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TODAY’S NEWS

It’s going to be a big week for Social Media in Pharma. Here’s the scoop.

Cancer drug Nexavar shows efficacy in breast cancer – Bayer and Onyx Pharmaceuticals‘  cancer pill Nexavar has demonstrated impressive results in treating breast tumours, brokerage Baird said on Monday, citing an abstract from a medical congress…Patients given Nexavar plus Xeloda had a 74 percent improvement in the time they lived without their disease progressing….more

AstraZeneca and Nektar Therapeutics in big licensing deal – Under the agreement, AstraZeneca will develop Nektar’s late-stage drug to treat opioid-induced constipation, NKTR-118, and NKTR-119, which is in its early-stage studies to treat pain without the side effects of constipationmore

Avastin for melanoma? That could be exciting. Melanoma has been notoriously resistant to everything thrown at it.

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100% accuracy for the weather? Announcing…The Weather Channel Classic! (spoof)

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FDA extends review of AstraZeneca/BMS experimental diabetes drug Onglyza.

Teva blocked from launching generic form of Lilly‘s Evista; also rumored to be eyeballing a purchase of Watson.

Roche/Genentech‘s Avastin misses the mark in colon cancer study.

PLUS – you want pharma growth? Sanofi says, Go East! (I know another big pharma also ramping up very rapidly in China…)

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Avastin approved for glioblastoma.

Nice results for experimental blood pressure drug from Gilead Gilead Sciences Inc said on Thursday its experimental drug to treat patients whose high blood pressure is not controlled by other medicines met both the primary goals of a late-stage study, sending its shares 5 percent higher. “In this study, more than half of the patients treated with darusentan achieved goal blood pressure, as compared to approximately one quarter of patients receiving placebo,” Gilead’s research chief Norbert Bischofberger said in a statement.

Pfizer launching Detrol replacement (Toviaz). The most interesting part of the article is what it has to say about less dependence on sales reps for promotion. As the clock ticks down on patents for Pfizer’s $1.2 billion blockbuster drug Detrol, the drug giant is launching a new one to take its place: overactive-bladder remedy Toviaz. The idea is to educate patients while freeing up physicians’ time — and reducing the need for a large sales force. Jim Maffezzoli, senior director-marketing in Pfizer’s new primary-care unit, which is marketing the drug, said the sales force will be “significantly smaller” than before and will be retrained to become more of a partner to physicians and understand their needs.

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Avastin + Tarceva = better results in lung cancerGenentech said the trial was stopped early after an interim analysis found that combining Avastin, known generically as bevacizumab, and Tarceva, or erlotinib, significantly extended the time patients with non-small cell lung cancer lived without their disease advancing.

Amylin‘s leadership under fire from Carl Icahn and others – “While we have not lost faith in the potential of Amylin’s products and pipeline, we have lost confidence in Amylin’s leadership to take this rich product portfolio and execute an operational strategy that is in the best interest of the shareholders…”

Does insulin help protect brains from the development of Alzheimer’s? – Insulin appears to shield the brain from toxic proteins associated with Alzheimer’s disease, U.S. researchers said on Monday, supporting a theory that Alzheimer’s may be a third form of diabetes.

PLUS – the usual rumor mill: blah, blah, blah…Sanofi-Aventis…blah, blah, blah…Bristol Myers-Squibb. You know the drill. And, business advice from the NY Times for navigating through a downturn.

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Sanofi-Aventis suspends sale of Acomplia in Europe. Acomplia, an obesity drug that once looked like it would be a blockbuster for Sanofi-Aventis, is being pulled off the market in Europe. The EMEA, the European version of the FDA, said today that a key committee “concluded that the benefits of Acomplia no longer outweigh its risks and the marketing authorisation should be suspended across the European Union.”…more

Jim Edwards summarizes what he calls Pfizer‘s Race to the Bottom. With some similar commentary on Novartis‘ growth/shrinkage.

Merck announces more big cuts – As part of its earnings announcement, the drugmaker says it expects to eliminate approximately 7,200 positions – 6,800 active employees and 400 vacancies – across all areas of the company worldwide by the end of 2011, with about 40 percent of the total reductions coming in the US (see statement). This amounts to 12 percent of the workforce…more

Pfizer’s Chantix: going down…or up, depending on which continent you’re on…US researchers say even more warnings needed.

