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Medicine

US Regulators Quickly Approve Roche's New and Faster COVID-19 Test (ibtimes.com) 238

schwit1 quotes the International Business Times: Swiss pharmaceutical giant Roche announced Friday it had received emergency approval from U.S. regulators for a new and much faster test for diagnosing the deadly new coronavirus...

The test can be run in high volumes on fully automated equipment, Roche said, suggesting it could provide more results far faster than other tests available. "We are increasing the speed definitely by a factor of 10," Thomas Schinecker, head of Roche's diagnostics unit, said in an interview with Bloomberg News. Widespread testing is essential in the race to rein in the spread of the virus, which has so far infected more than 130,000 people and killed nearly 5,000 worldwide. The new Roche tests, which will also now be available in markets that accept the European CE-mark certification, are run on Roche's widely available cobas 6800/8800 systems and can provide results within 3.5 hours, the company said.

In a 24-hour period, the largest machines can provide results on up to 4,128 tests, it said.

Fierce Biotech points out that "emergency use" of the test was quickly approved by U.S. regulators within 24 hours: In addition to the one-day approval, the FDA said it did not object to Roche pre-shipping its COVID-19 tests to laboratories ahead of time, so they could be used immediately following the authorization...

The test is designed to detect nucleic acid strands of the SARS-CoV-2 virus from nasal or oral swabs. However, the company said negative results do not preclude an infection and should be combined with clinical observations and the patient's history and contact with the disease...

"Roche is committed to delivering as many tests as possible and is going to the limits of our production capacity," the company said in a statement, and it expects to have millions of tests available per month.

Comment Re:I'm sure sanity will prevail. (Score 1) 230

You raise a good point. Perhaps these are visitors from an alternate universe rather than time travelers. Presumably the location of our earth would be in the general vicinity of alternate earths and would therefore negate the necessity of traveling the distance covered by the galaxy over time.

Comment Re:I'm sure sanity will prevail. (Score 2) 230

I find it interesting that people immediately jump to Aliens as the identity of these sightings. While still unlikely to me, I personally think it would be more believable that these are time travelers from earth's distant future. These might not even be evolved humans, if the human race goes extinct at some point and they evolved from some other species that survived an extinction even millions of years from now. Before you flame me about time travel, explain how exceeding light speed is any more far fetched. Don't get me wrong I don't believe in either Aliens visiting earth or time travel - just commenting on why only one of these explanations is ever proposed.

Comment Re:Look outside of Africa, too. (Score 1) 156

I am sorry, but with language like that, I have to assume you have a political agenda. i.e. I don't take you seriously.

That's not the worst of it - the claim about human ancestors in Bulgaria 7.2 MYA is incredibly speculative and based on a single study with very sparse evidence that just got published a few weeks ago. There are many alternative hypotheses, but as tends to be the case, the researchers went with the one that's likely to get them the most citations and media coverage. It's a perfect example of academic hand-waving combined with lousy science journalism.

Comment Re:Do you want a zombie apocalypse? (Score 2) 139

If I'm thinking of the same thing you are, the reason it is so expensive is that there are so few patients - like a few dozen. (It's not even clear to me why they pursued that in the first place, given that it seems like it would be impossible to even recoup their initial investment, much less make a profit.) There is a much larger pool of HIV patients (supposedly 1.2 million in the US alone), even if you just focus on rich nations, and they could still charge what sounds like an extortionate amount of money for it, because insurance companies and governments would love to not needing to keep paying for expensive HIV drugs every month. And whoever brings it to market could easily give it away to poor nations and still become spectacularly wealthy.

Comment Re:funny.. (Score 1) 22

Every time an article about cancer therapies (or pharmaceuticals in general) comes up, someone always makes this claim. Aside from the sheer misanthropy of assuming the worst of everyone involved in drug development, it's spectacularly ignorant of human biology, modern medicine, and the pharmaceutical business. The truth is that most drug candidates end up being colossal wastes of money with nothing to show for it, usually because of poor efficacy in large-scale clinical trials (but occasionally due to unforseen side effects, although these are less of an issue with cancer drugs where the patient will probably die anyway), and it's still very difficult to catch these expensive failures earlier in the process. No sane pharma exec is going to tell researchers "let's drop this one, it works too well" because the reward for a cure will still be vastly higher than the money it costs to bring it to market, and meanwhile they'll probably lose 10x that amount on failures.

