Thursday, September 30, 2010

Friday Alum Roundup: Berkowitz In At Wags | Sabatino Out At United Airlines -- And, On Merger's Eve?

This is a bizarre coupling -- both ex-Schering-Plough guys, both landing at Illinois-based companies, both not sticking around very long at New Merck. . . but tonight's story involving the now ex-UAL, ex-SGP, ex-BAX GC is puzzling indeed -- per this evening's Chicago Tribune:

. . . .The merger between United Airlines and Continental Airlines is scheduled to become official on Friday, and there is an unexpected hole in the senior management team.

Tom Sabatino, who was supposed to be the top lawyer inside the combined United-Continental airlines, has resigned, the Tribune has confirmed. . . .

Sabatino was a surprise pick considering that he had only been with United since March, less than two months before the merger was announced. . . .

A source familiar with both airlines said Glenn Tilton, United’s CEO who will become nonexecutive chairman of the combined airline, had lobbied hard to place Sabatino on the new management team, which is split between United and Continental executives.

Sabatino, 51, came to United from drug maker Schering-Plough, where he had been general counsel until November 2009, when Merck bought the company. . . .

Meanwhile, earlier today, Bloomberg had the Berkowitz announcement, thus:
. . . .Walgreen Co. said Thursday it has hired former Schering-Plough executive Jeffrey Berkowitz to take charge of its pharmacy contracting strategy.

The company said Berkowitz will be senior vice president of pharmaceutical development and market access. His responsibilities will include forming strategic relationships with other companies, and overseeing growth initiatives with drugmakers.

Berkowitz held a series of marketing and sales-related positions with Schering-Plough Corp. from 2002 until 2009, when the company was acquired by Merck & Co. He later became Merck's senior vice president of global market access. . . .

This is some good news, for Wags -- and some odd news, for United. It would certainly make more sense to have a veteran airline lawyer in the newly combined carrier's GC seat -- but that was true the day Sabatino was named. Strange.

Maybe Jeff Smisek had to wait until "New UAL" NYSE trading begins (tomorrow morning), to be able to overrule Tilton's pick. Who knows?

The Ongoing "Hassan Hangover": Another Schering-Plough In-Licensing Deal Bites The Dust

Just six days ago, we mentioned one of Ex-CEO Fred Hassan's deals that had to be unwound by New Merck management. Here is another. Trust me -- this won't be the last of these. To be clear, I think AVEO has a great shot with this cancer candidate, I just think it faces a longer horizon to approval than New Merck is willing to accept, given its other pressing needs.

For its part, New Merck officially (and politely) chalks the unwind up to "portfolio prioritization" -- that's corporate speak for "Mr. Hassan lacked focus" in the early-2007 period, as he could already (allegedly) see that Vytorin® was going to run out of runway. Here's the BusinessWire item:

. . . .The decision to return this program to AVEO is a result of portfolio prioritization. . . .

In April 2007, AVEO entered into a Research, Development and Commercialization Agreement with Schering Corporation, under which the company was granted worldwide rights to develop and commercialize AV-299. Under the terms of the agreement, Merck funded all research and development expenses and was obligated to pay development milestones, and, as applicable, royalties on product sales. AVEO retained primary responsibility for certain development activities through completion of the first Phase 2 proof-of-concept trial, and for conducting translational research to guide the clinical development of AV-299, as well as the option to co-promote AV-299 in the U.S. for certain oncology indications. . . .

Another one bites the dust -- this "Hassan Hangover" just won't fade away.

Wednesday, September 29, 2010

Pharmacia Ordered To Produce Hassan-Cox Era Celebrex® Documents

We've been following this particular story for years, now. The larger narrative establishes that the sorts of shenanigans seen at Schering-Plough in 2007-2009 were actually just the latest installment of a much longer pattern of malfeasance (alleged), across at least three separate public pharmaceutical companies, involving Fred Hassan and/or Carrie Cox.

