Oct 14 (Reuters) - U.S. Food and Drug Administration staff recommended that Pfizer Inc keep a severe warning on its controversial quit-smoking drug Chantix.
Approved in 2006, Chantix has been one of Pfizer's most controversial drugs, after severe side effects including suicidal thoughts, erratic behavior and drowsiness came to light in 2007.
The FDA placed a black box warning on the product in 2009, warning users of the neuropsychological effects. A black box warning is the most severe and most restrictive kind of warning on a product.
The FDA staff said on Tuesday observational post-marketing studies submitted by the company "had a number of study design limitations." (1.usa.gov/1CgJYlM)
The document said the studies did not cover the full range of the neuropsychiatric adverse events seen in postmarketing adverse event reports associated with varenicline, which is sold as Chantix.
"These limitations may underestimate the actual incidence of neuropsychiatric adverse events...associated with varenicline," the FDA said.
A panel of FDA staff and experts will vote on the recommendations on Oct. 16.
WASHINGTON – The Food and Drug Administration will ask a panel of experts later this week whether a bold-letter warning on the anti-smoking drug Chantix should be removed based on company-supported evidence that the drug does not cause suicidal behavior.
Pfizer's twice-a-day tablet has carried the FDA strongest warning label, known as a black box, since 2009 because of reports of suicidality, hostility and depression. But the New York drugmaker points to recent studies and analyses suggesting there is no difference in psychiatric problems between people taking Chantix and other smoking-cessation aids.
Still, the FDA notes in briefing documents posted online that there is little precedent for removing a boxed warning. And the agency will ask its panel of outside efforts whether more data is needed before consider removing the warning language.
After sending out a cryptic Tweet last week ("About time to unveil the D and something else") that had electric car fans lighting up Tesla forums from San Francisco to Stockholm, the billionaire tech giant Elon Musk took to the stage at Hawthorne Airport Thursday night — a stone's throw from SpaceX headquarters and Tesla's design studio — to detail his brand's newest engineering feat.
As we now know, the "D" stands for a new dual-motor version of the currently rear-wheel-drive-only Model S that will start being delivered to customers starting this December. Officially called the Model S P85D, the new vehicle includes a second electric motor that drives the front wheels, which eliminates the need for a front-to-rear driveshaft, leaving the vehicle floor flat while continuing to offer maximum interior space. It remains to be seen, however, how much front trunk space is lost to the second motor (by nature of being an electric car (translation: no engine), Tesla owners have come to resoundingly love their dual trunks).
Those concerned with any sacrifice of range or blinding acceleration need not fret. The top-of-the-line P85D, thanks to the coupling of two motors, sees a maximum driving range bumped up from 265 to 275 miles (225 and 295 for the 60D and 85D, respectively). What's more, thanks to the addition of AWD traction, 0 to 60 mph is reached in 3.2 seconds — one second quicker than the current P85+ RWD) and horsepower is increased by 221 to a blistering 691.
Naturally, none of this will come cheap. The P85D will set you back $120,170 and will be the first to be delivered, starting December. In February, AWD versions of both a 60 kWh model (60D) and standard 80 kWh (80D) will be available for a $4,000 bump in their respective prices.
Musk also revealed Tesla will be adding a number of autonomous safety features with the Tesla vehicles that start delivering in two months, including improvements on the standard lane departure warning — flick the turn signal and the Tesla will automatically change lanes (safely) — as well as adding the ability for the forward-facing camera to read speed limit signs and automatically adjust acceleration (if you allow it).
What's more, new Tesla models will feature a self-parking asset that utilizes ultrasonic sensors to park itself —...
Tesla's Model S P85D delivered the predicted level of performance, and little more.
With Model X deliveries delayed until summer 2015, this is Tesla's desperate attempt to have AWD available for ski season.
Tesla (and Chairman Elon Musk) may face huge buyback liability as 2WD Model S cars glut market when high-end Tesla owners switch to the P85D.
Tesla (NASDAQ:TSLA) product development is a lot like the mating of elephants. It goes on at a high level, is accompanied by a great deal of roaring and screaming, and it takes two years to produce a result. And this evening concluded the latest gestation. We are finally offered an AWD Model S.
