When I was editing stories for the Stanford Medicine special report on clinical trials a few years back, a recurring theme was the enormous cost of bringing new drugs to market. A 2003 study led by Joseph DiMasi at Tufts Center for the Study of Drug Development arrived at $802 million – and this was the figure always cited to me by the researchers and administrators I interviewed.
Today David Ng blogged about a recent critique of the article on Boing Boing and the discussion has heated up. Reading the comments, I learned that Donald Light and Rebecca Warburton, the authors of the critique in Biosocieties, have published previously on this topic and DiMasi has rebutted their arguments. And now Tufts has issued a press release in response.
So what is the cost of drug development? Is it more than $800 million? Or closer to $40 million, as Light and Warburton propose? If like me, you lack the enthusiasm to analyze both papers to reach a conclusion, you’ll be happy to hear about bioscience venture capital blogger Bruce Booth’scrowdsourcing solution:
We can all debate what the right statistics are for the R&D costs to support a drug: direct costs per phase, time per phase, failure rates, etc It all depends on the drug itself, its safety profile, how many fumbles it has in development, what indications (diseases) it goes after, what the organizational overhead costs are, how bureaucratic your processes are, etc Venture-backed biotechs have a very different cost structure than a Big Pharma. Some firms build Fords and others build Cadillacs. So the median and mean are essentially meaningless; the ranges and distributions are more interesting.
With all the good online discussion, I thought I’d have some fun and throw a model into the mix to see if crowdsourcing can generate a better answer. The link is below the image.
If you’ve actually developed a drug, why not download the one or both of Booth’s models (he’s got two posted now), punch in your numbers and add your result to the mix?
As editor, I’m always pleased when an article in Stanford Medicine magazine creates a buzz. And I’m especially glad when the story has the power to help people live healthier, happier lives.
The new issue includes one story that has opened up discussion about a topic that’s rarely aired – the anguish and controversy over “fixing” the sex of children born with ambiguous gender (a condition known as a disorder of sex development, or DSD). The usual approach in the United States has been to use surgery during infancy to make the sex clear cut – but now, as is detailed in our story by freelance writer Dianne Klein, this is being questioned.
The magazine came out just a few days ago, and we’ve already heard from readers thanking us for the article. One wrote to say:
Such articles are so important to get information out and share more than one side of the debate so maybe one day there won’t be so much secrecy and shame attached to DSDs.
And at least one major news outlet, ABC News, has used the article as a starting point for its own conversation on the issue.
The Harvard School of Public Health is hosting a forum today from 1 to 2 p.m. Pacific time on the public health response to the earthquake, tsunami and nuclear crisis in Japan.
What’s bioethics? It’s a field that didn’t exist 40 years ago but is central to today’s world of medicine. It’s a field that looks for answers to medicine’s virtually unanswerable ethical quandaries. And it’s the topic of the new issue of Stanford Medicine magazine, which just went online.
The stories in the theme package include:
A look at bioethics at midlife. Forty years after the field’s birth, the work that bioethicists do is changing.
A story on perspectives on using surgery to “fix” the sex of children born with ambiguous gender.
A feature on the quandary of patients who seek treatment with stem cells, despite the fact that those treatments are unproven and might even harm them.
An article on expanding the supply of transplant organs by broadening the definition of death for donors.
A Q&A with the father of Jesse Gelsinger, who at 18 became the first person to die as a result of a gene therapy clinical trial.
When I started writing our article about a new paper by Randall Stafford, MD, PhD, on electronic health records, I thought the message was as straightforward as can be: Electronic health records are doing nothing to improve the quality of health care. But my editor wasted no time in showing me that the article (co-authored by Johns Hopkins medical student Max Romano, and published today in the Archives of Internal Medicine) was more nuanced than I’d first considered.
When it comes to technological change in a massive industry like medicine, the impact can take a very long time to show up. Even the contribution to the nation’s productivity of computers themselves took decades to become evident in economic statistics. This New York Timesarticle from 2000 reports on the dawning of proof of computers’ productivity. It makes sense to me that the same slow change could come with electronic health records.
It would sure be nice if we could speed it up, though.
If someone had asked me a few weeks ago what’s the top-selling class of drugs in the United States I never would have guessed it’s the new generation of drugs to treat schizophrenia. But that was before I talked to Randall Stafford, MD, PhD, who just published a study that not only documents the widespread use of these drugs (they’re called atypical antipsychotic medications), but also shows that they’re very likely being used unwisely.
