BB&T

CT screening for lung cancer doesn't work. CT screening for lung cancer works.

This is one of those many debates in the diagnostics sector that continues to have no definitive answer — except perhaps between doctor and patient.

The American College of Chest Physicians (ACCP; Northbrook, Illinois) last month issued a report recommending against the use of low-dose computed tomography (LDCT) for the general screening of lung cancer since it doesn't appear to reduce mortality, even in high-risk patients.

In reply, the Lung Cancer Alliance (LCA; Washington) fired back with its own statement, reiterating its support for the screening test which it says can detect lung cancer at its earliest and most treatable stage for those at high risk. Its rationale is that even though some diagnostic tests fall in the efficacy grey area, their benefits shouldn't be ignored.

"Mammograms for breast cancer faced enormous opposition for decades and there is still heated debate over screening of women under the age of 50," said Laurie Fenton Ambrose, president of the LCA. She added that there are "reams of papers showing no mortality benefit for PSA testing for prostate cancer," and that scientific disagreements and debates of this type "are not new, especially when it comes to interpreting statistics about the true benefit of screening."

She called it "disappointing and frankly shocking that the ACCP would flatly oppose CT screening for those at high risk for lung cancer when even the government health agency responsible for setting diagnostic guidelines is more balanced."

That balance doesn't exactly support the ACCP's view.

The U.S. Preventive Services Task Force neither supports nor opposes screening for lung cancer, a neutral or "sitting-on-the-fence" stance that it also takes in terms of PSA testing for prostate cancer and breast self-exams for breast cancer.

On the anti-screening side of the fence, Peter Bach, MD, a pulmonary and critical care physician at Memorial Sloan-Kettering Cancer Center (New York), and author of the screening chapter of the ACCP guidelines, told Biomedical Business & Technology that multiple randomized trials have demonstrated there is no benefit from CT screening of lung cancer.

"You find a lot more small cancers [with CT], but you don't find any advanced cancers that are going to kill people sooner," Bach said. The cancers that do show up during a CT scan grow so slowly, he said, that they don't actually pose much threat to the patient because they would take 50 to 60 years to result in death.

LCA doesn't agree with that reasoning either.

"How many would take that gamble?" Kay Cofrancesco, a spokesperson for the LCA, told BB&T in an email. "The best option would be to remove the lung cancer and treat it early." And she noted that The International Early Lung Cancer Action Project (I-ELCAP)] demonstrates 88% 10-year survival rate."

Bach told BB&T that most clinicians do not currently order CT to screen for lung cancer and that the guidelines serve to reassure them of that decision.

But the LCA disagrees.

"The fact is that hundreds of thousands of Americans have already discussed lung cancer screening options with their physicians. Many of those individuals have exercised their choice and consumed their personal resources in an informed decision to undergo spiral CT evaluation for the presence of an early lung cancer," Fenton-Ambrose said. "Recommending against CT screening for lung cancer, as ACCP does, is an extreme position that is out of step with current realities."

Supporting the LCA's position is a New England Journal of Medicine study appearing in October 2006 supporting CT screening for lung cancer. According to that study, researchers report that lung cancer can be detected at its very earliest stage in 85% of patients using annual LDCT screening.

That study was launched by a team of researchers at NewYork-Presbyterian Hospital/Weill Cornell Medical Center (New York) in 1993 and has expanded into an international collaboration of 38 institutions in seven countries. That study, titled I-ELCAP is the largest, long-term study to determine the usefulness of annual screening by CT, the institutions said.

Among the 31,567 people in the study, CT screening detected 484 people who were diagnosed with lung cancer, 412 of whom were Stage I. All the patients in that group who chose not to be treated died within five years.

Instead of screening for lung cancer, the ACCP guidelines recommend mind/body modalities to reduce the anxiety, mood disturbances, and chronic pain associated with the disease. For example, massage therapy is recommended for patients who are experiencing anxiety or pain, while acupuncture is recommended for patients experiencing fatigue, dyspnea, chemo-induced neuropathy, or in cases where pain or nausea/vomiting is poorly controlled.

