Friday, September 30, 2011

JNJ Cashes New Merck Out -- Of Their Consumer Health JV

This is a few days old, but it will complete the record, here -- just couldn't get to it before (as a new graphic was needed). From BusinessWeek, of September 28, 2011 then:

. . . .Johnson & Johnson bought Merck & Co.’s half of the companies’ joint venture for over-the-counter medicines for heartburn and digestive diseases for $175 million, ending a 22-year partnership in the U.S. and Canada.

The deal. . . includes a manufacturing plant in Lancaster, Pennsylvania, that is part of a consent decree with U.S. regulators because of production violations. J&J, the world’s second-biggest seller of health products after Pfizer Inc., has recalled dozens of drugs and devices in the past two years, including nonprescription medicines such as Tylenol. . . .

So it goes -- this still leaves the recently-restructured prescription relationship on Simponi® (golimumab)/Remicade® in place between the companies, however -- post the arbitration settlement.

Now, Whitehouse Station says New Merck will be freed up to focus upon its legacy Schering-Plough Consumer Health offerings. We shall see.

Thursday, September 29, 2011

Second Shoe Falls On Merck's EPA Violations in PA: $1.5 Million, This Time -- $20 Million, Last Time

Ed Silverman, over at Pharmalot, has a very solid piece out, putting the latest EPA fine into a broader perspective, at least in Pennsylvania -- do go read it all (a bit appears below):

. . . .This is not the first time, by the way, that Merck has run afoul of environmental laws at its Pennsylvania facilities. In late 2007, Merck paid a $20.5 million for violating the Clean Water Act with three chemical discharges in 2006, one of which killed more than 1,000 fish and forced Philadelphia to temporarily shut off drinking water intakes. . . .

This led to a consent decree and also prompted the EPA to follow up with a more extensive investigation into Merck environmental practices. The agency then conducted what it calls a series of multi-media inspections to review both compliance with federal air, water, hazardous waste, spill prevention, and community right-to-know regulations. This led to the latest agreement. . . .

Also recall that the former Merck Albany, Georgia facility is now a large environmental impact abatement/clean-up site, and that the damages aren't yet know in the Merced, California Chromium 6 water contamination case (but some liability has been established, at an earlier jury trial in the federal courts in central California).

Merck's Secrest Fosamax® ONJ Jury Deliberations: Recess Until Monday, October 3, 2011

Apparently, the Secrest Fosamax® ONJ bellwether jury has deliberated for about a day and a quarter, now -- but hasn't yet returned a verdict. [My personal opinion is that, in a case like this one, the longer the jury is out, the higher the odds that Merck gets hit with damages.]

Probably due to the religious holidays (which began this evening), Judge Keenan has sent the jury home, not to resume deliberations until next Monday morning, the 3rd of October. From this evening's minute order, in the federal District Court for the Southern District of New York, sitting in Manhattan:

. . . .Jury deliberations continue[d]. . . to 10/3/11. . . .

Do stay tuned.

Wednesday, September 28, 2011

The Secrest Fosamax® ONJ Jury Is Deliberating

Closing arguments were completed yesterday, and the jury began deliberations late yesterday. Here is some background on this fourth Fosamax® ONJ bellwether trial. We will report the verdict -- up or down -- when it is reached.

And so -- it would seem that Merck's attempts to keep the case from reaching the jury have failed. From the overnight minute entry:

. . . .Minute Entry for proceedings held before Judge John F. Keenan: Jury Trial held on 9/27/2011. Jury deliberations begin. Deliberations to continue 9/28/11. . . .

Will this be another $8 million verdict against Merck (like Boles I)? Or a dismissal, as in the Rosenberg state court case, and the Maley and Graves bellwether cases? Do stay tuned -- as Hester (now replaced by Raber), and at least two more federal court bellwether trials -- are still to come. . . .

Monday, September 26, 2011

Vertex/JNJ Win European Approval For Incivek® (Telaprevir): More Bad News For Merck

This comes as no surprise, but with the 80-20 market split here in the US (in favor of Vertex), this early EU approval lead over the legacy Schering Plough boceprevir will likely skew worldwide splits closer to 90-10 in favor of Incivek®. Ouch.

From Reuters, this morning -- a bit:

. . . .The pill, which won U.S. approval in May, raked in strong sales of $75 million in the first five weeks it was sold in the country. Known as Incivek in the United States, it will be called Incivo in Europe.

