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Dermatology, Ethics, Health Costs, Research, Stanford News

Drug samples lead to more expensive prescriptions, Stanford study finds

Drug samples lead to more expensive prescriptions, Stanford study finds

drugs on money - big

It’s been years (fortunately) since I’ve needed a prescription for anything more than a simple antibiotic. But when I did, I remember I was always thankful on those occasions when my doctor offered a free sample of a medication to try before (or sometimes instead of) pulling out the prescription pad. I appreciated the chance to see if a medication would work for me, and I was happy for any opportunity to save myself (or, at times, my insurance company) a few dollars. The fact that the samples were invariably for drugs that were still on patent (known as brand name drugs or branded generics) to a particular company certainly escaped me.

Now, a study by Stanford dermatologist Al Lane, MD, highlights the dark side of such free samples, which are provided to doctors by the pharmaceutical companies who make the drugs. The research, along with an accompanying editorial, is published today in JAMA Dermatology. As Lane comments in my release on the work:

Physicians may not be aware of the cost difference between brand-name and generic drugs and patients may not realize that, by accepting samples, they could be unintentionally channeled into subsequently receiving a prescription for a more expensive medication.

Specifically, Lane and medical student Michael Hurley found that dermatologists with access to free drug samples wrote prescriptions for medications with a retail price of about twice that of prescriptions written by dermatologists without access to samples. All of the patients had the same first-time diagnosis of adult acne. The difference is nothing to sniff at – $465 for docs who accepted samples and about $200 for docs who did not. What’s more, the overall prescribing patterns of the two groups of physicians showed almost no overlap. Physicians without access to samples prescribed mainly generic drugs (83 percent of the time), whereas those with access to samples prescribed generics much less frequently (21 percent of the time). Only one drug of the top ten most commonly prescribed by physicians without access to samples even made it into the top ten list of physicians who did accept samples.

The distribution of free drug samples in this country is big business. It’s been estimated that pharmaceutical companies give away samples of medications with a retail value of about $16 billion every year. But many physicians feel the availability of samples doesn’t sway their prescribing choices, and instead feel the samples allow them more flexibility to treat their patients. Lane himself thought so, until Stanford Medicine prohibited physicians to accept samples or other industry gifts in 2006. As he explains in the release:

At one time, we at Stanford really felt that samples were a very important part of our practice. It seemed a good way to help poorer patients, who maybe couldn’t afford to pay for medications out-of-pocket, and we had the perception that this was very beneficial for patients. But the important question physicians should be asking themselves now is whether any potential, and as yet unproven, benefit in patient compliance, satisfaction or adherence is really worth the increased cost to patients and the health-care system.

Clearly Lane has had a change of heart, in part based on the data in the study. Now he’s hoping to get the word out to other physicians. He and Hurley conclude in the paper, “The negative consequences of free drug samples affect clinical practice on a national level, and policies should be in place to properly mitigate their inappropriate influence on prescribing patterns.”

Previously: Consumers’ behavior responsible for $163 billion in wasteful pharmacy-related costs and Stanford’s medical school expands its policy to limit industry access
Photo by StockMonkeys.com

Behavioral Science, Ethics, Medicine and Society, Research, Stanford News

Breaking down happiness into measurable goals

Breaking down happiness into measurable goals

sunflowersSo you want to be happy. Can you be more specific? A study published in the Journal of Experimental Social Psychology found that concrete, rather than abstract, goals for happiness tend to be more successful. Jennifer Aaker, PhD, Stanford social psychologist and marketing professor, and colleagues performed six field and laboratory experiments and found that participants who performed specific acts of kindness – such as recycling or making someone smile – reported greater happiness than participants whose prosocial goals were less precise – such as helping the environment or people more broadly.

From a Stanford News article:

The reason is that when you pursue concretely framed goals, your expectations of success are more likely to be met in reality. On the other hand, broad and abstract goals may bring about happiness’ dark side – unrealistic expectations.

Acting directly and specifically in service to others brings greater happiness to the giver, the study found. The piece continues:

For example, an experiment involving bone marrow transplants focused on the whether giving those who need bone marrow transplants “greater hope” – the abstract goal – or giving those who need bone marrow transplants a “better chance of finding a donor” – the concrete goal – made a giver more happy.

