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Personal Genetic Profiles Hide the Real Story

By Ryon Graf
Less than a decade after the human genome was decoded and made available to the public, a new novelty has arisen: personal genetic screening. California-based Google biotech startup 23andMe and Icelandic deCODE Genetics have developed a service to provide personal information about your genome. This includes testing for links to genetically inheritable traits, including diseases like breast cancer and Alzheimer’s, as well as other traits ranging from personal I.Q. to vegetable taste preferences and music learning potential. The cost for this service is just under $1,000, or within reach of the average consumer.

Making this information so easily available to the general public is dangerous and has the potential to be very individually damaging. Genetic screens do already exist and are in wide use, except these are usually administered in a clinical setting with a physician or genetic counselor present to put the results in context.

The new technology does not actually scan the responsible genes themselves. It scans known SNPs (pronounced “snips”), or single-nucleotide polymorphisms. These can be thought of as trademark patterns in DNA that are known to be closely associated with a certain genotype, or genetic makeup. Although testing with SNPs can often give great insights into whether you have a good or bad version of a particular gene, it is by no means comprehensive. A genetic disease can result from problems with one of many genes, or from different versions of the same gene that might or might not be associated with the right SNP. It is not the end-all proclamation that a disease or health risk is imminent, or that personal health or personal potential is written in stone.

Knowing one’s genetic makeup might cause an unnecessary state of alarm, or lure someone into a false sense of security. The vast majority of diseases that have a genetic component can often be overshadowed by environmental or lifestyle factors. The absence of genetic red flags for heart problems is not a license to eat too many cheeseburgers. Having no genes for breast or prostate cancer does not make physicals and check-ups obsolete. These tests do not screen for all genetically determined factors of a particular trait, either because there is not a known SNP for a particular gene, or there are important genes that are still unknown.

It is also not too hard to imagine a scenario where one’s testing reveals a genetic susceptibility to a chronic disease, such as cancer. The results might generate an unnecessary state of fear. People often fear the worst, especially with an ambiguous result. It is very difficult for the average citizen, with no training in medicine or molecular genetics, to be able to put the results in perspective, as many people would be prone to jump to conclusions. These tests are not a black-and-white physician’s diagnosis, but a gradient of gray encompassing an incomplete scope of risks and factors.

For people that have not yet reached their potential or set their path in life (like myself and most people reading this) there is the possibility of being impaired by the results. Imagine a compassionate kid with great leadership and people skills who never pursues his or her dream of medicine because she does not have the SNPs for high intelligence. Too much faith in genetic predetermination could be very damaging.

This summer I had the opportunity to meet and talk to Dr. James Watson, Nobel Laureate and co-discoverer of the structure of DNA. He is also the first man to ever have his complete personal diploid genome sequenced, which was released to the public earlier this year. Unlike SNPs, having one’s entire genome decoded makes the risks for genetic diseases and conditions much less ambiguous. In a casual conversation he was asked if, having known what he knows now about his genome, he might have changed his lifestyle. He had recently found out that he was supposed to have developed macular degeneration by the age of 50. Approaching 80 years of age, his eyes still work. It is amazing what we know about our own genes and genetic diseases, but this knowledge is not all-encompassing, and the results are still best interpreted by a genetic counselor or physician.

The last 50 years have yielded monumental strides in man’s understanding of his own DNA. Genetic diseases can now be screened for and many adverse effects can be avoided. It is hard to convey the magnitude of what is known about our genes and what they do. Personal interpretation and application of this knowledge has a number of challenges and dangers on its own, especially without proper context. There exists the dilemma of knowing too much about our genetic potential, or taking the results too seriously. Tools yielded by technological progress can easily outstrip proper application, and in this new age of personal genetic screening, caution is needed.

Ryon Graf is a fourth-year genetics major. He can be reached at rgraf@uci.edu."

Daily Herald | Abbott pipeline may produce strong earners next year

Daily Herald | Abbott pipeline may produce strong earners next year: "

New uses for a strong-selling drug and high hopes for the U.S. launch of a profitable medical device have Abbott Laboratories, the No. 3 U.S. health-care company, poised to remain a dominant player in its global industry.

Analysts forecast a double-digit profit increase next year for Abbott, especially in its lucrative pharmaceuticals business, which accounted for 57 percent of its 2006 revenues.

In the first nine months of this year Abbott earned $2.4 billion, already topping full-year 2006 earnings of $1.7 billion that were depressed by costs associated with its $3.7 billion acquisition of Kos Pharmaceuticals Inc., a producer of cholesterol treatments.

