It was an unprofessional attack that seemed to be a personal vendetta rather than a scientific discourse.
"sorry you had to sit through this" to the panel ? ARNA is trying very hard to improve quality of life for obese people, and the product does work to some degree with no adverse reactions to speak of for the people in the study. It actually lowered cholesterol. And yes, massive 80x doses cause problems in some rats.
That is no reason to sink into the mud and get combative and insulting doing whatever you can to drum up emotional hate in front of the panel.
There is more to this whole thing. It is disturbing that the FDA cannot at least display some level of professionalism and stick to the facts without adding in a bunch of unnecessary drama and Jerry Springer like attitudes. If they want to reject it for whatever reason then just reject it, no reason to add insult to injury. The reality is the company and the investor who backed have good intentions, and there is no evidence that this is bad product. The majority of drugs the FDA has approved have very nasty side effects.
I know why he most likely hates ARNA. Its because he sees this horribly run company being backed by investors who have no clue and are only in it to make a quick buck off its stock. Also, he prob wants fat people to lose weight the healthy way, not by shocing magic pills down their mouths and also risking serious safety issues.
By the way, Eric Colman appeared on the CNBC special of "One Nation Overweight" which focused on VVUS' QNEXA.
He was the FDA spokesman who said the FDA was pressured to pass obesity drugs. Pressured by whom??? Also, I wonder how Colman got "picked" by CNBC for the show. Did VVUS recommend Colman to CNBC??
Here's the featured cast from CNBC: "
""One Nation Overweight" Featuring: Henry Butler, Dr. Philip Schauer, Ken Thorpe, Gene Kotulka, Doreese Licari, Dr. David Ludwig, Scott Faber, Michelle Obama, Patrick Doyle, John Danner, Meg Evans, Dr. Michelle Look, Leland Wilson, Eric Coleman, Chris Dickerson, Dr. Donna Ryan, George Chay, Bill Weldon, Delos "Toby" Cosgrove, Harold Schmidt, Dr. James Levine"
HIGHLY, HIGHLY likely Coleman was paid off by hedge funds. They had their money on VVUS approval but when Coleman could not sway that panel in favor and the stock tanked about 50% Coleman had to make it up to his hedge fund masters... and he did so by taking down Arena.
I'm not expert but I have a very high IQ, I have a Master's Degree and to me it is very obvious that the guy is on the take and not serving the true interests of the American Public. He needs to be investigated and ultimately be forced off. He's acting like he is the law and he thinks he can get away with anything.
I am hoping the rest of the FDA is honest and does what is right based on the data, maybe a few are still not corrupt.
I believe Dr. White was the one who was arguing with Mr. Coleman regarding rat issue.
The fact that Mr. Lief left panel before it was ended has given me that he ( and others ) had been realizing what was happening.
Even Adam from Street mentioned during his live session that is seemed that Mr. Coleman looks upset that he has only one vote.
But he achieved his agenda.
I wonder what Lief and other management people at ARNA are assessing at this point.
That could be one of several good points that could be made with the FDA. Adam F notices something wrong. He could be a somewhat "neutral" party in the eyes of the FDA and his observation worth more than a common share holder. Although he has been very critical of some drugs in the past.
Maybe its because he used to be fat, but then lost the fat because he did the hard work and exercised and followed a good diet - and he doesnt want other fatties to get a quick fix for the fattness and he wants them to lose it by a good diet + exercise plan
yup you are correct...
The first new prescription weight-loss pill in more than a decade failed to win backing from U.S. health advisers, who said safety concerns about the drug outweighed its ability to help obese patients shed pounds.
Shares of Vivus Inc’s sank 62 percent on Thursday after U.S. Food and Drug Administration advisers expressed concern the once-a-day pill could cause depression, memory-loss and potential birth defects if used among millions of overweight or obese Americans.
Their decision stunned investors, who had more than doubled the share price of the California biotech in the last year on hopes that safety woes would not keep the drug from market.
An FDA official was also surprised.
“When you listen to even the no votes, you got the sense that a lot of people, they weren’t strongly against the drug,” said Eric Colman, deputy director of FDA’s division that oversees such drugs.
Shares of rival fat-pill hopefuls, Arena Pharmaceuticals Inc and Orexigen Therapeutics Inc, also sank after the vote.
Approving the drug would be “a huge public health experiment,” said panelist Elaine Morrato of the University of Colorado, one of the 10 panelists who urged against FDA approval. Six others supported the drug, called Qnexa.
The FDA will weigh the vote before making its final decision and usually follows its panelists’ advice.
The panel’s rejection is a blow to Vivus, which has not had a U.S. product approved since 1996.
Cowen and Co analyst Ian Sanderson said it was possible for Vivus to eventually win U.S. approval, but it would first have to test it in as many as 10,000 patients, at a potential cost of $150 million.
“They’d need a partner,” Sanderson said.
The California biotechnology company is seeking the FDA’s green light with the hope of beating Arena and Orexigen’s rival diet drugs to market.
It told FDA’s outside experts that Qnexa helped many patients shed 35 to 40 pounds and that its risks were not major.
There is little doubt the drug works, panelists said, but potential side effects such as depression, memory loss, increased heart rate and birth defects were a top worry.
“This medication, in term of efficacy, is far superior than anything that’s on the market. The concerns we have are with safety,” said Dr. Abraham Thomas of Henry Ford Hospital in Detroit.
Panelists were also concerned since patients may take Qnexa for years, but Vivus’ data only covered about 12 months.
Nearly 70 percent of people in the United States are overweight, and more than a third of them are obese, government statistics show.
“It’s like instant willpower,” said Erin Aycock, a clinical trial patient who lost 50 pounds on the drug but later regained most of it. “I would do anything to be back on this drug.”
In a statement after the meeting, Vivus said the panel’s vote was disappointing. The company had been expecting FDA’s approval decision by October 28.
Vivus has said it expects data from a longer, 2-year study by the end of this quarter.
Shares of Arena closed down 8.4 percent after the vote, reversing earlier gains. Orexigen closed 10 percent lower. Vivus shares were halted during regular trading on Thursday but fell heavily as they reopened in after-hours trade.
Some analysts saw hope for Arena’s candidate, lorcaserin, which tentatively faces FDA’s advisers September 16 and has 2-year data. Orexigen’s FDA panel is expected December 7.
His mind and his money. He must have an investment or a job lined up with VVUS. He is in love with them and hates everyone else. I am sure if you looked into it you could find a financial connection. Too much money at stake here, they did not want ARNA to get a big jump start on Qnexa that is easy to see.
His use of the prejuciail language "by a slim margin" and his amnesia concerning the Lorcaserin tumor data in monkeys speaks to a high level of disappointment that VVUS did not get recommended. It suggests he had something more at stake on the VVUS decision, but I would quickly add that FDA would instantly fire him if that was ever discovered.
That is the only reasonable explanation.
He feels bad about the drug he like with side effects being shot down, so he figures he will try and convince everyone that the drug most people thought was safe is just as bad or maybe even worse.
Kind of childish, but that is probably what happened.