A Merck Nobel Prize — For River Blindness Cure; Pacific Trade Pact Reached

October 5, 2015 - Leave a Response

Delivered in round-up fashion — the bigger news first: Dr. William C. Campbell (depicted at right), during a 33 year Merck career as a bio-science researcher (since retired), along with two others, has won a Nobel Prize in Medicine — for work on Ivermectin, the drug largely responsible for nearly eliminating river blindness in sub-Saharan Africa. Kudos!

In addition, as we mentioned late on Friday, the Trans-Pacific Trade treaty has this morning been agreed by all involved nations. Now begins a 90 day waiting period in the US, while Congress studies the pact. Then (because Congress cannot prevent it), Mr. Obama will sign it.

Here is the bit on Dr. Campbell — via the Gray Lady:

. . . .William C. Campbell and Satoshi Omura won for developing a new drug, Avermectin. A derivative of that drug, Ivermectin, has nearly eradicated river blindness and radically reduced the incidence of filariasis, which causes the disfiguring swelling of the lymph system in the legs and lower body known as elephantiasis. . . .

So much is new — and to be hopeful for — just as though new life. . . is arriving. Onward!

More On Drug Price Increases — “The Rule, Not The Exception” — Unfortunately. [Now IMPROVED With. . . Tech Industry Analogy!]

October 4, 2015 - Leave a Response

At the outset, let us recall that Apple is NOT pharma. Apple has tended (for the last five or so years) to hold prices steady, even as it delivers vastly improved capabilities in each iteration of its newest product. Let us also recall that no one will die, if they don’t use the Apple specific product. They can “limp along” — with a Samsung or HTC. [Ironic content fully-intended.]

So, perhaps it is unfair to draw parallels between tech pricing, and pharma pricing. But each industry asserts that a vast R&D expense line is needed to stay competitive. I think we all agree that is true. What happens above that expense line (at the sales revenue/pricing line), is where they differ most significantly — for the purposes of this post.

That is to say. . . what strikes me most, here is not the randomly obscene Valeant and Turing price increases — but the idea that pharma wide, prices on mid-stream, and older drugs are rising — in double digit percentages, year after year. In many of these cases, patients will either grow very sick or die, without the now well-vetted drugs. And pharma raises prices. It does so until some generic competitor is able to get to market and undercut them, usually, all at once. But that “frictional” often three to five year price climb, at or very near the end of a drug’s patented life — is more the rule than the exception, as a pharma pricing strategy.

And so (with technology industry examples in mind), it is high time to ask — why should we as a nation of consumers tolerate that? Apple knows keeping the customer is the best profit inducer. So, keeping the patient “on med” ought to be the number one priority of pharma. To be clear, I don’t think government price control (via legislated price mandates) is the answer.

No, I think free market negotiatingBETWEEN the government, and the drug companies (i.e., repealing the Bush 43-era no-negotiating legislation stance) — on Medicaid, Tri-Care and the analogous program payers’ drug purchasing contracts, is the answer. Clearly private insurers and prescription benefit management companies are negotiating — and negotiating hard. [Which is why some argue pharma must be free to charge the government payers — without negotiations. I disagree. The math doesn’t bear it out.]

We often hear WSJ pundits extoll the free market mechanism. It is time to let it work — on drug pricing. Here’s the snippet of the NYT article that put me in mind of making this point, this morning — over hot coffee, fresh orange juice, yogurt and a banana:

. . . .[W]hile more conventional [drug] companies do not typically triple or quadruple prices overnight, they do often raise them year after year at a rate far faster than inflation. Big pharmaceutical companies like Pfizer and Merck raised list prices an average of 13 percent in 2014 and 8 percent so far this year, according to Deutsche Bank. . . .

Inflation is barely two per cent, as experienced by consumers overall this year, and less if we fully load the decrease in gasoline prices into current estimates. Compare that to 13 per cent increases on drugs, on average. So — as I wrote last weekend, over my coffee — smaller versions of the Shkreli scenario are the rule, not the exception. And as I wrote, both he and Saunders learned these tricks from Fred Hassan. It is the rule — not the exception. And only a free negotiating market will curb it effectively. Legislation cannot. Here endeth the sermon.

