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U.S. diabetes patients turn to 'black market' for medications, supplies – Montreal Gazette

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Diabetes medications and blood-test supplies are sold, traded and donated on black markets because the U.S. health-care system isn’t meeting patients’ needs, a study shows. The price of insulin continues to increase, translating to $15 per day for the average user. Recent research indicates one in four people with diabetes ration their insulin because of the cost.


David Burns, 38, who has type 1 diabetes, prepares his insulin pen to inject himself in his home in North London on February 24, 2019. – Diabetics and insulin providers in Britain are stockpiling their precious medicine to avoid potential shortages in case Britain leaves the European Union without a deal in just over month’s time. Britain’s 3.7 million diabetics, which include Prime Minister Theresa May, depend almost entirely on insulin imports from continental Europe.


NIKLAS HALLE’N / AFP/Getty Images

(Reuters Health) – Diabetes medications and blood-test supplies are sold, traded and donated on black markets because the U.S. healthcare system isn’t meeting patients’ needs, a study shows.

In a survey, about half of people who participated in these underground exchanges said they do it because they lack access to the proper medications and supplies to manage their diabetes, researchers report in the Journal of Diabetes Science and Technology.

“It is important for healthcare providers and policymakers to understand what people are doing to support diabetes management when faced with medication and supply access issues,” said study leader Michelle Litchman of the University of Utah College of Nursing in Salt Lake City.

The price of insulin continues to increase, translating to $15 per day for the average user, the study authors note. Recent research indicates that one in four people with diabetes ration their insulin due to cost, they add.

“While there are risks to using medications and supplies that are not prescribed to them, there are also risks to rationing or not taking medications or using supplies at all,” Litchman told Reuters Health by email.

In early 2019, the researchers surveyed 159 people who were involved in online diabetes communities, including patients and caregivers. They asked questions about underground exchange activities, access to healthcare and difficulty in purchasing diabetes items from standard sources.

More than half of the survey participants said they had donated medications or supplies, 35% received donations, 24% traded medications, 22% borrowed items and 15% purchased items. These exchanges took place among family, friends, co-workers, online acquaintances and strangers.

Overall, people who reported financial stress due to diabetes management were six times more likely to engage in underground exchanges and three times more likely to seek donations.

“The current healthcare situation in the United States is substandard for many people with chronic disease,” said Mary Rogers of the University of Michigan, in Ann Arbor, who wasn’t involved in the study.

“It is too costly. It is too slow. It is too complicated,” she said by email. “Failure to fix these problems leads to diabetic complications and unnecessary hospitalizations.”

Participants who donated medications felt compelled to give because they knew about the dire need of others, the study authors note. These respondents described a sense of duty and obligation to help. Others built up stockpiles that they donated, including insulin, pills, glucose strips, sensors and pump supplies.

Underground exchange could lead to several repercussions, including unanticipated side effects, complications of incorrect use, delay in seeking professional help and drug interactions, the authors caution. In addition, sharing and trading prescription medicines is illegal in the U.S. and other countries.

In this study, the researchers did not identify any adverse events, Litchman said.

Kebede Beyene of the University of Auckland, in New Zealand, who wasn’t involved in the study, told Reuters Health, “It seems that health professionals rarely ask patients about medicine sharing, trading or exchange, so it would make sense for health professionals to ask about medicines exchange during consultations and when dispensing medicines, particularly for high-risk medicines, such as diabetes medications, antibiotics and strong pain medications.”

“Patients can then be given information about the possible risks of taking someone else’s medicine or giving their prescribed medicines to another person,” Beyene said by email. “Community pharmacy practitioners are also in a unique position to educate about risks of medicine exchange.”

SOURCE: https://bit.ly/2MtPQa6 Journal of Diabetes Science and Technology, online December 4, 2019.

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EU regulator backs month-long storage of Pfizer COVID-19 vaccine in fridges

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Europe’s drug regulator on Monday recommended extending the storage time for the Pfizer-BioNTech COVID-19 vaccine at normal fridge temperatures to 31 days from five days, easing logistical challenges during rollouts in the region.

