Posts tagged with "CDC"

Has Tamiflu perpetrated a $1.5-billion fraud?

January 27, 2020

According to estimates from the Centers for Disease Control and Prevention, as of mid-January, between 15 million and 21 million Americans already had contracted the flu—leading to as many as 250,000 hospital visits.

Many of these patients are asking their doctors for a prescription for the medication, Tamiflu, an antiviral made by Hoffman La-Roche, in hopes that it will shorten the length of their suffering by about one day—if it they take it within 48 to 72 hours of experiencing the first symptoms.

But aside from some nasty side effects from the supposed wonder drug—among them, nausea, vomiting, headaches, dizziness, eye redness, and even hallucinations in children—there’s another, more serious problem with the prescription: Tamiflu’s “cred” is dropping because, patients claim, it doesn’t perform as promised.

In fact, Oseltamivir, which goes by the brand name Tamiflu, has long claimed to shorten the duration of flu severity, to skepticism and sometimes even derision from the evidence-based science community, Science2.0 reports.

What’s more, a recently unsealed whistleblower lawsuit (United States of America, ex rel Thomas Jefferson, et al. v Roche Holding AG, Hoffman-La Roche Inc., and Genentech Inc. in the U.S. District Court for the District of Maryland— Case No. 14-CV-03665) claims the company bilked U.S. taxpayers out of $1.5 billion by misrepresenting clinical studies and publishing misleading articles falsely stating that Tamiflu reduces complications, severity, hospitalizations, mortality, and transmission of influenza .

And that $1.5 billion loss represents just the stockpiling of the drug by federal and state government agencies for availability in a pandemic. It does not include people who bought it with their own money, based on aggressive marketing campaigns which used the articles as evidence, the lawsuit alleges.

“As alleged in the complaint – Tamiflu does not do what Roche promised,” said attorney Mark Lanier of the Houston-based Lanier Law Firm. “Roche hid this fact for many years by selectively citing its studies and suppressing the data about Tamiflu. The company utilized lobbyists, key opinion leaders, and ghostwriters to promote Tamiflu with a deceptive promise to governments fearful of an influenza pandemic.”

The lawsuit brings claims under the False Claims Act, which allows individuals to bring claims on behalf of the government. It seeks reimbursement of taxpayer funds spent to purchase tens of millions of courses of Tamiflu for the Strategic National Stockpile. Roche is vulnerable to a judgment in excess of $4.5 billion—because the False Claims Act mandates payment of triple damages, plus civil penalties.

Whistleblower Dr. Thomas Jefferson, a physician and public health researcher affiliated with the respected global Cochrane Collaboration research network, has researched neuraminidase inhibitors like Tamiflu for more than two decades. He began questioning Tamiflu’s efficacy in 2009 and spearheaded efforts to have the company release the underlying clinical study data. When he finally received the data in 2013, Dr. Jefferson analyzed it and concluded that the clinical data does not support Roche’s claims about Tamiflu’s effectiveness for use in an influenza pandemic, the lawsuit states.

According to the data as analyzed by the Food and Drug Administration, Tamiflu’s effectiveness is limited to a small benefit of reducing the duration of flu symptoms and preventing onset of symptoms but not transmission or infection. In addition, as early as 2000, the FDA had warned Roche that data did not support its broader efficacy claims and that such statements were misleading.

Finally, has been no evidence of a reduction in hospitalizations or serious influenza complications; confirmed pneumonia, bronchitis, sinusitis or ear infection in either adults or children who take the drug.. There was a reported increased risk of psychiatric events of around 1% when Tamiflu was used to prevent influenza

Evidence also suggests that Tamiflu prevented some people from producing sufficient numbers of their own antibodies to fight infection.

Research contact: @Science20Radio

Sick puppies: CDC probes outbreak of illnesses linked to pet stores

December 26, 2019

Like all forms of love, “puppy love” occasionally can lead to malaise—even in the true, physical sense. In fact, more than two dozen people have been sickened by bacteria linked to pet store puppies, with the germs resistant to first-line antibiotics, the Centers for Disease Control and Prevention has announced and NBC News has reported.

