Last month the FDA approved a DNA-based genetic test for the presence of human papilloma virus (HPV) as a first-choice screening option for cervical cancer. The DNA-based HPV test takes advantage of the fact that nearly all cases of cervical cancer are caused by HPV infections. The FDA’s decision means that women (and their doctors) can now choose the DNA-based test for the HPV virus over the traditional Pap test for screening for cervical cancer, if they wish.
Just because the FDA approved the test doesn’t mean that doctors are required to switch to it, though. It just means that it’s available as another option. The Pap test has been the gold standard for screening for cervical cancer for fifty years, whereas the DNA-based HPV test has only been around for about 10 years. Millions of women routinely get a pap test (or smear) every three to five years; many of them may be reluctant to switch. On the other hand, some doctors will undoubtedly recommend both tests, just to cover all bases.
The DNA-based HPV test is likely to cost about twice as much as the traditional Pap test, but neither test is very expensive (under $100). At the moment there are no recommendations from professional medical societies regarding how often the new test should be done, and whether (or under what conditions) it has any advantage over the Pap test.
Regardless of which screening test is used, a positive result (possible cancer) is generally checked for accuracy by a biopsy before any treatment is undertaken.
For more on screening tests for cervical cancer, see a previous blog post titled "New Guidelines Advise Less Frequent Pap Tests."
Friday, May 30, 2014
Wednesday, May 21, 2014
A Sperm Donor’s Child Custody Battle
Does a sperm donor have any parental rights? Can he be held financially responsible for supporting the child? Sperm donors, and persons who use donated sperm for in vitro fertilization procedures should consider the ramifications carefully before deciding how to proceed.
An anonymous sperm donor who donates to an anonymous recipient through a registered sperm bank usually signs away all rights and is absolved of any future responsibilities. However, if the sperm donor and recipient are in a relationship, or even if they just know each other, what is agreed to beforehand can make a big difference. A lack of an agreement could spell trouble.
Consider the case of actor Jason Patric. Four years ago he donated sperm to an ex-girlfriend for an in vitro fertilization procedure (they had been unable to conceive during their relationship). After the baby boy was born he and his ex-girlfriend remained on friendly terms, and he contributed financially and spent time with the boy. But then the relationship soured. Now she wants sole custody. She claims that Mr. Patric never intended to be an equal parent, and that he only agreed to donate his sperm on the condition that he not be held responsible. She points out that his name does not appear on the child’s birth certificate. Mr. Patric is suing for shared custody of the boy in the state of California. He claims that he has been part of the boy’s life from the beginning and that he intended to be a parent to the child when he donated his sperm.
However this case turns out, it's a cautionary tale for anyone who is not married to the other biological parent of their biological child. Make sure you have a legally binding agreement describing your rights and responsibilities (if any). It wouldn’t hurt to know laws of the your state of residence as well.
An anonymous sperm donor who donates to an anonymous recipient through a registered sperm bank usually signs away all rights and is absolved of any future responsibilities. However, if the sperm donor and recipient are in a relationship, or even if they just know each other, what is agreed to beforehand can make a big difference. A lack of an agreement could spell trouble.
Consider the case of actor Jason Patric. Four years ago he donated sperm to an ex-girlfriend for an in vitro fertilization procedure (they had been unable to conceive during their relationship). After the baby boy was born he and his ex-girlfriend remained on friendly terms, and he contributed financially and spent time with the boy. But then the relationship soured. Now she wants sole custody. She claims that Mr. Patric never intended to be an equal parent, and that he only agreed to donate his sperm on the condition that he not be held responsible. She points out that his name does not appear on the child’s birth certificate. Mr. Patric is suing for shared custody of the boy in the state of California. He claims that he has been part of the boy’s life from the beginning and that he intended to be a parent to the child when he donated his sperm.
However this case turns out, it's a cautionary tale for anyone who is not married to the other biological parent of their biological child. Make sure you have a legally binding agreement describing your rights and responsibilities (if any). It wouldn’t hurt to know laws of the your state of residence as well.
Monday, May 19, 2014
First Case of MERS Transmission Within the U.S.