Instead of being prescribed for the purpose originally approved by the FDA, they’re given for anxiety, dementia and a host of other psychological ailments. That would be fine if there were good evidence that they help. But Stafford’s study, published today in Pharmacoepidemiology and Drug Safety, convinced me that for the most part there isn’t. And the drugs carry the risk of serious side effects – weight gain, diabetes and heart disease – and they’re super expensive. Some of the most widely used in the class are Abilify, Risperdal, Seroquel and Zyprexa, each of which have annual U.S. sales topping $1 billion.
When I interviewed Stafford for my article about this, I asked him why doctors prescribe them despite the lack of good evidence. He said it’s probably the result of marketing – both legal and illegal – and ingrained cultural biases:
“Physicians want to prescribe and use the latest therapies – and even when those latest therapies don’t necessarily offer a big advantage, there’s still a tendency to think that the newest drugs must be better.”
Interestingly, doctors often don’t even realize that the drugs they’re prescribing lack FDA approval for that particular use. The first author of Stafford’s study, Caleb Alexander, MD, at the University of Chicago, found in a previous survey of physicians that the average respondent accurately identified the FDA-approval status of drugs for a given condition just over half the time.
The creator of popular webcomic xkcd, Randall Munroe, shared a few weeks ago that he’s coping with a serious illness in his family. That’s very sad. But, as usual, his comics make me glad. And, now that he’s got medicine on his mind, it’s coming out in the strip – and I have an excuse to read it during working hours.
Wednesday’s comic was about one of my big bêtes noires: Guilt-tripping patients who dare to consider illness an unmitigated bummer. You can read the whole strip over at xkcd.
As a toddler I spent hours playing in the backyard sandbox. If I was lucky, my digging would turn up some especially moist clumps with an interesting smell that I loved squeezing into crumbs. Years later I realized with disgust that those clumps were the neighbor’s cat’s “doings.” (Thanks, Morris.)
My sandbox play was certainly uncouth, but was it also hazardous to my health? If so, children playing in Redwood City, Calif., parks are safe from similar dangers. Officials there think poopy sandboxes pose unacceptable risks to children. After spending $70,000 to get rid of E. coli in sandboxes in two parks, the city has given up the battle and removed the play equipment.
Today’s Bay Citizenexplains that about two years ago the city’s director of Parks, Recreation and Community Services, Christopher Beth, received an anonymous tip about a couple of children getting sick after playing in one of the sandboxes. So he ordered tests and found an E. coli problem in the original sandbox and one other:
After the contaminated sand was replaced, Beth continued to test for bacteria; soon, high levels of E. coli present were back. Nothing the city tried seemed to work – including turning off a nearby water feature, bleaching the sand, redoing the drainage system and changing the type of sand used.
The source of contamination was cat feces in one case and human feces in the other.
The solution? The city’s replacing of the sandboxes with water features: a “snail stream” and a trio of “spitting frogs,” which are less prone to contamination and a lot easier to clean. The expectation is that most of the harmful stuff will simply go down the drain.
It’s easy to believe that teens who spend a lot of time hanging out at convenience stores are more likely to smoke than their peers. It seems natural, somehow. But why?
An article published today in the journal Pediatrics by Stanford senior research scientist Lisa Henriksen, PhD, confirms that these teens are more likely to smoke, and concludes that exposure to cigarette ads in convenience stores is the reason.
If you’re dismissing this, as I did at first, thinking “Of course teens who spend time at convenience stores tend to smoke – they go there to buy their cigarettes,” Henriksen’s study shows there’s more to it.
The study’s starting point was with students who didn’t smoke. It shows that the time spent in cigarette-ad-saturated convenience stores (and gas stations and small groceries) before they started smoking correlates to whether they begin later. Students who had visited these stores on a regular basis were at least twice as likely to try smoking as those who visited infrequently.
In the article I wrote about the study in Inside Stanford Medicine, Henriksen suggests federal regulators should consider barring such marketing efforts.
“The tobacco industry argues the purpose of advertising is to encourage smokers to switch brands, but this shows that advertising encourages teenagers to pick up a deadly habit,” said Henriksen, who has studied tobacco marketing for more than a decade.
Ever since I assigned writer Sara Wykes to do a story on natural orifice surgery for the latest Stanford Medicine magazine, I’ve continued to come across new variations on the theme. Gallbladder removal by way of the mouth. Transvaginal kidney donation. Eye surgery through the nose (it’s described at the link in the sidebar).
