FT Health: Tough times for generics

Scott Gottlieb, the new head of the US Food and Drug Administration, accused Big Pharma this week of “gaming the system” to block generic competition and said he hoped to cut the time for generic drug reviews from four years to about 10 months.

Generic companies — the makers of copycat versions of off-patent drugs — are certainly in need of a boost. A disastrous second quarter has wiped billions of dollars from the sector's biggest companies — Israel's Teva and Netherlands-based Mylan.

US customers combining into “mega-buyers” (called general purchase organisations) are demanding large discounts, while Indian generic companies are increasing US market share. The next batch of drugs set to lose their patents are “biological” medicines harvested from living cells, rather than easy-to-copy pills. And FDA action could actually harm companies like Mylan if certain medicines are opened up to greater competition.

There is some good news for Mylan across the Atlantic. NHS England is planning to use its generic — and much cheaper — version of Gilead's HIV-prevention drug by designating it as a clinical trial. Medicines used in such trials are exempt from patent restrictions in English law.  

The overall picture for generic companies, however, remains gloomy. In the words of one analyst: “When you have that combination of oversupply and consolidation on the demand side, it's a recipe for catastrophe.” (FT, WSJ)

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Chartwatch

Cholera crisis The number of cholera cases in Yemen has now passed 500,000. Although the rate has been slowing since early July, an estimated 5,000 people are infected daily. There are also fears that the deadly mudslides in Sierra Leone could lead to outbreaks of the disease. (Stat, ITV News)

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News round-up

WHO priorities Expanding health coverage is not a technical issue but a political one and should be seen as a right, said Tedros Adhanom Ghebreyesus, head of the World Health Organization. His focus remains universal coverage, emergency response, women and children in adolescence, and climate change and health. “Anything outside this will be less of a priority and get fewer resources,” he said. (Foreign Affairs)

Stada deal finalised Cinven and Bain’s joint takeover of Stada was given the green light on Friday morning. The €4.1bn deal is Europe’s largest buyout in four years. (FT)

Beware the body brokers A disturbing side-effect of the US opioid epidemic is the emergence of unscrupulous rehab centres on the lookout for clients with good health insurance — creating an industry of “body brokering”. (NPR)

Indian reforms India is revamping its public health scheme. Planned reforms include cuts to bureaucracy and drug prices and encouraging companies such as PepsiCo to make healthier products. The country aims to raise health spending from 1.15 per cent of GDP to 2.5 per cent by 2025. (Reuters)

Factory farming fears The increasing use of antibiotics in Asian factory farms could lead to increased resistance to the drugs across the world and result in diseases such as bird flu. Separately, the European egg contamination scandal has spread as far as Hong Kong. (Guardian, FT)

Mosquitoes and malaria To mark World Mosquito Day on Sunday we recommend watching the acclaimed  Mosquito documentary and Bill Gates' virtual reality Mosquito Wars, while sipping an anti-malaria cocktail. Controls are having positive effects on mosquito-borne Zika in Miami while a US biologist aims to stop the creatures spreading disease by boosting their immune systems. (Discovery Channel, Gates' Notes, Master of Malt, Miami Herald, Philadelphia Inquirer)

Plotting epidemics The CFR’s interactive map lets you plot global outbreaks of diseases that could be prevented by vaccines. (Council on Foreign Relations)

Food fights The UK is targeting ready meals to fight childhood obesity while in the US a battle is intensifying over New York's calorie labelling law as the FDA tries to stop the city enforcing new rules. (NYT, FT). Sensible public health measures or too much state interference? Discuss on our Facebook page. 

Cancer treatment Despite the overexcitement of some newspaper reporting, there is still plenty of good news in cancer research. Researchers are, however, having problems finding enough patients for drug trials. (The Guardian, NYT)

Robotic revolution The FT's Lex analysts examine the market for medical robotics. The value of the diagnostics, physical rehabilitation and surgery segment alone is set to pass $14bn next year. (FT)

Health at work UK government efforts on work and wellbeing are falling short, according to an industry survey. The Fit For Work service aims to support people in work with health conditions and help with sickness absence. (EEF, Fit For Work) Watch out for our new Health at Work magazine, out in mid-September.

Wellcome's warrior A new video game funded by the Wellcome Trust aims to raise awareness of psychosis. Hellblade tells the story of a Celtic warrior's delusions as she dives into the Viking Underworld. The game, developed with a Cambridge neuroscientist, mimics 3D human hearing and lets players hear voices just behind them or whispering in their ear.

Best from the journals

TB and children Tuberculosis killed 239,000 children under 15 in 2015, of whom 80 per cent were under five. More than 70 per cent of the deaths were in Africa and Southeast Asia. TB, which killed an estimated 1m people in 2015, is not normally included in official estimates of under-five mortality. (The Lancet)

HIV crisis New infections in the Philippines have doubled in the past six years thanks largely to the stigma associated with the disease. The country has to act rapidly and target at-risk groups such as men who have sex with men and transgender women who have sex with men. (The Lancet)

Pollution processes We know air pollution has many adverse effects on health, but a new study examines the processes involved and how it affects our metabolism. It also points to the positive effects of indoor air purification. (Circulation)

Gene editing A look at the CRISPR technique that is only five years old but has already had a great effect on biomedical research. How does it work, and how could it change medical practice? Gene-edited pigs (CRISPR bacon?) have given new hopes for organ donation. (JAMA, Stat)

Yellow fever A study of more than 40 years of data estimates up to 473m people in risk areas still need vaccination for yellow fever to achieve the 80 per cent population coverage threshold recommended by the WHO. There have been substantial recent outbreaks in Angola and Brazil. (The Lancet)

Nuts news Probiotic and peanut oral immunotherapy (PPOIT) has found to be successful in treating peanut allergy. (The Lancet)

Fat, not fit A study of more than half a million people in 10 European countries demolishes the concept of “metabolically healthy obesity” or the idea you can be "fat but fit". Those suffering from obesity will always be at greater risk of a heart attack, it says. (European Heart Journal)

Decoding jargon A look at a scientist-friendly program for identifying medical jargon, based on words used on the BBC website. Enter text in the de-jargoniser to assess its readability. (PLoS, Scienceandpublic.com)

Medical marijuana Cannabis is increasingly being prescribed for chronic pain but a study says there is little evidence of its effects. A US neuroscientist is investigating the long-term effects of medical marijuana. The human body's own "version" of cannabis is being used to fight cancer. (Annals of Internal Medicine, Stat, The Conversation)

Vaping warning Teenagers who use ecigarettes are more likely to take up real cigarettes, a UK study shows. (BMJ Tobacco Control)

Booze news Light and moderate intake of alcohol might lead to a longer life, according to a large US study that also confirmed the negative effects of excessive drinking. (Journal of the American College of Cardiology)

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Podcast of the week

HIV/Aids Discussion of the big issues at last month's international HIV/Aids conference in Paris with Lisa Carty of UNAIDS and Chris Beyrer of John Hopkins Bloomberg School of Public Health. (CSIS Take as Directed podcast, 34m)

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In case you missed it

Last edition: The pursuit of the impossible

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Final thought

Taboo busting Discussion of mental health is becoming part of the national conversation. At this year's Edinburgh Festival there are so many shows tackling the issues that a new award has been introduced for shows about mental illness. (The Guardian)