#( since she's seen the reports and KNOWS that the evidence provided is inconclusive...and that's no reason to slap 'it was an accident' )

[kamipyre]

@rippleofwords sent in: talk about hyuk || the paper machine's gossip session ( ft. talk about meme )

send “talk about-” and a name for my muse to talk about that person!

embers verse:

“…He reminds me of my old colleagues.” Not that he’s actually heard her talk about them, save for, maybe Edgeworth. It’s okay- he doesn’t really talk much about his colleagues back in Seoul anyways. Maybe she wants to keep it that way since well, even if the corruption is weeded out of the LAPD, they’ll never be able to go back to the way things were before. Detective Lee ( @jeoseungsaja ) might be able to do in Seoul, but not hers. Deft fingers press along the fold. “They have a better sense of humor than he does, but he has a similar drive.” The exacting drive demanding nothing more and nothing less than the truth. The recklessness and sheer force to get the desired results. The hardheadedness. She sees them all in Detective Lee, the ghost of friends long gone, never to return…or maybe their spirit, the true nature of the LAPD,  is simply being passed down from one generation to the next. Either way, she makes another fold. This one is going to be a pigeon. “Is he done with questioning Mister Trevor?” That’s the parrot the court is bringing in as a witness for next week’s trial. “He said he had more PAPER for me!”

black knight verse:

 “I deserve a pay raise.” Not that her current salary is terrible- actually, it might be more affordable, living in Seoul rather than in LA. At the very least, she doesn’t need to give up half of her paycheck to cover rent…although then again, it can’t be traditional, living in her current boss’s apartment. One may say it’s even unprofessional…and she might agree if not for the fact that he’s hardly ever in there to begin with. The couch in the office is his actual bed these days. “No one told me I was going to have two jobs while I was here- he needs to find something to do outside of his job. At the rate he’s going, I’ll surprised if he makes it to the end of the year-“ Not that, mind you, she’s going to let him deteriorate to that point. Jae Hwan won’t let that happen either, but it doesn’t change that Lee is barreling in that direction and there’s so much either of them can do to slow his descent. And the quickest way to do that is get to the bottom of the case- if only pleasing him was as simple as pleasing the Pigeon Man…all that guy needs is a bag of seeds and the pigeons. Nevertheless, her eyes soften as she sets her folded report on the desk. “…It’s not like the truth is going to change anything.” But he’s going to go for it anyways, won’t he? Find out the full story or die trying. She doesn’t know the whole story behind this all-consuming desire, no one does and Lee isn’t planning on changing that but…

“I want answers.” Not only to figure out the irritating conundrum of the case, but also set Lee’s ghosts to rest. It’s hard to live one’s own life, when the ghosts of those beloved have not been properly buried.

She would know that BETTER than anyone else.  

[didanawisgi]

U.S. still hasn't ruled out lab accident origin for Covid because China hasn't been transparent. U.S. officials haven't shown any evidence pointing to a lab escape, and scientists call the scenario unlikely. The U.S. wants China to share information.

By Ken Dilanian, Carol E. Lee and Keir Simmons

“WASHINGTON — Despite a finding by the World Health Organization that the Covid-19 outbreak in China most likely first infected humans through an animal host, the United States is still not ruling out the possibility of a laboratory accident, as officials continue to sort through intelligence about the Chinese government’s initial handling of the outbreak, American and Western officials told NBC News.

A spokesman for the Office of the Director of National Intelligence told NBC News the agency is standing by a public statement it issued in April, which said that American intelligence agencies "will continue to rigorously examine emerging information and intelligence to determine whether the outbreak began through contact with infected animals or if it was the result of an accident at a laboratory in Wuhan."

U.S. officials have not made public any evidence pointing to a lab accident, and most scientists who have studied the matter said that such a scenario is unlikely. But Biden administration officials have faulted China in recent days for what they have termed a lack of transparency around the origins of the virus. And they have criticized how the WHO last week presented the initial findings of a visit to Wuhan, where the virus is believed to have emerged.

WHO investigators, after visiting three labs in Wuhan, said last week they found no signs that a lab accident could have caused the outbreak. One WHO researcher told reporters at a news conference the organization was halting any further inquiry into that theory.

But the director general of the WHO appeared to walk back that definitive statement a few days later, saying that "all hypotheses remain open and require further analysis and study."

A Western intelligence official who has seen classified material told NBC News the U.S. has substantial intelligence that has not been made public about actions the Chinese government took — related to the Wuhan lab and other issues — that were designed to obscure the origins of Covid-19 and conceal its early impact. A former U.S. official who has also seen the intelligence agreed that it was significant, if inconclusive.

Both sources said the material, which they did not detail, did not add up to evidence that a lab accident occurred. But they said it raised enough circumstantial questions that analysts have been unable to rule out the lab scenario. U.S. intelligence officials declined to comment.

The intelligence, which includes documents, paints a picture of a Chinese government initially trying to hide the burgeoning pandemic from the outside world.

"There is no doubt that, especially when Covid-19 first hit but even today, China is falling far short of the mark when it comes to providing the information necessary to the international community," Secretary of State Anthony Blinken told NBC's Andrea Mitchell this month. "All of the — that lack of transparency, that lack of being forthcoming, is a profound problem and it's one that continues."

The lab theory

The so-called lab theory refers to a hypothesis that the Covid outbreak emerged in Wuhan as a result of an accidental release from one of the labs working with coronaviruses in that city — perhaps from an improper disposal of lab waste or an employee who got infected at work and then infected others.

U.S. intelligence agencies and scientists say they have ruled out that Covid-19 was human-made or intentionally released. The lab theory hypothesizes an accidental release of a virus found in nature by researchers and brought in for study.

Download the NBC News app for full coverage of the coronavirus outbreak

Scientists say that scenario is unlikely on its face, because animal-to-human transmission of viruses are common, while lab accidents are relatively rare. The key scientists studying viruses in Wuhan say they were not studying the Covid-19 virus, which had not been previously documented in nature before the outbreak.

Intelligence officials counter that one key lab, the Wuhan Institute of Virology, removed from public view a database of 22,000 virus samples for security reasons, and has not allowed a detailed look at the lab's notes or other records.

They say it's suspicious that the virus outbreak arose in Wuhan, a hub of virus research in China, while the bats that commonly carry coronaviruses are typically found in caves a thousand miles from that city.

They note that scientists also have not found a host animal that could have transferred the virus to humans, after a year of looking.

WHO researchers acknowledged last week that the "wet" or live-animal market in Wuhan, which was originally thought to be a likely source of the outbreak, may not be the whole story, since early cases have been identified in people who had no connection to the market.

The WHO team included international and Chinese scientists. They say their summary report will be published within weeks.

One member of the team, Australian microbiologist and infectious diseases expert Dominic Dwyer, told NBC News that the scientists didn't get all the data they sought from the Chinese government, and that team members disagreed about various aspects of what they saw and heard.

"There were tense moments and disagreements and, you know, arguments about what things meant and so on, between both sides," Dwyer said. "And some of that is just because the data isn't strong enough to give a single, a great conclusion."

Dwyer says the team was given "aggregated data," as opposed to detailed, line-by-line case information, for the 174 known Covid cases from Wuhan in December.

Case information would enable researchers, he said, to "go along to a person who had this disease and say, OK, you know, how old are you? You know, what sort of work do you do? Who's in your family? What do you do for your hobbies? You know, do you go to the market? What sort of market do you go to, you know, what's your general health, like, all of those sorts of things to try and understand where a person had been, and where they could have been exposed to something."

Several members of the WHO team told NBC News they were provided with just 13 DNA sequences from the 174 cases. Of those, five had small genomic differences, suggesting a wider pool of virus, Dwyer said, though the sample was so small it was hard to draw conclusions.

"Actual infections is probably much higher than the 174," Dwyer said.

WHO investigators tasked Chinese researchers with surveying the wider community, he added.

According to Dwyer, the Chinese researchers said they examined the cases of 76,000 people presenting with fever or pneumonia from Oct. 1 to Dec. 31, 2019, and found 92 people with Covid-like symptoms. Of these, they tested 67 people, Dwyer said, and found no Covid-19 antibodies.

Those tests were carried out in January 2021, more than a year after the potential exposure. Scientists don't yet know how long Covid-19 antibodies remain in the body after infection.

Pompeo and the lab theory

The Trump administration, and in particular, then-Secretary of State Mike Pompeo, repeatedly said there was significant evidence in support of the lab theory.

On Jan. 15, five days before the end of the Trump administration, the State Department published a "fact sheet" making a series of allegations about the Wuhan Institute of Virology laboratory.

Among them: "The U.S. government has reason to believe that several researchers inside the WIV became sick in autumn 2019, before the first identified case of the outbreak, with symptoms consistent with both COVID-19 and common seasonal illnesses. This raises questions about the credibility of WIV senior researcher Shi Zhengli's public claim that there was 'zero infection' among the WIV's staff and students of SARS-CoV-2 or SARS-related viruses."

