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Science Policy Around the Web – April 12, 2019

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By: Saurav Seshadri, PhD

Photo by Elijah Hiett on Unsplash

With Vertex, NHS back at the pricing table, CF advocates ratchet up the pressure

petition demanding coverage of the cystic fibrosis (CF) drug Orkambi in the UK has now garnered over 100,000 signatures, and must therefore be considered by Parliament for debate.  The milestone is the latest development in the struggle between Orkambi maker Vertex Pharmaceuticals and the British government, which began soon after Orkambi was approved in 2015.  The main point of contention is the price of the drug.  The UK’s National Institute for Health and Care Excellence (NICE) has refused to recommend Orkambi at Vertex’s asking price of £104,000 ($136,000) per patient per year, but Vertex has rejected the UK’s offer of £500 million for 5 years’ access, leaving both parties at an impasse.

The UK is not the first country to clash with Vertex over pricing. Several health agencies have refused to pay for Orkambi on the grounds that it is only marginally effective; some now face lawsuits, as programs like Medicaid are required to provide available drugs for qualifying patients.  While Orkambi is not as effective as Vertex’s first drug Kalydeco, it can be prescribed to more patients (up to 50% of those with CF).  Life expectancy for patients with CF is less than 40 years, and many patients are children, so even small improvements can be life-changing.  However, as with the multiple sclerosis drug Ocrevus, NICE seems unlikely to relent; on the contrary, UK Health Minister Matt Hancock recently accused Vertex of ‘hold[ing] the NHS to ransom’ and ‘profiteering’.  

For its part, Vertex is unlikely to compromise on the price of its best-selling drug, which brought in $1.26 billion in 2018.  CEO Jeffrey Leiden insists that this revenue is critical to the company’s continued investment in CF research.  Ironically, this stance may be pushing the UK closer to a measure that would jeopardize all future medical R&D efforts: invoking ‘Crown’ use, which allows the government to sell a patent without the consent of its owner. While the idea has gained support among some British lawmakers, and has been used in the past (to make Pfizer-owned antibiotic tetracycline available in the 1960s), it would face legal challenges that could render it ineffective.  But with public pressure mounting, especially after Vertex recently admitted to destroying almost 8,000 packs of Orkambi amid the standoff, inaction may not be an option for much longer.

(Eric Sagonowsky, FiercePharma)


Why some low-income neighborhoods are better than others

A recent study, published in PNAS, builds upon a body of evidence that while race can influence upward mobility (with white children having a 4-fold higher chance of moving from the lowest to highest income brackets than their black peers), environmental factors also play a major role.  Previous work demonstrated that the neighborhood in which a child grows up has a large effect on their future success, with better outcomes for children raised in low-poverty neighborhoods, regardless of race.  However, black children are significantly less likely to live in such neighborhoods.  To combat racial inequality, it is critical to understand which aspects of poverty impact long-term socioeconomic progress. 

The new study is based on the Opportunity Atlas, and pulls together data from tax returns, Census surveys, police reports, prison admission records, and blood tests conducted by the health department. The data tracks a cohort of children born in 1978-1983 (age 31-37 in 2014), living in 754 Census tracts in Chicago.  The authors report that even after controlling for other variables, a large proportion of the racial disparity observed in adults can be explained by three factors: violence, incarceration, and lead exposure during adolescence.  Since these factors were highly correlated with each other, the authors combined them into a single ‘neighborhood harshness/toxicity’ factor; this variable proved to be a much stronger predictor of income, incarceration, and teen pregnancy than more traditional factors, such as poverty or college education rates.   

That these elements impair social mobility is perhaps not surprising, as exposure to both violence in the community and high levels of lead have both been linked to cognitive impairment. But the magnitude of the effect is striking: for example, according to their model, toxicity exposure could account for 60% of the difference in incarceration rates between black and white men in their sample, and a 10% increase in teen births among black women.  While the authors acknowledge they cannot establish causality, they conclude that ‘Chicago’s residential segregation is disproportionately exposing its black children to neighborhoods that are hazardous to their development’.  Recently elected mayor Lori Lightfoot ran on a platform that includes stopping violence, expanding affordable housing, and ‘investing in our neighborhoods’.  Insight into the mechanisms that perpetuate inequality can only enhance these policies’ power to improve the trajectories of vulnerable kids.      

