Per CSPAN2 Live video feed [My earlier perspective on the Senate's measure may be found here]:

. . . .The Senate is now in a series of three procedural votes and currently voting to limit debate on the Democrat’s substitute health care bill. . . .

Votes: 60 Aye; 39 No. . . .

This time, it’s Mylan Labs — trying to bring a generic version of Vytorin^® to market. Once again, New Merck has brought suit to halt that possibility — for at least 30 months. Do go read it all, but the AP’s Linda Johnson has the story, here.

Note that Glenmark is already pretty close to bringing a generic version of Zetia^® (Vytorin’s sister drug) to market, or at least, close to finishing its patent litigation with New Merck,the topic. [The automatic patent litigation 30 month stay on Zetia expired in October 2009.] In any event, here is a excerpt of the Mylan story:

. . . .Mylan Inc. said Tuesday it being sued by Schering Corp. and MSP Singapore over plans to make a generic version of the cholesterol drug Vytorin.

Mylan asked for Food and Drug Administration approval for a range of doses of Ezetimibe and Simvastatin tablets, or Vytorin. . . .

According to this item from the Bloomberg wires yesterday, Merck, as successor to Schering-Plough’s interests in the Nasonex branded inhaler, have sued Apotex, alleging patent infringement. Apotex seeks to bring a generic version of the drug to market. [The suit, Schering Corp. v. Apotex Inc., Case 09-6373, is now pending in the federal District Court in Newark. I'll keep an eye on it for the readers here assembled.]

So, are these the opening chess-moves, moves already known by Merck to be precursors to an end-game in which Merck pays Apotex to keep a generic version of the Nasonex inhaler off the market for a few more years? Or is this a benign, and legitimate, use of the patent statute to stop an unfairly-equipped interloper — an interloper named Apotex (arguably) equipped with proprietary technology it does not have the right to wield? Time will tell – but here is a snippet:

. . . . Merck & Co.’s Schering-Plough unit sued Canadian generic drugmaker Apotex Inc. in an effort to stop a copy of the Nasonex allergy inhaler from being marketed.

Closely-held Apotex is seeking U.S. regulatory approval for the generic which would [allegedly] infringe three of Schering-Plough’s patents. . . .

Stay tuned.

She fills the vacancy created this past summer, when Margie McGlynn, Ph.D. steppeed down from this post — surprisingly, prior to the bust-up, styled as a reverse merger closing date. [Margie McGlynn herself has since landed softly, taking a seat on the board of directors of Amicus.]

This — on balance — looks to be a good thing for Merck’s shareholders. Perhaps more importantly, from a global perspective — she also said she would work to expand “access” to Merck’s vaccines — and that is good for all stakeholders, per Reuters reporting:

. . . .She had led the agency from one crisis to another, including the investigation into the anthrax attacks that killed five people in 2001, the H5N1 avian influenza, the global outbreak of severe acute respiratory syndrome, or SARS, and various outbreaks of food poisoning.

“As a preeminent authority in public health, infectious diseases and vaccines, Dr. Gerberding is the ideal choice to lead Merck’s engagement with organizations around the world that share our commitment to the use of vaccines to prevent disease and save lives,” Merck Chief Executive Officer Richard Clark said in a statement.

“I am very excited to be joining Merck where I can help to expand access to vaccines around the world,” added Gerberding, who will head up the company’s $5 billion global vaccine business. . . .

Here’s to hopin’. . .

Do go read the whole article, and check out the graphical timeline side-bar, once there — but NPR has done the nation a great service here, distilling into plain English all the disparate, and fractured (pardon the pun), current learnings on ostepopenia, and the $3 billlion a year drug:

. . . .Increasingly, bone scientists like Cummings say Fosamax^® — and drugs like it — are not a necessarily a win for most women with osteopenia [not full-blown osteoporosis].

Studies in women with osteopenia show that while Fosamax and similar drugs reduce spinal fractures, the drugs may not reduce other types of bone fractures that are more common in women who have osteopenia, say Cummings and Susan Ott, an associate professor in the department of medicine at the University of Washington.

“There was no difference in the number of [nonspine] fractures you had, whether you took the medicine or a placebo,” says Ott. “It does make your bone density go up higher, but the number of fractures is what really matters, and that didn’t really change.”

And what about the long term?

There are no long-term studies that look at what happens to women with osteopenia who start Fosamax in their 50s and continue treatment long-term in the hopes of preventing old-age fractures. And none are planned.

So Cummings says treatment should start only when fracture risk is significant, bone density is low, or someone already has a spine fracture.

He says the WHO is promoting a new tool called the FRAX, which looks at a variety of factors that influence the risk of fracture. This allows women and their physicians to more accurately estimate their risk of experiencing a disabling bone break.

Ott agrees. And, she also worries that taking these medications long-term — over 10 years or more — might actually make bones brittle.

Ott points to a very small number of case reports about spontaneous breaks in the upper leg, which — though very rare — could be important, she says, given what’s at stake. . . .

Indeed — and, as we reported back in September 2009, that is exactly what some of these Fosamax suits are all about.

According to a Reuters story tonight, the Obama administration will continue to press for safe prescription drug reimportation — offering the prospect of lower drug prices to American consumers — just not as a part of this year’s health care reform package. I can live with that:

. . . .The White House pledged on Sunday to move forward on allowing imports of safe prescription drugs from nations like Canada where they are less expensive, but not in the healthcare reform legislation now before Congress.

The pharmaceutical industry’s powerful Washington lobbying group backs the healthcare reform legislation that is President Barack Obama’s top legislative priority, but its important support for that effort could evaporate if drug imports are included [in that package]. . . .

