January 22 marks the 35th anniversary of legalized abortion in the United States despite all of the facts demonstrating the presence of life at conception. You don't want to miss this powerful commentary! To read more from Frederica on this topic, you will want to pick up Real Choices published by Conciliar Press.

Maikel Franco followed the endless and often mind-numbing speculation the past few months from the Dominican Republic. Franco knows that Manny Machado could show up at Spectrum Field at any moment. The Phillies entertained him at Citizens Bank Park just before Christmas. They have made him at least one contract offer. If the Phillies sign him, Franco also knows he could be traded.

In the lawsuit, the Chicago-based team's parents allege Little League was aware of potential residency issues, "but chose to ignore and/or deliberately conceal these facts in order to garner higher ratings, publicity, and money."

Three national educational funders explain a new program that is highlighting innovative practices in schools around the country.

Title: Young Adults May Be Ignoring High Blood Pressure
Category: Health News
Created: 8/28/2017 12:00:00 AM
Last Editorial Review: 8/29/2017 12:00:00 AM

Results reporting requirements are pretty clear. Maybe critics should re-check their methods?

Ben Goldacre has rather famously described the clinical trial reporting requirements in the Food and Drug Administration Amendments Act of 2007 as a “fake fix” that was being thoroughly “ignored” by the pharmaceutical industry.

Pharma: breaking the law in broad daylight?

He makes this sweeping, unconditional proclamation about the industry and its regulators on the basis of  a single study in the BMJ, blithely ignoring the fact that a) the authors of the study admitted that they could not adequately determine the number of studies that were meeting FDAAA requirements and b) a subsequent FDA review that identified only 15 trials potentially out of compliance, out of a pool of thousands.


Despite the fact that the FDA, which has access to more data, says that only a tiny fraction of studies are potentially noncompliant, Goldacre's frequently repeated claims that the law is being ignored seems to have caught on in the general run of journalistic and academic discussions about FDAAA.

And now there appears to be additional support for the idea that a large percentage of studies are noncompliant with FDAAA results reporting requirements, in the form of a new study in the Journal of Clinical Oncology: "Public Availability of Results of Trials Assessing Cancer Drugs in the United States" by Thi-Anh-Hoa Nguyen, et al.. In it, the authors report even lower levels of FDAAA compliance – a mere 20% of randomized clinical trials met requirements of posting results on clinicaltrials.gov within one year.

Unsurprisingly, the JCO results were immediately picked up and circulated uncritically by the usual suspects.

I have to admit not knowing much about pure academic and cooperative group trial operations, but I do know a lot about industry-run trials – simply put, I find the data as presented in the JCO study impossible to believe. Everyone I work with in pharma trials is painfully aware of the regulatory environment they work in. FDAAA compliance is a given, a no-brainer: large internal legal and compliance teams are everywhere, ensuring that the letter of the law is followed in clinical trial conduct. If anything, pharma sponsors are twitchily over-compliant with these kinds of regulations (for example, most still adhere to 100% verification of source documentation – sending monitors to physically examine every single record of every single enrolled patient - even after the FDA explicitly told them they didn't have to).

I realize that’s anecdotal evidence, but when such behavior is so pervasive, it’s difficult to buy into data that says it’s not happening at all. The idea that all pharmaceutical companies are ignoring a highly visible law that’s been on the books for 6 years is extraordinary. Are they really so brazenly breaking the rules? And is FDA abetting them by disseminating incorrect information?

Those are extraordinary claims, and would seem to require extraordinary evidence. The BMJ study had clear limitations that make its implications entirely unclear. Is the JCO article any better?

Some Issues

In fact, there appear to be at least two major issues that may have seriously compromised the JCO findings:

1. Studies that were certified as being eligible for delayed reporting requirements, but do not have their certification date listed.

The study authors make what I believe to be a completely unwarranted assumption:

In trials for approval of new drugs or approval for a new indication, a certification [permitting delayed results reporting] should be posted within 1 year and should be publicly available.

It’s unclear to me why the authors think the certifications “should be” publicly available. In re-reading FDAAA section 801, I don’t see any reference to that being a requirement. I suppose I could have missed it, but the authors provide a citation to a page that clearly does not list any such requirement.

But their methodology assumes that all trials that have a certification will have it posted:

If no results were posted at ClinicalTrials.gov, we determined whether the responsible party submitted a certification. In this case, we recorded the date of submission of the certification to ClinicalTrials.gov.

