BIOTECH COLUMNS
San Francisco Business Times



August 25, 2006

Pharmaceutical company gives new meaning to 'spin doctors'

I would like to propose what I call the Moyers' corollary of scientific research.

I use the term in part because what inspired me was a speech journalist Bill Moyers delivered last year to the National Conference for Media Reform. In the speech, Moyers was talking about how journalists allow government to "spin" the news by failing to do more than repeat what officials in Washington say -- in other words, not subjecting those pronouncements to scrutiny, and failing to give readers the context and background to make sense of them. He said, "I came to see that news is what people want to keep hidden and everything else is publicity."

A recent study led by Michael Steinman, a staff physician an at the San Francisco VA Medical Center and an assistant professor of medicine and the University of California, San Francisco, makes me think there's a corollary in the world of scientific research and continuing medical education programs. For as it turns out, science is far from immune from "spin."

 

August 18, 2006
UCSF researcher targets biology that doesn't want to be targeted

When the pharmaceutical industry sets out to develop a new drug, it often starts with a specific target in mind.

A target is something in the body a drug can inhibit or otherwise modulate by binding to it as a way to interrupt the biochemical activity underlying a particular illness. Think of targets as locks and drugs as keys that fit into them.

There are many other issues on the way to developing a new drug such as potency, toxicity and whether that key fits into only the lock for which it is intended, rather than into other locks too, causing unwanted side effects. But the search for a new drug often begins with an automated process known as high-throughput screening, where thousands and sometimes millions of compounds are thrown at a desired target one at a time to see what sticks.

 

August 11, 2006

Small biotech sees opportunity in developing a new antibiotic

Johnson & Johnson's acquisition of Peninsula Pharmaceuticals received a lot of attention last year, largely because IPO-ready Peninsula changed its mind about going public and decided to be acquired instead.

What received less attention at the time, though, was the potential blockbuster J&J left behind for Peninsula executives to build a new company around.

Alameda-based Cerexa Inc., the spin-out of Peninsula, just announced positive data from a mid-stage clinical trial for its drug ceftaroline, a broad spectrum injectable antibiotic. It hopes to present data from the trial in a late-breaking session at the American Society for Microbiology's 46th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy in San Francisco next month.

 

August 4, 2006
Men are from Mars, women from Venus, drug firms from Pluto

From time to time, my wife and I engage in scientific discourse about the nature of her brain and mine.

On these occasions, I suggest that her estrogen-soaked noggin causes her to exhibit the behavior of a female dog that lacks the ability to distinguish fantasy from reality, although maybe not in those exact words. In response, she will throw out some fancy medical jargon like "anal-cranial inversion" and note that the presence of a Y chromosome within my cells has left me dumber than wood.

Turns out we may both be right, and that's something the biopharmaceutical industry needs to recognize.

 

July 28, 2006

Bush, called enemy of stem cell research, may be its best friend

I'm going to go out on a limb and say that George W. Bush is not a favorite among people with spinal cord injuries, Parkinson's disease and other ailments for which embryonic stem cells hold out hope.

Bush paused long enough from kissing "snowflake" babies (children born from frozen embryos) to veto legislation that would have eased restrictions he put into place on federal funding of embryonic stem cells. The legislation would have significantly expanded the availability of embryonic stem cells by allowing the use of excess eggs donated for in vitro fertilization procedures to be used in federally funded research.

But before supporters of embryonic stem cell research grab torches and pitchforks and head off to Washington, I suggest they write a letter thanking the president for his actions. You can argue that Bush has done more than anyone else to create funding for embryonic stem cell research. His veto -- the first of his presidency -- will continue that trend.

 

July 21

Medical device to ensure docs take their scalpels with them

In 2002, security guards at an airport in Regina in the Canadian province of Saskatchewan searched a woman after she set off a metal detector, but they were unable to find a thing.

A few days later, she had an X-ray as part of an effort to determine why she suffered from ongoing abdominal pain, according to a Reuters report at the time. The X-ray revealed she had been walking around with a 12-inch long and two-inch wide surgical retractor that had been left inside by surgeons who had performed abdominal surgery on her four months earlier.

Before a patient is sewed up in an operating room, staff take an inventory to make sure they account for all of the items used in the procedure. As the Canadian woman could tell you, the method is vulnerable to human error.

