“They’ll see how beautiful I am — and be ashamed — I, too, am America.” — Langston Hughes

September 24, 2016 - Leave a Response

mrk-2-fisk-jubilee-singers1882pngYesterday (by the time most of you read this, as I’m late in getting to it), at around noon-time, our 44th President spoke at the opening ceremony of what is certainly the definitive museum of African American History in these United States.

Like the countless stories of the peoples it documents, this project has traveled a slow and winding road. But now, it is open — in D.C. — and I will be there very, very soon to see it, with my own eyes.

As President Obama said, it is, in truth a series of stories that is the story of all of America. I might add that — though tinged with significantly more adversity — than the average American narrative, as these interlaced series of narratives unfolded over the last four hundred plus years in America — astonishingly, far more often than not, they brought glory to all the people of this nation. Despite what the Ohio County Chairwoman (now replaced) for the Trump campaign has said, it is a story of immense successes — against very, very long odds. Odds long stacked primarily by white men, and this nation’s laws, against even a chance to read — let alone advance. But as the museum’s collection well-documents, advance so many did.

I’ll choose just a small bit of the material that the White House historians themselves have contributed to the museum, as my imagery at right, and pull-quote focal point, below.

I know those of you with a real thirst for a non-sugar coated version of our history — American history — will visit in person. So I’ll choose just this one smallish glass case that most of the MSM has overlooked, at least for today:

. . . .[The image is. . . the] Fisk Jubilee Singers, a choir from the Fisk University in Nashville, Tennessee that first opened its doors during the Civil War for former slaves, became the first African American choir to perform at the White House in 1882. . . .

The group was originally organized as a fundraising effort for Fisk University. . . . At several points, the university faced serious financial difficulty. To avert bankruptcy and closure, Fisk’s treasurer and music director, George L. White, a white Northern missionary, gathered a nine-member student chorus to go on tour to earn money for the university. On October 6, 1871, the group of students, consisting of two quartets and a pianist, started their U.S. tour under White’s direction. They first performed in Cincinnati, Ohio. Over the next 18 months, the group toured through Ohio, Pennsylvania, New York, Connecticut, Rhode Island, New Jersey, Massachusetts, Maryland, and Washington, D.C. . . .

After a concert in Cincinnati, the group donated their small profit, which amounted to less than fifty dollars, to the relief to the victims of the Great Chicago Fire of October 1871. As soprano Maggie Porter recalled, “We had thirty dollars and sent every penny to Chicago and didn’t have anything for ourselves. . . .”

The group was awarded the 2008 National Medal of Arts during the Administration of President George W. Bush. . . .

Lovely. Just. . . lovely. Here we learn more about several (very likely) former slaves — sent out on the road — to try to keep this now storied Nashville institution of higher learning for people of color from going under, in its earliest days. They likely awoke one morning in October, only to read — in the Cincinnati papers — of the Chicago Fire of 1871. And they chose to send every penny on, to relief efforts, without any more self-interested thought.

That my friends is the history of America — this is no separate history museum — this IS American history. It is right well and good that the narrative be focused there — on African Americans. Make no mistake (as the President said) — this museum also shows us that love of country sometimes includes a need to speak out, when she is wrong — to address her short-comings. That too is patriotic — and that too is (as Mr. Hughes wrote). . . America. And we know Mr. Trump would be the polar opposite of all of that. I do trust that HRC completely understands how many voices, sometimes even rightfully discordant voices, are what makes America the great place that it is today. Still flawed, true — but so much progress. So much. I do love America — and I respect every story she tells.

नमस्ते

WSJ: China’s FDA Now Allowing Keytruda® — But Only On Its Hainan Resort Island Pilot “Medical Tourism” Basis…

September 24, 2016 - Leave a Response

mrk2-keytruda-hainan-med-tourism-2016 It would seem (per the WSJ, yesterday) that the party elites in China (and I suppose wealthy people throughout Southeast Asia, generally) who can afford to fly to Hainan, and stay on the tony resort island, will now be able to get an immuno oncology agent not yet approved by China’s FDA — for its vast mainland population.

I suppose in the grand scheme of things, Kenilworth’s Keytruda® (pemrolizumab) was never going to be offered in a setting affordable, on China’s mainland, for perhaps 99.999 per cent of its population. And so in my analysis, the Chinese government has made a decision to keep the elites’ spending power inside the confines of the broader Chinese economy on this score. Obviously, but unstated in the article — if wealthy Chinese oncology patients fly to Australia, Hong Kong or the US — all that spending power departs the Chinese economy, as they go.

[In this regard, while the hospital itself is required to be 100 per cent non-China owned, all the ancillaries — the resort hotels, meals, clothing and travel purchases made, while on the island (family included) do clearly benefit some set of these same Chinese party elites, in all likelihood.]

