Wednesday, July 31, 2013

FDA Concurs With EMA: No Elevated Pancreatic Cancer Risk With Sitagliptin's Class


This is good news for Merck -- and even so, it would be wise to continue to monitor, at a by-patient level, the ongoing data stream. So FDA will. Adverse events will be reported; and the data should always be scanned for emerging patterns. But this should help Whitehouse Station a bit, with Januvia® sales.

As I've said before, I did expect/predict this outcome: a relatively complete "all clear" signal.

Here is the irrepressible Ed Silverman, over at Pharmalot, on it all:

“. . . .The FDA concurs with the EMA’s conclusions regarding the potential pancreatic effects of GLP-1 based therapies,” the FDA spokeswoman writes us. “The agency believes that the current labeling for approved GLP-1 based therapies reflects the extent of our understanding of the safety signals at this point in time. FDA’s review is ongoing as pancreatitis and pancreatic cancer data are being collected in the cardiovascular outcome trials being conducted with this class of drugs. . . .”

Do stay tuned as J&J's Invokana® diabetes franchise continues to make inroads, here -- acting by a new, and differing mechanism. Invokana has posted clearly superior clinical trial results, but was only approved by FDA in March of 2013. We will watch this horse race unfold.

Tuesday, July 30, 2013

Merck Q2 2013 Sales A Little Light; EPS Slightly Better Than Consensus


I hate to say it, but Merck has become very predictable.

That's not horrible, but between the patent cliff, and the slowing growth of Januvia®/Janumet® -- offset by the "financial engineering" measures underway ($5 billion of executed share buybacks funded by borrowings, etc.) -- Merck will likely float along, languidly, at a slow cruise -- for the balance of 2013. It will meet its announced 2013 full-year guidance -- at the EPS line.

Even so, the foreign exchange effect of the strong dollar is really cutting into otherwise strong international sales growth.

. . . .“With seven of our top 10 products growing in the second quarter and solid performance overall, we continue to navigate significant patent expiries and adapt to the evolving global healthcare environment,” said Kenneth C. Frazier, chairman and chief executive officer, Merck. “We remain committed to pursuing innovative, best-in-class science that translates into medically important products, such as our PD-1 inhibitor for oncology. To enable further investment in promising growth opportunities, we continue to manage costs effectively, as reflected in our results for the quarter”. . . .


There you have it. Yawn. UPDATE: I can also report that Pfizer saw the same 3% currencies effect, so no worries there. All is as expected. Forward!

Sunday, July 28, 2013

Just A Few Early Guesses -- At Merck's Q2 2013 Results


Updated: I'll concur with the average Street estimates and expect EPS of $0.83, on revenue of $11.2 billion, come Tuesday morning.

I'll refine this a bit (see preliminary graphic at right) -- with some actual EPS and global sales revenue guesses at some point --  but since Pfizer's Q2 2013 results press release is also on Tuesday morning, I can't really cheat by looking at what Pfizer turns in.

Yes, Merck will be reporting at nearly the same time.

In any event, see the "Kentucky windage" I've thus far gleaned -- solely from reading J&J's Q2 release a few weeks back.

Most Wall Street analysts expect an "in-line" quarter, when Merck reports on Tuesday morning. Do tune in.

European Med Agency Sees No Need To Change Januvia® (Sitagliptin) Label

With all my goofy and sundry tech issues now solved, I may return to the usual pitter-pat about Whitehouse Station's fortunes.

This is about four days out of date, now -- but Ed, over at Pharmalot covered it well, in my downtime -- noting that despite one study (with some methodological problems) pointing the other way, the European Medicines Agency has concluded that there is no reliable evidence to suggest that diabetis drugs in the class of sitagliptin, or Merck's Januvia®/Janumet® brands (if you prefer) -- are driving elevated pancreatic cancer risks in patient populations studied.

Do go read all of Ed's report -- but here is a bit:

". . . .Data from clinical trials do not indicate an increased risk with these medicines. However, the number of events is too small to draw final conclusions. Due to their mechanism of action, some uncertainties remain in respect to the long-term effect of these medicines on the pancreas and more data collection efforts are under way,” the CHMP concluded. . . .

The drugs, which mimic a hormone called GLP-1 to stimulate natural insulin production, include Merck’s Januvia, which is the biggest seller in this group. . . .


We will keep an eye on this, but it is good news for Whitehouse Station. Speaking of sitagliptin, we still have seen no Indian MSM report on the outcome of the Glenmark sitagliptin phosphate patent hearing, there. We will keep a weather eye on the horizon for that, as well. Now, go enjoy your Sunday!

Saturday, July 27, 2013

Apologies For The Outage, Here


At about 4 pm yesterday, all my mobile tech crashed -- no phone, no home or work email, zip.

I'd childishly blame iOS 7 Beta 3 -- but that might be unfair.

Once everything is restored later tonight -- I'll have a few new items. In the mean time -- profanely (and deliciously-so!) off-topic: "I'd like to baptize you!" [From the show Jon Stewart of the Daily Show says is "so f-ing great, it makes me ANGRY!]



Wednesday, July 24, 2013

Almost Three Years After $1.7 Billion Write-Off, Merck Finally Submits Legacy S-P's Vorapaxar To FDA For Review


A little under three years ago, this candidate, one of Schering-Plough ex-CEO Fred Hassan's five stars, clanked -- and clanked loudly -- on a pivotal Phase II/IIb study. That forced Whitehouse Station to take a $1.7 billion write-off on the research, to that point, in early 2011.

Now, with reams of additional data in tow, Merck is finally submitting the candidate for standard FDA review, on a full New Drug Application (the slowest US path to approvability):

. . . .Merck. . . today announced that the New Drug Application (NDA) for its investigational anti-thrombotic medicine, vorapaxar, has been accepted for standard review by the U.S. Food and Drug Administration (FDA). Merck is seeking FDA approval of vorapaxar for the secondary prevention of cardiovascular events in patients with a history of heart attack and no history of stroke or transient ischemic attack (TIA). . . .


We shall see if the data is enough to win an FDA approval -- and if so, for which cardio-related indications. Even so, the indication listed is a shadow of the promise once claimed -- it is now only a secondary line drug -- at best.

Monday, July 22, 2013

Merck "No Longer Using" Chinese Travel Agency Being Audited In GSK's Chinese Bribery Probes


Certainly, at least a part of this is the "sharp end of the political spear" -- in China's accelerating effort to reduce drug prices inside its borders -- at least as charged by multinational pharmaceutical Levianthans. But some of it is likely substantive, as well.