The answer: Helping someone find a donor resulted in more happiness for the giver. This, the researchers wrote, was driven by givers’ perceptions that their actual acts better met their expectations of accomplishing their goal of helping another person.

Previously: Study shows happiness and meaning in life may be different goalsAre you happy now? Stanford Roundtable spotlights the science of happiness and wellbeing and Stanford faculty and students launch social media campaign to expand bone marrow donor registry
Photo by Iryna Yeroshko

Ethics, In the News, Sports, Stanford News, Women's Health

Arguing against sex testing in athletes

Arguing against sex testing in athletes

Testosterone does not a man – nor a woman – make. So argues Stanford medical anthropologist Katrina Karkazis, PhD, in a New York Times op-ed today. She cites evidence against the scientific and ethical soundness of sex-testing policies used since 2011 by sports governing organizations including the International Olympic Committee, the Fédération Internationale de Football Association and the International Association of Athletics Federations.

From the piece:

Rather than trying to decide whether an athlete is “really” female, as decades of mandatory sex tests did, the current policy targets women whose bodies produce more testosterone than is typical. If a female athlete’s T level is deemed too high, a medical team selected by the sport’s governing bodies develops a “therapeutic proposal.” This involves either surgery or drugs to lower the hormone level. If doctors can lower the athlete’s testosterone to what the governing bodies consider an appropriate level, she may return to competition. If she refuses to cooperate with the investigation or the medical procedures, she is placed under a permanent ban from elite women’s sports.

Sports authorities argue that screening for high T levels is needed to keep women’s athletics fair, reasoning that testosterone improves performance. Elite male athletes generally outperform women, and this difference has been attributed to men’s higher testosterone levels. Ergo, women with naturally high testosterone are thought to have an unfair advantage over other women.

But these assumptions do not match the science. A new study in Clinical Endocrinology fits with other emerging research on the relationship between natural testosterone and performance, especially in elite athletes, which shows that T levels can’t predict who will run faster, lift more weight or fight harder to win. The study, of a sample of 693 elite athletes, revealed a significant overlap in testosterone levels among men and women: 16.5 percent of the elite male athletes had testosterone in the so-called female range; nearly 14 percent of the women were above the “female” range.

Karkazis concludes, “Barring female athletes with high testosterone levels from competition is a solution to a problem that doesn’t exist. Worse, it is pushing young women into a choice they shouldn’t have to make: either to accept medically unnecessary interventions with harmful side effects or to give up their future in sports.”

Previously: Is the International Olympic Committee’s policy governing sex verification fair?, Researchers challenge proposed testosterone testing in select female Olympic athletes and Gender ambiguity gets attention

Ethics, Fertility, Genetics, In the News, Pregnancy, Stanford News

Daddy, mommy and ? Stanford legal expert weighs in about “three parent” embryos

Daddy, mommy and ? Stanford legal expert weighs in about "three parent" embryos

3519855504_9000d95a2aIt’s an interesting question that got a lot of traction in the media last week. Does the contribution of a tiny amount of DNA from a third person during in vitro fertilization really mean that the resulting child would have three genetic parents? Researchers in Oregon have proposed the technique as a way to avoid genetic diseases arising from faulty mitochondrial DNA by replacing an egg’s mitochondria with one from a second, healthy woman either before or after fertilization with a man’s sperm. They’ve shown that it works in monkeys, and the FDA met last week to consider whether the technique is safe enough to be used in humans.

Yesterday, Stanford law professor and bioethicist Hank Greely, JD, posted a great analysis of the topic on the university’s Law and Biosciences blog, complete with an elegant explanation of the problem for women with mitochondrial DNA mutations:

The mitochondria (high school biology’s “energy powerhouses of the cell”) have their own very short stretch of DNA, separate from the 6.8 billion base pairs found on 46 chromosomes in the cell’s nucleus (the nuclear DNA).  The 16,569 base pairs of the mitochondrial DNA (hereafter “mtDNA”) hold 37 (some say 38) genes, providing instructions for making 13 (or 14) proteins and another 24 RNA molecules.  The full importance of these genes is unknown, but it is clear that some (happily rare) variations in the mtDNA cause quite severe illnesses. Unfortunately, each child gets all of its mitochondria (and hence its mtDNA) in the egg from its mother; if the mother’s mtDNA is dangerously flawed, so will be the mtDNA of all her children. With almost all other genetic diseases, no matter how inevitably the “bad” genetic variation leads to a disease (how “penetrant” the genetic variation is), a woman will have only a 50% or 25% chance of passing on the condition.  With these, her genes can give rise to no healthy children.