In this particular pending federal securities class action suit, now over seven years old, the plaintiffs allege -- among other things -- that Pharmacia's then CEO Fred Hassan, and then EVP Carrie Cox withheld, or downplayed, various portions of study data related to the blockbuster drug then being launched under the name Celebrex® (which drug, and company: Pharmacia) was later acquired by Pfizer -- garnering many tens of millions of dollars in payouts to Hassan, personally.

Yesterday, Pharmacia's lawyers were ordered to turn over all deposition transcripts that mention Celebrex in connection with discussions of gastrointestinal safety, thus:

September 27, 2010


Re: Garber, et al. v. Pharmacia Corporation, et al.
Civil Action No. 03-1519 (AET)

Dear Counsel:

The Court has reviewed the parties’ recent correspondence regarding Plaintiffs’ Ninth Set of Requests for Production of Documents. The Court hereby grants Plaintiffs’ request for the production of deposition transcripts that refer to Celebrex with the following restrictions and requirements. First, the Court finds Plaintiffs’ request for all deposition transcripts that refer in any way, in the answers or questions, to Celebrex to be overbroad. The Court shall require Defendants to produce such transcripts only to the extent that they also discuss gastrointestinal safety. Second, the reasonable cost associated with redacting and producing the deposition transcripts shall be borne by Plaintiffs.


/s/ Tonianne J. Bongiovanni

Tonianne J. Bongiovanni
United States Magistrate Judge

We'll keep you informed -- it may take a decade or more, but this one looks like it will stick to Teflon Fred and Lycra Carrie.

Reuters Picks Up My "Merck Morning Meme" -- "Billions At Stake" -- Adds Analysts' Color. . .

Reuters just released a news-analysis story, to the wires that echoes -- almost to the word, each of the items I'd earlier ticked off, about the coming Merck v. J&J arbitration ruling. Reuters adds significant value by sourcing pull-quotes from various stock analysts -- to back up the meme. Do go read it all, but I do love being the start of a MSM news cycle:

. . . .J&J has said it is seeking a ruling that Merck's acquisition of Schering-Plough was a change of control that triggered J&J's right to terminate the deal.

"The termination of the agreements would return full rights to Johnson & Johnson for the distribution of these products in markets outside the United States where Schering-Plough currently has the rights to distribute these products," J&J said in a statement. . . .

J&J has little to lose from its challenge outside of legal expenses, but the stakes are extremely high for Merck. The company reported $669 million in second-quarter sales from Remicade, making it one of Merck's biggest products. And Simponi, with many years' more patent life than its older cousin, may prove to be the more important bargaining chip.

"I think this is more of a Simponi story than Remicade. It's a drug that has a bright future," said Funtleyder, who sees it becoming a multibillion-dollar medicine.

Merck said in a regulatory filing that it expects a ruling within 20 days of the conclusion of the arbitration hearing. . . .

Indeed -- I'll write it; they'll read it -- and repeat it. Perfect.

Merck v. JNJ Arbitration Wrapping Up Now?

Regular readers know this narrative nearly by heart:

The MSM is vastly understating the size of the potential downside liability to New Merck: it is not "only" $2.6 or $2.7 billion in lost sales revenue -- it is closer to $10 billion, over the next three years -- from Merck's perspective.

Simponi® sales are ramping up ferociously overseas, and Remicade® is a juggernaut -- outside the US. And all of that -- all the high-margin non-US revenue -- may vanish into the mists of Brigadoon, and soon -- for New Merck.

Moreover, Merck would owe J&J about $3.5 billion in refunds, in sales of the pair, just since November of 2009. So, $10 billion over the next three years is a fair estimate, if Merck loses. [BTW, there is no corresponding downside to J&J, should Merck win, as J&J will keep the US market under the agreement, no matter what. And it will still get its split on the non-US sales, from Merck, no matter how the arbitration ends.]

It was Schering-Plough, afterall, that had entered the non-US distribution pact with J&J's Centocor. Now its CEO is gone; its stock is no longer listed on the NYSE; its board of directors disbanded (save 3 -- of 12). . . yet "New" Merck would say that tiny old Schering-Plough ate its lunch. A ghost did it, I guess.