FDA: Another day, another stall – U.S. regulators have extended by three months their review of a proposed osteoporosis drug from Pfizer Inc to study the pill in more depth, a company spokeswoman said on Tuesday…more And, while we’re at it, a thumbs down (for now) for Abbott‘s new version of Vicodin. Oh, and hey, let’s delay Abbott’s new cholesterol drug while we’re in foot-dragging mode!

Novartis buys up Nektar’s pulmonary business – Nektar Therapeutics  today announced that Novartis AG has agreed to acquire from Nektar specific pulmonary delivery assets, technology, and intellectual property for $115 million in cash…more

Will BMS lead the charge in buying up undervalued biotechs?

Earnings roundup for Schering, Pfizer, Roche here’s the scoop.

What about Amgen’s growth? An interesting analysis here. Plus – how 6 pharma companies have dodged (or not) the current financial crisis (extracts from earnings announcements from Pfizer, Bayer, Abbott Labs, Gilead, Wyeth and Genentech, all on the topic of how each company has fared in the crisis.)

Celgene seems to be doing quite OK.

J&J’s HIV drug gets expanded approval – U.S. health regulators have expanded approval for Johnson & Johnson’s Prezista in combination with other drugs to treat HIV patients who are just beginning to take medication for the virus, the company said on Wednesday…more

Avastin: what doesn’t this drug do? – After tagging the antibody drug with a radioactive tracer and injecting it into mice, researchers found it successfully targeted cancer cells and this enabled them to produce well-defined images of tumours during scanning…more

Speaking of which, does leukemia drug Campath help stop early stage MS? Fascinating possibility – A drug developed to fight leukemia appears to stop multiple sclerosis in its early stages and restore lost function to patients, British researchers said on Wednesday…more

Forest Labs growing green – Forest Laboratories Inc posted higher-than-expected quarterly profit on Tuesday, fueled by stronger sales of its drugs for Alzheimer’s disease and depression and lower research spending…more

Biologics and safety concerns: really not a big surprise here – Approximately one in four biologics approved since 1995 in the US and Europe have had at least one safety-related regulatory action issued for them 10 years after their approval, including about 11 percent receiving a Black Box warning, according to a study in the Journal of the American Medical Association…more

Take a Chill, Pill: are oral cancer drugs all they’re cracked up to be?

B-I has some encouraging potential early results for novel cancer drugs.

The WSJ talks about healthcare, IT, and the future. Interesting stuff.

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J&J announces leadership transition – Johnson & Johnson appointed Sheri McCoy, leader of its surgical care group, on Thursday worldwide chairman of its pharmaceuticals group, effective Jan. 1. McCoy will replace Christine Poon, whose departure from J&J was announced last month. Poon, who has also served as J&J’s board vice chairman, plans to step down in March…more

Teva and AZ in a tiff about Crestor patents.

FDA to Takeda on Alogliptin review: Sorry, understaffed! – Takeda Pharmaceutical Co, Japan’s biggest drugmaker, said on Friday that U.S. health authorities have not been able to complete a review of a key diabetes drug candidate on schedule due to lack of resources…more

AZ‘s PurplePill website continues to generate impressive traffic numbers.

1 in 4 teenage girls have received Gardasil – Whether this means Merck’s HPV vaccine is making great inroads is unclear, but Gardasil does appear to be on its way to becoming accepted, according to the first federal government study of vaccination rates for the controversial shot…more

Rituxan OK’d for cancer treatmentRheumatoid arthritis drug Rituxan helps to fight cancer, but now its makers can actually share that with the world…more

Watson gets approval for Rapaflo for BPH – Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved RAPAFLO(TM) (silodosin), the company’s new alpha blocker for the treatment of the signs and symptoms of BPH…more

Neurontin: the gaffe that keeps on taking – Pfizer Inc  tried to suppress medical studies that did not support the use of its epilepsy drug Neurontin, internal Pfizer documents submitted in a U.S. lawsuit against the company showed…more

St. John’s Wort for depressiondoes he or doesn’t he?

