Precision medicine


#1

I hadn’t heard the term precision medicine until today, when reading Personalized medicine: Time for one-person trials. “Precision” seems to be intended to simply convey a slightly more accurate meaning than “personalized”, which can be understood to imply development of individual specific drugs (not happening, yet).

The linked article on one-person trials is interesting here for a few reasons:

Every day, millions of people are taking medications that will not help them. The top ten highest-grossing drugs in the United States help between 1 in 25 and 1 in 4 of the people who take them (see ‘Imprecision medicine’). For some drugs, such as statins — routinely used to lower cholesterol — as few as 1 in 50 may benefit. There are even drugs that are harmful to certain ethnic groups because of the bias towards white Western participants in classical clinical trials.

I had heard of the bias mentioned in the last sentence, but was not aware the appallingly small proportion of people taking blockbuster drugs who are helped by those drugs (emphasis added above). This is what we’ve bargained away freedom, equality, and security to obtain? Well, no doubt there are much more charitable assessments of the drug output supported by the patent regime, but this assessment seems to set a very low bar.

(It’s possible that those proportions aren’t bad at all and I’m just seeing them as such to confirm my biases. I asked if anyone could explain the proportions more where I learned of the article. Please disabuse me here or there.)

tailoring treatments to patients is costly. For example, the cancer-care company Foundation Medicine in Cambridge, Massachusetts, charges patients between US$5,000 and $7,500 to sequence their tumours and to use the results to advise on treatments. And there is a lot of work to be done on biomarkers, monitoring devices, study designs and data-analysis methods.

I am confident that, ultimately, governments, regulatory agencies and pharmaceutical companies will support sophisticated, well-designed N-of-1 trials. These could save the millions of US dollars that are spent on inappropriate interventions, the management and treatment of persistent or recurring diseases, and on conventional phase III trials (which can cost between $100 million and $700 million per drug). Regulatory agencies such as the US Food and Drug Administration are beginning to recognize the importance of individual responses10. And sufficient financial or market incentives provided by governments could persuade pharmaceutical companies to broaden their focus away from ‘blockbuster’ drugs — especially given the poor rates of return on drug discovery in recent years.

Physicians are having to become more acutely aware of the unique circumstance of each patient — something most people have long called for.

Taking these points together, it’s easy to imagine pharma holding up a move to precision medicine in order to extract additional IP incentives in addition to cost savings, and both access to (inclusive of equality of access to) and effectiveness of precision medicine hindered by pharma extractions and meddling from research to delivery.

N-of-1 trials are already a massive coordination problem (e.g., data sharing and practice adoption: read the entire article; the author proposes a sort of bottom-up approach: “transforming everyday clinical care into solid N-of-1 trials”). Surely out of the trillions spent on healthcare each year, it should be possible to coordinate drug and other therapy development that does not allow rent seekers to muck up the rest of the system. No?


IP harmonization is bad for IP science
"no-one owns the patent for spinach, so the FDA can't find a target to force to pay for the studies"
List of ways to improve drug discovery, development, and delivery independent of patents