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Following is the full text of: Kathie's Story: Misdiagnosed with Lung Cancer In July 2002, my wife Kathie was misdiagnosed with lung cancer in an American Cancer Society-sanctioned clinical trial. A few weeks later, she underwent an unnecessary $40,000 surgery from which she will likely never recover in full. Many others could find themselves in a similar position. The U.S. government's National Cancer Institute is currently conducting a clinical trial with 50,000 subjects, 25,000 of whom are getting computerized tomography (CT) scans to screen them for possible lung cancers. Some will probably, like Kathie, be misdiagnosed. In addition to that, CT scans are now being increasingly given at annual physicals to screen people most at risk of developing lung cancer. I have written this article in the hope that I can help people better understand CT and PET screening technology, permitting them to make intelligent, informed decisions while avoiding unnecessary pain and suffering. By discussing cautions that individuals may wish to consider if they are screened for lung cancer using low-dose helical computerized tomography (CAT) scans and positron emission tomography (PET) technology, I will hopefully help patients not familiar with these technologies better understand how they can go wrong. You're going to learn things here that your doctor, your surgeon or your radiologist might never tell you. Prior to beginning publication of this article, I sent an email to people prominently mentioned in the article asking if they would be interested in an advance copy to read for accuracy. One person responding was Dr. Michael V. Smith of Atlanta, who is mentioned prominently. He said in an email to me of the title, "I fear that while it makes good copy this description will frighten the uninformed and provide unsubstantiated ammunition to those opponents of early detection of lung cancer." It is not my intent to frighten. I hope that those who read the entire article will realize that my intent is to to inform, and that the title is an accurate description. The story begins when I first became interested in lung cancer while teaching public relations classes at the Universities of Wisconsin and Georgia. Reading about the history of public relations, I learned of the role played by advertising and publicity in promoting cigarette smoking, and of the persuasion effort needed to discourage people from smoking. This interest led me to ten years of service on the board of directors of the Georgia chapter of the American Lung Association. After that, I served with the American Cancer Society in a number of capacities, including stints on the board of directors and the executive committee of the Georgia Unit and Southeast Divisions, and in a number of committee assignments. Note that my areas of expertise are journalism and public relations. I'm not a doctor, and don't pretend to know what doctors know. I do know how to write, and have written 11 books on various subjects. 2. Meeting Dr. Smith In the late 1990s, or perhaps 2000 or 2001, one of the American Cancer Society committees on which I served was preparing recommendations for the position the American Cancer Society should take in lobbying the Georgia Legislature regarding a monetary windfall coming to the state as a result of the master settlement with the tobacco industry. The state expected to receive in the neighborhood of $200 million per year for 25 years. A number of community leaders, including Hamilton Jordan, former chief of staff for President Jimmy Carter and a three-time cancer survivor, wanted part of that money to go to improving Georgia's cancer infrastructure. The upshot was that then-Gov. Roy G. Barnes in 2001 launched the Georgia Cancer Coalition, which was to be a 10-year, $1 billion initiative to build a major cancer research and treatment presence in the state. Some $400 million in tobacco settlement funds and $600 million in federal and private money were to fund the initiative. At one of the morning meetings of the group, a young Atlanta surgeon and graduate of the Medical College of Georgia, Dr. Michael V. Smith, MD, FACC, FACS, FCCP, came in to talk about a clinical trial he hoped to conduct at Atlanta Medical Center, formerly the respected Georgia Baptist Hospital, which Tenet had bought and renamed. Tenet, a publicly owned corporation that operates health care facilities in a number of states, is the parent corporation that was involved in a number of unnecessary surgery cases in California. Dr. Smith had become familiar with the pioneering work of radiologist Dr. Claudia I. Henschke of the Weill Medical School of Cornell University in New York. She had for a number of years been using CT scans as a way to screen for lung cancer tumors in high-risk patients. Dr. Henschke pioneered in finding lung cancers in the people most likely to get them much earlier than they can be detected by conventional X-rays. Conventional X-rays don't detect lung tumors until they're about 30 mm. (the size of a quarter) or larger. CT scans can find them when they're no bigger than a grain of rice, a sixth of the size detectable by conventional X-rays. CT scans, like X-rays, rely on gamma radiation. Instead of a single picture like that taken by an X-ray machine, however, a CT machine takes many pictures as targets on a large hollow wheel whirl around the patient. The patient is examined in a series of thin slices, much as a loaf of bread might be sliced. In a chest scan, lung tissue appears black on the film produced by the machine. Blood vessels appear white. The radiologist reading the images or film looks for white spots that are not blood vessels. Those are suspect tumors. Computers assist in the recording and analysis of the images. Early detection of cancer is important to treatment. If tumors can be detected before they've metastasized or relocated to other parts of the body, the job of treating them with techniques such as surgery, chemotherapy and radiology is much more likely to be successful. Success in cancer treatment is measured by five-year survival—whether or not a patient is still alive five years after diagnosis. Most lung cancers are detected late, resulting in only 14 percent or so of all patients surviving for five or more years. Most die within a year of detection. But if lung cancers are detected early, five-year survival rates improve to 42 percent on up. In 1992, Dr. Henschke and her colleagues at Weill launched the Early Lung Cancer Action Project (ELCAP). Over six years, they recruited 1,000 high-risk volunteers—people over 60 with an extensive history of present or former smoking—who were given CT scans plus chest X-rays. Only four of the high-risk subjects turned out to have lung cancers detectable by X-ray, but CT scans uncovered tumors in 27 of the subjects, including 23 tumors at the earliest stage of development. Dr. Henschke by 1998 had shown that CT scans can an effective screening tool for lung cancer. Dr. Smith wanted to take her work a step further. One of the problems with CT scans as a screening tool is that almost half the high-risk population has fibrous masses in the lungs resembling cancer tumors. Most of these masses are benign, often dating back to childhood when a foreign substance was inhaled and the lungs took protective action by encasing the