The only situation where there's a real financial disincentive to develop a cure is when the compound isn't patentable - however drug companies are very good at finding ways to patent things and at least in the US there is an "orphan drug" program that allows companies to patent drugs that would otherwise be public domain if they invest the work and money to take it through clinical trials. The supposed cures that are being ignored are usually outright quack stuff like Vitamin C or antineoplastons, which are of no interest because no one has convincingly shown they are actually useful.

Comment Re:Read my post again (Score 1) 311

This is the kind of circular argument that's impossible to refute. "Show me the numbers!" "Here are the numbers!" "No, those don't support my predetermined conclusion, so they must be fake." It's exactly like the Trump administration's attitude towards climate science, to pick one recent example. But whatever, the same strategy worked out so well for the fossil fuel interests that I guess I shouldn't be surprised that other ideologues have latched onto it.

Comment Re:No it won't (Score 1) 311

This is common knowledge to anyone who has worked in the field - it's like asking for a citation for the claim that eating too much junk food leads to obesity. But here are two data points:

http://blogs.sciencemag.org/pi...
https://en.wikipedia.org/wiki/...

So that's less than 20% of approved drugs that are discovered in academia to begin with. Academic labs aren't large-scale operations - a single-investigator R01 grant from the NIH might be $5 million over 5 years, and most investigators won't have more than a handful of these. For the really big superstar labs, let's assume a very generous upper bounds of $10 million per year (not all of which is necessarily from the government). If it's a big multi-investigator project, maybe double that. Except for a handful of big centers (like the NIH itself, or genome sequencing centers), academia just doesn't operate at a large scale - a typical university research department is just an aggregation of many smaller units that are largely autonomous. The hidden advantage to these organizational limitations is that failed projects usually fail before anyone spends too much money on them. So let's hypothesize at the extreme, academics spent no more than $50 million per drug candidate. Compare to the numbers in the Wikipedia article.

Now, you could of course argue that because drug development is informed by the public-domain knowledge generated by taxpayer-funded researchers, drug companies are leaching off the public in that way too. I guess that's technically true (albeit difficult-to-impossible to quantify), but you might as well argue that because the government invented digital computers, companies like IBM and Intel should have been nationalized. (Note that the difference in salary between academia and big pharma is relatively large - to shift more drug development to academia, you'll need to raise salaries, or find a lot of scientists willing to work for academic salary while doing grunt work on massive projects that will mostly likely fail.)

To pick a more specific example, the NIH spends approximately $1.2 billion per year on aging-related research (including but not limited to Alzheimer's):

https://www.nia.nih.gov/about/...

Most of that will be single-investigator grants, and as anyone who has worked in basic research can tell you, the majority of the grants that are funded won't lead to any immediate treatments, although they may provide useful information in the long term. In contrast, here is an estimate of the total cost per Alzheimer's drug being $5.7 billion (including failures, and keep in mind the overwhelming bulk of that is spent by drug companies):

https://alzres.biomedcentral.c...

This isn't to argue that taxpayer funding of basic research isn't valuable - it's absolutely essential IMHO. But most of what it produces isn't going to lead directly to new drugs or treatments.

Obligatory disclaimer: I do not work for a drug company, but I did receive funding from them as a government scientist, and receive a small bonus from IP licensing fees every year. Frankly it was far more trouble than it was worth; drug companies are kind of a pain in the ass to deal with, even if you only talk to the scientists.

Comment Re:No it won't (Score 1) 311

They do a few clinical trials after the government has done the really expensive stuff (what's called "Basic Research", IIRC).

This is simply wrong. The development process (which includes a lot more than just clinical trials) is far more expensive than the basic research component - and that's without even counting how many projects simply fail without anything to show for it.

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