Personalizing Personalized Medicine

What is personalization? Its making things for the individual. This is seen all the time online. If you visit Amazon's website and search for toothpicks, you will start seeing ads for toothpicks popping up all the time. Until you search for something else.... Amazon's site is responding to your needs by reminding you about your recent search - meeting your needs.

Personalizing personalized medicine means not doing the same thing over and over again, and taking into account patient's individual needs. However, we talk about personalized medicine and then discuss starting mammogram screening for all women at age 40. Where is the personalized part of that? Its just changing the requirement for insurance companies. And no mention of who pays for the additional screenings.

Take this opinion for example, from Dr Montijo on Clinical Advisor:

"I am often concerned about articles summarizing screening mammography data. Without fail, organizations that materially benefit most from performing mammography conclude and advocate more frequent and earlier screening mammography. Organizations composed of primary care or with minimal material benefit conclude that a more conservative screening program and more personalization, such as shared decision making, has the greatest net benefit. The cost alone, from the most aggressive screening design to the most conservative design, is in the billions of dollars. No tradeoff analysis of alternative uses of such cost is entertained."

Again, just because we can, doesn't mean we should all the time.

"Mammography started in the early 1950s with a study from HIP of New York, among others. The use of screening mammography increased precipitously during the ensuing decades typical of new technology, often for assumed or wished for benefits. A major industry was born. As happens with most new technologies, finding the optimal use or non-use takes time but almost always perseveres past the optimal benefit point or in some cases full retirement."

I am not saying mammography does not have its benefits. It does. Some women should start screenings early. Maybe in their 20s - I had a benign lump at 23 and have had annual mammograms since. My breast cancer was found at age 45. And another benign lump appeared at age 46. I am someone who needed mammograms starting young. But this does not apply to everyone. 

In my opinion, anyone who is BRCA positive or has a family history of breast cancer should have annual screenings start at age 25 even. That should not be a discussion, but should be a standard for those women. I am sure there are other cases like this where mammograms should start early.

This is a basic idea to start a personalization discussion with an individual patient. But a global requirement for everyone doesn't help. Mammograms have a financial cost but also the cost of missed time at work for the patient to go to the appointment as well as emotional stress for the patient.

We need much more personalization if we are to make any progress in this area.

Who will pay for personalized medicine?

Inventors have faced this problem for centuries: just because you can make it, does it mean anyone will pay for it? And just because its possible, doesn't mean anyone wants it. Unless you can put some guarantee of a good result on it.

Personalized and precision medicine has been the buzz for several years now. But who is going to pay for it? I have never seen this discussed previously. I sort of assumed that someone would but never thought the process through. And what happens if the test result isn't a good one?

I just know I wouldn't be happy to shell out a few thousand without the guarantee that the results would lead me to a life saving recommendation. And what if I did spend the big bucks and all the result told me was that there were no good treatment protocols for me? That would not leave me a very happy camper at all.

Back to personalized medicine... What if no one wants to pay for it? And is there a guarantee that the test results would lead to the right treatment? What if there is no good treatment protocol available?

Right now we get an ailment and start a treatment protocol. If it doesn't work, we go on to plan B, or C, or D.... all the way to plan Z. Personalized medicine is supposed to tell us skip plan A and go directly to plan L as that is right for you. But what if there is no plan L yet? Or plan L only has a 50% chance of working for you? And plans A, B and C had a 30% chance of working for you.

One test for patients with a certain type of lung cancer has now been approved for payment by one insurance company. That's a very small start. Medicare has not decided if they will pay or not.

"Medicare and private insurers have been slow to embrace genetic tests such as Foundation Medicine’s that look at a broad array of genes. (Other genetic tests, such as those that analyze specific genes known to increase a person’s risk of cancer, are more widely covered.) The payers are concerned that the tests could lead to care that won’t improve patient outcomes."
I am right there with the insurance companies (how unlike me) on this one. I want a treatment that will improve my outcome... That's the whole point of personalized medicine.