According to the Centers for Disease Control and Prevention (CDC), an Illinois man has contracted the Middle East respiratory syndrome (MERS) virus in this country. There are now three confirmed cases of MERS virus in the U.S. The other two patients had traveled to or lived in Saudi Arabia. It is presumed that they picked up the virus there. The Illinois man met with the first MERS patient several times in the U.S. before the patient knew he was carrying the virus, and shook hands with him. He did not become particularly ill and did not require medical treatment.
MERS first appeared in humans in Saudi Arabia about two years ago. Scientists believe that it may have made the jump to humans from camels. It is a virus in the coronavirus family, making it a close relative of the common cold and of the SARS (sudden acute respiratory syndrome) virus that caused nearly 800 deaths a decade ago. Symptoms of MERS are similar to those of the common cold or flu, except that it can lead to pneumonia, kidney failure, and even death. Nearly 30% of the approximately 700 confirmed cases of MERS infection (most of them in the Middle East) have died. Transmission between humans seems to require close contact; most of the cases involve health care workers or relatives of infected patients.
A virus found in only three people in the U.S. hardly seems worth mentioning. Nevertheless, MERS is being watched closely because it is fairly deadly and because if it ever mutates to become easily transmissible (by casual contact, such as riding in the same bus), a major pandemic could ensue. For now, though, officials stress that the public is not at risk.
MERS first appeared in humans in Saudi Arabia about two years ago. Scientists believe that it may have made the jump to humans from camels. It is a virus in the coronavirus family, making it a close relative of the common cold and of the SARS (sudden acute respiratory syndrome) virus that caused nearly 800 deaths a decade ago. Symptoms of MERS are similar to those of the common cold or flu, except that it can lead to pneumonia, kidney failure, and even death. Nearly 30% of the approximately 700 confirmed cases of MERS infection (most of them in the Middle East) have died. Transmission between humans seems to require close contact; most of the cases involve health care workers or relatives of infected patients.
A virus found in only three people in the U.S. hardly seems worth mentioning. Nevertheless, MERS is being watched closely because it is fairly deadly and because if it ever mutates to become easily transmissible (by casual contact, such as riding in the same bus), a major pandemic could ensue. For now, though, officials stress that the public is not at risk.
Thursday, May 8, 2014
A Compounding Pharmacy Goes Bankrupt
New England Pharmacy Center, the compounding pharmacy responsible for preparing contaminated medications that ultimately sickened over 700 people in 20 states and caused 64 deaths (this blog Oct, 9, 2012) has gone into bankruptcy. According to a New York Times report, the bankruptcy settlement establishes a fund of approximately $100 million that will be used to compensate victims and their relatives.
This closes the book on a tragic accident that didn’t need to happen. As a result of this case, it came to light that many of today’s compounding pharmacies prepare medications for wide distribution to hospitals and doctors across state lines, while the regulation of pharmacies falls to the individual states’ pharmacy boards. There have been calls for national oversight of compounding pharmacies by the Food and Drug Administration (FDA), but so far the oversight is essentially voluntary (this blog Oct. 16, 2013).
We’ll hope there is not another tragic event in the future. Unfortunately, that may be what it takes before there is a stronger outcry for serious national oversight of compounding pharmacies that sell across state lines.
This closes the book on a tragic accident that didn’t need to happen. As a result of this case, it came to light that many of today’s compounding pharmacies prepare medications for wide distribution to hospitals and doctors across state lines, while the regulation of pharmacies falls to the individual states’ pharmacy boards. There have been calls for national oversight of compounding pharmacies by the Food and Drug Administration (FDA), but so far the oversight is essentially voluntary (this blog Oct. 16, 2013).
We’ll hope there is not another tragic event in the future. Unfortunately, that may be what it takes before there is a stronger outcry for serious national oversight of compounding pharmacies that sell across state lines.
Tuesday, May 6, 2014
WHO Report on Antimicrobial Resistance
A good source of current information on microbial resistance to antibiotics is the new World Health Organization (WHO) report entitled “Antimicrobial Resistance: Global Report on Surveillance 2014”. You can download a 7-page summary and/or the entire 257-page report.