Reuters is reporting this morning that Merck has severed ties with a Chinese travel agency that is at the center -- or very near it -- in Glaxo's unfolding bribery scandal in China. A GSK official has now said that it appears GSK executives violated local Chinese law, in arranging "off-books" pools of funding, for plying local prescribers (all allegedly, to this point).

Merck, for its part, is quoted in the same article as having ended its relationship in China with the same travel agency. AstraZeneca has said much the same.

And so, now we wait, in the hope that the other shoe deosn't drop, on either AZ or MSD China, here. From Reuters -- do go read it all:
. . . .Last week, Chinese authorities also visited the Shanghai office of Belgian drugmaker UCB and the latest visit to AstraZeneca shows Chinese authorities are spreading their net.

AstraZeneca said it believed the case involving its employee was a local police matter. . . .

Merck also said it had used the agency in the past and would no longer do so. The other drug companies could not immediately be reached for comment by Reuters. . . .
More -- as this one develops, but I do think that Whitehouse Station has, on balance, a stronger global FCPA compliance program than GSK does. I could recite chapter and verse, on GSK's problems in this area, of recent note -- but what's the point?

Hopefully, MSD China was not following along the same path as GSK, in trying to encourage local doctors to prescribe its life-saving drugs. But we shall see, in time.

Sunday, July 21, 2013

Arizona's Republicans Call Mr. Obama "Brilliant" -- On Medicaid Expansion Strategy


The state-by-state dominoes continue to fall -- in pretty much the way we had hoped, in 2010. States with a previous-vehemently opposed to Obamacare stance -- at the Governors' mansions, at least -- are finally seeing that there is no way to fight the tide. And that it is the right thing to do -- for their own people.

Mr. Obama's Medicaid expansion strategy has worked -- and Obamacare is here to stay. And even the fiscal conservative Republicans are admitting that Mr. Obama out manuevered them -- with their own base. Here's the salient quote from The New York Times on it, tonight -- but do go read it all:

. . . .“The real brilliance of Barack Obama when he made Medicaid an all-or-nothing proposition,” giving states no option but to cover individuals with incomes up to 133 percent of the federal poverty line if they were to qualify for federal reimbursement, “was that he pitted fiscally conservative Republicans against one another,” she said. . . .

Nobody likes to lose, and that’s what happened” the night the Medicaid expansion got past the Legislature, she said. “I believe we will heal. . . .”

And the ordinary people, in Arizona, and nationwide, won -- the ones who desparately need health care coverage.

Actually, there isn't much else Governor Brewer can say: Arizona's Republicans are fractured, and there are multiple primary challengers angling for her seat. Well played, Mr. Obama -- very well-played, indeed.

Saturday, July 20, 2013

Merck Gets Largest Canadian Pharma Patent Damages Win, Ever Entered Against A Generic Infringer


Apotex and Merck have a series of patent battles, in various stages of progress, around the globe -- on a number of drug franchises. But this is one battle we haven't mentioned before. This one has come out all Merck -- all the time.

And so, earlier this week, Merck took home a $180 million recovery from Apotex's Canadian operations -- for what the Canadian judge called a clear violation of Merck's patent rights in and to lovastatin -- a cholesterol management medicine.

Do go read all of the Lexology.com Canadian case summary -- but here is a bit:

. . . .This case dates back to 1993, when Apotex served a Notice of Allegation in which it undertook not to infringe Merck’s lovastatin patent if it obtained a Notice of Compliance (NOC). After obtaining its NOC, Apotex promptly moved its lovastatin production to a remote location in China. At the liability trial, the Federal Court found, contrary to Apotex’s undertaking, that 70% of the lovastatin made or imported by Apotex infringed Merck’s lovastatin patent and ordered a trial to quantify Merck’s damages. . . .

In the result, the Court found that Merck is entitled to its lost profits [and substantial pre-judgement interest payments] arising from Apotex’s infringement. . . .
Regular readers will recall that earlier in the second quarter, 2013, Merck lost a patent suit here in the US, to Apotex, on the Nasonex® patents. That charge may well appear in the July 30, 2013 earnings release -- but may now be offset by an accrual for this $180 million win, in Canada -- in the rolled up, consolidated results.

We will keep you posted.

Friday, July 19, 2013

Very Modest Payout: Merck Settles, In Louisiana Federal Court, States' Vioxx® Consumer Price Litigation


And the company is out, for only $23 million. This is clearly good news for Whitehouse Station.

It continues to put old problems in the rearview mirror. More later. Must dash. Here's a snippet from the Bloomberg piece, overnight:

. . . .Merck, which paid $4.85 billion to resolve lawsuits contending its Vioxx painkiller caused heart attacks, will pay another $23 million to settle claims it duped consumers into buying the drug.

Merck agreed to pay consumers seeking to band together in a nationwide group lawsuit at least $50 each for their economic losses tied to Vioxx, such as prescription costs, according to filings in federal court in Louisiana. A judge in New Orleans has overseen litigation spawned by the drug since 2005.

“This settlement is a fair, efficient and reasonable resolution of the disputed claims,” consumers’ lawyers said in a July 17 filing seeking preliminary approval of the accord. . . .


We will keep you posted, but recall that there are still a fair number of the Vioxx® "Zombie" opt-out cases, in the US, and an Australian judge has rejected the Vioxx aggregated personal injury settlement in Sydney, as too small, and potentially not reflective of the varying degrees of harm allegedly suffered by patients.

Thursday, July 18, 2013

More "Over-Delivery" Reported -- On Health Insurance Cost Containment -- By Mr. Obama's Health Care Reforms, This Morning


Despite another completely meaningless "show-vote" in the House, the ACA of 2010 steams forward, already likely beating the non-partisan GAO cost estimates for the mid-grades of health insurance to be offered under the exchanges in 2014.

Here is Bloomberg's report -- do go read it all.

The House Republicans are wasting their time -- and the voters' scarce resources -- by staging these entirely meaningless delay votes. The Senate will never pass such a bill -- and Mr. Obama has said repeatedly he will veto these sorts of obstructionist moves, even if the Senate (impossibly) were to today fall into the hands of similarly deluded Republican zealots. It is shameful that the House majority cannot seem to get on with conducting the nation's business. No, it wants solely to keep re-fighting the battle it long-ago lost. Sad -- for the state of our union. Now, here's a bit of the good news, from Bloomberg:
. . . .Monthly rates for “silver” plans, the second-least generous available next year, will be about 18 percent less than the Congressional Budget Office estimated last year when it calculated the cost of the Affordable Care Act, according to a report by the Health and Human Services Department scheduled to be released this morning and previewed by administration officials.

Premiums for the plan average $321 in 11 states examined in the report, while CBO assumed the rates would be about $392, according to the officials, who asked not to be identified talking about the report before it was made public.

