Imagine you had been taking the drug Tamoxifen in hopes of preventing a recurrence of your breast cancer. Then a new test comes out that suggests that because of your genetic makeup the drug is not doing you any good. This situation is not that uncommon for hundreds of thousands of women in this country, including Illinois, who have been taking Tamoxifen.
However, not only those taking Tamoxifen need to worry. Experts say that regardless of the disease, most drugs work for only about half the people who take them. Not only is much of the nation’s approximate $300 billion annual drug spending wasted, but patients are being exposed unnecessarily to risky side effects.
Many policy experts are calling for more studies to compare the effectiveness of different treatments. There is much hope riding on the promise of “personalized medicine” in which genetic screening and other tests give doctors more evidence for tailored prescriptions. Personalized medicine would go beyond the norm by determining which drug or drugs are best suited for which patient, rather than continuing to treat everyone the same in hopes of benefiting the fortunate few.
Take for example the colon cancer drugs Erbitux and Vectibix. Studies show that these drugs do not work for 40% of the patients whose tumors have a particular genetic mutation. The Federal Food and Drug Administration (FDA) held a meeting recently to discuss whether patients should be tested to narrow the use of the drugs that currently cost patients between $8,000 to $10,000 per month.
Or consider that genetic test might help doctors determine the optimal course of Warfarin, a blood thinner used by millions of Americans. Yet as compelling as the possibility of personalized medicine, it’s not going to happen overnight. “It’s going to take 20-30 years for all this to fall into place,” says Gregory Downing, who heads efforts by the Department of Health and Human Services to spur personalized healthcare.
There are hurdles that need to be jumped over before personalized medicine can become the norm. These hurdles include drug makers, which may be reluctant to develop or encourage tests that may limit the use of their drugs. Also, insurers may not pay for tests which may bump healthcare costs up to a few thousand dollars.
Yet for the makers of these tests, there is hope that their business will become one of healthcare industry’s next big growth industries. But first they must prove that their tests are accurate and useful. A cautionary tale is Herceptin, a breast cancer drug that is considered the prototype of personalized medicine because it works only for women whose tumors have a particular genetic characteristic. But now, 10 years after Herceptin reached the markets, scientists are finding that various tests, some approved by the FDA, some not – can be inaccurate.
Kreisman Law Offices has been practicing Illinois pharmaceutical law in Chicago and Cook County for over 30 years in areas such as Hoffman Estates, Winnetka, Naperville, and Tinley Park.