When does Yes mean No

May, 28, 2013 | 3 Comments

Comments

  1. “Just imagine how things are going in the private for-profit centers where the blockbuster drugs of tomorrow are tested…”

    About a month ago, the FBI raided a small, for-profit hospital on Chicago’s impoverished West Side called “Sacred Heart.” The owners and several staff physicians were charged, among other things, with defrauding Medicare by “seeking payment for the sedation, intubation and subsequent performance of tracheotomy procedures on patients absent the medical necessity to perform these procedures.” That is, forcing vent tubes down the throats of elderly patients who did not need them, then sedating them until their breathing started to fail and they could be trached and put on ventilators. All this so that Medicare could be billed for an expensive 28-day hospital stay. Sacred Heart was also paying multiple kickbacks to nursing homes, ambulance services and community doctors to steer their patients to Sacred Heart, often bypassing a half-dozen closer (and safer) hospitals on the way in. Essentially, patients were being bought and sold like livestock.

    What hasn’t been reported yet is that at least one of Sacred Heart’s indicted physicians, Dr. Percy Conrad May, runs a ContractResearch Organization called Suburban Clinical Research.

    http://suburbanclinicalresearch.com/about_us

    They boast of doing work for NovoNordisk, Cephalon, Takeda and Forest Pharmaceuticals, as well as several larger CRO’s like Quintiles. ProPublica’s “Dollars for Docs” app confirms that Pfizer, at least, paid about $25,000 to Suburban Clinical Research in 2012. And what do they offer their customers? Their medical staff are all in private practice and can access a pool of over 10,000 subjects who “have long-standing, patient-physician relationships … The physicians know their patients well, are able to readily identify subjects and have the comfort level of conducting one-on-one discussions when presenting trials and managing retention.”

    If Dr. May’s “retention management” skills are the ones he learned at Sacred Heart, watch out.

  2. Oxygen is a drug requiring prescription. Therefore, informed consent is mandatory although more often observed in the breach than the observance. How many parents would know this? It also seems as though the “bioethics” committees ignored this awkward fact as well.
    The Canadian Medical Protection Association Handbook for Physicians states
    For consent to treatment to be considered valid, it must be an “informed” consent. The patient must have been given an adequate explanation about the nature of the proposed investigation or treatment and its anticipated outcome as well as the significant risks involved and alternatives available. …..The obligation to obtain informed consent must always rest with the physician who is to carry out the treatment or investigative procedure.
    We know that excess oxygenation in persons with severe pulmonary disease can be lethal or at least exacerbate the underlying condition. Parents might well have been led likely to agree had they been told that their infant was going to be exposed to a drug with potentially lethal consequences.

  3. Just a quick clarification about that study in premature infants:

    The Univ of Alabama study wasn’t trying to use oxygen to prevent blindness – O2 is used to keep preemies alive, but too much O2 can damage their eyes it seems. The hope would be to discover an optimal level, just right as Goldilocks would say.

    So, in the study, a baby in the low O2 group faced a potential risk of death, and a baby in the high O2 group faced a potential risk of blindness. But the parents weren’t made aware of either possibility.

Leave a Reply