An aside — from CNBC’s Mike Huckman — on Schering’s Levitra. . . .

Well, we all know that Schering-Plough earns some decent revenue from Levitra — which, in the words of the above Mr. Huckman, is “an also-ran, me-too ED drug. . . .” Truer words were never typed.

It is what follows the-above comment, though, in his post, that most interested me:

“. . . .But I do know one new Levitra convert. A certain co-worker, who will remain unnamed, recently told me he spent more than 300 bucks to fill a Levitra prescription his neighbor wrote for him. Mr. Anonymous said he’d grown frustrated with his primary care physician who would only write him tiny, apparently insufficient, prescriptions for Viagra. . . .“

Wow — that seems like a dangerous recipe — at least if it’s all for one man — perhaps his co-worker is looking to be an “off-license distributor” of erectile dysfunction (or, “ED“, for short) drugs. Heh.

Let us (fairly) assume he isn’t. A dosing at that sort of size might have profound cardio-vascular implications — even for an otherwise-very-healthy young[er] man.

Now, what if the “anonymous co-worker” is a 40-something “weekend-warrior“, whose primary care physician knows about a history of heart-disease in the family, or in the co-worker, himself?

No doubt this is a dangerous thing — even if the “neighbor-Doc” admonished him to stay at the low-end of the daily-dosing on the label. Wow. What a sad “pill-poppin’ public” story that makes.

Thanks for the candor, just the same, Mr. Huckman. This sort of thing needs more sunshine, not less. Seriously. Thanks.

Senate Finance Committee Testimony of Stanford Law Professor John H. Barton, Yesterday, on Pharma IP. . . .

John H. Barton, the George E. Osborne Professor of Law, Emeritus, Stanford Law School, testified before Congress on a broad array of global intellectual property (or “IP“, for short) issues, yesterday. [Ed. Note: for a far more detailed look at the issues he discussed yesterday, do also read this 2005 JAMA article he authored.]

I found his remarks on global pharma IP to be quite enlightening — as he set the very-legitimate question of protecting property rights into the broader framework of whether there is a moral — if not legal — duty to provide life-saving medical developments across economic, and continental divides — at something other than the highest possible price – especially in the case of HIV meds — where it is literally the choice between a death-sentence, or life-saving “commutation“, if you will, hanging in the balance. I’ll leave you with the most intriguing of his, below, but do go read it all — quoting the professor’s testimony (PDF File), then [emphasis supplied]:

. . . .The area of current political tension is in the middle income nations. These nations are the growth pharmaceutical markets of the future, so that patent protection is of great importance to the future of the pharmaceutical industry’s business model. At the same time, these nations still have many poor people and thus view themselves as reasonably benefiting from the Doha Declaration. South Asia, for example, has more very poor people than Sub-Sahara Africa. Moreover, several, including Brazil and Thailand, have undertaken public programs to supply antiretrovirals to their HIV-affected populations, an expensive task whose overall cost depends heavily on the price of the drugs.

I believe that we must attempt new approaches in dealing with these nations. It is in our national interest to facilitate their growth in health. That may call for low, i.e., generic prices for at least some drugs for some people. This might be an exception for a limited time. In another approach, GSK is developing mechanisms for differential pricing within poorer countries based on charging a generic price to certain public or nonprofit distribution channels while charging a higher research-reimbursing price to others. Might the approach be extended?

But there will need to be reforms beyond prices. For example, in a number of nations, including China, much medical care is effectively financed through pharmaceutical sales by doctors and hospitals -– a process that certainly creates terrible incentives toward price markup to patients and toward overprescription. In India, the poor are not effectively served by the medical system. And some of these nations are pharmaceutical exporters at the same time that they have many needy citizens. Compromise seems reasonable; it will necessarily be more complex than a pure IP arrangement.