 

July 14, 2006

Researchers' findings may lead to treatment for Down syndrome

It's easy to think of the little white mouse from the novel "Flowers for Algernon" when reading about research at Stanford University that holds the promise of one day preventing or reversing the cognitive decline in people with Down syndrome.

Down syndrome, the result of a chromosomal abnormality that afflicts 350,000 people, is the leading cause of mental retardation in the United States.

While it's long been understood that people with Down syndrome have an extra copy of chromosome 21, there's been little research to understand it at the molecular level to search for possible therapies to treat its effects.

 

July 7, 2006

Pharmaceutical industry not yet hip to power of blogging 
July Pharmaceutical industry not yet hip to power of blogging

Peter Pitts describes himself as a "faithful blogger."

He is perhaps better described as a blog evangelist who is trying to show the light to the pharmaceutical industry about the righteous path of blogging.

Brothers and sisters, le'me hear you say "Yahoo!"

 
June 30, 2006

Art imitates science for painter inspired by microscopic views

I find I prefer Xanax to Zoloft. The colors are brighter, the light seems to dance and it's oddly calming.

I speak here not of the pharmaceuticals, but the works of San Francisco painter Klari Reis that bear their names.

Reis, 28, may not be the first artist to paint her drug-induced visions, but hers are unique in that she relies on the use of an electron microscope rather than psychoactivity to draw her inspiration.

June 23, 2006
New funds to offer investors a tiny slice of biotechnology pie

Bill Kridel wants to give you exposure to cancer and only cancer, if that's what you want.

If neurodegenerative disease is more your speed, or cardiovascular disease is what you're in the market for, he thinks you should have that choice. Or, if you prefer, get them all.

Kridel is not an evil geneticist, but a Wall Street wizard. His international investment banking firm Ferghana Partners may not have the household-name recognition of retail brokerage houses, but within the life science industry he is a well-known figure specializing in life science mergers and acquisitions, divestitures and private placements.

 
June 16, 2006

Red Sox-Yankees style rivalry emerges between drug firms

Coca-Cola has Pepsi Cola, the Yankees have the Red Sox, and Tercica has Insmed.

After 20 years without a new drug approved to treat severely short children, pediatric endocrinologists suddenly have two new and similar drugs to choose from for patients who don't respond to human growth hormone.

South San Francisco-based Tercica began marketing its drug, Increlex, at the start of the year. It's a hormone replacement therapy of recombinant human insulin-like growth factor-1 or IGF-1. Richmond, Va.-based Insmed joined the fray this month with its drug, Iplex, a recombinant human IGF-1 and a second that binds to it known as BP3.


June 9, 2006
Approval of generic drugs creates headache for the FDA

The U.S. Food and Drug Admin­istration's recent approval of a generic biotechnology product is anything but a generic OK.

The green light for Omnitrope, a form of recombinant human growth hormone produced by Novartis AG's generic subsidiary Sandoz, ends a three-year effort by the company to win approval for the drug. Omnitrope in recent years fueled a high-stakes fight in the biotechnology industry over how difficult the FDA should make the approval process for generic biologics, and its approval is now reigniting that battle.

Though the FDA completed its review of Omnitrope in August 2004, it told Sandoz at the time it was unable to make a decision on approval because of unresolved legal and scientific issues. The FDA only approved the drug after a federal judge in April ordered the agency to act on the application.


June 2, 2006
Genentech drug may get out your stubbornest type of tumors

Genentech should put the OxiClean pitchman under contract and start marketing Avastin as the cancer drug with 1001 uses.

That may seem a bit premature, at least from the point of view of sticklers like the U.S. Food and Drug Administration, but it's not too early to plan, given all of the clinical activity around Avastin.

Colon cancer? Avastin it! Lung cancer? Avastin it! Breast cancer? Avastin it! See those bubbles? That's the secret anti-angiogenic power of Avastin going to work choking off the tumor's blood supply. (I don't know if Avastin bubbles, but if Genentech goes the TV route, it should put some baking soda or Pop Rocks into the mix to get it to bubble because it makes for a good visual -- something the brainiacs in the lab often overlook).

 

May  26, 2006

Early-stage researchers have tough time digging up funding

Earlier this month Dale Bredesen walked into the auditorium of the Buck Institute for Age Research to take a look at a new slide projector, but instead found himself greeted by his staff yelling "surprise."