But Fenton-Ambrose said it is "difficult to take the ACCP guidelines seriously when they are dismissive of screening and only endorse massages and acupuncture for a disease as deadly as lung cancer."

According to the LCA, early detection is critical in lung cancer. By the time symptoms, such as a cough or bloody sputum, appear it is usually too late and in most cases death occurs in less than a year, the organization noted.

LCA says that since last year it has raised questions and concerns about the validity of underlying assumptions and modeling being used to provide the basis for the ACCP practice guidelines.

Harvey Pass, MD, chief of thoracic surgery and thoracic oncology at NYU School of Medicine (New York), an LCA board member and chair of LCA's Medical and Scientific Advisory Board, said that the just-issued ACCP guidelines "simply dismiss the mounting evidence which continues to mature from the largest international, protocol-driven screening effort [I-ELCAP] showing that CT screening in a high risk population has the potential to reverse the current 15% five-year survival rate."

But Pass recommended individual patient choice as the key decider. "[I]ndividuals at high risk for lung cancer should make it a personal choice after conferring with their doctors as to whether they want to participate in ongoing protocol-driven programs for the early detection of lung cancer using whatever means is being studied," he said.

ACCP said that its recommendations were developed and reviewed by 100 multidisciplinary panel members, including pulmonologists, medical oncologists, radiation oncologists, thoracic surgeons, integrative medicine specialists, oncology nurses, pathologists, healthcare researchers, and epidemiologists.

Vascular improvements offer greater life expectancy

Preliminary numbers for 2005 from the Centers for Disease Control and Prevention (Atlanta) indicate that life expectancy in the U.S. continues to nudge upward, with CDC's National Center for Health Statistics (NCHS) reporting that life expectancy "at birth for the total population in 2005 reached a record high of 77.9 years." The most conspicuous improvements in mortality by disease category were for heart disease and cerebrovascular disease.

However, neurological diseases and diseases of the lower respiratory system almost completely offset those improvements.

The NCHS's report said that the preliminary number-crunch for 2005 "puts life expectancy in the U.S. at 78 years, a figure that has been increasing steadily over the last 50 years." This life expectancy figure was one-10th of a year of life expectancy greater than in 2004.

Life expectancy in 1955 was 70 years and in 1995 76, according to NCHS.

The total number of deaths from "diseases of the heart" in 2005 was just under 650,000, and the age-adjusted death rate for this category fell 3.1%, from 217 to 210.3 per 100,000 people. In comparison, cancer took the lives of slightly less than 560,000, but the drop in the age-adjusted mortality rate for cancer fell only 1.1% to 183.8 per 100,000 in 2005.

Cerebrovascular disease, including stroke, came in as the third leading cause of death in the U.S., taking the lives of about 144,000 annually.

Treatments for this category have apparently had a huge impact if the decline of 6.8% in age-adjusted mortality is any indication — from 50 per 100,000 to 46.6 per 100,000.

The life expectancy number is calculated as the year in which a child is born to the year he or she is expected to live to, on average. Any comparison to life expectancy of those who had already reached adulthood in 2005 would look different, because overall expectancy at birth takes into account the deaths that will occur in infancy, childhood and adolescence.

Hsiang-Ching Kung, PhD, a survey statistician at NCHS, told Medical News Today that the declines in mortality from the three most deadly disease groups in the U.S., heart disease, cancer and stroke are "most likely due to better prevention efforts and medical advances in the treatments of these diseases. "If death rates from certain leading causes of death continue to decline, we should continue to see improvements in life expectancy," he added.

Other declining causes of mortality occurred in the "self harm" category, at 2.8%, and liver disease, including cirrhosis, at 1.1%.

The most conspicuous increases in mortality were charted for chronic lower respiratory diseases at an increase in the age-adjusted death rate of 5.1%, while deaths from Alzheimer's grew by 5%. Another neurocognitive disorder, Parkinson's disease, also registered a substantial up-tick of 4.9% in 2005.

