Recently in Bioethics Category

Grimes v. Kennedy Kreiger Redux

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The same folks who brought you Grimes v. Kennedy Kreiger bring you another ethically challenged study on poor black Baltimore families. Using federal grant money, scientists affiliated with Johns Hopkins University School of Public Health spread human and industrial wastes on the yards of poor African American families to test whether it might protect children from lead poisoning in the soil. According to the AP, the families were given food coupons to induce their participation and were told the sludge was safe commercial grade fertilizer; the researchers never informed them about any harmful ingredients.

One soil scientist, Murray McBride, who reviewed the study, commented: "It's not at all clear that the sludge binding the lead will be preserved in the acidity of the stomach. Actually thinking about a child ingesting this, there's a very good chance that it's not safe . . .If you're not telling them what kinds of chemicals could be in there, how could they even make an informed decision. If you're telling them it's absolutely safe, then it's not ethical. In many relatively wealthy people's neighborhoods, I would think that people would research this a little and see a problem and raise a red flag."

The study’s lead author, Mark Farfel, formerly was associated with Baltimore’s Kennedy Krieger Institute, where he was a project manager. In 2001, Maryland's highest court, in reviewing another Farfel/Kennedy Kreiger study concerned with lead abatement in poor black neighborhoods, compared it to the infamous Tuskegee syphilis study on poor black sharecroppers. The Court concluded: “These programs were somewhat alike in the vulnerability of the subjects: uneducated African-American men, debilitated patients in a charity hospital, prisoners of war, inmates of concentration camps and others falling within the custody and control of the agencies conducting or approving the experiments."

Alan Milstein 

Senate Passes GINA

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   In a rare act of nonpartisanship, the Senate passed the Genetic Information Nondiscrimination Act 95 to 0. The Bill, which is expected to shortly sail through the House and then be signed by the President, aims at the two areas of concern over the abuse of DNA testing: it will make it illegal for insurers to deny health coverage to someone on the basis of genetic information and will bar employers from hiring or firing anyone on the basis of such information.

              You might recall this office raised precisely these concerns when arguing that NBA center Eddie Curry could not be compelled by his then employer, the Chicago Bulls, to undergo genetic testing for hypercadiomyopathy. The Bulls ultimately backed down from the demand and traded Curry to the New York Knicks.

              The Senate Bill will be welcome protection to citizens in this brave new world where DNA testing may reveal our propensities, but not our certainties, to contract certain diseases, become addicted to certain behaviors, or engage in certain socially undesirable activities.

 

Alan Milstein

Here is an article about a lecture I gave recently at the University of Virginia.

 

Alan Milstein

            

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Here is an excellent essay by Paul Gelsinger and Adil Shamoo about whether any real change has occurred since Jesse Gelsinger’s death eight years ago.

         

stock_smoking-tax.jpgConflicts of Interest have risen their ugly head again in human subject research. This time hidden tobacco money appears to have funded a study suggesting that lung scans might help save smokers from cancer and thereby lessen the risks of smoking.

Both the New England Journal of Medicine and JAMA published studies by Weill Cornell Medical College researchers in 2006 without understanding or disclosing that the Liggett Group had provided funding for the study.

The issue of whether such routine scans are worthwhile is a hot topic and a critical public health issue. In fact, the American Cancer Society and numerous other groups have provided funding to the Cornell team to see if routinely screening smokers with CT scans can reveal early signs of lung cancer and prevent deaths.

John Niederhuber, director of the National Cancer Institute issued a statement that scientists must maintain the trust of patients in research studies and "any breach of that trust is not simply disappointing but, I believe, unacceptable."

JAMA’s editor in chief Dr. Catherine DeAngelis  said she contacted Cornell’s lead researcher Dr. Claudia Henschke months ago after learning that the Cornell group held patents related to CT scanning technology which also were not disclosed.  Said Dr. DeAngelis,  "We'd been working with Dr. Henschke trying to get her to write a letter of apology — which is our policy — and to take responsibility. It was not easy to get her to do anything." DeAngelis further said that, had she known big tobacco had funded the research, “ I would have turned down the paper."

