Bioethics: March 2008 Archives

Conflicts 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

Alaska 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 

In 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.

The 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

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

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   

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.

The Seattle Biomedical Research Institute wants to infect healthy human subjects with malaria to test a new vaccine. The Center will be offering $2000 to the human guinea pigs willing to rent their bodies for the greater good. Is it ethical? Depends who you ask. Here is a study with all risk and no benefit to the healthy subjects, other than the two grand, and money is not supposed to count as a benefit. The money is the problem, of course, as it always is. The money is used to induce the needy to be subjects, not for altruism, but for the basic necessities of life or maybe just some spending money. If you doubt that, see if there are any rich folks you know who want to volunteer.

        The researchers seem certain that they can quickly cure anyone infected and that the worst the subjects will experience are some flu like symptoms. Where have we heard that before?

     Stay tuned.

Alan Milstein

The New Jersey Legislature unanimously released an important bill out of committee today. The bill requires physicians to obtain informed consent from the parent of a child before prescribing a psychotropic drug containing a Black Box warning issued by the FDA. Testifying before the committee were firm clients Lisa Van Syckel and Laurie Yorke. The bill now goes before the full Senate.