Genetic testing and personalized medicine options could have a stronger presence in health institutions and hospitals, but the healthcare industry finds itself in a Catch-22 situation when trying to get to that point.
On one hand, doctors and physicians see a definite need regarding the role that genetic testing plays in affecting a patient's drug response. But on the other hand, physicians are hamstrung due to a lack of training and education to prescribe these genetic tests that could provide valuable information to guide the prescribing and dosing medications.
A study by Medco Health Solutions (Franklin Lanes, New Jersey) and the American Medical Association (AMA; Chicago) reported the findings of a national benchmark survey which shows the conundrum that widespread personalized medicine and genetic tests could fall into.
Specifically the study looked at Pharmacogenomic tests (PGx), which are tests that analyze a person's genetic make-up to determine how they metabolize certain medications. Using the tests are said to help improve the safety and effectiveness of drug therapies.
The findings based on responses from more than 10,000 physicians across the country found that only about 26% of the physicians have had any type of education in the field known as pharmacogenomics and only 10% of physicians believe they have the necessary information and training to put this test to use.
Also the survey found that only 13% of physicians had ordered or recommended pharmacogenomic tests in the last six months and more than 26% planned to do so within the next six months. Among total respondents, 10% reported that PGx tests had benefited their patients by improving drug effectiveness, and another 10% said their patients benefited from reduced drug toxicity due to testing.
Other survey findings show that physicians who feel well-informed about PGx testing are more than twice as likely to recommend or order a genetic test. Physicians, who currently use genetic tests, tend to be older males who have been out of medical school for 15 to 29 years and oncologists.
These are staggering numbers, which lead to the question, just how can the medical community escape this conundrum and embrace more forms of personalized medicine?
"It's the same question that came to our minds when we were looking at the survey," Felix Frueh MD, VP of Personalized Medicine Research & Development at Medco told Medical Device Daily. "The survey itself provides an opportunity to address this issue head on and offer solutions."
But those solutions won't come from physicians, but rather "additional stakeholders," Frueh told MDD. He added that the "medical community itself wasn't going to be the catalyst" for changing these results.
Part of the problem and the sobering statistics comes from the speed at which the sciences behind these tests are being released. That has caused a potential stumbling block from some physicians he said.
"One of the most shocking statistics from my perspective is that so many physicians believe that pharmacogenomics are important. But they aren't using the tests," he said. "I think the problem is the speed of which these tests have been developed and the science behind them. It wasn't that long ago that the human genome was mapped. I also think very few had training in pharmcogenmics in medical school. It's just not mainstream."
But the study shows that while this kind of testing might not be considered mainstream, it's beginning to make a huge impact in treatments across the country.
The study shows that one of every four patients in the U.S. was prescribed medications with PGx information in the label of the drug in 2006. These medications include antidepressants, analgesics, cancer treatments, cardiovascular drugs and gastrointestinal medicines.
For example, one enzyme – CYP2D6 (part of the cytochrome p450 system of liver enzymes) – may be involved in the metabolism of 30% of all drugs used today.
In a case showing a genetic connection to drug metabolism, a test is recommended for patients using the blood thinner warfarin since they can experience serious bleeds or blood clots if given the wrong dose; a genetic test can help determine the accurate dosage based on the patient's genetic profile and prevent these potentially life-threatening incidents. Genetic testing is also important for breast cancer patients on tamoxifen since about 10% of those women won't respond well to the medication because of their genetic make-up.
In the future, even more drugs may be linked to genetic tests. From the second half of 2009 through the first half of 2010, seven drugs paired with genetic tests are expected to be up for FDA approval, as well as nearly 10% to 20% of new drugs being labeled with PGx-related information over the next five to ten years.
In particular, the field of oncology will see many more of these drugs in the coming years, with roughly 50% of cancer drugs in the pipeline expected to be orally administered by 2013 and 85% of those will rely on a genetic biomarker.
"I think the risk for us to keep the status quo is going to be that we will have a harder time getting these assays into the clinical setting," Frueh said. "And that would be a [tremendous] opportunity missed for the medical community."
Omar Ford, 404-262-5546;