In approaching such a compromise, it is worth noting that price controls are likely to be the key topic for future international negotiations with developed nations in the pharmaceutical area. The importance of such controls is exemplified by the current European disputes over Roche’s anticancer drug, Avastin, as well as by the inclusion of price-related provisions in the 2004 U.S.-Australia Free Trade Agreement and the great attention paid to the issue in the 2008 USTR Special 301 Report. Moreover, at some point, price controls will almost certainly be an issue in our own country -– health care reform may increase the role of the government in purchasing pharmaceuticals, and it is hard to envision continued significant government purchasing of pharmaceuticals without pressure toward price controls. Unless the price controls are applied thoughtfully, the result will be to decrease incentives for research. Such harm may already have occurred in the U.S. childhood vaccine industry. In approaching health care reform and international trade both, we will need to define effective decision-making standards and procedures to maintain optimal incentives for research in medical technology. These various trends suggest to me that it is important to moderate our IP focus and to recognize that IP is only part of a broader package of pharmaceutical trade goals.

All nations want greater access to health care; all want to contain the cost of that health care; all want more advanced technologies. These are goals that have to be balanced; and the details of the balance may reasonably be different for nations at different income levels. . . .

Indeed. Hopefully the folks in Kenilworth are watching CSPAN.org.

LIVE VIDEO! — July 17, 2008 — Yet Another Health-Care Reform-themed Hearing — Senate Finance Committee

I’ll have a live, streaming video feed in an embedded window, here, of the entire hearing — the feed will go “live” at about 9:50 AM EDT, on Thursday July 17, 2008. Be sure to check back at this space, then. Here are the hearing particulars:

“The Right Care at the Right Time:
Leveraging Innovation to Improve
Health Care Quality for All Americans”July 17, 2008, at 10:00 a.m.,
in 215 Dirksen Senate Office Building

Member Statements:

Max Baucus, MTCharles Grassley, IA

Witness Statements:

Peter Orszag, Director, Congressional Budget Office, Washington, DC

Richard Hillestad, Ph.D., Principal Researcher; Professor, RAND Graduate School, Santa Monica, CA

George C. Halvorson, Chairman and CEO, Kaiser Foundation Health Plan, Inc., Oakland, CA

Gail R. Wilensky, Ph.D., Senior Fellow, Project Hope, Bethesda, MD

 

I’ll also have links to all testimony, anchored to the witnesses’ names, above, a few days after the hearing (most-likely as PDF files).

If this one really starts rockin’, I may live blog it, below:

See you Thursday, bright and early!

Dechert LLP’s latest — in the Sales Practices consolidated suit — comes up "a day late, and [more than a] dollar short". . . .

Overnight, Dechert LLP, on behalf of Schering-Plough, filed a letter in MDL 1938, the Vytorin/Zetia Marketing, Sales Practices, and Products Liability consolidated litigation, arguing essentially that no discovery should occur in that case, until the motions to dismiss now pending in the securities action, and any other related action (could that possibly mean the Organon Qui Tam action?), are decided.

[This all becomes very interesting since Arent Fox has effectively given all these various bunches of plaintiffs an avenue to take early discovery in the Organon Qui Tam case -- as I earlier noted -- a week or so before Lowenstein, Sandler replaced Arent, Fox as Schering's counsel of record in the Organon matter.]

In doing so, Dechert quotes cases interpreting the Private Securities Litigation Reform Act for the proposition that ERISA case discovery may be stayed while a pending securities law motion to dismiss is pending — as well as any discovery based on a state law claim or theory, in order to effectuate the intent of Congress in enacting the PSLRA, and the subsequent amendments to it. Take a look at this, from Dechert’s letter, at Page 5 (click to enlarge):

Now, what Dechert LLP wholly-fails to mention, in its letter to United States Magistrate Mark Falk, is that the express language of the PSLRA, at 15 U.S.C. § 78z-1(b)(1), provides that “in any private action arising under this subchapter, all discovery and other proceedings shall be stayed during the pendency of any motion to dismiss, unless the court finds, upon the motion of any party, that particularized discovery is necessary to preserve evidence or to prevent undue prejudice to that party. . . .“

In short, unless Dechert demonstrates that the current litigation was filed to thwart the stay provisions of the PSLRA, discovery in the MDL Case No. 1938 may well move forward.

