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Health groups warn Brexit drugs supply risk at code red

The U.K. governments preparations for maintaining drug supplies in the event of a no-deal Brexit are..

The U.K. governments preparations for maintaining drug supplies in the event of a no-deal Brexit are so lacking that the warning level should be raised to “red,” a group of health organizations has said.

National Health Service providers, pharmaceutical companies and patient groups wrote to the government to warn that Britain is seriously unprepared to maintain access to medicines if there are border delays after Brexit.

In the letter to Health and Social Care Secretary Matt Hancock obtained by POLITICO, eight organizations say industry has done all it can in preparing for a cliff-edge Brexit — and that the government needs to take action to prevent widespread drug shortages.

“If this is the reality of U.K. government preparation for No Deal we do not believe that the current medicine supply plans will suffice, and we will have widespread shortages if we do not respond urgently,” the letter dated October 31 says.

Expressing support for Hancocks “efforts to raise the warning level in Government,” the organizations say: “Only when we start to work through options will we all know where we are, but on medicines supply, on what we know and can glean from public information, we think we are at red.”

The groups calls on the government to be more transparent “and reveal what cover we have by therapy area and where there are gaps,” so that the signatories can “find further creative solutions to shortages, but we need the data to engage.”

They also request an urgent meeting in the form of a roundtable between ministers and industry.

A spokesperson for the Department of Health and Social Care said in a statement: “The Government is confident of reaching a deal with the EU that benefits patients and the NHS. However, as a responsible Government we are also preparing for a range of potential outcomes in the unlikely event of a no deal.

“As part of our contingency planning, we continue to work closely with pharmaceutical companies and storage providers to ensure the continued supply of critical drug and medicine supplies,” the spokesperson said.

The letter to Hancock is backed by, among others, the Association of the British Pharmaceutical Industry (ABPI), the Association of British HealthTech Industries (ABHI), the BioIndustry Association and the Brexit Health Alliance — a conglomerate of NHS, medical research, industry, patients and public health groups.

“When an incredibly broad group of medical organizations and bodies are telling the government we are at warning level red, it shows the preparations government has made are both shockingly inadequate and woefully behind,” said Liberal Democrat Brexit spokesperson Tom Brake.

The government in August asked drugmakers to stockpile an extra six weeks-worth of drug supplies in preparation for delays in importing medicines, but companies have since warned storage will be a major hurdle.

Speaking Wednesday evening on ITVs Peston show, Hancock said that in the event of six weeks of extra supplies not being enough, “then we will have to do things differently,” because “you cant have stockpiles for enormous lengths of delays.”

“All of this is doable. It is difficult. Theres a lot of work going on already to make it happen,” he said, adding that the government is “building refrigerator capacity right now.”

Companies advising the government on how to maintain supplies after a no-deal Brexit have signed strict non-disclosure agreements (NDAs) barring them from revealing information.

Outlining the extent of potential disruptions at Britains borders, the letter cites reports that U.K. minister David Lidington told the Cabinet the Dover-Calais trade route could be limited to 12 percent of normal capacity for six months after Brexit.

The letter points to a recent report from the National Audit Office that concluded 11 out of 12 critical upgrades to IT systems at the border are at risk of not being delivered on time, and that there is a high risk of failure in the government departments border programs for “day one of no deal” due to their scale, complexity and urgency.

With much of the necessary infrastructure unable to be built before March, the timescale is too tight for companies to make the necessary changes, it adds.

This article has been updated to add Health Secretary Matt Hancocks interview with ITV.

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The organization helping to bring new drugs for rare diseases to market

A research team has reason to celebrate after the Food and Drug Administration granted it approval o..

A research team has reason to celebrate after the Food and Drug Administration granted it approval on Friday to begin a clinical trial for a new pediatric brain cancer drug, one that might have ended up overlooked by pharmaceutical companies.

The lead researcher on the team, Dr. Teresa Purzner has already beat impossible odds. The neurosurgeon and mom of three managed to get the approval in record time and with little money thanks to the help of a team of scientific altruists called SPARK.

The development of new medications in the United States is driven by pharmaceutical companies; researchers at universities rarely bring their discoveries to the bedside. For every 10,000 potential new medicines sitting on laboratory shelves around the country, only one will ever reach patients in need, according to the National Institutes of Health. Why? Because the process can take 10 to 15 years, costing upwards of a billion dollars per drug.

As a result, the number of new medications approved by the FDA has remained stagnant at about 31 per year over the past 10 years. The majority of these medications are similar to already existing ones, and many target diseases for which there are large markets — like hypertension and high cholesterol — and therefore, a return on investment.

Enter SPARK, a non-profit program created in partnership between Stanford University and volunteers from the biotechnology, pharmaceutical, and investment industries, which helps academic researchers bring their discoveries to patients. Since its founding, SPARK has given special consideration to projects typically neglected by pharmaceutical companies, including rare diseases and diseases affecting children.

