Clinic in Rochester, Minnesota, said the evidence has been building against vitamin E supplements.

'Despite this ... I see many, many patients still taking vitamin E and I have to convince them not to,' he told a separate news conference.

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I think there's a sneaking suspicion that humans in wealthy nations probably make a pretty optimal use of key nutrients. The only dietary ways to extend life are likely to be calorie restriction and maybe fat restrictions. What helps in one regard may hurt in another. Disappointingly similar to medications, but unlikely to affect supplement sales.

Pfizer/Bextra joins Merck/Vioxx on the COX2 firing line

The New York Times > Business > New Study Links Pfizer's Bextra, Similar to Vioxx, to Heart Attacks

A weak retrospective study suggests Bextra is a disaster. If it were the only such study the appropriate action would be warning labels and more studies. However, in the context of Vioxx, this suggests Bextra should be withdrawn from the market. I'd be amazed if Bextra is on the market a month from now.

So what about Celebrex? It doesn't seem to be much safer on the stomach than well known NSAIDs. It's far more expensive. It's cousins look bad.

It's hard to believe any COX2 inhibitor is going to remain on the market in a year -- at least for their primary indications (arthritis, etc). They may turn out to be good drugs for other conditions where the risk/benefit ratio is better.

There are four interesting questions:

1. Did the pharmas cover up problems? Did they follow reporting requirements? What's their moral (if not legal) culpability if they aggressively market drugs about which their own scientists may have significant reservations?

2. What's with the pharmas anyway? They did a lot to suppress the release of worrisome data on SSRIs. Has the rise of patient-focused marketing completely corrupted the industry?

3. Was the FDA corrupt? It used to be a fairly reputable agency, but now it's run by Bush appointees. Their stated mission has been to be friendlier to the manufacturers and to accelerate drug development. Now we have the SSRI scandal, the Vioxx scandal, and the flu-vaccine scandal. Maybe Eliott Spitzer needs to litigate against the FDA?

4. Will Bush put in place a liability cap to save Merck?

Microsoft unchained

Silicon Valley - Dan Gillmor's eJournal - Microsoft Buys 'Peace'

... When the Bush administration made its odious deal to let Microsoft off the legal hook in 2001, it was giving the company a free pass to do whatever it wishes in the future. Everyone understood this. Today, no one with any serious knowledge of the industry believes the company has changed its business practices in any meaningful way; a few modest noodlings at the edges don't even rise to the level of window dressing. Microsoft continues to run roughshod over its customers, 'partners' and competitors.

Nobody much cares, it seems. Journalists, taking a lead from governments, have moved onto other things. Microsoft counts on our short attention spans.

The European Union's helpful refusal to give the monopolist everything it wants may also run out of steam. Only in China is there a government with anything like the clout to stand up to Microsoft. Our government is in bed with a company that effectively wants to charge taxes in the rest of the world; as China's world economic standing rises, it surely will continue to regard that situation with some concern.

Linux and other open-source software remain the best hope for actual competition, in part because of China's moves to support it. Here again Microsoft is getting the U.S. government's assistance, via policy and inaction in dealing with a badly broken patent system. It's clear that Microsoft is getting ready to use patents to make life hard for the open source community.

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So the future of software depends on ... China. In particular , it depends on the security considerations of China's military rulers.

I've been overdosing on irony lately. This doesn't help.

It's nice, though, that someone remembers Bush's payback for Microsoft's support in 2000 [1]. I'd love to know how much money Microsoft funneled into Bush's reelection.

Microsoft's a very aggressive company that's played plenty dirty in the past. It's their unrestrained power, however, that has made them capitalism's shame. With adequate competition they'd probably play a somewhat positive role in the evolution of information technology. Heck, I do like Excel.

[1] Almost no-one, however, remembers the role Ziff-Davis played in Microsoft's ascent to power.

The countries I've visited

World66 visited countries

Here's the map I made:



create your own visited country map
or write about it on the open travel guide

God has blessed the US

beliefnet: God intervened to re-elect President Bush; George W. Bush and evangelicals; divine intervention in elections

If Kerry won, then it was clear that God had cursed the US. Since Bush won, it's obvious God has had mercy.

Sodom, Gomorra. Moral values.

Hilary, on the other hand, would be a warning that the deluge is imminent.

Feeling bitter?

F___ the South

Amidst the somewhat tongue-in-cheek scatology, dark humor, and genuine frustration are some interesting points. We've seen electoral-college-by-county maps weighted by population, but we've not seen them weighted by GNP. I suspect if one were to weight by GNP the blue states would loom large.

States' Rights.

A calm and well reasoned analysis of the vote

The Washington Monthly

Based on this, my tentative conclusion is that the 'moral values' vote is a red herring. It played no bigger a role this year than in 2000.

Terrorism played a bigger role, mostly by being a more important issue to a lot more people. Bush's actual level of support among people who based their vote primarily on world affairs increased only modestly.

And that good old mainstay the economy was the most important of all. Compared to 2000, fewer people personally think they're doing better but more people believe the economy is in good shape anyway. And Bush was overwhelmingly successful in convincing those people that his policies deserved the credit.

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Evangelicals were important, but they didn't increase their turnout beyond 2000. Very interesting. Reading the full posting terrorism was a plus for Bush.

The economic perception may be tied to a surprisingly jump in employment in the month prior to the election. If Rove engineered THAT I'm even more impressed than I was.

Another electoral college vote by county map

The Washington Monthly

Of all the maps of this type I've seen this is the most interesting. Good guide on where to live. I'd like to see one where the counties are weighted by contribution to GNP however.

The Economist on the 100,000 dead Iraqis

Economist.com | Iraq

SOME 100,000 souls—perhaps even more—may have perished in Iraq as a result of the American-led invasion in March last year. So, at any rate, says a respected British medical journal, the Lancet. If only half that figure is the true one, it is shocking....

But whatever the precise death-count since Saddam Hussein's fall and however lethal his own regime, several bitter facts cannot be denied: the rate of killing in Iraq has been far greater than those (including The Economist) who advocated war had expected. Moreover, as American and Iraqi forces steel themselves for another heavy assault on insurgents in Fallujah and maybe other rebel towns in the Sunni triangle, the politicians in charge—including a re-elected George Bush—should pause before raining down another torrent of bombs that are sure to kill many civilians as well as fighters...

... Moreover, the Pentagon is quite wrong to refuse to estimate Iraqi casualties, albeit that the margin of error is bound to be high. Reports such as the Lancet's should be taken seriously—and bolster the case for selectivity and restraint, even against the bloodiest of foes.

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In a separate article The Economist reviews the Lancet article and finds the numbers to be plausible and the reasoning sound.

The US invasion of Iraq was followed by the violent death of about 65,000 people -- largely women and children. Another 35,000 deaths, largely of children, may have resulted from the general disruption and chaos. Those who died of violence were not all killed by American forces; many died from insurgent action.

The Economist implies that had they known the death toll they would not have advocated war.

Meanwhile, conservative commentators in the US have mocked the study and made a jest of the numbers. Moral values, you know.

Are You Living in a Computer Simulation?

Are You Living in a Computer Simulation?

It's been a while since I tracked this. Looks like Bostrom has put the discussions together in one spot. I confess to finding the arguments ... persuasive.

Update 2/22/07: The nice thing about living in a simulation is that quantum entanglement and nonlocal action are less mysterious ...

See also:

• The Algebraist and the religion of the eternal simulation
• Reality, perception, Hume, the red pill - and John Tierney
• Churches of the Singularity - is Horgan truly an unbeliever?