Obama will discuss the findings at the White House today. . . . His remarks, which will also highlight $500 million in excess premium payments rebated to 8.5 million Americans this year, are part of an administration effort to encourage uninsured Americans to sign up for policies under the law and generate greater public support. . . .


We will, as ever, keep you posted.

Tuesday, July 16, 2013

"Still Abed?": No New Date For FDA Review Of Latest Sugammadex Safety Data -- Now A Mid-2014 US Launch?


Ed Silverman over at Pharmalot.com is reporting that FDA has cancelled the July 18, 2013 advisory committee meeting to review the latest data on Bridion/Sugammadex.

And, that, in turn, makes a 2013 launch unlikely, now -- it may well be into 2014. And that puts it well over six years behind schedule vis-a-vis Ex-Schering Plough CEO Hassan's claims -- in 2008.

Here's Ed/Bloomberg -- do go read it all:
. . . .A Food and Drug Administration advisory panel was set to meet July 18 to discuss sugammadex, which enables the muscle movement necessary in a patient to extract a breathing tube after surgery. The trial site the FDA is concerned with is one of four where potential allergic reactions associated with the drug were studied, Merck said in a statement today.

Merck has been pursuing a second chance for the drug in the U.S. after the FDA rejected sugammadex in 2008 because of the potential for allergic reactions and bleeding. . . .

We will -- as ever -- keep you posted.

J&J Reports Very Solid Q2 2013 EPS "Beat" -- Even So, Currencies Took Almost 3 Per Cent From International Sales Growth


With Merck set to report its Q2 2013 results at the end of the month, it is (for me, at least!) always a fun parlor game to look at its comparables (those multinational pharma/med companies reporting results more rapidly than Merck) -- to get some "Kentucky windage" on where Merck's major franchises might come out -- in a few weeks' time.

Of course, J&J's operations do not map directly onto Merck's -- especially in the snese that J&J has a proportionately very-large diagnostics/medical equipment portfolio of businesses, compared to Whitehouse Station. Even so, J&J does operate at the same scale -- and in most of the same geographies -- as Merck, so as to its financial metrics, it is a relatively reliable "canary in the coal mine".

I would argue that J&J's experience -- on foreign currencies translation -- is particularly analogous to Merck's. [That is, both hedge pretty prudently, where it is not wildly-expensive to do so.] And so, J&J just reported a nearly 3 per cent erosion in international sales revenue growth rates, due solely to the effect of the strong US dollar. See this non-GAAP to GAAP reconcilation table (a PDF file).

Don't misunderstand -- J&J just posted largely terrific Q2 results, given the still recovering world markets, and the uncertainty around Obamacare implementation here in the US. So, I expect a strong quarter from Whitehouse Station, as well.

I do think currencies will be a drag on reported revenue -- even with significant hedging activity underway. Remember, you heard it here first. [I would sure love to know how Invokana® uptake is progressing, but it is not yet material to overall J&J -- having just been approved by FDA in March. That franchise, as I've repeatedly said, will likely materially-eat into Januvia® US sales growth, over time -- and significantly more than Wall Street consensus currently foecasts.]

Now we wait for Pfizer -- then Merck, at month's end.

Sunday, July 14, 2013

The Number Of Poorly-Reasoned Lawyer Opinion Articles Out There Today -- Lead Me To This Trayvon Update

Someone I love and trust predicted that the jury would acquit. I guess I should have thought more about that. I just wanted to believe a little more -- in common, color blind -- sense. But we are far from the end, here for Mr. Zimmerman's path before the law.

So... I've read several opinion pieces (including this one particularly blowharded version) which suggest that Florida's Stand Your Ground law was no factor in this case. That is simply incorrect. In 2005, the Florida version of Stand Your Ground removed the duty of any citizen to retreat -- if a retreat could safely be acheived -- before using deadly force, in a situation like even George Zimmerman's proffered version of his encounter with Trayvon Martin. [And what of Trayvon's right to stand his ground? I'll not cover that in detail, but Trayvon had a right to be where he was -- when he saw Mr. Zimmerman -- and did not have to leave, or flee, when he and Zimmerman started their physical confrontation. Of course, this will only come up in the civil lawsuits -- soon to be filed, for money damages.]

Thus, in Florida, as of 2005, Mr. Zimmerman was effectively immunized (and here is where, in my opinion, Florida, Arizona and Texas law is wrong-headed) if he used deadly force in a situation where he reasonably believed his life was in danger. Now, if one subscribes to the theory that -- as a 225 p0und MMA trained fighter -- Mr. Zimmerman was capable, and did in fact, pull Trayvon Martin (weighing a scant 155) over, onto the ground, and thus place Martin on top of him, during the struggle -- Mr. Zimmerman created the perfect scenario, for killing Trayvon with impunity (at least under Florida state law -- but federal law is another matter -- more on that a few paragraphs below -- or another post, as I need to run to the airport, shortly).

That is, Mr. Zimmerman, on his back, on the ground, with Trayvon above him -- then claimed he had absolutely no safe avenue of escape, even if he were inclined to do so. Moreover, he then is absolutely allowed (in Florida, Arizona and Texas) to draw his gun, fire it -- and claim both the shield of self defense, and the sword -- of stand your ground.

Yes -- it is my opinion -- based on the fact that Mr. Zimmerman studied these laws (extensively) prior to his encounter with Trayvon, that Mr. Zimmerman had set out with the express purpose of harming Trayvon, that night. He saw him; then he started hunting him (in my opinion). Trayvon had every right to be where he was -- and no one can dispute that. Mr. Zimmerman was told to stay in his car by police, and ignored that order -- to go "hunt" Trayvon. He is not a law enforcement officer, and thus -- in most other states -- would be held absolutely liable for his use of deadly force, thereafter.

So -- stand your ground shaped the outcome in this case, even though Mr. Zimmerman decided not to seek a preliminary immunity hearing based on it. It created a presumption in Mr. Zimmerman's favor, that wouldn't obtain in other states. It forced the state to affirmatively prove that the case was not a self-defense case -- even in manslaughter, and even where Mr. Zimmerman did not ask for a preliminary hearing, on the issue.

When we get to the civil suits (for wrongful death, and monetary damages), and to any subsequent possible federal prosecution for hate crime aggravated assault with lethal force/murder -- the fact that he ignored a lawful police order will become pretty important. More on that later -- but it is a near certainty now that Mr. Zimmerman will be largely unemployable -- and penniless for the rest of his natural days.

Tomorrow, In Delhi, India: A "Full On The Merits" Glenmark Sitagliptin Phosphate Patent Hearing?