Greely gets at the heart of the matter when he compares the statistically minute contribution from the donated mitochondria to a hypothetical child he calls Heather:

I have DNA from four people in each of my cells:  my mother’s mother, my mother’s father, my father’s mother, and my father’s father. Actually, my DNA really came from all eight of my great-grandparents, and all 1024 of my great great great great great great great great grandparents, and all roughly one million of my great (18) grandparents. Yes, all that DNA passed through my (genetic) parents before coming to me, but why does that matter?

Heather gets her DNA from more than two people a bit differently from the way the rest of us do, but so what? How does getting what is, in effect, “gene therapy,” where the gene is delivered in a natural package called the mitochondrion, turn our hypothetical (and healthy) child into a powerful argument against the procedure?

It shouldn’t.  Heather will not be getting superpowers, she will not be in any meaningfully way “designed” (except to avoid a nasty genetic disease), and she will not be given a newly made DNA sequence never before found in the human gene pool. She will get mitochondria with mtDNA that will allow her to have normal health, not a grave disease. That mtDNA will have been taken from a woman, who, though not a source of Heather’s nuclear DNA, is certainly a participant in the human gene pool.

“Heather has three parents” is NOT an argument. It is an irrelevant but attention-getting slogan that is uncritically put forward as, and sometimes mistaken for, a real argument. Yes, the proposed process is a way of bringing forth living and healthy babies that is somewhat new and different, but so were obstetric forceps, (safe) C-sections, and in vitro fertilization. Novelty is not, in itself, a respectable argument against it.

Previously: Medical practice, patents and “custom children”: A look at the future of reproductive medicine, Five million babies and counting: Stanford expert offers conversation on reproductive medicine and Stanford researchers work to increase the odds of in vitro fertilization success
Photo by Christian Pichler

Ethics, Medicine and Society, Stanford News

Stanford ethicist discusses brain death

Stanford ethicist discusses brain death

What exactly is “brain death?” And how does it differ from what you and I think of as death? That question and others are answered in this Q&A with David Magnus, PhD, director of the Stanford Center for Bioethics, who co-wrote a perspective piece on the topic that appears today in the New England Journal of Medicine. In that piece, he and his co-authors explained why the laws and ethics governing brain death should not be changed.

When asked by my colleague why he believes families (such as that of this young California girl) shouldn’t be able to determine when a loved one is dead, Magnus had this to say:

The line between life and death is legally, ethically and medically important. It determines when someone has full constitutional protections under the law, when someone’s will takes effect, whether someone is still married and when physicians are obligated to provide life-sustaining medical treatments. It also determines the line where it is allowable to procure organs. Without brain death, there would be little to no cadaveric organ procurement in the United States, leading to thousands of deaths every year.

It is important that these lines be drawn in ways that are medically and philosophically defensible. Imagine if we decided that parents could decide when their children are mature enough to be allowed the status of adulthood. Some 40-year-olds would never get to vote or make decisions, while some 10-year-olds would. Instead, we draw a clear boundary at age 18. If a religious minority decides that patients are adults at age 13, it does not follow that the law should be different for them. Similarly, there needs to be a bright line drawn by professionals who can reliably and accurately distinguish between life and death, as we distinguish between child and adult…

Applied Biotechnology, Ethics, Events, Genetics, Stanford News

Coming soon: A genome test that costs less than a new pair of shoes

Coming soon: A genome test that costs less than a new pair of shoes

Air JordansScarcely a week ago, a leading genomics company, Illumina, announced it could sequence a human genome for the new, low price of $1,000. This week attendees at a personalized medicine conference heard a Silicon Valley startup say it would get the price down to $100.