A Shortfall In US Public Funding Is Not Co-Terminous With “Pharma” Prevention Of Life Saving Drugs. Period.

October 3, 2015 - Leave a Response

I don’t want to overly belabor the point, but this very well-educated Upshot editorial commenter waits until paragraph 14 of his 16 paragraph essay to acknowledge that perhaps — just perhaps — not-for-profit, public-funded, or academic basic science programs should bring unpatentable (i.e., unprofitable) medicines and drug candidates to market — with yes, public assistance.

[Shareholders of for profit companies, on the other hand, expect. . . (gasp!). . . profits. And pharma profits flow from. . . patents. This is a point not mentioned by the commenter.]

While pharma could always donate more to such efforts, and pharma is very profitable, it is largely nonsensical to suggest that the companies “prevent” unpatentable tech from reaching market. And it is near-lunacy (in my estimation) to suggest that for profit companies be given patent like monopoly periods on such basic, obvious drug candidates, solely to hasten them to market. [Witness Mr. Shkreli’s various exploits, here.] So, the entire essay needs rethinking in my view — but here is the bit where he starts his slide. . . sideways:

. . . .By granting temporary monopolies to innovators, the patent system is widely credited with protecting and promoting innovation. But when it comes to pharmaceuticals, it may be preventing valuable therapies from coming to market. . . .

Now you know: granting pharma ever more profit opportunities by monopolies at law (even shortish ones), isn’t the right answer to a shortfall in basic public investment in public science — even obvious science. [There are, of course, other cases — where pharma arguably delays or prevents life saving medicines from reaching market — but these are not those cases.] Onward, on a gray Saturday here. . . but smiling just the same. In short, Prof. Outterson is right.

A Breath Of New Life — For A Possible Trans-Pacific Trade Accord? Could Be Good For Pharma. . .

October 2, 2015 - Leave a Response

Back in July of 2015 — and earlier, in June — we offered our perspective here on what such a pact might mean for US drug companies that compete in the Pacific Rim. Do read those. This is a complicated topic, with policy puts and takes, on all sides — and it covers everything from autos to technology goods. But pharma/biologics have long presented a particularly vexing set of trade issues.

And so, by late July, the talks had ended without an accord — or even a framework, for reaching one — in no small part due to the pharma/bio related issues. Chief among the sticking points was the US’s insistence on a 12 year biologics IP protection/exclusivity period. Well, tonight we read (courtesy of the New York Times) that there may be an eight year compromise afoot. It is my view that US multi-national drug companies would fare better, in the main, under an eight year compromise on biologics IP exclusivity, than to leave 2015 without an accord, at all. [With 2016 ushering in a full-on presidential election cycle, with protectionism looming as a key issue (on all sides), I think 2015 is the last best opportunity for several years.] I suspect BiO and PhRMA see it that way too — and will end up agreeing — after some gnashing and wailing. Still, a deal is far from certain, but this is a rather hopeful moment (again quoting The Gray Lady):

. . . .[Mr. Obama’s U.S. Trade Representative Michael] Froman was particularly embroiled on Friday in trying to settle the pharmaceutical drug issues. The most vexing question was how long drug companies can have exclusive rights to data related to their development of so-called biologic drugs (products made from living organisms and considered promising for cancer treatments) before they must share the information with generic manufacturers.

The United States, which had insisted on 12 years to ensure drug manufacturers have incentives to innovate, recently proposed an eight-year provision as a compromise. It would give companies five years of exclusive rights followed by a three-year period of limited market sharing. . . .

And so. . . “Hope is a good thing. In fact, it may be the best of all things.” Hope — of new life. Smile. G’night.

About Seven Months Behind BMS, Merck Likely To Receive A Preliminary Nod, For NSCLC FDA Label Expansion Tonight

October 2, 2015 - Leave a Response

MRK-Key-NSCLC-10-2015 UPDATED: The full Commission just granted immediate approval — so Keytruda® is now authorized for NSCLC. End, update.