So I suppose it doesn’t matter all that much, that the elites will fly to Hainan — instead of taking their money to Hong Kong. But in my opinion, it certainly reminds the world that there are two systems of health care, increasingly globally now — the system the elites are able to purchase, out of pocket, and the non-system(s) the rest of the world makes due with. Here is a bit from yesterday’s Journal:

. . . .An institution affiliated with Hainan Health and Family Planning Committee announced on its account on the WeChat messaging platform late Thursday that Keytruda will be the first imported drug used in a cancer hospital in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan.

Set up in 2013, the zone sets special rules on foreign investment, such as 100% foreign ownership in hospitals and fast-track approvals for new drugs and medical devices. The hospital gained approval from the China Food and Drug Administration to import Keytruda this March, and will import more foreign cancer drugs based on patients’ need, according to the announcement. . . .

sgp-china I am not so naive as to think the same sort of rationing doesn’t occur world-wide — and it makes economic sense for Merck to play along — benefitting its shareholders, but it is an uncomfortable feeling, at bottom, I’m left with: those who have will live longer, and generally better, than those who. . . have not (or have less).

And saying it has always been so, doesn’t really make it. . . right. Onward, humbly aware that I am blessed to be as comfortable, and healthy, as I am here. Do go be excellent to one another, whenever you possibly can.

नमस्ते

In Pharma PAC-Land, This 2016 Cycle Has Been Unlike Any In Recent Memory — In Fracturing Members Of PhRMA

September 23, 2016 - Leave a Response

This morning, a local New Jersey outlet is explaining how Merck’s PAC (in breaking with prior practice, and locking arms with Lockheed — another big NJ employer — and defense contractor) did not contribute to the Republican Fund for its Nominating Convention, in Cleveland in 2016. I obviously think that was not a snub of the city, or the fine people of Cleveland(!), or the RNC generally, as the Merck PAC did donate to lots of both GOP and Democratic Senate and House candidates this cycle. As did Pfizer, to be fair.

No, I think Kenilworth’s PAC was expressing an opinion (by its omission) on the nominee, himself. I’ve used the press report as a springboard for a slightly different (but to me, more interesting and nuanced) story — comparing Merck to Pfizer, led by Ian C. Read — and that PAC’s 2016 patterns.

As my graphic indicates, Pfizer’s PAC showed no such compunction. Which is a bit odd, given that both Presidential candidates call Manhattan home (also Pfizer’s HQ location). Near as I can tell, the Pfizer PAC did not donate to the Democratic Convention Fund — at all. In 2012, Pfizer favored Mitt Romney over President Obama (oops, on that!), in this regard — while Merck made equalized donations.

If Mr. Read is sending a message to HRC, here — about her stated positions on pharma price reform measures, I’d gauge that mission as decidedly “ill-starred“. I’m on record, and remain so — HRC will be our 45th President. And Merck is wisely looking to partner with her, in a constructive dialogue.

[Ever one to hedge my bets. . . I’m not all the way down with moving my practice, and relaxed life generally, to Europe for four years, should the Trumpkin prevail — but I could pretty effortlessly do that — seriously considering it, only to the extent that he has any plausible chance of being elected. Sheesh.] In any event, here’s a bit from the short NJ.com article:

. . . .Merck & Co. and Lockheed Martin, who each gave $250,000 to the host committee helping to stage the Republican National Convention four years ago, kept their corporate checkbooks closed this time around when the party gathered in Cleveland to nominate Donald Trump. [My editorial note: To be fair, the GOP Convention in 2012 was held in an important power-base, for both Lockheed and Merck. Not so, Cleveland. . . .]

The companies were absent from the list of contributors that gave $67.4 million to the Cleveland host committee, according to Federal Election Commission filings. . . .

I’ll likely offer a few more of these socio-political out-takes, given that we are now in the home stretch of Election Cycle 2016.

In addition, my masthead pull-quotes will almost uniformly express disdain for the Republican nominee’s disrespect for our constitutional rights (except the Second Amendment, of course!), abandoning our core founding values — of pluralism and inclusion, of peoples from all over the globe. Moreover, I am deeply troubled by Mr. Trump’s open hostility to our citizenry of color (praising aggressive “stop and frisk” operations under then NYC Mayor Rudy Guiliani, which have since been held unconstitutional — as violative of the 14th Amendment’s Equal Protection clause — i.e., it turned out that 83 per cent of those stopped and frisked were people of color — so Mr. Trump’s message here is plain — and disgusting).

Whew. Even so, I enter the weekend with a crinkle-eyed grin. . . out, for some fun!

नमस्ते

Legacy Schering-Plough Federal NuvaRing® MDL: Next Status Hearing Set For January 18, 2017

September 23, 2016 - Leave a Response

We mentioned this was scheduled, last week. The parties were in court for about an hour on September 15, 2016, in the Eastern District of Missouri — discussing next steps for the distribution of the $100 million, and then the ultimate remand of the opt-out cases and plaintiffs — to their respective home (originating) districts.