The fact sheet added, "Despite the WIV presenting itself as a civilian institution, the United States has determined that the WIV has collaborated on publications and secret projects with China's military. The WIV has engaged in classified research, including laboratory animal experiments, on behalf of the Chinese military since at least 2017."

One former official familiar with the intelligence on which Pompeo's statement is based said it was less than rock solid, and that some officials were surprised that the secretary aired it publicly. Pompeo did not respond to requests for comment made through his spokesman.

Dwyer told NBC News the WHO team inquired about the testing of researchers at the WIV lab and was told that there were standard tests of all staff in April 2019 and then again in 2020. They were told those tests were negative. But it's not clear when the 2020 tests were carried out, again raising questions about whether Coronavirus would be detected. The head of the Wuhan Institute of Virology Dr. Shi wrote on July 31, nine months after October 2019, that she "recently" tested all WIV employees and they were negative.

"I think the jury's still out," State Department spokesman Ned Price said last week about the origins of Covid-19. "Clearly the Chinese, at least heretofore, have not offered the requisite transparency that we need."”

[sciencespies]

A better pregnancy test for whales

https://sciencespies.com/biology/a-better-pregnancy-test-for-whales/

A better pregnancy test for whales

Humpback Whale Breaching. Credit: Sally Mizroch (NOAA)

It’s not easy to do pregnancy tests on whales. You can’t just ask a wild ocean animal that’s the size of a school bus to pee on a little stick. For decades, the only way scientists could count pregnant females was by sight and best guesses based on visual characteristics. For the last several years, researchers have relied on hormone tests of blubber collected via darts, but the results were often inconclusive (not negative or positive), and researchers couldn’t confidently say if the animal was pregnant or just ovulating.

Research from the National Institute of Standards and Technology (NIST) and Australia’s Griffith University points to a weakness of that testing and provides a new method for hormone testing that offers better results.

“Previous tests only looked at progesterone in blubber samples,” said Ashley Boggs, a research biologist at NIST who helped to develop the new tests. “We found that androgens, and especially androstenedione in combination with progesterone, are much more likely to be a reliable marker of pregnancy.”

Being able to determine whale pregnancy is important because it offers insight into the health of a population. Whales are sensitive to changes in their environment and can serve as early warning signals that something is amiss, including details about the health of the food web, the impact of ocean noise, and the levels of contaminant exposures. The Marine Mammal Protection Act was enacted in 1972 to protect whales, and since that time stock assessments and protections have been carried out by the National Oceanic and Atmospheric Administration (NOAA), including data on pregnancies. That’s why NOAA came to NIST to try to advance hormone measurement technology for marine mammals.

In recent years, humpback whale numbers have increased dramatically in many places, although they are still considered endangered. The animals’ large size makes it difficult to count or study them using traditional identification methods. Like most protected whales, this species cannot be held in captivity , and most of the information about them must be gained through observation in the wild. But humpbacks can serve as an indicator species for other, more endangered large whales, and by developing bioanalytical measurement techniques for these species that are doing well, scientists can confidently apply them to other, more protected species.

“Up to this point, most measurements had been conducted using immunoassays, which require a ‘one at a time’ approach to hormone measurements,” Boggs said.

“We know that hormones act together in suites to cause large physiological changes. If you focus on only one hormone at a time, you might miss the major hormone of interest or simply run out of money or samples.”

The research team studied female humpbacks along the east coast of Australia during two stages of migration. Fifty-two individuals were randomly sampled before reaching the calving grounds in June/July (austral winter) and again after departing the calving grounds in September/October (austral spring). Before reaching the calving grounds, only one had a high concentration of progesterone, the hormone that has previously been used as an indicator of pregnancy in this species. This number seemed too low to be reliable. The evidence indicated that the animals’ hormone profiles change in late pregnancy, since multiple calves were seen later.

Finding chemical indicators for pregnancy in marine mammals is very different from finding them in humans, where a protein hormone called human chorionic gonadotropin (hCG) is detected right after the implantation of the embryo. Other protein hormones are difficult to use as a standard indicator for pregnancy because their levels vary from one species to the other.

Previous whale reproductive research had relied on the measurement of the hormone progesterone using a test known as enzyme-linked immunosorbent assay, or ELISA. ELISA has been the “go to” assay for years, but NIST scientists have determined that not all species rely on the same hormones during pregnancy, and in addition, some species’ hormone levels exhibit significant shifts during different phases of the gestation process.

NIST researchers realized that a chemical analysis technique called mass spectrometry, which detects compounds based on their masses, would potentially allow the measurement of many hormones simultaneously and could help biologists to understand which hormones can be found at different stages of pregnancy.

The new analysis from NIST and Griffith University scientists allowed for gathering a simultaneous measurement of 11 steroid hormones in each sample of whale blubber using liquid chromatography tandem mass spectrometry. The technique identifies hormones based on molecular size and mass rather than attachment of the hormone to an antibody (as in the current method), ensuring higher accuracy and selectivity.

“By casting a wider net and looking for more hormones, we were able to get a better set of biomarkers,” said Boggs. The same technique will also likely be applicable to other species including North Atlantic right whales, which are dying at alarming rates and considered to be a species in peril.

Boggs noted that correct timing could also improve the tests’ accuracy rates.

“Criteria will change depending on how far along the pregnancy has progressed,” she said. “In some species, progesterone drops off toward the end of pregnancy. And even closely related species can have very different hormonal profiles. Each test would need to be tailored to the species to be accurate, but the beauty of the mass spectrometry method means you don’t have to know which hormone is dominant before you start looking. You can look at them all.”

Explore further

World-first study finds Merino sheep pregnancy can be detected using wool

More information: Greta Dalle Luche et al, Androstenedione and testosterone but not progesterone are potential biomarkers of pregnancy in Humpback Whales (Megaptera novaeangliae) approaching parturition, Scientific Reports (2020). DOI: 10.1038/s41598-020-58933-4

Provided by National Institute of Standards and Technology

Citation: A better pregnancy test for whales (2020, February 20) retrieved 20 February 2020 from https://phys.org/news/2020-02-pregnancy-whales.html

This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.

#Biology

[hethak-blog]

Article on Elisa Lam

Elisa Lam: Canadian tragedy turned American Horror Story .

Of the thousands of theories circulating about the death of Elisa Lam, the one best worth considering comes from the case's lead investigator.

Los Angeles police Det. Wallace Tennelle gave his thoughts in a deposition.

The veteran detective was answering questions posed by a lawyer for the notorious Los Angeles hotel where the 21-year-old passed her final hours.

Tennelle took the call in February 2013 about a Canadian national who was missing from the Cecil. And he had peered into the open hatch of the rooftop water tank and seen Lam's lifeless body.

"My opinion is that she fell off her medication, and in her state, she happened to find her way onto the roof, got into the tank of water," Tennelle told the lawyer.

"At the time, I think that water tank was maybe full. But as people used the tank, used water, unknown to her, the level was dropping to a point where she could no longer reach out and escape, and she died that way."

A Tragedy Linked to L.A. Legend

Tennelle's deposition was filed last month in response to a lawsuit launched by Lam's parents, David and Yinna Lam, who claim the owners of the 91-year-old Cecil failed to properly control guest access to the roof and water tanks.

The new court documents provide insight into a mystery that has only grown in the nearly two years since Lam stepped anxiously off a hotel elevator and into popular imagination.

The B.C. student's fate has inspired movie screenplays, an episode of Castle and — most recently — the fifth season of American Horror Story.

Tourists flock to the hotel. A four-minute surveillance video of Lam gesticulating to an off-screen presence and frantically pressing buttons before sidling off the elevator is the subject of endless internet speculation.

And by sheer coincidence, elements of the tragedy are linked to L.A. lore.

The detective who reviewed the tape is a consultant on the TV version of Michael Connelly's gritty Harry Bosch thrillers. The serial killer known as the Night Stalker, Richard Ramirez, reportedly lodged at the Cecil. So did Jack Unterweger, an Austrian serial killer and minor celebrity.

"Elisa Lam was young, pretty, on her own, in a country not her own," says L.A. crime historian Joan Renner.

"I don't think people are deliberately callous, but when they sink their teeth into something they feel is mysterious or otherworldly, they lose the importance of the actual victim in it. It becomes a puzzle."​

Mysterious Visitors

The facts are as follows: Lam made internet reservations to check into a shared room for three nights on Jan. 28, 2013.

She was first assigned 506B, but the hotel's general manager said Lam's roommates complained about her "odd behaviour." She was then moved to a private room.

According to the coroner's report, Lam had a history of bipolar disorder. Medication was found among her belongings, but tests were inconclusive as to the presence of the medication in her bloodstream.

