Friday, February 6, 2009


Send Us Your Post Suggestions--HERE!!!

Hi All,

This thread, which you will see reposted every now and then (to get to the top of the blog) is aimed to solicit your suggestions for PharmaLittle posts.

This could be a link to a news item and your own commentary on why it is important; a pharma-related policy question you would like to see discussed on the blog; a shot at humor (you've seen some of those); or some category no one has ever heard of. Feel free to use your name, Anonymous, or any other moniker created for the occasion.

We will try to get as many of these up as possible--particularly if they are in a form ready to post and especiallylikely to provoke discussion, inform, and/or entertain.

This is not an invitatation you will see on the WSJ or probably anywhere else -- Go for it!


  1. Saw this and thought that Justice might be interested- Anne PME

    Please see below:

    February 09, 2009
    Should CJ Roberts Recuse in Landmark Wyeth Case?
    One of the top cases of the current Supreme Court term is Wyeth v. Levine, asking whether a state law tort action challenging the labeling on a Wyeth drug is pre-empted by federal law. The Court heard the case last November, and presumably voted privately on how to decide it days later. But a decision has not yet emerged.
    Now, the outcome of the case could be in question, because of the recent announcement by Pfizer Inc. that it would acquire Wyeth. As we have reported here in the past, Chief Justice John Roberts Jr. owns Pfizer stock that has prompted his recusal in previous cases. The outcome of the Levine case is likely to affect Wyeth's value, and in turn Pfizer's.
    On Feb. 4, Wyeth's lawyer before the Court, Seth Waxman of Wilmer Cutler Pickering Hale and Dorr sent a letter to the clerk of the Supreme Court informing the Court of the pending transaction. But Waxman told the Court that because of pending stockholder approvals and other matters, the transaction will not be completed until July 31 at the earliest -- weeks after the end of the Court term, by which time its decision would have been released. As a result, Waxman said he does not believe the pending takeover "warrants amendment of the corporate disclosure statement" submitted by Wyeth when Wyeth petitioned the Court last year. That disclosure statement is ordinarily the way justices are informed about parent companies and subidiaries that lets them know if recusal is required.
    Whether or not Waxman's letter makes a difference may not be known until the Court issues its opinion -- and either Roberts is part of the decision, or not. It is also conceivable Roberts could shed his Pfizer stock to avoid the recusal issue, a strategy some justices have employed in recent years. Either way, it will be an interesting test of whether news of an acquisition -- even before it occurs -- will affect justices' recusal practices. (Hat tip to Drug and Device Law blog.)
    Posted by Tony Mauro on February 09, 2009 at 02:42 PM in Supreme Court | Permalink
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  2. Justice Roberts should have recused himself the minute he knew there was a merger. At that point, there was clearly a conflict of interest. Any judge is obligated to avoid even an appearance of conflict. The US Supreme Court has to be held to the highest standards.

  3. Suggested topic for Valentine's Day post:

  4. Hello Justice et al. - I see you've been perusing the WSJ Health Blog, did you happen to notice this little gem - Pfizer and Lilly Plow Marketing Money Into Fibromyalgia. I mention it because if things here go the way of many pharma marketing initiatives, there is a strong chance that it will eventually implode/explode into a huge scandal. If you get in on the ground floor, as it were, it could make a fine case study for disease-mongering and marketing techniques. You can use your Pharmalot-acquired skills to follow the bouncing ball. Just sayin'

  5. Harpy, I agree. Check out what the bloggers over at Health Care Renewal are sayin'...

  6. Hi Harpy and Nancy,

    Well, we're not "supposed to" discuss issues here, just consider them for threads. But I actually added something on the WSJ blog that never showed up for some reason.

    I myself had what was then called "chronic fatigue" in the 80s. It was five years of misery, and everything else under the sun was ruled out. I eventually found a very senior infectious disease prof here who did find a number of immunlogical "irregularities" that could explain my symptoms. When I got better, so did they.

    So...I am a not quick on dismissing fibro out of hand. Whether Lyrica and its pals have anything to contribute to it, on the other hand, is a different question.

