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I think Celera is playing nicey nice with everyone. It is a good strategy. The HGP is falling on its face without any one helping. When the joke is out that they are complete buffoons (re: gene count, etc.) they will not have anyone to blame but themselevs. In the meantime, any postivie announcements in the market should benefit CRA.
Good articles in WSJ today:
interactive.wsj.com
interactive.wsj.com (below)
May 26, 2000
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New DNA Map Is Expected to Advance
Experiments in Gene-Based Medicine
This article was prepared by reporters Scott Hensley, Laura Johannes, Rhonda L. Rundle, Thomas M. Burton and Stephen D. Moore of The Wall Street Journal.
Sometime in the next few weeks, if all goes as expected, scientists at Celera Genomics Group will announce an achievement of historic proportions: a rough draft of the complete sequence of DNA letters that make up the human genetic code.
Already, some scientists are calling the achievement the biological equivalent of landing a man on the moon. Rough or not, they say, the draft signifies the ability to explore and map in exquisite detail the landscape of human DNA, a realm that, like outer space, was long considered unknowable.
The strands of DNA, spread across the 23 chromosomes in the nucleus of every human cell, comprise four chemical units, or letters, used over and over in varying chemical sequences. These replicated letters total three billion or so and form the words, or genes, that instruct cells to manufacture the proteins that carry out all the functions of human life. It is the very slight variations in the makeup of these genes that account for biological distinctions existing between individuals and that are responsible for much of the differences been sickness and health.
The new map is expected to vastly speed identification of the tens of thousands of genes, eventually providing scientists with a clear picture of the human genome, the sum total of all human genes. In the near future, gains from this knowledge are expected to include much-earlier diagnosis of life-threatening disease, new ways to prevent illness and drug therapies tailored to treat a person's unique genetic profile, thereby ushering in a new era of medicine.
See charts illustrating drug projects related to genome research
"We can only imagine a tiny fraction of the breakthroughs that will take place from this," says Craig Venter, president of Celera, which is based in Rockville, Md., and is a unit of PE Corp. "But it will be a catalytic event. It's like creating a new enzyme -- it will make discoveries go 1,000 times faster."
Such benefits notwithstanding, some researchers play down the importance of Celera's expected announcement. William Haseltine, chairman and chief executive officer of Human Genome Sciences Inc., also based in Rockville, Md., calls it "more a psychological milestone" than a scientific breakthrough.
"It will symbolize to many people that we have the power to change human destiny," Dr. Haseltine says. "But the power is here, and it's already being used."
Indeed, several large and small pharmaceutical companies are already testing the first experimental drugs to arise from gene-based medicine. These therapies, to treat asthma, aging, cancer and wounds, are specifically designed to exploit genes that have recently been found to play crucial roles in these conditions.
Sequencing the genome is "clearly a milestone; but it's the first mile in a marathon," says Douglas E. Williams, chief technology officer at Immunex Corp. in Seattle. Nearly all biotechnology companies have specialists who comb computer databases looking for intriguing patterns in the DNA sequence. Already genomics is "far and away the dominant approach to identifying new candidates for drug development," Dr. Williams declares.
Immunex, for example, is developing a drug aimed at osteoporosis and cancer that was first spied in a snippet of DNA, Dr. Williams says.
The first wave of gene-derived drugs will probably hit the market in about five years, Dr. Williams predicts. Human Genome Sciences, for instance, is clinically testing three drugs discovered directly from the already existing genetic code. The furthest along are a factor that appears to speed healing of ulcers on the skin and digestive system and a protein that shows promise in curbing certain side effects from chemotherapy. Also in clinical trials is a protein that spurs growth of new blood vessels to feed the heart and other muscles.
But many other treatments will take much longer. That's because researchers must understand how a specific gene causes disease before they can develop effective drugs, and that will take time.
Meantime, as Celera prepares its announcement, researchers working for the Human Genome Project, a publicly funded international consortium formed in 1990, are on the verge of reaching an important goal of their own: completion of a working draft of a map that will cover 90% of the length of human DNA.
Francis Collins, who directs the U.S. government's National Human Genome Research Institute, says that with a working draft of the genetic code, researchers can come up with "pretty good answers" to many important questions. He notes that epilepsy researchers recently found a mutation of a gene on chromosome 2 that explains a hereditary form of the neurological disease.
Dr. Collins expects the public project will publish sometime late this summer or early fall. Celera's Dr. Venter also is aiming for publication late this year, which will be the first time his company's map will be available for study.
The parallel efforts of Celera and the public project have been called a race by some, though scientists involved in both programs bristle at the characterization.
"Everybody in the world has more data than the public [project] because we give away our data, and we are proud of that," says Eric Lander, who runs the largest of the government-funded genome-research centers at Whitehead Institute for Biomedical Research in Cambridge, Mass. "Because we give away our data freely, we can't win any race, and for the same reason, we can't lose any race."
More important, Dr. Lander says, is that the completed DNA sequence map is only the beginning of the quest to make sense of human genes. If you compare the project to compiling a dictionary, he says: "We are barely at the point where we have the lists of words and not the meanings. There are words left out of the dictionary. There are misspellings. It is silly to make a whole big party when we get to the word zephyr or Zuni."
Understanding which stretches of the code are important will take decades, Dr. Lander says. Genes, the prime targets for scientists seeking to understand disease and find new drugs, account for only 3% of the code; the rest is what scientists once called "junk DNA" -- long stretches of DNA gibberish whose role in human biology is still unclear.
For the time being, however, the Celera results combined with those of the government's genome-mapping project will provide "a nice blueprint that will be of enormous value to those of us trying to discover new drugs," says Steven M. Paul, group vice president of Eli Lilly & Co.'s Lilly Research Laboratories.
