Category Archives: Science And Society

The Avastin Decision

Did the FDA do the right thing?

The Wall Street Journal, and others, have denounced the FDA’s move as “a chillingly blunt assertion of regulatory power.” But my Manhattan Institute colleague Paul Howard is the guy who gets it right, in a blog post for Medical Progress Today:

If you think (as I do) that the FDA should be expanding the accelerated approval pathway and allow more drugs to get to market based on promising early studies. rather than waiting for large Phase III clinical trials that can take years to complete, you can argue that this outcome actually strengthens AA. Critics have charged that AA is sop to industry, and that companies never do the follow up studies to support AA. Avastin proves them wrong.

This is exactly the point. If you want the FDA to approve more innovative, new drugs based on promising but early clinical results, you have to give the FDA a way to revoke those approvals later on, should larger trials prove that those drugs aren’t as safe or effective as they first seemed. This is why the FDA should be congratulated for the way it has handled the Avastin breast cancer saga, and why I hope we will see the FDA handle more cases like this one, not less.

Yes, this is better than the way they’ve done it in the past, but this argument presumes that the FDA should have such regulatory power in the first place. It’s one thing to provide data on efficacy. It’s another to prevent people from making their own decisions about what drugs to use for which ailments.

The Penn State Cover-Ups

It wasn’t just child molestation:

Although State Senator Piccola had written to Penn State President Spanier asking him to ensure that “the university must deploy its fullest resources to conduct an investigation of this case”, the Inquiry Committee decided that the investigation committee should not investigate three of the four charges “synthesized” by the inquiry committee and, as a result, despite the request of Piccola and others, no investigation was ever carried out Penn State on any of the key issues e.g the “trick… to hide the decline”, Mann’s role in the email deletion enterprise organised by Phil Jones or the failure to report adverse data which the House Energy and Commerce Committee had asked about (but not investigated by the NAS panel, whose terms of reference were sabotaged by Ralph Cicerone, President of NAS).

This latest malfeasance in Not-So-Happy Valley makes the whitewash of Michael Mann look even less credible.

To Salt?

…or not to salt? That is the question:

…a series of studies looking at dietary salt have recently suggested the evidence base for population-wide salt-reduction policies may not be as strong as first thought.

A separate Cochrane Library review conducted by British researchers and published in July found no evidence that small reductions in salt intake lowered the risk of developing heart disease or dying prematurely.

And another study by Belgian scientists published in May found that people who ate lots of salt were no more likely to get high blood pressure, and were statistically less likely to die of heart disease, than those with low salt intake.

Graudal said his results showed that when salt intake is reduced, there are increases in some hormones and in fats known as lipids “which could be harmful if persistent over time.”

He added that because none of the studies in the review were able to measure long-term health effects, his team was not able to say “if low salt diets improve or worsen health outcomes.”

Graudal said the growing number of studies questioning the net benefit of salt reduction meant public health officials should look again at their guidelines.

Emphasis mine. But some people are sodium sensitive, and I think I’m one of them.

I cut way back on salt back in February, because my BP was through the roof, and it’s gotten it down from ridiculously high (sometimes above 200 systolic) to moderately high (e.g., 140/95 this morning and lower at night if I’ve had a couple drinks, like 117/75). When I heard this reported on the news this morning, they said that cutting back on salt intake might increase one’s cholesterol level by two percent, which seems trivial to me. So I’m not going to go back on a bacon and jerky diet. Since going paleo (of which salt reduction was just part) several months ago, my weight is down (not a goal, though not a problem either) and when I tested my cholesterol a couple weeks ago, it was 207 total, with tryglycerides less than fifty, and HDL of almost eighty, which is the best results I’ve ever had in my life, and all due to diet alone. So I think I’ll stick with what I’m doing.

But Bloomberg should butt out.

Brokeneck Mountain

An interesting story:

A 19st rugby player suffered a stroke while training – and discovered when he woke up that he was gay.

Chris Birch, 26, had proposed to his girlfriend and worked in a bank when he suffered a freak accident in the gym.

The rugby-loving Welshman was trying to impress his friends with a back flip but broke his neck and suffered a stroke.

He was taken to the Royal Gwent hospital where his girlfriend and family waited for news – but said: ‘I was gay when I woke up…’

Chris retrained as a hairdresser and now lives with his partner Jack Powell, 19, above the salon in which he works.

But I thought it was a “choice”?

How Smart Are Octopi?

A very interesting article:

…octopuses are neither long-lived nor social. Athena, to my sorrow, may live only a few more months—the natural lifespan of a giant Pacific octopus is only three years. If the aquarium added another octopus to her tank, one might eat the other. Except to mate, most octopuses have little to do with others of their kind.

So why is the octopus so intelligent? What is its mind for? Mather thinks she has the answer. She believes the event driving the octopus toward intelligence was the loss of the ancestral shell. Losing the shell freed the octopus for mobility. Now they didn’t need to wait for food to find them; they could hunt like tigers. And while most octopuses love crab best, they hunt and eat dozens of other species—each of which demands a different hunting strategy. Each animal you hunt may demand a different skill set: Will you camouflage yourself for a stalk-and-ambush attack? Shoot through the sea for a fast chase? Or crawl out of the water to capture escaping prey?

Losing the protective shell was a trade-off. Just about anything big enough to eat an octopus will do so. Each species of predator also demands a different evasion strategy—from flashing warning coloration if your attacker is vulnerable to venom, to changing color and shape to camouflage, to fortifying the door to your home with rocks.

Such intelligence is not always evident in the laboratory. “In the lab, you give the animals this situation, and they react,” points out Mather. But in the wild, “the octopus is actively discovering his environment, not waiting for it to hit him. The animal makes the decision to go out and get information, figures out how to get the information, gathers it, uses it, stores it. This has a great deal to do with consciousness.”

So what does it feel like to be an octopus? Philosopher Godfrey-Smith has given this a great deal of thought, especially when he meets octopuses and their relatives, giant cuttlefish, on dives in his native Australia. “They come forward and look at you. They reach out to touch you with their arms,” he said. “It’s remarkable how little is known about them . . . but I could see it turning out that we have to change the way we think of the nature of the mind itself to take into account minds with less of a centralized self.”

“I think consciousness comes in different flavors,” agrees Mather. “Some may have consciousness in a way we may not be able to imagine.”

We probably won’t find more fascinating creatures to study until/unless we find extraterrestrial life.

[Via Geek Press]