We've been waiting for a little over three months for this.

Tomorrow, in Delhi, India, the High Court is scheduled to hear a full argument about whether Glenmark's phosphate polymorph version of sitagliptin is sufficiently distinct from Merck's Januvia® (straight sitagliptin), to allow Glenmark to continue to sell its version to the perhaps 35 million diabetics in India. Recall that Merck's Indian subsidiary abandoned its patent application on that polymorph in India some years ago. [Recall also that, under US patent law, that wouldn't likely matter -- as Merck's US patent protection would very likely extend to such a polymorph.]

Getting back to the main story here, though -- of course, the Glenmark genericized version is already being sold in India -- for about one quarter of what Merck's branded drug fetches there. Thus, a permanent patent loss in India would materially affect the Januvia®/Janumet® franchise, globally.

Having said that, as I noted a few months back, there are signs that should it lose, Merck will partner with Sun Pharmaceuticals (another Indian generic manufacturer) to introduce an "authorized generic" version of Januvia/Janumet -- at perhaps one-third the price of the branded (and thus still slightly more expensive than the Glenmark phosphate polymorph).

In short, MSD India -- the operating branch of Merck in India -- may elect to canibalize its own brand, with Sun Pharma, there -- and thus recoup at least some of the margin it is losing to Glenmark, day by day, in country.

We will likely only have delayed reports, on the proceedings, as we have to rely on local Indian MSM reporting here -- there is (to my knowledge) no direct, real time, electronic version of full-text court records, and proceedings in India. At least not the sort that may be obtained over the 'net, from the US, as of yet.

Just the same -- here's a bit of my recent analysis (to which the graphic at right relates), as a refresher for tomorrow's head to head:

. . . .Apparently Glenmark's defense to Merck's sitigliptin patent infringement claim in India centers on the assertion (by Glenmark) that Merck never obtained a patent in India on the "phosphate polymorph" of sitagliptin (Merck sells sitagliptin around the globe as Januvia and Janumet). Merck has apparently patented the phosphate version of sitagliptin in some other geographies around the globe, but apparently abandoned its patent application in India, at some time in the past.

So -- if these reports prove accurate, the dispute in India looks a fair bit like the dispute that Novartis recently lost, before the Supreme Court of India -- as to a claim on Gleevec®'s patentability in India. In the hopes of making clear what the differences are between the two sitagliptin forms, I've highlighted in orange, at right, the key distinguishing features of each company's product in India. Let me know if it seems unclear -- it is handmade, afterall. . . .


And again (slipping into off-topic territory), do say a prayer (or offer a quiet contemplative moment of positive energy, if you prefer) for Trayvon's travels through the Universe, and for his family and friends -- and for all of us, as parents, who know that "but for the grace of the Infinite" -- Trayvon's own fate could easily befall our sons (and daughters, and nieces and nephews and grandchildren) -- even in states where concealed carry and stand your ground is not the law.

Saturday, July 13, 2013

O/T -- If You Have A Moment -- Say A Prayer For Broward County, Florida -- And For Trayvon's Family And Friends


Do take a moment, in a quiet place, to offer your meditation, or a prayer -- that justice will be done -- and that we all will learn (in time) accept whatever the jury's verdict might hold.

Whatever it might turn out to be, it will be largely a creature of the unique laws in Florida (and some very careful planning -- staging of a crime scene, if you will -- allegedly, by Mr. Zimmerman). Those Florida laws, in my opinion, allow shields to be turned into swords. [Much the same set of medieval rules would apply in Texas and Arizona.]

And, here's an older backgrounder, that tangentially connects this to Whitehouse Station -- in which CEO Frazier made the right decision.

Friday, July 12, 2013

Minor British Patent Spat, Involving A Merck-Licensed HIV Biotech Combo Therapy


This will change almost nothing, as to Merck's consolidated results of operations, since generic versions of Sustiva® (known chemically as efavirenz) have been available for some time, now (thus the other generics' logos in the graphic at right). And add to this that Merck's MSD sub only collects a license royalty in the UK, for efavirenz (from BMS) -- so its share of any damages are going to be "mere shillings, on the pound." It is an interesting case, at least partially involving Merck's UK operations, though -- under British law -- on a slow news week at Whitehouse Station.

Under British patent law, it seems, the branded manufacturer (here BMS) may ask a would-be generic competitor to clarify its intentions, in writing, about whether it will conduct an "at risk" launch of a given proprietary biotech product, prior to the expiration of the branded's UK patent rights. [And that's somewhat akin to the opening moves, in a Hatch-Waxman challenge, here in the US. But then the paths through the wood diverge. . . here's a similar prior case writeup I did, on the same topics -- with Sustiva and Merck, from 2010.]

And that's what BMS/Merck did. It asked. But Teva coyly said its plans were confidential, as trade secrets. The UK Judge didn't buy that answer -- noting the ambiguity of the answer, as to BMS/Merck's still-active proprietary patent interests, in Sustiva -- and granted an injunction. Here's a very well-thought out run-down of the whole case history -- and a bit from it:

. . . .[It was alleged that] Teva intended to infringe the patent and SPC by launching a generic efavirenz product at risk in the UK. BMS' evidence was centred on (i) a positive opinion on the grant of a marketing authorisation by the Committee for Medicinal Products for Human Use, (ii) the grant of a marketing authorisation to Teva by the European Medicines Agency, and (iii) the refusal by Teva in correspondence to provide details of its intentions regarding the launch of generic efavirenz in the UK – Teva stated that its intentions were confidential:

"It is not Teva's policy to disclose to its competitors information relating to the date on which any product the subject of a Marketing Authorisation will be launched in any given country. This is regarded by Teva, and we believe by all our competitors, as being confidential information."

At the same time as commencing the proceedings, BMS also issued an application for an interim injunction to prevent Teva from launching generic efavirenz pending trial. In March 2012, HHJ Birss QC (as he then was) granted the interim injunction. . . .

However, the Judge rejected the notion that telling an originator patentee that Teva had an unequivocal plan to launch only after expiry of the patent or SPC would cause Teva any damage at all, particularly if that information was imparted to the patentee under terms of confidentiality to prevent wider dissemination (e.g. to other generics). . . .


Do go read it all -- but the grant of the UK injunction was proper. That's a bit different than how Hatch-Waxman works, here, no? Have a great weekend.

Wednesday, July 10, 2013

On Fosamax® "Atypical" Claims: Lone Pine Order -- New Summary Proceedings To Dismiss -- For Non-Compliance With Prior Court Orders


The very able Judge John F. Keenan, sitting in Manhattan's federal District courthouse, just entered an order -- revising the procedures applicable to plaintiffs who've failed, thus far, to comply with his Lone Pine orders. In the latest batch (S through Z), perhaps 30 or so plaintiffs' groups were non-compliant. [My February 2013 backgrounder.]