ANOTHER fact Dechert fails to mention is that Cain v. Hassan, et al. is pending. It is a purported shareholders’ derivative suit, and the express terms of PSLRA, at 15 U.S.C. § 15 U.S.C. § 77p(f)(2)(B) specifically exempt shareholders’ derivative actions from these automatic stay provisions.

So, it would seem that, in order to “preserve evidence” — chiefly, the now-fading memories of the involved officers, directors and underwriters — the Magistrate Falk, or the court itself — in the person of Judge Cavanaugh — ought to find Dechert’s letter unpersuasive. But don’t trust me — read the cases, and you’ll agree. Quoting from Romero v. Career Education Corporation, Civil Action No. 793-N (Delware 2005), a memorandum opinion, now:

. . . .At the motion to dismiss stage where all inferences must be drawn in plaintiff’s favor, I am not convinced that [plaintiff]’s purpose is to circumvent the PSLRA’s proscriptions. The purposes identified in support of [plaintiff]’s May 26 Demand, for example, include investigating whether the [defendant] Board or officers breached their fiduciary duties by “actively participating in, or failing to make a good faith effort to detect, investigate, prevent and correct, violations of the Ethics Codes.” It is certainly conceivable that any resulting claim for violation of fiduciary duties under Delaware law would be entirely different from the pending federal claims against [defendant] or its agents. . . .

~~~~~~~~~~~~

Footnote 16: 15 U.S.C. § 77p(f)(2)(B); City of Austin Police Ret. Sys. v. ITT Educ. Serv., Inc., 2005 WL 280345, slip op. at *10 & n.2 (S.D. Ind. Feb. 2, 2005) (“[T]he PSLRA and SLUSA were not intended to protect corporate management from shareholder derivative claims. Those are left to state law.”). . . .

So, the-above letter, from Dechert, seems to have earned the sharholders. . . nothing, inasmuch as all the money Schering-Plough spent to have it researched, and drafted will lead no effect whatsoever.

And as I said yesterday — that is also a waste of scarce judicial resources. Unfortunate.

An aside — from CNBC’s Mike Huckman — on Schering’s Levitra. . . .

Well, we all know that Schering-Plough earns some decent revenue from Levitra — which, in the words of the above Mr. Huckman, is “an also-ran, me-too ED drug. . . .” Truer words were never typed.

It is what follows the-above comment, though, in his post, that most interested me:

“. . . .But I do know one new Levitra convert. A certain co-worker, who will remain unnamed, recently told me he spent more than 300 bucks to fill a Levitra prescription his neighbor wrote for him. Mr. Anonymous said he’d grown frustrated with his primary care physician who would only write him tiny, apparently insufficient, prescriptions for Viagra. . . .“

Wow — that seems like a dangerous recipe — at least if it’s all for one man — perhaps his co-worker is looking to be an “off-license distributor” of erectile dysfunction (or, “ED“, for short) drugs. Heh.

Let us (fairly) assume he isn’t. A dosing at that sort of size might have profound cardio-vascular implications — even for an otherwise-very-healthy young[er] man.

Now, what if the “anonymous co-worker” is a 40-something “weekend-warrior“, whose primary care physician knows about a history of heart-disease in the family, or in the co-worker, himself?

No doubt this is a dangerous thing — even if the “neighbor-Doc” admonished him to stay at the low-end of the daily-dosing on the label. Wow. What a sad “pill-poppin’ public” story that makes.

Thanks for the candor, just the same, Mr. Huckman. This sort of thing needs more sunshine, not less. Seriously. Thanks.

Despite Presidential Veto, Medicare Improvements Act becomes law

The United States Senate and House of Representatives have overridden a Presidential veto to improve Medicare for seniors, soldiers and low-income Americans.

All the details are here — but it is time for pharma to get out in front of this, and “stop sticking its collective head in the sand. . . .”

Just for the record, that italicized pull-quote, immediately above, was offered the other day by Billy Tauzin [yes, that Billy Tauzin], the President of the most influential U.S. pharmaceutical trade group — PhRMA. Gee, now where have I previously quoted language like that, before? Oh. Yes. Right. Quite-so. The Chairman of the Fed.

Senate Finance Committee Testimony of Stanford Law Professor John H. Barton, Yesterday, on Pharma IP. . . .