Drug samples under attack!

Eli Lilly buying up ImClone.

Dendreon’s Provenge has some tantalizing data, but still must wait – Amid the stock sell-off, a bright spot appears and, of all things, it turns out to be Dendreon, the controversial and much-maligned little company that continues to press ahead with its Provenge prostate cancer vaccine…more

Another university looks at banning pharma gifts – A university medical school task force recommends prohibiting faculty, medical residents and students from receiving gifts from drug and device makers, according to an unreleased report obtained by The Minnesota Daily, the university’s newspaper. Docs would also be required to disclose all relationships with a drugmaker before writing a prescription and create a website to report conflicts…more

King and Alpharma start talking – Are you surprised? After the usual posturing and harsh language, the two drugmakers have agreed to a confidentiality agreement, according to a filing with the US Securities and Exchange Commission…more

Who should get Avastin? Genetic tests may tellGenetic tests could in future show who will respond best to Genentech and Roche’s blockbuster cancer drug Avastin — a positive development for patients but not necessarily for sales…more

Spiriva: more not-so-great mixed results – Spiriva, marketed by Pfizer and Boehringer Ingelheim, offered no advantage over an inhaled placebo for moderate-to-very-severe chronic obstructive pulmonary disease, or COPD, researchers reported on Sunday…more On the other hand, Novartis has a promising new COPD candidate doing well in mid-stage trials.

Peter Rost whistleblower suit against Pfizer gains new traction.

Good results for Remicade in combo treatment – Crohn’s disease patients taking Johnson & Johnson’s (JNJ.N: Quote, Profile, Research, Stock Buzz) Remicade either alone or with azathioprine experienced steroid-free remission in significantly greater numbers than those taking azathioprine alone, according to results of a clinical trial…more

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The Xa factor: not looking so promising for Pfizer and Bristol – Bristol-Myers Squibb and Pfizer’s apixaban blood clot preventer raised rates of bleeding in a 6-month study but showed some encouraging signs of protecting at-risk heart patients, researchers said on Tuesday. Apixaban, which works through a new mechanism of action by blocking a protein called Factor Xa, suffered a setback last week when it failed its primary goal in a late-stage trial for preventing clots after orthopaedic surgery…more A little more promising for Daiichi Sankyo, however. 9/2

This potential advance on a drug to treat Hepatitis-C is quite interesting…especially if you really like medical-technical terms! 9/1

Sciele bought by Japanese pharma company: Shionogi & Co plans to buy U.S.-based Sciele Pharma Inc for $1.1 billion, the fourth big overseas deals in nine months by Japanese drug makers eager to expand overseas…more 9/1

Prasugrel (investigational anti-clotting drug) shows strong results in diabetic patients – Patients who were diabetic and diagnosed with acute coronary syndromes (ACS) were 40 percent less likely to suffer a heart attack if they were treated with prasugrel vs. clopidogrel…more 8/31

Crestor a no-go on heart failure – AstraZeneca Plc’s cholesterol drug Crestor has failed in a second clinical trial for heart failure, suggesting such statin medicines don’t improve survival in patients with the chronic condition…more 8/31

Glaxo does not score with preemption ruling in suicide case. I’m sure the lawyers are loving this. 8/30

A little fun – The Top 10 Weirdest Pharma Stories of the Month. 8/30

Anti-psychotics may double stroke risk – People taking antipsychotic drugs are nearly twice as likely to have a stroke compared to those not on the treatment, British researchers reported on Friday…more 8/29

A swipe at glitazones for diabetes treatment (from PharmaGossip) 8/29

Good news from Teva on Parkinson’s treatment: Teva Pharmaceutical Industries Ltd. said its Azilect pill is the first to slow the progression of Parkinson’s disease in new findings that may increase sales of the medicine to more than $1 billion…more 8/28

A few baby steps into social media by pharma companies. 8/28

Stroke prevention with drug combos: maybe not so much – Two studies released on Wednesday call into question the advantage of using a blood pressure medicine and a well-known blood thinner for preventing the recurrence of a stroke…more 8/28