It is clear that the able judge is being very careful -- to allow plaintiffs to preserve their rights -- and correlatively, directly sanction any attorney who is not communicating with his or her client on these important topics. Here is the order, in full:

. . . .It is hereby ORDERED as follows:

1. If any plaintiff identified in Exhibit A does not provide the required information and documents within thirty (30) days of the date of entry of this Order, this Court, upon motion, may dismiss the delinquent plaintiff's action with prejudice and/or impose other sanctions, which may include monetary penalties, based upon that plaintiff's willful failure to comply with the Court's discovery orders and/or inability to come forward with sufficient proof of his or her claim.

2. Dismissals made under this Order will dismiss the plaintiff's case in its entirety (as to all named defendants) and will be on the merits, with the intent that any further claim by a dismissed plaintiff arising as a consequence of his or her treatment with Fosamax shall be precluded.

3. The Court also may issue an injunction pursuant to the All Writs Act, 28 U.S.C. § 1651, enjoining plaintiffs and their counsel from re-filing in any court any claim or action so dismissed.

4. Any attorney who represents a plaintiff who has not served the required information and documents and as to whom a motion to dismiss has been made as provided herein, no later than twenty-one (21) days after the date thereof, shall provide a copy of this Order to that plaintiff and advise that plaintiff of the sanctions and/or judgment that may be imposed. Sanctions may be imposed upon any attorney who fails to notify his or her client as provided herein and the Court may bring such failure to the attention of disciplinary authorities in any state.

5. If counsel for any plaintiff identified in Exhibit A contends that he or she in fact has served the required information and documents, such counsel shall notify the Court and Defendants' Counsel of that fact within twenty-one (21) days of the date of entry of this Order, together with the date of such service and the name and address of the person upon whom it was served and, upon request, a copy of the necessary documents. To the extent any of the above directives are in disagreement with the November 20, 2012 Opinion and Order, this Order shall govern.

(Signed by Judge John F. Keenan on 7/9/2013) Filed In Associated Cases: 1:06-md-01789-JFK-JCF et al. . . .


Do stay tuned -- and if your client is claiming atypical injuries -- be sure their written expert report(s) (with all the requisite details) have been filed with the court. That is the central requirement of the standing Lone Pine order. We will keep the readership posted.

Great NYT Story -- On Injectible Biologic Candidates -- Promising To Revolutionalize LDL Management


As it's a rather quiet news week at Whitehouse Station, I'll point the readership to an older discussion we had here -- brought back to top of mind, by this fine article from Gina Kolata, writing for The New York Times, this morning.

It's a fast-paced, breezy plain-English, but scientifically accurate, read through -- of the exciting race to create a biologic (i.e., grown inside living cells) agent that mimmicks an exceedingly rare, and exceedingly beneficial, genetic mutation which makes certain people almost immune to heart disease. That mutation, it turns out, was discovered because someone noticed the racial differences in otherwise similar populations, related to LDL levels. But I am getting ahead of myself.

Do go read it all, but here's a bit:

. . . .She was a 32-year-old aerobics instructor from a Dallas suburb -- healthy, college educated, with two young children. Nothing out of the ordinary, except one thing.

Her cholesterol was astoundingly low. Her low-density lipoprotein, or LDL, the form that promotes heart disease, was 14, a level unheard-of in healthy adults whose normal level is over 100.

The reason was a rare gene mutation she had inherited from both her mother and her father. Only one other person, a young, healthy Zimbabwean woman whose LDL cholesterol was 15, has ever been found with the same double dose of the mutation. . . .


And so, this sleuthing for a drug/biologic to mimmick the beneficial LDL mutation story reminded me of a discussion we had, when Sen. John McCain was running for President (in the Spring of 2008) -- and lower LDL via a "gut mechanism" was being shown likely to be little more than an "extremely-expensive placebo" (Vytorin®/Zetia®), day by day. Back then, we all expected that IMPROVE-IT might well settle the question, definitively -- and be published by 2012. We now expect IMPROVE-IT results some time after 2014 (see my countdown counter, at left).

To be clear -- I do think the biologics' approach to LDL lowering has a very good chance of being wildly-successful in improving outcomes -- reducing heart attack risks. This is so because the mechanism each biologic employs (i.e., not a gut mechanism) is so different. If these biologics reach market before 2015, whatever IMPROVE-IT shows will become largely a footnote -- it will all have been leap-frogged, by advancing science.

So while the question is still open -- I'll rerun that 2008 piece here -- enjoy:

[UPDATED -- 05.26.08 Noon: Mike Huckman, of CNBC, just linked my blog -- presumably for the goofy graphic, below, right. Very cool. Here is the actual post-page of mine, to which he linked.]

Over the long Holiday weekend, once Ed at Pharmalot noticed the above change-in-meds in a news report of the Senator's recently-released health records, we had some fun with graphics -- creating a "collectible" campaign button for the above presidential-hopeful [click small version, at right, to view full-sized image]. Then, rather unexpectedly, a more serious discussion evolved in our comment-box. We highlight it here -- and hope that it will continue.

Thanks thus go to the Anonymous Commenter, below. My thoughts are in dark-blue, the Anonymous Commenter's are in dark orange [all as in the original, save the clean-up of a few obvious typos on my part]:

Anonymous said...
Yes, humorous. What about the idea around "getting the patient to goal?" If the Senator's LDL has elevated up to 123 from the 80's, the Vytorin was working and now the Zocor can not do the job. We are without the Senator's complete medical status and cannot determine what other major risk factors might be present. (McCain's age counts as one risk factor. What is his HDL? Does he have a family Hx of heart disease?) Using the word "acceptable" is only relative; some physicians are more aggressive and some are not. Many physicians treat all their patients to an LDL goal of less than 100.

I would prefer to rely on the more than 25 years of evidence that there is a clear relationship between lower LDL and fewer cardiac events - 4S, HPS, WOSCPS, ASCAP, POSCH, etc. Until the NCEP changes elevated LDL cholesterol as the primary target of therapy, chances are better that a smaller LDL number is a better number. We are starting to see patients who insisted on being removed from Zetia who are no longer at goal. Many are rethinking that original decision because their Vytorin was working and there are no safety issues in the Enhance trial. In spite of Enhance being handled poorly, it is only a piece of the pie - a bit of information in the long continuum of understanding how a drug behaves.

The drug's usefulness and the behavior of the executives continue to diverge. The issues of behavior continue to be troublesome but the issues around Vytorin are less so.

