Monday, October 8, 2007

bioethics.com » Blog Archive » I am creating artificial life, declares US gene pioneer

I am creating artificial life, declares US gene pioneer

Craig Venter, the controversial DNA researcher involved in the race to decipher the human genetic code, has built a synthetic chromosome out of laboratory chemicals and is poised to announce the creation of the first new artificial life form on Earth. ( The Guardian)

Nobel Season and a note on RNA

Nobel Season. In the Pipeline:

Interesting to note:

The Nobel in Medicine has gone this year to the inventors of gene-knockout techniques for mice, which seems well-deserved, considering how much has been learned through such experiments. This is, in fact, one of those discoveries that you'd think was already recognized by a Nobel if you hadn't been keeping count, which is as good a criterion as any. (It's rather odd, for example, that gene knockouts were recognized after RNA interference, don't you think, since a good ten or fifteen years separate the two in real life?)

My previous post noted that over 46,000 hits came up for "knock-out mice" search on PubMed.  Interesting, RNAi gets only 9868,  Certainly not a perfect measures but informative on some level. 

Nobel Season. In the Pipeline:

Nobel Season. In the Pipeline::

"... Wednesday morning is the announcement of the Chemistry award, so I'm throwing open the gates of speculation, as I do every year around here. Our track record (mine and the predictions in the comments) has not been very good, but nobody has a good batting average when trying to read the minds of the Nobel committees. I feel pretty safe in saying that this year will be a "real" chemistry prize - we're one out of the last four, compared to overflow from the nonexistent Nobel in molecular and cell biology.

So, who's it going to be? Last year's uninformed gossip is here, and there's plenty more over at Chembark. Put your bets down, but only with money you can afford to lose. . .

Update: Still more speculation."

Three Americans Win Noble Prize for Medicine

Two Americans and a Brit won the noble prize for medicine for their
work in gene targeting, a process using homologous recombination to
turn off a single gene. When used in mice it is known as using
"knock-out mice", as that gene has been knocked out. Having a single
gene, and only that gene, turned off helps to understand how that gene
functions.

The two Americans are Mario R. Capecchi and Oliver Smithies. Sir
Martin J. Evans is British.

To give an idea of how important this technique is today, a search on
pub med, the medical research literature database, for "knock-out
mice" gives you over 46,820 research papers.

Monday, September 10, 2007

New Cure for Depression: Fear (DrugWonks)

New Cure for Depression: Fear (DrugWonks): "'While some degree of decline in antidepressant prescribing was not unexpected after the black box warning was issued, few if any had predicted diagnosing to decline, or that other modes of treatment (psychotherapy or other medications) would remain relatively unchanged,' Dr. Robert J. Valuck told Reuters Health. 'It was thought that the latter two may increase to compensate for fewer antidepressant prescriptions being written.' That's worth repeating -- the black box warning has resulted in a decline not only in prescribing (no surprise there) but in diagnosis."
As patent reform is debated and makes it way through the congress it's good to have some background. This is the best example I could find of a nuisance suit.

Public Perception Of Biotechnology

Public Perception Of Biotechnology: "The term 'biotechnology' elicits a range of emotions, from wonder and awe to fear and hostility. Alan McHughen from the University of California in Riverside (CA, USA) now reviews public knowledge of biotech, popular misperceptions, scientific illiteracy and the role of the media. How is coexistence dealt with in the US and Europe? Who benefits from agricultural biotech -- only big companies or also the society at large? In the public interest, who is best suited to provide advice to weary consumers?

Find these answers in the latest issue of Biotechnology Journal, devoted to 'Talking Biotech with the Public' which will be entirely FREE for download during the month of September 2007, at http://www.biotechnology-journal.com/. "

SignOnSanDiego.com > News > Business -- Technology giants, banking firms win major victory with House approval of patent reform bill

SignOnSanDiego.com > News > Business -- Technology giants, banking firms win major victory with House approval of patent reform bill: "The Coalition for Patent Fairness and the Business Software Alliance, whose members include high-tech titans such as Apple Inc. and Microsoft Corp., lauded the decision as a boon for inventors and consumers. ...