  7. Justice, dare I begin a discussion in the Suggestion Box? Risky, but here goes...

    No health care professional worth their salt would dismiss a patient's symptoms. The question you raise is a good one, though. As harpy suggested, it may be interesting to see the manner in which this medication is marketed for FM. How much focus will be placed on the "team approach" required for the treatment of FM?

    Look here:

  8. Well, we've already crossed the line, so we might as well keep going!

    Here's my own "theory" - Fibro will eventually be to medicine what protists are to plants and animals, a "third thing" that is neither psychological nor physiological in the usual sense.

    Based on my own experience, what happened to me was initially the result of sustained life stress (helplessness/chronic outrage in job situation) which I really didn't understand at the time. My metaphor was that my "battery drained" eventually. Too angry, too long. There was just no more resilience.

    But then things took on a life of their own. Had they tested for cortisol, that would have been informative, I think, but it didn't happen. But I always felt "fatigue" was the wrong word. It was not about feeling sleepy/tired, nor about being depressed, but almost a drugged feeling--like someone "slipped you a mickey" as they used to say. Feeling spacey, etc. Also bizarre pains that were not joints for me - rather, facial, like severe sinus infection, but more acute/short-lived. So you can imagine the neuro work-ups, etc..

    What finally "cured me," I think, was a very rigorous exercise program that I made myself do regardless of how I felt. Heavy-duty aerobics every day, for at least an hour, usually more. Somehow, that recharged the battery. But I would say I never _fully_ recovered. My sleep has never quite been the same since, and I had no sleep problems ever before this happened (except, perhaps interestingly, when I had an infection). Findings included unusual immune-complexes and that sort of thing. So perhaps an autoimmune aspect as well.

    Anyway, while benzos did help with sleep on occasion, if today's FM patients are anything like what I experienced, drugs like Lyrica will only add to the spaceyness and probably delay addressing what might help.

  9. Here's a story for you. It appears that the researcher who originally postulated a link between the MMR vaccine and autism may have fudged his numbers a bit. It goes to show you that there are influences on researchers from all directions - not just the ones we tend to think about on this site.

    Here's a quote:
    LONDON, Feb. 11 -- The British researcher who first linked childhood vaccines to autism has been accused of falsifying data in a 1998 study published in The Lancet.

    The Times of London reported Sunday that Andrew Wakefield, M.D., apparently altered clinical findings on eight of 12 children whose cases were the basis for the study.

    The allegations follow disclosures in 2004 that Dr. Wakefield's research was partially, and secretly, funded by plaintiffs' lawyers in suits against vaccine makers, and that he had cut procedural corners in the research.

  10. Please don't think that I meant to discount or belittle the people who suffer from fibromyalgia - whatever it may turn out to be. My take, as is obvious from the headline, is that the pharma concern is less for the person suffering than for the acquisition of a new "market." I am no scientist, but I have to wonder if the myriad varities of pollution and poisons that permeate our environment haven't started to affect us in subtle ways that are currently beyond our technology. I have a friend who thought her chronic fatigue stemmed from being close to Mt. Redoubt the last time it blew and being caught in the subsequent ash storm. That was a natural poisoning - how much more potent is the man-made kind?

    No, my post was more about how desperately pharma tries to garner indications or, failing that, propogate off-label rumors of efficacy with little regard for the person taking the pill. There is still a part of me that really wants to believe some in pharma have our best interest at heart, but it's hard to do. Especailly when one sees the seamy side of corporate attitudes exemplified in, oh say, the Peanut King. and to those who may say it has no connection - really? and what was Kindler's last job? Or any head of pharma? I think that medicine ranks a little lower on my list of importance than food, and if that's their attitude to food...well, draw your own conclusions.

  11. Hi Harpy,

    I certainly didn't think you were discounting folks who suffer from FM, CFS, or whatever we call it. I understood your point, and my own comments intended to reinforce it.

    Of course, I have no ultimate idea how much the "fibro market" will help some folks and how much it will exploit them. But the big question of motive and the "big picture" is a challenging one.

    As you may know, there was a suvey that PriceWaterhouse did a couple of years ago which was intended to show how different are the perceptions of pharma execs and the general public on the industry. Yet, even in this survey, 20% of senior execs agreed that risk data is deliberately suppressed or fudged routinely in the interest of sales. (As compared with 60% or so of the general public believing that.)