Purzner put her neurosurgery practice on pause to study medulloblastoma, a type of childhood brain cancer. Compared to diseases like hypertension and high cholesterol, which affect millions of Americans, medulloblastoma is rare, affecting only 250 to 500 children every year.

“Theres something especially poignant about seeing children —beautiful, wonderful, innocent things — and seeing the impact of the therapies we are giving them. The medications, the radiation therapies impact their cognition, their quality of life and their ability to function as independent adults in the future,” Purzner said in an interview with ABC News.

Purzner had a clear goal: to find a targeted therapy that could shut down the basic biochemical pathway responsible for the development of this cancer, and she did. She tested the potential drug in mice with good results, and she just received FDA approval to test it in clinical trials, which she will do through the Pediatric Brain Tumor Consortium. She did it all in five years and for a price tag of $500,000.

“To get from my initial findings in the lab to the point where the Pediatric Brain Tumor Consortium picked it up for clinical trials would have never happened without the help of SPARK… they gave me a clear pathway and made me believe it was possible,” said Purzner.

Every year, SPARK provides 10 teams with funding and expert mentorship to promote efficient and cost-effective drug development. (more…)

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Widowed father works with congresswoman on legislation to prevent maternal deaths

Sitting in the hospital room, mother and newborn baby were sound asleep.

“I was overjoyed. I reme..

Sitting in the hospital room, mother and newborn baby were sound asleep.

"I was overjoyed. I remember thinking my family is complete," Charles Johnson told ABC News.

But then he looked down and saw his wife Kiras catheter turn pink and then red with blood.

April 12, 2016 was supposed to be a joyous day for the Johnson family, but it turned into a "nightmare."

Ten hours later, Kira Johnson died as a result of internal bleeding following a cesarean section.

Now, two years later, Johnson is raising two children on his own and advocating to rectify the country's maternal health policies and regulations to prevent anyone else from sharing the same tragedy. Johnson took to Capitol Hill to share his wife's story before members of Congress, working alongside a congresswoman who experienced her own personal difficulties during pregnancy.

Charles and Kira Johnson welcomed their first son Charles V. in 2014. He was delivered via C-section. Two years later, the Johnson family relocated from Atlanta to Los Angeles and learned they were expecting their second baby boy.

"Kira and I had always wanted two boys," Johnson said. "I was excited."

The Johnsons decided to have Langston delivered at Cedars Sinai medical center, a non-profit hospital that is currently ranked as the eighth best hospital in the country by U.S. News and World Report.

Charles Johnson said his wife was in exceptional health and that she took all the necessary prenatal measures to ensure their second child would be born healthy. Since their first son was born via C-section, the doctor suggested the same for their second. (more…)

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States look to breathalyze convicted drunk drivers to reduce fatalities

This story is from Kaiser Health News

On Jan. 1, California joined the majority of states that ha..

This story is from Kaiser Health News

On Jan. 1, California joined the majority of states that have laws requiring drivers with drunken-driving convictions to install breathalyzers in vehicles they own or operate.

Researchers, public health advocates and political leaders believe these laws are helping reduce alcohol-related road deaths.

The gadgets, known as ignition interlock devices, are mounted on the steering wheel of a vehicle and prevent it from starting if the drivers blood-alcohol reading is above a predetermined level.

In California, the breathalyzers are mandatory only for repeat offenders. Five other states — Georgia, Indiana, Massachusetts, Montana and Ohio — have similar laws. Thirty-two states and D.C. require the devices even for first-time offenders.

The advent of such laws across the United States in the past 15 years has been accompanied by some good news: Deaths involving drunken driving are only about half of what they were in the early 1980s, though they have ticked back up in recent years. The long-term decline is largely attributable to greater public awareness, stricter seat belt enforcement and the establishment in 2000 of a nationwide legal blood-alcohol threshold of 0.08 percent — far below the 0.15 percent standard commonly used before then.

State Sen. Jerry Hill (D-San Mateo), the author of the California law, said breathalyzers in cars will make roads safer than under the current law, which generally relies on license restrictions and suspensions.

“Weve seen people on a suspended license continue to drive and continue to cause destruction,” said Hill, who lost his best friend to drunken driving in the 1980s.

There is some evidence that the breathalyzers have an impact. Nationally, from 2006 to 2016, ignition-locking breathalyzers prevented 2.3 million attempts to drive by people with a blood-alcohol level at or above 0.08 percent — the legal threshold for driving under the influence — according to a 2017 report by the advocacy group Mothers Against Drunk Driving.

Emma McGinty, an associate professor at the Johns Hopkins Bloomberg School of Public Health, found that laws requiring interlocks for all DUI offenders were associated with a 7 percent drop in the rate of fatal crashes caused by drunken drivers. Another study found that laws covering all offenders were associated with 15 percent fewer alcohol-related fatalities compared with states that have less stringent laws. (more…)

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