Just as we predicted, Merck is now about seven (per our cogent and erstwhile anonymous commenter — thanks!) nine months behind BMS’s Opdivo®, in reaching approval for Keytruda, in the heavy burden of disease lung cancers. If all goes well, this afternoon, Merck will be on market, on Monday is about a month from market.

Assuming that FDA follows its normal course, and the staff recommends the accelerated approval to the full FDA Commission, after the close of trading on the NYSE today, we should see an that an approval (label expansion, actually) is granted to Keytruda, for NSCLC, after non-response to platinum chemotherapy. in about a month. [My math was off, by one — and the immediate full FDA approval cut a month from the lead, as well.] Should it materialize tonight, it will be good news for Merck, and will allow Kenilworth to beging to directly market the humanized monoclonal antibody to oncologists treating lung cancer patients, rather than relying on those oncologists to be willing to write “off label”. I do expect that a fair amount of completely appropriate direct and independent “off label” scrip writing was already underway, by oncologists around the nation. In any event — welcome news for Merck and its lately sagging NYSE stock price.

[Separately, I highly recommend catching “The Martian” this weekend — I did, late last night — and it was a great human interest treat; the sci-fi and amazing effects were. . . just a bonus. Onward!]

Merck Propecia® (Finasteride) MDL Update: First Bellwether Trial No Earlier Than September 2017

October 1, 2015 - Leave a Response

Unfortunately, we are looking at two full years yet, before the first Propecia® MDL test case is opened, before a federal jury, here. That, according to the latest revised PPO No. 10, in this litigation. Yes, the pace of such litigation is decidely. . . glacial.

Now, in addition to setting the aspirational trial schedule, the first few pages of the order set a new certification procedure — for all files Merck has turned over (essentially requiring Merck to swear that they are complete copies of the actual files). [Even so, no mention as of yet about what the very able judge will do regarding files withheld as privileged — and no mention of what happened regarding the doctor/PI’s clinical trials files.]

I’ll attach the entire order, as an 8 page PDF affair, for those who wish to study the time lines (which lead eventually to jury trials), in greater detail. Here are — to my eye — the most salient bits, though:

. . . .The Parties will serve upon the other their respective Case Pool selections to fill slots in the initial Case Pool with the Court on May 13, 2016 at 5:00 p.m. Eastern Standard Time. Neither party may select a case for the Case Pool unless the Plaintiffs supplied to Counsel for Merck both: (i) substantially completed medical record authorizations (meaning authorizations for the prescribing physician, the primary care physician, and pharmacy records), and (ii) a Plaintiff’s Profile Form by no later than January 1, 2015. . . .

On September 30, 2016 at 5:00 p.m. Eastern Standard Time, each party shall file with the Court its proposal for three (3) trial cases from its picks among the Case Pool, as the first wave of Bellwether dispositive motions and trials (the “First Bellwether Tranche”). . . .

The Court anticipates that the First Bellwether Tranche shall be trial ready by September, 2017. The Court will issue a scheduling order governing all trial related obligations, including the specific date for commencement of trial, following entry of the Daubert Orders. . . .

So patience will indeed be a virtue here. [It has taken me about a week to get this posted. So sorry.] And as ever, onward we sail — to see “The Martian” this evening, of course. Of course. Smile. . . .

O/T Kentucky Edition: It’s All Over — Except The Shouting, Now. . .

September 29, 2015 - Leave a Response

I’ll note — as I depart the office for the day — that the State of Kentucky’s latest salvo of responses to Kim Davis’ completely baseless (and tediously repetitious) claims (those having been ginned up by Liberty Law) are now public record in the Eastern District courthouse.

