Precision medicine in the real world

In a perfect world, doctors would have the diagnostics to determine the right treatment for each patient at the right dose and the right time. It would be called precision medicine.

In our world, researchers, doctors and patients are teased by the hope of precision medicine, as investment dwindles for the development of the diagnostics necessary to turn hope into reality. No incentives encourage that investment. Court rulings have rendered most diagnostics unpatentable. The FDA offers no exclusivity. And now Medicare is proposing drastic reimbursement cuts for diagnostic tests.

In a perfect world, life-saving drugs would be affordable. Congress and government agencies would weigh the cost of new laws and regulations. And no drugmaker would endanger lives, or the health care budget, with unjustifiable overnight price hikes.

In our world, drugs are too often priced out of reach of the patients who need them. Many of those prices reflect the billions of dollars companies have to gamble to get one new drug approved and marketed. They also reflect the growing burden that comes with each new hike in user fees, each new regulatory requirement and each new avenue Congress creates to challenge a patent.

In our world, there will always be a few bad actors who see the sky as the limit for pricing their drugs. And in a 24/7 information cycle driven by sound bites and opinions, the bad actors will be viewed as the rule rather than the exception.

In a perfect world, drug and device patents would be motivation enough for discovery and innovation.

In our world, such patents are part of a costly, never-ending legal game that gets more complex with every court ruling, every new regulation and every attempt to “modernize” the system. Even the Patent and Trademark Office holds to the premise that “profit is at the heart of nearly every patent.”

In a perfect world, investment rules would be fair and evenly enforced.

In our world, Congress and the SEC go the extra mile to protect investors from company execs who might enrich themselves through insider trading. But they sit on their hands while unscrupulous hedge fund managers and hostile acquirers create their own “inside” events to manipulate the market and line their pockets at the expense of other investors, drugmakers and, ultimately, patients.

Of course, in a truly perfect world, there’d be no sickness and, thus, no need for precision medicine, diagnostics, drugs, patents or investment.

But this is our world – a world far from perfect. So we need to make the most of what we have.

That requires regulatory commonsense and consistency across all arms of government. It means avoiding unintended consequences and lightening the burdens of proposed laws and regulations. It demands self-restraint – on the part of investors, lawmakers, agency officials and drugmakers. And it depends on vision and innovation.

Then perhaps someday, in the not-too-distant future, our world – as imperfect as it is – will benefit from precision medicine.

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