Her parents reported her missing when she failed to contact them on Jan. 31.

Tennelle set up a command post at the hotel when police intensified the hunt days later. He testified that "every nook and cranny of that building where we thought was a room, locked or unlocked, it was to be opened. It was to be searched."

The detective said Lam's appearance in the elevator video wasn't the only time she was seen on hotel surveillance tape.

"We did see her come in with two gentlemen. She had — they had a box, gave it to her," he said. "She went up into her — to the elevator. We never saw them again on video."

The search included the roof, but came up empty. Lam's belongings had been moved to the basement: a backpack, laptop and "things of value" that led police to believe she had planned on returning.

And then, nothing.

'It Was My Opinion ...'

Maintenance man Santiago Lopez discovered the body on Feb. 19. A guest in room 320 complained about the lack of water pressure and he went to check out the four large rooftop tanks.

Lam's body was found in a water tank on the top of the Cecil Hotel in downtown Los Angeles. (CBC)

There are only four ways onto the roof: three fire escapes on the sides of the hotel and one alarmed door connected to an interior staircase.

The hotel's engineer said he tested the alarm regularly. It was in working order when Lam went missing.

"I think she went through the door," Tennelle told the Cecil's lawyer.

Lam was naked when her body was found, but Tennelle said her clothes were in the tank. They're detailed in the coroner's report: a green Alexander Keith's India Pale Ale shirt, black shorts and a red American Apparel sweatshirt.

The coroner concluded there was no evidence of foul play, and that "a full review of circumstances" didn't support the idea Lam intended to harm herself.

With 35 years on the force, Tennelle has investigated rape, robbery and murder; he's no armchair internet sleuth.

He also knows first-hand the effect of a senseless death on a family. His son Bryant was slain in an apparently random shooting in 2007.

Tennelle concluded his deposition in a lawyer's office 15 minutes away from the roof where Lam died.

"It was my opinion that she climbed in on her own," he said.

"My partner and I tried to figure out how somebody could have put her in there, and it's difficult for someone to have been able to do that and not leave prints, not leave DNA or anything like that. So she climbed in on her own."

Written By: Jason Proctor

[bloojayoolie]

A Dream, Anaconda, and Andrew Bogut: ID 24534, @ 2 Years Old Brooklyn Ac Big as a pony, gentle as a lamb! 103 lbs of AVERAGE rated perfection. Adores everyone he meets, people dogs. Super Sweet, friendly, outgoing, a GEM! TO BE KILLED – 4/14/2018 <3 AVERAGE RATED PERFECTION!!!!! JIMBO is as big as a pony and gentle as a lamb. <3 JIMBO is so incredibly special that he has hearts melting wherever he goes. This big brindle beauty is 103 lbs of AVERAGE RATED perfection. He adores people big or small and he is a doggy playgroup star too! Easy going, good natured, a boy who checks in all the while he is walking with you to make sure you are having a good time, we can’t think of a sweeter or bigger hearted pup. Jimbo was found as a stray, so we don’t know his history, but what we do know is that LUCKY will be the family that fosters or adopts this magnificent boy. He hasn’t a bad bone in his whole body, he got all coveted 1’s across the board on his safer, and at only 2 years old, he is ready to join a perfect family for summer barbeques, walks in the park, or a swim at the lake. Be the center of attention, but more importantly, be the center of his world. No one will be a more loyal or affectionate companion than JIMBO. If you can foster or adopt him, PRIVATE MESSAGE our page or email us at MustLoveDogsNYC@gmail.com for assistance. He dreamed a dream of love. Make his dream come true. Jimbo – As big as a pony, and as gentle as a lamb <3 https://www.youtube.com/watch?v=nBYFwN5Adqc JIMBO, ID # 24534, @ 2 Years Old, 103 lbs. Brooklyn acc, Cane Corso Mix, Brown Brindle, Unaltered Male Came to the Shelter as: STRAY Shelter Assessment Rating: AVERAGE RATED! Behavior Condition: 1. GREEN AT RISK NOTE: Jimbo is at risk due to being diagnosed with Canine Infection Respiratory Disease Complex and will likely require home rest and a series of antibiotics for up to 14 days. This is a contagious illness to other dogs. Jimbo can go to an average home. INTAKE NOTE – DATE OF INTAKE, 4/5/2018: During intake Jimbo allowed the counselor to collar him and take his picture with no problems. SURRENDER NOTES – BASIC INFORMATION: Jimbo is a extra large brown brindle male dog who was found loose on the street and brought to the ACC as a stray. When meeting the staff at the ACC for the first time Jimbo was friendly and outgoing. He allowed the counselor to leash him and pet him with no problems. His history and previous behavior is unknown. SHELTER ASSESSMENT - DATE OF ASSESSMENT, 4/10/2018 Look: 1. Dog's eyes are averted, ears are back, tail is down, relaxed body posture. Dog allows head to be held loosely in Assessor's cupped hands. Sensitivity: 1. Dog stands still and accepts the touch, eyes are averted, and tail is in neutral position with a relaxed body posture. Dog's mouth is likely closed for at least a portion of the assessment item. Tag: 1. Dog follows at the end of the leash, body soft. Paw squeeze 1: 1. Dog gently pulls back his/her paw. Paw squeeze 2: 1. Dog gently pulls back his/her paw. Toy: 1. No interest. Summary: Jimbo came into the assessment room relaxed and quiet, he was friendly and affectionate towards the handlers. PLAYGROUP NOTES – DOG TO DOG SUMMARIES: Jimbo was surrender as a stray so his past behavior with other dogs is unknown. 4/6: When off leash at the Care Centers, Jimbo greet the novel female dog with a soft body. He is social and checks in with her while exploring the pens. 4/8- 4/10: Jimbo is used as a social greeter. He was respectful of a fearful female who moved very little and laid down for most of the session. He exchanged a few greets but moved away when she offered a head turn. With other more social dogs, Jimbo mostly just checks in with them while exploring the yard. ENERGY LEVEL:: Jimbo displays a medium to high activity level in the care center. BEHAVIOR DETERMINATION:: AVERAGE (suitable for an adopter with an average amount of dog experience) Behavior Asilomar: H - Healthy MEDICAL NOTES: 5/04/2018: DVM Intake Exam. Estimated age: ~2-3 years. Microchip noted on Intake? Negative. History : stray. Subjective: BARH. Observed Behavior - very sweet. Easily handleable. Did well for all medical handling and procedures. Soft muzzled for exam. Evidence of Cruelty seen – no. Evidence of Trauma seen – no. Objective: P = wnl, R = eupneic, BCS 4/9, EENT: Eyes clear, ears clean and cropped, no nasal discharge noted. Oral Exam: clean adult dentition, no oral lesions noted. PLN: No enlargements noted. H/L: NSR, NMA, CRT < 2, Lungs clear, eupneic. ABD: Non painful, no masses palpated. U/G: MI, 2 testicles descended. MSI: Ambulatory x 4, skin free of parasites, no masses noted, healthy hair coat. CNS: mentation appropriate - no signs of neurologic abnormalities. Assessment: Apparently healthy. Plan: Continue to monitor while at BACC. Prognosis: Excellent. SURGERY: ok to schedule for surgery. 8/04/2018: Progress exam. History : stray intake 4/5. Subjective: BAR. No csvd. Volunteer reported bleeding from face after walk yesterday but no abnormalities noted on cage exam. No blood in the cage. No signs CIRDC. Objective: EENT: Eyes clear, no nasal discharge noted. H/L: Normal RR/RE, eupneic. MSI: Ambulatory x 4, healthy hair coat. CNS: mentation appropriate - no signs of neurologic abnormalities. Assessment: Apparently healthy, Plan: Continue to monitor while at BACC. Prognosis: Excellent. 9/04/2018: Subjective: vomited large amount digested food this morning. Vomited again undigested food and black bits after AM walk. After morning rounds started having diarrhea. Objective: EENT: no ocular or nasal discharge. Oral Exam: mild tartar and gingivitis. H/L: no murmurs or arrhythmias, crt 1.5 sec, pink moist. strong synchronous femoral pulses. Abd: soft abdominal palpation; rectal exam mild symmetric prostatomegaly. MSI:ambulatory x 4. Mentation: BAR. temp: 101.8. Abdominal x-rays- suspicous gas patterns in the duodenum, stomcach not clearly visulized but suspect small amount of gritty mineral opacity in the stomach. Hard to obdain good x-rays because of size. Assessment: Vomiting- dietary indescretion v. FB v. other. diarrhea- dietary indescretion v. parasites v. stress v. other. Plan: sedation for x-rays- dexmeditomidine 0.4 mL IV, butorphanol 1ml IV. cerenia- 5mL SQ given at 12:30 pm. Metronidazole- 1000 mg PO BID x 5 days. cbc/chem- pending. PCV/ TS- pending. fecal exam- schduled for tomorrow. recheck tomorrow to assess v/d/ hydration. 9/04/2018: CBC-non-regenerative anemia 32.9 (37.3-61.7). Chem-nsf. PVC/TS-37%/7.2. Assessment: Mild non-regenerative anemia r/o GI bleed vs insignificant vs machine error vs other. Plan: Rec retesting tomorrow. Rec AUS to r/o FB. 10/04/2018: Pre-surgery exam. New wt 103# (lost ~7# since intake 4/5/18) S/O: QAR. ~5% dehydration. Allows all handling. Shows interest in food but not eating well. BCS 3/9. EENT: Eyes clear, no ocular discharge, moderate seromucoid nasal discharge, pink tacky mm, mild dental staining/tartar, ears clean. HL: Normal heart sounds, slightly increased lung sounds, no crackles or wheezes; coughing after chest coupage. ABD: Soft, non tender, no masses palpated. INTEG: Full coat. MS: Ambulatory x 4. UG: Male. Assessment: CIRDC, underweight/weight loss; concerns of possible FB yesterday due to vomiting and diarrhea, radiographs inconclusive. Plan: LRS 500ml SQ and baytril (100mg/ml) 4.7ml IM given. Continue with LRS 500ml SQ and cerenia 4.7ml SQ tonight. Continue with baytril 476mg (3.5 tabs) PO q24 x 9 days. Recheck tomorrow. Temporarily waived from surgery due to signs of CIRDC and being underweight. 10/04/2018: Pre-op exam/progress exam - concerns of FB on exam 4/9. New wt 103# (lost 7# since 4/5). T 104.4F. S/O: QAR. ~5% dehydration. Allows all handling, very docile. Shows interest in food but not eating well. BCS 3/9. EENT: Eyes clear, moderate seromucoid nasal discharge, mm pink and tacky, mild dental tartar/staining, ears clean. HL: Normal heart sounds, normal RR/RE, increased lung sounds, coughing after chest coupage. ABD: Soft, non tender, no masses palpated. INTEG: Full coat. MS: Ambulatory x 4. UG: Male. A: CIRDC, underweight. Signs of vomiting and diarrhea 4/9, none noted today, radiographs were inconclusive for signs of FB -- FB appears less likely at this time. Plan: LRS 500ml Sq and baytril 4.7ml IM given. Rec LRS 500ml SQ and cerenia 4.7ml SQ tonight. Continue baytril 476mg PO q24 x 9 days. Recheck tomorrow. 10/04/2018: Fecal: positive for whipworms. Start on panacur 100# dose PO SID x3d until 4/12 11/04/2018: Monitor appetite, vomiting, any signs of FB - started on baytril for signs of CIRDC 4/10, S/O: BAR. Active, attention seeking. No signs of reports of vomiting or diarrhea. Good appetite for wet food, ate medication, no interest in dry food. EENT: Eyes clear, mild serous nasal discharge. HL: No coughing or sneezing observed. INTEG: Full coat. MS: Ambulatory x 4. UG: Male. Assessment: CIRDC, no signs of foreign body - appears to be doing well with current treatment. Plan: Continue with current treatment and monitoring plan. Excellent prognosis. 12/04/2018: Monitor V/D. S/O: BAR. Active, attention seeking, eating well, no signs or reports of vomiting or diarrhea. EENT: Eyes clear, moderate serous nasal discharge. HL: Normal RR/RE, no coughing or sneezing observed. INTEG: Full coat. MS: Ambulatory x 4. UG: Male. A: On treatment for CIRDC and whipworms - doing well at this time. No signs of GI upset. Plan: Continue with current treatment and monitoring plan. *** TO FOSTER OR ADOPT *** If you would like to adopt a dog on our “To Be Killed” list, and you CAN get to the shelter in person to complete the adoption process **within 48 hours of reserve**, you can reserve the dog online until noon on the day they are scheduled to die. We have provided the Brooklyn, Staten Island and Manhattan information below. Adoption hours at these facilities is Noon – 8:00 p.m. (6:30 on weekends) HOW TO RESERVE A “TO BE KILLED” DOG ONLINE (only for those who can get to the shelter IN PERSON to complete the adoption process, and only for the dogs on the list NOT marked New Hope Rescue Only). Follow our Step by Step directions below! **PLEASE NOTE – YOU MUST USE A PC OR TABLET – PHONE RESERVES WILL NOT WORK! *** STEP 1: CLICK ON THIS RESERVE LINK: https://newhope.shelterbuddy.com/Animal/List Step 2: Go to the red menu button on the top right corner, click register and fill in your info. Step 3: Go to your email and verify account Step 4: Go back to the website, click the menu button and view available dogs. It should read, "reserve in progress". That is YOUR reserve. Step 5: Scroll to the animal you are interested and click reserve STEP 6 ( MOST IMPORTANT STEP ): GO TO THE MENU AGAIN AND VIEW YOUR CART. THE ANIMAL SHOULD NOW BE IN YOUR CART! Step 7: Fill in your credit card info and complete transaction Animal Care Centers of NYC (ACC) nycacc.org HOW TO FOSTER OR ADOPT IF YOU **CANNOT** GET TO THE SHELTER IN PERSON, OR IF THE DOG IS NEW HOPE RESCUE ONLY! You must live within 3 – 4 hours of NY, NJ, PA, CT, RI, DE, MD, MA, NH, VT, ME or Norther VA. Please PRIVATE MESSAGE our page for assistance. You will need to fill out applications with a New Hope Rescue Partner to foster or adopt a dog on the To Be Killed list, including those labelled Rescue Only. Hurry please, time is short, and the Rescues need time to process the applications. Shelter contact information Phone number (212) 788-4000 Email adoption@nycacc.org Shelter Addresses: Brooklyn Shelter: 2336 Linden Boulevard Brooklyn, NY 11208 Manhattan Shelter: 326 East 110 St. New York, NY 10029 Staten Island Shelter: 3139 Veterans Road West Staten Island, NY 10309

