Showing posts with label by Matthew Herper. Show all posts
Showing posts with label by Matthew Herper. Show all posts

Thursday, 26 July 2007

The Science Of Star Wars

For 30 years, moviegoers have thrilled to the sight of space-going swashbucklers slashing at each other with laser swords as they rocket from star to star.

The last movie in George Lucas' epic Star Wars series may have come and gone, yet the franchise lives on in books and games, and soon on television. But could any exploits of these warriors of a long time ago in a galaxy far, far away have actually happened? Are the fantastical sights--the speeding spaceships, the chattering robots, lightsabers in every imaginable color--even physically possible?

It's not as silly as it sounds. Science fiction has always played a role as a diviner of future trends. Sci-fi writers of the 1930s described moonshots and nuclear bombs, and Arthur C. Clarke was famously the first to conjure up the communications satellite. With the exception of warp drive and transporters, a lot of the technology in the 1960s Star Trek now looks antiquated. (Why, after all, is that guy with the pointy ears carrying such a clunky cellphone?)

Star Wars is, of course, a mishmash of B-movie and sci-fi conventions: laser pistols, hyperdrive ships and funny little men. But could it too, have some prophetic power? Forbes.com contacted scientists to find out.

Wednesday, 25 July 2007

The Dangers of Internet Drugs

hose pills offered via spam mail in your inbox each day? Don't buy them.

"Regulators and drug industry executives are pulling their hair out trying to stem a rising tide of fake or low-quality medicines being sold online," we wrote two years ago. "A Web site based in Canada may get its products from India or China, or may traffic in counterfeits."

At the time, Pfizer executive Jeff Kindler -- now the drug giant's chief executive -- complained that it was impossible to track where these medicines came from. "All you get is a plain brown envelope," he said.

The problem seems to be getting worse. China just executed its former head drug regulator for taking bribes in a crackdown on fake medicines. Tainted batches of pet food and toothpaste of Chinese origin are a reminder of how easy it is for poisonous products to make their way stateside.

Now, a death has been linked to poison pills from an online pharmacy, according to the Globe and Mail. Marcia Bergeron, 58, of Vancouver Island, Canada, bought drugs containing the active ingredients in Ambien, Xanax, and Tylenol. But the medicines also contained high levels of metals that built up in her system and caused an arrythmia that killed her.

Bergeron reportedly ordered the drugs from a Web site that claimed to be Canadian and had previously been flagged by the U.S. Food and Drug Administration for selling counterfeits.

The FDA recently put out a warning on the dangers of Internet medicines. Peter Rost, a former Pfizer executive whose blog is an annoyance to drug execs, notes an "irony" in the situation: that the first victim of drug reimportation lives in Canada, and got a drug that is not approved there but is available to the rest of the world.

As for the spammers who sell this stuff, they can be nearly impossible to track, as this Forbes story details.

Orac, the pseudynomous surgeon at ScienceBlogs, reports that he's seen particularly scary spam. "Did you know that spammers are claiming to be selling chemotherapeutic agents from India?" he writes.

You Can't Fight The FDA

This morning, shares in GPC Biotech and Spectrum Pharmaceuticals are plummeting after a panel of experts advised the U.S. Food and Drug Administration to delay approving their prostate cancer pill, satraplatin.

Shares in GPC, the German biotech that would have sold the drug, dropped 33% to $13.54. Spectrum, which would have received a royalty on sales, dropped 12% to $4.19. (For previous doubts on satraplatin, see "Cancer Drug Winners And Losers.")

There were big hopes for the pill because a clinical trial showed that it reduced the nearly constant pain of patients whose prostate cancer had spread to the bone and had failed other treatments. Better yet, it slowed the cancer's spread, according to a measure devised by the company. Those results were highly statistically significant.

But both the way pain was measured in the trial and the way that progression of the cancer was gauged were deemed unreliable by the 12-member FDA panel. There was a spectacle at the event, watched via a Webcast. It basically came down to a debate between the company and the FDA in which the FDA insisted, fairly strenuously, that it had let the biotech know that its measures of disease progression and pain were not valid.

Biotech companies are run by brilliant, somewhat stubborn people who have great faith in their opinions. Somehow, it sometimes seems, executives can forget that, whatever happens, you can't fight the FDA. If you come up with a brilliant way of proving your drug works but you can't convince the FDA that it's brilliant, you need to come up with another approach.

The meeting was vaguely reminiscent of the story earlier this year of Encysive Pharmaceuticals (nasdaq: ENCY - news - people ), which saw its drug for a rare lung disease rejected even as a rival from Gilead was approved. On a conference call, Chief Executive Bruce Given basically blamed the FDA for his troubles, saying he had thought that the agency had been convinced by existing data after several go-arounds. Encysive's drug might well have made it if Encysive had run another clinical trial earlier in the process. Given has since left the company.