Alan Milstein

Lilly Settles With Alaska for $15 Million

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zyprexa.jpgAlaska has settled its lawsuit with Eli Lilly for $15 million. The settlement occurs after two in a series of three closely watched Supreme Court opinions dealing with whether the FDA is the only watchdog the public needs over the drug and device manufacturers. Alaska filed the lawsuit in March 2006 lawsuit alleging the state and healthcare providers were insufficiently warned about possible side effects of Zyprexa, Lilly’s $5 billion bestseller, relating to weight gain, high blood sugar and diabetes, causing harm to the state's Medicaid recipients and increased costs.

          Alaska filed its claim under the state’s  Unfair Trade Practices and Consumer Protection Act. The trial began on March 6th before a jury and Anchorage Superior Court Judge Mark Rindner. With the jury out of the courtroom, the judge announced that without lawsuits like this one, claims that drugs cause health problems "might well go unaddressed" and that the evidence presented by the state had established that the FDA "isn't capable of policing this matter."

Alan Milstein 

three.jpgIn Glendale, California, the jury rendered a defense verdict in the malpractice trial over alleged negligence and liability in John Ritter's death. Jurors, who voted 9 to 3 against liability, said they were torn “between sympathy for Ritter's wife and children and their conviction that the doctors were blameless."

The family of John Ritter has sued Burbank's Providence St. Joseph Medical Center and the emergency room physicians charging failure to diagnose and treat the late actor’s rare aortic dissection in timely fashion. Ritter’s family had already received $14 million in settlements and was seeking another $67 million from the emergency room physicians who did not participate in the settlement. This in a state with a $250,000 cap on damages for pain and suffering. That 67 mil is the amount the experts projected Ritter would earn over the remaining course of his career.

Mis-Taken Identity?

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mist.jpgThe more things change and the more advanced we are with our technology, the more they remain the same. As long as there is any human component whatsoever to a process, there will always be a margin of error. The Washington Post reports today that a government laptop computer containing sensitive medical information on 2,500 patients enrolled in a
National Institutes of Health study was stolen in February. Yes, February.  

Included in the stolen data was seven years' worth of clinical trial data, including names, medical diagnoses and details of the patients' heart scans. The information was not encrypted, in violation of the government's data-security policy.

NIH officials did not publicly disclose the theft and did not formally, in writing, notify the affected patients of the breach in security until last Thursday -- almost a month later.  NIH officialts said they delayed because of concerns that they would provoke undue alarm. Yeah, ya think?

The Washington Post further reported that this month, the Government Accountability Office found that at least 19 of 24 agencies reviewed had experienced at least one breach that could expose people's personal information to identity theft.

 

John M. Hanamirian

 

      

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Representative Barney Frank announced he intends to introduce a bill decriminalizing possession of small amounts of marijuana. Whether it has much chance of success is another story, but hopefully the proposal will begin the much needed debate. Frank says his principal motivation is the absurd actions of federal law enforcement in prosecuting those using marijuana for medicinal purposes. Currently thirteen states allow those with cancer or aids or other debilitating illnesses to use marijuana to relieve their pain or nausea or to improve their appetite. The remaining states and the federal government would rather spend resources prosecuting the desperately ill who seek some measure of comfort from this ancient herbal remedy.  

Alan Milstein   

Art Caplan On the Ethics of Steroid Use

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Here is an excellent piece by Arthur Caplan writing in Science Progress about the ethics of steroid use. Art writes:

The battle over performance enhancement is often fought out as if one size fits all—what makes performance enhancement acceptable in one domain, sports, will make it acceptable in all aspects of life. What the fight between Harris and Sandel reveals is that this is not so. There are reasons to believe that steroids don’t belong in sports, even putting safety concerns aside. But this does not mean that performance-enhancing drugs have no appropriate role in any areas of life and achievement. The decision about what role pharmacology and genetics ought to play depends on whether you are trying to travel to another planet, solve a difficult math problem, learn a new language, or hit a home run.

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