UCB brings out a heavy axe – The Belgian drugmaker that bought Schwarz Pharma is cutting 2,000 jobs, or 17 percent of its staff, to spur profits and lower administrative costs. The move is part of an effort to redirect $444 million into research on meds for immunology and the central nervous system…more 8/28

Amgen getting rid of “bundling sales” practice (it’s about time) – the company is getting rid of “bundling” — giving docs discounts on other Amgen drugs based on how much of their anemia-drug business consisted of Amgen’s Aranesp…more 8/28

Cell Genesys plunges after troubling trial results…butRecent news of high fatalies during one its drug trials has weighed on Cell Genesys‘ stock price, but the company may be able to overcome the blow

if data from a different study helps it gain FDA approval…more 8/28

Replidyne plunging downhill fast – Drug developer Replidyne Inc said it will restructure its operations, reduce its headcount by about 80 percent to 5 employees and take a charge of $3.1 million…more 8/28

From Forbes: Vytorin efficacy questions still nipping at the heels. And, the cancer scare. 8/28

More bad pancreatitis news with Byetta. 8/27

An interesting analysis of Abbott’s strengths and weaknesses moving forward. 8/27

Lilly’s Cymbalta: a Swiss army knife drug with too many indications? 8/27

BMS/Pfizer new blood clotting drug not flowing smoothly – Bristol-Myers Squibb Co and Pfizer Inc said on Tuesday their apixaban blood clot preventer failed its primary goal in a late-stage trial, and that they no longer plan to seek marketing approval next year for the pill…more 8/27

Scrips and tripspharmas paying out big for “medical education” junkets 8/25

So now we have the Ambien rooster?? 8/25

Amgen gets drug approval from FDAAmgen Inc drug Nplate is safe and effective for treating a rare clotting disorder that can cause dangerous bleeding, the Food and Drug Administration said on Friday in approving the product for U.S. sales…more 8/25

King making bid for Alpharma – The unsolicited cash bid is a move to create a bigger specialty drugmaker and expand a nascent effor to develop meds for treating pain. The offer is $33 per share amounts to a 37 percent premium over the $24.04 closing price of Alpharma’s common stock yesterday. King actually first made the offer to Alpharma in a letter on Aug. 4 and said the offering represents a 49 percent premium, based on the share price that day…more 8/22

After all that battering in the press, a positive spin on HRT – Hormone replacement therapy can improve the quality of a woman’s life, easing the distress of hot flashes, sleep disturbances and restoring lost sexual functioning, researchers reported on Thursday…more 8/22

A promising experimental cystic fibrosis drug (PTC Therapeutics) 8/22

Abbott Diagnostics planning big cuts – Abbott Laboratories Inc  said on Thursday it would eliminate about 1,000 jobs over the next four years as part of a plan to streamline operations and cut costs in its medical diagnostics business…more 8/22

Genentech employees getting restless about potential Roche takeover: recruiters circling, retention bonuses adding up -Aside from announcing that Genentech is not settling for Roche’s $44 billion offer because it “substantially undervalues the company,” the San Francisco-based biotech made it known that if would be implementing an employee-retention program to help its people make sense of the Roche deal… more 8/22

Gilead Sciences – growing! 8/22

J&J’s Doribax for pneumonia: more info, please. 8/21

Buying out biotechs – A buyout bull’s-eye will likely remain on biotechnology companies over the next few years as major pharmaceutical companies continue taking advantage of a weak dollar and a surplus of cash to buy pipeline additions….more 8/21

Wyeth, Elan, and Alzheimer’s: is this experimental drug worth the pursuit? – In what is becoming a sadly common ritual, Wyeth and Elan are pressing forward with an expensive, large-scale “phase III” trial of a risky drug based on wishful thinking and shoddy statistical analysis…more 8/21

Expensive cost cutting at Sepracor. 8/21

Gardasil – not worth the cost? – That’s the conclusion of a new study that is going to make life much harder for Merck to wring needed sales out of its controversial HPV vaccine. The study, which appears in the New England Journal of Medicine, comes as the drugmaker is already struggling to convince college-age and older women to get the vaccine, which costs about $360 for a three-dose regimen….more 8/21

