I'm off to the ASJA Conference this week to moderate a panel on using widgets to maximize your blog (ahem, see the widget on the right for a link to the conference info). But this week's food for thought is the menigococcal disease vaccine Menactra, generally given to tweens and teens (and sometimes to at-risk children as young as 2), which the FDA just approved for children as young as 9 months old.
Will parents get the two-dose vaccine to help prevent bacterial meningitis in their young children - a rare but frightening disease that progresses so fast that it can outrun antibiotics? Or will they turn down the vaccine because there are already so many other vaccines on the CDC schedule for children under 2 years old? I'm wondering how this will play out.
Tuesday, April 26, 2011
Friday, April 22, 2011
Why it Matters How VCs Spend Their Money
In the biotechnology sector, when non-profit and government organizations can't or don't provide funding, venture capital firms (VCs) often do. The for-profit VCs, of course, want a good return on their investment -- first through promising clinical trials that lead to FDA approval for a product, then through wide and profitable adoption of the product by patients and their health care providers.
But because this process can take a decade or even longer, many VCs are putting their investment dollars into other projects with a quicker payout, particularly social networking, according to a recent Fierce Biotech post by John Carroll that cites a Reuters survey on the topic ("VCs: Chill sets in on biotech as social networking gets hot"). "Why invest in biotech companies which face years of risky clinical trial work," writes Carroll, "when you can grab a stake in a social networking company and potentially cash out in a year or two?"
This investment fickleness is one reason why we need government agencies like the NIH to fund promising research. But we also need VCs, because they have the deep pockets and the business expertise to bring needed health products to market, as long as their investors are willing to make long-term investments.Venture capital-funded companies are developing new vaccines, pain medications, gene therapies, and cancer treatments, to name just a few products.
Venture capital firms invested $5.9 billion in the first quarter of this year, and $784 million of that went to biotechnology, according to the MoneyTree (tm) Report created by PricewaterhouseCoopers, the National Venture Capital Association (NVCA), and Thomson Reuters. The software industry ($1.1 billion) and "Internet-specific companies" such as social networking sites ($1.2 billion) received the biggest pieces of the VC pie in the past quarter, according to an April 15 press release from the NVCA.
Venture capital firms invested more money in biotechnology over the past quarter than in the last quarter of 2010. But the NVCA press release stated that the money is divvied up among far fewer biotechnology companies now than in the past. This means that VCs are funding a smaller range of potential therapies.
It's hard to predict which therapies will succeed, but we need better treatments for widespread problems such as cancer and chronic pain. Ultimately we all benefit when VCs patiently fund the greatest possible number of promising therapies, instead of diverting funds to look for the next FaceBook.
But because this process can take a decade or even longer, many VCs are putting their investment dollars into other projects with a quicker payout, particularly social networking, according to a recent Fierce Biotech post by John Carroll that cites a Reuters survey on the topic ("VCs: Chill sets in on biotech as social networking gets hot"). "Why invest in biotech companies which face years of risky clinical trial work," writes Carroll, "when you can grab a stake in a social networking company and potentially cash out in a year or two?"
This investment fickleness is one reason why we need government agencies like the NIH to fund promising research. But we also need VCs, because they have the deep pockets and the business expertise to bring needed health products to market, as long as their investors are willing to make long-term investments.Venture capital-funded companies are developing new vaccines, pain medications, gene therapies, and cancer treatments, to name just a few products.
Venture capital firms invested $5.9 billion in the first quarter of this year, and $784 million of that went to biotechnology, according to the MoneyTree (tm) Report created by PricewaterhouseCoopers, the National Venture Capital Association (NVCA), and Thomson Reuters. The software industry ($1.1 billion) and "Internet-specific companies" such as social networking sites ($1.2 billion) received the biggest pieces of the VC pie in the past quarter, according to an April 15 press release from the NVCA.
Venture capital firms invested more money in biotechnology over the past quarter than in the last quarter of 2010. But the NVCA press release stated that the money is divvied up among far fewer biotechnology companies now than in the past. This means that VCs are funding a smaller range of potential therapies.
It's hard to predict which therapies will succeed, but we need better treatments for widespread problems such as cancer and chronic pain. Ultimately we all benefit when VCs patiently fund the greatest possible number of promising therapies, instead of diverting funds to look for the next FaceBook.
