Dance to the Music of Time: How clinical trials help pharma invent data

September, 24, 2012 | 6 Comments


  1. The use of “mark up” obscures far too much of the economics of the research and development of drugs. Big Pharma may get up to some nasty stunts, but the idea that it is an economically thriving industry is wide of the mark.

  2. The health and growth of the *industry* is a rather mundane topic when one considers the clear and present danger of the *indiustry’s* unchecked influence!
    {insert bells and whistles}

    Maybe WORDS are just too distracting for the mind whose focus is everywhere but on the salvation of humanity as we —once knew it?

    What other venues might we explore to impart Dr. Healy’s message? Here he has employed a writing style that demands little from the reader, but his attention. IF that misses the mark… what next?

    I’m thinking…. interpretive dance, mime, puppetry and a video game or two???

  3. The following is from Pfizer’s 2011 financial statement:
    “As is inherent in the biopharmaceutical industry, the loss or expiration of intellectual property rights can have a significant adverse effect on our revenues. Many of our products have multiple patents that expire at varying dates, thereby strengthening our overall patent protection. However, once patent protection has expired or has been lost prior to the expiration date as a result of a legal challenge, we lose exclusivity on these products, and generic pharmaceutical manufacturers generally produce similar products and sell them for a lower price. This price competition can substantially decrease our revenues for products that lose exclusivity, often in a very short period of time.
    Lipitor overview—In 2011, worldwide revenues from Lipitor were approximately $9.6 billion, or approximately 14% of total Pfizer revenues. Of this amount, approximately $5.0 billion was generated in the U.S. and approximately $4.6 billion was generated in international markets, including approximately $859 million in emerging markets. We expect that the losses of exclusivity for Lipitor in the U.S. and various international markets discussed below will have a significant adverse impact on our revenues in 2012 and subsequent years. • Lipitor in the U.S.—In November 2011, we lost exclusivity in the U.S. for Lipitor. Pfizer announced in June 2008 that we entered into an agreement providing a license to Ranbaxy to sell generic versions of Lipitor and Caduet in the U.S effective November 30, 2011. In addition, the agreement provides a license for Ranbaxy to sell a generic version of Lipitor beginning on varying dates in several additional countries. (See Notes to Consolidated Financial Statements—Note 17. Commitments and Contingencies for a discussion of certain litigation relating to this agreement.) We also
    granted Watson Pharmaceuticals, Inc. (Watson) the exclusive right to sell the authorized generic version of Lipitor in the U.S. for a period of five years, which commenced on November 30, 2011. As Watson’s exclusive supplier, we manufacture and sell generic atorvastatin tablets to Watson. We expect the entry of multi-source generic competition in the U.S., with attendant increased competitive pressures, following the end of Ranbaxy’s 180-day generic exclusivity period in late May 2012.”
    Now, perhaps I’m misreading this, but who is actually losing what? And $9.6 billion for ONE product in ONE year seems to me to be represent a financially healthy business.

  4. I don’t know how much difference it makes to the ultimate results of trials. But from what I can see, research volunteers are almost never motivated by civic duty anymore. Phase I “healthy” volunteers do it because they need the money. Phase II and III volunteers do it because they need the medical care, or because they need the money.

    Scientific American Mind recently ran an article about the warping effect of this system on clinical trials, where either the volunteers falsify their backgrounds to get into the study, or financially motivated investigators do it for them. I don’t quite trust the article; it repeats the most inflated official Pharma figures for the cost of clinical trials, and repeatedly suggests that some really awesome new drugs have been made to look ineffective just because of these bad actors at the bottom of the system. Still, it’s worth a look:

    This is not to knock the volunteers themselves. I did it once, and I definitely did it for the medical care. I was insured at the time, but my company’s HMO hired a subcontractor to slash “behavioral health” spending, so I lost two providers in a row when their contracts were terminated. Then I heard that “High-Class Medical Center” (HCMC) was running a study. I’d get free meds and regular monitoring from reputable people at HCMC, a hospital my HMO didn’t allow me to enter. What’s not to like? I thought. Plenty, as it turned out – but that’s another story. As more people lose their insurance benefits, I see more of these clinical-trial recruiting ads pop up in newspapers and on the El trains in Chicago. It’s kind of strange to look up in mid-commute and see “Are Symptoms of Schizophrenia Interfering With Your Life? Participate in a study …”

  5. From BBC News 31 August 2012
    German thalidomide maker Gruenenthal issues apology

    The manufacturer of thalidomide has apologised to the thousands of people born with disabilities as a result of their mothers taking the drug.

    Harald Stock, chief executive of German pharmaceutical company Gruenenthal, said it was “very sorry” it had remained silent on the issue.

    The drug was sold as a cure for morning sickness in the 1950s and 1960s.

    Mr Stock spoke as he unveiled a bronze statue symbolising a child born without limbs because of thalidomide….

    More at

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