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?
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