Either price is a steep drop from the $2 million it cost in 2007 to sequence the genome of DNA discoverer James Watson, PhD. Illumina, a San Diego-based company (and one of Stanford’s partner  in a just-funded stem cell genomics center), claimed the $1,000 price in a Jan. 14 announcement on its latest sequencer model. CEO Jay Flatley said the achievement shows that science has “broken the sound barrier” in the race to make genome sequencing affordable for medical care.

Speaking Monday at the sixth annual Personalized Medicine World Conference in Mountain View, Calif., Flatley predicted that genome sequencing would one day become so widely used in bedside medical care that it would be regarded as a “molecular stethoscope.”

Skeptics at the conference questioned whether a $1,000 genome test could include all the interpretation and analysis necessary to make the raw data useful for patients. But within minutes of the question, another company stepped up to say it was already working on a test that would lower the cost even more to $100.

“At $100, you get to be really competitive,” said Stefan Roever, CEO of Genia Technologies, a startup based in Mountain View, during a panel presentation at the conference. Genia is using a different method, called nanopore-based sequencing. The start-up was part of a consortium with Harvard Medical School and Columbia University that won a $5.25 million grant in September from the National Human Genome Research Institute to develop the technology.

The PMWC conference was a mix of academic researchers, companies commercializing the genomics, and venture capitalists checking out the new crop of start-ups. Stanford was represented by Stephen Quake, PhD, professor of bioengineering; George Sledge, MD, professor of medicine; and a multitude of others. Also making presentations were LeRoy Hood, MD, PhD, head of the Institute for Systems Biology in Seattle, and Eric Green, MD, PhD, director of the National Human Genome Research Institute.

Amir Dan Rubin, president and CEO of Stanford Hospital & Clinics, gave a keynote talk at the start of the conference. Stanford Hospital & Clinics was one of the cosponsors of the conference, held Jan. 27-28 at the Computer History Museum in Mountain View.

Donna Alvarado is a Bay Area-based writer and editor who volunteers at the Stanford Health Library and finds inspiration in medical and health topics.

Previously: Stanford researchers work to translate genetic discoveries into widespread personalized medicineWhole-genome fetal sequencing recognized as one of the year’s “10 Breakthrough Technologies”New recommendations for genetic disclosure released and Ask Stanford Med: Genetics chair answers your questions on genomics and personalized medicine
Photo by rondostar

Cardiovascular Medicine, Ethics, Health Policy, Stanford News

Will new guidelines lead to massive statin use?

As recently written about on Scope, new guidelines on statin use, and an accompanying risk-assessment calculator, have generated much conversation in the medical community. In a new Viewpoint piece in the Journal of the American Medical Association, Stanford professor and health research and policy expert John Ioannidis, MD, DSc, discusses potential implications of the guidelines, which could lead to more widespread use of statins for primary prevention. “It is uncertain whether this would be one of the greatest achievements or one of the worst disasters of medical history,” he writes of potential worldwide “statinization.” Read on to get more of his thoughts.

Previously: Stanford expert weighs in on new guidelines for statin useThe exercise pill: A better prescription than drugs for patients with heart problems?“U.S. effect” leads to publication of biased research, says Stanford’s John Ioannidis and A call for mega-trials for blockbuster drugs

Applied Biotechnology, Ethics, Fertility, Genetics, Medicine and Society, Parenting

Medical practice, patents, and “custom children”: A look at the future of reproductive medicine

Medical practice, patents, and "custom children": A look at the future of reproductive medicine

black and white baby

Recently, 23andMe, the direct-to-consumer genetic diagnostic company, announced it had been issued a patent for a system of applying genetic testing – and, consequently, genetic screening – to egg and sperm banks. (Full disclosure: I am a 23andMe consumer.) In brief, 23andMe’s system involves receiving information from would-be parents about which traits they’d like their children to possess, and then determining which egg or sperm donations would be the best genetic fit to create those children. While egg and sperm banks currently allow would-be parents to sort through the traits of egg and sperm donors – such as race, height, athleticism, and even SAT scores – 23andMe’s patent envisions applying statistics to the genetic profiles of both donors and recipients to create something of a “custom child.”

To be clear, 23andMe’s patent is just that: a patent. There’s no indication that 23andMe has put its system into implementation or even made a serious business attempt to do so. Nonetheless, others have discussed the ethics behind 23andMe’s system, the propriety of the patent, and 23andMe’s ultimate plans with its intellectual property. But one question I’m particularly intrigued by is: Assuming 23andMe’s vision comes to pass – one easily within our technological if not cultural grasp – what will the future of reproductive medicine look like?