J&J has European rights to the product, with Vertex receiving royalties. Vertex holds exclusive rights to the drug in the United States. . . .

And down, again, goes one of Ex-CEO Fred Hassan's "stars".

Saturday, September 24, 2011

California Governor Brown Mulls A Derivative Of the Texas Gardasil® Conflagration

While the abandoned 2007 Texas measure was a mandatory Gardasil® vaccination order (signed by Governor Perry, but then withdrawn) -- and the current California bill (a piece of legislation) is only a "no parental involvement required" for vaccination of girls-as-young-as-12 bill -- the issues are largely the same: whether the potential preventative (public health) effect of the HPV vaccine outweighs a long-standing parental right to be involved in their childrens' medical decision-making. [To be fair, this Califronia measure, unlike the Texas one, is not Merck-product specific, now that another brand of HPV vaccine has cleared FDA approval.]

Note that this is not a juvenile reproductive rights measure -- in those settings, I support childrens' right to access birth control devices and drugs. I have trouble, on the other hand, allowing even a vaccine which is generally well-tolerated to be given to a 12 year old girl without parental involvement. That strikes me as an unwise extension trasferring to the states the responsibilities of parenthood.

Here is a bit of the fine San Jose Mercury-Sun's coverage -- do go read it all:

. . . .Religious leaders, pro-family organizations and GOP lawmakers have warned the change would erode the rights of parents to be involved in their children's medical decisions. Supporters say the legislation is needed to keep up with new prevention treatments and help slow the spread of STDs among minors.

The bill passed the California Legislature along mostly party lines and now is on Brown's desk. He has until Oct. 9 to act on AB499 and has not signaled his intent.

Currently, California minors are allowed to seek diagnosis and treatment for STDs such as the human papillomavirus, known as HPV, without parental consent but cannot get vaccinated without their parent's approval. HPV is the leading cause of cervical cancer. . . .

There are some reasonable arguments on the other side of the debate, but I still think the measure is ill-considered. We will follow-up as developments warrant, between now and October 9.

Friday, September 23, 2011

Merck Loses Extraordinary Fosamax® ONJ Appeal In Boles II -- Damages Hearing Up Next

Back in January 2011, immediately after the very-able Judge Keenan declined to toss the Boles II Fosamax® ONJ verdict in its entirety, Merck took a mid-trial appeal, called an interlocutory appeal -- one I predicted it would lose. It. now. has. lost. that. appeal.

So -- not long after the Secrest bellwether trial ends (at the end of this month, or early next), Judge John F. Keenan will convene a jury, and charge it with only one task: How much damages are ultimately owed to Mrs. Shirley Boles, who originally won $8 million from Merck (reduced to $1.5 million -- by Judge Keenan -- an amount she declined to accept)?

An entirely new federal jury will now decide. From that Boles order, electronically filed today -- into Judge Keenan's trial court docket:

. . . .Petitioner, through counsel, moves, pursuant to 28 U.S.C. § 1292(b), for leave to appeal an interlocutory order of the district court. Upon due consideration, it is hereby ORDERED that the petition is DENIED because an immediate appeal concerning the issues presented therein is unwarranted. See Klinghoffer v. S.N.C. Achille Lauro, 921 F.2d 21, 23-25 (2d Cir. 1990).. . .

Yep -- next up? another Boles hearing; I'll style it Boles III -- a mini-trial, solely on the allowable level of damages against Merck.

[I suppose Merck could appeal this denial, by filing for a writ of cert., with the US Supreme Court (to interpose some additional delay), but that would plainly be a fools' errand, given the above.]

Thursday, September 22, 2011

Merck Creates 70 to 120 New R&D Jobs In Ireland, Investing €100M

This facility has been under construction since 2007 -- but is good news, nonetheless, after the closures and layoffs in Ireland, of exactly one year ago, this month. This, from a local online pharma news report:

. . . .The US giant, known as Merck, Sharp & Dohme (MSD) outside North America, noted that construction on the facility at the existing Ballydine site began in September 2007 and since then 70 new high calibre roles have been created. This number could increase to 120 as new innovative medicines are developed at MSD and an additional 6 million euro investment is already in the planning phase to extend the new site. . . .

There are currently six new drugs in development at MSD Ballydine, including a cholesterol/type 2 diabetes combination and a treatment for hepatitis C. . . .

