HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Thursday, January 17, 2008

Drug Studies Suppressed - but only the negative ones

The New England Journal of Medicine reports this week on a report showing that a majority of studies that get published about antidepressants are positive, while negative studies remain unpublished.  The article is entitled: "Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy." Here is the abstract: 

Background Evidence-based medicine is valuable to the extent that the evidence base is complete and unbiased. Selective publication of clinical trials — and the outcomes within those trials — can lead to unrealistic estimates of drug effectiveness and alter the apparent risk–benefit ratio. 

Methods We obtained reviews from the Food and Drug Administration (FDA) for studies of 12 antidepressant agents involving 12,564 patients. We conducted a systematic literature search to identify matching publications. For trials that were reported in the literature, we compared the published outcomes with the FDA outcomes. We also compared the effect size derived from the published reports with the effect size derived from the entire FDA data set. 

Results Among 74 FDA-registered studies, 31%, accounting for 3449 study participants, were not published. Whether and how the studies were published were associated with the study outcome. A total of 37 studies viewed by the FDA as having positive results were published; 1 study viewed as positive was not published. Studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published (22 studies) or published in a way that, in our opinion, conveyed a positive outcome (11 studies). According to the published literature, it appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis showed that 51% were positive. Separate meta-analyses of the FDA and journal data sets showed that the increase in effect size ranged from 11 to 69% for individual drugs and was 32% overall. 

Conclusions We cannot determine whether the bias observed resulted from a failure to submit manuscripts on the part of authors and sponsors, from decisions by journal editors and reviewers not to publish, or both. Selective reporting of clinical trial results may have adverse consequences for researchers, study participants, health care professionals, and patients. 

In response to this article and its findings, Dr. Steven Nissen recommends legislation that would require all drug studies to be placed in a public registry. To hear more about his proposal, listen here.

January 17, 2008 | Permalink | Comments (0) | TrackBack (0)

Childhood Cold Medicines and Cloned Food: Your FDA at Work

The FDA announed today that cold medicines are too risky for very young children age 2 and under.  They will decide later about the safety of such cold medicines for slightly older children.  From the Associated Press,

Parents may be left with only love and lots of liquid to give their sniffling babies and toddlers now that the government is declaring over-the-counter cough and cold medicines too risky for tots.  The Food and Drug Administration was issuing that warning Thursday to parents of children under 2.

It's a move expected for months: Drug companies last October quit selling dozens of versions of nonprescription cold remedies targeted specifically to babies and toddlers. That month, the FDA's scientific advisers also voted that the drugs don't work in small children and shouldn't be used in preschoolers, either — anyone under age 6.

The FDA still hasn't decided if OTC decongestants, antihistamines and cough suppressants are appropriate for older children, officials told The Associated Press. Expect a decision on that by spring, the deadline necessary to notify manufacturers before they begin production for next fall's cold season.

For now, FDA's first official ruling focuses on youngsters under 2, warning that "serious and potentially life-threatening side effects can occur."

The good news - well that "lots of liquids" can now included milk from cloned animals!! Woo!!  In a brief article yesterday, the New York Times noted that the FDA had found that food and milk from cloned animals and their progeny is safe.  I know that I trust them completely.

Also, further good news as an earlier story by the New York Times indicates that parents will be saving lots of money by not purchasing these drugs:   "There are about 800 pediatric cold products sold in the United States that use one or more of 39 different drugs. Parents spend around $500 million every year buying nearly 95 million boxes containing 3.8 billion doses of medicine."

As I have mentioned before - drugs for parents of sick children (something non-drowsy that makes one feel happy about the fact that they will be up all night  - perhaps singing soft songs) might be a lucrative nitch market. (Plus, you maybe need report only the positive clinical trials for these drugs - oo - the New England Journal of Medicine may have just squashed that as well, see here for brief overview of story).

January 17, 2008 | Permalink | Comments (0) | TrackBack (0)

Wednesday, January 9, 2008

State of Health Care: We're Number 19!!

The Washington Monthly's Kevin Drum reports on the state of our health care system: 

A pair of researchers has just published an update that compares various countries on their rates of "amenable mortality," defined as deaths that are "potentially preventable with timely and effective health care." In 1997, the United States ranked 15th out of 19 industrialized countries. So how are we doing now?

Answer: we're now 19th out of 19. The rest of the countries have improved their performance by an average of 16%, while the U.S., that well-known engine of healthcare innovation, has improved by only 4%. So now we're in last place. . . . .

