Once again, A Picture’s Worth 1,000 1,000,000 Words. . . .

NOTE: AND, once again, thanks to PM for the heads-up on all of this (her latest, on the benefits and costs of Avastin, the very-pricey Genentech cancer drug, is very-well-laid-out — do go read it). . . .

Now, the graphic at left (a part of this longer editorital) was originally derived from the data presented in this NEJM paper. What I want the readers to notice is that — at every subgrouping — ezetimibe did not outperform the statin-regimen in any statistically-significant fashion.

Perhaps even more importantly, in the sub-groupings in which ezetimibe performed worse — it did much worse. Note how “right weighted” those dots are (click the image to enlarge it). Only three of 25 sub-groups were fully-over the “zero-line”, and into the “left side — ezetimibe better” result — and all of those three were just barely better.

Now, let’s hear from Dr. Taylor, himself (do go read all of his, though):

. . . .[Earlier] in this issue of the Cleveland Clinic Journal of Medicine, Dr. Michael Davidson, a respected lipid expert but one invested in ezetimibe’s development, assures us that all is in order and that the results of ENHANCE can be explained away by several arguments, most notably that most of the trial’s participants had previously received lipid-lowering treatment, which obscured the effects of ezetimibe.

Moreover, he argues that ezetimibe’s mechanism of action is well understood and that the drug is safe and well tolerated and thus should remain a first-line treatment for hyperlipidemia.

These arguments may eventually prove to be correct, but as of now they are merely wishful post hoc hypotheses awaiting more data apart from ENHANCE. Negative clinical trials do occur as a matter of chance, but we should be cautious in any attempts to explain away a trial that was designed, executed, and reported as conceived simply because the results do not match our expectations.

Confronted with ENHANCE, the astute clinician should ask three questions: Do we really understand ezetimibe’s mechanism of action? Do other lines of evidence indicate the drug is beneficial? And how reliable is the arterial thickness as a surrogate end point?. . . .

That is exactly right — the bottom line?: There can be no lipstick red enough for this pig — the pig called ENHANCE.

UPDATED: I think Dr. Davidson’s opposing conclusion — in the vein of “the lady doth protest too greatly” — tells me all I need to know about his biases:

. . . .Enormous challenges are on the horizon for the pharmaceutical industry, with a shrinking pipeline of potential new drugs, increasing regulatory hurdles, greater liability risk, political pressure for price controls, enhanced scrutiny of sales practices, and a growing media bias. As a cardiologist and clinical researcher [appeal to emotion omitted]. . . . I am concerned that, unless change occurs, a vibrant pharmaceutical industry with the financial and intellectual capital to find and develop new, more effective treatments will cease to exist. . . .

With all due respect, Dr. Davidson, that is a conclusion not remotely supported by the actual data. This silly mantra of the “death of US Pharma” [as Samuel Clemens, in 1897, sort of intoned -- "is greatly exaggerated. . . ." and] — simply must stop. It is beneath the abilities of the people offering it. It suggests there is little else, of worth, to write in defense of the failed study. Perhaps that is the case.

Perhaps that is the object lesson, here.

[In the interest of being complete, here is the introduction of this Journal's editor -- Dr. Brian F. Mandell -- to the above point-counterpoint debate, found in this month's Cleveland Clinic Journal of Medicine. All of the pieces are PDF files -- emphasis here supplied.]

An important judicial teleconference — on discovery issues, and scheduling — on one “peninsula” of Schering-Plough’s “continent” of litigation. . . .

Last month, Judge Cavanaugh encouraged the plaintiffs’ lawyers in the consolidated actions now captioned In Re Vytorin/Zetia Marketing, Sales Practices, and Products Liability Litigation (Civil Action No. 08-285 (DMC); MDL No. 1938, US Dist. Ct. NJ), to meet with the defendants’ lawyers and try to work out some of their differences. One of the more important remaining differences is now scheduled to be the subject of a July 17, 2008 judicially-supervised teleconference. Quoting from the Magistrate’s letter order, just filed July 3, and entered as of July 4, 2008, then:

“. . . .Please be advised that this matter has been scheduled for a telephone conference on Thursday, July 17, 2008 at 10:00 a.m. The parties should be prepared to address the discovery scheduling issue raised in plaintiffs’ letter of June 19, 2008 to District Judge Cavanaugh (docket no. 61). Plaintiffs’ co-liaison counsel are responsible for arranging and initiating the conference call. . . .”