A glimmer of good news, eh?

Tuesday, September 20, 2011

Mrs. Secrest's Fosamax® ONJ Lawyers Have Rested Her Case-In-Chief

Merck's lawyers have filed a Rule 50(a) motion, which means that Mrs. Secrest's lawyers have finished putting on the main portion of her Fosamax® ONJ case, in Judge Keenan's federal District courtroom, in Manhattan, earlier today:

. . . .A motion for judgment as a matter of law under Rule 50(a) should be granted only if "a party has been fully heard on an issue during a jury trial and the court finds that a reasonable jury would not have a legally sufficient evidentiary basis to find for the party on that issue. . . ."

We will keep you informed, here -- as to whether Judge Keenan allows the trial to continue, and requires Merck to put on a defense (as I expect he will) -- or whether the trial is effectively over, by tomorrow morning.

"Next Wave" Of Merck Layoffs By October's End

Known to be coming in various forms since a few weeks after the November 2009 closing date, and most recently mentioned here in May 2011, it is still a disappointment to see it play out, in earnest in New Jersey and Pennsylvania.

I've quoted a bit from a local Philly paper, below, but do go read Ed Silverman's definitive piece on the development, here -- looks like he got his hands on the internal company email first. Do also read here about Jim Edwards' take on the Orwellian language used in the company wide email.

. . . ."In the coming weeks, we will restructure the following select HQ functions and field groups within the U.S. Market: Marketing & Customer Solutions; Managed Markets & Policy; Strategy & Commercial Model Innovation; and the Neuropsychiatric and Women's Healthcare specialty sales teams," Timney's e-mail said.

Merck [and legacy Schering-Plough both] eliminated jobs before and after [the] acquisition of Schering Plough. . . . [When the dust settles, Merck's workforce total will be about equal to what it was without Schering-Plough -- said another way, in terms of FTEs, effectively all the workers of legact Schering-Plough will be gone -- with New Merck back to about 53,000.]

Pharma-industry watchers have suggested that about 5,200 of the total cuts could be U.S. jobs, with from 3,000 to 4,000 in New Jersey and Pennsylvania. A Merck spokesman would not comment on the state-by-state plans. The cuts through October won't be the end of the process, though.

In August, Merck offered buyout packages to some employees, but there was no expectation that the buyouts alone would meet the numbers required by management. Merck said that in some areas it would continue to add employees but cut elsewhere.

Timney said the company was open to voluntary layoffs:

"We will also offer the opportunity for employees in the aforementioned select areas to proactively 'hand raise' and be considered for separation. . . ."

"Hand raise. . ."? Really?! My thoughts are with those affected -- as I've been through at least six separate rounds of such "right-sizings" -- but however it turns out, know that you are not alone. Over 100,000 have faced your fate, in Pharma in the last two years, alone. Ugh.

Thursday, September 15, 2011

One Danger Of Making Official Public Statements -- During Trial: Fosamax® Edition

One week ago today, Whitehouse Station put out a press release, essentially setting forth what would be its opening statement in the Secrest Fosamax® ONJ bellwether trial, now underway in Manhattan's federal District Court.

That choice "opened the door" to this: an online San Francisco Chronicle article, detailing the plaintiffs' lawyers opening arguments, in response (and allowing an ad to solicit additional potential Fosamax ONJ plaintiffs!).

Merck can scarcley be heard to complain about this influencing potential future jurors, when it has done essentially the same -- especially since its press releases garner much wider attention from the main stream media.

As I say, it is highly unusual to see this permitted -- a rehash of the opening argument, by the involved lawyers -- in the form of a press release by the lawyers, all permitted by the trial judge:

. . . .On September 8, 2011, opening statements in Secrest v. Merck, a Fosamax lawsuit that is part of the consolidated litigation, In re Fosamax Products Liability Litigation ("MDL No. 1789"), took place. The bellwether Fosamax lawsuit is pending in the U.S. District Court for the Southern District of New York before Judge John F. Keenan. This is the fifth Fosamax lawsuit to go to trial and is expected to last several weeks. The plaintiff in this Fosamax lawsuit, Linda Secrest, alleges that as a result of taking the bisphosphonate, she developed osteonecrosis of the jaw ("ONJ"), a serious side effect of Fosamax. The Fosamax lawsuit also alleges that Merck failed to adequately warn consumers that ONJ was a potential side effect of Fosamax. In addition to this current Fosamax lawsuit, Merck is also defending thousands of others filed by individuals who suffered Fosamax side effects, including those who sustained Fosamax femur fractures.

