Even As US Drug Spending Fell — For The First Time In A Half-Century

. . .Medical treatment/drug decision making waste still proliferated.

Do go read all of this fine article from the Memphis (Tennessee) Business Journal, but the papers nationwide were full of the news that — for the first time in decades, prescription drug spending declined in the United States in 2012. That is due to the rise of generics, and health care reform — the ACA of 2010 — beginning to kick in (as well as, to a lesser extent, the still-slow to recover economy).

Even though this is good news, we must not lose sight of the fact that — especially among the nation’s poorest patients — those receiving Medicaid — we still waste nearly $56 billion a year. And that is money that could be used to improve care, for all Medicaid recipients, in a more effective manner.

Do go read Cole Epley’s article — but here is a bit:

. . . .Per capita costs related to wasteful prescription spending totalled $1,623 in Mississippi, which led the nation in terms of per capita costs; Mississippians also earn the lowest per capita personal income of all 50 states, according to data from the U.S. Department of Commerce and the Bureau of Economic Analysis. [Arkansas wasted $1,442 per person per year, and Tennessee wasted $1,434 per person per year -- also among the nation's most-poor states. . . .]

Express Scripts defined waste as “extra medication-related spending that provided no additional clinical benefit.” Data suggested $55.8 billion was spent on high-priced medications when more cost-effective generics could have been used, for instance. . . .

“Our nation pays a huge price for bad medication-related decisions, and it is clear that the price is even more costly for those at the lowest end of the economic spectrum,” Steve Miller, chief medical officer at Express Scripts, said in a release. The data showed per capita costs were the highest in the Southeast. . . .

We will keep you posted on the trendlines — as Obamacare takes hold here in 2013. And to tie this back to Merck, I’d think specifically about Vytorin^®, and newly-approved Liptruzet^® when I think of expensive branded drugs which are providing no demonstrated additional clinical benefit.

Quick Additional Thoughts — On The Scope Of FDA’s Regulatory Charter

A friendly, and long-standing, commenter mentioned a link below — and I thought I’d post my answer, embellished a bit, as a new Saturday morning post, here. It amplifies this, of mine, from last Saturday, on Merck’s winning Liptruzet^® FDA approval.

Yes — I did see that. Ed Silverman is a really sharp guy. He’s right — as is the guy he quotes — who wrote for Forbes, on the same notion, on Thursday evening. I’m debating about whether I need to say more on the topic than I said last Saturday morning.

I do agree that the FDA risks denting its now largely-repaired reputation, here.

There was a time, during the second Bush-Cheney administration, when many (if not most) long-time industry watchers/insiders felt that industry had essentially acheived FDA “regulatory capture“. That is, many felt that industry was able to subtly (but effectively) influence FDA’s agenda — due to high profile placements of former pharma insiders, in FDA policy-setting roles — over the course of a decade. I personally never really worried that patient safety was being compromised, but I did worry that in some cases pharma marketing was trumping the soundest science. FDA wasn’t asking “is this the MOST effective drug?” — in a given class. But there was, and is, a perfectly benign reason for that. See below, for that.

With Mr. Obama’s election, then, a fair portion of the “marketing” regulatory capture drew to a close, in my estimation. FDA today is far more transparent — and more responsive — to public health needs than it has been in decades (perhaps going all the way back to its halcyon days — in the 1960s).

Having said that — and personally wishing that FDA would actively look at “comparative effectiveness” when approving new drugs — I do know that, strictly speaking, FDA’s regulatory authority ends at “is it an effective and safe medicine?”. . . not at “is it the MOST effective drug out there?”

While there are proposals to draft comprehensive comparative effectiveness regulations, under various parts of the ACA of 2010 — these remain proposals, not law (yet).

So — the experienced realist in me accepts that FDA would be likely have been sued by Merck, had FDA not approved Merck’s Liptruzet — its latest cholesterol management combo — for exceeding FDA’s currently-authorized regulatory portfolio.

