July 21, 2016
Study that reported sharp rise in prostate cancer is questioned
Bad news for men popped up in news media all over the country this week, based on a study from Northwestern University reporting that cases of advanced, aggressive prostate cancer had risen sharply from 2004 to 2013.
Newsweek, NBC, CBS, Fox News and United Press International were among the organizations that covered the study. The reports suggested that recent medical advice against routine screening might be to blame for the apparent increase in advanced cases, by leading to delays in diagnosis until the cancer reached a late stage. Another factor cited was the possibility that prostate cancer had somehow become more aggressive.
But the frightening news appears to be a false alarm — the product of a study questioned by other researchers but promoted with an incendiary news release and initially reported by some news media with little or no analysis from outside experts.
The claim of an increase in advanced cases does not hold up, according to the American Cancer Society, which posted a statement on its website challenging the findings. The main concern is that the study’s methods do not pass muster with statistics experts, so the increase may not be real.
In an interview, the cancer society’s chief medical officer, Dr. Otis W. Brawley, called the study “misguided epidemiology” and said its authors “don’t know that they don’t know.”
The episode began late last week when Northwestern University emailed an attention-grabbing news release to reporters. “Metastatic Prostate Cancer Cases Skyrocket,” it said, and described a study published Tuesday in the journal Prostate Cancer and Prostatic Diseases.
The study’s authors wrote that routine use of blood tests to screen for prostate cancer had declined, and that they wanted to find out if the decline had led to changes in the incidence of advanced disease at the time of diagnosis.
Prostate screening has long been a subject of intense debate, with advocates insisting it saves lives and detractors saying it leads to too much unnecessary treatment of tumors that would never have progressed. The operation can leave men incontinent and impotent. In recent years, expert groups have advised against routine screening, saying the risks outweigh the benefits. But some doctors worry that the drop in screening will leave some men with disease that is found too late to be easily cured.
The senior author of the study, Dr. Edward Schaeffer, a prostate cancer oncologist and the chairman of urology at Northwestern, said in an interview that he believed screening saved lives.
In the study, the doctors examined the records of 767,550 men with prostate cancer diagnosed from 2004 to 2013. Using the number of cases of metastatic disease in 2004 (1,685) and 2013 (2,890), they reported an alarming increase of 72 percent.
But for the United States population, that percentage could be meaningless. On the cancer society website, Dr. Brawley said that to measure whether a disease was becoming more common, researchers could not rely on just the absolute number of cases. They need to calculate rates, meaning the number of cases per a certain number of people.
The authors acknowledged in their report that the lack of rates was a “limitation.” But they said that because the number of patients was large, their findings probably reflected national patterns.
Dr. Schaeffer emphasized that the researchers did not claim a link between their findings and the advisories against screening; they noted that advanced cases started rising even before those.
Visit the New York Times for the article.
U.S. said readying suits against Anthem, Aetna insurer deals
U.S. antitrust officials are poised to file lawsuits to block Anthem Inc.’s takeover of rival health-insurer Cigna Corp. and Aetna Inc.’s deal to buy Humana Inc., according to a person familiar with the matter.
Justice Department officials, who are responsible for protecting competition, are concerned that the deals, which would transform the health-insurance industry by turning its five biggest companies into three, would harm customers, according to several people familiar with the situation. While the companies may offer to sell assets to gain approval for the deals, that’s unlikely to sway antitrust officials, one of the people said.
The final decision on whether to sue to block the deals could come this week or next, another of the people said. The companies could settle a lawsuit before or after one is filed.
Any lawsuit would continue a string of merger challenges by antitrust enforcers looking to stop industry consolidation and would deal a blow to bids by Anthem and Aetna to gain scale by snapping up rivals. According to the terms of both tie-up deals, the companies have agreed to fight any government lawsuits in court. Such a move would likely require months of litigation to rescue takeovers that were struck last year amid a wave of deals that swept the industry.