Plaintiff's Opening Statements: ONJ Is A Serious Side Effect Of Fosamax

The opening statements made by plaintiff's counsel in the Fosamax lawsuit summarized the points submitted to the Court in Plaintiff's Pre-Trial Memorandum* (Case No. 1:06-cv-06292-JFK). As described more fully in the Pre-Trial Memorandum, plaintiff's counsel told the jury that: (1) Fosamax causes ONJ; (2) it was reasonably foreseeable to Merck that Fosamax would cause ONJ; (3) Merck insufficiently monitored post-marketing adverse event data; (4) Merck made misleading representations regarding ONJ; (5) Merck made no attempt to study the risk of ONJ relative to Fosamax; and (6) Merck overstated the efficacy of Fosamax.

If you or a loved one sustained a side effect of Fosamax, such as a femur fracture, you may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries. . . .


Barclays Lowers Merck Target (Again!) -- Merck's NYSE Price Now Below Merger Price

For a good portion of the last 30 days, Merck's closing per share price, on the NYSE has been shy of the normalized price (November 10, 2009) at which the November 3, 2009 merger/bust-up of Schering-Plough was comsummated.

True enough, the markets have been pretty choppy this late summer, but it would defy logic to think that Merck, even with Schering-Plough's manifold problems, is worth less with Intervet, and Organon, than it is without the two.

But -- just the same -- Merck's NYSE stock price market cap [correcting edit courtesy of commenter MrSquare!] is actually now less than what it was before it bought-out/busted-up Schering-Plough. Over the longer term, common sense would suggest that such a condition would not persist. The question, though, is when -- and by how much -- will the NYSE price exceed the $33.61 price at which the merger was completed? $34? $36? "Again, I am shrugging*. . ."

Barclays, despite setting a near term target of $43 not long after the merger, and reducing that to $41 about a year ago -- has this week further reduced its upside target, to $38. Not entirely modestly, that is very close to my upside, but consistently stated -- over the last two years, of $37.

So, what has happened? Barclays (through its Blackrock transactions), has reduced its holdings of New Merck, from around 161 million shares (which was then about five percent of all the outstanding Merck shares), to just over 27 million shares (or less than one percent of all Merck shares).

Here is a bit of one of my prior pieces, on Barclay's conflicted pronouncements, and holdings (I've also updated the graphic, at right):

. . . .[When] it turns out that Barclays has dropped below the 5 percent threshhold, in its next SEC Schedule 13 filing (or in Merck's next proxy, whichever first appears), we ought to all agree that the target was upped, in part, to allow for higher exit prices, for Barclays, as it liquidated some of its outsized Merck position, on the NYSE and through off-exchange blocks. . . .

Do stay tuned -- will Merck return to its former glory, or will the world's second largest pharma concern be permanently hobbled by the antics of Fred Hassan, Carrie Cox, and their hangers-on? Only time will tell,


* A line for the forgettable Ally Sheedy/Steve Gutenberg '80s movie "Short Circuit"

Tuesday, September 13, 2011

Interim Analysis Of IMPROVE-IT Delayed -- Yet Again. Yawn.

Regular readers will recall that for at least the last two and a half years (and most recently here), I have been suggesting that Merck has been too optimistic about when it would report any real definitive results from IMPROVE-IT -- see counter at left, as well. I've long held that we won't know the results until mid-2014.

Increasingly, Merck now agrees with my time line. Yawn.

You may also recall that at one point in early May of 2008, Ex-CEO Fred Hassan (he, of legacy Schering-Plough) had suggested that the results of IMPROVE-IT would be out by late 2011; in other words, almost three years eariler than his own staff had predicted, given the size of the trial. More hucksterism, by the captain of a sinking ship.

Laughable, if it didn't affect the lives of millions of people struggling with high cholesterol. More precisely, it will have been some eight years after FDA approval of Vytorin (and 12 years after approval of Zetia) -- and after over $14 billion in cumulative sales, before we know whether this combo pill is simply an extremely expensive placebo.