Wednesday, April 13, 2011
RFID tags in Medicine
Radio frequency identification (RFID) tags can track people, equipment, and paperwork in a variety of settings. They are currently used to track objects ranging from military equipment and nuclear materials to more mundane retail merchandise. These chips are either passive, transmitting a signal only when an electronic device requests information, or active, constantly transmitting a readable signal.
RFID tags are gaining traction in medicine. Surgeons can use "smart" sponges embedded with RFID tags in the operating room, for example. Separate devices can electronically count the number of sponges used and scan the surgical site to make sure none are left in the body, where they can cause pain, infections, and other problems. RFID-embedded identification bracelets placed on infants in maternity wards and linked to alarms prevent unauthorized people from taking the infants from the area.
Outside the hospital wards, RFID-tagged pharmaceutical containers make it easier for the FDA to track the drugs' movement (especially the movement of controlled substances such as the pain reliever OxyContin) and to verify that the drugs are not counterfeit. Some paper medical records have been RFID-tagged to help health care workers find misplaced files.
The Affordable Care Act encourages the use of technology such as electronic medical records and RFID tags to improve medical care and (not coincidentally) to stretch health care dollars by decreasing administrative costs and other expenses. Technology like RFID chips, which can prevent expensive and damaging human errors, should remain just one tool used by health care providers, and does not relieve them of their responsibility to provide the best care they can. Tools can help them with data collection and analysis, but empathy, observation, and insight remain distinctly human, and necessary for good health care as well.
RFID tags are gaining traction in medicine. Surgeons can use "smart" sponges embedded with RFID tags in the operating room, for example. Separate devices can electronically count the number of sponges used and scan the surgical site to make sure none are left in the body, where they can cause pain, infections, and other problems. RFID-embedded identification bracelets placed on infants in maternity wards and linked to alarms prevent unauthorized people from taking the infants from the area.
Outside the hospital wards, RFID-tagged pharmaceutical containers make it easier for the FDA to track the drugs' movement (especially the movement of controlled substances such as the pain reliever OxyContin) and to verify that the drugs are not counterfeit. Some paper medical records have been RFID-tagged to help health care workers find misplaced files.
The Affordable Care Act encourages the use of technology such as electronic medical records and RFID tags to improve medical care and (not coincidentally) to stretch health care dollars by decreasing administrative costs and other expenses. Technology like RFID chips, which can prevent expensive and damaging human errors, should remain just one tool used by health care providers, and does not relieve them of their responsibility to provide the best care they can. Tools can help them with data collection and analysis, but empathy, observation, and insight remain distinctly human, and necessary for good health care as well.
Tuesday, April 5, 2011
The Skewed Values of Drug Prices
The eye-popping pricing strategies for two pharmaceuticals have been big news lately. First, the cost of a weekly progesterone injection, designed to prevent premature births in at-risk pregnant women, jumped from about $20 per shot to $1,500 per shot.
What happened? The active ingredient of the shot had been compounded by pharmacies as needed by physician request to prevent premature births in the past, while the FDA quietly looked the other way. But in February, the FDA officially approved KV Pharmaceutical's version of the shot, Makena, and KV Pharmaceutical decided to raise the price - a lot.
It was a stunning move for a product whose development was partially funded by taxpayers through the National Institutes of Health, and whose approval had been fast-tracked and supported by the FDA's Orphan Drug Act, according to a recent FDA statement. In response to public outcry, KV Pharmaceutical later dropped the price to $690 per dose.
Then, on March 30, Medicare announced (in a preliminary decision still in the comment phase) that it would cover the $93,000 price tag of Dendron Corporation's prostate cancer vaccine Provenge, which extends life for a few months in cancer patients.
Dendron's website currently runs an ad for Provenge called "Jonathan's story." In the ad, the patient says "fighting my cancer could mean meeting my new granddaughter, who is due in a few months." But ironically, current health care policy pits infant health against health care for the elderly.