harmful substance in a fibrous mass. So how do you distinguish the very few of these fibrous bundles that are cancers from those that are not? Dr. Smith believed the answer was a new technology called positron emission tomography or PET scanning for short. Here's how it works. The patient is injected with a radioactive substance in a glucose (sugar) solution. Cancer cells are hungry for energy and absorb 20 times as much of the radioactive glucose as normal cells. Targets whirling around the patient in the same way a CT scanner works pick up the radiation being emitted by the radioactive solution. Exactly how the PET scanner works is complicated, involving the annihilation of positrons and electrons with resulting vectored gamma radiation. Let's just say that if a lot of radiation is picked up by the PET scanner in the same area as a suspected tumor identified on earlier CT scans, then there's a fair probability that the fibrous mass showing up "hot" (emitting a lot of radiation) on the PET film is a cancer. Dr. Smith says he became interested in developing a better method of screening for lung cancer after his mother died of the disease. Having a parent die of lung cancer that was not diagnosed early is a powerful motivator. I know that, because both my mother and father died of lung cancer. When Dr. Smith became interested in using PET scanning as a screening tool, the technology was a relatively new tool, although it already had a track record in cancer diagnosis. Doctors at oncology (cancer treatment) centers were already using PET scanners to stage and track the progress of cancers that had been diagnosed in patients. The scanners were helpful in telling if treatment was successful (the cancer was shrinking) or, if instead, the cancer was growing. I don't recall that Dr. Smith said all this in the ACS meeting where he spoke of his proposed clinical trial, but he said enough to favorably impress the committee on which I served. The upshot was that the Southeast Branch of the American Cancer Society eventually approved Dr. Smith's research plans. 3. Kathie learns of the clinical trial I forgot all about that morning meeting until many months later, when my wife Kathleen heard a promotional spot on television about Dr. Smith's clinical trial. She wanted us to participate. She persuaded me to go with her to Atlanta Medical Center, where we enrolled on June 19, 2002. The person who registered us, Beatrice Saba, was a personable young lady visiting Georgia from Africa. She told us of the Tenet doctors who would be involved in the trial. One was Dr. Louis Lovett. Another was Dr. A. Hamblin Letton. Dr. Letton, a past president of the American Cancer Society, is renowned for his role in encouraging women to conduct breast self-examinations to detect cancer tumors. He once reportedly turned down an offer from President Richard M. Nixon to serve as U.S. surgeon-general. Beatrice also told us that Dr. Barry F. Jeffries would be the radiologist who would be reading CT and PET scans conducted during the clinical trial, the goal of which was to enroll 1,500 subjects over 55 who had at least a 20 pack-year history. A pack-year consists of smoking a pack of cigarettes a day for a year. Smoke one pack a day for a year—that's one pack-year. Smoke two packs a day for a year—that's two pack years. Smoke half a pack a day for a year—that's half a pack-year. My wife Kathie and I met the criteria, although, like the 1.3 million Americans per year who quit smoking for good, we had both quit many years earlier. We were, nonetheless, among the 90 million Americans who at one time or another had smoked. Another thing we learned from Beatrice was that PET scans would be given only to subjects who had suspect lung nodules on their CT scans. 4. We attend the introductory seminar On June 26, Kathie and I attended a two-hour "seminar" at Tenet's Atlanta Medical Center. The meeting was held in space provided by Tenet to GILCR for the clinical trial. It was during this meeting that I first realized Dr. Smith as the same physician who had talked of his proposed research to the American Cancer Society committee on which I was serving earlier. At the meeting, we were told that Reynolds Jennings, on behalf of Tenet, had donated $150,000 to jump-start the GILCR screening trial. The goal of the trial, we were told, was to detect lung cancers earlier, so that survival rates could be improved. As of that evening's meeting, we learned, three cancers and three probables had been found using CT plus PET technologies. Subjects for the trial had to be 50 years or older, with a 30 pack-year history. That was a little different from the 20 pack-year history we'd heard from Ms. Saba, but the difference seemed unimportant. At the June 26 meeting, Dr. Smith mentioned his frustration over getting money he'd asked from the Georgia Legislature. The Georgia Cancer Coalition (GCC) was now disbursing most of the money Georgia planned to spend on lung cancer research A major part of the money being channeled through GCC, at the urging of Hamilton Jordan and other influentials, was being allocated to fund what Georgia hoped would be a world-class cancer research center at Emory University. Emory, which graduates of the rival Medical College of Georgia sometimes say has an edifice complex, used much of the huge grant it was receiving to build a building. But researchers were being hired and brought in, and by mid-2004 Georgia had attracted 66 of the 150 cancer researchers it hoped to recruit for the Emory research center. The researchers by mid-2004 had brought $77 million in federal grants with them. While Emory was benefiting from the state's largesse, Dr. Smith's request for $1.5 million in funding had been cut in budget hearings to $300,000, and he had not received a single penny of that. As it would turn out, none of even the $300,000 would ever go to GILCR, which by July 2004 had closed down the lung cancer screening trial. As part of his presentation at the June 26, 2002, meeting, Dr. Smith mentioned that Dr. Hadyn Williams of the Medical College of Georgia was monitoring his research. Dr. Williams, he said, had studied at Cornell, where Dr. Henschke was conducting her pioneering work with computerized tomography to screen for lung cancer. Among other comments, Dr. Smith said at the meeting that PET scans were 90 percent accurate in determining whether or not suspect fibroids in lungs were tumors. Later in the presentation, he stated that PET scans were 95 percent accurate in identifying cancers. As for scanning for tumors, Dr. Smith noted that while conventional X-rays can find fibrous bundles if they are 30 mm. or more in size, CT scans can find fibrous bundles down to 5 mm. in size. That's the difference between finding something the size of a quarter versus something the size of a pencil eraser, as he put it. The earlier a tumor is found and treated, the greater the chances for successful treatment. He indicated that the ideal subjects for GILCR's Early Detection Initiative were individuals 55 or older, with a 30 pack-year or more history, who had stopped smoking no more than 10 years earlier and had no prior cancer history. Dr. Smith indicated that while GILCR study subjects were experiencing no delays in getting CT scans, PET scans were a different case. At the time, there were four fixed and three mobile PET scanners in the Atlanta area. The GILCR study accessed one of the mobile scanners once every two weeks. As of the July 26 2002 meeting, 50 subjects in the GILCR study were waiting to get PET scans for suspect nodules identified by CT scans. 