[amplia-mente]

Como bien saben nuestros lectores, el ánimo de este blog desde su inicio ha sido poner el foco en la actualidad. Hoy queremos dedicar nuestra entrada en amplia-mente.com a un tema que destaca por encima de otros muchos en las noticias de todo el mundo. Hablaremos de los abusos sexuales a menores.

Child sexual abuse: right interpretation of signs

As our readers know, the spirit of this blog since its inception has been to put the focus on today. Today we want to dedicate our post on amplia-mente.com to a topic that stands out above many others in news from around the world. We will talk about child sexual abuse.

Según las guias medico legales de actuación de la Organización Mundial de la Salud (OMS) se puede definir el abuso sexual a los niños como “la participación de un niño en una actividad sexual que él o ella no comprenden plenamente, no pueden dar su consentimiento informado, o para la cual el niño no está preparado dado su desarrollo o que viola las leyes o los tabúes sociales de la sociedad en la que viven”. Además se indica que “se evidencia por esta actividad sexual entre un niño y un adulto u otro niño que por edad o desarrollo se encuentra en una relación de responsabilidad, confianza o poder, siendo la actividad destinada a gratificar o satisfacer las necesidades de la otra persona”. Como vemos la definición queda bastante clara y no da lugar a dudas ya que nos pone en todas las posibles circunstancias o posibilidades que se puedan dar para llevar a cabo dicha actividad sexual.

According to the medico-legal guidelines of the World Health Organization (WHO), sexual abuse of children can be defined as “the participation of a child in a sexual activity that he or she does not fully understand, cannot give informed consent to, or for which the child is not prepared because of his or her development or which violates the laws or social taboos of the society in which he or she lives”. In addition, it is indicated that “it is evidenced by this sexual activity between a child and an adult or another child that by age or development is in a relationship of responsibility, trust or power, being the activity destined to gratify or satisfy the needs of the other person”. As we can see, the definition is quite clear and does not give rise to doubts as it puts us in all possible circumstances or possibilities that may be given to carry out such sexual activity.

Los abusos a niños generalmente se sospechan pero son difíciles de diagnosticar, principalmente por la dificultad de obtener un relato del menor o de confrontar los datos que este aporta. En algunos artículos publicados recientemente (en open access) se recoge la evidencia de que la mayoría de los niños abusados sexualmente no tienen signos de lesión genital o anal, especialmente cuando son examinados de manera tardía, no en el momento agudo de la agresión.

Child abuse is generally suspected but difficult to diagnose, mainly because of the difficulty of obtaining a story from the child or of comparing the data provided by the child. Some recently published articles (open access) provide evidence that most sexually abused children have no signs of genital or anal injury, especially when they are examined late, not at the acute moment of aggression.