The staff had gathered for a ceremony to present the CEO of the Novato-based institute a plaque commemorating the first patent awarded to the 7-year-old institute, which has 38 others pending.

The patent relates to inhibitors and inducers of paraptosis -- a new pathway involved in cell death discovered by Bredesen and his research team. The discovery of the pathway could lead to new treatments for cancer and neurodegenerative diseases, but the patent's immediate value is symbolic.


May 19, 2006
UC partnership builds bridges between M.B.A.s, device makers

Sometimes chance meetings have a funny way of leading to great things, but credit an enterprising M.B.A. student to know better than to leave a chance meeting to mere chance.

Last fall, Dan Brounstein, who became a student at the UC Berkeley's Haas School of Business after eight years in the medical device industry, had just been rejected in his efforts to become a Mayfield Fellow, a fellowship established by the venture capital firm The Mayfield Fund that exposes students to the world of high-tech startups by sending them to work for a portfolio company.

Brounstein thought it would be great if there were a similar program for students interested in entering the medical device industry. So when Bill Harrington, a partner with the venture capital firm Three Arch Partners spoke at a BioEntrepreneurship dinner that Brounstein helped organize, he placed himself on the seating chart next to Harrington.


May 12, 2006

Working on chimeras could put scientists in the doghouse

In my younger days I learned to spread my wings. There have been times when I've run with my tail between my legs. And I know my children would tell you my bark is worse than my bite.

Maybe that's why I don't get too worked up over talk of chimeras, the blending of human and non-human genetic material into a single organism. Beyond the specific controversy today surrounding chimeras is a more critical question about how science should be regulated.

For some, chimeras stir up nightmarish images of the Island of Dr. Moreau where scientists conjure up strange beasts that are not registered to vote. Among those critics is Sam Brownback, a Republican senator from Kansas who authored a pending bill that would criminalize the creation of certain chimeras.


May 5, 2006

Scientists feel deflated as NIH research bubble starts to pop

I never get too excited about bubbles, unless of course you are talking about the champagne stylings of Lawrence Welk.

As a breed, though, journalists love to look for bubbles. We love to blow them up big and then stick a pin in them and watch them go pop. First there was the dot-com bubble. More recently, there appears to be a race to the housing bubble (mostly by bitter journalists shut out of the Bay Area housing market).

Nevertheless, here I go. Ah-one, ah-two...

Benefits of research add up

April 28, 2006

Blame Stanley Cohen and Herb Boyer. It's their fault.

If there's a fight over how the California Institute for Regenerative Medicine should structure its intellectual property rules or if the University of California is the subject of criticism from industry and attorneys for being difficult, blame Cohen and Boyer.

Actually, don't blame Cohen and Boyer the people, blame Cohen-Boyer the patent. Held jointly by Stanford University and the University of California, the fundamental gene-splicing patent gave rise to the biotechnology industry.

It also gave rise to the notion that "technology transfer," the process of licensing out university inventions for commercial development, could be a cash cow.

April 21, 2006

University and nonprofit show power of combination therapy

Consider a global health problem and the high cost of producing the most effective drug to treat it.

Now add to that the obstacles of commercializing technology developed at a university and the general unwillingness of venture investors to invest in a startup company looking to develop a new platform technology.

Each of those poses a daunting challenge by itself, but a university researcher, a startup he helped found, his university and a Bay Area nonprofit seemed to have figured out a way to address those problems all at once.

April 14, 2006
Biotech bigwigs sweating over threat of U.S. price controls

The world is not round, it's flat. Red carpeting, not water, covers most of its surface. I know because this week I walked the four corners of the world -- actually, there are more like five.

What's more, the United States consists of 42 states and there are only 35 countries in the entire world. To travel from New York to Canada, you have to go through Japan. The temperature is a comfortable 68 degrees no matter what country you are in. If you need a break from your globetrotting, off the coast of Singapore there's a stand selling Starbucks.

Every year I get a new map of the world. They're not like the ones from Rand McNally. My new map is of the exhibit hall of the BIO 2006 convention, the largest annual gathering of the biotechnology industry. As 18,000 people gathered in Chicago from April 9 through 12 at McCormick Place South, states and countries touted their wares to an industry that economic development directors covet the world over. Here you can see how deeply valued the biotechnology industry is. You can feel the love.