The next date for status was agreed as January 18, 2017.

We will keep an eye on that.

Now you know. Onward — <I>smiling broadly, under gray skies, for a coming travel weekend</I>. . ..

नमस्ते

Jupiter’s Europa: NASA Press Conference From Hubble Team, Come Monday; Glitch Repaired — Back Online

September 22, 2016 - Leave a Response

Ahem. As often happens, the pending news from/of Europa has put me in mind of a moldingly old poet, from my catechetical youth. [Trivially, it also seems we are fully back in the saddle, with the live updating (and a mobile enabled) stats interface. Sweet.]

To the mold, then: Edgar Allen Poe doth writ, and read quite well (grin!): “I gazed awhile, on her cold smile” and realized I “more admire thy distant [sienna-hued, golden flecked] fire, than the colder, [closer] lowly light. . . .”

Where was I? Oh. Right. NASA’s Hubble team will hold a press conference webcast Monday, about developments observed by the great space telescope — at Europa. It is widely thought that — due to the unimaginably immense, completely irresistible and constantly pulling, twisting, mashing and crushing tidal forces of Jupiter’s behemoth gravity, tugging on the little shepherd moon — her moon Europa may in fact be very, very warm, underneath that darkly ruddy-sienna ice shelled exterior. Grin. In fact, it likely supports an undulating, rotating, hot water vented ocean. And all of that is not at all unlike what we expect primordial Earth’s oceans were once like.

If you cannot already tell, I am going to be glued to that web-cast — for any hint of primordial microbes, off-planet. But we will take a deep breath, and take one space science step, at a time.

Until Monday, at 2 PM EDT, then — here is Poe — in full (imaged, at right).

And so, we do draw — day by day — and mission by mission, inexorably closer to proof that at least microbial life exists off-planet. Even right here, in our local neighborhood. Ever onward we drift — forward, admiring that fire, from afar. . . a fire driven by the laws of attraction. . . on a celestial scale. Smile. Be excellent to one another. The Goddesses would want it that way.

नमस्ते

Unfortunate Technical Glitch: Live Updates Off-Line For A Bit

September 21, 2016 - Leave a Response

StatCounter is a great free service. I’ve relied on it for just over four years, to handle most of my live updating abilities, by mobile phone.

At the moment, that server is returning a “DNS error.”

It has been off-line, or only intermittently on-line, since early yesterday evening. So, I’ve had no live data, since 4:30 PM EDT yesterday.

They hope to have it fixed soon — but I am flying blind here. Thus updates will be hard to come by — unless I am seated in a perfect environment. Or unless service is restored to the mobile (i.e., cellular, non-wi-fi) environment.

In the mean-time (continuing my fascination with golden flecked watery lit!), let us ponder the enduring mystery of the epitaph on Keats’ headstone (of nearly 195 years past):

. . .There’s no doubt that Keats foresaw his death with brutal clarity. The question that begins in the London Keats House and continues in Rome—both at the Keats-Shelley House and at Keats’s gravesite—is how exactly he felt about that. Surely heartbroken, frightened, frustrated, despairing. But the words that he asked his friends to have carved into his gravestone—only these words, not his name—conjure an enigma: “Here lies One Whose Name was writ in Water.”

Is this epitaph an angry protest against the unfairness of a fate that appeared to have deprived him of a chance of immortality, or an almost zen-like statement of resignation and of the impermanence of all existence?. . . .

Writ in water, indeed. Onward, just the same. Smiling in the pelting rain.

नमस्ते

Irregular Merck Update Teleconference: SUNDAY October 9, 2016, 12:30 PM EDT, In Copenhagen — Accommodating EU Schedules

September 20, 2016 - Leave a Response

I will not cover this, as I will be off-grid on that day, and at that time, at an Iron Man, down South (cheering on, not competing — not yet!), but this one might be worth a listen.

During this call, Kenilworth will take analysts’ questions, and press questions, and host listen-ins, as it walks through the new information on immuno-oncology it will offer, at an important European medical conference called ESMO. Here’s a bit, from Yahoo Finance, just a moment ago:

. . . .Merck, known as MSD outside the United States and Canada, will host a teleconference for investors following the presentation of data at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen, Denmark, Oct. 7 – 11. The call will take place on Sunday, Oct. 9 at 6:30 p.m. CEST (12:30 p.m. EDT). Company executives will provide an overview of data presented and address questions. Investors, journalists, and the general public may access a live audio webcast of the call on Merck’s website. . . .

Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782 and using ID code number 84673546. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 84673546. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call. . . .

Now you know. Onward, on a gorgeous Tuesday morning here. . . .