5. I write an article about Dr. Smith's need for funding for the Atlanta Journal-Constitution I was impressed with what we learned at the meeting about what Dr. Smith had accomplished. I still believe that CT and PET scanning can play an important role in lung cancer screening. At the time, of greater reIevance to this narrative, I thought he deserved state funding for his research. Based on what I had learned at his seminar, I wrote an opposite-editorial (op-ed) piece for the Atlanta Journal-Constitution, Atlanta's daily newspaper. The piece, headlined "Broken promise limits cancer research funding," appeared in the July 5 issue of the paper. It detailed the results of Dr. Smith's research (at the time, three cancers found in 250 subjects screened), and recounted how he had been budgeted money by the Georgia Cancer Coalition, but that the money had not been forthcoming. 6. I question radiation doses Kathie and I followed separate paths for getting our respective CT scans. As it turned out, because of what turned up in our lungs at each test, we both got a CT scan, we both got a subsequent CT scan with contrast (more powerful) and we ultimately each got a PET scan. Except for her PET scan, which was done at a mobile unit at Northside Hospital in Atlanta, all of our tests were done at Atlanta Medical Center in downtown Atlanta. When I went for my CT scans, I made a point of asking about radiation doses. I was surprised to learn that the Atlanta Medical Center technicians were unable to answer my questions. They didn’t know what the radiation doses were. I didn’t find out until much later that CT scans expose a subject to significantly larger doses of radiation than X-rays. For those interested, One measure of radiation dosage is the REM. A standard or conventional X-ray likely exposes the subject to 1/100th of a REM (0.01 REM). A typical adult CT brain scan results in the patient absorbing about six REMs, or 600 times as much radiation as an X-ray. A chest or abdominal scan exposes the patient to two to three REMs, or 200 to 300 times the gamma radiation of an X-ray. More accurate estimates of radiation danger in the U.S. come from the National Academy of Sciences (NAS). A panel of NAS researchers reports every decade or so on radiation hazards. The panel issued one report in 1990, and another more recently in 2005. In the latter, it concluded that even very low doses of radiation—from X-rays, and from closely related gamma rays emitted by nuclear materials used in medicine and some commercial products—pose a risk of causing cancer over a person’s lifetime. The most recent report of the panel, issued after five years of study, rejected the contention of some scientists that tiny doses of radiation are harmless. Most of us get more radiation naturally from the environment than we do from medical testing. Activities such as eating, breathing and drinking account for about 82 percent of the radiation to which we are exposed. The remaining 18 percent of the radiation we get comes mostly from medical radiation, but also from television and computer monitors. Tobacco smoke and some building materials can also expose us to man-made radiation. For its 2005 report, the NAS panel used the millisievert as its unit of measurement. In the United States, the average person is exposed annually to about three millisieverts of natural background radiation, mainly from the sun. A chest X-ray exposes a patient to about 0.1 millisievert, while a CT scan is about 10 millisieverts, a little more than three times natural annual exposure and about 100 times the exposure from an X-ray. The NAS panel estimated that one out of 100 people exposed to 100 millisieverts of radiation over a lifetime probably would develop solid cancer or leukemia, and about half of those cancers would be fatal. An additional 42 cancers might develop in the same group of 100 from other causes such as genetics, workplace chemicals and environmental contaminants. That places the risk of getting cancer from medical radiation low. Doctors and radiologists argue with good reason that for patients at high risk of disease, the radiation dose from a CT scan is less a risk than not detecting, diagnosing or staging the disease. The NAS scientists concluded, nonetheless, that medical radiation is dangerous, and can, among other things, cause cancer. The risk is greater for those who get a large number of tests involving radiation. The use of medical radiation is on the rise. Where CT scans were once used largely for diagnosis, they are now being used widely for screening as well as for diagnostic purposes. About 45.4 million CT scans were performed in 2002 nationwide, up 14.6 percent from 39.6 million in 2001. The number of PET scans performed in 2003 was up an estimated 58 percent in 2003 from 447,200 in 2002. 7. The mystery of the dread diagnosis By July 9, Kathie had been given a CT scan plus a CT scan with contrast at Atlanta Medical Center, plus a PET scan, the last provided at Northside Hospital. Kathie and I were covered by my medical insurance, so the cost of our scans were paid by that. We met with Dr. Smith at his office on July 9. She was told then that she had three suspect nodules in her lungs. Of the three suspect nodules, PET scans had eliminated two of the three as cancers, and had probably eliminated the third, we were told. Kathie taped the conversation. I took some digital photos of the films from her scans as Dr. Smith discussed them with us. She and I went on to an appointment she had with her pulmonologist at St. Joseph's Hospital. Three days later, on Friday, July 12, Dr. Smith called. He had bad news regarding that third suspect nodule in the right hilum area of her lungs. He now believed the third abnormality in her lungs was a cancer requiring surgery. Someone had determined that this nodule was malignant. Dr. Smith did not tell us who had made that diagnosis, only that it had been made by "the best radiologist he knew." I doubted at the time that Atlanta Medical Center radiologist Dr. Jeffries, who was voluntarily reading the GILCR CT scans for those without insurance, was the one. He had earlier complained about the quality of Kathie's CT scans which we had discussed with Dr. Smith on July 9. If he had diagnosed the suspect masses as cancers, or even suspected that they were cancers, we likely would have heard about it on July 9, not three days later, on July 12. After reviewing my notes and Kathie's tapes, I decided Dr. Smith must have asked someone else to look at her films. Who had made the determination of malignancy? Was it Dr. Henschke of the ELCAP studies at Cornell's Weill Medical Center? Dr. Smith had mentioned that film from his study was being reviewed by the participating ELCAP people at Cornell. Could it have been Dr. Hadyn Williams of Dr. Smith's alma mater, the Medical College of Georgia? Dr. Smith and others had indicated that Dr. Williams, who had studied at Cornell before moving to Georgia, was involved in the GILCR study. As of this writing, I don't know who changed the earlier diagnosis. We'd both really like to know. I think Kathie has a right to know. She's the one who underwent