And so — as I wrote seven days ago, I think we have to count on the market-place, to make sure Liptruzet sees only very limited adoption.

As Ed said (but do go read it all):

. . . .Merck has been running the 18,000 patient IMPROVE-IT trial, but results are not due until September 2014. . . .

This prompts a question –- what happens if the results are unfavorable? Well, Merck is left with a pair of cholesterol pills generating flat to declining revenue. Even if the IMPROVE-IT trial results are favorable, the drugmaker faces a different dilemma, because the Vytorin patent expires in 2017. By winning approval for Liptruzet, Merck has found a way to overcome the odds.

This is where the skepticism and cynicism kicks in. In its announcement, Merck acknowledged that Lipruzet did not offer any “incremental benefit on cardiovascular morbidity and mortality over and above that demonstrated for atorvastatin” (read here). In other words, patients and physicians should not expect the combination pill to offer any advantage in reducing the chance of developing heart disease. . . .

This is a difficult — and still very gray — area. And, from Merck’s perspective, in my opinion, Merck was just completing the last little bit of a huge legacy Schering-Plough spend, on the chance that IMPROVE-IT vindicates such combos.

Thanks so much for mentioning it, directly, Anon. Saturday mornings are always luminous, if not entirely clear, here. Even so — I’m inclined to trust the nation’s good doctors — to figure this one out.

More “Roundin’-Up The Ole S-P Gang” News | Fact: Alex Kelly; Rumor: Carrie Cox(?) — To B&L

This just turned up, in the “Goofy Deal Goggles” bin, as a rainy Friday morning unfolds. So, we once again take a quick look at the various legacy Schering-Plough executives (at least six, at last count) who’ve followed Fast Fred in one role or another — over to the pre-IPO Bausch + Lomb C Suite — to take one more ride on one of Fred’s gilded Gulf-Streams.

Thanks entirely to our alert commenters — we have one more confirmed — and one more rumored. First, the facts: Merck has lost its VP of IR, Alex Kelly, who will join Fred, as his B + L Investor Relations maven (in much the same role he held at Pharmacia and Upjohn, and then at Schering-Plough, making him a triple bagger Fred follower):

. . . .Bausch + Lomb, the global eye health company, today announced that Alex Kelly has joined the company as vice president, Investor Relations, reporting to the company’s president and chief financial officer, Bob Bertolini [also a Schering-Plough alum]. In this capacity, Kelly will serve as the primary point of contact for the investment community. . . .

Kelly joins us from Merck & Co., where he served most recently as vice president, Investor Relations. Prior to Merck, he was group vice president of Global Communications and Investor Relations at Schering-Plough. Earlier in his career, Kelly held senior Investor Relations roles with Novartis and Pharmacia & Upjohn. . . .

It will surprise me if Carrie Cox returns to the Fast Fred Fold — given her other public company duties. [That is, I think she has a safer path ahead, if she stays put -- she'd at least arguably have to surrender her seat on the board of directors of Cardinal Health, a distributor of competing products, if she were head of pharmacy sales for B + L. She also sits on Celgene's board, and the board of Texas Instruments. Each of these public boards offer stable, safe income, and equity -- that is liquid. She is, in addition, CEO of a private company called Humacyte, at the moment -- lots of equity and cash there, as well.] Even so, Fred does have a way of platinum-plating his job offers — to those most loyal to his causes. So — it could be. It might be. But it is mere rumor, at this point.

Does anyone out there have a definitive piece of evidence on this? Do share.

In Three Months, An Additional 450 Fosamax® Femur Fracture Cases Were Filed Against Merck, And Are Pending: That’s Over 5,585 In Total

The net increase of about 450 cases is completely attributable to new femur fracture cases, allegedly related to Fosamax^® use — as the net number of similar ONJ cases has declined by about 20, net, net — due to the Lone Pine order exclusions, entered by the very able Judge Keenan in Manhattan’s federal District Court, thus far. [More of those will be dismissed this month, as the second deadline papers are finalized.] So, there are now 5,585 plaintiffs groups, and growing, day by day.