As Jim Edwards at B|Net's Placebo Effect has pointed out, the reverse merger was enough of a "change in control" to trigger Schering CEO Fred Hassan's $50 million golden handshake:

. . . .Remicade is now Merck's second-biggest drug. If it has to say goodbye to those revenues -- just as it did to Fred Hassan -- one of its reasons for buying Schering in the first place will have vanished. And Merck's stock price would suffer, angering investors. . .

The final, non-appealable arbitrators' decision in this matter could be announced at any time in the next 20 to 35 days -- if Merck's own previously announced timeline remains accurate. We'll keep you posted.

Tuesday, September 28, 2010

Generic Statins To See Wider Use -- In USA?

Reuters has a new story out this morning about how -- on the heels of a new study -- generic statins are likely to see wider deployment in the United States, as the population generally becomes heavier, more sedentary and continues to age. This would potentially be good news for Merck, except that Zocor® (simvastatin) is available as a generic (and has been for about three years), thus:

. . . .The latest study looked to see if giving statins to more people would be worth the extra cost -- something on the minds of U.S. politicians and insurers seeking to find ways to save costs as part of healthcare reform. Countries with national healthcare systems are also looking for ways to save money.

The team tested two strategies -- either simply giving statins to more people or only giving them to people with a high CRP test. . . .

Statins -- the world's top-selling drugs -- have been so effective at lowering low-density lipoprotein or LDL, the so-called "bad" cholesterol, that some doctors have jokingly suggested they should be added to the public water supply.

Not only do they significantly cut the risk of heart attack and stroke but they may reduce the risk of death from influenza, pneumonia and smoking.

Many brands such as Merck's Zocor are now generic and many more will soon go off patent, making the drugs even more affordable. . . .

Indeed -- I am not remotely anti-pharma, I am just allergic to excessive pricing, for very mature branded life-saving medicines.

Ex-Merck Chair and CEO Vagelos Donates $50 Million To Columbia Med School

This man was among Merck's finest. It is gratifying to see him using his well-earned bounty in this way. He was, in my estimation, at least -- ever a class act. A little more, per the Bloomberg wires, this morning:

. . . .The gift will support a $185 million plan to renovate the health complex in Manhattan’s Washington Heights neighborhood, the university said today in a statement. The donation means the university’s medical school has raised more than $1 billion.

Vagelos, 80, who graduated from Columbia’s College of Physician and Surgeons in 1954, is chairman of the medical center’s Board of Visitors. He was CEO of Whitehouse Station, New Jersey-based Merck from 1985 to 1994, and chairman from 1986 until 1994. He is now chairman of Regeneron Pharmaceuticals Inc., based in Tarrytown, New York. Diana Vagelos graduated from Columbia’s Barnard College in 1955. . . .

Good on ya', Roy. [Which of course reminds me: where is a med school bearing Ex-CEO Hassan's name -- accompanied by a similarly-outsized donation (to be comparable, it ought to be north of $100 million)? Right. Don't hold your breath.]

Monday, September 27, 2010

Schering-Plough: Hong Kong's Supply of PegIntron® Redipens™ Possibly Defective

According to published reports out of Hong Kong -- some of the in-country PegIntron® Redipens have exhibited a propellant-gas leak, resulting in uneven dosing. Here's a snippet:

. . . .According to Schering-Plough, the defect is related to individual Redipen device and it may affect the product quality, with possible safety consequence. Based on available information in hand, it is estimated that the defect occurred with a frequency of about 3 in 20,000.

Records in Schering-Plough showed that the products have been supplied to 10 medical practitioners and three local hospitals. Due to the low prevalence of the defect and no readily available stock replacement, Schering-Plough proposed to send medical representatives to visit all involved doctors and hospitals to inspect their stock before being utilised. Healthcare professionals should only administer the products to patients after Schering-Plough has confirmed that their products are satisfactory.