Lilly already is working with scientists at Columbia University and elsewhere to pinpoint the genes involved in diabetes.
Yet Dr. Paul cautions that finding a key gene doesn't guarantee that a new drug will follow. Six years ago, the BRCA1 gene linked to some breast cancers was identified, yet no marketable drug based on the discovery has emerged. The gene for cystic fibrosis was discovered in 1989 and, despite massive research efforts, there is still no cure.
Even before new gene-derived drugs are found, clinicians expect to be able to diagnose medical problems at the molecular level and individually tailor therapies. Small computerized chips the size of a postage stamp are already capable of holding a person's entire genetic code, when that becomes available, and can even tell whether particular genes are turned on or off.
These chips, made by Affymetrix Inc., can be used today to hold identified parts of the genetic code, but they are expensive -- as much as $1,000 to $2,000, says Richard Young, a professor at the Massachusetts Institute of Technology and a researcher at the Whitehead Institute But the price will fall, he predicts, and they will be widely used diagnostic tools by 2010.
Even now, Millennium Pharmaceuticals Inc. is close to commercializing a genetic test that will predict whether skin cancer is likely to spread throughout the body. Millennium and Bristol-Myers Squibb Co. have just launched a major alliance to individualize cancer therapies based on genetic profiling of patients.
In the common but clinically perplexing condition of asthma, scientists have identified two genes that appear to predict which drugs are most likely to provide relief. "Asthma is probably a half-dozen clinical disorders that have the same presentation" of shortness of breath, says Jeffrey Drazen, a pulmonologist and incoming editor of the New England Journal of Medicine who has worked on tests to better categorize asthma sufferers. Genetic tests that match the best drugs for each patient will be commercially available in three to five years, he predicts.
One of the great hopes is that the new genetics will lead to completely new types of therapy. Genzyme Corp. recently used a combination of genomic information and traditional research techniques to identify a protein commonly found in ovarian, lung, prostate and breast tumors -- a discovery it is now using to design a vaccine. Identifying the protein took less than three months. Without genomics, the same work "would have taken a year or two or more," says Gail Maderas, president of Genzyme's molecular-oncology division.
Some companies such as Millennium are relying almost entirely on genetic approaches to discover drugs. The Cambridge, Mass., company is studying 10 genes it believes play a role in obesity -- many of which it discovered by finding the mutations that cause strains of enormously fat mice.
Millennium's research partner, Hoffmann-La Roche Inc., is moving full-steam ahead on translating some of its early discoveries into drugs. Furthest along is the search for an oral drug that will enhance a protein believed to both reduce appetite and speed metabolism, says Joseph F. Grippo, senior research director of metabolic diseases at Hoffmann-La Roche. The company is tinkering with several drug candidates, and hopes to have one ready for human trials by the end of next year.
The new DNA mapping technologies are "already having a major impact on the rate of discovery of new drug targets," says Roy Whitfield, chief executive officer of Incyte Genomics Inc. in Palo Alto, Calif. In the future, "we'll be able to fine-tune drugs to make them more effective, and personalize them to work in individual patients.
Analysts believe SmithKline Beecham PLC already has begun development of drugs against eating disorders and hypertension that are aimed at targets identified by genomic analysis. The company declines comment, citing restrictions imposed by its pending merger with Glaxo Wellcome PLC.
Last week, officials of French drug company Aventis SA said at a research update in London that the company has advanced its first genomics-derived compounds to preclinical development, the final phase before a drug begins human trials. The first Aventis medicine derived from genomic analysis targets a cardiovascular disorder, says Errol de Souza, head of U.S. research operations, but he declined to elaborate.
Taken together, these genetic advances will have "an extraordinary impact on medicine and health care, and are likely to make them more complex," says David Lawrence, chief executive officer of Kaiser Permanente, one of the nation's biggest health-maintenance organizations, based in Oakland, Calif. Standard dosing of medicines, which is based largely on patient weight today, will give way to widely varying doses based on genetic insights, he says.
Yet the health-care system is already struggling with the cost and complexity of modern medicine, Mr. Lawrence says, and the expected explosion of genetic information will only compound the challenge for clinicians.
Further, the very power of the coming genetic tools demands proper protections for patients, says Arlene Judith Klotzko, a bioethicist and lawyer in the UCLA School of Medicine's program on medicine, technology and society.
Dr. Klotzko points out that genetic profiles that will identify an individual's susceptibility to disease could be abused if health or life insurers are able to use them to discriminate against prospective customers. In the hands of employers, such information could be used to disqualify people from certain jobs.
"We hear about personalized medicine, and the possibility of being screened for 20 diseases at once," she says, "but right now I wouldn't do it."
Dr. Klotzko and others say that while the promise for human health is incalculable, the public also should be alert to the potential for peril, too. Both, she suggests, will bear very close attention as scientists continue their relentless unraveling of mysteries locked within DNA.
For now, even with all the astonishing progress that has been made in deciphering the genome, scientists still can't even say how many genes humans have. Estimates range from 28,000 to 200,000.
This month, genome specialists meeting in Cold Spring Harbor, N.Y., placed more than 200 $1 bets in a sweepstakes for how many genes make the recipe for human beings. The average of the wagers was 62,598 genes. A winner will be decided in 2003. Even then, scientists don't expect to have a full list of all the genes until the year 2010 at the earliest, and it likely will be decades more before researchers understand what the genes actually do.
Write to Scott Hensley at scott.hensley@wsj.com, Laura Johannes at laura.johannes@wsj.com, Rhonda L. Rundle at rhonda.rundle@wsj.com, Thomas M. Burton at tom.burton@wsj.com and Stephen D. Moore at stephen.moore@wsj.com |