Excellently maneuvered, indeed.

This new drug class, Amgen-developed denosumab, is a potential eventual replacement for Merck’s Fosamax. Denosumab, to be marketed under the brand name Prolia, is to be distributed by GlaxoSmithKline in Europe, upon approval. Now that the EMA has given a positive opinion on the candidate, EU approval is projected by mid-2010, per a Friday Reuters story:

. . . .Amgen’s keenly awaited new drug Prolia, or denosumab, has been recommended for approval in Europe as a treatment for the brittle bone disease osteoporosis, the European Medicines Agency said on Friday. . . .

Interestingly, in the United States, Prolia^TM is a registered trademark of Cargill — as a food ingredient — a soy flour, precisely. So, denosumab will likely carry a different branded name here in the States.

Moreover, the non-partisan CBO sees a net-decrease in federal budget deficits attributable to this change in law (compared to the present non-system of health care delivery, of course) — approaching 0.5 percent of GDP, in the later years of the coming decade.

Um, that’s likely to be a deficit reduction of over $1 trillion. More, from the CBO’s official government blog:

. . . . Over the 2010–2019 period, the net cost of the coverage expansions would be more than offset by the combination of other spending changes that CBO estimates would save $483 billion and other provisions that JCT and CBO estimate would increase federal revenues by $264 billion. In total, the legislation would increase outlays by $366 billion and increase revenues by $498 billion between 2010 and 2019. . . .

Based on the longer-term extrapolation, CBO expects that inflation-adjusted Medicare spending per beneficiary would increase at an average annual rate of less than 2 percent during the next two decades under the legislation—about half of the roughly 4 percent annual growth rate of the past two decades. . . .

CBO expects that the legislation, if enacted, would reduce federal budget deficits over the ensuing decade relative to those projected under current law — with a total effect during that decade that is in a broad range around one-half percent of GDP. . . .

One other (tangential) thought: based on my quick reading of it, the measure regarding separated funding (two-check writings, etc.) of insurance premiums for abortion services — and abortion services, alone — may well turn out to be unconstitutional. [Some other time, I'll explain in detail, but there may be "no rational basis" (magic words, those) for discriminating against women -- and women only (as men do not need/are not biologically-eligible for this coverage) -- making obtaining coverage of this particular reproductive choice-making irrationally cumbersome]. Ironic.

If so — in the end, the pro-choice forces will have scored a very-adroit victory, here. The bill already plainly contains a so-called “severability” savings provision. That means if one part is invalidated as unconstitutional, the rest remains intact. Ergo, we get reform — and we may jettison the invasive fiscal strictures on women’s reproductive decision-making.

If so enacted, it would seem that Senator Nelson and Rep. Stupak will not ultimately secure any new governmental controls over the collective American female uterus (via the purse-string power, or otherwise) — despite all these machinations. And that — in my opinion — will be a good thing for American civil liberties, and health care law and policy.

On a “Patients’ Bill of Rights“:

. . . .The President calls on the Senate to allow an up-or-down vote, and for those opposing reform to stop using parliamentary maneuvers to drag it out. . . .

It has now been nearly a century since Theodore Roosevelt first called for health care reform. And ever since, nearly every President and Congress, whether Democrat or Republican, has attempted to meet this challenge in some way. A bill for comprehensive health reform was first introduced by John Dingell Sr. in 1943. Sixty-five years later, his son continues to introduce that same bill at the beginning of each session. . . .

Our collective failure to meet this challenge — year after year, decade after decade — has led us to the breaking point. Everyone understands the extraordinary hardships that are placed on the uninsured, who live every day just one accident or illness away from bankruptcy. These are not primarily people on welfare. These are middle-class Americans. Some can’t get insurance on the job. Others are self-employed, and can’t afford it, since buying insurance on your own costs you three times as much as the coverage you get from your employer. Many other Americans who are willing and able to pay are still denied insurance due to previous illnesses or conditions that insurance companies decide are too risky or too expensive to cover.

We are the only democracy — the only advanced democracy on Earth — the only wealthy nation — that allows such hardship for millions of its people. There are now more than 30 million American citizens who cannot get coverage. In just a two-year period, one in every three Americans goes without health care coverage at some point. And every day, 14,000 Americans lose their coverage. In other words, it can happen to anyone. . . .

The time is drawing near — to cast an up or down vote — time for Republicans to stand in the way of progress, or agree to get on board the train, and ride with it. But make no mistake, without the sea-change signaled by President Obama’s election, this effort would be dead in the water.

Not without its rather-noticable warts and moles, but it is finally taking shape, per Reuters, a minute ago:

. . . .The Senate bill would extend coverage to 30 million uninsured Americans, provide subsidies to help them pay for the coverage and halt industry practices like refusing insurance to people with pre-existing medical conditions. . . .

And from the Wall Street Journal, an hour ago:

. . . .Democrats released Saturday a broader amendment to the bill, which includes proposals designed to boost support for small businesses, toughen federal regulatory oversight of insurers, and strengthen provisions intended to curb the rapid growth of health care costs.

Lawmakers were awaiting a formal estimate of the bill’s cost from the Congressional Budget Office. An estimate of an earlier version by the CBO found that the bill would reduce the budget deficit by $130 billion over the next decade and extend coverage to some 30 million Americans. . . .

I am not sure that I agree that the bill is a case of “the perfect being the (unintended) enemy of the good” — but it is, in the broadest sense, what is needed. So — I say “Huzzah!”