Several interesting demographic changes also showed up, but the question of whether these represent a trend cannot yet be answered.

The NCHS numbers show that life expectancy for whites was flat between 2004 and 2005 at age 78.3, but for African Americans, expectancy rose from 73.1 in 2004 to 73.2 in 2005. The gap between women and men also closed, with women expected to outlive men on average by 5.2 years, "the smallest gap since 1946," according to the report.

The report also says that the preliminary estimate for infant mortality "went up from 6.79 [deaths] per 1,000 live births in 2004 to 6.89 in 2005, but this was not thought to be statistically significant." Sudden infant death syndrome ranked third among causes of infant mortality, a category led by birth defects and low birth weight.

In 2005, infant mortality rates for African American babies (13.69 deaths per 1,000 live births) was still much higher than for the demographic catch-all of white babies (5.76), but the rate for white babies actually rose from 5.66 the previous year whereas black infant mortality fell from 13.79. Aggregate infant mortality in 2005 registered at 6.89 per 1,000 lives births.

The report is based on about 99% of death records reported in all 50 states and the District of Columbia for 2005 and documents the latest trends in the leading causes of death and infant mortality.

HIDA report: GPOs were overpaid $700M over last 10 years

Group purchasing organizations (GPOs) say they save hospitals significant dollars and help them spread healthcare resources. The critics of GPOs say they skim off too much profit for themselves and keep the small players with new technologies out of the hospital supply game. The Health Industry Distributors Association (HIDA; Alexandria, Virginia), in a just released position paper, sides with the critics.

GPOs have been overpaid by almost $700 million in fees across the last 10 years, according to the HIDA paper, "Group Purchasing Organizations' (GPO) Distributor Fee Formula Requires Scrutiny." which examines the fee structures charged by GPOs and paid by acute care medical products distributors.

"HIDA is calling for discussion on the fee structure topic with the goal of bringing the fee structure for medical products distributors in line with recently elevated standards in GPO contracting," said Matthew Rowan, HIDA's president/CEO, in a statement issued with the paper.

"More than two years of federal government scrutiny and new commitments by GPOs to increase transparency and promote integrity initiatives, demand a close reexamination of fee structures and practices," the organization said.

Acute care medical products distributors are currently charged GPO fees on a basis greater than the value of the distribution service they provide, according to the paper. Rather than being charged solely on the basis of the service they perform, distributors are also assessed fees based on the manufacturer's product price, according to HIDA. It says that this occurs even though distributors have no control over product prices, which are negotiated between GPOs and manufacturers. Moreover, GPOs also charge manufacturers fees based on these same product prices, the group said.

According to HIDA, distributors should only pay fees based on the distribution services they provide. "Distributors are being affected by an outdated fee structure that is out of sync with current industry integrity and transparency expectations -- now is the time to update this system," Rowan said.

One reason HIDA says charging distributors any GPO administrative fee based on any part of the product price is a questionable practice is because GPOs already collect a fee up to 3% on the product cost.

"By charging distributors a second fee based on the product cost, GPOs appear to 'double dip' - collecting two product-based fees on the sale of a single product," the paper notes.

HIDA is an international trade association representing medical products distributors.

NIH implements order to expand pluripotent stem cell lines

The National Institutes of Health reported last month that it will begin implementing President Bush's executive order to explore methods to expand the number of approved pluripotent stem cell lines "without creating a human embryo for research purposes or destroying, discarding, or subjecting to harm a human embryo or fetus."

The order calls on Michael Leavitt, secretary of the Deaprtment of Health and Human Services, to support research that takes advantage of emerging potential alternative methods for generating stem cells that are pluripotent — that is, capable of producing all or almost all of the cell types in the developing body.

"The NIH has developed a sound, ambitious strategy to advance pluripotent stem cell research and generate more opportunities in this critical area," Leavitt said. "I sincerely hope that these steps will accelerate the discovery of new cures and treatments."