Opponents of the bill included pharmaceutical and biotechnology companies, such as Johnson & Johnson and Amgen Inc., who say it weakens patent protection by reducing infringement penalties and permitting post-approval challenges to patents. ...

The Senate Judiciary Committee approved a similar version of the bill in July and it awaits a vote in the full Senate.

That bill includes a provision that would protect banks from damage awards in patent infringement cases involving electronic check-clearing technologies, such as check-imaging systems.

Banks have paid millions of dollars to settle allegations of infringement of such technologies, the American Bankers Association said in July.

"

Patent Docs: Patent "Reform" Bill Passes House of Representatives

More at Patent Docs:: "There are significant differences with the Senate version of the bill, which may come to a vote in the next few weeks. The Bush administration opposes certain provisions of the House version as well, and the political considerations make it unlikely that the bill as passed in the House will be the final version of any bill signed into law by the President. "
Patent reform passes the house.  This version isn't supported by biotech industry groups.  There's a good round up at California Biotech Law Blog.  The main problem, among others, is the limiting of damages for infringement.  Limiting of damages doesn't seem like a smart way to try to deal with over patenting.  Weak patents should not be issued and that reform needs to take place at the USPTO (has this problem been mitigated at all by the KSR decision?).  Huge damages is the only way or small companies to keep big ones with deep pockets from infringing. 


Off Label Juice

Health Blog : Hospital's Acoustic Makeover, Jocks Gulp Baby Beverage & Anemia Drugs Hit Again:

I've also noticed a lot of college kids buying it to cure hangovers. Who knew.
"As beverage giants add vitamins, electrolytes, bright colors and flavors to their bottles in search of the next best-seller, Abbott Laboratories has won some converts — without even trying. Scores of amateur and professional athletes are hooked on Pedialyte, a liquid meant to quickly rehydrate toddlers experiencing diarrhea, the New York Times reports . The fluid, which comes in bubble gum and other kid-friendly flavors, contains the basic ingredients in most sports drinks. Abbott doesn’t market its product as a sports drink, nor does it track its sales to athletes, but company doctors say they’re aware of off-label locker-room use and that Pedialyte does work on the field. “It’d be different if they were drinking formula,” the Minnesota Vikings’ coach told The St. Paul Pioneer Press last year. “But Pedialyte is used in hospitals throughout the United States for hydration. It’s different than just your regular sports drink.”"

Friday, September 7, 2007

Health Business Blog � Blog Archive � No biogeneric legislation this year

Health Business Blog � Blog Archive � No biogeneric legislation this year:

Biogeneric legislation is not happening just yet. And Health Business Blog adds:
"I’m hopeful that the biogeneric push –which apes the path taken for generic versions of traditional drugs– will be rerouted. The newer proposals are not terrible, but my preference is for price regulation of biotech drugs post-patent expiry. No biogenerics or “biosimilars,” no new clinical trials, FDA inspections and reviews. Rather, same drugs, same factories, same processes, lower prices."

Wednesday, September 5, 2007

RGJ.com: Popcorn maker changes butter chemical

RGJ.com: Popcorn maker changes butter chemical: "INDIANAPOLIS -- Weaver Popcorn, which sells 600 million bags of microwave popcorn a year, said Tuesday it is the first popcorn maker to develop an alternative to a chemical that provides the buttery flavor but could harm the lungs of workers who breathe it in at popcorn-packaging plants."

The smell of movie popcorn. Seems so unfair.

Tuesday, September 4, 2007

All Mapped Out - Forbes.com

All Mapped Out - Forbes.com: "Comparing the genes Venter got from his mom to those he got from his dad led to the banner conclusion of the paper on his genome: that people are more genetically different from each other than scientists expect. Venter's team of researchers found that whole genes were missing from one set of DNA, and that others repeated. Church points out that the differences were exactly what would have been predicted by previous studies of genetic diversity, including the government-funded HapMap project. The idea that people are basically clones of each other comes from big statements Venter and others made back in 2000."

So where does this leave Ventor's patent on a gene chassis?

Health Business Blog � Blog Archive � Are we really 99.9 percent identical? No.