After risk assessment, DH endorsed the above proposal. Meanwhile, DH is also liaising with leading overseas authorities about the issue and will continue to monitor the wholesaler's inspection. . . .

We'll keep a weather-eye on this horizon.

Update On Durham, NC Facility: Vaccine Manufacturing "Transfers" Progress

We have been following this story for about a year now, as Merck ramps up vaccine capacity in the non-union Durham, NC facility, and inexorably phases lines out of its West Point, Pennsylvania (union) shop.

Here is the latest, from a local NC paper (via a H/T to Ed, at Pharmalot):

. . . .By the end of 2012, plant manager John Wagner said, the company could invest upwards of $900 million total, adding equipment upgrades and a new 40,000-square-foot building for quality control laboratories projected to cost $30 million.

The company also plans to hire 310 people in the next two years, 250 of whom would be hired by the end of 2011. About 50 to 60 of the new hires will work in the quality control laboratories. . . .

Merck is currently awaiting approval from the U.S. Food and Drug Administration to transfer Varivax, the chickenpox vaccine, for production at the Durham site.

"Over the next four years, we'll be doing more product transfers," Wagner said. . . .

By 2012, Wagner said, the plant should be completed and operational and have up to 700 workers, manufacturing vaccines for measles, mumps, rubella and chickenpox in children, as well as a vaccine for shingles in older adults. . . .

So while this is good news in North Carolina -- these are times of darkening skies in Pennsylvania. As much as I regret to say so -- it is true -- West Point, Pennsylvania vaccine employees will have to take note, and make other plans.

Sunday, September 26, 2010

Two More Fosamax® ONJ Bellwether Cases Selected For Trial

On the 23rd of September, federal District Court Judge John F. Keenan ordered (upon the agreed selections of each side) that these two additional "bellwether" Fosamax® ONJ cases -- Secrest (Case No. 06-cv-06292), and Hester (Case No. 06-cv-9450) -- be set for trial. We had earlier reported that this accelerated selection mechanic was put into play, here.

From the order, then:

. . . .The Court has received letters on behalf of the Plaintiffs' Steering Committee, dated September 17, 2010, and on behalf of Merck, dated September 17, 2010, setting forth their bellwether trial selections.

The Plaintiffs' Steering Committee has selected Secrest v. Merck & Co., Inc., 06-cv-06292, which is hereby scheduled for trial on March 14, 2011. Merck has selected Hester v. Merck & Co., Inc., 06-cv-9450, which is hereby scheduled for trial on May 9, 2011.

So Ordered. (Signed by Judge John F. Keenan on September 23, 2010). . . .

Next case up? Graves, at the end of October 2010. There are well-over 1,000 "jaw-bone death" cases pending around the nation now.

Perhaps ominously, we are seeing just the beginnings of a new class of Fosamax cases -- these newer ones alleging atypical "stress" femur fractures. They are just starting to emerge, as the scientific evidence starts to pile up, here and in Europe.

We will keep you up-to-date. [And, perhaps immodestly, I will point out that -- as of midday on Sunday, September 26, 2010 -- I have scooped the actual Fosamax MDL lawyers' site, by getting this news out. Those guys are making millions to keep track of this stuff. Me? Not so much.]

Update On Merck/Intervet's Vetsulin® -- For Diabetic Companion Animals

The web is a wonderful space. Last Tuesday, I noted that Merck had cleared its November 2009 FDA-issued warning letter. By late Friday night, an anonymous commenter had quite correctly edited my post of Tuesday, in the comment box, to indicate that Vetsulin® remains available only for critical needs -- i.e., may only be given to dogs and cats whose diabetis will not respond to other brands effectively. So the Intervet/Merck product remains restricted to the general market, thus (an FDA update, from May 2010):

. . . .FDA is allowing Intervet to offer a limited supply of Vetsulin through their Vetsulin Critical-Need Program. The supply is only to be used for a critical-need dog or cat that, in the medical judgment of the pet’s veterinarian, cannot be effectively managed on another insulin product. . . .