How about this question: If lower LDL is better for sick patients, why wouldn't lower LDL be better for patients without heart disease, especially those that may be serving as president?


May 24, 2008 2:29 PM


condor said...
It is well to note that we share a sense of humor -- that ought to serve us well, in our discussions.
Now, I think the crux of our disagreement will boil down to "Why that particular goal level (LDL number)?"

I think it fair to say that for his advanced age, Senator McCain enjoys very robust cholesterol/heart health. Did you see his scores on the treadmill/stress test? Pretty impressive -- for a guy his age.

That is the (very) good news.

Now, some clean-up, here: your "25 years of evidence" do not speak at all to gut-mechanism LDL lowering (the Vytorin/Zetia method). All that data is from statins, and earlier drugs (i.e. liver mechanisms).

"Gut mechanisms" for LDL lowering may -- emphasis may -- simply change/lower the number, without any real benefit to mortality risks.

Because Sen. McCain is so relatively-healthy, this may be a smaller concern for his case, but aren't you at all concerned that using Vytorin in all cases, aggressively, may lull patients into a false sense of security i.e., "my NUMBER is way low; that's GREAT!" -- so much so, that they stop eating a healthy diet, or stop exercising, and then suffer a cardiac event?

What if it just doesn't work?

I think I would be concerned about that. What if Vytorin is like being "book smart" (a kid who tests really well on the ACT), but lacking "street-sense" -- getting rolled all the time, for lack of common sense (out well after midnight, alone, in a tough neighborhood -- one he doesn't know, at all -- in a dark alley, on foot)?

That is why we must wait until 2012, at the earliest, to know whether Vytorin is worth all the extra money, and all that (circa 2006) fanfare.

Thanks for the thoughtful, and thought-provoking, commentary.

Do stop back.

May 24, 2008 5:52 PM


Anonymous said...
Ah, yes, it certainly will. Humor me now.

LDL goals are carefully designed by a large group of experts. (Refer to the NCEP guidelines.) These goals are not advised without a great deal of evidence as well as taking risk of side effects into consideration. I am not alone in believing an "acceptable" LDL is not the best approach. I quote the press briefing for Senator McCain, "But several outside cardiologists not involved in Sen. McCain's care said cholesterol tests and blood-pressure measurements also included in the records suggest his risk of having a heart attack in the next 10 years is at least 17% -- and perhaps a little above 20% -- and they recommend more-aggressive treatment than the senator is getting."

There is substantial evidence that the more aggressive approach in lowering LDL produces a greater reduction in LDL and fewer cardiac events.

Back to basics: LDL can be lowered by a variety of strategies. The comment that "All that data is from statins, and earlier drugs." is simply not correct.


1. Diet and exercise (life style changes) are frequently recommended for patients and can lower LDL.

2. Statins, Fibrates, Bile Acid Sequestrants, Nicotinic Acid and Cholesterol Absorption Inhibiors (Zetia and the gut mechanism) ALL lower LDL.

3. Ileal bypass lowers LDL as well. The POSCH study, not a statin study at all, demonstrates this effect. See the review:

In 838 patients followed for 9.7 years, the marked lipid modification achieved by partial ileal bypass in the POSCH trial led to demonstrable increases in the disease-free intervals for overall mortality, coronary heart disease mortality, coronary heart disease mortality and confirmed nonfatal myocardial infarction, and coronary intervention procedures. For the clinician and the patient, estimation of disease-free intervals may be more relevant than assessment of differences in incidence rates and risk ratios.

The POSCH findings in women support the aggressive treatment of hyperlipidemia in the general management of atherosclerosis in women.

Effective lowering of total cholesterol and low-density lipoprotein cholesterol in a postmyocardial infarction population significantly reduces atherosclerotic coronary heart disease (ACHD) mortality, ACHD mortality combined with a new confirmed nonfatal myocardial infarction, and the number of coronary artery bypass grafting and angioplasty procedures performed.

Significant differences in morbidity and mortality were preserved over a 5-year period following the trial.

Let's return to the initial 25 years of evidence referenced, which DO speak strongly of the relationship of lower LDL (from MANY sources AND not limited to statin use only) to fewer events.

There is a Log-linear relationship between LDL-C levels and relative risk for CHD. This relationship is consistent with a large body of epidemiological data and with data available from clinical trials of LDL-lowering therapy. These data suggest that for every 30-mg/dl change in LDL-C, the relative risk for CHD is changed in proportion by about 30%. The relative risk is set at 1.0 for LDL-C =40 mg/dl.
Citation:
Grundy SM, Cleeman JI, Bairey Merz CN, et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines. J Am Coll Cardiol 2004;44:720-732.

As to a false sense of security, it is commonly agreed that life style changes are easier said than done. Even if they are executed perfectly, this strategy only lowers LDL by 10-20%. Patients commonly need 40% lowering or more.

Good street sense can be demonstrated by following the mountain of evidence pointing to the importance of lower LDL. It is reasonable to conclude that any strategy that lowers LDL will most likely result in fewer events. A variety of strategies can be implemented to achieve reduction in LDL including (but not limited to) "the gut mechanism". It is simply naive to propose that Vytorin/Zetia "don't work."

Using appropriate Tx and combinations of strategies, including Vytorin and Zetia when indicated takes advantage of this evidence. Waiting until 2012 for additional confirmation will prove deleterious for some. There is enough evidence to adopt an aggressive strategy at the present. Lower LDL prolongs life, therefore I stand by the argument that Senator McCain, and you and I should not settle for an LDL above 100.

Thank you for your extensive research regarding these troubles of SP. The drugs created by scientists are not the source of SP difficulties. Instead continue to follow the money.


May 25, 2008 12:28 AM


condor said...
Thank you for this thoughtful discussion. Your points deserve a longer response -- one which I will return to offer, after the Holiday weekend, here in America (circa Tuesday). I'll likely post your very fine comments, and my responses as a new, headlined blog-post, then, okay?

For now -- let me be more precise -- as your insightful replies have revealed my muddy word-choices here.

Is there any study that shows an outcome benefit -- in any population -- for lowering LDL via a "gut mechanism"?

You and I both know the answer to that. The answer is "no".

And you are right -- I am not upset with most of the Schering scientists -- it is their keepers, in K-1, I am disappointed with.

I did, in fact, "follow the money", and I found that Vytorin costs between 3 and 10 times what generic statin-only-regimens cost.

That is plainly the fault -- the shared fault -- of Schering's executive team, and the FDA (for approving a drug that shows no incremental "outcomes" benefit).