/s/ Mark Falk
United States
Magistrate Judge

The issue to be discussed on this call is whether the plaintiffs will be allowed to begin “discovery” — that is, start reviewing Schering documents (including Schering’s “due diligence” files), and potentially taking depositions — before the court rules on the pending Schering-Plough motion to dismiss these consolidated actions.

It may take several months — into early 2009 — before the court will be fully-briefed on the issues that will drive its decision on the pending motion to dismiss. So, quite sensibly, the plaintiffs do not want this to be a period of “lost time“, in terms of moving the litigation forward, should the judge deny Schering’s motion to dismiss (given the considerable amount of potential evidence of alleged negligence, if not outright malfeasance, and the variety of the plaintiffs’ theories for recovery, I personally doubt that Schering has much of a chance of winning on its motion to dismiss — I’ll explain why some other time).

So — here’s “what’s-up” for July 17: whether the plaintiffs may begin to force Schering to turn over that potential evidence, essentially immediately, perhaps entirely mooting the pending motion to dismiss.

While I think it likely that Magistrate Judge Falk (for District Court Judge Cavanaugh), is likely to allow immediate discovery — it is a certainty that Schering will seek to have the judge — Judge Cavanaugh — reconsider the Magistrate’s decision — in the event that the Magistrate allows immediate discovery. Delay, in these situations, is usually the ally of the defendants — that is, the longer Schering can hold-out, and avoid offering up its internal files for review, the greater the chance that various peoples’ memories will have faded, or clouded-over, and sharp recall of details will have been “lost” — such that no clear trail of wrong-doing (or exoneration!) will appear from any of the documents (and the depositions of witnesses, as they are quizzed about the relevance, meaning and import of the documents).

So — I’ll predict that Magistrate Judge Falk will allow essentially immediate discovery (an important “first-step” toward victory for the plaintiffs); Schering will file a motion for reconsideration — and, if Judge Cavanaugh (after a Schering motion to reconsider) then allows discovery to proceed immediately, Schering’s lawyers will take an immediate appeal of that order “upstairs” — to the Court of Appeals.

However, there are ways in which Judge Cavanaugh’s ultimate order may be crafted to minimize the chance that Schering could acheive additional delay (by filing that appeal). For example, Judge Cavanaugh could enter his order (allowing immediate discovery against Schering) as a “non-final“, or conditional, order — it could be an interim order allowing discovery to proceed, subject to his ruling on the motion to dismiss. That would leave Schering with almost no basis to appeal, as only “final orders” are generally appealable, under the federal rules. If non-final, the order would be non-appealable — but might be vacated, if, at some future point, as briefing on the motion to dismiss evolves, Judge Cavanaugh sees the motion for dismissal as being more meritorious than it now would appear to be.

So — and the reason for all this circumlocution, here — if this July 17 conference call goes well for the plaintiffs, internal Schering documents could begin to emerge as early as late-August, 2008. More likely, it will be late-September 2008, but soon enough, Schering will have to begin to make those diligence files available. And there will very-likely be a treasure trove of evidence there.

Evidence that radiates well-beyond these consumer fraud cases — to the derivative actions, to the ERISA cases, to the RICO actions and, of course, to the securities fraud claims — and, very-little of it likely helpful to Schering’s defenses. Remember, you read it here, first.

Pharmalot and Herper; on Nissen — then Lipitor’s CASHMERE data. . . .

I’ve been out of pocket most of the day, but saw this one by Matt Herper — and Ed Silverman’s cogent remarks on the same topics, earlier — thanks to PM (her latest, on reducing preventable inpatient death-rates, is great — do go see it, BTW!).

Sort of as a tangent off of those few — there is also, tonight, a budding CafePharma thread — in which the Schering-Plough Joint Venture faithful see CASHMERE [a small Pfizer/Lipitor study that came out inconclusively, using CIMT (carotid intima-media thickness) as a proxy-measure] as some vindication of Vytorin.

My take? “Well — that’s. just. Odd. . . .”

I am all for vigorous scientific debate — but to paint CASHMERE as vindicating Vytorin is simply wishful-thinking. I am sure someone will immediately correct me if I am wrong, here, but Vytorin has no “outcomes data” in its favor. Lipitor plainly does — tons of it.

So — I’d allow that a smallish study involving Lipitor came out inconclusively — and the use of CIMT as a measurement is now suspect. That is all relatively-fair.

It is a horse of a completely different color, though, to suggest that this means Vytorin should be, in any way, elevated to be on a par with Lipitor — as to outcomes data. That is rubbish. Simply rubbish.

