The fully personalized medicine of which genetic testing will be the key component is not here yet, but the drug industry is increasingly working on it, as semi-personalized forerunners such as Herceptin begin to pay off handsomely. GE Healthcare Bio-Sciences also has personalized medicine in the cross-hairs.

Also:

• Many physicians, not to mention patients in need, are unaware that intestinal transplants, first successfully conducted in the 1980s, are even possible.
• Stories continue to accrue of substantial savings to be achieved by going to India for major surgeries.

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President Bush’s Council on Bioethics has proposed four alternative approaches to generating embryonic stem cells from living human embryos. But according to the New York Times, two of the 18-member council’s three research scientist members have “vigorously rejected” the proposed alternatives as “high-risk gambles.”

Two of the four approaches are conceded by the Council to be ethically problematic, but the Times does not elaborate on these. Of the two “ethically acceptable” ways, one is to take viable cells from dead human embryos. One dissenting council member called it the “height of folly” to allow healthy surplus embryos to be discarded while scientists struggled to salvage a few living cells from dead embryos. The council’s other “ethically acceptable” way is to make the nucleus of an adult cell revert to its embryonic state with chemical signals – something researchers have long been pursuing, without success (says the Times, but see Stem Cell Regeneration in the Therapeutics section of this issue of the Digest.

While scientists and ethicists “have a long history of sitting together on government panels and generally reaching consensus on how research can ethically proceed,” says the Times article (citing as an example proposed guidelines for human embryonic stem cell research established without major dissent by a committee of scientists and ethicists convened by the National Academy of Science), the sharp division between the scientist and ethicist members of the president’s council is “unusual.” Council chair Leon Kass counters that other committees are unbalanced, with little representation of pro-life views.

ESC in Corporate Hands

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A survey by the Wall Street Journal of the world’s largest drug firms, as well as leading U.S. biotechnology firms and medical-device makers, “found several previously undisclosed research programs involving human embryonic stem cells,” although many companies said they weren’t using stem cells and none was working directly with human embryos, instead using (and in some cases backing) intermediaries to obtain supplies of the cells.

California’s $3 billion stem-cell spending plan and similar initiatives in other states may partly explain the apparent sudden interest. Johnson & Johnson has made an equity investment in a California company that is trying to turn stem cells into insulin-making cells for transplant into Type-1 diabetics. GE intends to acquire embryonic stem cells in order to develop drug-testing products for the pharmaceutical industry. Invitrogen (another California company) intends to supply both stem cells and chemicals needed to study to them. Novartis’ research institute in Cambridge, Mass., plans to turn stem cells into heart cells.

Although Eli Lilly, Baxter International, and GlaxoSmithKline say they are not using embryonic stem cells currently, they do not rule out the possibility. According to the Journal, “after saying it had never used human embryonic stem cells, Merck & Co. later confirmed an account by outside experts that the company had obtained the cells,” but then claimed it destroyed them before they were used.

George Daley, a prominent stem-cell scientist at Children’s Hospital in Boston, told the Journal that once the potential of the cells is clearly demonstrated, companies’ qualms would “evaporate.”

Unfettered Free Marketeering

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According to an article in the Wall Street Journal, Tanox Inc. was forced effectively to “kill” a promising experimental drug called TNX-901 that might have helped more than 1.5 million Americans who are allergic – sometimes fatally — to peanuts. Genentech and Novartis spent US$100 million – and forced tiny Tanox to spend $75 million — on lawyers to make this happen, because (according to the detailed analysis presented in the Journalarticle) TNX-901 would have competed with Xolair, Genentech’s asthma drug the company hopes will also be effective against allergies.In an early trial among more than 80 people, TNX-901 was shown to bolster tolerance to the equivalent of nine whole peanuts, versus less than half a peanut for those receiving a placebo. The trial results were published in the New England Journal of Medicine in March in 2003, “triggering a wave of publicity and lifting the spirits of allergy sufferers. But the drug was on its last legs,” says the Journal.

Genentech and Novartis are testing Xolair, which is similar to TNX-901, against peanut allergy in 150 people, but “Even if successful, the delay in bringing a peanut-allergy treatment to market would be significant since TNX-901 completed its similar trial in 2001.”

DNA Tests

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In exchange for about US$400 and a swab from inside your cheek or a drop of your blood delivered in the mail, Genelex is one of several US labs that will tell you if you are genetically predisposed to heart disease, cancer, obesity, diabetes, liver disease, blood clots, dementia, and more than 1,100 other ailments — even alcoholism and gambling. It will then recommend diet and lifestyle changes and the type of medication you ought to be considering to avoid health problems in five, 10, 20 or more years.

The “soaring popularity” (as the Washington Post describes it) of such tests is “fueling a new ‘DNA diet’ craze with health clinics in Los Angeles and New York offering meal and supplement recommendations based on your genes and boosting the sale of self-help books such as ‘Feed Your Genes.'” They mark the start of medicine customized to the individual, and thus a radical transformation of health care. Some scientists (according to the Post ) say the tests are premature and not all have been validated scientifically. One calls their predictive value “a myth.” Another says direct-to-consumer sales of such tests are “a catastrophe.” But the fact is they are here and they are growing fast in a market unregulated and ripe for all manner of abuse, from misleading marketing to invasion of genetic privacy.