Below is a complete comparison of the first quarter 2013 disclosure, compared to the year end 2012 disclosure on the topic, specifically marked to show changes. As an unrelated side note, I’ve also included Merck’s entirely new paragraph — on Januvia^®/Janumet^® litigation, at the bottom — fascinating. That appears to be emerging as another material trend in Merck’s litigation defense spend.

All of this is in Merck’s SEC Form 10-Q — as filed after 5 PM EDT, this evening, at the EDGAR window.

 

Fosamax

 

As previously disclosed, Merck is a defendant in product liability lawsuits in the United States involving Fosamax (the “Fosamax Litigation”). As of DecemberMarch 31, 20122013, approximately 4,560990 cases, which include approximately 5,140585 plaintiff groups, had been filed and were pending against Merck in either federal or state court, including one case which seeks class action certification, as well as damages and/or medical monitoring. In approximately 1,230210 of these actions, plaintiffs allege, among other things, that they have suffered osteonecrosis of the jaw (“ONJ”), generally subsequent to invasive dental procedures, such as tooth extraction or dental implants and/or delayed healing, in association with the use of Fosamax. In addition, plaintiffs in approximately 3,330780 of these actions generally allege that they sustained femur fractures and/or other bone injuries (“Femur Fractures”) in association with the use of Fosamax.

Cases Alleging ONJ and/or Other Jaw Related Injuries

In August 2006, the Judicial Panel on Multidistrict Litigation (the “JPML”) ordered that certain Fosamax product liability cases pending in federal courts nationwide should be transferred and consolidated into one multidistrict litigation (the “Fosamax ONJ MDL”) for coordinated pre-trial proceedings. The Fosamax ONJ MDL has been transferred to Judge John Keenan in the U.S. District Court for the Southern District of New York. As a result of the JPML order, approximately 960940 of the cases are before Judge Keenan. In the first Fosamax ONJ MDL trial, Boles v. Merck, the Fosamax ONJ MDL court declared a mistrial because the eight person jury could not reach a unanimous verdict. The Boles case was retried in June 2010 and resulted in a verdict in favor of the plaintiff in the amount of $8 million. Merck filed post-trial motions seeking judgment as a matter of law or, in the alternative, a new trial. In October 2010, the court denied Merck’s post-trial motions but sua sponte ordered a remittitur reducingthe verdict to $1.5 million. Plaintiff rejected the remittitur ordered by the court and requested a new trial on damages. Plaintiff and Merck subsequently entered into a confidential stipulation as to the amount of  plaintiff’s damages that enabled Merck to appeal the underlying judgment, and Merck filed its appeal in the Boles case onin October 18, 2012. Prior to 2013, three other cases were tried to verdict in the Fosamax ONJ MDL. Defense verdicts in favor of Merck were returned in each of those three cases. Plaintiffs have filed an appeal in two of the cases – Graves v. Merck and Secrest v. Merck. On January 30, 2013, the U.S. Court of Appeals for the Second Circuit affirmed the judgment in Merck’s favor in Secrest. On April 30, 2013, plaintiff in the Secrest case filed a petition for writ of certiorari with the U.S. Supreme Court.

In February 2011, Judge Keenan ordered that there will be two further bellwether trials conducted in the Fosamax ONJ MDL. Spano v. Merck and Jellema v. Merck were selected by the court to be tried in 2012, but each case was dismissed by the plaintiffs. OnIn March 28, 2012, the court selected Scheinberg v. Merck as the next case to be tried. Trial in the Scheinberg case began on January 14, 2013 and, on February 5, 2013, the jury returned a mixed verdict, finding in favor of Merck on plaintiff’s design defect claim, and finding in favor of plaintiff on her failure to warn claim and awarding her $285 thousand in compensatory damages. On March 5, 2013, Merck filed a post-trial motion for judgment as a matter of law in the Scheinberg case and that motion is still pending.