(Sujata Gupta, Science News


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Written by sciencepolicyforall

April 12, 2019 at 5:21 pm

Science Policy Around the Web – May 11, 2018

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By: Mohor Sengupta, PhD

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source: Max Pixel

Drug prices

Why Can’t Medicare Patients Use Drugmakers’ Discount Coupons?

With high drug prices, affordability of specialized medicines is a matter of concern for many individuals, especially those on life-saving brand-name drugs.

Manufacturers of brand-name medicines provide discount coupons to people with private health insurance. Such discounts are denied for people with federal healthcare plans such as Medicare or Medicaid. For example, for one patient on Repatha (a cholesterol reducing drug), the co-payment is $618 per month with the Medicare drug plan, but it is only $5 for patients with commercial insurance plans. This discrepancy has resulted in a “double standard” because arguably, the discount is denied to the people who need it most, that is the retired population subscribing (compulsorily) to federal healthcare programs.

Drug manufacturers have an incentive to offer discounts on branded medicines as they increase the likelihood of purchase and results in greater access to and demand for the products. While these discount coupons are immensely beneficial for life-threatening conditions for which generic drugs are not available, a 2013 analysis has shown that lower cost generic alternative and FDA approved therapeutic equivalent was available for 62% of 374 brand-name drugs.

The federal government has argued that with the discount coupons, patients might overlook or be discouraged from buying cheaper variants of the brand-name drug. Even if a patient chooses to use a brand-name drug with a discount coupon over cheaper alternative, their health insurance plan still has to pay for the drug. That amount maybe more than Medicare or Medicaid may be willing to pay. This has resulted in the federal anti-kickback statute which prohibits drug manufacturers to provide “payment of remuneration (discounts) for any product or service for which payment may be made by a federal health care program”.

One important question is why do drug makers sell the brand-name drugs at a much higher price bracket when generic, cheaper options are available? In the present scenario, insurance companies should make the judgement about whether they are willing to cover such brand-name drugs for which generic alternatives are available. Often doctors prescribe brand-name drugs without considering their long-term affordability by patients. It is the responsibility of doctors and insurance providers alike to determine the best possible drug option for a patient.

Taking in both sides of the picture, use of discounts must be exercised on a case basis. It must be enforced for specialized drugs against which generic alternatives are not available and which are usually used for severe or life-threatening conditions. Currently for people with such conditions and on federal healthcare plans, affordability is a major challenge.

(Michelle Andrews, NPR)

 

EPA standards

EPA’s ‘secret science’ rule could undermine agency’s ‘war on lead’

Last month the Environmental Protection Agency (EPA) administrator, Scott Pruitt issued a “science transparency rule” according to which studies that were not “publicly available in a manner sufficient for independent validation” could not be used while crafting a regulation. This rule is at loggerheads with Pruitt’s “war on lead” because a majority of studies on lead toxicity are observational, old and cannot be validated without consciously exposing study subjects to lead.

Lead is a potent neurotoxin with long term effects on central nervous system development. It is especially harmful to children. There are several studies showing lead toxicity, but many do not meet the inclusion standards set by the EPA’s the new science transparency rule. Computer models developed to assess lead toxicity, which played important role in EPA’s regulations on lead in the past, have amalgamated all these studies, including the ones that cannot be validated. If the science transparency rule is retroactive, it would mean trashing these models. An entire computer model can be rendered invalid if just one of its component studies doesn’t meet the transparency criteria.

Critics say that the transparency measure will be counter-effective as far as lead regulations are concerned. “They could end up saying, ‘We don’t have to eliminate exposure because we don’t have evidence that lead is bad’”, says former EPA staffer Ronnie Levin. Another hurdle is the proposed data sharing requirement. Lead based studies tend to be epidemiological and authors might be unwilling to share confidential participant data.

Bruce Lanphear of Simon Frazer University in Canada is skeptical of EPA’s intensions because the agency has not imposed similar transparency measures for chemical companies like pesticide producers.

Finally, this rule could set different standards for lead safely levels in different federal agencies. Currently Center for Disease Control and Prevention (CDC) and Department of Housing and Urban Development (HUD) consider 5 micrograms per milliliter of lead in blood as the reference level. The EPA rule could lead to a new reference level, leading to discrepancies when complying with agencies across the U.S. government.

(Ariel Wittenberg, E&E News)

 

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Written by sciencepolicyforall

May 11, 2018 at 10:24 pm