This is the third posting in a series in which I present evidence about the ill effects of some drugs and medical devices, the ways these Sickening Meds are pushed by those who profit from them, and the reasons the FDA is neglecting its regulatory duties. (Check back next Monday for the next installment. See previous postings here: Part I: Zyprexa, Part II: Baycol.) If you agree that this is an issue that deserves attention in short order—please consider passing the word on to others. Maybe together we can put it on the national agenda. In the process we are sure to discover who keeps the politicians mum and how the drug companies are able to continue in this nefarious business.
At first glance it is hard to imagine an issue that politicians would seem more likely to raise than the scandalous marketing of Sickening Meds—medications that cause numerous casualties. One would surely expect elected officials and those who seek to be elected or reelected to raise Cain every time a drug company violates the law by failing to report to the FDA adverse findings about the meds they peddle, and continues to sell these meds to millions of ill people after they prove to be harmful-or even fatal. The issues raised by these Meds scandals seem, on the face of it, God’s gift to an aspiring politician. Yet, not one of the presidential candidates has raised this issue; it was not featured in the last Congressional elections; and neither party is addressing this outrage.
Case III: Guidant failing defibrillators
In June of 2005 Guidant announced the recall of three models of its heart devices. The Ventak Prizm DR 2, Contak Renewal 1, and Contak Renewal 2 models of defibrillators and pacemakers did not deliver needed shocks to the patients’ hearts due to short circuiting. The short circuiting of these devices can lead to death or serious injury depending on the medical condition of the patient. (1) At least seven deaths have been confirmed. (The number is likely to be significantly higher; heart devices are not routinely checked when those who use them die). (2) An FDA memo reports, "[the death rate associated with the flaw] is probably greater than reported, and may be much greater than reported." Guidant should have taken steps to deal with the problem on the Prizm model at least three years earlier, and ten months earlier for the two Renewal models, because it was aware of the short circuiting dangers.
In 2002, Guidant fixed the Prizm model’s susceptibility to short circuiting. However, it continued to sell its remaining inventory of 4,000 of the old defective devices. Similarly, in 2004, Guidant stopped shipping the Renewal models susceptible to short circuiting from its factories but continued to sell the inventory of 400 devices susceptible to the problem.(3)
In both instances, in 2002 and 2004, Guidant did not disclose to doctors the susceptibility of its models to short circuiting. In the winter of 2004, Guidant drafted letters to sales representatives and doctors informing them that a problem existed and that the inventory was being recalled; but these letters were not sent and inventories were not recalled. (4) Instead, in early 2005 Guidant included in a generic product update covering all their defibrillators advice that doctors be alert for signs of electrical problems; Guidant did not point out the short circuiting issue, though the company was aware which specific models had this flaw and that it could lead to fatalities.
At several points, Guidant executives and consultants argued for disclosing their knowledge of the short circuiting issue to doctors. Additionally, as internal Guidant records show, some of these Guidant staff wanted the inventories of the flawed devices withdrawn. Unfortunately, these executives and consultants were ignored by Guidant’s top management. It decided in February of 2005 not to reopen its investigation of the issue until the failure rate reached to 15 devices per year.
Only in May 2005 did Guidant take steps to inform doctors of its devices’ problems. This disclosure occurred when the information was about to be made public. The New York Times was set to reveal information about Guidant’s continuing to sell flawed devices and failing to disclose its knowledge about the short circuiting problem. (5) The Times reported on the March 2005 death of Joshua Oukrop, a patient using the Prizm model. As of Oukrop’s death, Guidant was aware of 25 cases where the defibrillator failed due to short circuiting. But even after Oukrop’s death, the company did not inform the public of their device’s flaw. It was Oukrop’s doctors who went to the New York Times with the information.(6)
Guidant’s defense has been to say that the risk posed by replacing potentially flawed devices outweighs the risk of the device short circuiting. Even if this argument is correct, doctors and patients are charged with determining the proper healthcare choice given the best information available. Guidant is not responsible for preemptively determining what best therapy to prescribe. As a consultant for Guidant wrote in an internal memo,
"Neither the doctor nor the patient consider themselves to have signed up to have Guidant dictate any treatment plans." (7)
Additionally, this memo challenges the risks argument. The memo highlights the conflict of interest involved in Guidant determining what flaw to inform doctors about, advising that the statistical, risks arguments will encounter "bitter derision towards our protests that we were only acting with the patients’ best interests at heart." (8) In mid-2005 when reviewing Guidant’s behavior, the FDA remarked in an internal memo that Guidant’s risks analysis "minimizes the problem [of risk to health] and is incorrect."(9)
(1) Barry Meier "Maker of Heart Devices Kept Flaw From Doctors" New York Times, May 24, 2005; Barry Meier "Citing Flaws, Maker Recalls Heart Devices" New York Times, June 18, 2005
(2) Barry Meier "Papers Show Guidant Considered Warning Doctors of Hazards" New York Times, June 7, 2006
(3) Ibid.
(4) Ibid.
(5) Barry Meier "Maker of Heart Device Kept Flaw From Doctors" New York Times, May 24, 2005
(6) Barry Meier "Citing Flaws, Maker Recalls Heart Devices" New York Times, June 18, 2005
(7) Barry Meier "Guidant Consultant Advised Company to Release Data on Defects" New York Times, March 9, 2006
(8) Ibid.
(9) Ibid.
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Amitai Etzioni is University Professor at The George Washington University and, most recently, the author of Security First: For A Muscular, Moral Foreign Policy (Yale, 2007).
(www.securityfirstbook.com)