Outside the Fosamax ONJ MDL, in Florida, Carballo v. Merck was set for trial on October 15, 2012, but plaintiff dismissed the case and refiled it in the Fosamax ONJ MDL. Anderson v. Merck had been set for trial on January 14, 2013, but plaintiff dismissed the case prior to trial.In November 2011, Judge Keenan issued an order requiring plaintiffs who do not allege certain types of specific injuries to provide expert reports in support of their claims. The deadlines for submission of these reports are staggered throughout the first half of 2013, and failure to comply with the order may result in dismissal of a plaintiff’s claim. The first deadline passed on February 20, 2013, and Merck submitted to the court on February 27, 2013 a list of several hundred plaintiffs who failed to comply with that first deadline. On March 13, 2013, Judge Keenan ordered that those plaintiffs who failed to provide reports by the February 20, 2013 deadline had 30 days to provide the required reports or, upon motion, the case may be dismissed with prejudice and/or the court may impose sanctions for failure to comply. To date, more than 225 plaintiffs subject to the order have dismissed their claims with prejudice.

 

In addition, in July 2008, an application was made by the Atlantic County Superior Court of New Jersey requesting that all of the Fosamax cases pending in New Jersey be considered for mass tort designation and centralized management before one judge in New Jersey. In October 2008, the New Jersey Supreme Court ordered that all pending and future actions filed in New Jersey arising out of the use of Fosamax and seeking damages for existing dental and jaw-related injuries, including ONJ, but not solely seeking medical monitoring, be designated as a mass tort for centralized management purposes before Judge Carol E. Higbee in Atlantic County Superior Court. As of DecemberMarch 31, 20122013, approximately 260265 ONJ cases were pending against Merck in Atlantic County, New Jersey. In July 2009, Judge Higbee entered a Case Management Order (and various amendments thereto) setting forth a schedule that contemplates completing fact and expert discovery in an initial group of cases to be reviewed for trial. In February 2011, the jury in Rosenberg v. Merck, the first trial in the New Jersey coordinated proceeding, returned a verdict in Merck’s favor. In April 2012, the jury in Sessner v. Merck, the second case tried in New Jersey, also returned a verdict in Merck’s favor. Plaintiffs have filed an appeal in both cases. On March 25, 2013, the New Jersey Appellate Division affirmed the judgment in Merck’s favor in the Rosenberg case.

In California, the parties are reviewing the claims of two plaintiffs in the Carrie Smith, et al. v. Merck case and the claims in Pedrojetti v. Merck. The cases of one or more of these plaintiffs may be tried in 2013.

Discovery is ongoing in the Fosamax ONJ MDL litigation, the New Jersey coordinated proceeding, and the remaining jurisdictions where Fosamax ONJ cases are pending. The Company intends to defend against these lawsuits.

Cases Alleging Femur Fractures

In March 2011, Merck submitted a Motion to Transfer to the JPML seeking to have all federal cases alleging Femur Fractures consolidated into one multidistrict litigation for coordinated pre-trial proceedings. The Motion to Transfer was granted in May 2011, and all federal cases involving allegations of Femur Fracture have been or will be transferred to a multidistrict litigation in the District of New Jersey (the “Fosamax Femur Fracture MDL”). As a result of the JPML order, approximately 8201,015 cases were pending in the Fosamax Femur Fracture MDL as of December March 31, 2012.2013. A Case Management Order has been entered that requires the parties to review 40 cases (later reduced to 33 cases). Judge Joel Pisano has selected four cases from that group to be tried as the initial bellwether cases in the Fosamax Femur Fracture MDL and has set an April 8, 2013 trial date for the . The first bellwether case, which will be Glynn v. Merck, began on April 8, 2013 and the jury returned a verdict in Merck’s favor on April 29, 2013. The Zessin v. Merck case  s was set to be tried in September 2013; the Young v. Merck case is set to be tried in  but has been sescheduled for January 2014; the Young v. Merck and the Johnson v. Merck case is setcases are expected to be tried later in May 2014.

