The relation between promotional spending on drugs and their therapeutic gain: a cohort analysis

https://goo.gl/QvYthb

Background: Whether drug promotion helps or hinders appropriate prescribing by physicians is debated. This study examines the most heavily promoted drugs and the therapeutic value of those drugs to help determine whether doctors should be using promotional material to inform themselves about drugs.

Most of the money spent on promotion in the form of journal advertisements and visits by sales representatives in Canada goes to drugs that offer little to no therapeutic gain. Similarly, most of the top-selling drugs offer little to no therapeutic gain. The finding that there was a difference in therapeutic distribution between the most-promoted drugs and the top-selling drugs in only 1 of the 3 years studied may mean that there are few therapeutically significant products that can be promoted. It is, of course, possible that this group of drugs is being promoted through other methods or that the minority of drugs with a high therapeutic value may sell well without the need to promote them.

Promotional material does not appear to be a way for doctors to learn about therapeutically important products. Other factors besides therapeutic gain, including patient preferences, adverse reactions to specific drugs, insurance coverage and other medications a patient is taking, enter into decisions about what drug to prescribe to an individual patient. However, none of this information is available through promotional channels.

The pharmaceutical industry spent almost $563 million in total on journal advertising and sales representative visits in 2015, with unknown amounts going to the 14 million samples left behind,10 engaging key opinion leaders to give talks, meetings, direct-to-consumer advertising, booths at medical conferences and other forms of promotion. In 2015, just over a third of Canadian doctors were not seeing sales representatives, but 11% saw 6 or more a month,14 and in that year there was a total of 3 720 000 visits.10The comprehensiveness of the safety information provided by sales representatives when they visit doctors was investigated in a study involving primary care practitioners in Vancouver and Montréal.15 Minimally adequate safety information, defined a priori as the mention of 1 or more of approved indications, serious adverse events, common nonserious adverse events or contraindications and no unapproved indications or unqualified safety claims (e.g., "this drug is safe"), was provided in 5/412 (1.2%) promotions in Vancouver and 7/423 (1.6%) in Montréal.Representatives did not provide any information about harms (a serious adverse event, a common adverse event or a contraindication) in two-thirds of interactions.


Small Doses Matter

https://goo.gl/my2z2G

More than 100,000 new chemicals have been invented in the past 50 years. Many have become widely disseminated in the environment, and the Centers for Disease Control and Prevention (CDC) surveys document that low-levels of several hundred man-made chemicals can now be found in the bodies of nearly all Americans, even in our youngest children. Children are exquisitely sensitive to these chemicals.

Over the summer, two events have drawn our attention to the impacts of low-level chemical exposures on children’s health. First was the story in the New York Times and other national news outlets reporting that measurable levels of the plastic chemical, phthalate, has been detected in mass-produced macaroni and cheese products. Phthalates are toxic chemicals that can injure children’s developing brains and cause reproductive problems. Yet, spokespersons for the processed food industry assured the world that the levels of phthalates present in their products were too small to cause concern.

The second event was the death on July 18 of Dr. Herbert Needleman. Dr. Needleman, a pediatrician and child psychiatrist, conducted landmark studies of childhood lead poisoning using analyses of lead levels in discarded baby teeth. He documented that low-level lead exposures — even exposures at levels widely considered “safe” — were actually causing permanent damage to children’s brains. He showed that children exposed to lead can have reduced IQ scores, short attention spans, and difficulties in controlling their behavior. These injuries occur even when there are no obvious symptoms of lead poisoning.

But even as blood lead levels were going down, new chemicals have entered the market, fouled the environment, and entered children’s bodies. These toxic chemicals include the phthalates found in macaroni and cheese, new classes of insecticides, brominated flame retardants, and components of air pollution. In the last three years, seven published studies have found that early-life exposures to phthalates are linked to lower intelligence, memory problems, attention deficit disorder, aggression, impulsivity and other behavioral problems in children. Twenty-one additional studies have found evidence for reproductive injury in children exposed to phthalates — lower levels of testosterone, abnormalities in the structure of the male reproductive organs in baby boys, and earlier onset of puberty. The food that we Americans eat and the products that we use every day were the sources of this exposure.


Allergy Med Often Given by Nonmedical Staff at U.S. Schools

https://goo.gl/ZdNHCE

About a quarter of school nurses reported that U.S. students during the 2015-2016 school year had epinephrine administered and, in many cases, it was by unlicensed staff, a researchers reported here.

Around 16% of all reported doses of epinephrine were administered by unlicensed staff or students, according to Michael Pistiner, MD, of Massachusetts General Hospital in Boston, and colleagues.

Moreover, about a third of epinephrine doses were given to students who had no previous allergy known to the school, the authors stated in a presentation at the American Academy of Pediatricsannual meeting,

Pistiner's group argued that even though food allergy prevalence is under 10%, about 16% to 18% of kids have had an allergic reaction at school or daycare. Moreover, in the authors' home state of Massachusetts, 25% of epinephrine administration was to children whose allergy was unknown to the school, and added that new regulations addressing epinephrine in school are becoming widespread throughout the U.S.


New rule may change how federal special ed dollars can be used

https://goo.gl/uxUoNs

Dive Brief:

  • Starting in 2018-19, states must start using a standardized method to determine if school districts have wide disparities in how they identify, place in segregated settings, or discipline minority students with disabilities, Education Week reports.
  • School systems found to have state-defined "significant disproportionality" in one or more of those areas must use 15% of their federal special education dollars on remedies for the issue.
  • The cost to states to implement the special education regulations over 10 years are estimated at between $50 million and $91 million, depending on how many districts reach the threshold.

Dive Insight:

The new special education bias rule that will begin to be implemented next year is an Obama-era revision of a George W. Bush policy signed into effect in 2004. However, under the old plan, fewer than 5% of school districts meet the disproportionality threshold. The new revisions to the Individuals with Disabilities Education Act (IDEA) calls for states to provide better definitions and methodologies for determining this threshold and will likely mean that more school districts will be identified in the coming years. The funding method under the new provisions has also been broadened, as well.


Deregulated & Unaccountable: For-Profit Nursing Homes in Florida Face Scrutiny After Irma Deaths

https://goo.gl/upNtdG

Authorities in Florida have obtained a search warrant to investigate the deaths of eight elderly residents at a nursing home in Hollywood in the aftermath of Hurricane Irma. 

The victims ranged in age from 71 to 99 years old. They died in the Rehabilitation Center at Hollywood Hills after a transformer was knocked out following the hurricane, causing the nursing home’s air conditioning unit to shut down. Authorities say that the administrators of the nursing home were aware that the air conditioning unit had failed, and that they installed fans and portable air coolers inside the facility. But the remedies did little to protect the residents from the sweltering heat. 

At 3 a.m. on Wednesday morning, one nursing home resident was rushed to the emergency room of Memorial Regional Hospital, a Level I trauma center just down the street. 

By 5 a.m., when the hospital received a third rescue call, some hospital workers went down the street to check on the nursing home. They found a situation so critical, the hospital sent in more than 50 medical workers under a mass casualty protocol. At least 150 people were evacuated, many with severe dehydration and other heat-related symptoms. 

We speak with Dale Ewart, vice president of 1199SEIU, the United Healthcare Workers East union. We also speak with Stephen Hobbs, a reporter for the Sun Sentinel who has been covering the eight deaths.