If a sponsor gets approval from FDA to delay reporting (as is routine for all drugs that are either not approved for any indication, or being studied for a new indication – i.e., the overwhelming majority of pharma drug trials), but doesn't post that approval on the registry, the JCO authors deem that trial “noncompliant”. This is not warranted: the company may have simply chosen not to post the certification despite being entirely FDAAA compliant.

2. Studies that were previously certified for delayed reporting and subsequently reported results

It is hard to tell how the authors treated this rather-substantial category of trials. If a trial was certified for delayed results reporting, but then subsequently published results, the certification date becomes difficult to find. Indeed, it appears in the case where there were results, the authors simply looked at the time from study completion to results posting. In effect, this would re-classify almost every single one of these trials from compliant to non-compliant. Consider this example trial:

• Phase 3 trial completes January 2010
• Certification of delayed results obtained December 2010 (compliant)
• FDA approval June 2013
• Results posted July 2013 (compliant)

In looking at the JCO paper's methods section, it really appears that this trial would be classified as reporting results 3.5 years after completion, and therefore be considered noncompliant with FDAAA. In fact, this trial is entirely kosher, and would be extremely typical for many phase 2 and 3 trials in industry.

Time for Some Data Transparency

The above two concerns may, in fact, be non-issues. They certainly appear to be implied in the JCO paper, but the wording isn't terribly detailed and could easily be giving me the wrong impression.

However, if either or both of these issues are real, they may affect the vast majority of "noncompliant" trials in this study. Given the fact that most clinical trials are either looking at new drugs, or looking at new indications for new drugs, these two issues may entirely explain the gap between the JCO study and the unequivocal FDA statements that contradict it.

I hope that, given the importance of transparency in research, the authors will be willing to post their data set publicly so that others can review their assumptions and independently verify their conclusions. It would be more than a bit ironic otherwise.
Thi-Anh-Hoa Nguyen, Agnes Dechartres, Soraya Belgherbi, and Philippe Ravaud (2013). Public Availability of Results of Trials Assessing Cancer Drugs in the United States JOURNAL OF CLINICAL ONCOLOGY DOI: 10.1200/JCO.2012.46.9577

Uorfi re-shared the note on her Instagram Stories and wrote, "PETA India is a scam! Unless you're famous and they know they can get publicity out of you, they don't care. Bunch of hypocrites."

The revival of agricultural growth from its long-term slump requires imaginative policy shifts and decisive fiscal measures, but the Budget provides no indications of such a plan or intent

A study by AdRoll and Priceonomics breaks down which cities and states are most and least likely to click.

The group of senior Ministers and security officials was due to meet on Thursday but did not, meaning a full NSC meeting has not been convened since February.

The group of senior Ministers and security officials was due to meet on Thursday but did not, meaning a full NSC meeting has not been convened since February.

Floods are devastating natural hazards, which can cause loss of life and substantial damage to buildings and other infrastructure. Assessing future flood risk is complicated by the influence of climate change, land-use change and economic development in an area. A study on an Alpine valley suggests that land- use change and urbanisation will affect future flood risk by 2030 more than climate change, but risks can be reduced by adopting low-cost adaptation strategies, such as building restrictions in flood-prone areas and residents taking their own precautions against flooding.

In its Week in Review video, a USDA rep says it’s OK to eat that dry pasta several months past its sell-by date.

Studies reveal what cat owners have suspected all along: Your cat hears you when you call — he just chooses not to respond.

The screenshot above is my Google traffic over the last 12 months. As you can see, my traffic is growing. And there are many reasons for that, but there is one trend that’s really caused the majority of my SEO growth. You might be thinking it is Ubersuggest because it makes up 22.4% of my […]

The post The Biggest SEO Trend You’re Ignoring appeared first on Neil Patel.

South West farmers accuse Deputy Prime Minister Barnaby Joyce of knocking back Wellington Dam desalination funding in favour of cash splashes in the east.

With American flags and Trump banners waving, angry citizens are taking to the streets to protest stay-at-home edicts.

Vladimir Putin and Russia played it safe for their Victory Day parade, but Belarus.

In the lawsuit, the Chicago-based team's parents allege Little League was aware of potential residency issues, "but chose to ignore and/or deliberately conceal these facts in order to garner higher ratings, publicity, and money."

Three national educational funders explain a new program that is highlighting innovative practices in schools around the country.