नमस्ते

A Small Word Of Encouragement — To The Middle Division’s Young Scientists, At Berkeley Prep — In Tampa, FL…

September 19, 2016 - Leave a Response

I used to see these sorts of “educational” traffic spikes, more often around five years ago — but this will be the first time I’ve publically remarked on them.

I am doing so, solely to encourage all the young government studies students, and budding pharmaceutical scientists out there, researching for credible blog information on drugs and biologics policies, to keep at it.

The assignment (as your web site materials suggest) is to find blogs that seem unbiased, reliable and documented by research. We hope we fit the bill, on those scores. Smile.

So, here is to all of you — not just in Tampa, but nationwide — and in fact world-wide: you young women and men, you who will lead us all into the future — use your time in class, and out of it, wisely — make great friends, and make a difference in your communities. Know that we here are rooting for you, to be even more adept scientists, and policy makers, than those out practicing today. Thanks for visiting, and now go do well, in writing up the results of your research. We are proud of you.

नमस्ते

After Striking A “Pay For Delay” Deal With Lilly — On Lantus® — Sanofi Now Sues Merck For Infringement: MK-1293

September 19, 2016 - Leave a Response

Since early 2014, we’d been watching, and waiting very patiently — as Merck’s MK-1293 candidate was added to the Samsung Bioepis JV mix, and the pair took aim at Sanofi’s space in diabetes. Since then, however, Sanofi had sued Lilly for patent infringement, and then settled in early 2016 — effectively creating a “pay for delay” deal, on a biosimilar version of its insulin glargine construct until at least Christmas 2016, with Lilly, in cahoots.

In August, Merck filed at the US FDA — on MK-1293 — its Samsung-partnered biosim version, which might otherwise allow for an as early as Q1 2017 launch date.

So, this morning, it is no surprise to learn that Sanofi has now sued Merck in the federal courts in Delaware, claiming MK-1293 infringes several of Sanofi’s Lantus® patents, as well. Thus the Sanofi suit. [This whole convoluted dance is exactly what was contemplated by the Hatch-Waxman amendments to the patent process. Except that US House Reps. Hatch (R) and Waxman (D) did not expect that branded manufacturers would pay to keep biosimilars off market. Oh well — that’s unbridled capitalism at work. Enough editorializing, right? Right.]

Here’s a bit — from The Wall Street Journal, this morning:

. . . .The French drugmaker’s all-important diabetes business is under siege, as a flurry of pharmaceutical companies seek to sell knockoffs of its blockbuster insulin Lantus in the U.S. The expected launch of lower-cost copies of Lantus and growing pricing pressure on diabetes drugs in the U.S. is rapidly eroding earnings at Sanofi’s diabetes division, which accounts for about 20% of the firm’s total revenue. . . .


In January 2014, Sanofi filed a suit against Eli Lilly & Co. to defend its patents on Lantus. It had reached a deal with the U.S. drugmaker nearly two years later, under which Lilly agreed to delay the launch of its insulin to December 2016 and pay royalties to Sanofi. . . .

With the election cycle in full swing, expect to hear only crickets about how some large multinational life-science companies effectively game the system, to keep cheaper generics (and biosimilars, in this case) off-market for years at a time.

Now you know. Onward — on a sunny Chicago morning.

नमस्ते

Nurse Pauline Cafferkey: Hero — In Scotland, And Sierra Leone…

September 19, 2016 - Leave a Response

I’ve held this one for Monday morning, to be sure it gets its full and fair due, from all who look in primarily from their office computers.

Make no mistake: Pauline Cafferkey is certainly an international hero. True — many, many people risked their lives to end the latest Ebola outbreak in Western Africa, but few were so deeply affected by their efforts, personally — and I can think of none who were then “hung out to dry” by their own home nation, nearly a year after returning. [And still she waits for her bonus.] Here is a bit, from the Sunday Guardian in London:

. . . .Last week Cafferkey was cleared of all wrongdoing by the Nursing and Midwifery Council, but critics have questioned why she was ever brought before the panel when it transpired there was no case to answer.

“I should have been sent to the infectious diseases unit from Heathrow – not allowed to get in a plane to Glasgow. The minute they let me fly they put the health of the public at risk,” she said.

She spent a month fighting for her life in a special unit in the Royal Free hospital in London before being discharged, apparently free of Ebola. Nine months later she relapsed as the virus had not cleared from her nervous system and she was back at the Royal Free with meningitis triggered by the virus. . . .

So — here is a heart-felt Irish toast to the true health care heroes — the volunteers, who march right into the path of the storm, where so many others cower in fear. Here’s to Scottish Nurse Pauline Cafferkey. Let history (from this past Thursday, onward) record that she is a true international hero. Onward, indeed. Would that we were all so brave, and perserverant.

नमस्ते