The change is applicable to unopened vials, the European Medicines Agency (EMA) said, adding that the advice by its human medicines committee came after assessing additional stability study data submitted by Pfizer and BioNTech.

“EMA is in continuous dialogue with the marketing authorisation holders of COVID-19 vaccines as they seek to make manufacturing improvements to enhance vaccine distribution in the EU,” the watchdog said.

The EU has allowed for ramped-up production of the Pfizer-BioNTech vaccine in the region and is eyeing a new deal to secure more doses of the shot after the bloc was hit by cuts in the supply of AstraZeneca’s vaccine.

Vaccine deliveries were also slower initially under the EU’s centralised procurement strategy.

U.S. authorities in February had approved storage and transport of the Pfizer-BioNTech vaccine at standard freezer temperatures of -15 to -25 degrees Celsius for up to two weeks instead of the ultra-cold temperatures between -80 to -60 degrees Celsius it usually requires.

The EU storage change also comes as the U.S. and German drugmakers are seeking approval of the vaccine for inoculating adolescents aged 12 to 15 years. The United States and Canada have started vaccinating this group with the shot, which uses the brand name Comirnaty.

The two-dose vaccine, similar to the one developed by Moderna, uses new mRNA technology to deliver instructions to the human body to build immunity against COVID-19.

With 200 million vaccine doses delivered overall, the EU is on track to achieve its goal of inoculating 70% of its adult population by summer, European Commission President Ursula von der Leyen tweeted on May 9.

(Reporting by Pushkala Aripaka in Bengaluru; Editing by Ramakrishnan M. and Alex Richardson)

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Sanofi-GSK report positive interim results for their COVID-19 shot

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An experimental COVID-19 vaccine developed by Sanofi and GlaxoSmithKline showed a robust immune response in early-stage clinical trial results, enabling them to move to a late-stage study, the French drugmaker said on Monday.

Sanofi and Britain’s GSK said a global Phase III trial would start in the coming weeks and involve more than 35,000 adults, with the hope of seeing the vaccine approved by the fourth quarter after having initially targeted the first half of this year before a setback.

Sanofi and GSK last December were forced to restart their trial when the vaccine showed a low immune response in older adults as a result of a weak antigen formulation.

Sanofi and GSK shares were little changed in early trading.

“The Phase II interim results showed 95% to 100% seroconversion following a second injection in all age groups and across all doses, with acceptable tolerability and no safety concerns,” Sanofi said.

Seroconversion refers to the vaccine’s ability to prompt the body to produce antibodies against the coronavirus, as measured by blood readings. Later mass trials will be based on real infections.

“Interestingly, we also observed that our vaccine generated a higher antibody response in those with previous COVID-19 infection, we are analysing this further as it may suggest our vaccine could serve as a potential booster, regardless of what vaccine someone may have received (beforehand),” Su-Peing Ng, Sanofi’s global head of medical for vaccines, told reporters.

Ng said the vaccine had not been tested against so-called variants in the Phase II trial but that the Phase III study would be assessing it against various strains including a virus lineage known as B.1.351 first detected in South Africa.

But Sanofi, Ng said, has conducted parallel studies evaluating its vaccines against variants, with results expected to be published soon.

GSK and Sanofi’s vaccine candidate uses the same technology as one of Sanofi’s seasonal influenza vaccines. It will be coupled with an adjuvant, a substance that acts as a booster to the shot, made by GSK.

‘QUITE A POTENTIAL’

Some 162.75 million people have been reported to be infected by the coronavirus in more than 210 countries and territories since the first cases were identified in China in December 2019, while economies have taken a hit and restrictions have turned daily life upside down.

The United States and Europe have embarked on mass vaccinations programmes in the past months, raising hopes of a gradual reopening, although the virus is still in circulation in many regions, with variants causing concern.