Aetna and Humana will probably fight any lawsuit in court, while Anthem and Cigna are less likely to litigate against the government, said Ana Gupte, an analyst at Leerink Partners. “They’re obligated by the terms of their merger agreement, but they both may decide to walk away,” she said about Anthem’s bid for Cigna. “They recognize the probability is low, and there’s also been a lot of conflict between the two companies.”
For antitrust officials at the Justice Department, it’s standard practice to prepare complaints against deals even in cases that are ultimately settled with remedies like asset sales.But in recent years, the department has shown an increasing willingness to go to court to block deals it believes could stifle competition, andfor months antitrust officials have signaled their skepticism about the insurer tie-ups.
The Justice Department’s No. 3 official, Bill Baer, who previously ran the antitrust division and is overseeing the investigations into the insurer mergers, said this year that the two deals were “transformational” and represented a “game changer” for the industry.
The government’s concerns echo a broader sentiment within the Obama administration that competition must be protected among health insurers in order to deliver quality health care to Americans.
This month, President Barack Obama and Health and Human Services Secretary Sylvia Mathews Burwell both cited the importance of competition in insurance markets.
The insurers need approval from state insurance regulators in addition to the Justice Department. Aetna has secured far more state approvals for its deal than Anthem has, according to analysts at Wells Fargo & Co.
Visit Bloomberg for the article.
Dutch study shows IVF doesn’t increase breast cancer risk
Hormones can play an important role in how breast cancer develops and grows. The medicines used to treat women’s infertility problems affect hormone levels. So researchers have wondered if fertility treatments might increase breast cancer risk.
A large Dutch study strongly suggests that in vitro fertilization (IVF), a type of fertility treatment, doesn’t appear to increase breast cancer risk, even years after the fertility treatment.
One type of fertility treatment involves harvesting mature eggs from a woman’s ovaries. Without fertility drugs, only one or two eggs at most per cycle will be harvested. With fertility drugs, as many as 8 to 10 mature eggs can be released and harvested. To minimize any risk, most fertility doctors develop a customized egg-stimulating regimen for each woman. In IVF, harvested eggs are fertilized in a test tube with sperm from a woman’s partner or a donor. The fertilized eggs grow briefly into tiny embryos which are then implanted in a woman’s uterus.
In the study, the researchers followed more than 25,000 Dutch women who had fertility treatment from 1980 to 1995. The women were followed for about 21 years, which is a very long follow-up time.
The women were about 33 years old when they started fertility treatments and had about 3.6 IVF cycles. During the follow-up period:
· 839 cases of invasive breast cancer were diagnosed
· 109 cases of DCIS (ductal carcinoma in situ, which is non-invasive disease) were diagnosed
The incidence of breast cancer at age 55 was:
· 3.0% for the women who had IVF
· 2.9% for women who had other fertility treatments
After taking into account a number of factors that are linked to a higher risk of cancer, the researchers found that women who had IVF treatments had no higher risk of breast cancer than women who had less intensive fertility treatments and had about the same risk of breast cancer as the average women.
Visit the Breast Cancer Organization for the study.
Florida may have its first Zika virus outbreak
Florida health officials said Tuesday they were investigating a possible case of Zika that wasn't carried back by a traveler.
If it's confirmed, it would be the first evidence that Zika has spread to mosquitoes in the continental U.S. All cases up to now have been in people who traveled to Zika-affected regions or their sexual partners.
Small, local outbreaks of Zika virus are fully expected in southern states such as Florida, Louisiana and Texas. These states are home to the Aedes aegypti mosquitoes that most commonly transmit the virus.
"Today the Florida Department of Health announced that it is conducting an investigation into a possible non-travel related case of Zika virus in Miami-Dade County," the health department said in a statement.
"The department is actively conducting an epidemiological investigation, is collaborating with the Centers for Disease Control and will share additional details as they become available."
The CDC said it will help investigate.