Is it wise to pay for medication that could extend a long life a few months longer, while allowing companies to create financial barriers to accessing medicine that could help an infant get a healthy start on life? It isn't if you look at health care as a tool to extend healthy years of life, a view that is currently shifting kidney allocation rules, as I've blogged before. In an opinion piece in the Washington Post this weekend, a prostate cancer survivor points out a similar resource allocation problem with Provenge:
What happened? The active ingredient of the shot had been compounded by pharmacies as needed by physician request to prevent premature births in the past, while the FDA quietly looked the other way. But in February, the FDA officially approved KV Pharmaceutical's version of the shot, Makena, and KV Pharmaceutical decided to raise the price - a lot.
It was a stunning move for a product whose development was partially funded by taxpayers through the National Institutes of Health, and whose approval had been fast-tracked and supported by the FDA's Orphan Drug Act, according to a recent FDA statement. In response to public outcry, KV Pharmaceutical later dropped the price to $690 per dose.
Then, on March 30, Medicare announced (in a preliminary decision still in the comment phase) that it would cover the $93,000 price tag of Dendron Corporation's prostate cancer vaccine Provenge, which extends life for a few months in cancer patients.
Dendron's website currently runs an ad for Provenge called "Jonathan's story." In the ad, the patient says "fighting my cancer could mean meeting my new granddaughter, who is due in a few months." But ironically, current health care policy pits infant health against health care for the elderly.
Is it wise to pay for medication that could extend a long life a few months longer, while allowing companies to create financial barriers to accessing medicine that could help an infant get a healthy start on life? It isn't if you look at health care as a tool to extend healthy years of life, a view that is currently shifting kidney allocation rules, as I've blogged before. In an opinion piece in the Washington Post this weekend, a prostate cancer survivor points out a similar resource allocation problem with Provenge:
One thing I can assure you is that I would never ask Medicare to pay $93,000 for a treatment to extend my life four months. However, I would ask Medicare officials this: if Provenge is prescribed to me as a possible treatment and I turn it down, could I put the savings into a college fund trust account for my grandchildren? I feel the country would benefit much more from educating three of its citizens than from keeping me around another four months. I have a hunch Medicare's answer would be no.We need to ask what society owes to two vulnerable populations - pregnant young women at risk of preterm delivery, and terminally ill older men. Rather than pittting ACOG against the AARP, we should step back and ask what is a reasonable amount of funds to invest in protecting each of these populations. And what is a fair and ethical price to charge for the medications they need?
Tuesday, March 29, 2011
MD Face-Off: Generalists vs. Specialists
Much has been written about the shortage of primary-care doctors needed to treat the influx of patients anticipated when the Affordable Care Act is fully implemented in 2014. To help solve this problem, Kaiser Health News reported today that some states are expanding the role of nurse practitioners to serve as a patient's primary care provider. The KHN Daily Report also cited a Chicago Sun-Times article about the increasing number of medical school students who choose to enter primary care fields ("More young doctors choosing careers in primary care"). These students are spurred on by health care reform's financial incentives for this choice, such as increased Medicare reimbursement.
But like many things in medicine (heck, in life as well), fixing the problem is more complicated than it first appears. More doctors alone don't always mean better patient care. In February, The Commonwealth Fund reported that a nationwide survey of about 2,500 Medicare patients found that patients with more doctors in their area weren't any happier with their care than patients with fewer doctors in their area. Improving health policy and organizing health care networks better might be more effective than adding more doctors to the mix, the survey's authors said in Health Affairs, which posted the study.
And when we look at the "doctor shortage" problem, should we focus on supporting generalists or specialists? Fierce Healthcare recently reported that a shortage of surgeons (not general practitioners) in some areas of the country leads to higher mortality rates after motor vehicle accidents. A recent study in the Journal of the American College of Surgeons found that in areas with fewer surgeons, accident victims are less likely to receive timely life-saving surgery.
Not that every doctor should specialize, though, because specialization in medicine has its own limitations. The title of a March report from the New England Journal of Medicine shows the absurdity of current specialization trends: "Specialization, Subspecialization, and Subsubspecialization in Internal Medicine." The report's authors explain that formalized specialization fragments care, and the time spent maintaining certification might undermine a doctor's broader knowledge of his or her field. Patients, on the other hand, are impressed by the skill set implied by specialization. Health plans promote specialization as a marketing tool to attract more patients. There must be a reason to create each specialty, though, the authors write. "A proliferation of specialties without adequate justification may simply confuse the public without creating a social good," they conclude.