unnecessary surgery as a result. From July 12 on, things began to progress rapidly, pretty much out of our control. We were at the mercy of medical professionals who knew a lot more than we did. 8. Kathie's story: Even radiologists get it wrong when reading CT and PET scans On July 16, while we were waiting for a test procedure to be performed on Kathie, we both read an article by David Wahlberg in the Atlanta Journal-Constitution about body scans for cancer that gave us pause. Headlined "Inside Story," it argued that CT scans for hidden diseases can save lives, but that many physicians felt drawbacks of the scans outweighed their worth. The article pointed out that a spot in a lung, kidney or liver that shows up on a CT scan could be a cancer, but was more likely to be a harmless tumor or a scar from an infection. A related story in the same paper detailed the experiences of Dr. William Casarella, head of the radiology department at Emory University's Medical College in Atlanta. Dr. Casarella, who is in charge of overseeing the reading of CT scans at Emory Hospitals, had undergone a screening CT scan that turned up suspicious masses in his left kidney, his liver and his lungs. As a result of these suspicious spots, he had subjected himself to a number of painful, probably unnecessary procedures and surgeries. I did not realize until I reread Dr. Casarella's story two years later that it had contained a warning Kathie and I might have heeded if our doctor had explained the significance. Among the things that had turned up on Dr. Casarella's full-body CT scan, in his own words, were seven or eight spots on his lungs. To get more information, he had undergone a second, more detailed CT scan of both lungs, which was inconclusive. "After that," he wrote, "we did a PET scan to see if the lesions were active in taking up glucose, which would mean they are cancerous. There was no uptake, but the lesions were at the limits of resolution for current PET scans, so it wasn't really that helpful." Dr. Casarella went on to explain that he could have followed the fibroids with periodic CT scans to see if they grew, which would indicate malignancy. But he decided instead to have the lung lesions biopsied surgically. Before the operation, he had blood tests, a pulmonary function test and a cardiac stress test. Then, during the surgery, he said, "they made a 6-inch incision on the side between the ribs. They deflated my lungs so the surgeons could feel it and find the nodules. They cut out three lesions, which showed I had histoplasmosis, a benign fungus infection that had healed itself. Millions of people have this and never know it." His bill for the needless surgery and hospital stay was $47,000 It would turn out that Kathie would be one of those millions of people who underwent a similar needless surgery, and she was being rushed toward it at a relentless speed. We were, unfortunately for Kathie, too naive to ask that if even expert radiologists were being confused by CT and body scans, what were our odds? 9. The bronchoscopy We'd asked Kathie's pulmonologist to perform a bronchoscopy in the hope that it would confirm or eliminate the need for surgery on Kathie's suspect cancer. In a bronchoscopy, a thin tube containing fiber-optic strands is inserted into the bronchus of the patient's lungs. The doctor can use the instrument to examine the larger passages of the lungs. If a cancer was indeed growing in the right hilum area of Kathie's lungs, it was possible the cancer's presence could be seen by the doctor through the bronchoscope. The bronchoscopy was performed on July 16. The doctor played back the images for me after the procedure. No cancer was detected. That didn't mean there wasn't one—just that it was not detected by examination of the bronchus with a bronchoscope. Dr. Smith felt the bronchoscopy left surgery as the only viable way to confirm the cancer and begin treating it. Kathie's pulmonologist disagreed. He thought it would be more prudent to wait for three months or so for another CT scan to see if the suspect mass had grown, eliminating the need for surgery to prove that the suspect mass was a cancer. I'd been reading what I could to update myself about cancer and treatment in the free time I had in these days. Kathie and I asked Dr. Smith if it wasn't more practical to get a tissue sample for biopsy using fine needle aspiration rather than radical thoracic surgery. Dr. Smith warned against that, cautioning that the needle used could drag cancer cells with it as it was withdrawn, spreading cancer cells behind it. 10. Putting together a treatment team We'd gotten recommendations from friends and medical professionals for several surgeons who, other than Dr. Smith, might perform surgery if it proved to be necessary. One of the recommendations was for Dr. John Moore of St. Joseph's Hospital in Atlanta. Dr. Moore had been Dr. Michael Smith's partner before Tenet lured Dr. Smith away to head the cardiac surgery unit at Atlanta Medical Center. As a bargaining chip in the effort to lure Dr. Smith to Tenet, Tenet had agreed to help him with the lung cancer screening clinical trial he wanted to conduct. We decided to use Dr. Moore for a second opinion on whether or not Kathie really needed surgery to treat a likely lung cancer, and made an appointment with his office. From among the oncologists recommended to us by friends was Dr. Colleen Austin. Dr. Austin was also recommended by another physician. We made an appointment with Dr. Austin in case her assistance was needed to treat Kathie with chemotherapy. By this time, Kathie and I were talking to anyone and everyone who had experience in dealing with lung cancer. One of our neighbors, with whom we had regularly played bridge, had died of it, but only after a valiant fight that considerably extended his life expectancy. His family gave us information on immune system stimulants he had taken in massive amounts to enhance his body's ability to fight his cancer. Because Kathie hadn't been conclusively diagnosed with lung cancer yet—there was no biopsy of tissue to confirm a cancer—it didn't seem critical that we take that course. I went to the health food store where the neighbor had purchased his supplements. I learned that there were a mind-numbing number of immune system stimulants. After talking with the store manager, I felt he seemed more interested in selling expensive products than in discussing how they work, so we put that on hold. 11. The pressure is on Although we had gotten a few warning signals, we kept coming back to Dr. Smith's declaration that CT scans plus a PET scan could identify a suspect cancer with 90 to 95 percent accuracy. That meant the odds of what had turned up in Kathie's scans were 90 to 95 out of 100 that a cancer was involved. And, as Dr. Smith warned me on several occasions: "Noel, this is a cancer!" With a growing cancer—especially an aggressive small cell lung cancer—your odds of survival go down with each passing day, with each doubling of the cells in the tumor, with each possibility that the cells are spreading to other parts of the body. We were scheduled for a July 23 pre-operation meeting at St. Joseph's to finalize Kathie's surgery, now scheduled for 7:30 a.m. on July 29. The date had been moved up because Dr. Smith was leaving town for a trip immediately after that, and wanted to complete the surgery before he