En un estudio reciente se informó que sólo el 2.2% de las niñas abusadas sexualmente examinadas tenían hallazgos físicos diagnósticos, mientras que entre las examinadas en forma aguda, la prevalencia de lesiones fue del 21.4%. Un grupo de 10 pediatras especialistas en abusos infantiles han revisado los estudios de investigación y las recomendaciones de las organizaciones profesionales con respecto a las pautas para proporcionar atención médica a los niños sospechosos de haber sido víctimas de abuso sexual. Con el apoyo del Midwest Children’s Advocacy Center, las pautas fueron actualizadas y publicadas en 2016. Desde entonces, se han publicado algunos estudios adicionales que han proporcionado orientación adicional, y se han vuelto a actualizar algunas partes de las directrices, incluido un cuadro en el que se enumera un enfoque para la interpretación de los resultados médicos en el abuso sexual infantil.

In a recent study reported that only 2.2% of sexually abused girls examined had diagnostic physical findings, while among those examined acutely, the prevalence of injuries was 21.4%. A group of 10 pediatricians specializing in child abuse have reviewed research studies and recommendations from professional organizations regarding guidelines for providing medical care to children suspected of sexual abuse. With support from the Midwest Children’s Advocacy Center, the guidelines were updated and published in 2016. Since then, some additional studies have been published that have provided additional guidance, and parts of the guidelines have been re-updated, including a chart listing an approach to interpreting medical outcomes in child sexual abuse.

Esta claro que si bien debemos detectar de forma precoz aquellos signos que nos lleven a diagnosticar una situación de abuso sexual infantil, no podemos cometer el error (por las repercusiones que tiene el mismo) de confundir determinadas situaciones normales con signos patológicos. En el artículo anteriormente mencionado se detallan en una tabla aquellos hallazgos documentados en recién nacidos o comúnmente vistos en niños que no han sufrido abusos o hallazgos comúnmente causados por condiciones médicas que no son traumatismos o contacto sexual (estos hallazgos requieren que se considere un diagnóstico diferencial, ya que cada uno puede tener varias causas diferentes). También existen situaciones traumáticas que no tienen su origen en una etiología sexual, como pueden ser caídas, laceraciones accidentales, etc. Por otro lado se señalan aquellos signos con un alto índice de sospecha de abuso sexual y aquellos que indudablemente nos indicarían este abuso.

It is clear that although we must detect early those signs that lead us to diagnose a situation of child sexual abuse, we can not make the mistake (because of the repercussions it has) of confusing certain normal situations with pathological signs. The previously mentioned article details in a table those findings documented in newborns or commonly seen in children who have not suffered abuse or findings commonly caused by medical conditions other than trauma or sexual contact (these findings require that a differential diagnosis be considered, as each one may have several different causes). There are also traumatic situations that do not have their origin in a sexual aetiology, such as falls, accidental lacerations, etc. On the other hand, those signs with a high rate of suspicion of sexual abuse and those that would undoubtedly indicate this abuse are pointed out.

Otro indicador que se puede evaluar para determinar la existencia o no de este tipo de abusos son las infecciones, así algunas de ellas no son indicativas de abuso sexual (vaginitis causadas por Candidas o por Escherichia coli o úlceras genitales producidas por Virus de Epstein-Barr por ejemplo), otras que pueden o no ser transmitidas por vía sexual (Molluscum contagiosum o el Condiloma acuminado) y por último aquellas infecciones que inequívocamente son de transmisión sexual (Gonorrea, Sífilis, Chlamydias, etc). Se adjunta la tabla (haz clic para ampliar).

Another indicator that can be evaluated to determine the existence or not of this type of abuse are infections, so some of them are not indicative of sexual abuse (vaginitis caused by Candidas or Escherichia coli or genital ulcers produced by Epstein-Barr Virus for example), others that may or may not be sexually transmitted (Molluscum contagiosum or Condyloma acuminatum) and finally those infections that are unequivocally sexually transmitted (Gonorrhea, Syphilis, Chlamydias, etc). The table is attached (click to enlarge).

Como vemos hay que ser muy precavidos a la hora de diagnosticar un abuso sexual en un niño. Como ejemplo, en el artículo se menciona que el hallazgo de una muesca profunda en la región posterior del himen sigue siendo un hallazgo poco concluyente, sin que haya consenso entre los expertos en cuanto al grado de importancia con respecto al abuso. Otra conclusión a la que han llegado los expertos es que si lo exámenes se graban en vídeo, a diferencia de aquellas en las que únicamente se toman fotografías de los hallazgos, hacen que haya un mayor acuerdo entre varios médicos en cuanto al diagnóstico del desgarro del himen.

As we can see, we have to be very cautious when diagnosing sexual abuse in a child. As an example, the article mentions that the finding of a deep notch in the posterior region of the hymen remains an inconclusive finding, with no consensus among experts as to the degree of importance with respect to abuse. Another conclusion experts have reached is that if tests are videotaped, unlike those where only photographs of the findings are taken, there is greater agreement among several physicians on the diagnosis of hymen tear. We hope that the table with the described signs will be useful to our readers at the time of arriving at a conclusive diagnosis of sexual abuse of a child, given the importance and seriousness of this diagnosis we should not fall into the irresponsibility of a misinterpretation of these signs. In the meantime, we will continue to be attentive to new updates.

Esperamos que la tabla con los signos descritos sea de utilidad a nuestros lectores a la hora de llegar a un diagnóstico concluyente de abusos sexuales a un niño, dada la importancia y la gravedad de dicho diagnóstico no debemos caer en la irresponsabilidad de una mala interpretación de estos signos. Mientras tanto seguiremos atentos a nuevas actualizaciones.

[battybat-boss]

FDA Approving Dangerous Drugs that Are Injuring and Killing People

FDA Repays Industry by Rushing Risky Drugs to Market

As pharma companies underwrite three-fourths of the FDA's budget for scientific reviews, the agency is increasingly fast-tracking expensive drugs with significant side effects and unproven health benefits.

by Caroline Chen ProPublica

Nuplazid, a drug for hallucinations and delusions associated with Parkinson's disease, failed two clinical trials. In a third trial, under a revised standard for measuring its effect, it showed minimal benefit. Overall, more patients died or had serious side effects on Nuplazid than after receiving no treatment.

Patients on Uloric, a gout drug, suffered more heart attacks, strokes and heart failure in two out of three trials than did their counterparts on standard or no medication.

Nevertheless, the U.S. Food and Drug Administration approved both of these drugs - with a deadly aftermath. Uloric's manufacturer reported last November that patients on the drug were 34 percent more likely to die from heart disease than people taking an alternative gout medication. And since the FDA fast-tracked approval of Nuplazid and it went on the market in 2016 at a price of $24,000 a year, there have been 6,800 reports of adverse events for patients on the drug, including 887 deaths as of this past March 31.

The FDA is increasingly green-lighting expensive drugs despite dangerous or little-known side effects and inconclusive evidence that they curb or cure disease. Once widely assailed for moving slowly, today the FDA reviews and approves drugs faster than any other regulatory agency in the world. Between 2011 and 2015, the FDA reviewed new drug applications more than 60 days faster on average than did the European Medicines Agency.

Europe has also rejected drugs for which the FDA accelerated approval, such as Folotyn, which treats a rare form of blood cancer. European authorities cited “insufficient” evidence of health gains from Folotyn, which shrinks some tumors but hasn't been shown to extend lives. It costs more than $92,000 for a seven-week course of treatment, according to research firm SSR Health.

As patients (or their insurers) shell out tens or hundreds of thousands of dollars for unproven drugs, manufacturers reap a windfall. For them, expedited approval can mean not only sped-up sales but also - if the drug is intended to treat a rare disease or serve a neglected population - FDA incentives worth hundreds of millions of dollars.

“Instead of a regulator and a regulated industry, we now have a partnership,” said Dr. Michael Carome, director of the health research group for the nonprofit advocacy organization Public Citizen, and a former U.S. Department of Health and Human Services official.

“That relationship has tilted the agency away from a public health perspective to an industry friendly perspective.”

While the FDA over the past three decades has implemented at least four major routes to faster approvals - the current commissioner, Dr. Scott Gottlieb, is easing even more drugs' path to market. The FDA okayed 46 “novel” drugs - whose chemical structure hadn't been previously approved - in 2017, the most in at least 15 years. At the same time, it's rejecting fewer medications. In 2017, the FDA's Center for Drug Evaluation and Research denied 19.7 percent of all applications for new drugs, biologics, and efficacy supplements, down from a 2010 peak of 59.2 percent, according to agency data.

President Trump has encouraged Gottlieb to give patients faster access to drugs.

“You're bringing that down, right?” Trump asked the commissioner at a May 30 event, referring to the time it takes to bring drugs to market. “You have a lot of good things in the wings that, frankly, if you moved them up, a lot of people would have a great shot.”