First, it would be a tremendous boon to the medical care of those “custom children,” as it would likely eliminate many common gene variants responsible for disease. These range from simple, single-gene diseases, such as Marfan syndrome, spinal muscular atrophy, and Huntington’s disease, to complex multi-gene diseases, such as breast and ovarian cancer, for which certain gene variants play a significantly large etiological role. And, as is demonstrated by the list above, these diseases need not be limited to the traditional fatal-in-childhood diseases, such as Tay-Sachs or Niemann-Pick syndrome, that are currently screened for. Rather, as is the case with Huntington’s disease, which only afflicts its sufferers in mid-life, the method could quash those genetic variants that cause disease through all stages of life.

Second, the robustness of the technology behind the 23andMe patent may spur demand for  in vitro fertilization. Few couples capable of conceiving without technological intervention undergo IVF today. But some of that is ultimately a matter of choice: that there are few benefits to be had through IVF relative to natural conception. The possibilities for customization described in the 23andMe patent – choosing a child possessing hundreds of hand-picked traits, from curly hair down to caffeine metabolism – may, at least for some, change that calculus. The potential for customization drives demand in other enterprises – smartphones, cheeseburgers, insurance policies, even house paint. It’s culturally naïve to think it will have no effect on reproductive technology.

And lastly, I suppose it also means that reproductive medicine will increasingly come within the ambit of patent law. Since its inception in the 1970s, IVF has largely been free of the destructive and costly patent litigation seen in other industries, such as smartphones. If 23andMe’s patent is indicative of a future norm, reproductive medicine may very well operate in a world controlled by licensing agreements and cowered by threats of litigation. Whether one is entitled to a particular genetic screening method may have little to do with the quality of the institution – as it generally does now – but more with whether an institution has agreed to pay the appropriate royalties. At least this aspect of reproductive medicine is not so futuristic: The current set of patent infringement lawsuits among Verinata, Sequenom, Natera, and Ariosa has held up much non-invasive, prenatal screening for Down’s syndrome.

These issues are both fascinating and complex, and the larger concerns raised by the system described in the 23andMe patent only touch a small fraction of the ethical and practical quandaries involved. For a discussion of the remainder, Stanford’s own Hank Greely, JD, will attempt to address them in his upcoming book, “The End of Sex“. Let us at least hope that that institution’s end is not because of patents.

Jake Sherkow, JD, is a fellow at Stanford Law School’s Center for Law and the Biosciences. His current research focuses on the intersection of patent law, biotechnology, and agency regulation.

Previously: Whole-genome fetal sequencing recognized as one of the year’s “10 Breakthrough Technologies”Stanford bioethicists discuss pros, cons of biotech patents, The end of sex? Maybe not just yet, New techniques to diagnose disease in a fetus, and Sex without babies, and vice versa: Stanford panel explores issues surrounding reproductive technologies
Photo by Lisa Williams

Ethics, Patient Care, Podcasts

What happened inside New Orleans’ Memorial Hospital? A conversation with Pulitzer Prize-winning author Sheri Fink

What happened inside New Orleans' Memorial Hospital? A conversation with Pulitzer Prize-winning author Sheri Fink

Memorial Medical Center is seen Monday, Sept. 12, 2005, in New Orleans, after more than 40 bodies were recovered Sunday at the 317-bed hospital. Hospital assistant administrator David Goodson said patients died while waiting to be evacuated over the four days after the hurricane hit, as temperatures inside the hospital reached 106 degrees.  (AP Photo/Rick Bowmer)What happened at Memorial Hospital in New Orleans after Hurricane Katrina struck and paralyzed the city? Pulitzer Prize winner Sheri Fink details the hospital’s struggles for survival in her new book, Five Days at Memorial. It’s a harrowing tale of colossal failures within Memorial and also outside as the federal, state and local governments bungled their response. I find myself still outraged eight years later, wondering how a tragedy of this magnitude could happen to an American city.