left. Our first appointment with thoracic surgeon Dr. John Moore for a second opinion on July 24 was canceled because he was running late. Frustrated that critical decisions had to be made quickly, and time for gathering information was running out, we rescheduled for the morning of July 25. At 11:30 on the 24 th, we attended a pre-op session at St. Joseph's Hospital in Atlanta. We were told to have Kathie at the hospital by 5:30 a.m. on Monday, July 29, to check her in for the surgery.At 1:30 on the afternoon of the 24th, Kathie underwent a number of pulmonary function tests at the hospital to be sure her lungs would withstand the rigors of surgery. After that, we met with the anesthesiologist who went over with us the procedures that would be followed to render her unconscious for the surgery. Kathie was particularly apprehensive about the discussion of how her lungs would automatically collapse when the surgeon opened her chest cavity. She looked pretty much like a deer caught in the headlights of an approaching car. 12. We attend the GILCR seminar again On the evening of July 24, we attended for the second time the two-hour seminar at GILCR that we had attended a few weeks earlier. This time, our daughters and their significant others—husbands and boyfriends—attended with us. Like us, they wanted to learn all the could about lung cancer and how it might be affecting Kathie. My training as a journalist—I've been a newspaper reporter and editor, have a master's in journalism and taught journalism and public relations at two major universities—had led me to take copious notes at the first seminar, before Kathie's diagnosis. This night, with surgery in the offing, I took far more notes than before. Dr. Louis Lovett, first on the program that evening, mentioned that Tenet's Atlanta Medical Center was one of only ten centers in the United States screening for lung cancer using CT and PET technology. Mention was made at the meeting of the pioneering work of Dr. Hadyn Williams, chief of nuclear medicine at the Medical College of Georgia, who had worked with Claudia Henschke at Cornell, and Dr. A. Hamblin Letton. Mention was also made of pioneering work in Japan at Nippon Kyobu Geka Gakkai Zaoshi (did I spell that right?) in the use of PET scanning in lung cancer screening and diagnosis. As for the GILCR screening study at Atlanta Medical Center, we were told that 275 patients had by this time been enrolled, and a total of four cancers had been found in the high-risk subject group. Mention was made that while PET scanning was not yet approved by the medical profession or insurance companies as a screening tool for lung cancer, it was approved for staging firmly diagnosed cancers. The statement was again made that PET scanning was 95 percent accurate in diagnosing lung cancers. The urgency of treating suspect cancers was emphasized in the evening presentations. Data were presented warning that in non-small cell lung cancer (NSCLC), tumor cells divide on average every 99 days, in a range of 90 to 120 days. In the case of more aggressive small cell lung cancers (SCLCs), doubling of cells occurs every 26-30 days. Survival rates are greatly improved if lung cancers are detected and treated early, before metastasis. 13. The second opinion: Another warning On the morning of June 25, Kathie and I met with Dr. John Moore for a second opinion. He pointed on Kathie's CT scan films to two masses in the upper lobe of one of her lungs, one of normal lumpy shape, the other dumbbell shaped. The masses were in the area where the trachea splits into the two bronchi. Dr. Moore said that he and Dr. Smith disagreed on the efficacy of PET scanning. He was not as big a proponent of PET scanning as was Dr. Smith, his former partner. He said he thought there was a 60 percent to 65 percent chance—at best a 70 percent chance—that the masses in Kathie's lung were cancer. He emphasized that inflammations of the lung can register as false positives for cancer on PET scans. He then said that if a mediastinoscopy had turned up negative results, he'd go ahead with a thoracotomy. He thought getting tissue biopsied was more important than a positive PET scan. He went on to discuss survival rates. Surgery is performed on many stage IIIA cancer patients, and on some IIIB patients, he said. Kathie was thought to be a stage IIIA. Dr. Moore then returned to the subject of accuracy of PET scans. Four years earlier, he said, he had heard radiologists say PET scans were the greatest thing ever. But he didn't think PET scans were as accurate as once held. Prayer, on the other hand, he felt to be positive. I think now that Dr. Moore was trying to warn us, albeit indirectly, that he was suspicious of the GILCR study. I don't know that to be the case—it's just an impression I now have. At any rate, we pressed him. What did he recommend, we asked? He answered that if a mediastinoscopy—a medical procedure to biopsy the mediastinal lymph nodes for the presence of cancer requiring a day or two at the hospital— came up negative, then a pulmonectomy would be advisable. He himself would more than likely do a lobectomy if a mediastinoscopy did not indicate a cancer. A ventilation perfusion scan before the pulmonectomy surgery would be needed to assure that the patient could withstand the aftermath of a lobectomy. Kathie's pulmonologist should be consulted, he advised. 14. Last meeting with surgeon Smith On the afternoon of June 25, Kathie, two of our children and I went to Dr. Smith's office for the pre-op consultation. He was busy talking to some medical students and was an hour and a half late for the appointment. The children, who had come with us and had to get back to jobs, were ready to leave when he finally arrived. The main purpose of the consultation turned out to be the signing of surgical consent forms, although Dr. Smith answered some questions and briefly discussed the results of several tests Kathie had taken, including maximum oxygen uptake. He said the operation would take 35 minutes to one hour to get epithelial squamous cells for examination, plus another hour and a half if he had to do a resection. He mentioned that PET scans were 94 percent accurate for detecting lung lesions, and 88 percent accurate for detecting metastasis to lymph nodes. Kathie's PET scans indicated two tumors plus metastasis. This was the last chance for Dr. Smith to talk about the serious consequences of the operation. This is important. He never told us the mortality statistics for the kind of surgery Kathie was about to undergo. Nor did any of the other doctors with whom we consulted. So I'll tell you what none of the doctors would tell us. Of those over 65 who undergo a partial lung removal, five percent die. Of those over 65 who have a full lung removed, 16 percent die. We did know by the end of this meeting from email exchanges with Dr. Smith, telephone conversations and the pre-op consultation that there would be two stages to Kathie's surgery. In the first stage, a mediastinoscopy would be performed. A small slit would be made in the area of the breastbone. An instrument would be inserted that permitted the doctor to look at the mediastinal lymph nodes, and take a tissue sample from them for biopsy. If the mediastinoscopy was negative for cancer, we were told, the next step would be a thoracotomy. This involved an opening of the chest cavity between two of the left ribs. The lungs would collapse as soon as the surgeon's opening broke the pleural membrane, and with it the vacuum inside the thoracic cavity. A portion of the lung where the suspect tumors were located would be removed, and the suspect masses would be biopsied for cancer. Kathie is still of the opinion that if the mediastinoscopy was negative for cancer, the first surgery would end there, and she would be awakened to go home after a day or two. A second surgery would follow if the tumors grew. While she thinks that, according to my notes, the plan was to perform both a mediastinoscopy and thoracotomy to remove the suspect tumors, thereby saving her the stress of two separate anesthesiologies. 