Faster reviews mean that the FDA often approves drugs despite limited information. It channels more and more experimental treatments, including Nuplazid, into expedited reviews that require only one clinical trial to show a benefit to patients, instead of the traditional two.

The FDA also increasingly allows drugmakers to claim success in trials based on proxy measurements - such as shrunken tumors - instead of clinical outcomes like survival rates or cures, which take more time to evaluate. In return for accelerated approval, drug companies commit to researching how well their drugs work after going on the market. But these post-marketing studies can take 10 years or longer to complete, leaving patients and doctors with lingering questions about safety and benefit.

“Clearly, accelerated approval has greater uncertainty,” Dr. Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, said in an interview. When only a single trial is used for approval, “in some cases, there may be more uncertainty about safety findings or with the magnitude of effectiveness.”

She attributed the increased use of expedited pathways to more drugmakers developing treatments for rare diseases, “where there's unmet need, and where the patient population and providers are eager to accept more uncertainty.”

The FDA's growing emphasis on speed has come at the urging of both patient advocacy groups and industry, which began in 1992 to contribute to the salaries of the agency's drug reviewers in exchange for time limits on reviews. In 2017, pharma paid 75 percent - or $905 million - of the agency's scientific review budgets for branded and generic drugs, compared to 27 percent in 1993.

“The virginity was lost in '92,” said Dr. Jerry Avorn, a professor at Harvard Medical School. “Once you have that paying relationship, it creates a dynamic that's not a healthy one.”

Industry also sways the FDA through a less direct financial route. Many of the physicians, caregivers, and other witnesses before FDA advisory panels that evaluate drugs receive consulting fees, expense payments, or other remuneration from pharma companies.

“You know who never shows up at the [advisory committee]? The people who died in the trial,” lamented one former FDA staffer, who asked not to be named because he still works in the field. “Nobody is talking for them.”

The drug industry's lobbying group, Pharmaceutical Research and Manufacturers of America, continues to push for ever-faster approvals. In a policy memo on its website, PhRMA warns of “needless delays in drug review and approval that lead to longer development times, missed opportunities, higher drug development costs and delays in treatments reaching patients.”

The agency has internalized decades of criticism that painted it as an obstacle to innovation, said Daniel Carpenter, a professor of government at Harvard and author of a 2010 book on pharmaceutical regulation at the FDA.

“They now have a built-in fear of over-regulation that's set in over the last 20 years.”

To be sure, nobody wants the FDA to drag out drug reviews unnecessarily, and even critics acknowledge that there's no easy way for the agency to strike the perfect balance between sufficient speed and ample information, particularly when patients have no other treatments available, or are terminally ill.

FDA Is Approving More New Drugs and Rejecting Fewer Overall

“I think it's reasonable to move drugs faster particularly in the case where you're dealing with an extremely promising new product which treats a serious or life-threatening disease,” said Dr. Aaron Kesselheim, an associate professor at Harvard Medical School.

“The key, though, when you do that is that you've got to make sure you closely follow the drug in a thoughtful way and unfortunately, too often we don't do that in the U.S.”

After thalidomide, taken by pregnant women to prevent nausea, caused thousands of babies in the early 1960s to be born with stunted limbs, Congress entrusted the FDA with ensuring that drugs going on the market were both safe and effective, based on “substantial evidence” from multiple trials.

Assembling this evidence has traditionally required three stages of clinical trials; the first in a small cohort of healthy volunteers to determine a safe dosage; the second to assess the drug's efficacy and side effects; and then, if results are positive, two larger trials to confirm the benefit and monitor for safety issues. An FDA team of in-house reviewers is then assigned to analyze the results and decide whether the agency should approve the drug. If reviewers want more input, the agency can convene an advisory committee of outside experts.

As the FDA's responsibilities expanded in the 1970s, review times began to lag, reaching more than 35 months on average in 1979. The AIDS crisis followed soon thereafter, prompting complaints from Gonsalves and other activists. Their protests spurred the Prescription Drug User Fee Act in 1992, which established industry fees to fund FDA staff salaries. In return, the FDA promised to review drugs within 12 months for normal applications, and 6 months for priority cases.

The more that the FDA relied on industry fees to pay for drug reviews, the more it showed an inclination towards approval, former employees say.

“You don't survive as a senior official at the FDA unless you're pro-industry,” said Dr. Thomas Marciniak. A former FDA medical team leader, and a longtime outspoken critic of how drug companies handle clinical trials, Marciniak retired in 2014.

“The FDA has to pay attention to what Congress tells them to do, and the industry will lobby to get somebody else in there if they don't like you.”

Staffers know “you don't get promoted unless you're pro-industry,” he added.

This tilt is reflected in what senior officials choose to highlight. The agency's Center for Drug Evaluation and Research gives internal awards to review teams each year, according to Marciniak and the former FDA employee who requested anonymity. Both said they had never seen an award granted to a team that rejected a drug application. The FDA did not respond to ProPublica's request for a list of award winners.

Higher-ups would also send congratulatory emails to medical review teams when a drug was approved.

“Nobody gets congratulated for turning a drug down, but you get seriously questioned,” said the former staffer, adding that the agency's attitude is, “Keep Congress off your back and make your life easier.”

Read the full report at ProPublica.

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[lopezdorothy70-blog]

FDA Approving Dangerous Drugs that Are Injuring and Killing People

FDA Repays Industry by Rushing Risky Drugs to Market

As pharma companies underwrite three-fourths of the FDA's budget for scientific reviews, the agency is increasingly fast-tracking expensive drugs with significant side effects and unproven health benefits.

by Caroline Chen ProPublica

Nuplazid, a drug for hallucinations and delusions associated with Parkinson's disease, failed two clinical trials. In a third trial, under a revised standard for measuring its effect, it showed minimal benefit. Overall, more patients died or had serious side effects on Nuplazid than after receiving no treatment.

Patients on Uloric, a gout drug, suffered more heart attacks, strokes and heart failure in two out of three trials than did their counterparts on standard or no medication.

Nevertheless, the U.S. Food and Drug Administration approved both of these drugs - with a deadly aftermath. Uloric's manufacturer reported last November that patients on the drug were 34 percent more likely to die from heart disease than people taking an alternative gout medication. And since the FDA fast-tracked approval of Nuplazid and it went on the market in 2016 at a price of $24,000 a year, there have been 6,800 reports of adverse events for patients on the drug, including 887 deaths as of this past March 31.

The FDA is increasingly green-lighting expensive drugs despite dangerous or little-known side effects and inconclusive evidence that they curb or cure disease. Once widely assailed for moving slowly, today the FDA reviews and approves drugs faster than any other regulatory agency in the world. Between 2011 and 2015, the FDA reviewed new drug applications more than 60 days faster on average than did the European Medicines Agency.

Europe has also rejected drugs for which the FDA accelerated approval, such as Folotyn, which treats a rare form of blood cancer. European authorities cited “insufficient” evidence of health gains from Folotyn, which shrinks some tumors but hasn't been shown to extend lives. It costs more than $92,000 for a seven-week course of treatment, according to research firm SSR Health.

As patients (or their insurers) shell out tens or hundreds of thousands of dollars for unproven drugs, manufacturers reap a windfall. For them, expedited approval can mean not only sped-up sales but also - if the drug is intended to treat a rare disease or serve a neglected population - FDA incentives worth hundreds of millions of dollars.

“Instead of a regulator and a regulated industry, we now have a partnership,” said Dr. Michael Carome, director of the health research group for the nonprofit advocacy organization Public Citizen, and a former U.S. Department of Health and Human Services official.

“That relationship has tilted the agency away from a public health perspective to an industry friendly perspective.”

While the FDA over the past three decades has implemented at least four major routes to faster approvals - the current commissioner, Dr. Scott Gottlieb, is easing even more drugs' path to market. The FDA okayed 46 “novel” drugs - whose chemical structure hadn't been previously approved - in 2017, the most in at least 15 years. At the same time, it's rejecting fewer medications. In 2017, the FDA's Center for Drug Evaluation and Research denied 19.7 percent of all applications for new drugs, biologics, and efficacy supplements, down from a 2010 peak of 59.2 percent, according to agency data.

President Trump has encouraged Gottlieb to give patients faster access to drugs.

“You're bringing that down, right?” Trump asked the commissioner at a May 30 event, referring to the time it takes to bring drugs to market. “You have a lot of good things in the wings that, frankly, if you moved them up, a lot of people would have a great shot.”

Faster reviews mean that the FDA often approves drugs despite limited information. It channels more and more experimental treatments, including Nuplazid, into expedited reviews that require only one clinical trial to show a benefit to patients, instead of the traditional two.