Sara started off writing the story as a serious skeptic. Her early reporting turned up concerns about the surgeries’ steep learning curve, and frustrations over a lack of good tools.
So is this trend a good thing? Her reporting convinced me that this kind of surgery can be a great thing, at least when done by physicians with plenty of experience. In fact, in some cases, as with a man with a brain tumor described in Sara’s story, it makes a treatment feasible.
No surgeon goes near the brain without a keen awareness of what inadvertent damage can do. The pituitary is one of the body’s master control organs, surrounded by critical neurological structures. Drilling a hole into Cherry’s skull was out of the question. Instead, Cherry’s tumor would be reached and removed through his nose.
On one hand, health-care reform is increasing the pressure on U.S. teaching hospitals to cut costs and improve care. On the other, since they’re set up to promote innovation, they’re a natural source of solutions. Will they make good on their potential?
The summer issue of Stanford Medicine magazine reports on U.S. teaching hospitals today, with an emphasis on Stanford Hospital & Clinics. “It’s clear that business as usual – and certainly one based simply on growth – is not sustainable,” Philip Pizzo, MD, dean of School of Medicine, says in the report’s lead article.
Here’s what else is in the magazine:
The lead story, describing a new approach to hospital management, which adopts some strategies from the corporate world
A Q&A with the federal chief health information technology officer, David Blumenthal, MD
A story on the effort to revive the bedside exam, along with a description of 25 essential exam techniques
A look at the trend toward “stealth” surgeries – gaining access through natural openings such as nostrils to minimize damage to tissues and scarring
An article on Stanford Hospital’s pneumatic tubes, which whisk medical samples from one side of the medical center to the other
A feature on hospitals’ growing use of green building practices
During the debate over health-care reform, we heard a lot about emergency rooms jammed with people who couldn’t afford to go to a doctor. Today, I read a post on the May 24 Storytellerdoc blog about another way emergency rooms pick up society’s slack: providing food for the hungry.
In the post, Storytellerdoc describes an encounter with a woman who came to the ER with complaints of abdominal pain and vomiting:
She continued, however, to explain that since eating the fish, she had vomited three times later that evening and once this morning, prior to coming to our ER. “I feel better now, though,” she said. She hesitated before continuing. “I’m feeling well enough for a cup of coffee and a sandwich, even.”
And there we go — the main reason why Rose was in our ER. She was hungry.
The comments make clear that other ERs face the same dilemma, to feed or not to feed.
As I edit the next issue of Stanford Medicine magazine, a special report on teaching hospitals, I’ve learned a lot about the roles hospitals play in their communities. And I’m still learning.
Adam Cole’s sweet, folky tune has lyrics that biologists and moms (and especially biologists who are moms) will find irresistible, even though it’s a little late for Mother’s Day now.
I came across Cole’s video yesterday on a biologist/mom friend’s Facebook page and tracked down the singer, a Stanford biology student, who posted his performance on YouTube May 8.
Cole whimsically makes the point that inheritance isn’t really an exactly 50/50 deal. Moms give a little bit more.
In his words:
Just like two strands of DNA are spirally entwined
Your nature and your nurture are inspiringly combined
Scientists remind me and I find that it is true
Slightly more than half of everything I am is thanks to you
And here’s a bonus for science celebrity spotters: That bushy-bearded man who pops in toward the end with a few seconds of a lecture on inheritance is Stanford biology professor Robert Sapolsky, PhD.
Cole says his mom loved the song (though she loved the macaroni necklace he made her in kindergarten too), and his dad, who’s also a biologist, was very understanding: “He knows that my love for him is not proportional to the biological effect he had on my genetics and development.”
Dead celebrity effect – the surge in patient volume when a celebrity suffers from some severe or deadly process. A related process is the Hystericus reportercillium in which whatever illness is in the news is immediately contracted by one third of your patient population (e.g., Swine Flu), even those without any symptoms.
As previously reported on Scope, Stanford geneticist Michael Snyder, PhD, and colleagues conducted an unprecedented analysis of Snyder's genome using a newly ...
What’s bioethics? It’s a field that didn’t exist 40 years ago but is central to today’s world of medicine. It’s a field that looks for answers to medicine’s virtually unanswerable ethical quandaries. And it’s the topic of the 