As of DecemberMarch 31, 20122013, approximately 2,075305 cases alleging Femur Fractures have been filed in New Jersey state court and are pending before Judge Higbee in Atlantic County Superior Court. The parties have selected an initial group of 30 cases to be reviewed through fact discovery. Judge Higbee has set March 11, 2013 as the date for the The first trial of the New Jersey state Femur Fracture cases, which will be Su v. Merck, began on March 11, 2013, but a mistrial was declared on March 28, 2013 after the plaintiff suffered a serious medical issue unrelated to her use of Fosamax that prevented her from proceeding with the trial. The next trial, Unanski v. Merck, is currently set to be tried beginning November 4, 2013.

     As of DecemberMarch 31, 20122013, approximately 420440 cases alleging Femur Fractures have been filed in California state court. A petition was filed seeking to coordinate all Femur Fracture cases filed in California state court before a single judge in Orange County, California. The petition was granted and Judge Steven Perk is now presiding over the coordinated proceedings. No scheduling order has yet been entered.

Additionally, there are eightnine Femur Fracture cases pending in other state courts. A trial date has been set for August 12, 2013 for the Barnes v. Merck case pending in Alabama state court.

Discovery is ongoing in the Fosamax Femur Fracture MDL and in state courts where Femur Fracture cases are pending and the Company intends to defend against these lawsuits.

Januvia/Janumet

 

As of March 31, 2013, there were 43 filed complaints against Merck alleging that plaintiffs’ use of  Januvia and/or Janumet caused them to develop pancreatic cancer. These complaints were filed in several different state and federal courts, with the majority filed in the United States District Court for the Southern District of California. On April 5, 2013, a law firm representing certain plaintiffs filed a request with the JPML to create a federal MDL for lawsuits alleging pancreatic cancer due to use of the following medicines: Januvia, Janumet, and Byetta and Victoza, the latter two of which are products manufactured by other pharmaceutical companies. In its MDL request, the law firm asked the JPML to appoint Judge Anthony Battaglia of the United States District Court for the Southern District of California as the MDL Judge. On April 29, 2013, Merck and the other defendant manufacturers individually filed responses, all of which agreed that Judge Battaglia should preside if the JPML determines that an MDL is warranted. The Company intends to defend against these lawsuits.

We will, as ever, keep you informed, as the next Fosamax trial date approaches.

This May Take A Few Days. . .

Especially since I am particularly busy with other duties, at present – I am uncertain as to whether I will be in a position to provide coverage of the just-filed New Jersey gender and maternity discrimination lawsuit against Merck. I want to more carefully analyze the complaint — especially since it seeks federal class action status, and makes a rather um. . . eye-popping damages calculation.

And so, you’ll find no links to it, here, yet.

For now, I am going to remain silent on it. I want to be rather circumspect on this — if every word of it turns out to be true, and provable, it covers enough sales reps that it might become material to New Merck, at some future point.

But without a careful review of the evidence, and without an officially-filed answer at law to the complaint, it would be irresponsible to lend too much credence to the plaintiffs’ assertions.  At least for now.

Afterall, Merck is regularly lauded, by numerous independent analyses, for being a very-mom friendly place to work. That doesn’t mean the plaintiffs aren’t right — it just gives one a little pause.

GSK And Merck Are Certainly To Be Commended, Here [With A Footnote]

This morning’s coverage of Whitehouse Station¹ is dominated by the joint Glaxo-Merck announcement, with GAVI, of a very-low cost HPV vaccine initiative in the developing world — some 40 countries by 2020. The aim is to vaccinate over 30 million girls — and thus prevent the burden of the disease of cervical cancer — at least the strains of cervical cancer caused by chronic HPV infections. At $4 to $6 per, as compared to over $100 per, here in the States, this is a very generous, humane and charitable endeavor.