Ultimately, the problem of generalists versus specialists comes down to policy: what mix of generalists and specialists will best serve the public good? And what policies need to be in place to provide a steady supply of each type of doctor needed, and to help both types of doctors provide the best possible patient care?
But like many things in medicine (heck, in life as well), fixing the problem is more complicated than it first appears. More doctors alone don't always mean better patient care. In February, The Commonwealth Fund reported that a nationwide survey of about 2,500 Medicare patients found that patients with more doctors in their area weren't any happier with their care than patients with fewer doctors in their area. Improving health policy and organizing health care networks better might be more effective than adding more doctors to the mix, the survey's authors said in Health Affairs, which posted the study.
And when we look at the "doctor shortage" problem, should we focus on supporting generalists or specialists? Fierce Healthcare recently reported that a shortage of surgeons (not general practitioners) in some areas of the country leads to higher mortality rates after motor vehicle accidents. A recent study in the Journal of the American College of Surgeons found that in areas with fewer surgeons, accident victims are less likely to receive timely life-saving surgery.
Not that every doctor should specialize, though, because specialization in medicine has its own limitations. The title of a March report from the New England Journal of Medicine shows the absurdity of current specialization trends: "Specialization, Subspecialization, and Subsubspecialization in Internal Medicine." The report's authors explain that formalized specialization fragments care, and the time spent maintaining certification might undermine a doctor's broader knowledge of his or her field. Patients, on the other hand, are impressed by the skill set implied by specialization. Health plans promote specialization as a marketing tool to attract more patients. There must be a reason to create each specialty, though, the authors write. "A proliferation of specialties without adequate justification may simply confuse the public without creating a social good," they conclude.
Ultimately, the problem of generalists versus specialists comes down to policy: what mix of generalists and specialists will best serve the public good? And what policies need to be in place to provide a steady supply of each type of doctor needed, and to help both types of doctors provide the best possible patient care?
Monday, March 21, 2011
Japan and America, Post-Quake
I'm not a morning person, but on Friday, March 11 I woke up fast when I heard the news announcer on the clock radio say something about a 9.0 earthquake in Japan, and a tsunami afterward, heading for the West coast where I live. The tsunami arrived a few hours later, around 8:00 a.m. PST, smashing boats together in Santa Cruz.
Since then, I've been following the news out of Japan as closely as I can, both because I've been writing about it for work and because I live in California. First, there were fears of another major earthquake on the West coast, at the other end of the Pacific plate. Then the worries shifted to the damaged Fukushima Daiichi nuclear reactors in Japan that were leaking radioactive materials, a scenario made more vivid by a somewhat misleading New York Times forecast of the jet stream whipping its way east from Japan. Stories about panicked Americans buying potassium iodide began to pop up in the media.
There's a certain myopia at work here, though. With Japan 5,000 miles away, for example, the radiation risk to the West coast is minimal. People in Japan are obviously much, much closer to the source. Furthermore, some of the daily aftershocks in Japan are bigger than some of the big earthquakes we've had out here, such as the Loma Prieta quake in 1989, a 6.9 on the Richter scale. Our troubles are small in comparison to Japan.
I worry about natural (and manmade) disasters as much as the next person. I've got my earthquake kit - I put it together long ago - and water bottles stashed around the house. But right now it's Japan that needs our help, and whose problems loom the largest.
Since then, I've been following the news out of Japan as closely as I can, both because I've been writing about it for work and because I live in California. First, there were fears of another major earthquake on the West coast, at the other end of the Pacific plate. Then the worries shifted to the damaged Fukushima Daiichi nuclear reactors in Japan that were leaking radioactive materials, a scenario made more vivid by a somewhat misleading New York Times forecast of the jet stream whipping its way east from Japan. Stories about panicked Americans buying potassium iodide began to pop up in the media.
There's a certain myopia at work here, though. With Japan 5,000 miles away, for example, the radiation risk to the West coast is minimal. People in Japan are obviously much, much closer to the source. Furthermore, some of the daily aftershocks in Japan are bigger than some of the big earthquakes we've had out here, such as the Loma Prieta quake in 1989, a 6.9 on the Richter scale. Our troubles are small in comparison to Japan.
I worry about natural (and manmade) disasters as much as the next person. I've got my earthquake kit - I put it together long ago - and water bottles stashed around the house. But right now it's Japan that needs our help, and whose problems loom the largest.
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