What there appears is a state increasingly (and justifiably) frustrated by a George Wallace like refusal to follow the now-settled law of the land. Here’s a bit of what we find (a 17 page PDF file), in the moving papers:

. . . .[A]ny liberty interest Davis might possibly have as a private citizen does not extend to her role as a governmental official. Even if KRS 446.350 were somehow to apply to Davis, it cannot apply in her official capacity as the Rowan County Clerk because accommodating her in the manner she suggests would amount to a violation of the [federal First Amendment] Establishment Clause. . . .

Davis asserts that had the Beshear Letter not been issued, the plaintiffs “would have had to sue Gov. Beshear (not Davis)” to obtain their marriage licenses. See Response at 14 (D.E. 123). This incredible
statement demonstrates Davis’ stubborn disregard for the rule of law. Obergefell held that the plaintiffs have a fundamental right to marriage. Following Obergefell, they should not have been required to sue anyone in order to exercise that right. Of course, Davis ensured that was not the case in Rowan County. . . .

When an official such as Davis acts in her official capacity to perform an obligation imposed by law, she is acting as the government. Cf. Kentucky v. Graham, 473 U.S. 159 (1985); KRS 62.210 (“[t]he office of county clerk, rather than the individual holder of the office, shall be liable for acts or omissions of deputy clerks”). At issue here are marriage licenses issued by the Office of Rowan County Clerk and not Kim Davis individually, as Kim Davis individually has no authority to issue such licenses. The Office of Rowan County Clerk does not have a right to free exercise of religion. If government officials were permitted to exercise religion in their official capacity, such action would directly violate the Establishment Clause, which prohibits governments from favoring or promoting one set of religious beliefs over another. . . .

[Issuing a marriage license] is a ministerial act statutorily required of the Office of Rowan County Clerk. The issuance of a marriage license simply certifies that the couple satisfies the legal prerequisites for marriage. KRS 402.100. To the extent the issuance of marriage licenses constitutes speech, it is attributable to the government and not Davis. . . . [Even for argument sake, if we assume it was speech] “restricting speech that owes its existence to a public employee’s professional responsibilities does not infringe any liberties the employee might have enjoyed as a private citizen.” Garcetti, 547 U.S. at 421-22. . . .

She has no standing. — so true. Onward. Smile. . . .

“Some Days, This Stuff Just Writes Itself”: Reprised From September 2009

September 29, 2015 - Leave a Response

Given the propensity of Mr. Shkreli to continue to damage his private company’s brand — and his own meager credibility — in the last two weeks, I thought it would be useful to rerun my September 2009 piece — on his “Godpharma” — one fast Fred Hassan. Mr. Hassan did pretty much the same, by blogging — in intemperate fashion — in those days. Morever, the two were thick as thieves not long after this post — as Hassan was investing in, and guiding the young Shkreli (albeit at his former company), according to numerous MSM published reports. So here it is, in full (I did update the graphic, a bit, though — at right):

Some days, this blog just writes itself. Today is one of them, per the WSJ Health Blog:

. . . .Ever since Merck announced it was taking over rival Schering-Plough, inquiring minds have wanted to know: What will Schering-Plough CEO Fred Hassan do next?

SGP-godpharmaPerhaps now we have a clue: Hassan is joining us bloggers, at least for some of his time.

In a Huffington Post piece, Hassan weighed in yesterday on the health-care debate, arguing that the discussion has unwisely ignored serious and long-term threats such as Alzheimer’s disease. . . .

The deal for the very-life of his company hangs in the balance. . . and he is off, blogging? Cool. I can FINALLY relate.

Credit for the original work on the fabulous graphic, at right, goes to “The InsiderPharmaGossip.

Overall, though — sometimes, the truth is far stranger than anything we could make up. . . . This is one of those times, for dead certain (Kudos to The Insider!):

The music in that clip is (given the subject matter, to my ear, at least). . . soul-less, overwrought and sinister. . . perfectly evocative, of the 2015 — and 2009 — versions, no? Onward, just the same.

I should also note that this post came to be, in a passing thought, from an anoymous visit, to the original September 2009 item — by someone on the Warburg Pincus backbone. Thanks for that inspiration, friend(!):


BMS — And Opdivo® — Well Ahead In Kidney Cancers @ ECCO 2015

September 28, 2015 - Leave a Response

Over the weekend (through to tonight), in Vienna, Austria, the ECCO (or European Cancer Conference) has been underway.