Here is a bit of the Reuters report, from today's Morgan Stanley conference, at which New Merck CFO Peter Kellogg spoke:

. . . .Whitehouse Station, New Jersey-based Merck said the executive committee overseeing a trial known as IMPROVE-IT has scheduled the study's second interim analysis for the first quarter of 2012, rather than late 2011, as previously anticipated.

Peter Kellogg, Merck's CFO, said at the Morgan Stanley global healthcare conference that the delay is purely one of scheduling and will not affect overall timing of the trial, expected to be complete in 2013.

"That [a delay in being able to publish results] has not been part of the discussion so far," he said. . . .

Finally, recall that this trial will resolve whether there is any benefit to taking the very-pricey branded combo pill. And so, of course, a jaundiced eye might suggest that "later is better," if one suspects it will not be a clear win for Merck. ENHANCE redux, anyone?

Monday, September 12, 2011

FDA Nixes Expanded Simponi® Label In US -- More Wood to Chop, Before "Active Psoriatic Arthritis" Labeling

While this additional disease indication was green-lighted in the United Kingdom in March 2011, and the EU, it has hit a snag here in the US. Indeed, Merck is benefitting in Europe, on Simponi® (golimumab) sales for the indication, but it possible that if the US FDA requires additional data of Janssen, for Simponi, and that data doesn't support the treatment of active psoriatic arthritis, NICE and the EMEA could revisit each of the earlier approvals. [Recall that back on April 15, 2011, Merck settled, and relinquished exclusive marketing rights to the drug in Canada, Central and South America, the Middle East, Africa and the Asia-Pacific area starting July 1, 2011, while keeping rights in Europe, Russia and Turkey. Remicade and Simponi generated $2.8 billion for Merck in 2010. Merck also kept the UK and European Union.]

We'll keep an eye on this, but here is a bit of Friday's PR Newswire press report:

. . . [T]he U.S. Food and Drug Administration (FDA) issued a Complete Response letter for the Simponi® (golimumab) supplemental Biologics License Application (sBLA) seeking an expanded label in the treatment of active psoriatic arthritis. The application, filed in November 2010, included data from a Phase 3 trial evaluating the effect of Simponi in inhibiting the progression of structural damage and maintaining improvement in signs and symptoms and physical function in the treatment of patients with active psoriatic arthritis.

Janssen Biotech, Inc. intends to request an end-of-review meeting with the FDA to thoroughly understand the details of the Complete Response letter and discuss what future steps may be necessary to achieve the intended approval. . . .

Just the same, this is disappointing news for Merck's franchises, no doubt -- even though Merck wouldn't see any of this future revenue from the US -- as Janssen holds the rights to all the US Simponi revenue.

The Case Against A New Vytorin® Indication -- Cogently (And Tersely) Made

On November 2, 2011, Merck with seek approval from FDA, based on the small SHARP study, for a new indication -- on its Vytorin® combo-pill.

Friend of the blog, Marilyn Mann makes a succinct and cogent case against the approval. Do go read it all (longer version here), but here is a bit:

. . . .[B]ecause SHARP compared the combination of simvastatin and ezetimibe with placebo — there was no simvastatin arm — we have no way of knowing if ezetimibe contributed anything to the result. The FDA requires that combination drugs have additive effects over either drug alone. Merck has not shown that ezetimibe contributed anything to the effect in SHARP, so the new indication should not be approved. . . .

Stay tuned -- for the FDA Advisory Committee meeting -- I know we will.

Another Choppy Monday In The Markets -- Yawn.

If, due to the Euro-zone instability, Merck trades below $30 on the NYSE in the next few days, it will be a screaming buy.

Getting MRK with a handle that starts with a $29 would be a steal. You heard it from me -- and everyone here knows, I am a Merck skeptic.

Simply put, Merck is fundamentally undervalued at any $29 and change price -- even in today's choppy markets. The markets will recover, and Merck will rise -- to at least $34, in a more rational market.

Do your own diligence, here, but Merck is a far more sound company, fundamentally, than Schering-Plough ever was.

[As an aside, Merck's CFO, Peter Kellog, will present at the Morgan Stanley Healthcare Conference (webcast link there) in New York tomorrow morning, at 8:35 am EDT. I don't expect anything new, of material import.]