What I don't get is how the Schering spin-meisters can convince themselves that they are serving the common good by overcharging for an in-the-best case (at present) "me, too!" product.

There is simply no evidence that the "gut mechanism" -- Vytorin/Zetia's -- works to improve actual outcomes.
Follow the money, indeed -- it leads to a marketing flim-flam.

May 25, 2008 7:54 AM


Anonymous said...

I propose the reason for your continued insistence that Vytorin/Zetia are a medical rip-off: We are offering these divergent views due to differing definitions of the word "outcomes". We are approaching the word as if it has one meaning and we each are using a meaning that is learned from our own experiences. This careless handling of the word is akin to running fast and loose without agreement on basic vocabulary and definition.

Based on that wide chasm, you believe there is a "flim-flam" and I argue that bad behavior from executives aside, there is significant evidence that using Vytorin/Zetia does have merit.

Recent developments in medical program evaluations address the two primary concerns of cost and quality of care. Political concerns about the rate of increase in cost of medical care led to an intense interest in evaluating procedure- or treatment-specific costs in order to curtail them. However, there is a great danger that uninformed attempts to cut costs may, while achieving their goals, significantly sacrifice quality of care. Thus, it is essential that quality of care ought not be relegated to second place in deference to pure cost containment issues, but rather be given at least equal status.

The theory and practice of measuring quality of care has evolved over time. The recent evaluative history of quality has centered on the assessment of patient outcomes, appealing to the last of the sequence of structure, process and outcome as originally proposed by Donabedian (1966). It has been recognized that evaluating only structure or process in health care delivery falls short of the ultimate measure of interest--patient outcomes. While structure and process are not irrelevant for evaluating health care systems and technologies, neither are they sufficient. Measuring patient outcomes is paramount.

Theoretical and conceptual research in pharmaceutical outcomes evaluation is focused on the relationships between biological parameters, clinical manifestations and health outcomes and the relevance of each of these levels of measurement for economic evaluations. Moreover, structure and dependence of each of these levels of outcomes is a fruitful area for conceptual development so you come by your bias honestly.

You might consider an in depth review of the FDA process for new drug approval, interviews with study designers or pharmacists to understand their definition of what different types of "outcomes" are possible. In this way you might narrow your complaint to a single interpretation of the word's meaning.

Traditionally, medical "outcomes" refer to mortality and morbidity. From your comments, "outcomes" might mean patient outcomes, patient cost satisfaction, short term outcomes or a variety of other interpretations.

Using your perceived definition of "outcomes", the Enhance trial had none but the Sands trial has. Neither are powered for or provide "Outcomes" in the traditional sense.

Before we can advance, you must "see" that the discussion should be narrowed by further and more specifically defining "outcomes". There is a whole field of emerging study around this topic.

The development of more precise models and more efficient methods for assigning dollar values for changes in disease status and treatment processes are also needed to establish cost profiles for various treatment protocols. This costing research requires a detailed understanding of the clinical course of the disease, methodological issues and the potential clinical manifestations of the treatment regimen.

I remain interested in your evaluation of these problems. I remain steadfast in my belief that Vytorin and Zetia are clearly NOT "me too" products and are worth a premium as well. Over time, we most likely will converge on these issues.


May 25, 2008 11:43 AM

condor said...
I think you are right. We have not yet agreed about the word "outcomes" -- in this context. Here is what I mean, when I refer to "outcomes":
Improved outcomes would mean, to my way of thinking, a reduced rate of mortality, or reduced rate of cardiac events, all as compared to a "statins-only" regimen, in similarly-situated patients.
That is what IMPROVE-IT is, ostensibly, looking at. So, I guess we wait until 2012.


As to the POSCH study -- lowered LDL via a liver mechanism [note that POSCH also relied on ". . . .an indirect cholesterol drain from increased hepatic conversion of body cholesterol stores to bile acids to replenish the depleted bile-acid reservoir. . . ." -- a liver-draning mechanism, that!], IMO, does not equal lowered LDL via a gut mechanism -- that much may safely be inferred from the ENHANCE study [non-] results. Else, why would we not have seen statistically-significant improvement in Vytorin patients, vis-a-vis statins-only patients. Remember here that -- contrary to the companies' claims -- Dr. Bots declared the data were "fine. . . . no better, and no worse. . . ." than comparable sets of data measured the same way. So it will not advance the discussion, between the two of us, to suggest that ENHANCE is simply a case of bad measurements/faulty data.
I await your relpy. Thank you for the wisdom of your commentary, here.
May 26, 2008 11:14 AM
Anonymous said...
72 comments from the WSJ blog emphasize the practice of medicine as one of both art and science. “We must carefully evaluate cardiovascular risk and follow evidence based guidelines to HELP prevent heart disease”, as Dr. Cannon suggests. The POSCH study was quoted to remind that cholesterol can be reduced by a variety of methods, even surgery. I can not see where Enhance was suggested to be "simply a case of bad measurements/faulty data." This game is one of chance. In making a move, it is useful to look at evidence and trends, individualize the approach and make a calculated decision on Tx. It is complicated and reminds us that we are doing our best without knowing all of the answers, even if one chooses to "wait" until 2012.

May 28, 2008 12:10 AM

condor said...
It could be that WSJ commenters have a little more skin in the game than some of those at the general health-care blogs, but we certainly agree as to that last sentence: ". . . .It is complicated and reminds us that we are doing our best without knowing all of the answers, even if one chooses to "wait" until 2012."
May 28, 2008 4:10 AM




Monday, July 8, 2013

China's None-Too-Subtle Play: Control Procurement Prices On "Essential" Drugs


Over 60 companies, most of them multinationals like Baxter, Merck and Astellas (to select just three, as an example of the varying sizes) have been informed that an agency of the Chinese government is looking into the way the companies price what China deems as essential medicines.

This should be rightly seen through the lens of political jaw-boning -- and not enforcement, for any bad act -- as the Chinese government is far and away the primary payer, for all medicines delivered there. It makes sense that the agency would -- from the Chinese cultural perspective -- say that as to "essential" medicines, the profits ought to be modest, for the drugmakers.

[These general Chinese pricing reviews should not be confused with a specific investigation now underway as to GSK's marketing practices for Botox in China (H/T Ed Silverman). That -- according to the Chinese agencies -- is allegedly ripe with "bad acts" aromas. It may or may not actually be, IMHO.]

In any event, here is a bit of the Bloomberg story, out this morning -- do go read it all:

. . . .Officials from the center will visit the companies between July and October, according to the statement. GlaxoSmithKline, Merck, Novartis, Baxter and Astellas Pharma Inc. are in the cost part of the review, along with a number of Chinese drugmakers, it said. . . .