Last month, the European Union executive’s President Ursula von der Leyen said protein-based COVID-19 vaccines such as the one developed by Sanofi and GSK offered “quite a potential”, a positive signal as the bloc develops its purchasing strategy for the next two years.

Sanofi’s shot, however, even if approved, will come long after ones from Pfizer/BioNTech and Moderna, which have produced efficacy results of more than 90%.

So far, Sanofi has purchasing agreements with the United States, the EU, Britain and Canada, as well as with the World Health Organization-backed COVAX facility.

The company has pledged to help other drugmakers this year, striking “fill and finish” deals for vaccines made by Pfizer/BioNTech, Moderna and Johnson & Johnson.

In addition to its vaccine project in collaboration with GSK, Sanofi is working on a mRNA candidate with U.S. company Translate Bio for which it has started clinical trials.

 

(Reporting by Matthias Blamont; editing by Louise Heavens and Jason Neely)

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Worldwide coronavirus cases cross 161.42 million, death toll at 3,488,751

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More than 161.42 million people have been reported to be infected by the novel coronavirus globally and 3,488,751​ have died, according to a Reuters tally.

Infections have been reported in more than 210 countries and territories since the first cases were identified in China in December 2019.

Interactive graphic tracking global spread of coronavirus: open https://tmsnrt.rs/2FThSv7 in an external browser.

Eikon users can click  for a case tracker.

The following table lists the top 50 countries by the number of reported cases. A complete list is available with the above links.

COUNTRIES AND TOTAL DEATHS CONFIRMED DEATHS PER

TERRITORIES CASES 10,000

INHABITANTS

United States 584,768 32,926,288 17.9

India 262,317 24,046,809 1.94

Brazil 430,417 15,433,989 20.55

France 107,423 5,848,154 16.04

Turkey 44,301 5,095,390 5.38

Russia 254,590 4,922,901 17.62

United Kingdom 127,668 4,446,824 19.21

Italy 123,927 4,146,722 20.51

Spain 79,339 3,604,799 16.95

Germany 85,903 3,579,871 10.36

Argentina 69,254 3,242,103 15.56

Colombia 79,760 3,067,879 16.06

Poland 71,311 2,849,014 18.78

Iran 76,433 2,732,152 9.34

Mexico 219,901 2,375,115 17.43

Ukraine 47,620 2,143,448 10.67

Peru 65,316 1,873,316 20.02

Indonesia 47,823 1,734,285 1.79

Czech Republic 29,857 1,651,178 28.09

South Africa 55,012 1,605,252 9.52

Netherlands 17,423 1,589,282 10.11

Canada 24,825 1,312,408 6.7

Chile 27,520 1,266,601 14.69

Iraq 15,910 1,134,859 4.14

Philippines 18,958 1,131,467 1.78

Romania 29,413 1,070,605 15.11

Sweden 14,275 1,037,126 14.03

Belgium 24,645 1,026,473 21.56

Pakistan 19,384 873,220 0.91

Portugal 16,999 841,379 16.53

Israel 6,379 839,076 7.18

Hungary 29,041 796,390 29.71

Bangladesh 12,102 779,535 0.75

Jordan 9,203 722,754 9.24

Serbia 6,646 705,185 9.52

Switzerland 10,179 679,510 11.96

Japan 11,396 673,821 0.9

Austria 10,455 635,780 11.83

United Arab Emirates 1,626 543,610 1.69

Lebanon 7,569 534,968 11.05

Morocco 9,091 514,670 2.52

Malaysia 1,822 462,190 0.58

Nepal 4,669 439,658 1.66

Saudi Arabia 7,134 431,432 2.12

Bulgaria 17,194 413,320 24.48

Ecuador 19,442 405,783 11.38

Slovakia 12,168 387,162 22.34

Greece 11,322 373,881 10.55

Belarus 2,681 373,351 2.83

Panama 6,288 369,455 15.05

Source: Reuters tally based on statements from health ministries and government officials

Generated at 10:00 GMT.

 

(Editing by David Clarke)

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