New Blood Test Aids in Lung Cancer Screening

The US Preventive Screening Task Force updated its recommendations in 2021 for screening patients with  increased risk for lung cancer. Current guidelines call for providing a low radiation dose CT scan of the lungs annually for patients 50- 80 years old who have a smoking history of twenty pack years (calculated number of packages smoked per day x number of years smoking) and are still smoking or have quit within the last 15 years. These expanded criteria reduced the age to 50 from 55 and pack years from 30 to 20 years.  The recommendation is based on research showing that these criteria reduce deaths due to lung cancer by 20% as seen in the National Lung Screening Trial.

Despite this recommendation, many smokers who meet these criteria never get tested. Access to CT scans is one problem along with financial costs. For this reason, a group of researchers at MD Anderson Medical Center, led by Sam Hanash, MD, PhD, professor of clinical cancer prevention, developed a 4-panel blood test to screen for lung cancer. Their four test blood panel results were published in the Journal of Clinical Oncology on January 7, 2022.

The researchers then combined the results of the blood test with low dose CT scans of the chest and found that the accuracy of this method was far more sensitive than performing lung CT scans alone in the groups recommended for the procedure by the USPTF guidelines. Using the blood test and the low dose CT scan of the lungs, they found 9.2% more lung cancer cases for screening and reduced referrals for further evaluation by almost 14%

The blood test is still in the research phase and not available commercially for screening just yet. It will have to go through the full Food and Drug Administration (FDA) approval and evaluation process first.

The panel included tests for surfactant protein B, cancer antigen 125, CEA and cytokeratin-19 fragment. Currently the Ca125 test and CEA are available through commercial labs but there were no comments or recommendations from the authors or reviewers about whether clinicians should be using those two tests now with low dose lung CT scanning for screening.

Aspirin & Heart Disease Prevention Recommendations

In the 1950’s a research paper based on work done at a Veterans Administration Hospital found that men 45 years of age who took a daily aspirin tended to have fewer heart attacks and strokes. The VA patients were mostly male WWII and Korean War Veterans. That was the basis for most of the men in my Baby Boomer generation to take a daily aspirin.

Yes, we knew that aspirin gives us an increased risk of bleeding from our stomach and intestine. And we knew that if we hit our head while on aspirin the amount of bleeding on the brain would be much greater. It was a tradeoff – benefits versus risks.

Over the years the science has advanced to now distinguish those taking aspirin to prevent developing heart disease, cerebrovascular disease or primary prevention and those seeking to prevent an additional health event such as a second heart attack or stroke. To my knowledge there are no studies that examine what happens to someone in their 60a or 70s who has been taking an aspirin for 40 plus years daily and suddenly stops. It’s a question that should be answered before electively stopping daily aspirin.

Over the last few years researchers have hinted that the daily aspirin may protect against developing colorectal cancer and certain aggressive skin cancers. The downside to taking the aspirin has always been the bleeding risk. This data is now being questioned by the USPTF looking for more “evidence.”

The US Preventive Services Task Force was formed in 1984 with the encouragement of employers, private insurers selling managed health care plans and members of Congress to try and save money in healthcare. It is comprised of volunteer physicians and researchers who are supposed to match evidence with medical procedures to ensure that we are receiving high value procedures only.

In 1998 Congress mandated that they convene annually. Under their direction, recommendations were made to stop taking routine chest x rays on adult smokers because it didn’t save or prolong life and it took $200,000 of X Rays to save one life. They reversed their opinion decades later deciding that the math on that study wasn’t quite right and now recommend CT scans on smokers of a certain age and duration of tobacco use. I point this out to emphasize why I am not quite as excited today about their change in aspirin guidelines as the newspaper and media outlet stations seem to be.

I am a never smoker, frequently exercising adult with high blood pressure controlled with medication, high cholesterol controlled with medication and recently diagnosed non obstructive coronary artery disease. What does that mean? At age 45 my CT Scan of my coronary arteries showed almost no calcium in the walls. 26 years later there is enough Calcium seen to increase my risk of a cardiac event to > 10% over the next ten years. I took a nuclear stress test and ran at level 5 with no evidence of a blockage on EKG or films. The calcium in the walls of the arteries however indicates that cholesterol laden foam cells living in the walls of my coronary arteries and moving towards the lumen to rupture and cause a heart attack were thwarted and calcified preventing that heart attack or stroke. I am certainly not going to stop my aspirin.