Might daily Cialis help with symptoms of enlarged prostate? 8/20

Just came across this BNET Industries site which consolidates Pharma news. Looks pretty good! 8/20

Feel like debating a single-payer (government-run) healthcare system? Here’s a lively debate, from the WSJ Health blog (see the comments). 8/20

Roche, Accutane, and IBD – is there any link? 8/20

Clinical trials: cancer gets the lion’s share – Most registered trials were in oncology, followed by central nervous system disorders, cardiology, infectious diseases, endocrinology, and respiratory diseases. These six therapeutic areas accounted for 68 percent of 3,515l protocols…more 8/20

BMS and PDL go after MMLBristol-Myers Squibb Company and PDL BioPharma, Inc.  today announced an agreement for the global development and commercialization of PDL BioPharmas anti-CS1 antibody, elotuzumab, previously known as HuLuc63, currently in Phase I development for multiple myeloma…more 8/19

Vytorin prescriptions: hitting bottom? 8/19

My pipeline’s bigger than your pipeline – who’s got the goods to be able to claim it? You might be surprised… 8/18

Warning on deaths associated with Byetta – The FDA is working on a stronger label for the widely used diabetes drug, which is marketed by Lilly and Amylin Pharmaceuticals after deaths continue to be reported despite earlier government warnings. Six new new reports were received of patients developing a dangerous form of pancreatitis while taking Byetta… more 8/18 But, fair balance 8/20

Jersey jobs walking out – Layoffs and restructurings are taking a toll on drug and device makers in New Jersey, which for decades has prided itself on being home to many of the world’s biggest such companies…more 8/18

Was a key Vioxx study less than scientifically stellar? – A 1999 Merck study of Vioxx, which was touted to participating doctors and patients as easier to stomach than another drug, was primarily a stealth marketing strategy, according to a report to be published this week in The Annals of Internal Medicine…more 8/18

Do “charming” sales reps earn more? (from John Mack’s Pharma Marketing blog). And, in a similar vein: D’uh! 8/18

What’s Next? Ban Free Drug Samples? (from John Mack’s Pharma Marketing blog). 8/18

Which presidential candidate has received more donations from pharma execs? By a factor of three? 8/18

Abbott to co-promote Crestor – Seeking to increase its share of voice without beefing up its sales force, AstraZeneca is partnering with Abbott on a co-promotion of Crestor in the US…more 8/14

New antibody drug helps nail blood cancer – A new kind of antibody drug that makes the body’s own “killer” cells fight tumors has produced promising early-stage results in patients with a deadly form of blood cancer, researchers said on Thursday…more 8/14

Genentech to Roche: No thanks, but maybe. 8/13

MS drug may work against viral infection – A drug that Novartis AG is testing in people with multiple sclerosis also has the potential to treat certain viral infections, perhaps including the AIDS virus, U.S. researchers said on Wednesday….more 8/13

FDA extends review of Centocor drug – Centocor, Inc., today announced that the U.S. Food and Drug Administration (FDA) hasextended the review timeline for the Biologic License Application for ustekinumab, a subcutaneous biologic therapy, by three months to December 2008. The application, filed by Centocor late in 2007, seeks approval to market ustekinumab for the treatment of adult patients with chronic moderate to severe plaque psoriasis…more 8/8

It’s a slow year so far for FDA drug approvals 8/8

Go ahead, Massachusetts…make my day – This morning, five trade groups representing drugmakers and biotechs took out a full-page ad in The Boston Globe arguing the bill will “significantly curtail, if not end altogether, the availability of these last hope clinical trials in Massachusetts….more 8/7

Kidney cancer drugs too costly? Yes, says UK – Is extending life by a few months worth $50,000? No, says the UK’s National Institute for Health and Clinical Excellence. In a report out today, the group concluded that several new drugs for advanced kidney cancer aren’t cost-effective…more 8/7

King Pharma income takes a plunge. And some other question marks about an upcoming pain treatment here. 8/7

Rituxan may help a kidney disease – The cancer drug rituximab can help heal the kidneys of patients with a common condition known as membranous nephropathy, Italian researchers reported on Wednesday…more 8/6