Finally! Ex-Schering-Plough Director Hans Becherer To Be Deposed -- By Halloween 2011

In the ENHANCE shareholder derivative action (called Cain v. Hassan, now pending in the federal District courthouse in Newark, NJ), the former chairman of the compensation committee of legacy Schering-Plough board of directors, one Hans Becherer (pictured at right, and the single longest serving director at Schering-Plough, at the time of his departure in mid 2010) will be sworn under oath, and asked about (among other matters) the basis for his mega-grants of very cheap stock options (at $18.85 per share) in May of 2008, to Carrie Cox, Fred Hassan, Tom Sabatino, Tom Koestler and Bob Bertolini, among others.

At that time, Schering-Plough was reeling from the delayed ENHANCE study results disclosure, yet he voted these executives boatloads of additional mid-year discretionary compensation -- in the form of cheap stock options, due to a market price decline they had collectively caused by mismanagement of the disclosure of the study results, it is alleged. That stock option grant helped push Fred Hassan's payout, on the bust-up/merger with Merck, to over $235 million*, from what would have been closer to $170 million, all in one fell swoop. Astonishing.

From the amended Cain v. Hassan complaint, then:

. . . .The Pharmaceutical Leadership Board ("PLB"'). comprised of the highest level of Schering executives, existed within the Schering-Plough Research Institute ("SPRI"), the division with responsibility for research on new and existing drugs. Included among its membership were Officer Defendant Chief Financial Officer Bertolini, and the Insider Trader Defendants Executive VP and President of Global Pharmaceutical Business, Cox, Chief Executive Officer Hassan, and President of the SPRI, Dr. Koestler (among others). . . .

Therefore, if there was ever a moment for the Board to be on red alert that it had to exercise its oversight role diligently to ensure lawful, ethical conduct by management, it was this moment: [REDACTED] the results of the ENHANCE trial, positive or negative, were highly material infonnation. The federal securities laws and the Company's commitment to ethical management required this information to be disseminated in a timely, professional manner to investors and all other stakeholders, with no profiteering permitted from insiders trading on inside knowledge and no foot-dragging permitted by officers concerned about achieving their incentive compensation targets. . . .

[Instead,] over 5,500 employees were terminated, ten percent of Schering's 55,000 employees. Defendant Hassan was quoted as stating: "We are taking the tough actions that are needed to respond to a tough situation." While public investors, who overpaid for a falsely inflated stock, employees, who were downsized, and patients, who overpaid for an ineffective product, all faced a tough situation, the Board members and the wrongdoers did not. . . .

As the bust-up of Schering-Plough unfolded -- per this story, we learned in 2009 that Gary Lawson, head of global compensation and HRIT at Schering-Plough -- was retiring in late 2009. That was particularly interesting, especially since he was a recent high-ranking alum of Wyatt Wheeler.

Regular readers may recall that Wyatt Wheeler was the firm where Ira T. Kay (pictured, at right), Hans Becherer's designated compensation consultant, resided. Cozy.

Of course, Hans Becherer was the Chairman of Schering's Compensation Committee of the Board -- he oversaw Ex-CEO Hassan's (and the other executives') pay, and bonus opportunities. Very. Cozy. [Finally, and as indicated above, he is to testify under oath, and under cross examination, about all these matters before Halloween, 2011 -- by an order entered Wednesday in Cain v. Hassan -- the ENHANCE "Breach of Fiduciary Duties" and shareholders' derivative action.]

Moral of this story: when public companies don't restrain themselves (especially as to mulitple hundreds of millions of dollars in golden parachute pay to CEOs who so mismanage a company that there is no real alternative, except to solicit, and then accept, a low-ball bust up bid), the SEC, and the securities litigation plainftiffs' bar, will step in and do it for them.

Halloween sure seems apt, no?

* The increase is due to post-bust up increases in New Merck stock values on the NYSE (from $26, to around $33, by merger time). These May 2008 $18.85 options were outsized, by any measure.

Sunday, September 11, 2011

"All the Justice Money Can Buy" -- A Book Review, Of The Vioxx® Affair

On this somber tenth anniversary of 9/11, we will take a slightly different, but very sobering, look backward -- this time, at Vioxx® (one of my background posts, which links to others), from the perspective of the plaintiffs' bar (as covered by an award-winning NPR reporter):

. . . .Vioxx was an immediate commercial success. In 2000, the first full year Vioxx was on the market, Merck spent $160 million on advertising, a sum greater than what PepsiCo, Inc. spent peddling soda, or Budweiser on beer. A sales force of 3,800 representatives touted the drug to doctors. Vioxx revenues bounced past the $1 billion mark; by 2003, they surpassed $2.7 billion, one–eighth of Merck’s total revenues. As Merck documents showed, according to Prakash, at the peak, “every dollar spent on the campaign was generating $4 in new Vioxx prescriptions.”