My thin healthy friend who works out harder than I do told me he doesn’t have heart disease and is going to stop his baby aspirin. I asked him what about his three stents keeping several coronary arteries open? He told me he had heart disease before he got the stents but now he doesn’t. I suggested he talk to his internist or cardiologist prior to stopping the aspirin.

I may take a different path in starting adults on aspirin for cardiovascular and cerebrovascular event protection. I am certainly not going to withdraw aspirin from patients taking it for years unless they are high risk for falls and head trauma or bleeding. I suggest you ask your doctor before considering changing any of your medications.

Try an exercise by writing down all the prescription medicines and next to them list what condition you take them for. Once you have established that information, set up an appointment and talk about it with your physician. The decision-making is much more complicated than the USPTF and headline hungry media discussed and reported.

Some Health Issues Should Not Be Evaluated in the Office

I received a phone call from an elderly gentleman who was closer to ninety years of age than 80, was taking an aspirin and had just suffered a fall and hit his head. He did not know why or how he fell. He asked for an appointment the same day to “check me out.” 

My staff asked all the pertinent questions and immediately brought the information to me.  After reviewing it, I felt for his safety his best course of action was to immediately call 911 (or have us do it) and go to our local emergency department for evaluation. The patient takes daily aspirins to prevent a second heart attack or stroke.

The antiplatelet action of the aspirin, plus his age and the head trauma necessitate an immediate and thorough evaluation with imaging. I do not have an X Ray unit, CT Scan unit or MRI unit in my internal medicine office. If I bring this gentleman into my office, he must transport himself, wait until I have time later in the day and probably will then have to wait to be scheduled by an imaging facility for a non-contrast CT scan of the brain to make sure doesn’t have a bleed between his brain and skull or a bleed in the brain. The delay in evaluation can threaten his survival and recovery. 

The patient was quite angry at the suggestion – quoting my concierge practice contract that says we will bring you in for a visit same day for an acute condition. The non-stated content is that we will bring you in same day for a condition that is appropriate for evaluation in an office setting. The same can be said for someone calling with acute substernal chest pain which could be a heart attack or sudden inability to breathe.  Add in excessive bleeding that does not respond to compression or loss of consciousness as conditions that are best evaluated and treated in an emergency department. These are all conditions that require a call to EMS via 911 and an immediate evaluation in an Emergency Department where the equipment exists to quickly evaluate and treat these problems safely. 

The patient was worried about the wait in the ED and COVID-19 exposure. Both concerns are understandable despite little transmission of Covid recorded in ED visits or in patient hospitalizations.

This patient has emailed me twice now demanding a full refund of his membership fee due to violation of the contract. The reasoning and concern have been explained to him several times already. My concern is that his new onset short temper and grumpy demeanor are the result of the fall and head trauma which still has not been evaluated.

Patients need to know that there are times a health issue requires evaluation and treatment in an emergency department.  It has nothing to do with a contract.  It has everything to do with making the right clinical recommendation for the patient.

Sugary Drinks & Increased Colon Cancer

The Nurses Health Study II followed 95,464 nurses’ health from 1991- 2015. Principal researcher Yin Cao, ScD, MPH, of Washington University in St. Louis and co-researchers found that those women consuming two sugar sweetened beverages a day in adulthood had more than double the early onset colorectal cancer risk as those consuming less than one serving a week. The risk rose by 16% with each additional serving per day.

In adolescents aged 13-18, each serving per day increment was accompanied by a 32 % higher risk of early onset colorectal cancer. As adolescents reach adulthood, replacing these sugar sweetened beverages with artificially sweetened beverages, coffee or milk was associated with a 17-36% lower risk.

The diagnosis of colorectal cancer in those born around 1990, and risk of developing it, is twice as much risk of developing colon cancer and four times the risk of developing rectal cancer as in adults born around 1950. Cao and associates offered several theoretical reasons for the findings including the use of fructose corn syrup as a sweetener instead of real sugar. Fructose corn syrup is known to make changes to the intestinal wall making it more susceptible to carcinogens. And, it has been shown to cause intestinal tumors in mice.

