Tag: approval

Einride driverless delivery trucks approved for US public roads testing

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Freight technology company Einride announced today that it has received approval from the National Highway Traffic Safety Administration (NHTSA) to operate its Autonomous Electric Transport (AET) vehicles on U.S. public roads. With this approval, Einride will conduct a public road pilot to support operational flows for customer GE Appliances, a Haier company, showcasing the Einride Pod’s purpose-built functionality for future commercialization. The autonomous and electric Einride Pod’s design does not leave room for a driver on board and is instead remotely monitored by a Remote Pod Operator, marking this pilot as an industry first for this new type of vehicle.

The Einride Pod will operate on public roads with mixed traffic while executing real life workflows. This will include the movement of goods and coordinating with teams at various warehouses for loading and unloading. A Remote Pod Operator will be remotely monitoring the vehicle at all times – a first of its kind role that Einride sees critical in safely scaling autonomous vehicles by keeping humans in the loop and creating jobs to fulfill a future way of shipping.

If I wasn’t one of the happiest retired old geezers in northern New Mexico … this is probably the sort of work I’d be waiting in line to get hired for. Just sayin’.

Safety risks found in one-third of drugs approved by the FDA

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❝ Almost a third of drugs cleared by the Food and Drug Administration pose safety risks that are identified only after their approval…

The researchers said the study, which appeared in JAMA, shows the need for ongoing monitoring of new treatments years after they hit the market.

❝ To win FDA approval, medications must be shown to be safe and effective. But many pivotal clinical trials used for approval involve fewer than 1,000 patients with follow-up of six months or less, according to the study. Safety problems often crop up years later after therapies have been used by much larger numbers of patients.

❝ The researchers reviewed 222 products approved between 2001 and 2010 and followed them through February of this year. With 32 percent of the medications, they found, the FDA took some kind of action to deal with safety issues that emerged after approval.

❝ Three of the drugs were withdrawn from the market. The FDA also required 61 new black-box warnings — the agency’s most serious safety alert, included in the drug’s packaging — and issued 59 safety communications to inform doctors and consumers about newly identified concerns. Some products had more than one boxed warning added or safety communication issued over the time of the study.

The median time for an FDA action was 4.2 years after approval…

You, too, can be a beta tester for the FDA. Betting your life on it.

Trump approval rating sets new record – for low

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❝ President Donald Trump’s approval rating is at a new low since he assumed office in January, hitting 37%, 36%, 35%, according to Gallup.

His disapproval rating, at 58% 59%, is at a high point since he became president.

❝ These latest approval ratings come on the heels of a tumultuous week for the Trump administration and congressional Republican leadership, who are working to drum up support for their Affordable Care Act replacement bill…

The proposal, as it currently stands, would most negatively impact senior citizens, rural Americans, and low-income Americans. It would also leave an additional 24 million people uninsured by 2026, according to estimates from the nonpartisan Congressional Budget Office.

❝ A majority of Americans disapprove of Trump’s efforts to repeal and replace Obamacare, according to a Quinnipiac University poll.

The White House has also been playing defense on Trump’s unfounded claim that former president Barack Obama had Trump Tower wiretapped during the 2016 campaign. There has been no evidence to support that theory, according to bipartisan consensus in Congress and in the intelligence community…

The lowest rating of any president’s starting 60 days since I’ve been voting.

Kite Pharma’s gene therapy for cancer shows hopeful results

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❝ An experimental gene therapy that turns a patient’s own blood cells into cancer killers worked in a major study, with more than one-third of very sick lymphoma patients showing no sign of disease six months after a single treatment…

In all, 82 percent of patients had their cancer shrink at least by half at some point in the study.

Its sponsor, California-based Kite Pharma, is racing Novartis AG to become the first to win approval of the treatment, called CAR-T cell therapy, in the United States. It could become the nation’s first approved gene therapy.

❝ A hopeful sign: the number in complete remission at six months — 36 percent — is barely changed from partial results released after three months, suggesting this one-time treatment might give lasting benefits for those who do respond well…

The worry has been how long Kite’s treatment would last; there’s also been concern about its side effects, which…seem manageable in the study. Follow-up beyond six months is still needed to see if the benefit wanes…

The therapy is not without risk. Three of the 101 patients in the study died of causes unrelated to worsening of their cancer, and two of those deaths were deemed due to the treatment.

❝ The treatment involves filtering a patient’s blood to remove key immune system soldiers called T-cells, altering them in the lab to contain a gene that targets cancer, and giving them back intravenously. Doctors call it a “living drug” — permanently altered cells that multiply in the body into an army to fight the disease.

First opportunity for peer review will be at an April meeting of the American Association for Cancer Research. Fascinating stuff. Methodology that holds promise for any number of difficult deadly diseases.

First genetic test submitted by 23andMe approved by the FDA

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A test for Bloom syndrome carrier status, a rare condition seen mainly in Ashkenazi Jews (and uncommon among them as well), was approved by the FDA — remarkable primarily because it’s the first time a direct-to-consumer test for a specific genetic condition has won the agency’s OK.

The decision was also notable because the test will be sold by 23andMe, the company that initially began selling a panoramic health-risk test directly to consumers and was slapped down by the FDA. The agency told the firm that it had to seek formal approval for each and every specific component of the test, with proof that the tests were accurate, that consumers could provide proper samples, and that they could understand the results and their health implications.

Although the FDA was widely criticized for discouraging innovation and preventing people from getting access to their own genomic data, 23andMe promised that it would comply with the agency’s demands.

First out of the box for 23andMe was the carrier status test for Bloom syndrome, which is marked by short stature, extreme sun sensitivity, and increased cancer risk. About one in 107 people of Ashkenazi Jewish ancestry carry the gene, two copies of which are needed to cause the clinical syndrome, according to 23andMe…

Additionally, 23andMe conducted a “user comprehension” study with its results report to confirm that individuals understood them and the implications for family planning decisions.