The FDA also increasingly allows drugmakers to claim success in trials based on proxy measurements - such as shrunken tumors - instead of clinical outcomes like survival rates or cures, which take more time to evaluate. In return for accelerated approval, drug companies commit to researching how well their drugs work after going on the market. But these post-marketing studies can take 10 years or longer to complete, leaving patients and doctors with lingering questions about safety and benefit.

“Clearly, accelerated approval has greater uncertainty,” Dr. Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, said in an interview. When only a single trial is used for approval, “in some cases, there may be more uncertainty about safety findings or with the magnitude of effectiveness.”

She attributed the increased use of expedited pathways to more drugmakers developing treatments for rare diseases, “where there's unmet need, and where the patient population and providers are eager to accept more uncertainty.”

The FDA's growing emphasis on speed has come at the urging of both patient advocacy groups and industry, which began in 1992 to contribute to the salaries of the agency's drug reviewers in exchange for time limits on reviews. In 2017, pharma paid 75 percent - or $905 million - of the agency's scientific review budgets for branded and generic drugs, compared to 27 percent in 1993.

“The virginity was lost in '92,” said Dr. Jerry Avorn, a professor at Harvard Medical School. “Once you have that paying relationship, it creates a dynamic that's not a healthy one.”

Industry also sways the FDA through a less direct financial route. Many of the physicians, caregivers, and other witnesses before FDA advisory panels that evaluate drugs receive consulting fees, expense payments, or other remuneration from pharma companies.

“You know who never shows up at the [advisory committee]? The people who died in the trial,” lamented one former FDA staffer, who asked not to be named because he still works in the field. “Nobody is talking for them.”

The drug industry's lobbying group, Pharmaceutical Research and Manufacturers of America, continues to push for ever-faster approvals. In a policy memo on its website, PhRMA warns of “needless delays in drug review and approval that lead to longer development times, missed opportunities, higher drug development costs and delays in treatments reaching patients.”

The agency has internalized decades of criticism that painted it as an obstacle to innovation, said Daniel Carpenter, a professor of government at Harvard and author of a 2010 book on pharmaceutical regulation at the FDA.

“They now have a built-in fear of over-regulation that's set in over the last 20 years.”

To be sure, nobody wants the FDA to drag out drug reviews unnecessarily, and even critics acknowledge that there's no easy way for the agency to strike the perfect balance between sufficient speed and ample information, particularly when patients have no other treatments available, or are terminally ill.

FDA Is Approving More New Drugs and Rejecting Fewer Overall

“I think it's reasonable to move drugs faster particularly in the case where you're dealing with an extremely promising new product which treats a serious or life-threatening disease,” said Dr. Aaron Kesselheim, an associate professor at Harvard Medical School.

“The key, though, when you do that is that you've got to make sure you closely follow the drug in a thoughtful way and unfortunately, too often we don't do that in the U.S.”

After thalidomide, taken by pregnant women to prevent nausea, caused thousands of babies in the early 1960s to be born with stunted limbs, Congress entrusted the FDA with ensuring that drugs going on the market were both safe and effective, based on “substantial evidence” from multiple trials.

Assembling this evidence has traditionally required three stages of clinical trials; the first in a small cohort of healthy volunteers to determine a safe dosage; the second to assess the drug's efficacy and side effects; and then, if results are positive, two larger trials to confirm the benefit and monitor for safety issues. An FDA team of in-house reviewers is then assigned to analyze the results and decide whether the agency should approve the drug. If reviewers want more input, the agency can convene an advisory committee of outside experts.

As the FDA's responsibilities expanded in the 1970s, review times began to lag, reaching more than 35 months on average in 1979. The AIDS crisis followed soon thereafter, prompting complaints from Gonsalves and other activists. Their protests spurred the Prescription Drug User Fee Act in 1992, which established industry fees to fund FDA staff salaries. In return, the FDA promised to review drugs within 12 months for normal applications, and 6 months for priority cases.

The more that the FDA relied on industry fees to pay for drug reviews, the more it showed an inclination towards approval, former employees say.

“You don't survive as a senior official at the FDA unless you're pro-industry,” said Dr. Thomas Marciniak. A former FDA medical team leader, and a longtime outspoken critic of how drug companies handle clinical trials, Marciniak retired in 2014.

“The FDA has to pay attention to what Congress tells them to do, and the industry will lobby to get somebody else in there if they don't like you.”

Staffers know “you don't get promoted unless you're pro-industry,” he added.

This tilt is reflected in what senior officials choose to highlight. The agency's Center for Drug Evaluation and Research gives internal awards to review teams each year, according to Marciniak and the former FDA employee who requested anonymity. Both said they had never seen an award granted to a team that rejected a drug application. The FDA did not respond to ProPublica's request for a list of award winners.

Higher-ups would also send congratulatory emails to medical review teams when a drug was approved.

“Nobody gets congratulated for turning a drug down, but you get seriously questioned,” said the former staffer, adding that the agency's attitude is, “Keep Congress off your back and make your life easier.”

Read the full report at ProPublica.

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[twittermemesofficial]