. . .FDA and Intervet heard from many veterinarians and pet owners who expressed significant concerns about specific diabetic dogs and cats which could only be controlled with Vetsulin.

As a result of these concerns, FDA is recommending veterinarians with qualified patients contact Intervet’s Technical Services Department at 800-224-5318, to request enrollment of the patient in the Vetsulin Critical-Need Program. The veterinarian will need to provide the medical rationale for why the patient cannot be effectively controlled using another insulin product.

Intervet continues to work with FDA to address concerns associated with the manufacture of Vetsulin. Because Vetsulin may have varying amounts of crystalline zinc insulin in the formulation, it could cause a delay in insulin action and an overall longer duration of insulin activity. Insulin products that do not remain within specification throughout the entire shelf life could potentially result in unpredictable fluctuations in the glucose levels of diabetic patients.

Use of this product under the Critical-Need Program will require close monitoring of the patient, all of which is described in an owner consent form. . . .

Again, the web allows sharing of knowledge, and refinements to that knowledge, so rapidly -- it is truly a wonder to live in these times. Thanks to my erstwhile commenters -- and have a great (rest of your) day of rest, one and all.

Friday, September 24, 2010

Euro-Zone Safety Review: Merck's Fosamax®, And Stress Fractures

The EU's drug regulator, the EMEA, has begun conducting a safety review of Fosamax® (and similar drugs in this class), per Reuters, just now:

. . . .European drugs regulators said they had started a safety review of a class of osteoporosis bone drugs called bisphosphonates after studies suggested a possible link to stress fractures.

The review by the European Medicines Agency follows a statement from the U.S. Food and Drug Administration earlier this month, which said it may require bisphosphonates to carry new information related to unusual femur fractures.

The bisphosphonate class includes Fosamax, made by Merck. . . .

As ever, we'll keep you up to date. In about a month, the next Fosamax ONJ bellwether trial gets underway in Manhattan's federal courthouse.

Another Fred Hassan "Masterpiece" Drug Deal? This Time, In Favor Of Anacor Pharma

As this morning's InVivo blog notes (H/T!), smallish Anacor Pharmaceuticals has restarted its efforts to go public, as of September 10, 2010 (see the refiled Anacor SEC Form S-1 registration statement here). And, to be crystal-clear, here -- as a preliminary matter -- I think Anacor is a fine company. [They likely saw a by-then desperate Fred Hassan a-comin' though, toward the end of 2008, and extracted a great deal from him, for their company. As is their right.]

Anacor's earlier attempt to go public was moth-balled by the Fall 2008 financial freeze-up, but in that earlier filing, Schering-Plough was scheduled to buy shares of Anacor (from Anacor stockholders) for $10 million (see the prospectus cover page of this the original 2008 Form S-1 registration statement): It recites that ". . .Schering-Plough. . . agreed to purchase in private placements $10 million in common stock at the initial public offering price. A portion of the stock being sold to Schering will be purchased from certain of our stockholders. . . ." [By the way, it is generally speaking no mean feat -- to navigate the SEC regulations to be able to purchase, in a private offering, the same class of securities that are being concurrently sold, to the public, in a registered offering -- as was contemplated by the 2008 Anacor S-1 filing's cover page. It can be done, but it is a very complicated, nuanced and convoluted process, to prove one has secured a regulatory exemption for such a transaction. But I digress.]

Back to the main story, here -- in Anacor's new SEC filing made September 10, 2010, on page 50, we read this:

. . . .In February 2007, [Anancor] entered into an exclusive license, development and commercialization agreement with Schering Corporation, or Schering, for the development and worldwide commercialization of AN2690. Pursuant to the agreement, Schering paid [Anancor] a $40.0 million non-refundable, non-creditable upfront fee and assumed sole responsibility for development and commercialization of AN2690. In addition, in accordance with the agreement, Schering invested $10.0 million in a preferred stock financing completed in December 2008. The agreement also obligated Schering to pay all of the remaining costs for development and commercialization of AN2690, including paying [Anacor] for [its] development-related activities to transition AN2690 to Schering. In November 2009, Schering merged with Merck & Co., Inc., or Merck, and in May 2010, [Anancor] entered into a mutual termination and release agreement with Merck. Under this agreement [Anancor] regained the exclusive worldwide rights to AN2690, Merck paid us [ANOTHER] $5.8 million and we released each other from any and all claims, liabilities or other types of obligations under the 2007 agreement. Merck did not retain any rights to this compound. . . .