Then, disaster. A rash of heart attack deaths around the country, killing persons who were taking Vioxx, became a tidal wave. In addition to hundreds of individual personal injury cases around the country, plaintiff lawyers prepared to file class action suits in New Jersey, where Merck is based, and elsewhere.

Alarmed, Merck pulled Vioxx off the market in September 2004, a move that coincided with an alarming study showing that persons taking the drug suffered heart attacks and strokes at twice the rate of subjects given placebos. In a single day, Merck stock lost a quarter of its market value.

[NPR reporter] Prakash was “embedded” (to use the current journalistic term) with a team of plaintiff lawyers suing Merck in an Atlantic City, New Jersey, court on behalf of two men who had suffered heart attacks, allegedly because of Vioxx. One died, the other survived. With you–are–there immediacy, Prakash describes late–night conferences at which trial strategies were discussed. The author rides to and from the Atlantic City courthouse in plaintiff team vehicles, and she is privy to trial tactics and plans to discredit Merck witnesses. . . .

Do go read the DC's review, toward the bottom of the column -- and if it strikes your fancy, do go buy the book on Amazon.

Saturday, September 10, 2011

California To Repeat Texas Error -- No-Parental Consent Needed, To Gardasil® HPV Vaccines For 12-Year-Old Girls?

It is often said that those unable to learn from history are doomed to repeat it. Seems true here: over at Pharmalot, Ed Silverman has a great -- if troubling -- piece up on a minor echo of the Gardasil® Texas mandate flap (which still dogs Gov. Perry's presidential nomination hopes) of a few years back. This version is unfolding in California, where Merck donated to a state legislator who introduced the bill, and then later claimed, falsely, that she hadn't received any Merck donations.

It seems unlikely that the California Governor will ultimately sign the bill, given the Perry debacle, but we will keep a weather eye on it for you, thanks to Ed, at Pharmalot (here is some of his -- do go read it all)

. . . .The legislation, which has been dubbed the Gardasil bill after the Merck HPV vaccine, generated criticism over Gardasil side effects as well as concerns among some parents and social conservatives that passage would amount to a green light to premarital sex. The California Catholic Conference, for instance, sent notices warning parents that minors do not have adequate judgment about vaccination (see this).

Such views run contrary to public health officials. The Centers for Disease Control and Prevention declared that Gardasil is needed as public health tool not long after the FDA approved the vaccine in 2006 to protect against the 6, 11, 16 and 18 strains of the human papillomavirus, which can lead to cervical cancer. The FDA approved the vaccine for girls and women ages 9 to 26, but has resisted raising the age bracked. Since then, GlaxoSmithKline won approval to market Cervarix.

Meanwhile, a look at campaign donations by CalWatchdog found that many members of the California senate and assembly who voted to approve the legislation also received money last year from Merck. This group includes representative Toni Adkins, who introduced the bill and earlier this summer denied that she ever received money from the drugmaker.
Adkins, for instance, received $1,000, according to the Merck corporate and political action committee report for 2010 (read here). She was among 15 members of the assembly who voted in favor of the bill and also received Merck money (see here). Similarly, 10 state senators who voted in favor of the bill this week also received money from the drugmaker (look here). . . .

We will keep you informed -- but I'll be shocked if Gov. Brown ultimately signs this abomination of an act into law. Gov. Perry did, though -- in Texas a few years ago -- so, I should perhaps not be so sanguine.

To make my views abundantly plain, I'll note that I support condoms for all, without parental involvement, as there are essentially no direct side effects from their use. While we may disagree about the frequency of the adverse events associated with Gardasil, we are all likely to agree that there have been some -- and some are truly debilitating and life-long.

Is a 12 year old girl really equipped to weight these matters, judiciously, any more than she is able to judiciously weigh a choice to become sexually active at that age? I'd suggest not. And it is beyond dispute that the only way to contract the virus is through deep sexual contact. Thus, all California parents must have a right to step in here -- as this is only a partial prevention (with risks), not after the fact treatment.