"At this time, state and local officials in Florida are leading the investigation, and CDC is closely coordinating with Florida officials. To date, Florida public health officials have confirmed Zika infection through laboratory testing; upon request, CDC will conduct additional laboratory testing," the agency said in a statement.
"To date, CDC has provided Florida more than $2 million in Zika-specific funding and about $27 million in emergency preparedness funding that can be used toward Zika response efforts. "
The Florida health department said it would give out Zika prevention kits and repellant in the area under investigation. "Zika kits are intended for pregnant women," it said. "Mosquito control has already conducted reduction and prevention activities in the area of investigation. Residents and visitors are reminded that the best way to protect themselves is to prevent mosquito bites through practicing good drain and cover methods."
The CDC's reported more than 1,300 cases of Zika in the continental U.S., all linked to travelers. Among them, 346 are or have been pregnant women. Nine babies have been born so far with Zika birth defects and another six were miscarried or aborted.
Visit NBC for the report.
USF researchers find dangerous bacteria after sewer spills
University of South Florida researchers investigating the aftermath of a September, 2014 sewer line break in St. Petersburg, Florida, have found dangerous antibiotic-resistant bacteria in the untreated wastewater that gushed into neighborhoods and into Boca Ciega Bay at a rate of 250 to 500 gallons per minute.
Their findings, just published in Applied and Environmental Microbiology raise several significant public health concerns.
First, a strain of bacteria found in the water tested resistant to vancomycin, an antibiotic considered to be a "last resort" treatment for serious infections that do not respond to other antibiotics. Second, the combination of aging sewer infrastructure and an increase in stormwater flooding with extreme rain events increases the likelihood of more spills occurring and continuing to spread these dangerous, drug-resistant bacteria in populated areas.
Finally, the researchers found that the vancomycin-resistant enterococci (VRE) bacteria found in the untreated wastewater contains a gene capable of transferring vancomycin resistance to other strains of bacteria. This fuels the greater problem of increasing antibiotic resistance among other kinds of bacteria.
The researchers sampled the water and soil for seven weeks following the spill from the broken sewer line that totaled about 500,000 gallons of released untreated sewage. Genes from the vancomycin-resistant bacteria were detected for nearly two weeks following the spill.
"While we have known that raw sewage contains many disease-causing bacteria, this experience tells us that sewage and fecal pollution also carry vancomycin-resistant bacteria," said Dr. Valerie Harwood, a professor in the USF Department of Integrative Biology and study co-author. "Most VRE are confined to hospitals, but detecting them in waters of the Tampa Bay community is quite concerning. People need to be aware of what may be entering the water after heavy rains, accidental spills, or after intentional sewage releases."
According to study lead author, USF PhD student Suzanne Young, their finding is also a public health "wake-up call" to be more prudent with the use of antibiotics in both humans and animals.
The researchers also called for more monitoring of VRE and the presence of resistance genes outside of the hospital setting where they are more commonly found.
"The spread of pathogens with high levels of vancomycin resistance beyond hospitals and into the community is a public health threat," concluded the researchers. "While further studies are needed to better define risks, knowing these pathogens are in Tampa Bay sewage is an important development."
Visit Eurekalert for the study.
Examining oversight of the privacy & security of health data collected by entities not regulated by HIPAA
Many of us now use wearables and other types of health information technology to help us manage our health and the health of our loved ones. These fitness trackers, their related social media sites where individuals share health information, and other technologies are changing the way we interact and control our own health. However, they did not exist when Congress originally enacted the Health Insurance Portability and Accountability Act (HIPAA) in 1996.
HIPAA serves traditional healthcare well and supports national priorities for the safe and secure flow of health information, but its scope is limited. It applies only to organizations known as “covered entities”—health plans, health care clearinghouses, and health care providers conducting certain electronic transactions—and their business associates. Yet these days, scores of new businesses use consumer-facing technology to collect, handle, analyze, and share health information about individuals – sometimes without those individuals’ knowledge.