The message is clear. Obstetricians, family practitioners, pediatricians and internists need to start asking about sugar sweetened beverages in our patient histories. Screening for colon and rectal cancer at a younger age with fecal globulin tests, Cologuard fecal genetic testing and fiber optic exams in a younger group is essential. Most importantly, we must educate teenagers and young adults about the dangers of these sugar sweetened beverages so they don’t give them to their friends and eventually their own children.

Advances in Prostate Cancer

Should we get a routine PSA on men at risk for prostate cancer? This debate has been raging for the past few years with the United State Preventive Task Force coming out against screening men for prostate cancer because if the PSA is elevated the subsequent diagnostic testing is painful , expensive and comes with many complications.

The specialty societies representing urologists, especially amongst European physicians, show a drop in deaths from prostate cancer since they started annual screening using PSA blood tests in senior men. When we find an elevated PSA, ultimately, the gold standard was the ultrasound guided biopsy through the rectum performed by urologists in their offices, which was both uncomfortable and accompanied by a post procedure infection at times. That has changed with the introduction of the MRI of the prostate which can detect prostate cancer. If the MRI is negative, then, in most cases, even if there is microscopic prostate cancer present, it would be treated with watchful waiting not surgery or radiation. If something is seen, biopsy interventional radiologists are now able to biopsy the prostate through the perineum under local anesthesia which is less painful and carries fewer post procedure complications.

If prostate cancer is found and the pathology and grading of the specimen indicates a significant risk of spread of disease we now have the capability of using the PET scan with gallium 68 PSMA-11 which targets prostate specific membrane antigen and highlights metastatic disease. This agent was approved by the FDA recently after studies at UCLA Medical Center and University of California San Francisco were reviewed. It has a second use in detecting recurrent disease in men already treated for prostate cancer who now have a chemical increase of their PSA but no detectable mass or lesion on imaging studies.

Radiologists have been using F-18 fluciclovine and or C-11 Choline as imaging enhancers, but these were not as effective as the Ga-68-PSMA just approved. By identifying areas of recurrent disease, it may allow physicians to locally treat the recurrent areas directly. Trial investigator Jeremie Calais, MD, of UCLA feels “Because the PSMA PET scan has proven to be more effective in locating these tumors, it should be the new standard of care for men who have prostate cancer, for initial staging or localization of recurrence.” Peter Carrol , MD, of the University of California, San Francisco added, “I believe PSMA PET imaging in men with prostate cancer is a game changer because its use will lead to better, more efficient and precise care.”

Lung Cancer Screening is Underutilized

Dr. Jinai Huo of the University of Florida (Go Gators!) presented data to Reuters Health that primary care physicians are under-utilizing the technology available to screen for lung cancer. This is a particularly sore topic to me because my associate and I always screened smokers and heavy past smokers for lung cancer with an annual chest x-ray until the United States Preventive Task Force issued guidelines that it didn’t save lives and was not cost effective.  They said, it cost $200,000 in normal x-rays to find one cancer early and it was deemed not worth it.

We actually sold our chest x-ray unit, let go our certified radiology technician and cancelled a contract with radiologists to read our films because insurers stopped paying for chest x-rays after the USPTF ruling.  Twenty years later that same group said “woops” an error was made. The statistical analysis on that study was done incorrectly and actually screening does save lives and is cost effective.

Today we have the fast low dose CT scanner to screen for lung cancer and screening does save lives according to the data.  Who should be screened?

Current smokers or those who have quit smoking within the last 15 years who are 55 to 77 years old and have a smoking history of 30 packs or more per year (one pack per day for 30 years or 2 packs a day for fifteen years).  Screening should be done on individuals in good health so if a lesion is found they are considered well enough to undergo diagnostic tests and treatment.

Screening is also recommended in those individuals over 50 years old with a twenty (20) pack year smoking history and a family history of lung cancer or lung disease or occupational exposure to items associated with causing cancer such as radon.