Shares of Libertyville Township-based Abbott jumped 27 percent last year and have risen another 8 percent this year, while the American Stock Options Exchange Pharmaceutical Index was gaining 6 percent last year and this year has risen less than 1 percent.

"We continue to believe that Abbott stock is undervalued, given the prospects for robust sales and earnings growth," Glenn Navarro, an analyst with Bank of America, wrote in an October note.

The shares now trade at $55.49, off the 52-week high of $59.50.

Analysts with Bear Stearns, Morgan Stanley and Bank of America all reiterated their confidence in the company despite its flat third-quarter earnings of $717 million. Without charges related to the acquisition of Guidant Corp.'s vascular stent business in the third quarter, Abbott's diluted earnings per share were 67 cents, 1 cent higher than the analysts' estimate.

These three analysts cite the expected 2008 approval of Xience -- a drug-coated stent -- and the company's high margin on pharmaceuticals as key reasons to feel confident about Abbott's earning outlook.

Abbott awaits a Thursday U.S. Food and Drug Administration panel review of Xience, a drug-eluting stent that proved popular in Europe when it was made available in late 2006. Abbott hopes to launch Xience in the U.S. in the first half of 2008.

The company says, and outsiders concur, results of clinical trials of Xience compared against the leading drug-eluting stent, Boston Scientific Corp.'s Taxus, have so far been positive. Xience and other drug-eluting stents brought in revenues of more than $185 million in the first nine months, a figure expected to skyrocket if Xience gains FDA approval.

"Even if Xience were delayed, we remain confident in the long-term outlook for the stock and would be buyers at current levels," Glenn Reicin of Morgan Stanely wrote in an October statement. The firm maintains its overweight rating and considered Abbott a "top pick" within the health-care industry.

In addition, investors and analysts are responding to strong global sales of top-selling arthritis drug Humira, which grew almost 49 percent in the third-quarter to $803 million. Humira hit the U.S. market in 2002 as a rheumatoid arthritis treatment and since has received FDA approval for the treatment of psoriatic arthritis, ankylosing spondylitis, or spine arthritis, and Crohn's disease, a type of inflammatory bowel disease.

That array of treatment options has helped Humira smash sales expectations. Further, the company is currently seeking approval to market Humira to treat psoriasis.

"It's a pipeline in a product," said Scott Stoffel, Abbott spokesman, noting the company has more than doubled spending on research and development to $2.3 billion in 2006 from $1.1 billion in 1999.

Abbott and other major pharmaceutical companies, however, continue to face pressure from expiring patents. Abbott's Depakote, a drug used to treat epilepsy and bipolar disorder, will likely face generic competition this year.

Also being watched by the analysts: Abbott's underperforming vascular stent business.

Abbott has applied for regulatory approval of three other drugs as well: a controlled-release version of the pain killer Vicodin and cholesterol drugs ABT-335 and Simcor.

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Wyeth Quietly Turns Itself Into A Biotech Power

Wyeth Quietly Turns Itself Into A Biotech Power: "

Wyeth Quietly Turns Itself Into A Biotech Power

November 23, 2007: 08:05 PM EST

Nov. 26, 2007 (Investor's Business Daily delivered by Newstex) --

Pop quiz: Name the top three biotech companies by sales.

A no-brainer, right? Amgen (NASDAQ:AMGN) AMGN leads with 2006 revenue of $14.3 billion. Genentech (NYSE:DNA) DNA follows with $9.3 billion.

And next up is ... Wyeth (NYSE:WYE PR) (NYSE:WYE) WYE?

Though best known as one of a handful of U.S.-based big pharma companies, Wyeth actually generates about $7 billion in annual sales from biotech products, says Cavan Redmond, executive vice president and general manager of Wyeth's biopharma business unit.

That's more than twice the sales of the next big biotech, Genzyme (NASDAQ:GENZ) GENZ.

Wyeth's biologics-based products account for 35% of total sales. Its biggest seller is Enbrel, which it markets with Amgen, for various forms of arthritis, ankylosing spondilitis and psoriasis.

Biologic drugs use proteins rather than chemicals to fight disease.

Wyeth began transforming itself more than a decade ago, when it was known as American Home Products. Redmond's goal is to push biotech sales to half of the total.

He spoke with IBD.

IBD: How did Wyeth start meshing conventional pharmaceuticals and biotech?

Redmond: We acquired a company called Genetics Institute in 1996. From a business standpoint 20hat gave us an in-house biotech.

We already had partial ownership of Immunex, which was purchased by Amgen in 2002.

We currently have a relationship with Amgen for Enbrel (to treat rheumatoid arthritis). We have rights outside North America.