The agency is investigating the outbreak of Campylobacter jejuni in 13 states–with 30 cases reported as of December 17.. Four people had to be hospitalized, but no one has died. The illnesses have been reported throughout the year, with patients ranging in age from 8 months to 70 years.

In interviews, ill people answered questions about the foods they ate and any animal contact in the week before they became ill. Ninety-nine percent of people reported contact with a puppy in the week before illness started, and 87% reported they had contact with a puppy from Petland stores, or had contact with a person who became sick after contact with a puppy from a Petland store. Twenty-five ill people worked at Petland stores.

The bacteria is closely related to germs that infected more than 100 people during a 2016–2018 Campylobacter outbreak, which was also linked to pet store puppies, the CDC said.

In a statement, Petland noted that more than one-third of the 2019 cases have been found in people living in places where it doesn’t have stores.

The Chillicothe, Ohio-based chain of pet stores—which has over 130 locations nationwide—said,“Petland takes the health and welfare of our employees, our customers and our pets very seriously.” “Since an earlier outbreak in 2016, in which no specific source of infection was identified, Petland has implemented all recommended protocols from federal and state animal and public health officials to prevent human and puppy illness.”

Campylobacter causes 1.5 million illnesses each year in the United States, according to the CDC. Symptoms include diarrhea that’s often bloody, fever and stomach cramps. The illness usually lasts about a week and most people recover without having to take antibiotics.

Most cases involve contaminated food, so animal-associated illnesses are rare in comparison to food poisoning episodes, Dr. Jeanette O’Quin, a clinical assistant professor at Ohio State University’s College of Veterinary Medicine, told NBC News.

Pet stores can contain a perfect storm of risk factors for the animal-related outbreaks to happen, she said: Puppies from different breeding kennels get mixed together; they’re usually housed in close proximity to each other; and they’re often stressed, so they’re more likely to get sick and easily spread the illness.

People can get sick by accidentally ingesting the bacteria in the stool of an infected animal—petting a puppy and then putting an unwashed hand into their mouth, for example. The animal doesn’t have to look sick for it to shed the bacteria in its stool.

The best prevention is basic hygiene, NBC News reports. People should always wash their hands thoroughly with soap and water after touching a puppy or dog, after handling their food, and after cleaning up after them, the CDC advised.

O’Quin also urged pet owners to pick up dog waste regularly so that it didn’t accumulate in their yards, and bathe dogs recently bought from a group setting or those who have soiled their fur.

“Preventing is where we can have the most impact,” O’Quin said.

Research contact: @NBCNews

Strong-arm tactics: Bottle feeding is linked to left-handedness

January 11, 2019

Bottle feeding infants is associated with left-handedness, according to findings of a study conducted at the University of Washington and released on January 7.

The study found that the prevalence of left-handedness is lower among breastfed infants, as compared to bottle-fed babies. This finding was identified in about 60,000 mother-infant pairs and accounted for known risk factors for handedness.

The results provide further insight into the development of complex brain functions which ultimately determine which side of the batter box the infant likely will choose.

“We think breastfeeding optimizes the process the brain undergoes when solidifying handedness,” said Philippe Hujoel, the study’s author, a professor at the UW’s School of Dentistry and an adjunct professor of Epidemiology at the School of Public Health. “That’s important because it provides an independent line of evidence that breastfeeding may need to last six to nine months.”

The study does not imply, however, that breastfeeding leads to right-handedness, Hujoel said. Handedness, whether it be right- or left-handed, is set early in fetal life and is at least partially determined by genetics. The research does sheds light on when the region of the brain that controls handedness localizes to one side of the brain, a process known as brain lateralization. Possibly, the research shows, breastfeeding optimizes this lateralization towards becoming right- or left-handed.

