Open the DNA Doors
Gottlieb, Scott
"Open the DNA Doors" BY SCOTT GOTTLIEB, M.D. So now we find out: The DNA used to make Celera Genomics' celebrated map of the human genome was not picked at random from anonymous donors, as...
...This is where Venter's blood sample becomes important...
...In the future, if government rules still allow scientists to access tissue samples, some of those accusing Mr.Venter of hubris could have the chance to pick apart his brain and try to understand what was really going on...
...But these pioneering efforts are threatened by new rules about to be adopted by the Department of Health and Human Services...
...While some Celera executives are chagrined that their former boss bypassed elaborate privacy safeguards, the company's lawyers should berelieved.WithVenter's DNA sitting in their database, Celera can sidestep some of the sticky social and legal questions that have hobbled other efforts to commercialize genomic information...
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...by fax: (415) 356-7804 En Visit our website at www.haverhills.com JULY/AUGUST 2002 • THE AMERICAN SPECTATOR 27...
...And, finally, a rigorously exercised brain will not develop Alzheimer's disease.This breakthrough book (soft cover, 460 pages, 8-1/2" x 11" format) will be your trainer and monitor to your new well-developed brain...
...Health and the National Cancer Institute...
...HOW YOU TOO CAN DEVELOP A RAZOR-SHARP...
...OPEN THE DNA DOORS BY SCOTT GOTTLIEB, M.D...
...Biotech companies say it can take up to nine months to finalize an agreement with an academic institution for a single tissue sample, due primarily to red tape...
...Its Probably this year's most important self-improvement book...
...So called "safe harbor" specifications—originally intended to address the use and disclosure of patient information for things like quality assurance audits of HMOs—have been broadened to regulate standards for research...
...sometimes they trolled the operating rooms and asked surgical colleagues: "Do you need that...
...By taking the next step—correlating genetic markers with tumor samples, what scientists call phenotypic data—scientists can identify proteins responsible for a cancer's growth...
...Genetic defects are often the cause...
...It recently used that data-base to discover a gene linked to Alzheimer's disease...
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...Many cancers, for example, occur when mutations activate so called oncogenes that cause uncontrolled cell growth by signaling cell proliferation...
...MIND AND A STEEL-TRAP MEMORY ~roi-cF lour I (;er4rito Joffe It is scientifically proven: Your brain is like a muscle...
...Sid Tuchman of Indianapolis, IN says: "What an astonishing hook...
...Some-times they quietly took it from their own patients...
...DNA information by itself only has limited value...
...This is genomic data, but it only answers half the question...
...Companies like Ardais render this black-market system obsolete...
...Exercise it vigorously and you will indeed bey able to develop a razor-sharp mind and a steel-trap memory...
...Its true worth emerges when these DNA markers are correlated against their donors' medical histories, especially in samples of their diseased tissues and organs...
...And it would effectively shutter private banking efforts, by redefining who can have access to the data...
...Finding a way to block these proteins is often pharmaceutically easy, and it is through similar efforts that we have breakthrough drugs such as Herceptin for breast cancer and even ImClone's Erbitux...
...This book may (really...
...And Lloyd Hammett of Winnfield, LA says: "If this book will not make you smarter, nothing will...
...It is the closest thing we have to a national standard for the collection and sharing of this vital data...
...It is a static picture of the body's complex machinery...
...What a deal...
...This research relies not only on DNA data such as Venters—taken from a blood sample—but also from pieces of tissue, such as cancerous tumors, the diseased pancreases found in diabetes or the placentas discarded from troubled births...
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...HHS is threatening to undermine all this, through rules included in the Health Insurance Portability and Accountability Act that would impose onerous burdens on how samples are procured and used...
...DNA data is crucial, but researchers also need actual tissue samples to isolate the proteins that triggered the disease and then find ways to neutralize them...
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...So now we find out: The DNA used to make Celera Genomics' celebrated map of the human genome was not picked at random from anonymous donors, as previously stipulated...
...change your life...
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...From his blood, scientists can discern the sequence of codes contained in his strand of DNA...
...The department has solicited opinions on how to modify its HIPAA (Health Insurance Portability & Accountability Act) regulations to accommodate the private tissue banks, but so far hasn't changed the draft rules...
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...There may even be a bonus of better sex and longer life...
...Facilitating that are a number of bold new commercial enterprises that collect and manage such samples and make the information available to researchers...
...Should Washington's busybody bureaucrats succeed, the result will be to hobble many of the most promising efforts at developing new drugs...
