Bernie Sanders surrogate, Dr. Paul Song, said this at a rally in New York:
“Now Secretary Clinton has said that Medicare for all will never happen. Well, I agree with Secretary Clinton that Medicare for all will never happen if we have a president who never aspires for something greater than the status quo. Medicare for all will never happen if we continue to elect corporate Democratic whores who are beholden to big pharma and the private insurance industry instead of us.”
Dr. Song’s choice of words, “corporate Democratic whores,” was poor. He apologized and I believe he regrets what he said. I’m sure he was very amped up in front of such a crowd and he is clearly full of passion. Every one of us has at one time or another spoken and emailed in ways we wish we hadn’t, so I really try not to hold someone accountable for one phrase. Anger, passion, joy, and frustration can all temporarily unhinge our better judgement.
I decided to take a step back and look at the bigger picture for Dr. Paul Song and I was a little surprised that he isn’t working at a County Health Department or at an academic institution (the kind of places that see a lot of Medicare and uninsured patients), he is a “biotechnology executive.” His LinkedIn profile lists his current position as Chief Medical Officer at ATGen Global and Cynvenio Biosystems.
A Chief Medical Officer of a biotech company and vocal Sanders supporter who hates Big Pharma. I was beyond intrigued. What does Cynvenio Biosystems make that somehow sets them apart from Big Pharma?
The NK Vue™ measures the level of natural killer (NK) cells in the body. Natural killer cells recognize and attack certain infected cells and cancer cells as well as producing chemicals called cytokines that help with the body’s defense mechanisms. It seemed to me to be an awfully imprecise tool for predicting anything, but I am just a country gynecologist so I downloaded the patient brochure to further educate myself.
According to the brochure:
Determining NK cell activity is just as important as performing other blood tests, such as a complete blood count (or CBC).
Your doctor might make recommendations based on my NK cell activity results, such as, “lifestyle changes (weight loss, exercise, diet changes, smoking cessation, etc.), which could help to improve your immune system and improve your ability to fight cancer and other diseases.
And I was encouraged to speak with my doctor about it. And that it is affordable.
How affordable? I called and spoke with a customer representative, it’s $150. A CBC is about $21.
If the NK cell activity is as important as a complete blood count surely I would have heard of it before especially as the promotional brochure clearly promotes it as a screening test, but I hadn’t.
Screening tests need a lot of studying before they can be recommended. How do studies on the NV Vue™ stack up? There are two according to the brochure, 41 patients with colorectal cancer and 54 patients with prostate cancer (and matched controls). Let’s just say it took more than 95 women with cervical cancer to get Pap smears recommended and more than 95 people with colon cancer to recommend screening colonoscopies. The brochure alludes to a study of 3,000 patients over 11 years, but it is not listed in the references and I couldn’t find it on the company’s page or in PubMed. Unpublished data doesn’t count. My search on the US Preventative Task Force Page turned up a “0 results” for natural killer cells and for NK Vue™.
I turned to an oncology colleague Dr. Deanna Attai, a breast cancer surgeon and Assistant clinical Professor of Surgery at UCLA and the President of the American Society of Breast Surgeons (and someone you should follow on Twitter). She discussed it with several colleagues who have experience with biotechnology startups and said, “Interesting in theory, but too preliminary to be ready for prime time.” And she added that even if the test were very inexpensive say $10, “If we can’t prove the results correlate with tumor progression, it’s $10 that the patient could have spent on something else.” Until there is data to back it up she likened it to “selling false hope.”
In short, there are no studies right now to support the statement that the NK Vue™ test will help “your doctor to better understand your situation.” It will however frustrate your doctor and possible get them to order tests they wouldn’t have.
But the test is not just marketed to cancer patients (who are obviously very worried about recurrences so a most vulnerable population), it seems to be marketed to everyone to see how well “equipped” your immune system is. Get screened with the NK Vue™ and then do your other screening if your risk is elevated. To recommend this kind of algorithm requires massive studies and they do not exist, so the brochure in my opinion is the definition of Big Pharma marketing.
Then I asked Dr. Matthew Katz, Director of Radiation Medicine at Lowell General Hospital (and also a doctor to follow on Twitter) what he thought about the LiquidBiopsy®. This is a test that detects small amounts of cancer DNA fragments in the blood, much in the same way a blood test can now diagnose Trisomy 21 in pregnancy with a blood test. He said, “The technology to detect cancer DNA fragments as a ‘liquid biopsy’ is available. But currently there are no quality clinical data supporting its use as a screening tool to diagnose cancer early or to guide treatment decisions.”
A review in Clinical Chemistry concluded, “Although the analysis of ctDNA is a promising area, and despite all efforts to develop suitable tools for a comprehensive analysis of tumor genomes from plasma DNA, the liquid biopsy is not yet routinely used as a clinical application. Harmonization of preanalytical and analytical procedures is needed to provide clinical standards to validate the liquid biopsy as a clinical biomarker in well-designed and sufficiently powered multicenter studies.“
Maybe these tests will pan out after more data, but lots of promising research never makes the leap to being useful to patients. How can one justify offering an unproven test to an already overburdened US health care system? Isn’t the bloat and expense of American health care something Sanders has to fix to get his universal Medicare off the ground? And what about the direct marketing of unproven tests, I thought Sanders was against those kind of “Big Pharma” practices?
Last year in the New Yorker Dr. Atul Gawande wrote the following, “An avalanche of unnecessary medical care is harming patients physically and financially.” He reported on a study of more than 1 million Medicare patients and a “huge proportion has received care that was simply a waste.” He’s right. We spend well over $100 million a year of Medicare dollars annually just on PSA screening for prostate cancer despite recommendations that the harm outweighs the benefits and now Dr. Song wants doctors to order a pre-screening test before the PSA with no long-term studies to back it up? A PSA only costs about $40 and his test is $150, or more than three times the price.
Then there is the emotional harm of getting a test that a physician can’t interpret, the “false hope” of erroneously believing you have a lower risk of cancer, and all the potentially harmful tests that a positive result might generate. People could end up with unnecessary biopsies based on fear of the unknown stoked by the results.
Dr. Song gets to work wherever he wants and I’m all for innovation and if his company were just studying these tests I would have no issue at all. However, Americans are already being harmed by excessive diagnostics so I find it ironic and rather disingenuous that a physician who sells an unproven and expensive screening test and an unproven diagnostic test and markets them directly to the consumer while expecting us practicing physicians to somehow interpret these tests is speaking as a surrogate for Sanders on the concept of Medicare while railing against Big Pharma.
I am eager to hear from Sanders how his Medicare plan will deal with over screening, direct to consumer advertising, and the marketing of tests directly to the public that have not been sufficiently studied.
Update, 13:10 April 16
A comment below identified the article with “3,000 patients.” Thanks for finding that. It is from 2000 and followed 3,625 people, 154 who developed cancer. It would be a massive (and unscientific leap) to say that this study means the NK Vue is like a CBC or useful for cancer screening or following people for cancer recurrences. In my opinion and the opinion of the cancer specialists I spoke with this should only be used in a study. For example an 11 year study on the PSA looked at 162,000 men. That’s only one of the many PSA studies.
So by all means study it, just don’t promote it as a useful or meaningful test because it isn’t. Might it be one day? Possibly, but we don’t recommend universal screening tests at $150 a pop on possible.