By Lisa Rapaport (Reuters Health) - Drug companies generally don’t disclose all the reasons new medicines fail to win U.S. marketing approval, even though regulators often reject treatments over concerns about safety or effectiveness, a study finds. Researchers compared the details companies made public in press releases with confidential documents from the U.S. Food and Drug Administration known as complete response letters, which explain why a new medicine can’t be sold. Often, companies made no announcement when a drug was rejected, or omitted most of the reasons the FDA cited for denying approval, the study found. “Only a minority of the press releases clearly stated that receipt of a complete response letter meant that marketing could not commence, and most findings associating the drug with a higher mortality rate went unmentioned,” lead study author Dr. Peter Lurie, FDA associate commissioner for public health strategy and analysis, said by email. Lurie and colleagues analyzed 61 complete response letters issued from August 2008 through June 2013, assessing what elements of the letters, if any, companies disclosed in press releases. When multiple letters were issued as part of the same application process, the researchers only included the initial letter from the FDA in the analysis, not subsequent ones issued after companies responded to the original concerns. If, however, companies received separate letters on the same new drug for two different uses, the researchers counted those as separate and included both in their analysis. In 11 instances, or 18 percent of complete response letters, companies didn’t issue any press release, the study found. For 13 releases, none of the statements matched what was said in the complete response letter. About half of the time, the complete response letters cited shortcomings in both safety and effectiveness. Out of 191 concerns about effectiveness raised in the letters, drugmakers disclosed a total of 30 in press releases, while companies shared 22 of 150 safety concerns. Roughly half of the letters asked for new clinical trials to study safety or effectiveness; and in 59 percent of these cases companies disclosed this in a press release. While seven letters reported that drugs had higher mortality rates in treated people compared to those not treated with the medicine, only one press release shared this detail. Publicly-traded companies, which may need to share details on the drug rejection under securities regulations, were more likely to issue press releases about complete response letters. These releases also tended to include more statements that matched points made in the letters. Companies were also more likely to issue press releases when their drug application was for the first in a new family of medicines. Making the full contents of complete response letters public would allow the FDA to increase transparency and combat misconceptions about why regulators refuse approval for new drugs, Lurie said. Doing this would probably require a change in FDA regulations, he added. Public access to these letters would help patients better understand the risks and benefits of medications, particularly when the complete response letters are issued for new uses of previously approved drugs, said Barbara Mintzes, a professor of pharmacy at the University of Sydney and author of an editorial accompanying the study in the journal BMJ. Even though companies aren’t allowed to advertise drugs for unapproved uses in the U.S., doctors are free to prescribe medicines for what’s know as off-label use, Mintzes said by email. “Doctors who are considering prescribing a drug for a specific use would likely reconsider if they knew the FDA had rejected an application for marketing for that specific use,” Mintzes said. “Medicines are important treatments but they are capable of causing harm as well as benefit, and harmful drug reactions are a leading cause of death and hospitalizations,” she said. SOURCE: http://bit.ly/1FbTJ50 BMJ, online June 10, 2015.
Pete Davidson wore a T-shirt with a cryptic message a day after announcing his split from Kim Kardashian
The former "SNL" star was photographed while filming on location in Cairns, Australia, where he appeared to make an interesting fashion statement.
- The Hill
Senate Minority Leader Mitch McConnell (R-Ky.) clinched a victory on Wednesday when the Senate — including 48 of the chamber’s 50 Republicans — voted overwhelmingly to admit Finland and Sweden to NATO. The resolution, which cleared the chamber in a bipartisan 95-1 vote, was a top priority for the Republican leader, who wanted to send a signal…
They were together for nine months.
- The Hill
Sen. Lindsey Graham (R-S.C.) received a warning early Sunday morning to follow the Senate’s decorum rules after he accused Sen. Maggie Hassan (D-N.H.) of being “deceitful” and “dishonest” and vowed “we’re going to call you out.” “This gives phony and cynical a bad name,” Graham exclaimed when Hassan introduced her amendment. Graham’s outburst at Hassan…
- KTLA - Los Angeles
Witnesses looked on with horror after a crash in the Windsor Hills Thursday that was caused by a speeding driver who ran through a red light.
Queen Elizabeth II Reportedly Begged Prince William To Stop a Hobby That Could ‘Threaten the Line of Succession’
While Queen Elizabeth II is okay with many of Prince William’s hobbies, like motorcycles and sailing, there’s one that she “stays up at night” worrying about. And truthfully, we don’t blame her. It’s reported by Daily Mail that the Queen has repeatedly asked William not to fly helicopters, especially to not pilot them himself in […]
GOP strips insulin out-of-pocket cap from bill: ‘Republicans have just gone on the record in favor of expensive insulin’
The bill retains a $35 per month for out-of-pocket insulin co-pays under Medicare even through the GOP successfully removed the cap for private insurance.
- The Hill
CORRECTION: Seven Democrats voted for the GOP amendment that would extend a cap on the SALT tax deduction. A previous version of this story included incorrect information. Maverick Sen. Kyrsten Sinema (D-Ariz.) on Sunday backed a Republican amendment to shield businesses that rely on capital investment from private equity groups from the 15 percent corporate minimum…
The fast-food chain teased its biggest fans on Twitter, but now it has actually brought back a much-requested item.
- Business Insider
Actress Anne Heche crashed her car into a Los Angeles home while the owner was in the backyard. It took 59 firefighters to put out the blaze.
The incident occurred just before 11 a.m. on Friday when Heche crashed into a home in the Mar Vista neighborhood of Los Angeles.
- Associated Press
The Tampa Bay Rays already have 15 players on the injured list. Now pitching coach Kyle Snyder might be on the shelf, too. Snyder injured himself walking toward the mound to visit ace Shane McClanahan during the seventh inning of a 9-1 loss to the Detroit Tigers on Saturday.
- E! News
One day after the news broke that Kim Kardashian and Pete Davidson called it quits, the former SNL star was spotted on set in Australia wearing a t-shirt with an interesting message on it.
- Argus Leader
There were also 25 drug arrests on the rally’s first day.
- Rolling Stone
"If you're going to ask me to have the federal government take over defining marriage, I'm going to say no," the Republican senator said
- The Hill
The Senate voted along party lines Saturday afternoon to advance a sweeping bill to reform the tax code, tackle climate change and lower the cost of prescription drugs, taking a big step closer to giving President Biden a major victory before the November midterm elections. The Senate voted 51-50 to proceed to the 755-page bill, after Vice President…
- KABC – Los Angeles
A woman has been arrested and publicly identified the day after the car she was driving plowed into multiple vehicles at an intersection in Windsor Hills.
Britney Spears is responding to recent claims made by her ex-husband, Kevin Federline.
The Real Housewives of New Jersey couple tied the knot on Saturday in a ceremony filmed for a Bravo special — and PEOPLE has all the exclusive details from inside!
- Ukrayinska Pravda
ROMAN PETRENKO - SUNDAY, 7 AUGUST 2022, 09:23 Russian forces launched a new wave of forced "mobilisation" on the Russian-occupied territories of Donbas on 1 August in order to staff mobilisation reserve units.
Parliamentarian nixes Democrats’ plan to lower drug prices for Americans with private insurance.