Good news for everyone interested in easy access to knowledge about their genetic factors particularly as they relate to inherited conditions. Easy – in that you needn’t cave to the medical-industrial complex. Good news especially because it looked from the start that the FDA was out for a classic bureaucratic shutdown of an entreprenuerial challenge to the status quo.

Good science seems to have prevailed. Maybe reason and understanding are next. I hope.

US Special Forces struggle with record rate of suicides

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Click to enlarge – “Have to trust someone to be betrayed. I never did.”

Suicides among U.S. special operations forces, including elite Navy SEALs and Army Rangers, are at record levels, a U.S. military official said on Thursday, citing the effects of more than a decade of “hard combat.”

The number of special operations forces committing suicide has held at record highs for the past two years, said Admiral William McRaven, who leads the Special Operations Command…

It may take a year or more, he said, to assess the effects of sustained combat on special operations units, whose missions range from strikes on militants such as the 2011 SEAL raid that killed al Qaeda chief Osama bin Laden to assisting in humanitarian disasters.

He did not provide data on the suicide rate, which the U.S. military has been battling to lower. In 2012, for example, more active duty servicemen and servicewomen across the U.S. armed forces died by suicide – an estimated 350 – than died in combat, a U.S. defense official said.

That trend appears to have held in 2013 although preliminary data is showing a slight improvement, with 284 suicides among active duty forces in the year to December 15, the official added…

Kim Ruocco, who assists the survivors of military members who commit suicide, said members of the closely knit special operations community often fear that disclosing their symptoms will end their careers.

Additionally, the shrinking size of the U.S. armed forces has put additional pressure on soldiers, whose sense of community and self-identity is often closely tied to their military service, said Ruocco, director of suicide prevention programs for the Tragedy Assistance Program for Survivors, an advocacy group for military families.

It’s my guess that disclosing fear, suicidal tendencies, any questions of survival will absolutely be interpreted as weakness and inability to make “the mission” more important than life itself. Very few military units have ever developed an understanding of human emotions beyond convincing troops that killing folks is more important than anything else.

Scientist gets jail time for falsifying drug test results

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A scientist who faked research data for experimental anti-cancer drugs has been jailed for three months for falsifying test results…Steven Eaton, from Cambridgeshire, has become the first person in the UK to be jailed under scientific safety laws.

Eaton, 47, was working at the Edinburgh branch of US pharmaceutical firm Aptuit in 2009 when he came up with the scam…If it had been successful, cancer patients who took the drug could have been harmed, the court was told…Edinburgh Sheriff Court heard how Eaton had manipulated the results of an experiment so it was deemed successful when it had actually failed.

When bosses at his firm scrutinised his work, they noticed that it was fraudulent.

They stopped work on the project that Eaton was involved in, and reported him to watchdogs at the Medicines and Healthcare Products Regulatory Agency…Investigators there discovered that Eaton had been selectively reporting research data since 2003…

The story emerged after Eaton was convicted last month under legislation called the 1999 Good Laboratory Practice Regulations…Sentence had been deferred so that the court could obtain reports about Eaton’s character.

Sheriff Michael O’Grady said: “I feel that my sentencing powers in this are wholly inadequate. You failed to test the drugs properly – you could have caused cancer patients unquestionable harm…

Almost bemusing to see the long arm of the law come down on an individual crook in the pharmaceuticals industry. The cardinal rule of commerce in drugs and potions designed to extend life, ease and enable the ill is that nothing supersedes profitability.

Certainly, long term balance sheet considerations played a role in this case – as well as the potential for killing off customers. Providing an opportunity for politicians and bureaucrats to pat themselves on the back is always a hit, as well.

Yes, I’m glad to see a corrupt, phony scientist get jail time for his crime. Mail me a penny postcard when there is comparable effort focused on corporate theft from the body politic.

Transcanada Corp. resubmits application for Keystone pipeline

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A Canadian company has reapplied for a permit to build the Keystone XL pipeline that would connect the tar sands oil development in northern Alberta to the U.S. Gulf Coast…

TransCanada Corp. wants a permit for a section of the pipeline that would run from the Canadian border to connect to an existing pipeline in Steele City, Nebraska, according to a State Department statement.

The issue has become a political football in the United States, with Republicans accusing the Obama administration of delaying the project in an election year to placate the environmental lobby.

Top Republicans, including presumptive presidential nominee Mitt Romney, say the issue shows that Obama’s energy policies are harming economic growth…

Which should make it clear who is bought-and-paid for by Big Oil. Right now, the United States is producing more oil than any time in the last 12 years. Right back before the Bush/Cheney farce.

Earlier this year, the State Department, which has authority over permits for international pipelines, rejected TransCanada’s first application because it lacked an alternate route to avoid a vital aquifer in Nebraska.

Last month, TransCanada proposed an alternate route through Nebraska, and state officials say it will take six to nine months to fully review it…This is a state governed by Republicans. Old-fashioned enough to care about water quality.

The American Petroleum Institute, which advocates for the oil industry, called Friday for the government to approve the new permit application without further review…Their say-so should be sufficient, right? Just like trusting them for oil spill security.

Opponents, including environmentalists, say that the pipeline might leak and that it would lock the United States into a particularly dirty form of crude oil that might ultimately end up being exported anyway…Half-right. We have millions of miles of domestic pipelines and leaking is truly rare.

Yes, my understanding is that the petroleum products from this oil are destined for export. So what? That still means jobs and profits made in the USA. I have no beef with increasing our export income. It will provide one more opportunity for Romney and the Republicans to lie about our balance of trade.