Pharmacogenomics

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“The era of truly personalized medicine, when every pill you take will be tailored to your genetic makeup, is still the stuff of science fiction; even the most optimistic medical thinkers don’t envision drugs with a market of one. But drugs for groups of people who share a genetic profile are already a reality,” says a writer in Fortune magazine. Herceptin, a drug targeted specifically at the 25 percent of metastatic breast cancer patients who overproduce the HER2-positive gene, is one example. Gleevec, for chronic myeloid leukemia patients (who have a genetic variation that causes an overproduction of white blood cells, which is the essence of the disease) is another. With the cost of genomic analysis coming down, one market research firm predicts that personalized drugs will account for more than three-fourths of pharmaceutical company revenues over the next two decades.

“Almost every major drug firm has launched a pharmacogenomics division,” notes Fortune, and many have begun to identify patients who will benefit from drugs that failed as remedies for broader populations, a process known as drug rescue. “I think in the next five to ten years you will see the life sciences explode,” a GlaxoSmithKline executive told the magazine, “because we now have the ability to do things that we simply couldn’t do just a few years ago.”

In March the FDA established a framework for reviewing and approving pharmacogenomic drugs, which action alone is expected to double the number of pharmacogenomic drug applications by providing clarity about what the FDA wants in the way of data.

Pharmacogenomics could rescue the pharmaceutical industry from the unsustainable “blockbuster drug” business model, whose costs have gone through the roof as have the risks (think Bextra and Vioxx). Consumers, especially the aging boomers, are also alert to the possibilities of pharmacogenomics and are starting to demand them, according to a Genentech official. With Target stores now selling at-home genetic profile kits starting at US$29.99, such demand is unsurprising.

Pharmacogenomics: The Future of Medicine is Here

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Genentech’s Herceptin, approved to treat late-stage breast cancer in women with a specific genetic mutation (about a quarter of all women with breast cancer), reached US$129.6 million in sales in the first quarter of 2005, making it one of the most successful semi-personalized medicines on the market. Two trials involving 5,000 patients showed that Herceptin halved the risk of recurring breast cancer in patients who had been successfully treated.

Genentech’s chief medical officer said genetically targeted therapies were “the future of the treatment of oncology” and “the future of medicine.”

Another Genentech drug, Avastin, was a disappointment in the late-stage breast cancer patients for whom it was originally intended, but is now showing promise in earlier stage breast cancer and colon cancer, and in lung cancer victims.

Personalized Medicine at GE

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The books show that GE Medical Systems acquisition, over a year ago, of bioscience firm Amersham is already paying dividends. But this is just the beginning. Advances in imaging and data storage capacities, together with the ability to digitize records and the development of sophisticated genetic and proteomic tools for understanding genes and proteins, have created the environment in which GE can leap to the forefront of individualized medicine.

GE Healthcare Bio-Sciences CEO described to the Milwaukee Journal Sentinel how, after Harvard researchers found a gene mutation that increases a lung cancer patient’s likelihood of responding to the drug Iressa, he arranged the gene sequencing of a colleague with lung cancer. It turned out the colleague indeed had the mutation, so he is now taking Iressa. GE Healthcare wants to extend such individualized medicine to everyone.

Doctors Unaware of Advances

Source: Pittsburgh Post-Gazette, May 11.

Many physicians, not to mention patients, are unaware that intestinal transplants, first successfully conducted in the 1980s, are even possible. Few candidates for the procedure, including children and adults who have intestinal failure and have not reacted well to IV feeding, are told of the option. The surgery’s relative infrequency (only 152 small intestinal transplants in 2004, compared with 16,000 kidney transplants and 6,100 liver transplants) may be one reason for the ignorance not only of doctors and patients, but also of organ donor groups, which contributes to a shortage of donor intestines. The surgery’s complexity and lack of profitability may also have held it back, but CMS decided five years ago to cover the procedure at large hospitals with high success rates, and the number of private insurers covering the transplants is growing.

The University of Pittsburgh Medical Center and Children’s Hospital of Pittsburgh have the busiest intestinal transplant programs in the US and currently report one-year survival rates above 90 percent.

Medical Tourism/Globalization/Outsourcing

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The New York Times tells of yet another instance of “medical tourism” taking a bite out of US healthcare revenue – a San Franciscan who had a US$25,000 hip procedure performed in India for $6,600. Such anecdotes, says the Times, are “becoming increasingly common,” with “about 150,000” foreign patients going to India for treatments in the year ending in March 2004 and a projected 15 percent annual growth rate. A British patient went to India for coronary bypass surgery, exchanging a six-month wait for a National Health Service-provided operation or a US$38,000 procedure at a private hospital for an $8,400 operation in India, travel expenses included.

The Indian surgeon who last year performed a $60,000 mitral heart valve operation on a US man for $10,000 is building a $250 million multispecialty hospital modeled after the Cleveland Clinic, while down the road Fortis Healthcare’s Medicity, a 43-acre hospital complex for foreign patients, which will have special immigration and travel counters and interpreters, wants to become known as the Johns Hopkins Hospital of the East.

Cardiac surgeries in India cost about one-fifth of what they would in the United States; orthopedic treatments about one-fourth, and cataract surgeries as low as one-tenth. A McKinsey health consultant who also advises the auto industry seems to hint, in the Times article, that US automakers might want to take heed of all this as they struggle to reduce the health benefits paid out to retirees. This is not to mention India’s already deep inroads into radiology reading and lab testing for US hospitals. A Gartner analyst notes also that “India is equipped to provide long-term in-patient rehabilitation services, which are very labor intensive, require large facilities and are under serviced in North America.” And this is not to mention Singapore and Thailand, which are competing with India to woo medical tourists.