Just as we said it would, back in July 2015, BMS’s nivolumab has pretty much turned out to be the belle of the ball. Advanced renal (kidney) cancer is generally a pretty dire prognosis. But on Opdivo®, such patients saw on average, two years of added survival time — and that led researchers to end the study very early, and give all comers the study drug — for obvious ethical reasons.

This doesn’t mean Merck won’t eventually get Keytruda® approved for kidney cancer — but it does mean BMS is at least a year ahead. And it means that BMS is racking up lots of heavy burden of disease cancers — as the likely first mover. Here’s a bit from the New York Times, of Saturday:

. . . .[A] study of the drug nivolumab (sold as Opdivo), was stopped ahead of schedule because safety monitors found that patients receiving the drug were living longer than those in a comparison group taking the usual treatment, everolimus (sold as Afinitor). The study was halted for ethical reasons, to offer the comparison group nivolumab. . . .

Nivolumab belongs to a class of drugs called immune checkpoint inhibitors, which work by unleashing the patient’s own immune system to fight cancer. The new study included 821 patients with advanced kidney cancer. Half received nivolumab, and half everolimus. Of all who got nivolumab, 25 percent responded, meaning their tumors shrank significantly; only 5 percent responded to everolimus.

With nivolumab, the median survival was 25 months, compared with 19.6 months for everolimus. Patients taking nivolumab were also more likely to have lasting responses and fewer side effects like fatigue and nausea. . . .

Onward on a lovely fall Monday — one on which liquid (albeit briny) water has just been found to be presently flowing on. . . Mars. And that makes some form of life. . . at least a slightly closer possibility, there. What a time we are privileged to be living in. . . . Whoosh!

Even As PhRMA Declares “Shkreli Is NOT One Of Ours” — It Elects A New Chief; Former Device Lobbyist Ubl

September 26, 2015 - Leave a Response

Earlier this week, both BIO and PhRMA — likely sensing a PR disaster in the making — openly disavowed Martin Shkreli. PhRMA declared that privately held Turning Pharmaceuticals, and Martin Shkreli, are not, and were not members, and “did not reflect” the trade group’s “values or views.” This was a wise first step, I think.

But now, PhRMA — chaired through April 2016 by Merck’s Kenneth C. Frazier — has tapped a legendary medical device lobbyist (understated and pragmatic, is Ubl) to lead PhRMA through these almost certainly more widely-emerging US firestorms — on pharmaceuticals pricing (even without regard to whether Hilary Clinton is ultimately able to win wider backing for price controls).

From the New York Times, overnight:

. . . .For the last 10 years, Mr. Ubl has been the top lobbyist for medical device makers. He has led efforts to persuade Congress to repeal a tax on medical devices imposed by the Affordable Care Act.

Mr. Ubl, 46, is well known in Washington for his deep knowledge of health policy, shrewd political instincts and low-key manner that sets him apart from many lobbyists.

His selection was announced by Kenneth C. Frazier, the chairman of Merck, who is also chairman of the pharmaceutical trade group.

Some people who have worked with Mr. Ubl said he might be open to pragmatic pro-consumer compromises, but some consumer advocates said he had not been receptive to their appeals for help in recent years.

Marc M. Boutin, the chief executive of the National Health Council, a coalition of advocacy groups for people with chronic diseases, said Mr. Ubl had been a strong ally. As a member of the council’s board from 2008 to 2013, Mr. Ubl helped patients influence the writing of the health care law and the way it has been carried out, Mr. Boutin said. . . .

Almost trivially, I’ll note that a
NYC punk rock recording label has also cut all ties with Shkreli (he was reputedly an early angel investor). I’m pretty sure he did not expect that following Fred Hassan’s playbook would make him such a pariah. But it is 2007 no longer, friends. Health care reform is here to stay. How the world turns. . . Onward, with a grin. . . .


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