Sunday, November 16, 2008

Matt Herper's Very-Sensible Article -- on Cholesterol Levels -- in Forbes. . . .

Matt Herper has done a quite-admirable job of sorting through all the latest statin-hype, this morning -- and putting together 10 plain-English slides to help ordinary people parse the whole Crestor's "Jupiter" findings v. generics v. diet-and-exercise matrix.

If [over a ten-year period, as cogently noted by Marilyn Mann] an otherwise pretty-healthy American adult has perhaps a two-in-one-hundred chance of having a heart-attack -- after age 50 -- is it really worthwhile to lower that risk to one-in-one-hundred, if the cost (at $100 per month, for life) and side-effects (potential muscle weakness, and pain) of taking statins is fully-factored-in?

I dunno. But that, I think, is what healthy patients ought to ask their doctors -- before starting a generic, or branded, statin regimen.

Do go take the Forbes-provided Reynolds Risk Calculator for yourself -- it will help you be prepared for the above-dialogue with your doctor -- Bonus: it is linked in Herper's fine ten-slide sidebar to the article, as is the Framingham assessment calculator, available directly from the NIH website, right here.

Herper's most relevant paragraph, insofar as this blog's topics are concerned, may be his last -- he is certainly spot-on, about a coming "second-wave" of Vytorin/Zetia sales declines, as the AstraZeneca-Crestor "Jupiter" tide rolls through doctors' offices, nation-wide:

. . . .There is disagreement over whether statins work just by lowering LDL or also by preventing inflammation in the arteries, which also may have a role in heart attacks. That could explain why Jupiter outperformed previous statin trials, Ridker argues, and could lead some doctors to prescribe Crestor over generics. Use of Zetia, the non-statin cholesterol drug from Merck and Schering-Plough that is also part of the combo pill Vytorin, could continue to drop, because it may not have the same anti-inflammatory effects, and there's no evidence it stops heart attacks. Pfizer could catch a tailwind as health plans fearing Crestor's long patent life encourage docs to prescribe the similar Lipitor [Editor: or generics] instead.

That leaves plenty for scientists, investors and marketers to fight over. But statins have proved their worth in 18 clinical trials stretched out over two decades. If these drugs aren't worth using widely, pharmaceutical chemists better get out of the prevention business entirely. Statins may be as good as drugs get. . . .

I might quibble, just a bit about that last line -- it may be a little over the top, but in the main, this is a tremendous article -- be sure to walk through his ten slides!

You'll be a far-better-informed "American pill-popper" for having done so.


Anonymous said...

Last week, I returned from San Fran AASLD liver meeting where I had the opportunity to review first hand both the SP boceprevir and the Vertex telaprevir data.

Vertex was the clear meeting winner presenting ground-breaking evidence of telaprevir efficacy in previous treatment non-responders, the #1 unmet clinical need in hep C. With only 50% of patients responding to current therapy, a status quo that has existed for approximately 10 years, the telaprevir non-responder data opens up a huge market of already identified patients that did not respond to current therapy.

The comparative significance of the data was not lost on AASLD organizers as they chose to award an oral presentation to Vertex whereas the SP data was buried in a poster session despite the "buzz" they were attempting to generate.

The SP data from my perspective was "ho hum" at best. Although showing an outwardly impressive response rate in naive patients, the patient population was arguably an "easier to treat population" with a very low proportion of patients with advanced liver disease (less than 10% cirrhotic). The claim that induction dosing was providing superior response was met with dubious reaction of many liver specialists as the concept of induction dosing has been "dead" for a number of years with many trials failing to show a benefit of this therapeutic approach.

The big commercial issue for SP in my mind is that all of the data they have presented demonstrates benefit with 48 WEEKS treatment, whereas telaprevir has been shown to be effective in the same naive population with half the duration of therapy ie. 24 WEEKS. This is not insignificant as these molecules must be administered in combination with peginterferon injections, a therapy which is extremely difficult to tolerate (think flu, fever, hair loss, rash, tremors, depression, bone marrow toxicity, suicidal ideation etc.). With similar response rates, specialists and patients (not to mention payers) would choose a 24 week therapy compared to a 48 week therapy ever time. This presents a huge problem for SP as they will likely enter market after telaprevir is established with at best a "me-too" treatment that requires double the duration of therapy.

I am also bewildered by the SP choice to only develop bocepevir in combination with their brand of peginterferon ie. PEG-INTRON which currently holds about 35% of world share vs 65% PEGASYS (Roche). Vertex is developing telaprevir with PEGASYS. Why SP would choose to pair themselves with the market loser either demonstrates arrogance or extreme stupidity. Not only is their interferon market failing, they are likely to drag boceprevir down with it.

Perhaps the same SP strategists that worked on the release of the ENHANCE study data have now picked up boceprevir?


Marilyn Mann said...

"If an otherwise pretty-healthy American adult has perhaps a two-in-one-hundred chance of having a heart-attack -- after age 50 -- is it really worthwhile to lower that risk to one-in-one-hundred, if the cost (at $100 per month, for life) and side-effects (potential muscle weakness, and pain) of taking statins is fully-factored-in?"

Over what period of time are you measuring risk? If over 10 years, you are talking about very low risk people.

There are generic statins available that are much cheaper than rosuvastatin. In a few years, atorvastatin will be available generically.


Condor said...

I'm glad you've pointed this out, Marilyn. . . . I am about to post on the New York Times' take on Jupiter (from last night), momentarily, above.

It seems to come out about where I did.

Thanks as ever, for the corrections!

Your input is valuable beyond measure.