[U] GAO Notes: Some 87 Cyber-Security Issues At FDA — All Are Non-Alarming

September 30, 2016 - Leave a Response

UPDATED @ 7:00 AM EDT 10.01.2016: I’ve just now read the GAO report (60 page PDF file attached) in full (over coffee, yogurt, a banana and OJ), and I am convinced that there would be minimal meaningful “real-world” probable risk here. From the report itself, then:

. . .FDA did not always (1) adequately protect the boundaries of its network, (2) consistently identify and authenticate system users, (3) limit users’ access to only what was required to perform their duties, (4) encrypt sensitive data, (5) consistently audit and monitor system activity, and (6) conduct physical security reviews of its facilities. . . .

That may sound a little more ominous that it actually would be, in most likely practical scenarios. So, as opposed to a likely or real-world meaningful hack, it is frankly largely a remote possibility that this sort of data access would be of any real value to a hacker, or group. There is very little chance of high-value access, and therefore little real market value, for such data access. So — while I think the report is worthwhile, and the fixes now being undertaken are appropriate — I’ve decided it presents scant real world risk to pharmaceutical, bio-science and device manufacturers and their patients, doctors or hospitals. [End, Updated Portion.]

09.30.2016 | 8:00 PM EDT: It is good to learn that the FDA has already begun to implement the GAO report’s suggestions (see below), it is also worth noting that patient data, from clinical trials might — at least in theory — be compromised in this way. And Kenilworth should keep that in mind.

Here is the bit, from Bloomberg, overnight:

. . . .A review of the FDA’s online information systems found more than 80 weaknesses including a lack of cybersecurity firewalls, according to the Government Accountability Office, Congress’s investigative arm.

The GAO audit was part of a congressional initiative to fortify data security at government agencies that stockpile volumes of public data. The GAO made 15 recommendations for strengthening FDA’s systems, including a complete risk assessment, employee training and consolidation of systems. . . .

FDA said it has begun adopting the recommendations in response to the report. . . .

Sleep well one and all (like little round rocks) — just chillin’ — and watching old movies — here, on a Friday night. Smiling widely, as visits roll by. . . .


Commanded Journey: At An End. Rosetta Falls Silent.

September 30, 2016 - Leave a Response

mrk-rosetta-touchdown-2016 So it has all just now drawn to a close, thus, from Seamus Haney:

“. . .And lightening? One meaning of that

Beyond the usual sense of alleviation,

Illumination, and so on, is this:

A phenomenal instant when the spirit flares

With pure exhilaration. . . .”

Here’s the bit from ESA this early Friday morning.

. . . .ESA’s historic Rosetta mission has concluded as planned, with the controlled impact onto the comet it had been investigating for more than two years.

Confirmation of the end of the mission arrived at ESA’s control centre in Darmstadt, Germany at 11:19 GMT (13:19 CEST) with the loss of Rosetta’s signal upon impact.

Rosetta carried out its final manoeuvre last night at 20:50 GMT (22:50 CEST), setting it on a collision course with the comet from an altitude of about 19 km. Rosetta had targeted a region on the small lobe of Comet 67P/Churyumov–Gerasimenko, close to a region of active pits in the Ma’at region. . . .

Seamus Haney was a very fine poet. And he was a philosopher king. Clearly he was right — a time comes, when it is time to move on, in silence. Yet as Philae and Rosetta show, that need not be a melancholy moment. Onward, grinning.


One Small (Proposed) Change — In Merck v. Merck Court Calendaring: Choice Of Law Being Settled

September 29, 2016 - Leave a Response

Just a minor procedural Thursday update here. In an overnight letter, both sides are requesting some more (purely interim) date extensions — probably in order to settle the argument over what’s known as “choice of law.” [Background here.]

Simply stated, this argument involves deciding which state(s) or federal laws will govern the interpretation of the dispute. It is also possible, but unlikely, that one side wishes for German law to apply (the German Merck). More on why I’d think that, tonight, or on another day — running to a lunch appointment, then meetings. Back late this afternoon. Here’s the request, in full:

. . . .We, along with Hogan Lovells, represent Plaintiffs Merck & Co, Inc., and Merck Sharp & Dohme Corp. in the above referenced action. We write, with the consent of Defendant Merck KGaA, to modify a deadline originally proposed in the parties’ Joint Discovery Plan filed on July 11, 2016 (D.E. 18).

Sections 6(h) and (i) of the proposed Joint Discovery Plan provide that if the parties are unable to reach agreement on choice of law, Plaintiffs’ motion regarding choice of law would be due on or before September 28, 2016, and Defendant’s opposition would be due on or before October 29, 2016. The parties have agreed, subject to Your Honor’s approval, to modify the deadlines to October 12 and November 14, 2016, respectively.