January 9, 2008 | Permalink | Comments (0) | TrackBack (0)

New Health Care Ad

ThinkProgress shows us the latest in health care advertising:  CheneyCare.  ThinkProgress reports,

Last month, the California Nurses Association and the National Nurses Organizing Committee ran ads in Iowa newspapers advocating for a single-payer health-care bill, highlighting the fact Vice President Dick Cheney has benefited from his government-provided coverage. “If he were anyone else, he’d probably be dead by now” due to his long history of health problems, claimed the ad. . . .

The ad “asks readers to go to CheneyCare.org and sign a petition in support of CheneyCare for all Americans”:

cheneycare.jpg

Cheney’s office “did not respond to a request for comment” by the Washington Examiner, but in December, when the original ads ran, Cheney spokesperson Megan Mitchell said that “something this outrageous does not warrant a response.”

As ThinkProgress noted at the time, what is actually outrageous is the fact that there are roughly 47 million people in America without health insurance, including 3.2 million children, but President Bush twice vetoed legislation that would have expanded coverage to 4 million more children.

January 9, 2008 | Permalink | Comments (0) | TrackBack (0)

Friday, January 4, 2008

Child Support from Sperm Donor

Interesting case from Pennsylvania concerning the right of a private sperm donor to contract away his right to make child support payments.   From the Associated Press,

The Pennsylvania Supreme Court ruled that a woman who promised a sperm donor he would not have to pay child support cannot renege on the deal. The 3-2 decision overturns lower court rulings under which Joel L. McKiernan had been paying up to $1,500 a month to support twin boys born in August 1994 to Ivonne V. Ferguson, his former girlfriend and co-worker.

“Where a would-be donor cannot trust that he is safe from a future support action, he will be considerably less likely to provide his sperm to a friend or acquaintance who asks, significantly limiting a would-be mother’s reproductive prerogatives,” Justice Max Baer wrote in the majority opinion issued last week.

Arthur Caplan, chairman of the Department of Medical Ethics at the University of Pennsylvania, said the decision runs counter to the pattern established by similar cases, where the interests of the progeny have generally been given great weight.  “It sounds like the Pennsylvania court is trying to push a little harder into the brave new world of sperm, egg and embryo donation as it’s evolving,” Caplan said.

McKiernan’s lawyer, John W. Purcell Jr., said Wednesday an adverse decision against his client would have jeopardized the entire system of sperm donation.  “That wouldn’t just include Pennsylvania, because we found out in the course of this trial that many doctors order their sperm for their artificial inseminations out of state,” he said. . . . .

Courts found that the two agreed McKiernan would not have to pay child support and would not have visitation rights, but Ferguson later changed her mind and sued.  A county judge said it was in the twins’ best interests that McKiernan be required to support them. In addition to monthly payments, McKiernan also was ordered to come up with $66,000 in back support. The appeal reverses that order. . .

Justice J. Michael Eakin, in a dissent, said a parent cannot bargain away a child’s right to support. “The children point and say, ’That is our father. He should support us,”’ Eakin wrote. “What are we to reply? ’No! He made a contract to conceive you through a clinic, so your father need not support you.’ I find this unreasonable at best.”

The case is: IVONNE  V. FERGUSON v.  JOEL L. MCKIERNAN, [J-60-2005], which is available on the Pennsylvania Supreme Court website.

January 4, 2008 | Permalink | Comments (0) | TrackBack (0)

Thursday, January 3, 2008

Intensive Care Revamped

Atul Gawande has a great article in the December 10th New Yorker (ok, yes, I am a little behind on my reading - something about grading . . . ) concerning the use of checklists in intensive care and the impact such helpful lists may have on improving the quality of health care in general.  He writes,

                                                    
                                                                                                                                                                                                               

The damage that the human body can survive these days is as awesome as it is horrible: crushing, burning, bombing, a burst blood vessel in the brain, a ruptured colon, a massive heart attack, rampaging infection. These conditions had once been uniformly fatal. Now survival is commonplace, and a large part of the credit goes to the irreplaceable component of medicine known as intensive care.

It’s an opaque term. Specialists in the field prefer to call what they do “critical care,” but that doesn’t exactly clarify matters. The non-medical term “life support” gets us closer. Intensive-care units take artificial control of failing bodies. Typically, this involves a panoply of technology—a mechanical ventilator and perhaps a tracheostomy tube if the lungs have failed, an aortic balloon pump if the heart has given out, a dialysis machine if the kidneys don’t work. When you are unconscious and can’t eat, silicone tubing can be surgically inserted into the stomach or intestines for formula feeding. If the intestines are too damaged, solutions of amino acids, fatty acids, and glucose can be infused directly into the bloodstream. . . .