April 7, 2006

Pray that science finds the truth behind our assumptions

Science has the ability to challenge our beliefs. Sometimes it does that in big ways -- challenging our notions about the very nature of what it means to be human.

Sometimes it does so in smaller ways that force us perhaps to acknowledge that as much as we hoped some things were true, they simply are not.

Two studies that have received a fair bit of attention in recent days are challenging some widely held beliefs in small ways. One reports that drinking isn't as good for you as studies have suggested and the other that praying for heart patients did not help them and, if they knew about the prayer, they actually fared worse.


March 31, 2006

Genentech finds high drug prices stick to teflon image

During Genentech's annual investor meeting in March in New York, CEO Art Levinson made an unusual pitch to analysts and investors.

He touted the fact that EBay, Adobe and Microsoft all boast bigger profit margins than Genentech.

Though it's not the typical point you'd expect a CEO to make to Wall Street, Levinson was not trying to convince the audience that there were more attractive investments for them. Instead, he was trying to assure the room that Genentech was not gouging cancer patients.


March 24, 2006

Bid for Chiron highlights CEO's uncertain future at company

Chiron's problems with contamination at its Liverpool flu vaccine plant, though resolved, have overshadowed Howard Pien's tenure as CEO.

The flu vaccine troubles helped secure Pien the dubious distinction from BusinessWeek of being named among the worst managers of 2004. And the Business Times named him the Bay Area's most over-paid CEO in 2004.

When I have asked people who know the Emeryville-based biotechnology company why Pien hadn't been fired, they have consistently answered along the lines of "I've been wondering the same thing myself."

So when I read a letter the other day from a Chiron shareholder to the Chiron board, I wasn't surprised that it threatened to lead a campaign to oust Pien. What did surprise me is the case it made based on his positive performance as CEO. Have people failed to see Pien's accomplishments? Does Pien stink, or is he just misunderstood?


March 17, 2006
Research challenges idea that minorities shun clinical trials

Last year when federal regulators approved the drug BiDil for heart failure specifically in black patients, it pointed to an age of personalized medicine when the efficacy of drugs is increasingly seen as tied to the genetics of a patient.

But it also highlighted an ongoing concern among researchers about the difficulty of enrolling minorities in clinical trials.

A diverse group of clinical trial participants can help answer not just whether a drug works, but also for whom.


March 10, 2006
Science has no easy answers for symptoms of menopause

I am not looking forward to menopause. It's not that I'm planning on going through it myself, but I know someday my wife will make that passage, and she'll be taking me along for the ride.

So it is with some personal interest that I read "The New Menopause Book" (Avery), edited by three women's health experts at Bionovo Inc., an Emeryville-based biotechnology company working on an alternative to available hormone replacement therapies.

The book, which includes chapters from a variety of experts, explores hormone replacement therapy and also other approaches ranging from herbal medicine to yoga. It is intended to help women make decisions about how best to cope with the health effects of menopause.


March 3, 2006

Investors have yet to embrace tool to identify rare viruses

A few weeks ago, a 28-year-old woman showed up in the emergency room of Stanford University Medical Center with fever caused by what appeared to be a virus.

The woman had been healthy, had not been traveling and did not suffer from any conditions that would compromise her immune system.

Doctors used available diagnostics, but they were unable to find a positive result for a virus. They spent more than $100,000 on the patient, which included an invasive open-lung biopsy, in the hopes of identifying the cause of her illness. They tried treating her with a variety of antibiotics and antivirals. By the third day, she slipped into acute respiratory failure and came close to dying.


February 24, 2006

Will you be alive in four years? 12 questions seek one answer

If you knew that you were going to die soon, what would you do? Try skydiving? Take a cruise around the world? Skip having that colonoscopy?

That last question is the type that Sei Lee hopes to provoke, at least among those for whom the bell may be tolling a little sooner then later -- within four years, to be precise.

Lee, research fellow at the division of geriatrics at the San Francisco VA Medical Center, is the lead author of an article in the Journal of the American Medical Association that describes an index he and other researchers created to predict the likelihood that someone age 50 and older will die within four years -- with 81 percent accuracy.