As The Guardian noted over this past weekend, though — I’d be less than candid if I didn’t mention that cervical cancer is not a “top five” cause of mortality in most of these 40 countries. It is true that most of those women who do die of cervical cancer tend to live in the developing world, because — as a rule — the disease goes undiagnosed for many many years, in most cases. But that is not the same as being a “leading” cause of death, in these countries.

At least in Africa, one of the first countries to benefit from the initiative, women are far more likely to die from complications in childbirth (primarily sepsis from infections, and ruptured-uterus related bleeding), than cervical cancer. Data also suggest that men are far more likely to die of hypertensive disease, diarrheal disease and HIV/AIDS. And, candidly, each of these public health burdens would be far more expensive to widely address — than a three-shot regimen of vaccines.

No doubt abut it, the HPV vaccines will save thousands of lives. But the vaccine is highly unlikely to save the lives of millions of women, primarily because they are likely to die of other causes, related to inadequate access to basic health care. That is, we should not expect a one-to-one correlation in doses administered, connecting to an equal number of lives saved.

UPDATED: Noon | 05.09.13 EDT – I should have noted specifically that I think the New York Times’ “275,000 deaths/year from cervical cancer in the developing world” figure. . . is not helpful, and perhaps a little misleading.

There is no evidence that these cervical cancer deaths in Africa, for example, are from the small handful virally-induced cervical cancers the vaccines prevent. [No one is paying for the tests needed to do a truly-precise post-mortem analysis, on the specific strains of virus/types of cancers these women are dying of (it's all just likely listed as "cervical cancer" to the extent it is reported at all, in Sub-Saharan Africa, of that much I am certain.] There is also no evidence that the HPV vaccines on sale at deep discounts, are as effective against the most common strains which cause cancer, in Africa, for example. My understanding is that there are over 20 strains in Europe and North America alone. As is often true, mutations are likely to have occured, by geography — and so, we cannot assign one-for-one results in Africa, for example, to North American data.

Surely, there will be some hefty number of saved lives, but I’d guess-timate the figure at closer to 10,000 than any number over 100,000 — especially in this, the pilot phase, with only a few hundred thousand doses being made available — for all the above reasons. [END, UPDATED PORTION.]

Here is the Wa Po on today’s news — in any event:

. . . .Starting with pilot programs in eight Asian and African nations, the ambitious project ultimately is intended to inoculate more than 30 million girls in more than 40 countries by 2020. Given that most women killed by cervical cancer live in developing countries, the project could have a huge impact. . . .