John H. Barton, the George E. Osborne Professor of Law, Emeritus, Stanford Law School, testified before Congress on a broad array of global intellectual property (or “IP“, for short) issues, yesterday. [Ed. Note: for a far more detailed look at the issues he discussed yesterday, do also read this 2005 JAMA article he authored.]

I found his remarks on global pharma IP to be quite enlightening — as he set the very-legitimate question of protecting property rights into the broader framework of whether there is a moral — if not legal — duty to provide life-saving medical developments across economic, and continental divides — at something other than the highest possible price – especially in the case of HIV meds — where it is literally the choice between a death-sentence, or life-saving “commutation“, if you will, hanging in the balance. I’ll leave you with the most intriguing of his, below, but do go read it all — quoting the professor’s testimony (PDF File), then [emphasis supplied]:

. . . .The area of current political tension is in the middle income nations. These nations are the growth pharmaceutical markets of the future, so that patent protection is of great importance to the future of the pharmaceutical industry’s business model. At the same time, these nations still have many poor people and thus view themselves as reasonably benefiting from the Doha Declaration. South Asia, for example, has more very poor people than Sub-Sahara Africa. Moreover, several, including Brazil and Thailand, have undertaken public programs to supply antiretrovirals to their HIV-affected populations, an expensive task whose overall cost depends heavily on the price of the drugs.

I believe that we must attempt new approaches in dealing with these nations. It is in our national interest to facilitate their growth in health. That may call for low, i.e., generic prices for at least some drugs for some people. This might be an exception for a limited time. In another approach, GSK is developing mechanisms for differential pricing within poorer countries based on charging a generic price to certain public or nonprofit distribution channels while charging a higher research-reimbursing price to others. Might the approach be extended?

But there will need to be reforms beyond prices. For example, in a number of nations, including China, much medical care is effectively financed through pharmaceutical sales by doctors and hospitals -– a process that certainly creates terrible incentives toward price markup to patients and toward overprescription. In India, the poor are not effectively served by the medical system. And some of these nations are pharmaceutical exporters at the same time that they have many needy citizens. Compromise seems reasonable; it will necessarily be more complex than a pure IP arrangement.

In approaching such a compromise, it is worth noting that price controls are likely to be the key topic for future international negotiations with developed nations in the pharmaceutical area. The importance of such controls is exemplified by the current European disputes over Roche’s anticancer drug, Avastin, as well as by the inclusion of price-related provisions in the 2004 U.S.-Australia Free Trade Agreement and the great attention paid to the issue in the 2008 USTR Special 301 Report. Moreover, at some point, price controls will almost certainly be an issue in our own country -– health care reform may increase the role of the government in purchasing pharmaceuticals, and it is hard to envision continued significant government purchasing of pharmaceuticals without pressure toward price controls. Unless the price controls are applied thoughtfully, the result will be to decrease incentives for research. Such harm may already have occurred in the U.S. childhood vaccine industry. In approaching health care reform and international trade both, we will need to define effective decision-making standards and procedures to maintain optimal incentives for research in medical technology. These various trends suggest to me that it is important to moderate our IP focus and to recognize that IP is only part of a broader package of pharmaceutical trade goals.

All nations want greater access to health care; all want to contain the cost of that health care; all want more advanced technologies. These are goals that have to be balanced; and the details of the balance may reasonably be different for nations at different income levels. . . .

Indeed. Hopefully the folks in Kenilworth are watching CSPAN.org.