    Is that a large number or not? If I leared that one in five physicians routinely and _knowingly_ misdiagnosed patients, I'd be pretty worried.

    This could be a good general thread. We have some "big news" cookin', but it will get there.

  12. Harpy writes: "My take, as is obvious from the headline, is that the pharma’s concern is less for the person suffering than for the acquisition of a new market."

    That's a little like saying (as a parent) that "I'm more concerned about my source of income than I am about the welfare of my child." It's impossible to disconnect the two: Of course as parents we are more concerned about the welfare of our child than about our jobs. But the reality is that without the steady job, the welfare of our child WILL suffer! Therefore, we care DEEPLY about our source of income.

    The same goes for pharma. We are, of course, concerned about the patient. But without the revenue stream to support new product development, the patient will also suffer. You can't disconnect the forces of the free market from the desire to help patients – they are interdependent.

    This is true throughout the healthcare industry - not just pharma. Look at how many hospitals in the US are closing and consolidating due to lack of revenue. They just happen to be in a poor area of town and serve patients who don't have health insurance. They can't make money, and they close down. Where's your outcry over that? What about the hospitals now advertising for elective surgeries such as gastric bypass and Lasic? Are they just looking out for patients? Of course not - they are trying to stay in business so that they can keep serving the patients they already have. The alternative (completely socialized medicine) seems equally unappetizing to me.

  13. I hear what you're saying, Nathan. But we also have instances where the direct quote from inside pharma is that the revelation of known dangers will "kill the drug"--while not revealing those dangers might well be killing patients.

    I believe that was the case during the Vioxx saga and absolutely the case during Baycol and fen-phen.

    So, yes, there is no _inherent_ conflict between wanting to do well financially and wanting to do well for patients. The goals can, indeed, reinforce each other. But there are also certainly instances when they conflict.

    How often? And how responded to? I think those are far more difficult questions to answer, as I suggested up thread.

  14. I agree, Nathan. We are not volunteers, but I think there is a difference between profiting and being able to reinvest in business and raking in money hand over fist on the backs of people who have little or no choice in the matter. I haven't been in this industry long, and really paid no attention before, but it seems to me that things changed after Lipitor became a "blockbuster" and suddenly pharma had a new business model. Kind of like the difference between investing in a treasury bond and winning the lottery. Once pharma won the lottery, treasury bonds weren't good enough. Can anyone tell me if that's true? Has the model for pharma changed?

    On the heels of what Justice says above (and typical of what I like to call the "daddy-state") is this little tidbit from Tampa about AZ:

    Seroquel maker wants to seal info from you, "for" you

  15. In the hopes that you're still checking the suggestion box, I want to know what you think of this:

    Millions of middle-aged American men who get tested regularly for prostate cancer but show no signs of the illness might benefit from taking a drug that substantially lowers their risk of getting the disease, according to new guidelines issued by two leading medical groups that treat prostate cancer.

    The article goes on to say, "Each year, about 200,000 Americans are diagnosed with the disease, and about 29,000 die." And that the drug "...can reduce the risk of developing prostate cancer by as much as 25 percent."

    And can someone tell me if this is really considered a benefit? About 71 men would have to take finasteride for seven years to prevent one case of prostate cancer. Kramer said a quick call to his Bethesda pharmacy showed that generic finasteride costs about $3 a day or around $1,080 a year, meaning that it could cost about half a million dollars to head off each case of prostate cancer -- while exposing dozens of men to unnecessary treatment and potential side effects, including incontinence and impotence. A small number of men taking finasteride also experience sexual side effects, such as a decrease in libido.


  16. Harpy, here is another article on finasteride:,2933,499884,00.html

    As you point out, harpy, deciding whether or not to use finasteride involves weighing the risks and benefits. A health care provider can help an individual decide which cancer prevention methods would be likely to help the individual.

  17. Andrew von Eschenbach joins regulatory consulting firm...

  18. My, my, my...tonight is FDA news night! Good timing...President Obama plans to submit his budget to Congress tomorrow.

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