Vytorin simply has no data to back that claim. None.

Lipitor now has one inconclusive study, to add to its several larger favorable outcomes studies. Doesn’t that say it all?

Have a safe and happy Fourth, one and all!

44 days later. . . . on DTC — and Merck and Pfizer have YET to respond?

The Schering-Plough “immediate” response to US House of Representatives Engergy & Commerce Committee Chairman Dingell’s written requests — for industry’s assurances about some of the ethical issues involved in so-called “Direct to Consumer” (or DTC) advertising of FDA-regulated pharmaceuticals — is now available (PDF file) on the web.

It was 44 days ago that the Chairman asked for an “immediate written response” from these four companies. Smartly, J&J hand-delivered its response to the Chairman on May 30, 2008. [Those apple-polishers(!) -- click the image, at right.]

Though CEO Fred Hassan’s letter on behalf of Schering is also dated as of May 30, 2008 — it would seem highly-unlikely that it was delivered to the Committee at the same time as CEO William C. Weldon’s, on bhalf of Johnson & Johnson. Why? Well, because the Committee’s website has featured a link to the J&J letter of response for over a month, now – and the Schering link appeared sometime during the afternoon, yesterday — on July 2, 2008.

Note also that the PDF file shows a series of hand-written “routing” notes on the upper right portion of the first page (or, click on the image, below). That would suggest that the letter was dumped into the “ordinary” U.S. Postal Service Congressional Mail-bins (note that the Committee’s Room Number is hand-written at the far upper-right) — and so, at a minimum, it took a few weeks to arrive on the Chairman’s desk. Not so smart, Mr. Hassan:

Seriously — how much does hand-delivery cost? Or FedEx, signature required?

And, what are we to make of Pfizer? And of Merck? No letter — in 44 days? Wow.

Miscellaneous Schering-Plough Putative Class Actions — Litigation Updates, here. . . .

Rather than set each of these up separately, I’ll consolidate these few litigation developments — as each one, individually, is relatively minor:

(1) The plaintiffs will have until September 22, 2008 to file their amended, consolidated complaint in In Re: Vytorin/Zetia Marketing, Sales Practices and Products Liability Litigation (MDL Case No. 1938, original lead case captioned Polk v. Schering-Plough et al., Case No. 08-285) — and, I bet some version of this Complaint Paragraph 72 will be featured, then and there. Heh!

(2) As earlier mentioned, the consolidated amended securities fraud complaint is at the moment due on August 1, 2008 — it too will likely feature some version of the above-mentioned Complaint Paragraph 72.

(3) Dr. Jeffery Feldstein’s attorneys — in USA v. Organon, et al. (Case No. 07-2690), the Qui Tam/False Claims Act case, are seeking an unspecified additional chunk of time to respond to, or otherwise move against the Schering Motion to Dismiss, filed by Arent Fox — Judge Cavanaugh hasn’t yet ruled on this rather customary request for an extension, but if nothing else happens, the response to motion will be returnable (due) on July 21, 2008. July 21, 2008, of course, is also the morning on which Schering will announce its second quarter financial results — a webcast, with a conference call.

I’d suspect Dr. Feldstein’s lawyers are thinking “there are so, so many grounds upon which to oppose — and so very little time(!)“. . . .

Said another way, I’d expect that response, when it comes, to lay the issue of “due diligence” directly at the feet of Schering-Plough, and its various investment bankers and securities underwriters.

(4) As earlier mentioned, Judge Cavanaugh consolidated two civil ERISA actions Gradone v. Schering-Plough, et al. (Case No. 08-1432 (DMC), U.S. Dist. Ct. N.J.) and Oettinger v. Schering-Plough, et al. (Case No. 08-2436 (WJM), U.S. Dist. Ct. N.J.), for all purposes and appointed interim class counsel. The now-consolidated cases have been re-named In re Schering-Plough Corp. ENHANCE ERISA Litigation (Case No. 08-1432 (DMC), U.S. Dist. Ct. N.J.).

Have a safe and happy Fourth!

From a Friend of the Blog — Forbes’ Herper — on the “Statin Showdown” Comparing Statins v. Ezetimibe

[Headline Revised, per the below: "Comparing and Contrasting Statins v. Ezetimibe". . . .]

An occasional guest blogger at Gooznews — one PM alerted us to the mobile edition (fancy!) of last night’s Forbes piece updating the state of the play on statins. Do go read it. It is delivered sans graphics and ads. Nice.