In addition to the horror of a hospital in chaos due to a storm of historic proportions, the story of Memorial is filled with ethical conundrums about what constitutes humane health care. Did health care workers choose life for some patients and death for others? Three health care workers were arrested and faced criminal allegations that they deliberately injected a number of patients with drugs to hasten their deaths. In the end, a New Orleans grand jury declined to indict even though the State Attorney General maintained to the end that a number of the dead were victims of homicide.

In her finely detailed investigative work, Fink brings the reader into Memorial for a minute by minute harrowing recounting of what happens when things fall apart in a hospital. Five Days at Memorial is a stunning read, and I was pleased to be able to talk with Fink at length for my latest 1:2:1 podcast. As I wrote in an earlier blog entry:

Put yourself [in place of the health care workers]. What would you have done? Are the ethical lines clear to you? Is what happened inside Memorial black and white? Or is it gray?

Fink holds an MD and PhD from Stanford’s School of Medicine.

Previously: Pulitzer Prize-winner Sheri Fink: the final hours at New Orleans Memorial, New York Times wins three Pulitzers for health stories and Murky waters: A look at Memorial Medical Center after Hurricane Katrina
Photo by ASSOCIATED PRESS

Behavioral Science, Ethics, Neuroscience, Research, Stanford News

Mind-reading in real life: Study shows it can be done (but they’ll have to catch you first)

Mind-reading in real life: Study shows it can be done (but they'll have to catch you first)

mind readerIt’s not a given that experimentally obtained results accurately reflect goings-on in the real world. The former are obtained under rigidly controlled, reproducible conditions in which every possible confounding factor has been either eliminated or statistically accounted for; the latter, we all know, is a chaotic kaleidoscope of nonrecurring coincidences.

Previous research (including a study by Stanford’s Mike Greicius, MD, that I wrote about a couple of years ago) has enabled scientists to determine, retroactively, which of several different types of mental activity an experimental subject was engaged in while sequestered inside an MRI scanning chamber.

Now Stanford neuroscientist Josef Parvizi, MD, PhD, and company have demonstrated that with the right hookup, you can see what someone is thinking about even when they’re not in a tightly controlled environment. In a study just published in Nature Communications and described for nonscientists here, Parvizi and his colleagues were able to discern a particular electrical-activity pattern in the brains of the people they were studying whenever those people were thinking about numbers or even general quantitative terms such as “more than” or “the day before yesterday.” This pattern, first identified in more-standard experimental circumstances, could be observed even when the experimental subjects were more or less just going about their everyday lives.

Well, not exactly. These subjects were patients with recurring drug-resistant epileptic seizures, who were spending a week in a hospital during which their brains were continuously monitored so neurologists could locate the exact spot in these patients brains (it’s different for each person) where the seizures were originating. Doing this required surgically placing recording electrodes against the surface of patients’ brains, leaving patients free to eat, drink, think, talk on the telephone and move around – albeit tethered to a “leash”: the cable linking the electrodes to a recording device.

The patients were also (with their consent) monitored continuously by video cameras. Later, Parvizi’s team found that every time a patient mentioned a quantitative term or heard one mentioned, the signature electrical spike occurred, and vice versa. Think a thought, cause a spike.

This opens the door to the prospect that in some dark, dystopian future one or another Evil Entity will be able to read – or, worse, control! – our every thought after, say, slipping a chip under our skulls while we’re unknowingly abducted and anesthetized. Some of the globe’s looser lips are already claiming this kind of thing is being done in the here and  now.

So I asked Stanford legal scholar and bioethicist Hank Greely, JD, what he thought about it. As per my news release about Parvizi’s study, Greely’s response (in so many words) was: Get a grip. “Practically speaking, it’s not the simplest thing in the world to go around implanting electrodes in people’s brains,” he said. “It will not be done tomorrow, or easily, or surreptitiously.”

Parvizi wholeheartedly agreed that it’s a bit premature to be freaking out about impending mind-control schemes. “We’re still in early days with this,” he told me. “If this is a baseball game, we’re not even in the first inning.”

Previously: We’ve got your number: Exact spot in brain where numeral recognition takes place revealed, Metamorphosis: At the push of a button, a familiar face becomes a strange one and A one-minute mind-reading machine? Brain-scan results distinguish mental states
Photo by pds209

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