In this new filing Schering-Plough/Merck is not listed as a selling stockholder, presumably because it has already agreed to some form of cancellation, or buy-back, of the shares, as a part of the most recent $5.8 million payment to Anacor. So (in part), Merck had to pay Anancor to take the Hassan-purchased shares off of its hands, and release it from a very pricey commitment to develop and commercialize the Anacor AN2690 product. Brilliant, Fred. Simply brilliant.

It would all be rather droll, if Hassan hadn't carted off perhaps $225 million for his almost completely-failed stewardship -- conducting this sort of nonsense, day after day, for six years -- and put over 30,000 good people out of work, in the process. Oh, and he also -- almost single-handedly -- ended the life of one of the oldest independent pharma players in America. Ni-i-i-i-i-ice.

A Little More -- On GlaxoSmithKline, And The New England Journal Of Medicine Debate

Here is a little more to and fro', from a careful, well-intentioned anonymous commenter, in our comment box, on the above topic, yesterday (with my various typos corrected, by edits):

Anonymous said...

Just for debating purposes: Isn't this a 'death panel' pathway?

September 23, 2010 8:18 AM

Condor said...

Just responding, then:

Um. . . non-life threatening condition; expensive treatment?

Nope. No death possible -- except to our wallets.

The more general point -- as to cost v. benefit (in truly life v. death calls) -- will always raise that difficult question, though.

Just because it is a difficult question, however, we are not exempt from being required to think it through, right?


September 23, 2010 9:18 AM

Anonymous said...

I'd love to continue this exercise.

What 'someone' now is proposing that my access to medical care needs to be overseen by a committee/panel that will determine if my quality of life meets their fiscal priorities.

As mentioned over on Pharmalot:

"HervĂ© Decousushe tells the Times, noting that clots can be seen expaning in the veins under skin toward deeper veins where they can also migrate to the lungs. “It’s painful, and you can see the clot in front of you…We don’t want to wait for a fatal pulmonary embolism.”
Last I knew, fatal=death.

Slippery slope to 'death panels.'

BTW: this is just an exercise.

What I believe is that we do have to have these conversations on; exactly what are we (as a nation) willing to pay for and what we aren't. Knowing full well, that the lines for that will change.

Thanks for the exchange.

September 23, 2010 12:22 PM

Condor said...

Yes, this is a nice exchange -- civil and easy.

And, near as I can tell (for the sake of argument) no one is suggesting these superficial topical clots are (by themselves) life-threatening.

Is $186,000 per each potential new event avoided too high, when the event (while painful) is considered not life-threatening?

I don't know. But like you, I think it is the sort of hard discussion we ought to have, openly -- rather than simply letting the savage allocation of excessive wealth v. poverty force that allocation indiscriminately -- if we are after a more humane system, overall.


September 23, 2010 11:10 PM. . . .

Now, what do you think? Do go take the poll, in the left sidebar (points slightly above, and left)!

Small Organon BioSciences Update -- On the Radio, In Oss, The Netherlands

We were off the grid most of yesterday, with other duties.

Even so, courtesy of Ed Silverman at Pharmalot, we were alerted yesterday morning to a smallish follow-up piece on Merck's agreement to continue discussions, and negotiate in good faith -- at least through December 31, 2010 -- as to the fate of the 4,500 Organon R&D workers in Oss. [Here is the Radio Netherlands source item -- do go read it all]:

. . . .Merck is willing to talk with interested parties about a long-term solution. The company may even invest in a science campus. However, there are no guarantees that all jobs will be saved as Organon will still have to undergo a reorganisation. It is not clear how many jobs may have to go. The minister says a deadline of 31 December to find solutions still stands.