February 17, 2006

Gilead takes heat over efforts to provide AIDS drug for poor

It's not unusual for Gilead Sciences to find itself the target of criticism. Third-world prostitutes slapped it around over a drug trial, Brazil roasted it like a coffee bean over drug prices and AIDS activists out it whenever they feel it falls short of its responsibilities.

Now a humanitarian group of doctors are giving it a bilingual tongue lashing as they yell "J'accuse!"

The Foster City-based biopharmaceutical makes the critical AIDS drug Viread, and the politics surrounding the disease often puts Gilead, the guys who have the drug, at odds with the patients who need it. Gilead has appeared to take the notion of good corporate citizenship seriously, but this controversy may be more than a matter of no good deed going unpunished.


February 10, 2006
Researchers working to bring TB testing out of 19th century
On most mornings I can be heard in my cubicle with a hacking cough that sounds like someone with a three-pack-a-day habit trying to birth a piece of lung.
I'm not a smoker, just asthmatic. I have tried to reassure my colleagues, telling them it's just my TB acting up.
For a long time, the cubicles near me sat vacant. Colleagues tried to assure me that it was merely my poor hygiene or the way I constantly muttered vulgarities at my computer like a deranged street person that kept them away. But I fear they may have taken my TB joke too seriously -- with good reason.

February 3, 2006
Stem cell research gives rise to donation ethics conundrum
Donating sperm is not just quick and painless, but getting paid to view a sampling of contemporary adult cinema while engaging in an act of autoeroticism in the name of science approaches many a young man's notion of a dream job.
The thought of egg donation, on the other hand, is enough to make a grown man cry (assuming, of course, that the grown man has a pair of ovaries).
A woman who has been approved for egg donation must subject herself to weeks of daily injections of hormones to stimulate production of eggs. With this can come discomfort and pain. When the eggs are ready to harvest, a needle is inserted through the top wall of the vagina and into the ovary to remove them. This is repeated to remove one egg at a time.

January 30, 2006
S. Korea stem cell scandal has scientists doing soul searching
Religion may have claimed the domain of the soul, but lately it's been scientists that have been forced to do some soul searching.
Though this usually happens in very private moments, Donald Kennedy, editor in chief of Science magazine got to do some of this in public at a recent symposium on the ethical issues surrounding stem cell research that go beyond the highly publicized debate over the status of the embryo.
At issue was the publication of two now-discredited stem-cell papers from South Korean researchers.

January 23, 2006
New FDA rules could cut cost and time for drug approvals
In 1937, S.E. Massengill Co.'s Elixir Sulfanilamide was an effective treatment for sore throats in people with streptococcal infections, so much so that it created demand for a liquid formulation that could be given to children.
The company developed a sweet-tasting version that used diethylene glycol. Patients who used the liquid found their sore throats disappeared -- along with their pulses. Diethylene glycol is better known today as antifreeze and ingesting it carries lethal consequences.
The company hadn't tested the safety of the liquid formulation of its drug and 107 people, mostly children, died painful deaths from its poisonous effects before the U.S. Food and Drug Administration was able to gather and account for every drop.

January 13, 2006
Man's best friend may hold key to sniffing out certain cancers
It's hard for me to grasp that my dog's nose is a finely tuned instrument with the sensitivity to detect concentrations as low as parts per trillion given his proclivity to stick it in places my own dulled sensor has the good sense to avoid.
But researchers at the Pine Street Foundation in San Anselmo have found that beneath those wet snouts may lie clues to developing means of early detection of certain cancers.
In a peer-reviewed study to be published in March in the journal Integrated Cancer Therapies, researchers report ordinary dogs put through a simple three-week course of training were able to accurately detect all stages of lung and breast cancer from samples of patients' breath

January 6, 2006
Unloved by most, pesky termites may hold key to alternative fuels
Termites are a scourge to homeowners -- unredeemable wood eaters fit only for the business end of a can of Raid to exterminators. But to some scientists, these vermin may hold a key to freeing us from our dependence on oil.
At the Department of Energy's Joint Genome Institute in
Walnut Creek, scientists are working to sequence the genome of microbes that live in the hindguts of termites. It is these microbes that allow the pesky creatures to be highly efficient bioreactors capable of transforming a single sheet of paper into two liters of hydrogen.
My wife has told me I too am an efficient bioreactor capable of producing large amounts of methane in my sleep. She, on the other hand, never does, but curiously my dog always seems to when she is around, but that's another story.


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