UPDATED — 07.01.08 @ 6:00 PM EDT: Several developments lead me to float this to the top of the blog.

First, read this reaction, posted over at CafePharma, to the Herper story being pasted-in there by someone:

Forbes article on ezetimibe v. statins

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

What’s very interesting about this article is I distinctly remember, as do several of my counterparts, a particular cardiologist asking the same thing about Zetia. However, the conversation occurred years ago when I launched Vytorin. In fact, he was my very first call when I began launching the product. I was happy to be launching this new product and was terribly disheartened after my first call in the field with Vytorin. He questioned me about the effect Zetia could have on inflamation and suggested that Zetia could have a negative effect. We had a very long discussion as the cardiologist carefully outlined his concern over lack of data for the Zetia component of Vytorin. Interestingly, I discussed with my manager that this cardiologist was concerned and would not use the product until we have proof that Zetia did NOT have a negative effect on inflamation. In typical manager fashion the eyes rolled and the rant began about how this guy was an idiot and we need to find a way to convince him to use it. Another interesting parallel is the fact that Cordaptive was not approved based on lack of evidence of one component of the combo. HMMMM, makes me question what I do in the field each day. . . .

Well, that war-story is entirely fascinating. Shove the drug into the docs’ bags — don’t listen to actual feedback on mechanism of action. “Don’t confuse me with any actual facts – my mind is already made up — we’re positively going to flog this new product — it’s the best thing since sliced bread! — so that’s that. . . .”

Now the second reason, and perhaps more importantly, the real reason for floating, as well as updating, here, is that I have revised — at PM’s astute suggestion — the title of this post. PM writes:

. . . .The headline to [the Forbes] article doesn’t really fit the content of the article. The intent of the piece is to point out that statins have pleiotropic effects, i.e., beneficial effects unrelated to cholesterol lowering. Ezetimibe appears not to have these effects, due to its different mechanism of action. So I was wondering if you could revise your post so it is clear that the article contrasts ezetimibe with statins. . . .

Done. I originally read it — looking for new information on the marketing of Vytorin — and saw none. Clearly, PM’s eyes are more discerning than mine. Have a safe and happy 4^th, one and all! May be light blogging through the weekend, here. . . .

Now, that’s what I’m TALKING about. . . .

[UPDATED -- 07.02.08 @ 10:00 PM EDT: A gent named Random John (who really isn't -- all that "random", that is), at Realizations in Biostatistics, has also weighed in on this topic -- the likely irrelevance of "blinding/unbliding" in non-inferiority studies, where non-inferiority does NOT result -- and, he linked my post. Thanks!

07.01.08 @ 11:00 PM EDT: That gentleman across the pond, the Insider -- at PharmaGossip, has linked this story, and featured its graphics! Thanks a ton!

Apparently, Dr. Peter Rost at The PharmaLaw Blog has also linked this, freely-liberating the graphics -- COOL! (that's what they are here for, folks!) -- while adding significant additional detail about the possible origins of Sen. Grassley's scientific understanding of "non-inferiority" studies -- studies like ENHANCE. Did the Senator's staffers "go to school" on all of this via The Insider and Dr. Rost? Read the above two links, and decide for yourself!]

I missed this earlier in June, but it would seem that the first case reciting Sen. Grassley’s theory of the irrelevance, from a scientific/statistical and legal point of view, of the blinded v. unblinded ENHANCE data-sets — has now been filed. This will likely become a central theory advanced in the yet-to-be amended securities fraud complaints, the shareholders’ derivative action, and all the others, due to be filed later this summer.

This particular case is a consumer fraud case, filed June 13, 2008, by a health-care plan in Minnesota, captioned Electrical Workers 242 Health and Welfare Fund, et al. v. Merck & Co., Inc, et al. (Case No. 2:08-cv-03025-DMC, Complaint filed June 13, 2008, US Dist. Ct. NJ).

This is the legal theory I think I was the first to really outline, and then amplify, back in early April 2008, after reading Sen. Grassley’s February letter, referenced in the below paragraph. As ever, click the image to enlarge it.

Cool.

[Late-night edits: the original PDF of the complaint, as well as my original .jpg of this portion, above, contained a typo: "unblended" where "unblinded" was plainly intended -- I've fixed it, in three places, just now. Also, "not" was used once where "no" was intended. Even though the original at the federal district courthouse in Newark still contains these typos -- this one will be fully-correct. In this way, it will make a better model -- for all of the other plaintiffs' lawyers, likely to graft it into their respective complaints.]