The AWD P85D is a spectacularly efficient vehicle. It still carries seven passengers like the RWD version, and it is still nearly twice as efficient as a Prius. In fact the AWD Model S delivers even more range than the RWD drive version. (Those ICE car companies whose AWD models get worse mileage than their two wheel drive cousins should note how things are done in Silicon Valley.)
Then there is the performance. Tesla's AWD, 4-door, seven passenger sedan is quicker to 60 than any other car with four doors. Period. Of all the street legal cars from GM, Ford, Chrysler, Mercedes, BMW, Honda, Toyota, Hyundai, or Tata, only the Corvette C7 is quicker. By 1/4 of a second. This is great, but is it news?
The problem for Tesla isn't the car, it's the announcement itself. There simply is not much new or unexpected here. Aside from the slight increase in range, the performance of an AWD Model S has been anticipated for years. And the driver-assist features, while cleverly presented, are in line with what other luxury cars are offering.
It would have been better to see a production of Model X. The Tesla SUV has slipped again and again, and is now promised for next summer. Tesla had to do something for the coming ski season. We have already been through one winter where Tesla owners were shunted aside at "chain control" on the way to the slopes whilst their peers were whisked past in their AWD Mercedes, Audis, Panameras, and even Escalades. Tesla's reputation demanded something be done.
The AWD P85D is Tesla's desperation attempt to preserve the honor, prestige and proper station of Tesla owners facing the travails of winter. It is good they have done something, but too bad they were unable to do more. At the same time, Tesla may have done too much and be facing dangerous...
South Korea, 8 – The captain in charge of the Sewol ferry when it sank told a South Korean court Wednesday that he “deserved the death penalty” but denied sacrificing passenger’s lives to save his own.
Lee Joon-Seok, on trial for murder in the city of Gwangju, was vilified after the April disaster for abandoning the stricken ferry while hundreds were still trapped inside.
More than 300 people perished, most of them school children in a tragedy that stunned South Korea.
The captain and many crew members were among the first to climb onto rescue boats.
Video footage taken from the phones of those who perished showed increasingly worried students patiently waiting in their bunks as messages were broadcast over the ship’s tannoy telling them to stay where they were despite the ferry listing heavily.
But Lee said his passenger evacuation orders had fallen on deaf ears and denied accusations by the prosecution that he sacrificed the lives of his passengers to save himself.
“I sincerely apologise to the victims and their relatives and I will pray for them for the rest of my life”, Lee said at his trial, according to Yonhap news agency.
“I think I deserve a death penalty for what I have done. But I never thought for a moment to sacrifice the passengers (to save my own life)”.
“No matter how God helps me, I know I won’t be able to leave the prison before I die. But I cannot give my children and grandchildren a bad name as a murderer’s relatives”, Lee added.
He insisted he had told a crew member to broadcast a passenger announcement that passengers should wear life jackets and jump into the sea, around five minutes before the first rescue boat arrived.
The message was never relayed, he added. But Lee he was unable to provide any evidence that he issued this instruction.
The disaster caused outrage in South Korea, knocking the entire country off its stride and triggering widespread public anger as it emerged that incompetence, corruption and greed had all contributed to the tragedy.
– Captain blames ship owners -
Lee has insisted that the ferry owners are the real culprits of the disaster as it was their decision to consistently overload the vessel and commission an illegal redesign.
His murder prosecution comes as the son of the ferry’s owner also faces a separate trial for embezzlement.
Prosecutors on Wednesday called for four years in prison for Yoo Dae-Kyun, the eldest...
The captain of the ill-fated South Korean ferry that capsized in April killing more than 300 people told a courtroom this week he was “confused and not in his normal state of mind” when the accident occurred.
Lee Joon-seok made the claim repeatedly during his trial in the South Korean city of Gwangju, where he is on trial and charged with negligent homicide, reports the BBC.
Lee says he ordered the vessel to be abandoned but his command was not followed by crew members; however, prosecutors claim this contradicts an earlier statement the captain made to police, the BBC says.
Most of the passengers killed when Sewol capsized, en route to the resort island of Jeju in April 16, were high school students participating in a field trip. The public and politicians alike have lambasted the captain for abandoning his ship while hundreds remained aboard.
Days after the ferry capsized, South Korea’s President Park Geun-hyesaid the captain and his crew’s actions were “unforgivable” and “murderous.”