BRAVE NEW LAW: Liability, Health, and Genetics
How federally funded hospitals must sequence their patients and you'll be sequenced whether you like it or not.
Do you know of any phenomena that are becoming cheaper faster than Moore’s Law? If so, I’d like to build a business around it.
There aren’t many phenomena that are supra-Moore’s Law. The cost per human genome is an example.
This past week Oregon Health & Science University settled a lawsuit with the widow of a cancer patient who died due to an adverse reaction to a chemo drug for about $1 million.
Here’s the write up in The Oregonian:
OHSU denied fault in the case, saying in an email it “has followed, and continues to follow, national cancer and evidence-based medicine set forth by national expert consensus in the field.”
Still, McIntyre said the changes the university is making could have saved her husband’s life.
David McIntyre was diagnosed with bile duct cancer in September 2018 and sought treatment from OHSU. But because of a genetic condition that affects as many as 8% of people, his body couldn’t process one of the chemotherapy drugs he received from the hospital. He became extremely ill, with vomiting, a rash and diarrhea, according to the lawsuit, which Joanne McIntyre’s attorney, James Huegli, filed in Multnomah County Circuit Court.
By the time doctors gave him the antidote, it was too late for it to be effective. The 78-year-old Portland man died Dec. 12, 2018.
But, as Joanne McIntyre learned, he didn’t have to die. Not only is there a test for the genetic condition, it’s possible to reverse a reaction to the drug, capecitabine, if the patient gets the antidote fast enough after showing symptoms. The university never told him about the genetic condition or that it can be tested for, nor did it give him the antidote in time, according to the lawsuit.
Outraged and grieving, Joanne McIntyre has spent the years since her husband died advocating for increased education and mandatory testing for the genetic condition before giving the chemotherapy medication to patients. Not only did she file the wrongful death suit against OHSU, she has also helped form a nonprofit that advocates for increased education and testing for the condition.
It really is quite shocking that this sort of care isn’t mandatory as part of the Hippocratic Oath. I suppose we are a long way away from the “do no harm” edicts when we had doctors pushing opioids.
Whenever someone has ill health I advise them to get genetically sequenced. Some take me up on it though many do not. They should. It could save their life.
We spend a lot of time talking about bending the cost curve when it comes to health care costs. And yet curiously genetics are seldom mentioned. That may begin to change, according to a recent presentation by David Skomo at a conference in Las Vegas.
…about a third of adverse drug interactions were caused not by drug-drug interactions but by patient genetics. Additional research has put the estimated financial impact, or additional health care spend, of nonoptimized medication in the United States at $528 billion.
Precision medicine offers potential for benefits in many different fields, including mental health where 30% to 50% of patients fail initial antidepressant therapy due to ineffectiveness or intolerance, Skomo said. Individual differences in metabolization of certain medicines will result in time and drug waste “because the medication is not optimized for that patient.”
Heart disease poses another area of opportunity as 40% to 75% of patients stop taking statin therapy within the first year due to intolerance and adverse effects, he explained.
Overall, precision medicine can help improve prescribing and clinical outcomes for patients, align patients to the right therapy using genetic panels and metabolic metrics, and cut down on drug waste by eliminating trial and error prescribing.
Big Pharma may hoot and holler — they want you to waste their drugs and buy more (or have the government buy more)! — but a mass sequencing campaign would necessarily reduce deaths and costs. Perhaps we can even use the settlement money from Purdue Pharma to pay for it.
Florida recently settled with Walgreens to tune of $683 million over the opioid epidemic, adding to the $3 billion the Sunshine state already got. At $100 a sequence, Florida could sequence every single Floridians and then some. (There are 21 million or so Floridians.) In so doing, Florida would totally transform health care around the world.
If the state has the power to compel (or coerce) you to take an experimental vaccine which may or may not protect against coronavirus than it almost certainly has the power to strongly encourage you to get genetically sequenced, which would have an arguably more demonstrably positive effect.
Like space travel or the intercontinental highways or the Internet itself, my view is that the US government ought to seriously invest in building genetic databases and then allowing approved developers to build off of that data.
Given that Oregon, like most state hospitals or teaching hospitals receives the lion’s share of its funding from the federal government, this was money that came right out of the taxpayer’s fisc anyway. So why not be more efficacious with it? And can the trial lawyers force that change by suing hospitals? Or will the hospitals do the right thing given that they are essentially auxiliaries of the state anyway.
To put that in perspective, Oregon could have spent that million on sequencing 10,000 people for that same $1 million.
We might call this pharmacogenomics, brought to you by litigation.
Companies like Nebula (owned by ProPhase) envision a world where genomic sequencing is less than a hundred dollars. I think that that’s right and my company Traitwell is helping to bring it about. Check it out.
I like the trends which are driving down the cost of sequencing.
A recent ruling invalidating Illumina’s patents might see to it that genomic sequencing gets cheaper still. We could be looking at genetic sequencing that is roughly $50-$100 in a matter of years.
My view is that the nation state which has the largest biobank will determine the course of history.
Besides, doesn’t China already have your DNA through 23andMe (backed by Jeffrey Epstein and Harvey Weinstein) or Ancestry?
Why not give Uncle Sam a chance?