A Dream, Anaconda, and Andrew Bogut: ID 24534, @ 2 Years Old Brooklyn Ac Big as a pony, gentle as a lamb! 103 lbs of AVERAGE rated perfection. Adores everyone he meets, people dogs. Super Sweet, friendly, outgoing, a GEM! TO BE KILLED – 4/14/2018 <3 AVERAGE RATED PERFECTION!!!!! JIMBO is as big as a pony and gentle as a lamb. <3 JIMBO is so incredibly special that he has hearts melting wherever he goes. This big brindle beauty is 103 lbs of AVERAGE RATED perfection. He adores people big or small and he is a doggy playgroup star too! Easy going, good natured, a boy who checks in all the while he is walking with you to make sure you are having a good time, we can’t think of a sweeter or bigger hearted pup. Jimbo was found as a stray, so we don’t know his history, but what we do know is that LUCKY will be the family that fosters or adopts this magnificent boy. He hasn’t a bad bone in his whole body, he got all coveted 1’s across the board on his safer, and at only 2 years old, he is ready to join a perfect family for summer barbeques, walks in the park, or a swim at the lake. Be the center of attention, but more importantly, be the center of his world. No one will be a more loyal or affectionate companion than JIMBO. If you can foster or adopt him, PRIVATE MESSAGE our page or email us at MustLoveDogsNYC@gmail.com for assistance. He dreamed a dream of love. Make his dream come true. Jimbo – As big as a pony, and as gentle as a lamb <3 https://www.youtube.com/watch?v=nBYFwN5Adqc JIMBO, ID # 24534, @ 2 Years Old, 103 lbs. Brooklyn acc, Cane Corso Mix, Brown Brindle, Unaltered Male Came to the Shelter as: STRAY Shelter Assessment Rating: AVERAGE RATED! Behavior Condition: 1. GREEN AT RISK NOTE: Jimbo is at risk due to being diagnosed with Canine Infection Respiratory Disease Complex and will likely require home rest and a series of antibiotics for up to 14 days. This is a contagious illness to other dogs. Jimbo can go to an average home. INTAKE NOTE – DATE OF INTAKE, 4/5/2018: During intake Jimbo allowed the counselor to collar him and take his picture with no problems. SURRENDER NOTES – BASIC INFORMATION: Jimbo is a extra large brown brindle male dog who was found loose on the street and brought to the ACC as a stray. When meeting the staff at the ACC for the first time Jimbo was friendly and outgoing. He allowed the counselor to leash him and pet him with no problems. His history and previous behavior is unknown. SHELTER ASSESSMENT – DATE OF ASSESSMENT, 4/10/2018 Look: 1. Dog's eyes are averted, ears are back, tail is down, relaxed body posture. Dog allows head to be held loosely in Assessor's cupped hands. Sensitivity: 1. Dog stands still and accepts the touch, eyes are averted, and tail is in neutral position with a relaxed body posture. Dog's mouth is likely closed for at least a portion of the assessment item. Tag: 1. Dog follows at the end of the leash, body soft. Paw squeeze 1: 1. Dog gently pulls back his/her paw. Paw squeeze 2: 1. Dog gently pulls back his/her paw. Toy: 1. No interest. Summary: Jimbo came into the assessment room relaxed and quiet, he was friendly and affectionate towards the handlers. PLAYGROUP NOTES – DOG TO DOG SUMMARIES: Jimbo was surrender as a stray so his past behavior with other dogs is unknown. 4/6: When off leash at the Care Centers, Jimbo greet the novel female dog with a soft body. He is social and checks in with her while exploring the pens. 4/8- 4/10: Jimbo is used as a social greeter. He was respectful of a fearful female who moved very little and laid down for most of the session. He exchanged a few greets but moved away when she offered a head turn. With other more social dogs, Jimbo mostly just checks in with them while exploring the yard. ENERGY LEVEL:: Jimbo displays a medium to high activity level in the care center. BEHAVIOR DETERMINATION:: AVERAGE (suitable for an adopter with an average amount of dog experience) Behavior Asilomar: H – Healthy MEDICAL NOTES: 5/04/2018: DVM Intake Exam. Estimated age: ~2-3 years. Microchip noted on Intake? Negative. History : stray. Subjective: BARH. Observed Behavior – very sweet. Easily handleable. Did well for all medical handling and procedures. Soft muzzled for exam. Evidence of Cruelty seen – no. Evidence of Trauma seen – no. Objective: P = wnl, R = eupneic, BCS 4/9, EENT: Eyes clear, ears clean and cropped, no nasal discharge noted. Oral Exam: clean adult dentition, no oral lesions noted. PLN: No enlargements noted. H/L: NSR, NMA, CRT < 2, Lungs clear, eupneic. ABD: Non painful, no masses palpated. U/G: MI, 2 testicles descended. MSI: Ambulatory x 4, skin free of parasites, no masses noted, healthy hair coat. CNS: mentation appropriate – no signs of neurologic abnormalities. Assessment: Apparently healthy. Plan: Continue to monitor while at BACC. Prognosis: Excellent. SURGERY: ok to schedule for surgery. 8/04/2018: Progress exam. History : stray intake 4/5. Subjective: BAR. No csvd. Volunteer reported bleeding from face after walk yesterday but no abnormalities noted on cage exam. No blood in the cage. No signs CIRDC. Objective: EENT: Eyes clear, no nasal discharge noted. H/L: Normal RR/RE, eupneic. MSI: Ambulatory x 4, healthy hair coat. CNS: mentation appropriate – no signs of neurologic abnormalities. Assessment: Apparently healthy, Plan: Continue to monitor while at BACC. Prognosis: Excellent. 9/04/2018: Subjective: vomited large amount digested food this morning. Vomited again undigested food and black bits after AM walk. After morning rounds started having diarrhea. Objective: EENT: no ocular or nasal discharge. Oral Exam: mild tartar and gingivitis. H/L: no murmurs or arrhythmias, crt 1.5 sec, pink moist. strong synchronous femoral pulses. Abd: soft abdominal palpation; rectal exam mild symmetric prostatomegaly. MSI:ambulatory x 4. Mentation: BAR. temp: 101.8. Abdominal x-rays- suspicous gas patterns in the duodenum, stomcach not clearly visulized but suspect small amount of gritty mineral opacity in the stomach. Hard to obdain good x-rays because of size. Assessment: Vomiting- dietary indescretion v. FB v. other. diarrhea- dietary indescretion v. parasites v. stress v. other. Plan: sedation for x-rays- dexmeditomidine 0.4 mL IV, butorphanol 1ml IV. cerenia- 5mL SQ given at 12:30 pm. Metronidazole- 1000 mg PO BID x 5 days. cbc/chem- pending. PCV/ TS- pending. fecal exam- schduled for tomorrow. recheck tomorrow to assess v/d/ hydration. 9/04/2018: CBC-non-regenerative anemia 32.9 (37.3-61.7). Chem-nsf. PVC/TS-37%/7.2. Assessment: Mild non-regenerative anemia r/o GI bleed vs insignificant vs machine error vs other. Plan: Rec retesting tomorrow. Rec AUS to r/o FB. 10/04/2018: Pre-surgery exam. New wt 103# (lost ~7# since intake 4/5/18) S/O: QAR. ~5% dehydration. Allows all handling. Shows interest in food but not eating well. BCS 3/9. EENT: Eyes clear, no ocular discharge, moderate seromucoid nasal discharge, pink tacky mm, mild dental staining/tartar, ears clean. HL: Normal heart sounds, slightly increased lung sounds, no crackles or wheezes; coughing after chest coupage. ABD: Soft, non tender, no masses palpated. INTEG: Full coat. MS: Ambulatory x 4. UG: Male. Assessment: CIRDC, underweight/weight loss; concerns of possible FB yesterday due to vomiting and diarrhea, radiographs inconclusive. Plan: LRS 500ml SQ and baytril (100mg/ml) 4.7ml IM given. Continue with LRS 500ml SQ and cerenia 4.7ml SQ tonight. Continue with baytril 476mg (3.5 tabs) PO q24 x 9 days. Recheck tomorrow. Temporarily waived from surgery due to signs of CIRDC and being underweight. 10/04/2018: Pre-op exam/progress exam – concerns of FB on exam 4/9. New wt 103# (lost 7# since 4/5). T 104.4F. S/O: QAR. ~5% dehydration. Allows all handling, very docile. Shows interest in food but not eating well. BCS 3/9. EENT: Eyes clear, moderate seromucoid nasal discharge, mm pink and tacky, mild dental tartar/staining, ears clean. HL: Normal heart sounds, normal RR/RE, increased lung sounds, coughing after chest coupage. ABD: Soft, non tender, no masses palpated. INTEG: Full coat. MS: Ambulatory x 4. UG: Male. A: CIRDC, underweight. Signs of vomiting and diarrhea 4/9, none noted today, radiographs were inconclusive for signs of FB — FB appears less likely at this time. Plan: LRS 500ml Sq and baytril 4.7ml IM given. Rec LRS 500ml SQ and cerenia 4.7ml SQ tonight. Continue baytril 476mg PO q24 x 9 days. Recheck tomorrow. 10/04/2018: Fecal: positive for whipworms. Start on panacur 100# dose PO SID x3d until 4/12 11/04/2018: Monitor appetite, vomiting, any signs of FB – started on baytril for signs of CIRDC 4/10, S/O: BAR. Active, attention seeking. No signs of reports of vomiting or diarrhea. Good appetite for wet food, ate medication, no interest in dry food. EENT: Eyes clear, mild serous nasal discharge. HL: No coughing or sneezing observed. INTEG: Full coat. MS: Ambulatory x 4. UG: Male. Assessment: CIRDC, no signs of foreign body – appears to be doing well with current treatment. Plan: Continue with current treatment and monitoring plan. Excellent prognosis. 12/04/2018: Monitor V/D. S/O: BAR. Active, attention seeking, eating well, no signs or reports of vomiting or diarrhea. EENT: Eyes clear, moderate serous nasal discharge. HL: Normal RR/RE, no coughing or sneezing observed. INTEG: Full coat. MS: Ambulatory x 4. UG: Male. A: On treatment for CIRDC and whipworms – doing well at this time. No signs of GI upset. Plan: Continue with current treatment and monitoring plan. *** TO FOSTER OR ADOPT *** If you would like to adopt a dog on our “To Be Killed” list, and you CAN get to the shelter in person to complete the adoption process **within 48 hours of reserve**, you can reserve the dog online until noon on the day they are scheduled to die. We have provided the Brooklyn, Staten Island and Manhattan information below. Adoption hours at these facilities is Noon – 8:00 p.m. (6:30 on weekends) HOW TO RESERVE A “TO BE KILLED” DOG ONLINE (only for those who can get to the shelter IN PERSON to complete the adoption process, and only for the dogs on the list NOT marked New Hope Rescue Only). Follow our Step by Step directions below! **PLEASE NOTE – YOU MUST USE A PC OR TABLET – PHONE RESERVES WILL NOT WORK! *** STEP 1: CLICK ON THIS RESERVE LINK: https://newhope.shelterbuddy.com/Animal/List Step 2: Go to the red menu button on the top right corner, click register and fill in your info. Step 3: Go to your email and verify account Step 4: Go back to the website, click the menu button and view available dogs. It should read, "reserve in progress". That is YOUR reserve. Step 5: Scroll to the animal you are interested and click reserve STEP 6 ( MOST IMPORTANT STEP ): GO TO THE MENU AGAIN AND VIEW YOUR CART. THE ANIMAL SHOULD NOW BE IN YOUR CART! Step 7: Fill in your credit card info and complete transaction Animal Care Centers of NYC (ACC) nycacc.org HOW TO FOSTER OR ADOPT IF YOU **CANNOT** GET TO THE SHELTER IN PERSON, OR IF THE DOG IS NEW HOPE RESCUE ONLY! You must live within 3 – 4 hours of NY, NJ, PA, CT, RI, DE, MD, MA, NH, VT, ME or Norther VA. Please PRIVATE MESSAGE our page for assistance. You will need to fill out applications with a New Hope Rescue Partner to foster or adopt a dog on the To Be Killed list, including those labelled Rescue Only. Hurry please, time is short, and the Rescues need time to process the applications. Shelter contact information Phone number (212) 788-4000 Email adoption@nycacc.org Shelter Addresses: Brooklyn Shelter: 2336 Linden Boulevard Brooklyn, NY 11208 Manhattan Shelter: 326 East 110 St. New York, NY 10029 Staten Island Shelter: 3139 Veterans Road West Staten Island, NY 10309 LIKE AND FOLLOW FOR NEW CONTENT EVERYDAY <3 for more visit: www.memelang.ml