Perhaps that will change, now that personalized medicine has its own advocacy body and now that other signs of its arrival are starting to multiply, including the availability of genetic testing at retail.

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“A series of advances are [sic] finally beginning to make personalized medicine a reality” write Ron Winslow and Anna Wilde Mathews in the Wall Street Journal. Among them:

• A new test predicts side effects from colon-cancer drug irinotecan. FDA approved, commercially available.
• A test predicts benefit from breast-cancer drug tamoxifen. Commercially available but needs further validation.
• Tests for two different genetic variations that predict best dose of the blood-thinner warfarin. FDA weighing whether to include information in the drug’s label about the link to the genetic variations.

However, they note, a broad spectrum of such tests is probably five to 10 years away, and in the meantime there are other important issues (such as whether insurers will pay for them) to tackle as well. And the US Food and Drug Administration is doing just that — developing new regulatory guidelines for personalized medicines, including guidelines for companies that want to apply for joint approval of a drug and a related genetic test and how to apply for approval of tests for inherited genetic markers, meaning genetic characteristics that a person gets from her parents.

Trend is Growing

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“The age of personalized medicine is on the way,” writes New York Times reporter Andrew Pollack. He cites the case of acne drug Aczone, approved last July for patients who test negative for an enzyme deficiency that could put them at risk of developing anemia from the drug. Although Aczone’s developers fear the cost of the enzyme deficiency test will discourage doctors from prescribing it (one has already abandoned the drug), personalized medicine is inevitable.

The Mayo Clinic’s chairman of psychiatry told Pollack that about 40 of the 50 psychiatrists there use genetic tests to help choose which drugs to prescribe. Genetic tests are also available directly to consumers — one patient paid about US$600 for genetic tests that not only showed she would have trouble tolerating certain drugs, but also enabled her to advise doctors who were about to perform an emergency appendectomy on her to use a low dose of anesthesia.

US Federal Drug Administration guidelines now encourage drug companies to include information about genetic tests to the labels of a few drugs. For example, the label for colon cancer drug Camptosar advises a lower starting dose for the 10 percent of people who have a particular version of a gene called UGT1A1 and are therefore susceptible to a serious decline in white blood cells if they take a higher dose.

Still, even those with a vested interest point out that a specific DNA-targeted (pharmacogenomic) drug is at least five years away, given that there are no Phase 3 clinical trials of any such drug currently under way. The closest thing to pharmacogenomic medicine today include the breast cancer drug Herceptin, given to the 20 to 30 percent of patients whose tumors have high levels of the Her2 protein, and tests for drug-resistant viral mutations in HIV/AIDS patients. Pollack points out that in both these cases “it is the disease-causing agent that is being tested, not the patient’s genes.”

Which bring us back to enzyme testing. “The first widespread use of testing a patient’s own genes is likely to be for variations in enzymes involved in metabolizing drugs,” says Pollack. People with genetic variations that limit the production or effectiveness of a particular enzyme may not be able to break down a drug quickly enough, and thus need a lower dose to avoid side effects. Or they may metabolize a drug too quickly for it to have much effect on its target. Last year, the FDA approved a DNA chip test for detecting variations in two genes involved in the metabolism of about 25 percent of prescription drugs, and other tests (as noted earlier) are already available, even direct to consumers.

One barrier to the spread of pharmacogenomic medicine appears, from Pollack’s article, to be the doctor:

• Many doctors are unfamiliar with pharmacogenomic tests, and the few that are aware are mainly psychologists.
• Some doctors do not accept that the tests work.
• Doctors are reluctant to change the habits of their practice.

As patients and (especially) their lawyers grow aware of the benefits of such tests, however, doctors may be at risk for malpractice.

The pharmaceutical companies will need to turn from the one-size-fits-all blockbuster toward “minibusters” which, though less lucrative, may still be profitable since high prices could be obtained for them, their clinical trials — using only patients for whom they would be likely to work — would be cheaper and quicker, and since they might be able to resuscitate drugs that failed clinical trials in a more general population.