Thunberg has become a leading voice for action on climate change, inspiring millions of students to join protests around the world.

Bank of England governor warns of financial collapse linked to climate emergency

• Top asset managers oversee $300bn fossil fuel investments
• Why are asset managers investing in fossil fuel companies?

Companies and industries that are not moving towards zero-carbon emissions will be punished by investors and go bankrupt, the governor of the Bank of England has warned.

Mark Carney also told the Guardian it was possible that the global transition needed to tackle the climate crisis could result in an abrupt financial collapse. He said the longer action to reverse emissions was delayed, the more the risk of collapse would grow.

Continue reading...

US vice president was condemned for ignoring strict rules about protective gear put in place to slow the spread of coronavirus

TV chef is said to have been seen 'multiple times in several places'

Pfizer and partner BioNTech are right in the middle of one of the most important vaccine trials in the world right now, but that doesn’t mean the Big Pharma is taking its eyes off the inoculation ball elsewhere.

Kimi Raikkonen says that any negative comments about his return to Formula One have "no effect" on him

Vali Nasr says that President Obama has resisted American involvement in Syria because it challenges a central aim of his foreign policy: shrinking the U.S. footprint in the Middle East and downplaying the region’s importance to global politics. Nasr examines why doing more on Syria would reverse the U.S. retreat from the region.

Giving out money revealed something that flew in the face of a common American philosophy.

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A 40-year-old man allegedly attacked his wife with a chopper after he felt she was giving more importance to watching a show, 'Pakistani Drama', on her mobile phone than speaking to him, police said on Tuesday.

The accused, Asif Sattar Nayab, has a business of installing hoardings and stays with his family in the Salisbury Park area, they said. Nayab was arrested by the Swargate police and booked for attempt to murder after his wife registered a complaint against him on Monday evening, the police said. According to the police, the couple had a quarrel on Monday morning.

"The woman had sent her son to bring milk from a shop but when she found that the milk pouch was damaged and some milk had spilled over, she started scolding him. "Listening her voice, Asif intervened, which led to a heated argument between the couple," said a senior officer from the Swargate police station. The woman, in her complaint, said the quarrel escalated in the evening when Nayab came home and found she was not speaking to him, he said.

"When Asif came home from work, his wife went to the bedroom. When he went to the bedroom to speak to her, she kept watching a show named 'Pakistani Drama' on her mobile. "Asif felt she was ignoring him and giving more importance to the show on her mobile phone. Felt ignored, Asif attacked her with a chopper (a knife-like tool) in which her right hand's thumb broke," the officer said.

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The flashy car, an eco-friendly hybrid BMW i8, patrolled the roads near the Met's headquarters yesterday as part of the police's efforts to prove it is obeying the city's new Ultra Low Emission Zone.

Royal fans accused Prince William, 37, and Kate Middleton, 38, of 'ignoring' Meghan Markle, 38, and Prince Harry, 35, as they attended the Commonwealth Service today.

Jennifer Lawrence is upset with Amy Schumer's parenting schedule. She asked the comedian questions about The Handmaid's Tale via text and Amy was too busy with her son to answer.

Images have emerged of large crowds at the Jan Powers Powerhouse Farmers' Markets in Brisbane on Saturday morning.

At a recent public hearing for the Parsa Coal Block in Chhattisgarh, citizens likely to be affected by mining there raised several concerns. However, much of it has been completely ignored in the official record of minutes, reports Kanchi Kohli.

Effective district-level bodies could have played a critical role in ensuring legal environmental protection for coastal zones and communities. Manju Menon, Kanchi Kohli and Meenakshi Kapoor discuss how these have been continuously disregarded. 

Earlier this week that the state government opened a website and by now 3.98 lakh Keralites in 201 countries, and 1.38 lakh Keralaites within the country have registered from various states, wanting to return.

BJP Tuesday accused Bihar Chief Minister Nitish Kumar of not providing adequate security for Narendra Modi''s Hunkar Rally.

This week, how Flickr photos could help predict floods, why it might be a good idea to ignore some cyberattacks, and new questions about the existence of human pheromones with Online News Editor David Grimm. And Sarah Richardson joins Alexa Billow to discuss a global project to build a set of working yeast chromosomes from the ground up. Read Sarah Richardson’s research in Science. Listen to previous podcasts.   Download the show transcript. Transcripts courtesy of Scribie.com. [Image: Drew Gurian; Music: Jeffrey Cook]