...In a diseased cell, this elaborate protein network is somehow disrupted, deranged or hyper-active...
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...Its source was none other than the company's flamboyant founder and erstwhile chief executive, Craig Venter...
...Working with the rest of the biotech community, these companies are developing powerful safeguards on donor confidentiality and uniform consents and computer programs to make accessing the tissues a breeze for researchers...
...Common rules championed by private firms and shared across research institutions have successfully addressed privacy concerns...
...One of the medical community's dirty little secrets is that good researchers always had access to the tissue they needed...
...Nor are any legislative fixes floating around Capitol Hill...
...Sometimes they looked to places like China, where money talks...
...But collaborations like this one can take a year or more to negotiate, which is time and money that energetic scientists would rather spend at their research tables...
...One of these companies, Ardais, is collaborating with many of the leading academic medical centers, as well as working in parallel with the National Institutes of 26 THE AMERICAN SPECTATOR • JULY/AUGUST 2002 Scott Gottlieb, a practicing physician, is a fellow at the American Enterprise Institute and author of the Gilder Biotech Report...
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...Genetic samples are the mother's milk of efforts to develop drugs that target our bodies' precise molecular machinery...
...In Iceland, a company called DeCode Genetics has one of the most extensive collections of population-based genetic information anywhere in the world...
...Segal would know, since his company relies on fresh tissue samples to carry out its innovative research...
...How You Too Can Develop a Razor-Sharp Mind...
...By stretchingVenter's sequence out and comparing it against other samples, they can search for telltale genetic markers that might be correlated with certain traits and diseases...
...The conventional wisdom in biotechnology circles is that if it's left up to Congress or to the bureaucrats of HHS, then the regulations will stand...
...But the process of collecting genetic material has been slowed by a patchwork of ill-conceived regulations...
...And getting access to those samples "is very rapidly becoming the biggest bottleneck for solving the most important medical problems," says Lloyd Segal, CEO of Caprion Pharmaceuticals, a Canadian-based biotechnology company that specializes in uncovering unique protein switches found on the surfaces of every cell...
...Sit in front of the tube, preferably with a six-pack and a bag of potato chips and it will turn flabby and quite useless...
...The new rules would require, for example, that genetic samples exclude certain health-related information, such as age or diagnoses—rendering the corresponding information useless to researchers...
...NUTS AND BOLTS Fast and full access to tissue samples is increasingly important as the drug discovery process increasingly leaves the level of the genome and zeroes in on the proteins involved in the nuts and bolts of managing bodily processes...
...In Europe, by comparison, uniform standards for collecting genetic information have spawned a thriving industry in the banking and sharing of this vital data...
...Like many such companies, Caprion collaborates on tissue sampling with an academic medical center—in this case, McGill University in Toronto...
...Indeed, one result of Mr.Venter's charity is to increase his body's value, since researchers around the world will undoubtedly want to try to correlate his DNA with actual pieces of his organs...
...Craig Venter's genome now sits on thou-sands of computers—does anyone seriously think we now know "more than we should" about his genetic history...
...But those advances will be for naught if HHS doesn't come to grips with the impact of what it's proposing...
...Hugh Cunningham, DDS, of Albany, GA says: "This is marvelous...
...So it's practically FREE...
...To understand the value of this information, take a hypothetical scenario duplicated in hundreds of biomedical labs every day.A scientistsearching for new ways to treat cancer collects DNA samples from people with the disease, then looks for telltale genetic markers that correlate with their propensity to develop tumors...
...We are the publishers of this book and are able to sell it for just $29.95...
...One can almost hear those brain cells crackle...
...30 days refund/return, except for shipping/insurance...
...In the United States, a half-dozen private tissue banks have sprung up in recent years, with the sole purpose of collecting patient DNA samples in what would normally have been discarded tissue...
...HHS's intervention would upend the uniform standards that have grown up in the private market and which enable the sharing of information between scientists...
...Their systems safeguard privacy by de-linking donors from their samples at the same time that they foster medical research...
...He's not likely to sue for having mishandled his own genetic data...
...That's where companies like Ardais come in...
...I already feel a whole lot smarter than before I immersed myself in Joffe's 16-Level Paradigm...
...Those who fear a "post-human" future, Big Brother and the boogeyman, should take heart knowing that the existing research framework has enabled elaborate systems for ensuring their privacy, adopted by companies that want to stay out of court...
Vol. 35 • July 2002 • No. 4