Getting Ready

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San Francisco Business Times writer Daniel S. Levine says that:

• Antidepressants fail in 20 percent to 50 percent of patients who use them,
• Cholesterol-reducing statins fail in 30 percent to 70 percent of patients who use them, and
• Beta2 agonist drugs fail in 40 percent to 70 percent of all patients who use them.

Clearly, the one-size-fits-all drug paradigm leaves many people untreated, and personalized medicine is the ultimate answer. The closest we have come to such medicine so far is the breast cancer drug Herceptin, which is known to be effective in one in four breast-cancer patients with a particular gene anomaly, but it’s a start.

The Personalized Medicine Coalition is also a barely-started education and public policy advocacy group for personalized medicine. The group’s executive director Ed Abrahams told Levine that politics, regulation, economics, and ethics — rather than science — were the biggest potential barriers. The issues include:

• Public fear that genetic information can be used against people by insurance providers and employers. The solution: Legislation to prohibit genetic discrimination.
• Lack of incentives for drug developers. “Developing a test that eliminates the 50 percent of patients that won’t benefit from a drug also promises to eliminate 50 percent of its sales.” Solution: Extended patent protection for developing pharmacogenomic drugs, which are almost by definition safer and more effective than one-size drugs.
• How payers will reimburse for personalized medicine test/drug combinations, which will be expensive in the short term even though they promise to deliver overall economic benefits in the long run.

Ethical questions include: What to do with patients who will demand a drug (perhaps because there is no alternative for them) even if tests show the drug will not work for them? Should the doctor prescribe it anyway? Should the payer refuse to reimburse for the drug?

Arrival of Personalized Medicine

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The US Food and Drug Administration’s approval last June of BiDil for use specifically by African-Americans — the first drug approved for a specific racial group — is a sign of the arrival of personalized medicine. USA Today‘s Jim Hopkins notes that the involvement of venture-capital giants such as Kleiner Perkins Caufield & Byers in funding companies working on pharmacogenomics is another, as is the growth of the Personalized Medicine Coalition, launched in 2004, to 50 members, including not only major biotechs such as Amgen and traditional drug makers such as Abbott Laboratories and Pfizer, but also IBM and General Electric.

“IBM sees big business opportunities as more researchers use its technology, such as the new Blue Gene supercomputer, to grind through mountains of data to find cures for cancer and other ailments,” writes Hopkins, citing an IBM executive.

Hopkins also notes that the ability to target drug candidates to narrow populations should lower the cost of clinical trials and therefore help keep the price of pharmacogenomic drugs down, as well as minimize blockbuster debacles such as happened with Vioxx.

Genetic Test Kits Sold at Retail

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Four US retailers began testing over-the-counter sales of the Cellf Genetic Assessments for bone health, heart health, insulin resistance, inflammation and antioxidant/detoxification late last year. The tests cost $99.99 each, and each test kit includes cotton swabs that customers rub on the inside of their cheeks and send to a lab, which then tests for genetic aberrations associated with various risk factors. “They do not diagnose the presence of a specific condition — only genetic factors that might make someone more susceptible to certain conditions,” writes Kristi Arellano in the Denver Post.

Test-takers also fill out a questionnaire about their exercise, eating and supplement-taking habits. The combined data are used to create specific health recommendations for the customer, mailed within four weeks to the customer in a 35-page report that includes general information on the conditions that were tested for.

Arellano cites several medical experts who “maintain that human genetic research isn’t advanced enough to support direct-to-consumer sales” and who doubt “whether getting tested has any immediate practical value. Other critics claim the reports merely provide common-sense diet and vitamin regimens, or question the wisdom of allowing all this to happen without medical advice.

Even so, the development of gene-specific testing and products has taken off since the completion of the human genome project in 2003, says Arellano. “Companies have popped up offering everything from DNA-specific face cream to at-home paternity tests. One company . . . offers a test to determine genetic ancestry.”

Another company has sold genetic assessments directly to consumers over the Internet for two years, with US$15 million in serious venture funding.