According to Scientific American magazine, about 15% of people are left-handed—and males are more than twice as likely to be left-handed as females. How does that match up with statistics for breastfeeding and bottle feeding? Based on data released by the Centers for Disease Control and Prevention , among U.S. children born between the years 2009 and 2015, 10% were exclusively bottle-fed for the first six months of life; while 30% were bottle-fed exclusively up to the age of three months.

The good news, according to Daily Infographic, is that left-handers are more likely to be geniuses and left-handed men are, on average, 15% more affluent than their right-handed peers.

Interestingly enough, statistically, the older a mother is, the more likely she is to give birth to left-handed children. But we don’t know how likely older mothers are to bottle-feed versus breastfeed.

Research contact: @UWMedicine

Vaping companies offer college scholarships to high school students

June 11, 2018

Just five years ago, nearly three times as many U.S. high school students smoked as puffed on e-cigarettes. Today, almost twice as many secondary school kids vape as smoke, based on findings of a National Youth Tobacco Survey released by the Office of Smoking and Health at the U.S. Centers for Disease Control and Prevention (CDC).

That amounts to one in every four high school students and more than one in every 14 middle school kids who have been hooked on nicotine by e-cigarettes, according to a report by Science News for Students. It is not a risk-free practice. In fact Irfan Rahman, a professor of Environmental Medicine at the University of Rochester in New York says that, while vape pens—including the Juuls and KandyPens that are trending with teens—are far less dangerous than conventional butts, not only will they ruin a user’s gums and loosen his or her teeth, but studies suggest that kids who vape are more likely to smoke real cigarettes in the future.

According to Rahman, “The liquid and vapor that vape users inhale (and exhale onto others) contain harmful chemicals such as anti-freeze, a host of carcinogens, and other substances known to cause cell death. Meanwhile, the concentrated nicotine in vaping solutions poses a unique, toxic threat to small children who unintentionally swallow the liquid or spill it on their skin. In a word, e-cigarettes aren’t safe for your kids and aren’t safe around your kids.”

Rahman emphasizes that even flavored vapes can be harmful to the lungs. ““Nicotine-free e-liquids have generally been considered safe; however, the impact of flavoring chemicals, especially on immune cells, has not been widely researched  Even though flavoring compounds are considered safe for ingestion, it is not safe for inhalation.”

Scholarships sweeten the success of vaping

The data show that an estimated 16% of high school kids vaped in 2015. That adds up to 2.39 million teens. By comparison, just 1.37 million high school kids smoked cigarettes. And the number of vapers is increasing—partially because of a new marketing campaign launched by the companies that sell e-cigarettes and vaporizers. Their latest tactic: Offering college scholarships and getting students to write essays about the joys and benefits of vaping, in contrast to cigaretttes, in order to win the money.

News of the grants is spreading quickly online—posted at such websites as DaVinci Vaporizer, Slick Vapes, and SmokeTastic For example, SmokeTastic says on its site, “Under the ST Scholarship Program, we shall be awarding one scholarship award of $1000 to the winning candidate which will be determined by our judges and possibly published on our site. Our scholarship is aimed at helping all students, from all walks of life, afford the rising costs in education fees, books, and living costs. The scholarship will be made payable directly to the university/school that the winners are from by cheque.

Eligibility is no problem, the company says: “We are open to any current college-going student, including incoming freshman enrolled in any educational program to apply. We do ask however, students must be enrolled at an accredited college, university or trade school. No major or trade requirements. We have opened the scholarship up to students to apply from all countries. We do also ask that the students have a minimum GPA of 2.5.”

And under “Details of the Essay,” SmokeTastic tells students to submit an essay of 500 to 1,500 words, talking about such subjects as:

  • Why do people still choose to smoke in society?
  • Is vaping a new problem with younger smokers and potentially introducing them to smoking?
  • Would a smoke-free world really improve society?
  • What message do you have for current smokers thinking about vaping?
  • Is vaping addiction a real concern?