On any given day in the United States, some ninety thousand people are in intensive care. Over a year, an estimated five million Americans will be, and over a normal lifetime nearly all of us will come to know the glassed bay of an I.C.U. from the inside. Wide swaths of medicine now depend on the lifesupport systems that I.C.U.s provide: care for premature infants; victims of trauma, strokes, and heart attacks; patients who have had surgery on their brain, heart, lungs, or major blood vessels. Critical care has become an increasingly large portion of what hospitals do. Fifty years ago, I.C.U.s barely existed. Today, in my hospital, a hundred and fifty-five of our almost seven hundred patients are, as I write this, in intensive care. The average stay of an I.C.U. patient is four days, and the survival rate is eighty-six per cent. Going into an I.C.U., being put on a mechanical ventilator, having tubes and wires run into and out of you, is not a sentence of death. But the days will be the most precarious of your life.

                                            
                   

A decade ago, Israeli scientists published a study in which engineers observed patient care in I.C.U.s for twenty-four-hour stretches. They found that the average patient required a hundred and seventy-eight individual actions per day, ranging from administering a drug to suctioning the lungs, and every one of them posed risks. Remarkably, the nurses and doctors were observed to make an error in just one per cent of these actions—but that still amounted to an average of two errors a day with every patient. Intensive care succeeds only when we hold the odds of doing harm low enough for the odds of doing good to prevail. This is hard. There are dangers simply in lying unconscious in bed for a few days. Muscles atrophy. Bones lose mass. Pressure ulcers form. Veins begin to clot off. You have to stretch and exercise patients’ flaccid limbs daily to avoid contractures, give subcutaneous injections of blood thinners at least twice a day, turn patients in bed every few hours, bathe them and change their sheets without knocking out a tube or a line, brush their teeth twice a day to avoid pneumonia from bacterial buildup in their mouths. Add a ventilator, dialysis, and open wounds to care for, and the difficulties only accumulate. . . .

Substantial parts of what hospitals do—most notably, intensive care—are now too complex for clinicians to carry them out reliably from memory alone. I.C.U. life support has become too much medicine for one person to fly. 

Yet it’s far from obvious that something as simple as a checklist could be of much help in medical care. Sick people are phenomenally more various than airplanes. A study of forty-one thousand trauma patients—just trauma patients—found that they had 1,224 different injury-related diagnoses in 32,261 unique combinations for teams to attend to. That’s like having 32,261 kinds of airplane to land. Mapping out the proper steps for each is not possible, and physicians have been skeptical that a piece of paper with a bunch of little boxes would improve matters much.

In 2001, though, a critical-care specialist at Johns Hopkins Hospital named Peter Pronovost decided to give it a try. He didn’t attempt to make the checklist cover everything; he designed it to tackle just one problem, the one that nearly killed Anthony DeFilippo: line infections. On a sheet of plain paper, he plotted out the steps to take in order to avoid infections when putting a line in. Doctors are supposed to (1) wash their hands with soap, (2) clean the patient’s skin with chlorhexidine antiseptic, (3) put sterile drapes over the entire patient, (4) wear a sterile mask, hat, gown, and gloves, and (5) put a sterile dressing over the catheter site once the line is in. Check, check, check, check, check. These steps are no-brainers; they have been known and taught for years. So it seemed silly to make a checklist just for them. Still, Pronovost asked the nurses in his I.C.U. to observe the doctors for a month as they put lines into patients, and record how often they completed each step. In more than a third of patients, they skipped at least one.

The next month, he and his team persuaded the hospital administration to authorize nurses to stop doctors if they saw them skipping a step on the checklist; nurses were also to ask them each day whether any lines ought to be removed, so as not to leave them in longer than necessary. This was revolutionary. Nurses have always had their ways of nudging a doctor into doing the right thing, ranging from the gentle reminder (“Um, did you forget to put on your mask, doctor?”) to more forceful methods (I’ve had a nurse bodycheck me when she thought I hadn’t put enough drapes on a patient). But many nurses aren’t sure whether this is their place, or whether a given step is worth a confrontation. (Does it really matter whether a patient’s legs are draped for a line going into the chest?) The new rule made it clear: if doctors didn’t follow every step on the checklist, the nurses would have backup from the administration to intervene.

Pronovost and his colleagues monitored what happened for a year afterward. The results were so dramatic that they weren’t sure whether to believe them: the ten-day line-infection rate went from eleven per cent to zero. So they followed patients for fifteen more months. Only two line infections occurred during the entire period. They calculated that, in this one hospital, the checklist had prevented forty-three infections and eight deaths, and saved two million dollars in costs. . . .