Senator Grassley — on the Unaccounted-for “Billions of Dollars Spent on Medicaid/Medicare Supplemental Payments”

Yesterday, the Senator’s office released the following statement:

June 30, 2008

M E M O R A N D U M

TO: Reporters and Editors
FR: Jill Kozeny, 202/224-1308
for U.S. Senator Chuck Grassley of Iowa

RE: GAO report on supplemental payments to hospitals

Senator Chuck Grassley is urging the Centers for Medicare and Medicaid Services to implement recommendations issued today in a new report of the Government Accountability Office payments of disproportionate share (DSH) funds to hospitals. The report, GAO-08-614 [Full-text of PDF file at link], is titled MEDICAID CMS Needs More Information on the Billions of Dollars Spent on Supplemental Payments. . . . Senator Grassley also said he will continue to study the practices of non-profit hospitals to confirm that they are providing a public benefit commensurate with the public subsidies they receive. . . .

Hospitals in America, particularly non-profit hospitals, receive numerous forms of support from federal, states, and local governments. The Medicare and Medicaid programs provide disproportionate share (DSH) funds to hospitals that provide care to a significant caseload of uninsured patients. The Medicaid payment system for hospitals allows states to pay hospitals up to an Upper Payment Limit (UPL) which is greater than their costs under the state Medicaid program. In addition to not paying income taxes, non-profit hospitals receive tax-deductible contributions, issue tax-exempt bonds and receive exemptions from state and local property and sales taxes.

Hospitals were granted special status back at the turn of the last century when hospitals were the only places where the poor could go when they were sick. The enactment of Medicare in 1965 and the explosion of the insurance market since then has resulted in incentives for hospitals to treat only paying patients. The current environment is no different than where we were over a hundred years ago. Back then, people with money had private physicians who made home visits. The poor received treatment at alms houses supported by philanthropy. The only difference now is that many of those former alms houses have become rich institutions that believe they no longer need to serve the poor to reap all the benefits of their tax-exempt status.

In my investigation of non-profit hospitals, I have found disturbing evidence that some hospitals are not delivering the services that they should in exchange for the benefits they receive. Some hospitals lack charity care policies, or don’t make them known to the public. They bill the uninsured or underinsured chargemaster rates, which are significantly higher than what insurance companies and Medicare actually pay. They engage in questionable collections practices. They pursue payments from the poor and near-poor uninsured without consideration of the DSH funds that they receive from states or the funds they hold in endowments. On June 10, 2008, the Finance Committee heard testimony from Lisa Kelly, who was required to come up with a cashiers check for tens of thousands of dollars before receiving treatment for cancer at the MD Anderson Center. An institution with an endowment of more than a half billion dollars required an underinsured woman with cancer to come up with tens of thousands of dollars before they would treat her.

We need to know that the public appropriately benefits from these numerous federal subsidies. We need to know that federal funds are being properly spent. In 2003, Congress passed a provision in the Medicare Modernization Act (MMA) to require states to submit annual audits of their DSH payments to CMS. Almost five years have passed, and CMS has still not implemented the final rule for the MMA provision. The GAO report I am releasing today shows how critical it is CMS issue the final rule.

CMS doesn’t know where DSH funds are being used.

That simply cannot continue.

United States Senator
Ranking Member,
Committee on Finance

[Emphasis supplied.]

Tomorrow’s WSJ — Glaxo, Novartis CEOs Evince "Vision", by asking Euro-Regulators about Priorities for Approvals. . . .

Tomorrow’s print Wall Street Journal will carry a very interesting counter-point to Fred Hassan’s recent lament — also aired on the front page of the Wall Street Journal, just a week ago — that Hassan just doesn’t know what it takes to get a drug approved at FDA, anymore. Ah, the poor dear.

In contrast to Mr. Hassan’s proffered befuddlement, UK-based-GlaxoSmithKline PLC CEO Andrew Witty did the apparently-truly-remarkable:

He asked — asked UK, French, Italian and Spanish regulators. Whoa. Novel concept.

Quoth The Wall Street Journal:

. . . .British pharmaceutical giant GlaxoSmithKline PLC is taking the unusual step of giving government health-care systems a say in deciding which drugs advance in its research pipeline, a move it hopes will result in more products these customers will pay for.

Glaxo’s new chief executive, Andrew Witty, said the effort is part of his drive to help the world’s second-largest drug maker adapt to a tough pharmaceutical market. In recent years, soaring health-care costs have led insurers, governments and other drug buyers to tighten their belts.