GPC's case is less onerous. But either the FDA failed to give good guidance or GPC failed to listen. If it had used a more validated measure of patients' pain, the panel might very well have voted to approve its drug. Instead, Otis Brawley, the Emory University oncologist who is the incoming chief medical officer of the American Cancer Society, answered the question of whether satraplatin had been proved to reduce pain with one of the most painful words in biotech: "almost."

Still, one has to wonder if the stock market is overdoing its punishment of GPC today. Certainly, the company won't win any prizes for wisdom or foresight. And at the meeting, it revealed that it would take much longer for final data, which it hopes will prove satraplatin increases survival, to become available. Patients in its study are simply living longer than expected, whether they got satraplatin or a placebo.

Now, those data won't be available until next year; they were expected at the end of this year. Megan Murphy, an analyst at Lazard Capital Markets, who covers Spectrum, has removed all satraplatin royalties from her model of that company, which she still rates a "buy." And there is also the problem that it's not clear whether the study will really prove to oncologists that they need to use this drug. It could get approved, and then not sell.

But this appears to be a medicine that works, although GPC hasn't proved that yet, and the proof could come next year. Not everyone is so confident. In a note to investors, Matthew Osborne, a biotech analyst at Lazard Capital Markets, said the odds of a survival benefit were only 50/50.

Given all the lousy bets out there in biotech, investors might want to watch the stock closely as a potential value play.

Venter Takes Step Toward Synthetic Cells

A team led by Craig Venter, the maverick geneticist best known for his fight to sequence the human genome, has moved a step closer to making cells from scratch. But huge hurdles remain to making practical use of this new technology.

The team at the J. Craig Venter Institute took all of the genes from one species of bacteria, Mycoplasma mycoides, and transferred them into another, Mycoplasma capricolum. The result: The genes from the mycoides took over, changing the cells from one species to another simply by moving around DNA.

However, experts say it will be very difficult to apply the technique to other types of bacteria, and for now its use may be limited to the fragile and tiny mycoplasma germs.

This research, published in the new issue of Science magazine, is part of a larger quest by Venter and his team to create a cell with a genome designed from scratch. The idea is that researchers could chemically synthesize the DNA they wanted outside the cell--something companies like Codon Devices of Cambridge, Mass., or Blue Heron Biotechnology of Bothell, Wash., can already do relatively cheaply--and implant it into bacteria, effectively creating a new species that did not exist before.

"With this new bacterial genome transplantation technique, we are now one step away from taking a newly constructed genome and transplanting it into a recipient cell," says Drew Endy, a synthetic biologist at MIT who did not work with the Venter team.

Jay Keasling, a synthetic biologist at University of California-Berkeley, calls the work "an indication that it will one day, perhaps soon, be possible to create an organism with a completely synthetic genome."

Researchers hope that custom-engineered cells could be useful in producing new types of medicines, including bacteria designed to help the body attack disease, or to produce biofuels that could help ease the world's reliance on oil. Such applications are far off, and no fully synthetic organism has yet been created.

Companies are already being started to take advantage of new technology that makes it easier to bioengineer organisms. Codon, of which Endy is a director, is looking to sell synthetic biology tech to other firms. Venter's own firm, Synthetic Genomics, is aiming to solve problems related to energy and recently signed a deal with British Petroleum (nyse: BP - news - people ). Amyris Biotechnologies, founded by Keasling, is looking to solve both health-related and energy problems. A company called LS9 is looking to use synthetic bacteria to make fuels.

Only the Venter team has married its approach so closely to creating life from scratch. Other researchers are marveling at the potential to do genetic engineering by modifying multiple machines at once, allowing them to work with cells as if they were machines. Amyris, for instance, has worked to solve a key production problem needed to make cheap malaria drugs.

But the Venter approach is more audacious and more costly. On a conference call with the press, he said that ideally, someday, he'd like to have all the components for a living cell in a chemical soup and then see them assemble. Now he has shown that it is possible to take a genome from one organism and move it to a similar one. The next step would be to manufacture a genome and transplant that.

Other synthetic biologists are taking existing cells and making hot rods; Venter wants to make one from scratch. But there are big drawbacks to his approach. His researchers are working with mycoplasma, a bacteria that has only 500 genes, close to the minimum number necessary. Mycoplasma is fragile, especially compared to the E. coli and yeast other synthetic biologists work with.

It also may be costly, with the estimated cost to reach the first synthetic organism being at least $10 million, according to a slide presented at a recent scientific conference by Hamilton Smith, the Nobel laureate who is heading the Venter Institute's synthetic biology effort. Venter's spokeswoman did not return an e-mail checking the accuracy of that figure.

George Church, a Harvard biologist who is a co-founder of LS9 and Codon Devices, argued that it was "not clear" that creating a wholly engineered cell, especially a fragile mycoplasma, would be more cost effective than just inserting or changing a few genes.

However, he says a related charge, that Venter is restricting biology and setting up a potential monopoly by patenting some of his institute's earlier work with Mycoplasma, is a "tempest in a teapot." Other researchers will still have plenty of room to invent their own work, and the patent does not, as some have asserted, cover the creation of any synthetic organism.