15. The surgery is performed Kathie's surgery was performed as scheduled on the morning of July 29. At about 11:45 a.m., Dr. Smith came to the waiting room to inform assembled family members that he had performed a wedgectomy and removed some inflamed tissue elsewhere in the lung. All the tissue was negative for cancer. Many tears were shed by the daughters, who had been very frightened and were relieved and overjoyed to learn that their mother's biopsies were negative. Dr. Smith said immediately after the surgery that the false positive for lung cancer was the result of an aspergilloma infection that Kathie had. Responding to the invitation for an advance copy of this article, he said in an email to me on June 27, 2004, that "As you recall her biopsy did diagnose an aspergillosis infection in her lung which was previously unknown and was deemed to be in need of treatment by her infectious disease specialist. This would have gone undetected had it not been for her participation in the lung cancer study."In actuality, two rare disease specialists with offices at St. Joseph's Hospital were involved in culturing the tissue removed from Kathie's lungs. It takes a number of days to try to culture and confirm aspergillosis from a tissue sample. As it turned out, the specialists were never able to verify that aspergillosis was present in the removed lung tissue. Nor were they able to verify any other reasons—viral, bacterial, fungal or chemical—that the tissue might have shown up positive for cancer on Kathie's PET scans. Be forewarned—medicine is still far from an exact science. We never did find out what might have fooled the PET scanner into thinking that what turned out to be benign masses in Kathie's lung was a malignant cancer. Like Dr. Casarella mentioned earlier in this article, whose scans had mistaken a fungus infection that had cured itself long before, Kathie may well have fallen into the category of the millions of Americans carrying such benign lesions that fool expensive medical technology. Doctors would have us believe, from the persuasive messages disseminated by the public relations specialists at the American Medical Association, that medical mistakes are rare, and that doctors should be excused from the consequences of their mistakes lest the cost of malpractice insurance make medical practice so expensive that doctors go out of business and everyone is denied health care as a result. According to the results of a new national review of Medicare records by a Denver agency release in late July 2004, medical mistakes are all too common. The number of hospital patients who die from preventable errors may be twice as high as previously estimated. The finding would make medical mistakes the third-leading cause of death in the country, behind only heart disease and cancer. Kathie and I elected not to sue for malpractice. Better, we thought, to make Kathie's story public. 16. The aftermath For Kathie, who had been told recovery would take about six weeks, there was a much longer and extremely painful recovery period of six months. She still hasn't regained full use of her left arm two years later, and probably never will. I would be remiss if I did not mention that a few days after the surgery, while Kathie was still connected to tubes and a machine draining her chest cavity, Dr. John Moore (the second opinion physician) briefly visited her Intensive Care Unit hospital room at St. Joseph's Hospital in Atlanta. "I told you so," he said pointedly. The remark could be taken to mean a number of things, but Kathie and I have taken it to mean he had been trying to warn us off in the second opinion consultation before the surgery.17. Dr. Brawley objects to the GILCR study At about this time, while I was spending night and day at Kathie's bedside at St. Joseph's Hospital, I received an email from Dr. Otis W. Brawley. Dr. Brawley at the time was professor of medicine, hematology and oncology at Emory University School of Medicine and professor of epidemiology at Emory's Rollins School of Public Health. He was also serving as associate director of the Winship Cancer Institute at Emory University and as director of the Georgia Cancer Coalition Center of Excellence at Atlanta's Grady Hospital, an important medical facility that, among other missions, treats many of the medically uninsured in the Atlanta metro area. From 1995 to April 2001, Dr. Brawley had served at NCI headquarters as the assistant director of the National Cancer Institute's Office of Special Populations Research. Before that, he had been a senior investigator at NCI, and from 1993 to 1995 headed NCI's intramural prostate cancer clinic. Dr. Brawley had apparently read my op-ed piece in the Atlanta Journal-Constitution. He may have taken exception to some or all of it. I learned that he had written a letter to the American Cancer Society's Southeast Division, which has responsibility for several states including Georgia, recommending that it withdraw its approval for Dr. Smith's GILCR screening study at Atlanta Medical Center. Any reservations he had about Dr. Smith's research study certainly deserved consideration. From Kathie's hospital room, I sent him an email that begged off answering his email, noting that I'd get back to him after my wife had recovered. To my regret, I never did so. Dr. Smith subsequently told me that Dr. Brawley had objected to the Cancer Society about his study. He said that he had successfully defended the study with ACS, which continued to sanction his work regardless of Dr. Brawley's objections. He also told me at a later meeting that he had lunch with Dr. Brawley to discuss the issues involved, but had been unable to resolve differences between them. I never learned exactly what Dr. Brawley's objections were to the GILCR study. 18. At Kathie's bedside, I begin to question the surgery In Kathie's room in the Intensive Care Unit at St. Joe's I began to question what had taken us so quickly to unnecessary surgery. I had read about how the head of the radiology unit at Emory University Hospitals underwent unnecessary surgery when his CT scans were misdiagnosed. I had heard Kathie's pulmonologist recommend that we wait for three months to see if the suspect masses in her lungs grew instead of going ahead with surgery. A cancer was more likely if the tumors grew. I had heard Dr. Smith's former partner, when asked for a second opinion, express doubts about the accuracy of PET scans. I'm not sure if I learned of Dr. Brawley's objections to the GILCR study before or after Kathie's surgery. Despite the flags being raised, in that critical period from the cancer diagnosis on July 12 to surgery on July 29, we mostly heard Dr. Smith, the trusted physician of the GILCR study, telling us that it was urgent that the cancer be identified and surgically removed. 