Clin­ton’s chief strate­gist urged tough drug stance that aimed straight for the "cost pain point”

Hillary Clin­ton, cred­it: Max Gold­berg

Last fall, Bernie Sanders, Hillary Clin­ton’s chief De­mo­c­ra­t­ic op­po­nent in the pri­maries, was get­ting promi­nent at­ten­tion for his at­tack on drug com­pa­nies. In the words of Joel Be­nen­son, Clin­ton’s chief strate­gist, Sanders’ mes­sage was: “drug com­pa­nies are screw­ing Amer­i­cans three ways to Sun­day and he’s go­ing to put an end to it.”

Be­nen­son, in an email from Sep­tem­ber 16, 2015 which was hacked by Wik­iLeaks, want­ed to do some­thing about it, aim­ing straight for the “cost pain point” felt by the Amer­i­can con­sumer. And he out­lined a num­ber of steps that could put Clin­ton ahead on the is­sue, tack­ling some of the holi­est cows on Big Phar­ma’s ranch­ing the process.

Why aren’t we call­ing for an end to tax de­duc­tions for di­rect to con­sumer ad­ver­tis­ing of pre­scrip­tion drugs and for sam­pling to docs? They are spend­ing hun­dreds of mil­lions to goad con­sumers in­to ask­ing for drugs from their doc­tors they shouldn’t get tax breaks for do­ing it.  (I would go fur­ther and con­sid­er ban­ning TV ad­ver­tis­ing to con­sumers,  (I know there may be 1st amend­ment rights; al­though we do ban cig­a­rette ads).

We have to make sure that what­ev­er our plans are here – they are sim­ple, di­gestible and ad­dress a re­al cost pain point with a clear so­lu­tion that fix­es it.  Things like cost shift­ing to em­ploy­ers/in­sur­ers seem less like bold so­lu­tions that will bend the cost curve down and ul­ti­mate­ly could leave us open to an easy at­tack from Sanders that “HRC’s plans aren’t bold, don’t change the sys­tem of cor­po­rate greed in health care and will end up mak­ing you pay more one way or an­oth­er while drug and in­sur­ance com­pa­nies con­tin­ue to make mass prof­its at your ex­pense. ”

Seems to me that our pro­pos­als have to be able to counter that.

Clin­ton made her po­si­tion on drug pric­ing a key is­sue dur­ing her cam­paign, which in­flict­ed con­sid­er­able dam­age on biotech share prices. As we re­port­ed ear­li­er, her tweets and state­ments on the is­sue had been care­ful­ly craft­ed by a team that was con­vinced that at­tack­ing phar­ma com­pa­nies was a sure-fire method for spurring sup­port.

Five days af­ter Be­nen­son sent his email, Clin­ton would mount a di­rect at­tack on Mar­tin Shkre­li, the volatile biotech ex­ec who had in­curred the wrath­ful at­ten­tion of a vi­ral on­line mob for his de­ci­sion to boost the price of Dara­prim by more than 5000%. And in the af­ter­math, Ann O’Leary, a se­nior pol­i­cy an­a­lyst on the Clin­ton team, would ex­ult: “FYI — We have start­ed the war on phar­ma!!”

(Shehla Shakoor con­tributed to this sto­ry.)

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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Tal Zaks. Moderna

The mR­NA uni­corn Mod­er­na has more ear­ly-stage hu­man da­ta it wants to show off — reach­ing new peaks in prov­ing the po­ten­tial

The whole messenger RNA field has attracted billions of dollars in public and private investor cash gambled on the prospect of getting in on the ground floor. And this morning Boston-based Moderna, one of the leaders in the field, wants to show off a few more of the cards it has to play to prove to you that they’re really in the game.

The whole hand, of course, has yet to be dealt. And there’s no telling who gets to walk with a share of the pot. But any cards on display at this point — especially after being accused of keeping its deck under lock and key — will attract plenty of attention from some very wary, and wired, observers.

“In terms of the complexity and unmet need,” says Tal Zaks, the chief medical officer, “this is peak for what we’ve accomplished.”

Moderna has two Phase I studies it wants to talk about now.

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It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. But the idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

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Rit­ter bombs fi­nal PhI­II for sole lac­tose in­tol­er­ance drug — shares plum­met

More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.

This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).

Ear­ly snap­shot of Ad­verum's eye gene ther­a­py sparks con­cern about vi­sion loss

An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy.

Adverum, on Wednesday, unveiled 24-week data from the OPTIC trial of its experimental therapy, ADVM-022, in six patients who have been administered with one dose of the therapy. On average, patients in the trial had severe disease with an average of 6.2 anti-VEGF injections in the eight months prior to screening and an average annualized injection frequency of 9.3 injections.

Alex Ar­faei trades his an­a­lyst's post for a new role as biotech VC; Sanofi vet heads to Vi­for

Too often, Alex Arfaei arrived too late. 

An analyst at BMO Capital Markets, he’d meet with biotech or pharmaceutical heads for their IPO or secondary funding and his brain, trained on a biology degree and six years at Merck and Endo, would spring with questions: Why this biomarker? Why this design? Why not this endpoint? Not that he could do anything about it. These execs were coming for clinical money; their decisions had been made and finalized long ago.

Arde­lyx bags its first FDA OK for IBS, set­ting up a show­down with Al­ler­gan, Iron­wood

In the first of what it hopes will be a couple of major regulatory milestones for its new drug, Ardelyx has bagged an FDA approval to market Ibsrela (tenapanor) for irritable bowel syndrome.

The drug’s first application will be for IBS with constipation (IBS-C), inhibiting sodium-hydrogen exchanger NHE3 in the GI tract in such a way as to increase bowel movements and decrease abdominal pain. This comes on the heels of two successful Phase III trials.