"NIH has been pursuing the potential of stem cells on all fronts, whether they are human embryonic, adult, or cord blood — they were discovered. It is one of the central scientific challenges of our time," said Elias Zerhouni, MD, director of NIH. "NIH will continue to consult widely with the scientific community to determine the best approaches."

"The Executive Order recognizes the recent developments in adult mouse cells that can be reprogrammed to behave like embryonic stem cells, and we've laid out a strategy to explore their possible applications to human cells," said Story Landis, PhD, director of the National Institute of Neurological Disorders and Stroke. She also serves as the chair of the NIH Stem Cell Task Force.

The NIH plan includes a number of new or accelerated activities.

For example, the NIH Stem Cell Task Force will develop several funding opportunity announcements, including a Program Announcement (PA). The PA will ask for grant applications proposing research on human pluripotent stem cells derived from non-embryonic sources, such as somatic cells or cells found in amniotic fluid.

In addition, the Stem Cell Task Force will create two supplement programs that will stimulate research in specific areas rapidly. They would be awarded to researchers already working in stem cell research to augment certain areas of their work that are of particular interest to NIH.

NIH also will hold a symposium to explore what avenues of stem cell research eligible for funding under federal law and policy offer the greatest potential for clinical benefit.

Under the plan, NIH will rename its Human Embryonic Stem Cell Registry as the "Human Pluripotent Stem Cell Registry" and will consider the addition of new human pluripotent stem cell lines to the registry that are deemed eligible.

Bill pushes diagnostics for prostate cancer detection

U.S. Representatives Elijah Cummings (D-Maryland) and Albert Wynn (D-Maryland) reported that they will co-sponsor legislation that would fund the development of advances for improving the diagnosis of prostate cancer.

"Current diagnostic tools for prostate cancer are grossly inadequate," said Angelo De Marzo, MD, PhD, associate professor of pathology, oncology and urology at Johns Hopkins University (Baltimore), who joined Cummings and Wynn at a press conference on Capitol Hill, hosted by the AdMeTech Foundation (Boston), an organization pursuing advanced technologies for diagnosing this disease.

"They often produce inconclusive or misleading results, leading to widespread unnecessary treatment that can cause complications and ratchet up our nation's ever-growing health care costs," De Marzo said.

The bill would authorize $650 million to the National Institutes of Health and the U.S. Department of Health and Human Services for prostate cancer imaging research and education. A Senate version of the bill, known as the Prostate Research Imaging and Men's Education Act (PRIME Act. S. 1734), was introduced by Sen. Barbara Boxer (D-California) in June.

NADL wants tougher FDA regulation of dental restoration

The National Association of Dental Laboratories (NADL; Tallahassee, Florida) has asked the FDA to implement more stringent regulations governing dental restorations.

Dental-restoration products — the crowns, provisionals, dentures and bridges permanently seated in mouths — are under-regulated, with few legal requirements for technicians to be certified and no mandates for dentists to document the source of dental work, the association said in a letter to the Presidential Interagency Working Group on Import Safety.

The products are manufactured by dental technicians employed by a dental laboratory anywhere in the world, so much of the dental work used in the U.S. is imported from China, Pakistan, the Philippines and India, according to the organization.

"These products are not tested or inspected for sterilization or for the precision of the fit," the NADL said. "Even for products manufactured within the U.S., most domestic dental laboratories are exempt from registering with the FDA, and most typically employ less than four people."

The association called on the FDA to act in the interest of protecting Americans, recommending the following:

• Promote certification of dental technicians employed at both domestic and foreign labs.
• Require that dentists label and disclose to patients the source of dental devices, so all dental-restoration products can be traced back to the laboratory that made them.
• Step up inspections of the content and quality of imported dental-restoration products.
• Mandate that dental labs register with the FDA or with state health departments.
• Require that dentists include the registration number of their contracting dental laboratory on a prescription that is kept in patients' dental records; so that dental devices can be traced even long after they have been implanted in patients' mouths.