Our biotech revenues come from Enbrel and two hemophilia products. And we have the world's largest biotech vaccine, Prevnar, for pneumococcal (bacterial) diseases.

IBD: What about creating new biotech science?

Redmond: In the mid-'90s, many small-molecule (chemically based) drugs, including our own, were growing rapidly and doing well.

Our company was looking at new ways to attack different diseases. We had a huge investment in arthritis pain medication.

Originally biotech was just seen as a tool -- another way to go after diseases. You can keep going after the pain for arthritis, but could you affect the underlying disease? Proteins go after that underlying disease.

We had a group in research and development and the executive wing who looked at that as a good area to invest in. It was new and exciting. They were able to place multiple bets.

IBD: What kind of bets?

Redmond: In the last seven years we spent over $3 billion on manufacturing capabilities, in and outside of the U.S.

Historically when you build biotechnology plants, you need to build early in the product development life cycle.

That's very expensive. If the drug fails, you end up with an empty, expensive facility.

But if you don't build enough capacity, patient demand outstrips your ability to manufacture, and you can't provide the market with enough product.

We took a different approach. Our goal is to have multiple products in the same development area simultaneously and manufacture them in a pilot facility.

When a product gets through the regulatory process, we apply that product into our current infrastructure. We don't have to keep building every time we have a new product.

We created a development facility in Andover, Mass. It does all of our work for products in the R&D stage. It's a standard platform that can be applied to any of our manufacturing plants. If it were a computer, this would be the operating system.

If I get one or 10 proteins, we have a way to manufacture them and get them in the clinic for trials, without constantly expanding and contracting my manufacturing. As a result, a third of our R&D pipeline is in biotechnology.

IBD: What is your plan for product development?

Redmond: I'd like to see us take individual diseases and apply all three of our technologies to them simultaneously.

In the war on Alzheimer's we have 11 different projects in R&D. Some are small molecules, some proteins and some vaccines.

The amount of technology transfer from my biotechnology unit to the small-molecule group, and vice-versa, is what's allowing us to push the science and manage our risk differently from other companies.

It takes years. It takes a major cultural shift. Pharma companies that are now going into biotechnology will take years to integrate it into their core businesses.

IBD: What's next out of your integrated pipeline?

Redmond: Prevnar 13 (to prevent pneumococcus). We believe it's a significant improvement over our current Prevnar because it will go after more strains of pneumococcal disease. It has the potential to deal with pneumococcal disease in children as well as adults. Phase three trials are underway for both.

We've been working on it for a number of years. The product is slotted for 2010. Prevnar will soon be the first vaccine with $2 billion in annual sales. We anticipate Prevnar 13 to have comparable success.

Newstex ID: IBD-0001-21196933

Originally published in the November 26, 2007 version of Investor's Business Daily.

Copyright (c) 2007, Investor's Business Daily, Inc. All rights reserved. This article is protected by United States copyright law and may not be reproduced, distributed, transmitted, displayed, published or broadcast without the prior written permission of Investor's Business Daily, Inc. You may not alter or remove any trademark, copyright or other notice from copies of the content.

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Rural Cancer Patients Diagnosed Earlier Than Urban Resident - Associated Content

Rural Cancer Patients Diagnosed Earlier Than Urban Resident - Associated Content: "Dartmouth College researchers have discovered that, contrary to popular belief, it is rural patients--not urbanites--who receive the earlier cancer diagnosis. These findings, according to a press release from Dartmouth, is applicable at least for those who wound up receiving diagnoses of colorectal cancer and lung cancer--two diseases most treatable when caught early.

This information can also be found in an article, "Rural Versus Urban Colorectal and Lung Cancer Patients: Differences in Stage at Presentation," which has been published in the November 2007 issue of Journal of the American College of Surgeons. Ian Paquette (a general surgery resident), and Sam Finlayson (surgeon and vice chair for academic affairs for the Department of Surgery) are both of Dartmouth-Hitchcock Medical Center (DHMC) and wrote the article.

The researchers pored over data concerning national figures on lung and colorectal cancers and discovered that rural patients were trending toward getting diagnosed earlier than urban dwellers even when such factors as race, gender, marital status, and income and education levels were controlled; such demographic information is usually significant when determining which patients are diagnosed with late-stage cancers.

These findings are highly important in determining where to focus screening efforts, which can help reduce the number of people who are first diagnosed with their cancers in later stages. Generally speaking, the earlier a cancer is caught, the better the prognosis will be for the patient. The press release states that the reasons colorectal and lung cancer received the focus of this study is because these are two types of cancer surgeons usually see among their everyday patients. "