19. The immediate aftermath Kathie was released from St. Joseph's Hospital for home recovery Aug. 8, almost two weeks after she was admitted for the surgery. Her release was several days later than had been anticipated. Her release from the hospital was delayed for two reasons. The first was that she developed an ileus. That is a severe colic accompanied by repeated vomiting due to an intestinal obstruction. We were told it was likely due to medicines she was taking to control pain from the surgery. Dr. Smith was still out of town. Doctors covered for him, but were pretty much unfamiliar with Kathie's case. They visited her room at best once a day to review vital sign records. Some advice to those reading this: be careful about consenting to surgery, unless your life is threatened, if your surgeon is going to be out of town during your recovery. The other reason her release was delayed was a misunderstanding by the doctors covering for Dr. Smith during the last few days of his absence. For several days, they were unaware that they were supposed to be filling in for him. A physician from this office showed up on Aug. 7, two days late, to check to see if Kathie was ready to be released. We had to go looking for the same doctor on Aug. 8 to get her release signed. At home, Kathie continued to endure severe pain. She was administered oxygen around the clock by one machine in our upstairs bedroom, the other downstairs. She connected to the machines with neoprene lines hooked up to them and to her. Baths were initially out of the question, but I created a bench for her in the master bath. Using a flexible shower line that I installed, we were able to let her take showers at first with my help, and later alone. 20. In defense of Dr. Smith We like to think of medicine as a science. It is that, but not a perfect science. Physicians make mistakes. They're human, they don't always have all the information they need and they're overworked. Dr. Smith was working on the cutting edge, in an area where there's a bias against doing research. Compared to breast and prostate cancer, lung cancer research is underfunded. It's not a particularly popular research area. Because most lung cancers are the result of smoking, a behavior people choose, there's a feeling in the general public, often reflected among researchers, that lung cancer is the fault of people who get it. That bias neglects such facts as that one in six lung cancer patients never smoked. It also fails to comprehend that those who chose to smoke were subject to the a hard advertising sell over the years that got people them hooked. It ignores the fact that much of the advertising was based on misleading advertising, some of it featuring doctors testifying to the health effects of smoking. It fails to recognize that nicotine is highly addictive, and it takes only two cigarettes to addict a smoker. Despite all that, there's no denying that a bias against finding a cure for lung cancer exists. Dr. Smith is to be commended for being willing to devote time to an underfunded and not particular popular research niche where there is a huge need for medical investigation. Finally, keep in mind that it was a radiologist, not Dr. Smith, who determined that something on Kathie's scans looked like a cancer. 21. A fourth physician questions the surgery On August 14, I had an appointment with our family physician, an internist with special skills in cardiac treatment. He told me that in his opinion CT and PET scans gave too many false positives, and that Kathie's surgery was probably unnecessary. He's normally not emotional when we talk, but he was quite animated in this case. I passed a vetted version of what he had said on to Dr. Smith in an email, asking that we talk further about the problem of false positives. I added our internist to the list of physicians saying that the surgery was unnecessary or unwise. The list now included: • Dr. Smith's former partner, surgeon John Moore. • Kathie's pulmonologist. • Our internist. I didn't include on the list Dr. Brawley, the eminent physician who had headed the Prostate Cancer unit at the National Cancer Institute, who had questioned the GILCR research project for reasons I never learned. 22. I write two books As Kathie was recovering in her hospital room, I continued to read extensively about cancer, but still had little more than a layman's knowledge of lung cancer screening. I decided to correct that. The result was that I started an online newsletter about cancer research, and since July 2002, read enough about the subject to write two books. The first book, New Hope: Avoiding Lung Cancer, was published in 2003. It is primarily an argument for people to quit smoking with advice on how to go about it. It also discusses the efficacy of current technology for screening high-risk populations for lung cancer, and talks about measures present and former smokers can take, above and beyond quitting smoking, to reduce the risk of lung cancer. The second book, Conquering Cancer 2003, was published in 2004. It is a summary of the most significant research in screening for, diagnosing and treating cancer announced during the year 2003. To write Conquering Cancer, I daily read through the most important cancer research announcements. The most important of these stories I summarized in a monthly online newsletter called "Current CancerNews" that I posted on the Internet. Subscriptions were free for anyone who wanted to read the information being posted. These monthly stories I consolidated into an eBook to keep down the cost to those who wanted it, although a conventional version with paper pages is also available. 23. Why I decided to write this article Early in 2004, Kathie and I were concerned when we heard that a routine CT scan in Wisconsin of the husband of her only sister had turned up something suspicious in one of his lungs. We were happy to hear a few months later that a subsequent CT scan had detected no growth in the mass detected, and that the threat of cancer was lifted. In late May 2004, Kathie and I drove to Chicago for a family wedding, some sightseeing and to allow me to attend the big annual book show, BookExpo America. From there, we drove to Wisconsin to spend a week at Fox Hills Country Club near Green Bay with the relatives. There I talked to Kathie's brother-in-law. It seemed to me that his suspect lung cancer had been treated prudently. A CT scan had found a mass on one of his lungs. They waited a few weeks and then gave him a follow-up scan to see if the mass was growing. It wasn't, so the diagnosis was "it's not cancer." There was no expensive PET scan as part of the diagnosis. There was no elaborate immediate surgery to biopsy suspect tissue, no pressure to undergo an excruciatingly painful surgery and recovery with the risk of never regaining lung capacity. Driving back to Atlanta, I thought long and hard about that, and began to outline this article in my mind. Soon after getting back home and unpacking, I decided there was a public right to know Kathie's story. Spreading the word might well help others from an experience similar to hers. So I sat down and began to write from the extensive notes I'd taken during her crisis, the audio tapes she had recorded at the time, the email and medical records we had from the period. I did my best in telling Kathie's story to do so accurately. As I said in the beginning of the article, I'm a writer and journalist, not a doctor, so I could have gotten one thing or another wrong about the technology or the exact chronology. If I've said anything that is incorrect, and a reader notes the mistake, please let me know so I can make it right. 