“I’m going to deal with the pharmaceutical realities of the next 10 years, and they’re very different from those of the 1990s,” Mr. Witty said in an interview at a company townhouse. . . .

The current Novartis CEO also drew approving ink in the article for consulting with European regulators over pipeline priorities.

Confidential Note to Fred Hassan: This — the above — is just a thought. Feel free to ignore it. I mean, it is pretty far “out of the box” thinking to ask some of your most-important payors — and key regulators — what each might be most-inclined to approve, and “pay” for, respectively.

But really — you, and Schering have no need for nutty, stake-holder/customer-focused ideas like these. I mean, you are sitting perfectly “pretty” right where you are, now, right? Right.

It is just so much easier to hold that last, long, wailing note, seemingly-forever, on your lament: “We just don’t know what to do with the FDA-a-a-a-a-a–a-a-a-A-A-A-a. . . .”

Once again, A Picture’s Worth 1,000 1,000,000 Words. . . .

NOTE: AND, once again, thanks to PM for the heads-up on all of this (Gooz’s her latest, on the benefits and costs of Avastin, the very-pricey Genentech cancer drug, is very-well-laid-out — do go read it) and do go read this, on preventible inpatient death rates, by PM. . . .

UPDATED — 07.06.08 @ 7:00 PM EDT: The Insider, at Pharmagossip is on the case — and has featured my derivative graphics, at right. Brilliant!

Now, the graphic at left (a part of this longer editorital) was originally derived from the data presented in this NEJM paper. What I want the readers to notice is that — at every subgrouping — ezetimibe did not outperform the statin-regimen in any statistically-significant fashion.

Perhaps even more importantly, in the sub-groupings in which ezetimibe performed worse — it did much worse. Note how “right weighted” those dots are (click the image to enlarge it). Only three of 25 sub-groups were fully-over the “zero-line”, and into the “left side — ezetimibe better” result — and all of those three were just barely better.

Now, let’s hear from Dr. Taylor, himself (do go read all of his, though):

. . . .[Earlier] in this issue of the Cleveland Clinic Journal of Medicine, Dr. Michael Davidson, a respected lipid expert but one invested in ezetimibe’s development, assures us that all is in order and that the results of ENHANCE can be explained away by several arguments, most notably that most of the trial’s participants had previously received lipid-lowering treatment, which obscured the effects of ezetimibe.

Moreover, he argues that ezetimibe’s mechanism of action is well understood and that the drug is safe and well tolerated and thus should remain a first-line treatment for hyperlipidemia.

These arguments may eventually prove to be correct, but as of now they are merely wishful post hoc hypotheses awaiting more data apart from ENHANCE. Negative clinical trials do occur as a matter of chance, but we should be cautious in any attempts to explain away a trial that was designed, executed, and reported as conceived simply because the results do not match our expectations.

Confronted with ENHANCE, the astute clinician should ask three questions: Do we really understand ezetimibe’s mechanism of action? Do other lines of evidence indicate the drug is beneficial? And how reliable is the arterial thickness as a surrogate end point?. . . .

That is exactly right — the bottom line?

There can be no <font color =”#FF0000
“>lipstick red enough for this pig — the pig called ENHANCE.

UPDATED: I think Dr. Davidson’s opposing conclusion — in the vein of “the lady doth protest too greatly” — tells me all I need to know about his biases:

. . . .Enormous challenges are on the horizon for the pharmaceutical industry, with a shrinking pipeline of potential new drugs, increasing regulatory hurdles, greater liability risk, political pressure for price controls, enhanced scrutiny of sales practices, and a growing media bias. As a cardiologist and clinical researcher [appeal to emotion omitted]. . . . I am concerned that, unless change occurs, a vibrant pharmaceutical industry with the financial and intellectual capital to find and develop new, more effective treatments will cease to exist. . . .

With all due respect, Dr. Davidson, that is a conclusion not remotely supported by the actual data. This silly mantra of the “death of US Pharma” [as Samuel Clemens, in 1897, sort of intoned -- "is greatly exaggerated. . . ." and] — simply must stop. It is beneath the abilities of the people offering it. It suggests there is little else, of worth, to write in defense of the failed study. Perhaps that is the case.

Perhaps that is the object lesson, here.

[In the interest of being complete, here is the introduction of this Journal's editor -- Dr. Brian F. Mandell -- to the above point-counterpoint debate, found in this month's Cleveland Clinic Journal of Medicine. All of the pieces are PDF files -- emphasis here supplied.]