Please take a nanosecond to feel sorry for Myriad Genetics

They have become lawsuit happy. The Supreme court has said no company can hold the patent to a gene last summer. This means that Myriad Genetics has lost their monopoly, huge prices, and ability to strong arm the breast cancer population with their patent on the BRCA genes Okay that nanosecond is now long over.

Now we can get on the road to reality. Myriad has decided that since they have lost their patent, their lawyers are going to get rich. They are in the "let's sue so we can keep our monopoly as long as possible".

"Last week's ruling by Judge Shelby is perfectly clear about all that is at stake for Myriad:

Although Plaintiffs [Myriad Genetics] have shown that they are likely to suffer irreparable harm through erosion of their test pricing structure, loss of their share of the testing market, and loss of their exclusive patent terms if an injunction does not issue ... Plaintiffs are unable to establish that they are likely to succeed on the merits of their claims.

In other words, Myriad's earnings will undoubtedly take a serious hit from increased competition, but this fact cannot override the substantial doubt about whether they will prevail in their legal claims."

I hate people that are lawsuit happy.

But this underscore additional issues with genetic testing and personalized medicine.

"Not only have the courts pushed back on Myriad's monopoly, at the end of 2013, the Food and Drug Administration (FDA) moved to stop the direct-to-consumer genetic testing company 23andMe from marketing and selling its DNA testing service without approval.

As with all medical drugs and devices we must balance the desire for innovative new treatments with our demands for safety and efficacy. As more labs and companies enter the BRCA testing market, we must ensure that these tests are properly regulated to protect public health and patient interest. Genetic tests claiming to provide medical information must be analytically and clinically validated so we know that what companies are telling customers is in fact accurate. Nor should companies be permitted to overpromise the benefits of genetic testing or to drum up people's fear of disease in order to sell more tests. All genetic testing should be accompanied, both before and after testing, by independent and professional genetic counseling so that potential customers understand the limitations of testing, their individual test results and all of their medical options.

Finally, we should refuse to allow companies to hoard, for their own gain, our medical and bio-data collected through the process of testing. Critics of Myriad have long noted that the company stopped contributing to the primary international database on genetic mutations related to breast cancer, in what is widely seen as a move to further capitalize on their monopoly access to more than a million women's family history and genetic information. Similar critiques have been made that 23andMe is using its customers' bio-data and familial information to launch new business products."

Genetic testing is the new thing. I'm  not ready to turn my DNA over to just anyone. And I would be very upset if they tried to upsell me on additional tests based on what I already have...

But I will follow this story and see where it ends up. But I never felt sorry for Myriad Genetics.

News of the day

Random news that piqued my interest this morning:

1. Three Quebec mammography clinics missed 109 cases of breast cancer - primarily due to one radiologist who has since retired. I am glad I did not go there. But also this is just an example that errors can occur everywhere and if we are not happy with results or have questions, we should get a second opinion or ask our questions until we get the answers we need.
   
2. A giant leap in personalized medicine occurred as two Boston area teams compiled a giant encyclopedia   "...that predict the vulnerability of hundreds of different subtypes of cancer to dozens of drugs. The massive catalogs, which were made freely available online Wednesday, are an important step toward the routine personalizing of cancer care, in which patients will receive treatments tailored to the specific genetic changes that influence a tumor’s response to drug regimens."
   
   This is sounds cool and sounds like lots of progress but its more than my tiny brain can comprehend. I'll just let someone else summarize it for me. If I could find the encyclopedia I might attempt to look at it.
   
3. Its time for all of us to start growing wild tomatillos - which are a native weed - which has been discovered to contain medical properties.
   "So far, the researchers have demonstrated 14 compounds found in the plant can fight numerous cancers and tumors without any apparent side effects or toxicity—namely: melanomas, thyroid cancer, head and neck squamous cell cancer, breast cancer, glioblastoma brain tumors, and certain leukemias. Other studies suggest these same molecules may combat both esophageal cancers and pancreatic cancers." I'll ditch the flower garden and lawn and grow some weeds instead.

Now I am off to work for the day to ponder these latest advances.