24. The economics of cancer screening So, what is my opinion now of screening for lung cancer using CT and PET scanning? I think it's impractical. Briefly consider the economics. Lung cancer is mainly the result of tobacco use. An estimated 87 percent of lung cancers are caused by smoking. True, one out of six lung cancers occurs in people who have never smoked. Those cases occur mostly in innocent people exposed to second-hand smoke, to radon or to microparticulates. An estimated 90 million U.S. citizens are past and present smokers. About 23 percent of the population, perhaps 43 million people, continue to smoke. A CT scan directly costs only about $75 to give. However, CT scans, whether for screening or for diagnosis, are profit centers for hospitals—and for private companies that give them from vans at places like churches. The mobile vans that provide them for profit generally charge $200 to $600 to give them. People who get them from their doctors or hospitals are charged in the neighborhood of $300 to $600. CT scans for the purpose of diagnosis are generally covered by medical insurance, but much of the U.S. population is not insured. CT scans for screening purposes are usually not covered by medical insurance. PET scans are far more expensive than CT scans. They cost in the neighborhood of $2,000 to $4,000, although the direct cost of giving them is again far lower. Like CT scans, they are profit centers for hospitals and mobile entrepreneurs. For the sake of argument, let's assume that 10 percent of the 90 million past and present smokers are in a high-risk group—over 55, with a 30 pack-year history of smoking—that we decide initially to screen. That's nine million people we'll be screening for starters. Assume further that we will initially give a CT scan to the nine million people to screen them for possible tumors, at an average cost of $450. That's $4 billion. Further assume that half of those, or 4.5 million people, require a CT scan with contrast at an average cost of $500 each. That's another $2.25 billion. Now assume that half of those, 2.25 million people, need a PET scan at an average cost of $3,000 each. That's an additional cost of $6.675 billion to screen our initial test group of nine million. But our first-year costs are not yet complete. There will also be some costs for surgeons and oncologists to treat the new cases of lung cancer we detect. In the nine million present and former smokers over 55 that we screened, we might expect to find in the neighborhood of 200,000 lung and related cancers that would not have been found by routine chest X-rays. Assuming a cost of around $40,000 per tumor for surgery, chemotherapy, radiation and other treatment, that's another $8 billion in costs, over and above the $13 billion screening cost. Now our total first-year cost is $21 billion. (Expect also that all the radiation to which we expose our patient group will cause some cancers that would not otherwise have occurred.) Will the nation's already stressed health system bear the additional expense? Now, before we answer "no" to that question, consider that the present cost of smoking to the health system is around $75 billion per year. Double that to allow for other costs to the economy, such as the more frequent absence of smokers from the workforce because of illnesses, and smoking is costing the economy in the neighborhood of $155 billion per year. The $21 billion cost I roughly estimated above for screening a high-risk group is far less than the current cost of smoking to the economy. Further, it's a minuscule part of the current $1.7 trillion estimated annual cost of health care in the United States. But for political reasons I discuss immediately below, I don't believe the nation's medical provider system or health care insurance system will tolerate the additional cost of screening. 25. So what's the answer? The answer to screening for lung cancer in high-risk populations, in my opinion, is not CT and PET scans. The answer is simple and inexpensive. The first part of the answer is to get people to quit smoking. It's far less expensive to outlaw cigarettes than it is to treat lung cancer. There will, of course, be a public outcry. Only a muted cry will come from the smokers whose supplies would be cut off. Their cry will be muted because they have little political clout. A much louder cry will come from the tobacco industry and from the states that have become dependent on revenue from the tobacco companies. They have considerable influence or clout. Short of outlawing tobacco, campaigns to persuade people to quit smoking are also more cost-effective than treating lung cancer and the other diseases caused by smoking—heart disease, chronic obstructive pulmonary disease, stroke and a host of other ailments. The second part of the answer, in my opinion, is serum testing. A number of serum tests that detect various types of cancer at the very earliest stages—far earlier than the cancers can be detected by CT or PET scans, much less X-rays—are already in large-scale clinical testing. Some of the tests detect predictive proteins in urine. Others detect the warning proteins of cancer in the blood. Some are based on proteomics (complex computer analysis of serum proteins), some are not. In responding to my invitation for a copy of this article, Dr. Smith wrote in an email to me that "...no modality has been shown to be 100 percent accurate in the early detection of lung cancer. I am unaware of any non-invasive modality for the detection of any cancer that has zero percent false negatives." Actually, a Colorado company that developed a proteomics-based serum test claimed that in early trials it was 100 percent accurate in early detection of lung, prostate and breast cancer, and gave zero false positives. That test, the last I heard, was in large-scale testing at the Karolinska Institute in Sweden, home of the Nobel Prize for medicine. In those tests, the results were positive but not nearly as accurate as the early proteomics-based tests. Nonetheless I expect that it won't be long before one or another of these inexpensive serum tests is on the market, providing a low-cost method for annually screening high-risk subjects. I know Dr. Smith will share my enthusiasm if and when such tests become available. Once an inexpensive serum test used in screening has indicated the presence of an early-stage cancer, it's still necessary to locate the cancer. Here, CT and PET scanning will likely continue to play an important role. As for treating the lung cancers discovered by serum tests, remarkable progress is being made in that area as well. It's remotely possible that anti-tumor agents, perhaps delivered by viral vectors, agents far less brutal than the surgery, chemotherapy and radiation therapy used today, will be introduced in my lifetime. I certainly hope and pray that proves to be the case.
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