Although some of the scholarships are limited to students 18 and older—the nation’s legal age to buy vaping products—many are open to younger teens or have no age limit.

Research contact: Irfan_rahman@urmc.rochester.edu

Accidents are now #3 cause of death in America

January 18, 2018

Are many of us simply an accident statistic waiting to happen? Unintentional, preventable injuries—classified as accidents—claimed a record high 161,374 American lives in 2016, to become the third leading cause of death in the United States (after heart disease and cancer) for the first time ever, according to a report from the National Safety Council released on January 17.

In fact, in America, someone is accidentally injured every second and killed every three minutes by a preventable event.

Highest on the list in 2016, according to the council, were poisoning (58,335 deaths), motor vehicle accidents (40,327), falls (34,673) choking (4,829), drowning (3,786) and fire/flames/smoke (2,730).

Along with other nonspecific accidents, that led to a total of 14,803 more people who died unexpectedly during 2016 than in 2015— a 10% year-over-year increase.

This represents the largest single-year percentage rise since 1936, and the largest two-year rise (+18.6%, for 2015-2016) since 1903.

According to the NSC, the unprecedented spike has been greatly fueled by the opioid crisis. Unintentional opioid overdose deaths totaled 37,814 from drugs—including prescription opioid pain relievers, heroin, and illicitly made fentanyl.

NSC analysis of the data— tracked annually by the National Center for Health Statistics at the Centers for Disease Control— also confirmed the council’s motor vehicle fatality estimate for 2016. Motor vehicle deaths rose 6.8% in 2016 — in step with the NSC’s  original estimate of 40,200 deaths. NSC can now confirm that the final 2016 data marks a 14% increase in roadway deaths since 2014 – the largest two-year jump in 53 years.

“Our complacency results in 442 deaths each day,” said NSC CEO Deborah A.P. Hersman. “For years our country has accepted unintentional injuries as an unavoidable reality. The truth is, there is no such thing as an accident. Every single one of these deaths was preventable. We know what to do to save lives, but collectively we have failed to prioritize safety at work, at home and on the road.”

Preventable deaths have been rising since 2009 after years of declines and plateaus, and they trail only heart disease and cancer when it comes to the number of lives lost annually. Unlike other causes of death, preventable injuries are a threat at every age.

Finally, there is just a bit of good news: We’re safer than we were a century ago: In 1903, the accidental standardized death rate was 99.4 per 100,000 population—twice as high as the current death rate of 47.2. However, the current death rate is 39% higher than the lowest recorded rate, 34.0, achieved in 1992.

Research contact: customerservice@nsc.org

Most U.S. teens have sex by 18, but pregnancies are down

January 17, 2018

More than half of American teens have had sex by age 18, but teenage pregnancy and birth rates continue to decline because of increased contraceptive use, according to a U.S. government study released in 2017 and posted on the Reuters website.

The study measured sexual activity, defined as vaginal intercourse between a female and a male, by teens aged 15 to 19 from 2011 through 2015.

Most of the 55% of teens who have had sex by 18 used some type of protection, typically a condom (80%), the study of more than 4,000 teenagers who attend U.S. public schools by the U.S. Centers for Disease Control (CDC) National Center for Health Statistics found.

The researchers credit the more widespread use of contraception for helping to reduce the rate of births by teenagers to 22 per 1,000 females in 2015 from 62 per 1,000 in 1991

Teen pregnancy rates peaked in 1990 and have since fallen more than 50%, said Joyce Abma, a social scientist at the National Center for Health Statistics, who co-authored the report with Gladys Martinez.

The study found that among males aged 15 to 19, about 44% have had sex, down from 60 percent in 1988. For females, that rate was 42 percent in the recent study compared with 51 percent in 1988.

Among the teen females who have had sex, 74% hadintercourse for the first time with someone with whom they were “going steady,” compared with 51% of the males, the study found.

Research contact: Contact CDC–INFO