Eat your broccoli! 8/6

Artificial blood producing genuine problems. A recent meta-analysis of trials on several substitutes — including Hemopure — contains some gory results. Turns out, the fake bloods scavenge nitric oxide, causing vasoconstriction; patients who get them are 2.7 times more likely to have a heart attack and 30 percent more likely to die… 8/6

Abbott dips into podcasting (for Chrohn’s patients). 8/6

Live long and prosper, with Byetta? – Can Byetta, an injectable drug that lowers blood sugar, really help people with diabetes to live longer? Possibly, according to the results of a major clinical trial presented at the American Diabetes Association annual conference…more 8/6

Which pharma company will be biggest in 2014? The projections might surprise you… 8/6

FDA to advertise fake blood pressure pill – OK, that’s weird… 8/5

Maybe sleep meds not so great – In its latest bid to track prescription drug use, Consumer Reports conducted a survey last spring of 1,466 Americans who took sleeping pills and found that nearly half have difficulties. Consquently, many are turning to prescription meds with what CR calls “frightening results.” Here they are…more 8/5

Rutgers unveils mini-MBA program for pharma professionals. 8/5

Feel-good story about Sinemet helping a young boy who has Parkinson’s. 8/5

SGP entangled with a whistleblower mess (inherited from Organon) – Last month, Schering-Plough’s lawyers filed a motion in federal court in New Jersey arguing that a former medical director at Organon, which the drugmaker recently paid $14.3 billion to acquire, wasn’t qualified to bring a whistleblower lawsuit alleging Organon covered-up serious side effects prior to launching two drugs several years ago…more 8/5

The Medicines Company gets approval for cleviprex – The Medicines Company announced today that the U.S. Food and Drug Administration (FDA) has approved the intravenous (IV) therapy CleviprexTM (clevidipine butyrate) injectable emulsion for the reduction of blood pressure when oral therapy is not feasible or not desirable…more 8/4

Careful about giving cold meds to babies – Yet another study raises questions about the dangers of giving cough and cold meds to babies. A “surprising” number of small children taken to emergency rooms after they stop breathing or lose consciousness have OTC meds in their systems, USA Today writes, citing the study in Pediatricsmore 8/4

Beware of Mass. reps bearing gifts – When Massachusetts’ House of Representatives approved a big healthcare bill last month, drug and device makers and data firms thought they’d ducked several bullets, but the final bill, passed by both houses last night, includes a few nasty surprises for industry – including a code of conduct for drug marketers, an academic detailing program and stringent reporting requirements for payments to physicians…more 8/4

GSK cutting down oncology personnel – The ax is falling again at GlaxoSmithKline (GSK). This time it’s the oncology group… more 8/4

Who might be next in the pharma takeover phrenzy? 8/4

A doctor’s balanced perspective on the recent Vytorin kerfuffle. 8/4

Schering announces encouraging results for experimental Hep-C drug – Schering-Plough Corp  said on Monday that interim results from a mid-stage study of its experimental hepatitis C drug showed promising results, sending shares of rival Vertex Pharmaceuticals Inc down more than 10 percent in early trading…more 8/4

Novartis get two big approvals for HPB combo pills – The US Food and Drug Administration (FDA) has approved two single-pill combination medications, Diovan HCT® (valsartan and hydrochlorothiazide) and Exforge® (amlodipine and valsartan), as initial or ‘first-line’ therapies in patients likely to need multiple drugs to achieve their blood pressure goals…more 8/4

Good news on statins and memory loss – People at high risk for dementia who took cholesterol-lowering statins are half as likely to develop dementia as those who do not take statins, a new study shows…more 8/4

New/old cancer treatment: methadone effective against leukemia! – “Methadone kills sensitive leukemia cells and also breaks treatment resistance, but without any toxic effects on non-leukemic blood cells…”more 8/4

Backing away from CME – Trying to steer clear of potential conflicts of interest, two medical industry giants are distancing themselves from a little-known breed of marketing specialists. The recent steps by the drugmaker Pfizer (PFE) and Zimmer Holdings (ZMH), a medical device manufacturer, illuminate subtle promotional tactics other companies continue to aim at doctors, despite mounting concern on the part of some physicians and ethicists…more 8/4

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