The recently announced plans caused commotion among staff, who threatened legal steps against mass sackings. . . .

This came after a visit by a Dutch official to Whitehouse Station, to discuss the plight of the workers, according to Radio Netherlands. Earlier reports have it that the "other Merck" -- KGaA, in Germany -- might venture, or partner-up to ultimately assume the operation, en todo. We'll keep you posted. That "other" Merck KGaA is reeling from yesterday's Cladribine EU washout -- KGaA's once-vaunted MS drug candidate. So we shall see.

Wednesday, September 22, 2010

For Many Americans, Health Care Relief Really Begins After Midnight, Tonight

So, at 12:01 a.m. EDT on Thursday -- in under an hour or so -- some of the most-anticipated features of US health care reform will commence.

Again, the New York Times is right on the spot, with this:

. . . .Starting now, insurance companies will no longer be permitted to exclude children because of pre-existing health conditions, which the White House said could enable 72,000 uninsured to gain coverage. Insurers also will be prohibited from imposing lifetime limits on benefits.

The law will now forbid insurers to drop sick and costly customers after discovering technical mistakes on applications. It requires that they offer coverage to children under 26 on their parents’ policies.

It establishes a menu of preventive procedures, like colonoscopies, mammograms and immunizations, that must be covered without co-payments. And it allows consumers who join a new plan to keep their own doctors and to appeal insurance company reimbursement decisions to a third party. . . .

Again, the NYT -- on point.

NEJM: Good Study Result; But A Poor Value Proposition -- For A Marginal Problem

Increasingly here (as has long been the case in EU countries), United States journals are explicitly highlighting the cost v. benefit of new drugs -- even when the study results are overwhelmingly positive. Tonight, it is an editorial in the prestigious New England Journal of Medicine -- looking askance at a study it published in the very same issue. The drug is Arixtra®, the maker is GlaxoSmithKline, and here is the New York Times' Duff Wilson -- covering it all -- do go read his:

. . . .But the study did not talk about the costs, they wrote, which could range from $2,124 to $7,380 per person for 45 days of injections, or at least $186,000 for 88 people to avoid one new problem.

“The paradox is, it’s effective, but for a condition that’s usually not considered an overwhelmingly serious medical problem,” Dr. Goldman said in an interview. “The fact that it’s a medicine that’s expensive really raises an issue, not just for this trial, but we tried to make the point more broadly.”

Cost-effectiveness researchers in America have benchmarks that suggest that “good value for the money” is $50,000 per added year of high-quality life, Dr. Resch said. In some cases, where cheaper treatments are unavailable, up to $120,000 per added year have been suggested, he said. . . .

Plainly, this is a discussion we really should be having about all drugs -- not just the newest ones (think Merck's Vytorin®, here).

Merck Expands Access To Medicines Progam, For Neediest US Patients

Today, Whitehouse Station announced that it would expand its subsidized access to medicines program in the United States, thus [earlier backgrounder]:

. . . .Merck provides its medicines and adult vaccines for free to people who do not have prescription drug or health insurance coverage and qualify for a Merck HelpsTM program. Merck Helps programs include:
•The Merck Patient Assistance Program, which helps eligible patients who earn up to 400 percent of the federal poverty level gain access to Merck medicines for chronic conditions like asthma and diabetes.

• The Merck Vaccine Patient Assistance Program, which provides free vaccines to adults over age 19 who do not have health insurance coverage for vaccines and who earn up to 400 percent of the federal poverty level.

• The ACT Program for Oncology and Hepatitis C medicines, which provides free reimbursement support services and refers appropriate patients to a patient assistance program for eligible individuals who earn up to 500 percent of the federal poverty level.

• The SUPPORT Program® for HIV/AIDS, which provides free reimbursement support services and refers appropriate patients to a patient assistance program for eligible individuals who earn up to 500 percent of the federal poverty level.