The report paints a fairly gloomy picture of where we stand right now with respect to resistance to antibiotics. High rates of resistance to antibiotics are now found in common disease-causing bacteria in all regions of the world. To make matters worse, there are gaps in information gathering and surveillance that make it difficult to know the full extent of the problem. According to the summary, “The problem is so serious that it threatens the achievements of modern medicine.” The report warns that in this century we may return to an era similar to before antibiotics, when even simple infections and minor injuries routinely killed people.
The report concludes that improved surveillance is needed, and that governments will have to take action if we expect the situation to get any better. No surprise there. WHO is responsible for overseeing worldwide disease surveillance for the United Nations, but neither it nor the United Nations is empowered to take the kinds of specific actions that governments can take, such as passing laws to prevent antibiotic over-use or spending more money on antibiotic research. It’ll be interesting to see if anything comes of this report.
The report paints a fairly gloomy picture of where we stand right now with respect to resistance to antibiotics. High rates of resistance to antibiotics are now found in common disease-causing bacteria in all regions of the world. To make matters worse, there are gaps in information gathering and surveillance that make it difficult to know the full extent of the problem. According to the summary, “The problem is so serious that it threatens the achievements of modern medicine.” The report warns that in this century we may return to an era similar to before antibiotics, when even simple infections and minor injuries routinely killed people.
The report concludes that improved surveillance is needed, and that governments will have to take action if we expect the situation to get any better. No surprise there. WHO is responsible for overseeing worldwide disease surveillance for the United Nations, but neither it nor the United Nations is empowered to take the kinds of specific actions that governments can take, such as passing laws to prevent antibiotic over-use or spending more money on antibiotic research. It’ll be interesting to see if anything comes of this report.
Friday, May 2, 2014
Advanced Biofuels Production Targets Reduced
Most of the ethanol used in blended gasoline is produced from corn. Only about 15% is “advanced biofuels” - ethanol made from various types of non-food biomass such as cornstalks and corncobs, wheat stalks, wood chips, and the pulp waste from fruit processing.
Under the Energy Independence and Security Act of 2007 (EISA 2007), the EPA establishes specific production targets each year for corn ethanol and advanced biofuels. The EPA recently proposed reducing the production targets for 2014. A large proportion of the proposed reduction will come at the expense of advanced biofuels. Back in 2007, EISA set a target for advanced biofuel production of 21 billion gallons by 2022. With a proposed 2014 production rate of only 2.2 billion gallons, that target looks like a pipe dream now.
Why is the EPA reducing its targets for advanced biofuels? A steady supply of corn ethanol is one reason. In addition, gasoline manufacturers (and even the publics) general dislike the mandate that ethanol be blended with gasoline. The original proposal was that gasoline should eventually contain 15% ethanol, but resistance to the higher level means that most gasoline still only contains 10% ethanol. With corn alcohol production high and fuel alcohol demand low, advanced biofuels aren’t really needed right now.
The new proposed production targets may create difficulties for several companies doing research into advanced biofuels, as well as those companies currently building production facilities. That’s too bad, because in the long run it would be nice to be able to produce ethanol economically from something other than a food source (corn).
Under the Energy Independence and Security Act of 2007 (EISA 2007), the EPA establishes specific production targets each year for corn ethanol and advanced biofuels. The EPA recently proposed reducing the production targets for 2014. A large proportion of the proposed reduction will come at the expense of advanced biofuels. Back in 2007, EISA set a target for advanced biofuel production of 21 billion gallons by 2022. With a proposed 2014 production rate of only 2.2 billion gallons, that target looks like a pipe dream now.
Why is the EPA reducing its targets for advanced biofuels? A steady supply of corn ethanol is one reason. In addition, gasoline manufacturers (and even the publics) general dislike the mandate that ethanol be blended with gasoline. The original proposal was that gasoline should eventually contain 15% ethanol, but resistance to the higher level means that most gasoline still only contains 10% ethanol. With corn alcohol production high and fuel alcohol demand low, advanced biofuels aren’t really needed right now.
The new proposed production targets may create difficulties for several companies doing research into advanced biofuels, as well as those companies currently building production facilities. That’s too bad, because in the long run it would be nice to be able to produce ethanol economically from something other than a food source (corn).
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