Sunday, October 18, 2009


It's Not Good-bye. It's Onward!

Friends--Now that our beloved Ed Silverman and Pharmalot have returned, Pharmalittle will refine its focus.

Of course, we never imagined we could be more than a small stop-over for a few people. We are glad that we have been that and had some fun along the way. That will continue. But, beginning today, we will devote the lion's share of our reporting and commentary to the issues of accountability in the medical device and drug industries--both nationally and, for drugs, especially in Michigan. That means the issues of FDA preemption and civil liability, of course. But it also includes FDA regulation, Department of Justice actions, incentives for integrity, and examples of self-regulation that we view as terrific.

We expect to discuss these issues in detail--not only the law, but the politics, the spin, the tactics, the money, and more. We will connect the dots. And we will do so as advocates. No surprise there.

We are also what we have always been--a group of people representing both major political parties, healthcare professionals, academics, folks from industry (yes, that's true), patient advocates, and--above all--concerned citizens.

Our discussions will be linked directly to the combined organizations, Americans for Drug and Device Accountability / Justice in Michigan.

Whatever our own positions, we fervently hope that this space will serve as a forum for discussion and debate. In our view, the greatest travesty of all is that most people know nothing about these issues, or what they think they know is simply false.

For those who represent perspectives we oppose: If we think you knowingly lied, we will call you a liar, and we will say why. If we think you are arguing sincerely, you will maintain our respect, and we will tell you so. Count on both.

Let's hash it out. Let's tell the truth. Let's see what just and rational policy dictates.



  1. Well, maybe it _is_ good-bye. Pharmalot is too much fun....

  2. The attached link to an article on cancer research funding may be of general interest and fit within the parameters set out by JiM.

  3. Contrary to sooth sayer, I do not think it is good bye - just stayed tuned... SOme important stuff is about to appear....

  4. Anon--Do tell!.....

    James--Thanks for the interesting link. My impression is that doc's offices are being more aggressive in promoting clinical trial participation. In my experience, it's often what you hear about on the line while waiting to reach the appointments person. I have been approached several times in the context of being a pt. at an academic medical center.

    To me, it comes down to how clearly risks and benefits are relayed to the average person. As we know, the likelihood is most instances is that there are no benefits to the trial participant. There might be to others in the future. Or it may be about phase IV marketing of whatever drug.

    In any event, the average pt., I think, believes they are getting the "latest, greatest" and is inclined to participate. Pleasing their doctor can also be a motive. Almost no pts. are aware of the financial benefit to docs in recruiting them.

    In one recent instance, I agreed to be part of a study. It was financed entirely by public funds, and, indeed, had the potential to provide information of real and immediate use to me. There was full disclosure about the purpose, risks, benefits. It turned out I did, indeed, get useful, tx-related information.

    But I agree that this is a significant amount of corrupt practice in this area.

  5. A related issue is how many of these trials are being done in developing countries which have little or no regulatory requirements, including informed consent. While a variety of other codes are supposed to guide practice, that is not always reality.

  6. It would be interesting to know if human trials carried out in developing countries are more dangerous than some conducted at prestigious hospitals in the U.S..

    Columbia University Medical Center (now New York-Presbyterian Hospital) conducted a study from 1999-2001 involving 215 heart patients, some of whom were “Spanish-speaking patients who lived in low-income neighborhoods near the hospital and were admitted through the emergency room…”

    The study involved four FDA approved blood expanders, two of which contained hetastarch. Although studies as far back as 1981 had shown that high doses of hetastarch could prevent blood from clotting, “…the Columbia trial was to test whether a new formulation of hetastarch, manufactured by Abbott Laboratories, was less likely to trigger serious bleeding at high doses than the other fluids.”

    The study was “largely funded from a $150,000 unrestricted grant given by the drug company to the hospital and lead researcher.”

    “In the consent form used in the study, patients were told that they would receive one of four fluids approved by the FDA and routinely ‘used to replace blood and fluid lost during surgery.’" Patients were not advised that one of the fluids (hetastarch) might cause severe bleeding.

    Approximately half of the patients were given hetastarch. Some received up to three times the recommended amount.

    Two patients died soon after being given the fluid and more than two dozen others required transfusions.

    Over the past decade, Columbia has conducted several internal reviews regarding this study. Although reviewers posed serious questions, they always concluded that there was no evidence of wrong-doing. Federal regulators did not agree, however, and in 2003 insisted that Columbia contact trial patients (or their survivors) to inform them that patients had not been advised of the “‘true nature’ of the drug study, the risks they faced or the consequences of their participation.”

    That hasn’t happened yet. However, in a March 2009 letter to regulators, Columbia conceded some fault, but still concluded that, “…the conditions necessary for a finding of patient harm had not been met."

    Once again, federal regulators have asked the hospital to contact former patients, or their survivors. They also want a full accounting of what happened to the heart patients. If Columbia fails to comply, they could lose federal funding for research.

    If they wait a little longer there won’t be anyone to contact.


  7. Thanks for the interesting and important post, Dianne.

    In one of the recent cases in which court documents were released--perhaps just as well that I don't recall which one--there was a memo which specifically noted that Hispanic patients were easy to "manipulate."

    Ugly, to say the obvious.

  8. Yes Justice. This story is important, and sad, and heartbreaking. I’m sure the trial patients had a lot of hope for good outcomes and never guessed they were being lied to and mistreated.

    After Tuskegee, this type of thing was not supposed to happen again.


Note - Due to a time out issue with Blogger, you may receive a message that requires you to resend your comment. This will not affect its contents.