Do not misunderstand, this is a very good thing — no two ways about it — we just need a whole lot more of it, in many many more disease states. Primarily in the truly heaviest burden of disease-states — now. The “we” I refer to, is the “we” — of the peoples — all peoples, as a planet. We can do it — the question is do we have the will to do it?

~~~~~~~~~~~~~~~~~~~
^{1. You may generally assume, as I’ve written in the past, that if I don’t mention a set of Merck press releases, it is because they are either puffery, or definitively immaterial to Merck’s prospects and financial condition. Exhibit A for that proposition, would be yesterday’s ragweed FDA BLA filing announcement. Here endeth my reminder.}

Today’s Object Lesson? There Will Be No Quick Answers — For Alzheimer’s Disease Drug Candidates

I think Matt Herper, writing for Forbes, has a very well-thought out analysis of what the disappointing Baxter announcement of this morning — on its GammaGard^® (immunoglobulin) for Alzheimer’s research program — might mean, for other companies working on an Alzheimer’s candidate. [Baxter's product is already on-market, around the globe, for other disease states. Baxter says it is stopping work in Alzheimer’s, as of today, though.]

I am forever fascinated by how often — in human biology — it seems that any given cognitive function disease/impariment is driven not by one or two clear defining change(s), in brain chemistry, or its DNA replication process — but by perhaps thousands (or tens of thousands?) tiny, almost imperceptible ones. . . occuring seemingly almost at random. That, my friends, will likely make Alzheimer’s one very tough problem to solve.

Do go read all of Matt’s take — but I’d be a little concerned, if I were looking at Merck’s current very high-spend R&D program, almost exclusively aimed at a pill for the Alzheimer’s Beta Amyloid pathway. Here’s a bit from Matt:

. . . .Here’s what may make scientists working on Alzheimer’s disease nervous, though. Eli Lilly had noted a reason for hope when its Alzheimer’s antibody failed: it seemed to work in patients with mild Alzheimer’s disease, and not in those who had the more severe moderate form of the disease. Lilly is continuing to develop its drug.

It would be comforting if the Baxter trial had found the same thing. That would mean that this approach was consistently working in the same group of patients Instead, Baxter says it is seeing efficacy in the moderate form of the disease. This is more in line with what you’d expect if targeting beta amyloid resulted in only slight benefits or none at all. There will probably be more information as Baxter scientists continue to look at the results. . . .

I do not mean to sound overly-alarmist — and it is not (yet) time to drop any of the other programs — but it is very clear that we know less about Alzheimer’s than we thought, before this morning.

Thanks Again To Our Readership! West Point USW Deal Is Final — New Details Emerging

Okay — I’d still love to be able to report that this is at least a three year, locked-in contract (with signing bonuses!?) — but I’ve no independent confirmation of that, as of the moment. With over three-quarters of the members voting in favor of ratification, the contract is final — and binding — upon Merck.

. . . .Anonymous said…

The agreement calls for 3 floating holiday business work days in a calendar year. The union members vote for their preferred days off. The days getting the most votes become the 3 floating holidays for all USW employees.

May 7, 2013 at 8:49 AM. . .

Once again, thanks to all the loyal readers, around the globe! [There are now regular, repeating readers in at least 120 different countries, according to my stat-logs. Cool!]

West Point Collective Bargaining Agreement Ratified Tonight — One Small Issue Remains

Here’s the vote tally, from tonight’s meeting:

. . . .Local 10-00086 membership voted this evening to accept the proposed contract. Out of 1133 votes cast, 864 members accepted while 269 members rejected the tentative agreement. Votes on the floating holiday will come later. Stay tuned.

In Solidarity. . . .

Can any crowd sourcer out there enlighten us about the floating holiday issue?

The History — Of MMR Vaccine Discovery — Saving Hundreds of Thousands Of Lives — And Merck Is Rightly Featured

This New York Times long-form article (on the front page, center, tonight) is a story about which anyone who has ever worked at Merck (including my eldest surviving aunt, as a fine scientist, in the 1960s) ought to be immensely proud. It is the story of science “finding a way” — to end childhood diseases that once were nearly universal scourges. [The vaccines which comprise MMR (measles mumps and rubella) are no longer sold separately, thus the graphic at right.]

Here’s a bit, from tonight’s paper — do go read it all — fascinating:

. . . .The general practice was to isolate a disease organism, figure out how to keep it alive in the laboratory, then weaken or “attenuate” it by passing it over and over through a series of cells, typically from chicken embryos, until it could no longer reproduce in humans but could still elicit an immune response. Other steps followed, particularly for Dr. Hilleman, who was obsessed with safety and with stripping away unwanted side effects.

That spring of 1963, the Food and Drug Administration also granted the first license for a vaccine against measles. Much of the early work on the virus had been done in the laboratory of John F. Enders at Boston Children’s Hospital, but the vaccine still commonly produced rashes and fevers when Dr. Hilleman began to work on it.

Under pressure from public health officials to stop a disease then killing more than 500 American children every year, Dr. Hilleman and Dr. Joseph Stokes, a pediatrician, devised a way to minimize the side effects by giving a gamma globulin shot in one arm and the measles vaccine in the other. It was the beginning of the end of the disease in this country. . . .

Do go read it all. Great stuff.