In Runup to 2020 election, Renewed Action to Regulate the Pharmaceutical Industry

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Overt the last several years, the pharmaceutical industry has been accused of inappropriately and misleadingly advertising prescription drugs to consumers, charging exorbitant prices, paying competitors not to release less expensive generic drugs, and negotiating trade agreements that benefit the industry at the expense of the public.   As public concern about these practices grows and as the 2020 election gets closer, Big Pharma is getting closer scrutiny.

A few recent actions illustrate this new climate. Earlier this month, reports The New York Times, the Trump administration announced that  for the first time will, it will require pharmaceutical companies to include the price of prescription drugs in television advertisements if the cost exceeds $35 per month.  The move is the most visible action the administration has taken so far to address the rising cost of prescription drugs. It has been a key issue for American voters and one that both Republicans and Democrats have vowed to address.

In Congress, Reps. Judy Chu (CA-27) and Devin Nunes (CA-22) last month  introduced the Sunshine for Samples Act of 2019. This bill would amend the Sunshine Act, which requires pharma companies to report payments to doctors,  to require companies that manufacture drugs, devices, biologics, or medical supplies to publicly make available the number and value of free drug samples given to health care providers and charities each year. The bill closes a loophole in the Sunshine Act and does not prevent drug and device manufacturers from continuing to provide free samples, nor does it add any new burdens to providers under the Open Payment Programs.

Both the Federal Trade Commission and Congress have also acted to oppose “pay for delay” a costly legal tactic that more and more branded drug manufacturers have been using to stifle competition from lower-cost generic medicines. These drug makers have been able to sidestep competition by offering patent settlements that pay generic companies not to bring lower-cost alternatives to market.  Last month , Congressman Jerrold Nadler introduced H. R. 2375 , the Preserve Access to Affordable Generics and Biosimilars Act. The bill proposes to prohibit prescription drug companies from compensating other prescription drug companies to delay the entry of a generic drug, biosimilar biological product, or interchangeable biological product into the market.

These recent actions suggest that the 2020 election will provide public health professionals and advocates with opportunities to educate the American people and elected officials about the practices of the pharmaceutical industry and to counteract pharma’s extensive spending to influence Congress.

 

 

Do alcohol control policies work? An umbrella review and quality assessment of systematic reviews of alcohol control interventions (2006– 2017)

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The 2010 World Health Organization Global Strategy to Reduce the Harmful Use of Alcohol recommends countries adopt evidence-based interventions. A recent review in PLOS One updated, summarized, and appraised the methodological rigor of systematic reviews of selected alcohol control interventions in the Strategy. The authors identified 42 systematic reviews. Most reviews identified only observational studies with no studies from low or lower-middle income (LMIC) countries. Ten reviews were rated as low risk of bias. Methodological deficiencies included publication and language limits, no duplicate assessment, no assessment of study quality, and no integration of quality into result interpretation. We evaluated the following control measures as possibly beneficial: 1) community mobilization; 2) multi-component interventions in the drinking environment; 3) restricting alcohol advertising; 4) restricting on- and off-premise outlet density; 5) police patrols and ignition locks to reduce drink driving; and 6) increased price and taxation including minimum unit pricing.  The authors concluded that robust and well-reported research synthesis is deficient in the alcohol control field despite the availability of clear methodological guidance. The lack of primary and synthesis research arising from LMIC should be prioritized globally.

Citation: Siegfried N, Parry C. Do alcohol control policies work? An umbrella review and quality assessment of systematic reviews of alcohol control interventions (2006–2017). PLoS One. 2019 Apr 10;14(4):e0214865.

Alcohol exposure between 1990 and 2017 and forecasts until 2030: a global modelling study

Alcohol use is a leading risk factor for global disease burden, and data on alcohol exposure are crucial to evaluate progress in achieving global non-communicable disease goals. A new report in Lancet presents estimates on the main indicators of alcohol exposure for 189 countries from 1990–2017, with forecasts up to 2030.

The authors found that between 1990 and 2017, global adult per-capita consumption increased from 5·9 L to 6·5 L, and is forecasted to reach 7·6 L by 2030. The report forecasts that abstinence will decrease to 40% by 2030 and the proportion of current drinkers will increase to 50% by 2030. In 2017, 20% of adults were heavy episodic drinkers (compared with 1990 when it was estimated at 18·5%, and this prevalence is expected to increase to 23% in 2030.

Based on these data, global goals for reducing the harmful use of alcohol are unlikely to be achieved, and known effective and cost-effective policy measures should be implemented to reduce alcohol exposure.

Citation: Manthey J, Shield K, Rylett M, Hasan OS, Probst C. JR Alcohol exposure between 1990 and 2017 and forecasts until 2030: a global modelling study. Lancet.2019https://doi.org/10.1016/S0140-6736(18)32744-2

Public Policies to Reduce Sugary Drink Consumption in Children and Adolescents

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Excess consumption of added sugars, especially from sugary drinks, contributes to the high prevalence of childhood and adolescent obesity, especially among children and adolescents who are socioeconomically vulnerable. It also increases the risk for dental decay, cardiovascular disease, hypertension, dyslipidemia, insulin resistance, type 2 diabetes mellitus, fatty liver disease, and all-cause mortality. The 2015–2020 Dietary Guidelines for Americans recommend that added sugars contribute less than 10% of total calories consumed, yet US children and adolescents report consuming 17% of their calories from added sugars, nearly half of which are from sugary drinks. A new reportfrom the American Academy of Pediatrics and the American Heart Association finds that decreasing sugary drink consumption is of particular importance because sugary drinks are the leading source of added sugars in the US diet, provide little to no nutritional value, are high in energy density, and do little to increase feelings of satiety. To protect child and adolescent health, the report recommends, broad implementation of policy strategies to reduce sugary drink consumption in children and adolescents is urgently needed.