Thank you for your consideration of this matter. The parties look forward to meeting Your Honor at the initial [October 18] conference. . . .

[Signed by a Blank Rome partner]

Smiling widely, as I walk (seeing two locations, now). . . and I hope all is sanguine for all assembled this noon-hour. With all those unwasted graces, still a-flowing. . . . grin.


After This Long-Commanded Journey… There Will Be “No Next Time ‘Round”: Goodnight, To Rosetta

September 27, 2016 - Leave a Response

mrk-phil-rev-09-29-2016 We will dearly miss this pairing, in truth. They were an enigmatic, captivating way to engage kids in space science, all over the globe. Yet, in silence, too — there is some heady solace — as some freeze, nearby — and some others burn. . . at a distance, indeed. As for our headline, it was coined by the fine black Irishman Seamus Haney: after the commanded journey, there may well be no next time ’round. . . and so, we will reiterate a bit of what we wrote, about 20 days ago on the topic:

By all accounts, ESA (the European Space Agency) ran an excellent science mission with Rosetta — and little Philae. We’ve covered it from time to time.

But as is true with all good things, they do come to an end. On September 30, that time comes — for this pair.

As the unwasted grace of these waning elliptical orbits draws to a close, we will see Rosetta join Philae on the comet’s surface, albeit on the other side of the comet — and then fall silent. So it is with many pairs, initially found, then lost — separated only to be reunited, and then. . . silently slipping into eternity. Yes, that’s the sort of poetry space offers us. Here’s a bit, from ESA:

. . . .The final flyover was completed on 24 September. Now, a short series of manoeuvres are underway, to line Rosetta up with the target impact site, over the three days as it transfers from flying elliptical orbits around the comet onto a trajectory that will eventually take it to the comet’s surface on 30 September. . . .

Now you’ll be able to follow Rosetta until touchdown on the comet surface, right here. Be excellent to one another — there’ll be no next time ’round — not for this little pair.


Propecia®/Proscar® MDL Scheduling Update; Minor Changes Only — Post-HRC-Debate-Win Edition

September 27, 2016 - Leave a Response

Okay — so some of the middle dates have moved back by a week, but the overall selection date holds firm, for bell-weather case pools. A proposed agreed order was offered overnight in Brooklyn on this MDL.

Here was our last substantive update, as background. And the bolded bit below is new — with a court response still expected to be due before Halloween 2016:

. . .The parties reached an agreement and jointly submit a scheduling modification regarding PPO No. 10 Discovery and Trial Plan submission dates, concerning three proffered trial pick selections. The current schedule requires parties to submit their selections on September 30, 2016 with responses due October 7, 2016 (see dkt. 295). The parties respectfully request a one-week extension as follows:

1. The Parties will file a statement selecting their three proffered trial pick selections on or before October 7, 2016.

2. The Parties will file a response, if any, on or before October 14, 2016.

3. In order to maintain the current trial plan schedule, the Court’s date regarding selection will remain the same, i.e., the Court will endeavor to select the First Bellwether Tranche on October 28, 2016. . . .

Now you know. And, as I walk in, on a perfectly clear, crisp morning here, I will be grinning widely — at how soundly HRC bested Mr. Trump — using her estimable wit, acumen and aplomb — as well as offering lots of specific, well-thought out proposals (as opposed to his dark, vaguely hateful bluster and lack of any coherent, actionable and lawful policy pronouncements).

Even most GOP operatives now agree: Mr. Trump utterly failed at attracting any (much-needed) new demographic — of the likely registered, voting electorate.

HRC will be our 45th President. And it will likely be Colorado that pushes her over the top — past 270. Smile.


As Of Last Friday, It Looks More And More Likely That Merck Will ALSO Lose In Delaware — As It Did In California — In The Hep C Patent Wars, With Gilead

September 26, 2016 - Leave a Response

As of Friday evening, in Delaware’s federal US District Court, Gilead had filed its redacted version of the papers which recite why Merck’s patent infringement claims should be bounced without need for any trial, there. You’ll recall that Merck saw those infringement claims bounced out of court in California’s Northern District Court, just a few months back. I foresee much the same outcome here — especially after this latest filing, from Gilead’s legal team.

Here is that memo of law in support of the motion (as a PDF file), and a bit that was not redacted:

. . .[Merck’s] problem is that it seeks to limit the claims to a subgenus of effective nucleosides, yet its patents provide no antiviral data or other blaze marks that distinguish between nucleosides that work and those that do not.