“This isn’t surprising as drug prices are often under scrutiny from the NDRC,” said Jason Siu, a health-care analyst with RHB OSK Securities Hong Kong Ltd. “It makes sense for them to try to keep procurement costs low. . . .”


I suppose it is remotely possible that the Chinese officials will suggest that local Chinese drug manufacturers might make these essential meds available less expensively, if China were to nationalize the intellectual property behind them. And that, afterall, is a power other agencies of the Chinese government retain, to this day.

That would be an extremely unfortunate turn of events, for the multinational pharmacos, but I suspect the Mercks and Baxters of the world will head that effort off at the pass -- with some modest price concessions, during the reviews. We will keep you posted -- as ever. And happy return to the mid-summer's office-week!

Sunday, July 7, 2013

Merck Voluntarily Recalls ONE Lot Of Hep B Vaccine Conjugate -- On Small Possibility Of Cracked Vials


This really should be of no concern -- either in the providers' offices around the US, or on the NYSE, tomorrow. It affects only one lot; and presumably any damaged conjugate vials would be readily seen as cracked, upon the FDA-required visual inspection by the nurse, immediately prior to administration by injection (still an entirely manual process, thankfully, here).

Just the same, West Point, Pennsylvania is smart to fully recall the entire lot -- for safety's sake. I am certain there will be no impact on availability of the Hep B vaccine, as several weeks' supply is already on hand, in finished goods, and wholesaler inventories, around the nation. Here's a bit of the story from last Wednesday do go read it all:
. . . .Merck said Wednesday that it was recalling one lot of its hepatitis B vaccine Recombivax HB that was made in West Point, Montgomery County, because of fears that some of the vials could have cracked. . . .

The U.S. Food and Drug Administration posted a notice of the voluntary recall on its website. The medication is delivered via injection. . . .
Back to the regular daily routine/grind, in the morning -- Namaste, one and all. Have a safe last evening of hammock-snoozing celebrations, beachfront barbeques, etc.

Wednesday, July 3, 2013

Where To Submit Your Claim Form: ENHANCE Vytorin® Federal Securities Class Action Litigation


The entire 10 page claim form -- needed to receive a payment for a portion of the $688 million, on your legacy Schering-Plough stock trading losses between 2006 and 2008 -- is here. The legacy Merck version is here. Be sure to fill in the right one (or both, if you owned both stocks).

Download it, fill it in completely -- and include COPIES of any of your stock certificates (not originals), and copies of supporting documents (brokerage statements if your shares are/were in uncertificated form, or in street name) -- then mail it to (as applicable):
In re Schering-Plough Corporation/Enhance Securities Litigation
c/o Epiq Systems, Inc. Claims Administrator
P.O. Box 3127
Portland, OR 97208-3127

or to:

In re Merck & Co., Inc. Vytorin/Zetia Securities Litigation
c/o Epiq Systems, Inc. Claims Administrator
P.O. Box 4178
Portland, OR 97208-4178


We will keep you posted, here -- as the October 1 settlement approval hearing date draws nearer -- but it may take up to 60 days to process your completed form. You must submit your claim by mid-November 2013 (actually postmarked by November 18, 2013) to be eligible for a payment -- so jump right on this.

Do write back in or call (as listed on the form), if you don't receive a return post card within 60 days, confirming that the Administrator got your completed claim form.

Happy Fourth, one and all. Good luck! All the information, and supporting explanations may be found here (for Schering-Plough holders), and here (for Merck).

[And thanks again, Hans, "Fast" Fred, Carrie, Tom, Bob and Tom (especially)! You were -- by your acts and omissions -- able to max out the policy limits on all the insurance Schering Plough carried on you, for alleged bad acts/breaches of duty. You must be terribly proud of that.]

Tuesday, July 2, 2013

BREAKING: Key Component Of Affordable Care Act -- Employer Insurance -- Delayed To 2015 By Obama Administration


This is now confirmed by both the Washington Post and the New York Times:

More analysis, later this evening; I must bounce, now.

. . . .The Obama administration will not penalize businesses that do not provide health insurance in 2014, the Treasury Department announced Tuesday.

Instead, it will delay enforcement of a major Affordable Care Act requirement -- that all employers with more than 50 employees provide coverage to their workers until 2015. . . .

“We recognize that the vast majority of businesses that will need to do this reporting already provide health insurance to their workers, and we want to make sure it is easy for others to do so.”

The Affordable Care Act requires all employers with more than 50 full-time workers provide health insurance or pay fines. . . .


Stay tuned.

As I Predicted -- Judge Keenan Did Let Mrs. Scheinberg's $285,000 Fosamax® ONJ Jury Award Stand


I am rather tardy getting to this (busy with other duties) -- but it is very much as expected, so no great news value here. [This was my prediction of about 10 days ago.]

Just the same, the very able Judge Keenan has reaffirmed that, under New York law, a drug's warning label will take a case of injury away from the jury only if there has been no credible evidence about the inadequacy of the label's warning. Using "mumbo jumbo" magic words (alone) won't do, under New York law, wrote Judge Keenan. [Compare: In New Jersey, for example, showing that the label warned of the victim's precise malady might well be enough. Not so here.] Judge Keenan reminded Merck's lawyers that Mrs. Scheinberg's experts had clearly suggested that Merck's label didn't address ONJ Fosamax® adverse events, with a level of gravamen (at or around 2005) to give the prescribing physician the "unmistakable impression" that the risk involved with the matter was serious.

Here is the operative bit of Judge Keenan's opinion (as a 10 page PDF file), handed down overnight in Manhattan's federal District courthouse:

. . . .Finally, the jury was presented with testimony from Dr. Parisian [plaintiff's expert] about other drugs' labels that addressed ONJ and oral bisphosphonates. Under New York law, evidence that a manufacturer "diluted" a label or introduced confusion or inconsistencies is relevant to the failure to warn inquiry. The Plaintiff introduced evidence to show that [at or around 2005] the FDA had suggested a label change to include language that most cases of ONJ "have been in patients treated with bisphosphonates intravenously, but some have been in patients treated orally." The jury learned that Merck rejected this proposed change. Dr. Parisian also spoke to the jury about the labels that were used by Fosamax competitors, namely Actonel and Boniva. These drug labels reflected the FDA's proposed language almost verbatim. In considering the competitors' labels and the suggestions made by the FDA, a reasonable juror could have concluded that Merck's ONJ precaution was inadequate. . . .


Of course, Merck might appeal, but as I've said, I think its chances are slim to none here. This was properly a factual question for the jury. The jury carefully weighed the evidence; that makes the jury's verdict nearly immune from attack. So it goes.