All Merck Helps programs are confidential and patients may qualify for the Merck Patient Assistance Program and the Merck Vaccine Patient Assistance Program if they have a household income of $43,320 or less for individuals, $58,280 or less for couples, or $88,200 or less for a family of four, even if the financial situation is temporary due to unemployment or other reasons. Patients may qualify for The ACT Program and the SUPPORT Program if they have a household income of $54,150 or less for individuals, $72,800 or less for couples, or $110,250 or less for a family of four. With the Merck Helps programs, there are no application fees, no co-payments and a simple enrollment process. Many medicines can be delivered to a patient’s home or doctor’s office at no charge. Patients in need of information should visit or call (800) PAP-5400. . . .

Credit -- where credit is due. To be fair though, Merck's adult Hep B vaccine is still MIA (manufacturing issues), with no date for US reintroduction -- unavailable at any price.

Some Additional Small-Employer Health Care Tax Subsidy Discussion

I've received some very good commentary on my post, from this past weekend, about the small employer health care tax subsidy -- so I'll reprint the back and forth, here:

Anonymous said...

Great idea!! Give tax incentives to keep salaries low. Way to help the little guy.

September 21, 2010 8:48 AM

Condor said...

I take it you mean as opposed to returning the tax break to the richest 1/10th of one percent -- a break President Obama is ending.

In any event, arguing that the health care package will keep salaries low is -- at best -- a selective reading. Afterall, with health care, the effective salary is actually increased (for at least 50 million Americans without health benefits, at present).

So -- it boils down to this will cost some group something -- in order to secure our future. Would you rather that the wealthiest carry their share, or not? If not, vote with the Republicans -- that is the center plank of their entire platform, this time around.

Namaste, and thanks for your observations!

Do stop back.

September 21, 2010 11:16 AM

Anonymous said...

Don't get me wrong, I think there are good things in this law that Fox News is not mentioning, but I think this particular part misses the mark. Why is it tied to salary at all?

If you have 10 employees earning an average of $25K or less you get a 35% tax credit. If you give them a raise or hire more people, your tax credit goes down.

Seems like they're incenting the wrong behavior. If I can think of that, why can't the New York Times? That's all I'm saying.

September 21, 2010 1:47 PM

Condor said...

I do hear you, but I certainly think that small companies with much-higher-per-employee average salaries ought to be able to fund their own health plans, with only a graduated tax subsidy.

If your particular business has only 11 employees, but all are making $100,000 or more (like many a small architectural, accounting, or law firm), it is not clear in my mind that taxpayers should subsidize health care, there.

The measure we are talking about should help lower-skill, lower income positions at small companies remain eligible for some form of affordable health care coverage. Just as the NYT example suggested -- think of a "mom & pop" independent bookstore here.

So, I think it is actually wise policy. In both of our minds, I think, the number of employees ought to be indexed to average earnings -- to be eligible for a sliding-scale tax subsidy -- so I don't think we are arguing about whether a line should be drawn -- only about WHERE it gets drawn, right?

Thanks for the additional input, here.


September 22, 2010 8:12 AM. . . .

Now, what do you think?

Tuesday, September 21, 2010

Intervet's March 2010 FDA Warning Letter Was Resolved Last Week

Here is a link to the original FDA warning letter from March 12, 2010 -- regarding Vetsulin® (porcine insulin zinc suspension), manufactured by Intervet Inc., a subsidiary of Merck, in Unterschleissheim, Germany. Below is the FDA's close-out letter, in full text:

Department of Health and Human ServicesPublic Health Service
Food and Drug Administration
 Rockville MD 20857

September 13, 2010

Mr. Raul E. Kohan
Executive Vice President
and President Animal Health,
Merck & Co., Inc.
2000 Galloping Hill Road
Kenilworth, NJ 07033

Dear Mr. Kohan:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, March 12, 2010. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.



Neal Bataller, ME, DVM
Director, Division of Compliance
Center for Veterinary Medicine

Not unexpected, but good news for Intervet, just the same.