I inquire about smoking at each visit and have been fortunate in that few of our patients still smoke so we spend less time on counseling for smoking cessation.  If you fall into one of the screening groups mentioned in this article, and have not been screened, please notify us so we can arrange for the testing which will be a low dose chest CT scan.

How Often Do Screening Colonoscopies Result in a Complication?

Harlan Krumholz, MD is the director of the Yale Center for Outcomes Research and Evaluation (CORE). His team at Yale is being paid extraordinarily well to determine what works and what doesn’t in Medicare. Their data will theoretically allow Medicare to issue payment for services based on success rates of care without complications. His group is part of a national program promoted by the Center for Medicare Services (CMS) to spend less for more effective high quality care. This in my humble opinion is “voodoo” health care policy.

One of their areas of interest is trips to the emergency room or hospital within 7 – 14 days of a colonoscopy. They developed a formula to look at this problem and applied it to Medicare claims data in the year 2010 in NY, Nebraska, Florida and California. They found 1.6% of healthy individuals going for screening colonoscopy ended up at the hospital within seven days. They found wide variations in this rate coming from different facilities and different doctors. When the data is extrapolated to the 1.7 million Medicare beneficiaries undergoing screening colonoscopy annually it indicates there will be at least 27,000 unplanned hospital visits within seven days of the procedure.

Determining what causes complications of a screening procedure so we can determine a root cause and then prevent it is a good thing. However; the research needs to be done by independent groups not receiving funds from CMS which has a clear and strong conflict of interest!

We need to be looking at complications related to the choice of preparation, choice of colonoscopy, choice of anesthesia and whether polyps were removed and or biopsies taken. We additionally need to assess the definition of “low risk patient.”

Within the recommended age group for screening colonoscopies of 50-75 years old, very few patients are not taking prescription medications as well as supplements. The research needs to look at procedures such as CT Scan virtual colonoscopy and fecal immunochemical human occult blood testing as well for efficacy and complication rate.

There are currently DNA analysis tests of columnar epithelium colon cells sloughed during a normal bowel movement. Pre-cancerous polyps and colon cancer have distinctive DNA patterns that can be detected by looking at fecal material. There is no prep but the cost of $500 makes determining if it works and under what circumstances important. If it works then shouldn’t it be the screening test to determine who needs to have a colonoscopy? Yes, the research must be done but it must be done by agencies not affiliated with CMS with their stated goal of spending less for better service and better quality.

Does Not Testing the PSA Lead to More Advanced Prostate Cancer?

Mortality from prostate cancer has diminished by almost 40% since the introduction of the PSA test in the late 1980’s. Much of this is due to the use of the PSA blood test for screening purposes. In 2011 The US Preventive Screening Task Force strongly condemned the use of PSA screening. They felt that we were finding too many inconsequential early malignancies that would not lead to death and were being over treated. In their eyes, prostate cancer treatment with surgery and or radiation carried a high price tag with multiple long term complications and the benefit of screening was not worth the risk. Prior to the USPSTF”s 2011 recommendation against screening for prostate cancer with a PSA there were 9000 – 12,000 new cases of prostate cancer diagnosed per month. In the month following the USPSTF recommendation not to screen with PSA the number of new cases dropped by almost 1400 a month or over 12%. Over the next year the decline in prostate cancer diagnosis was 37.9 % for low-risk prostate cancer, 28.1% for intermediate risk, 23.1 5 for high risk and 1.1% for non-localized cancer. Clearly if you do not look for a disease you will not find it.

In the December issue of the Journal of Urology, Daniel Barocas, MD, of Vanderbilt University and colleagues discussed the PSA testing controversy. They too noted that the consequences of not screening for intermediate and high risk prostate cancer by performing the PSA test may lead to individuals presenting with far more advanced disease that is more difficult to treat, has more complications and ultimately leads to disease related deaths. His position was debated by two major urologists in the editorial section of the journal with no firm conclusion being reached.

In an unrelated article, the Center for Medicare Services or CMS announced that it is considering penalizing physicians who test the PSA for screening in Medicare patients beginning in 2018 as part of their paying for value and quality. They said that physicians need to present their patients with an ABN (advanced beneficiary notice) stating that Medicare will not pay for this test, before the blood is drawn or face fines and penalties.