[Merck] cannot have it both ways: if the claims are limited in that manner, then the patent must direct the skilled artisan to that narrowed set. [Merck’s] main response is to try to use its expert to backfill what the patent lacks, but precedent prohibits that approach. [Merck’s] few citations to the patent itself are both legally insufficient and telling: the only supposedly exemplary compounds and data it relies on were not in the original May 2000 application and were added only in May 2001, when [Merck’s precursor company] was still just beginning to start testing compounds without yet knowing what was effective. [That precursor company’s] patents present nothing more than a research plan that left the real work — identifying an effective nucleoside like 2’-F down — to others. The claims, under any construction, are thus invalid as a matter of law. . . .

Now you know. And onward we sail, out into the oncoming cold — of The frigid shepherd moons’ Jovian orbital space — but not quite so alone, after 2 PM EDT today. . . smile. [Getting ready to watch HRC gracefully lop off the GOP nominee’s rhetorical head, tonight. He so richly deserves it.]


Interstellar Space Science: China Brings The World’s Largest Radio Dish ‘Scope Online

September 26, 2016 - Leave a Response

It seems that — for me — space science is lately filling the void of the slow news trickle, out of Kenilworth. For we know nature simply abhors a vacuum. And this latest piece of news is anything but that. Smile.

Eclipsing Arecibo (in Puerto Rico) in dish diameter (nearly doubling it) — and completely blowing it away in overall sky coverage — this is an engineering marvel.

It positively buries Arecibo on sky coverage because, as opposed to being fixed into the mountain-side, this Chinese FAST radio dish can “gimbal” almost 40 degrees, in any direction, by altering the shape of its parabolic dish’s curve — thus covering a much wider swath of sky. [But as we all remember from Billy Bob Thornton in Armageddon, it is “a big a$$ sky. . . .”]

In any event, this stretches our ability to look back in time, to much closer to when the Universe was first born. Courtesy my lovely eldest daughter, via National Public Radio:

. . . .Xinhua reports the telescope cost $180 million, and displaced 8,000 people from their homes to create the necessary 3-mile radius of radio silence around the facility. It will be used for “observation of pulsars as well as exploration of interstellar elements. . . .”

[FAST will also be used to search for] interstellar communication signals, [which] could be more simply referred to as searching for intelligent extraterrestrial life. “In theory, if there is civilization in outer space, the radio signal it sends will be similar to the signal we can receive when a pulsar … is approaching us,” Qian told Chinese state media. . . .

Indeed. [And perhaps one day, at least possibly, we might — with this device — hear a signal. One that might suggest we are not alone in this Universe. I firmly believe we are not — but as a scientist — I’d like even just a small hint, of some proof of that idea. That is also why I’ll be watching the Europa news, this afternoon.] Be excellent to one another — for at least for now — we are all we know we have.


[U] Europa’s “Warm Water”: What We’ve Learned — At 2 PM EDT — From NASA’s Hubble Team

September 26, 2016 - Leave a Response

UPDATED — 2:20 PM EDT: Plumes of water and water-vapor, rising perhaps 290,000 feet — or almost 50 miles — have been spotted by Hubble, on several occasions in 2014. I’ll embed a great updated NASA video — 2 minutes only — desribing the science behind all of it, immediately below. I will update my now dated graphic, shortly. But the evidence for the warmth of an undulating water ocean — well below a sienna colored ice exterior shell — is now nearly conclusive.

Yet again, a most sublime celestial epiphany is fittingly “writ in water” — the stuff upon which we are all based. It is grin-worthy indeed that verdant life may already reside in Europa’s (metaphorical) sloshing motherly womb. Astonishing.

[End, updated portion.]


mrk3-europa-09-2016In an update to this post, of last week. . . I’ll go out on a limb this late Sunday evening/early Monday morning, and guess that Hubble has spied more evidence of warm water — an ocean of it, in fact — subsisting below an icy shell, on the Jovian moon, Europa.

In a more fantastical iteration (as I wait for sleep to find me), I might guess (though I’ve not depicted it, at right) that Hubble has seen a recurrence of the 2012-era Europa surface water geysers — then likely spouting up to ten times the height of Earth’s Mount Everest — or almost 290,000 feet. It seems some times, that which was “writ in water,” cannot be forever restrained, nor even contained.

In any event, we will know it all — at 2 PM Eastern. Onward, as beneath that deep space long iced-chilled shell, there moves an undulating, warm ocean — and just possibly, an ocean where verdant life will one day again arise — and that is truly grin-worthy. . . .


“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 young people (at least a few of whom were very likely born into bondage) — 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.


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.