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.]