Men in their forties and older have been put in an uncomfortable and inappropriate position by health policy leaders. The truth is we are currently unsure how and when to test for prostate cancer in men with a normal digital rectal exam (DRE). The consequences of not paying for screening will not be known or understood for easily ten to fifteen years. It is clear that early stage disease has the option to be observed for progression with minimal consequences in the short term. Not enough time has elapsed for anyone to know the long term effects of this policy change. Unfortunately, men in this age group are all guinea pigs in the public health policy laboratory while the data to reach a firm scientific conclusion is assembled. The predominant policy today is spending less and doing less. With this in mind, it is best for men to see their doctor, have an annual digital rectal exam, discuss their family history of prostate disease and reach an individual decision on PSA screening appropriate for their unique situation rather than one based on large population policy.

A Blood Test for Irritable Bowel Syndrome?

Researchers presented a paper at the annual Digestive Disease Week meeting which introduced a commercial blood test which can help distinguish irritable bowel syndrome (IBS) from Cohn’s Disease or Ulcerative Colitis (Inflammatory Bowel Diseases) and Celiac Disease ( Gluten Sensitive Enteropathy). The test was especially effective in identifying the diarrhea predominant form of Irritable bowel syndrome. The issue was discussed today on line in the periodical MedPage Today.

Patients with Irritable Bowel Syndrome get sudden abdominal bloating, cramping and progressively watery loose bowel movements. The symptoms often occur after a meal and leave the patient frightened and exhausted. Symptoms can be prolonged and emotionally and physically incapacitate an individual. Until now physicians were forced to schedule barium enemas, small bowel x ray series and fiber optic examinations (sigmoidoscopies, colonoscopies, upper endoscopies) to distinguish irritable bowel syndrome from the more ominous inflammatory bowel diseases. Very often we needed to collect stool specimens to look for white blood cells, red blood cells, bacteria, parasites and chemical constituents. The cost, radiation exposure and risks of invasive procedures causing complications made the experience expensive and unpleasant but necessary.

The current blood tests, used in a trial of 2700 patients, detect antibodies to cytolethal distending toxin B and vinculin. Mark Pimental, MD of Cedars-Sinai Medic al Center in Los Angeles said to the tests were successful in distinguishing IBS from the other entities with specificity well above 90% and a positive predictive value of 98.6% allowing clinicians to rule out Crohn’s Disease or Ulcerative Colitis.

This is a step in the right direction but it remains to be seen when the test will be available locally through commercial labs and if it really will allow us to eliminate the many tests we now do to distinguish these problems from one another.

Real Food for Colonoscopy Preparation

Colonoscopies save lives. It is recommended that adults start having them at age 50 to detect pre malignant colon abnormalities and early colon cancer. For the physician performing the test, the colon must be clean of digested food and stool to observe the lining cells of the colon. The presence of fecal material blocks the view of the colonic mucosa. Those of us who have taken screening colonoscopies are well aware that the preparation for the test is far worse than the actual procedure (which you are usually sedated for in some manner.) Most colonoscopy preps involve starting a laxative the afternoon before the procedure and staying on clear liquids the whole day until the procedure is complete. Some preps ask you to drink large volumes of soapy flavored liquids. Others use smaller quantities of chemicals but the end result is frequent loose and watery stools until the stool looks the same on the way out as it does on the way in. At best the preparation is a necessary but unpleasant experience.

Corey Siegel, MD MS and Dough Knuth, RD along with Joshua Korzenik, MD, of Harvard Medical School have produced real food laced with PEG-3350 as a colonoscopy prep. They are so confident of this preps efficacy that they formed a company to produce it called Colonary Concepts Inc. Foods such as pasta, pretzels with dipping sauce, smoothies and nonalcoholic Pina coladas have been mixed with laxatives to produce a colonoscopy prep. They reported on their study results at Digestive Disease Week and in MedPage Today. According to the endocscopists who performed the studies on these patients, the colon was good to excellent in preparation for viewing. The patients had no problems with the prep and said they would gladly choose the real food prep again for future colonoscopies. Based on the favorable review of this prep a larger Phase II study is now in progress. This is a step forward for a necessary but uncomfortable screening procedure.