Health Business Blog � Blog Archive � Are we really 99.9 percent identical? No.: "The 99.9% number that you hear about is bogus. The human genome has about 2 or 3 billion DNA base pairs. That is indeed about 99.9% similarity at the level of DNA base pairs, but if all of our DNA consisted of our ~20,000 genes and associated regulatory areas, the differences observed would average about 200 differences per gene. In practice, many genetic differences are outside coding areas, and many differences in proteins are relatively or completely silent when translated into proteins, but still the notion of sharing 99.9% of our genes is totally bogus. Sharing 99.9% of DNA base pairs is very different from sharing 99.9% of genes. It would be interesting if the paper actually runs the numbers of the number of genes that are identical at the amino acid level (this controls for redundancies in the genetic code). This probably comes as no surprise to most folks, who know that kids tend to look like their biological parents. But it will be a surprise to many people."

Putting some perspective on recent genetics news.

Sector Glance: Biotech Stocks Rise - Forbes.com

Sector Glance: Biotech Stocks Rise - Forbes.com:

"Porges also said the regulatory environment, despite some high profile safety driven labeling changes, is relatively benign for biotech companies.

'Biotech companies tend to be developing and marketing treatments for serious, often life-threatening illness. Such treatments are not subject to the same risks of rare serious side effects in broad usage,' he wrote."
I'm not sure I agree with that, but we'll see.

Tuesday, July 24, 2007

biosink: www.kansascity.com | 07/23/2007 | Kansas City lags in biotechnology investment

biosink: www.kansascity.com | 07/23/2007 | Kansas City lags in biotechnology investment: "www.kansascity.com | 07/23/2007 | Kansas City lags in biotechnology investment: 'Those investors, however, did not write any checks in Kansas, according to the report. They did back four companies in Missouri with more than $25 million, but the deals all were on the other side of the state.

Kansas City-area leaders recognize the challenge that companies in this region face when trying to obtain money for refining their technology, hiring executives or making other moves to advance their business.'"

One wonders what the country will look like when all of these local biotech encouragement efforts kick in.

FuturePundit: Low Cholesterol From Statins Slightly Boosts Cancer Risks?

FuturePundit: Low Cholesterol From Statins Slightly Boosts Cancer Risks?:
"I hear Joe Jackson singing:

Everything
Everything gives you cancer
Everything
Everything gives you cancer
Theres no cure, theres no answer
Everything gives you cancer"


I haven't read this study, but it seems to me that ALL THE TIME studies showing correlative data are reported with a "serious chance of causality" sort of tone. That plus the frequency of such stories are undermining people's interest in paying attention to cancer health.

Thursday, April 26, 2007

The Volokh Conspiracy - Regulatory Reform:

The Volokh Conspiracy - Regulatory Reform::
"Economists have long observed that regulators at, say, the Food and Drug Adminstration face unbalanced incentives. When people die because an unsafe drug got FDA approval, everybody blames the commissioners. When people die because a potentially lifesaving drug never made it to the marketplace (or was never developed in the first place because of costly regulations), the FDA's role is largely invisible. Therefore the commissioners are biased toward excessive caution."
A problem to be worsened by what will surely be riskier follow on biologics approval?

Wednesday, April 25, 2007

Pharmalot: Kennedy Circulates Biogenerics Bill

Pharmalot: Kennedy Circulates Biogenerics Bill:
"Ted Kennedy is reported to be circulating draft legislation which would provide an approval pathway at the FDA for generic versions of biotech drugs. His proposed bill would also provide a period of market exclusivity for brand-name biotechs before generic versions of their products could come to market.

The Democrat, who chairs the Senate Help, Education, Labor and Pensions committee, began circulating his proposals this month after the committee voted 15-5 in favor of the Food and Drug Administration Revitalization Act (S 1082), which he co-sponsored with the panel's ranking member, Republican Senator Mike Enzi.

That bill would reauthorise the Prescription Drug User Fee Act, which expires on September 30, for another five years, and increase by $50 million the amount which has been agreed between the FDA and industry to fund drug safety activities. It would not, however, create a biogenerics approval pathway at the FDA, although Kennedy forecast after the vote that this would be added before the bill goes to the Senate floor for a full vote, which he expected would be some time in June."
Still curious to see who takes the fall when we have the biotech generic equivalent of a Vioxx scandal. I don't think the supporting legislators who create the pathway should be off the hook.