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Curbside Consult with Dr. Jayne 12/10/18

December 10, 2018 Dr. Jayne 5 Comments

The physician lounge was abuzz on Friday due to a piece on CNN claiming that Australian researchers have developed a “10-minute cancer test.” Supposedly it “can detect the presence of cancer cells anywhere in the human body” and stems from research looking at the structure of cancer DNA when placed in water. Physicians were mostly grumbling about having to respond to patient questions about such a sensational announcement when the ink on the publication was barely dry. Patients tend to take hold of these kinds of announcements, especially if they have a particular concern about cancers for which there aren’t good screening tests, such as ovarian cancer.

There’s always more to the story when these announcements are made. Despite author Matt Trau’s statements that the study “led to the creation of inexpensive and portable detection devices that could eventually be used as a diagnostic tool, possibly with a mobile phone,” in this case, the test hasn’t even been used on humans. People tend to hear the part about diagnosing cancer with their phones and miss the part about animal studies. The authors are excited and with good reason, but it’s a long way from where they are with this test to having it available at the primary care office.

The test mentioned in the publication, which was released this week in “Nature Communications,” has only been used to detect lymphoma, along with cancers of the breast, prostate, and bowel. It’s also only been used on around 200 samples, although it did have 90 percent accuracy. Researchers using high-resolution microscopy noted differences between the structure of cancerous DNA fragments and non-cancerous fragments when the DNA was placed in water. The test uses colloidal gold particles to bind to cancerous DNA, creating an electrochemical reaction that can be quantified.

One of the urologists around the table was particularly vocal about suggesting that this test could be used for prostate cancer since there has already been a fair amount of controversy about prostate cancer screening. We’ve seen the Prostate-Specific Antigen (PSA) fall in and out of favor – first approved by the FDA in 1986 to monitor prostate cancer progression, it was approved in 1994 to be used along with a digital rectal exam for screening of asymptomatic patients. Over the next two decades, we saw patients with “abnormal” tests who underwent procedures that may have been overly aggressive given the slow-moving nature of prostate cancer, not to mention the non-cancerous conditions that can cause PSA elevation. Over time, we learned that the test was being relatively overused certain populations without definitive evidence that it drives outcomes in a beneficial way, leading to recommendations that we don’t just order it, but rather have a risk/benefit decision between the patient and the physician before deciding to test.

As we consider new technology and new tests, we need to heed the lessons of the past and proceed with caution, guarding against “shiny object syndrome” and the assumption that just because we can theoretically use a smart phone to do a test that it’s a good idea. CNN ran a similar piece back in January, covering a test developed at Johns Hopkins University that screens blood samples for eight common cancers by detecting cancer proteins and gene mutations. That test, called CancerSEEK, is still being studied to determine its applicability in clinical medicine and whether it can be widely used to screen patients who aren’t experiencing symptoms. CancerSEEK was evaluated in a much larger study that included humans with almost 2,000 patients participating. The test was 70 percent sensitive among the eight cancers, but the range of accuracy for individual cancers ranged from 33 percent in breast cancer to 98 percent in ovarian cancer. The Hopkins team also used an algorithm to evaluate the source of the cancer for positive tests, but the ability to pinpoint a source was only 63 percent.

It will take a tremendous amount of money to bring either of these technologies to the point of care, and unfortunately with medical research, the money doesn’t always follow the hype. Even when tests are promising, they have to be shown to be effective and to be able to make a difference across large patient populations before payers will cover them, which often the main barrier to patients receiving new tests and treatments. EHR and other healthcare vendors follow these discoveries closely since they need to stay ahead of the curve for supplying appropriate clinical decision support information and including new discoveries into order sets and EHR content.

Those changes don’t happen overnight. I work with one EHR vendor that still hasn’t incorporated standard-of-care screenings that were recommended by the United States Preventive Services Task Force (USPSTF) back in 2007. It’s understandable that providers are frustrated when it takes more than a decade to update the EHR.

The conversation about detecting cancer DNA quickly segued into one about the recent “gene-edited baby” announcement coming out of China. A scientist claims to have used the hot new CRISPR gene-editing technology to alter two human embryos to be resistant to HIV. The babies have now been born and the news led to significant outrage from the international scientific community. The processes of announcing the research has broken with the standards of research, with the information being revealed via YouTube rather than through rigorously-reviewed scientific channels. That’s not surprising in the era of social media, but should be viewed with caution. There are many other concerns with the research, including lack of appropriate Institutional Review Board protection for the participants, lack of documentation of the work actually done, and the lead researcher owning patents around the techniques used in the process. It wouldn’t fly in the US or in many other nations.

The conversation came full circle when one of family medicine docs at the table spoke up. She said she felt sad that everyone was excited about these media sound bites around research whose practical use was years away, but she has difficulty getting medical professionals engaged around her work with school-based clinics and mobile outreach to our city’s homeless population. I mentioned working with providers who struggle with EHR adoption and the challenges of trying to get them to use the guideline prompts and alerts that are already in the system for tests that are proven to be clinically effective as well as cost effective. It’s certainly something to think about in this world where we’re used to getting our information 200 characters at a time and the deeper discussions sometimes elude us. Physicians don’t have the time to pull the original articles and read the primary source data, so it’s unlikely that patients asking about these new advances are going to have done so either.

Given our work in healthcare information technology and the seemingly relentless push for innovation, we often become skeptical (if not cynical) about developments. We’ve seen plenty of creative new technologies fizzle and watch the industry continue to search for the next big thing. And we understand how hard it is to take technology from the idea stage to practical use at the patient bedside whether physical or virtual. It will be interesting to look back on these developments in a year, or five or 10, and see where we have landed.

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Currently there are "5 comments" on this Article:

  1. Unfortunately, money frequently follows the hype, before the reality sets-in… “Please be advised that on September 12, 2018, Theranos, Inc. (“Company” or “Theranos”) entered into an Assignment for the Benefit of Creditors (“Assignment”) and appointed Theranos (assignment for the benefit of creditors), LLC as assignee (“Assignee”). An Assignment is a state level insolvency proceeding undertaken under state law, in this case California, with the primary governing law found in California Code of Civil Procedure sections 493.010 to 493.060, sections 1800 to 1802, and section 1204.”

  2. It was just announced that Theranos Inc. has decided to regroup and rename the company –
    TheRawAnus
    The chief of communications, Mr. Pinochiozzo stressed that the new name better reflects the new core values of the company.







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