The checklists provided two main benefits, Pronovost observed. First, they helped with memory recall, especially with mundane matters that are easily overlooked in patients undergoing more drastic events. (When you’re worrying about what treatment to give a woman who won’t stop seizing, it’s hard to remember to make sure that the head of her bed is in the right position.) A second effect was to make explicit the minimum, expected steps in complex processes. Pronovost was surprised to discover how often even experienced personnel failed to grasp the importance of certain precautions. In a survey of I.C.U. staff taken before introducing the ventilator checklists, he found that half hadn’t realized that there was evidence strongly supporting giving ventilated patients antacid medication. Checklists established a higher standard of baseline performance. . . .

I called Pronovost recently at Johns Hopkins, where he was on duty in an I.C.U. I asked him how long it would be before the average doctor or nurse is as apt to have a checklist in hand as a stethoscope (which, unlike checklists, has never been proved to make a difference to patient care).

“At the current rate, it will never happen,” he said, as monitors beeped in the background. “The fundamental problem with the quality of American medicine is that we’ve failed to view delivery of health care as a science. The tasks of medical science fall into three buckets. One is understanding disease biology. One is finding effective therapies. And one is insuring those therapies are delivered effectively. That third bucket has been almost totally ignored by research funders, government, and academia. It’s viewed as the art of medicine. That’s a mistake, a huge mistake. And from a taxpayer’s perspective it’s outrageous.” We have a thirty-billion-dollar-a-year National Institutes of Health, he pointed out, which has been a remarkable powerhouse of discovery. But we have no billion-dollar National Institute of Health Care Delivery studying how best to incorporate those discoveries into daily practice.



















January 3, 2008 | Permalink | Comments (0) | TrackBack (0)

Wednesday, January 2, 2008

Year's Top Ten Science and Tech Stories

Will Saletan at Slate.com presents his list of the top ten "Human Interest" stories of 2007.  Quite frankly, some of them were a little scary and some do provide hope for the future.  For example, these two I found quite hopeful -

1. Cellular rejuvenation. Say goodbye to the stem-cell war. In November, two research teams announced that they had turned regular body cells into the equivalent of embryonic stem cells just by injecting four genes. Everyone agrees this is better than conventional embryonic stem-cell derivation or cloning: It's easier, avoids the human egg shortage, kills no embryos, is eligible for federal funding, and can produce tissue customized to each patient. Now the fight is over whether conservatives deserve credit for pushing the idea of nondestructive stem-cell derivation—or blame for impeding the original stem-cell research that made this breakthrough possible. (Related: Human Nature's previous takes on the new method.)

3. Regeneration. In November, doctors announced that they had restored amputees' sensations of lost limbs by relocating the severed nerves to other parts of the body. They concluded that through mechanical transmission of stimuli to re-innervated skin, "An amputee may one day be able to feel with an artificial limb as although it was his own." Meanwhile, the U.S. military is trying to go beyond artificial limbs altogether. It's testing a way to regrow lost body parts using "extracellular matrix," the material that tells cells where to go and what to become. One man photographed his finger's regrowth (after losing the last three-eighths of an inch) over four months. (Related: regeneration through embryo farming.) .
. . . .

These next two - not so much hopeful as why are we trying this??  I, for one, will not be purchasing a talking hamster for my son anytime soon . . .

4. Humanized animals. In September, British regulators approved the creation of human embryos with animal DNA. The usual method is to substitute a human cell nucleus for an animal cell nucleus in an animal egg, thereby cloning embryos for stem-cell research without having to get human eggs. Britain's Academy of Medical Sciences reported that scientists have created "thousands of examples of transgenic animals" carrying human DNA, largely to study the effects of diseases and drugs on human systems without involving actual human beings. In a separate experiment, researchers improved eyesight in mice by inserting a human gene. Everyone agrees that these mixtures are scientifically useful. But the moral complications are drawing concern, including from Catholic bishops, who are now demanding human rights for "interspecies embryos." (Related: Humanized animals are the future of medicine.)

5. Cyborgs. First U.S. military researchers put computer chips into moths, allowing them to be remotely controlled. Then Chinese scientists remotely controlled a flying pigeon. By implanting electrodes in its brain and activating them from a computer, they operated the bird as though in a video game. Another research team immobilized a moth and attached an electrode to its brain so that the moth's eye movements steered the robot. Now the U.S. military is merging artificial intelligence with humans, including a helmet that, according to its manufacturer, delivers "a visual readout for combat commanders showing the cognitive patterns of individual soldiers." In humans, unlike animals, the cybernetic component hasn't become internal or dominant. Yet. (Related: Voluntary cyborgs.)

January 2, 2008 | Permalink | Comments (0) | TrackBack (0)

Happy 2008!

January 2, 2008 | Permalink | Comments (0) | TrackBack (0)