How the FDA’s drug regulations may mean the death of capital punishment.
original post date: April 6, 2011
Last month, Eric John King was put to death in Florence, Arizona, for committing a double homicide during a convenience store robbery gone wrong. As is their duty, King’s attorneys worked every last angle in an attempt to spare their client the ultimate punishment. As the burden is on the state to execute people by the book, so much of the legal jockeying is less focused on proving innocence than snagging the process in the bramble of regulation surrounding capital punishment. It may come as a surprise to note that, even in the world of executions, some of those regulations came from the FDA.
The majority of states in the US practice capital punishment, and all of them that do use lethal injection as their primary method. Most of these states use a method of injection that requires drugs that are becoming increasingly difficult to obtain legally, and as a result, incidents are cropping up in which the drugs’ origins are being called into question. These questions involve complex rules, licenses, and procedures that, in the end, are designed to keep us safe from harmful substances. In a great irony, these rules are proving tight enough to keep even the condemned from injections that—to put it mildly—may be hazardous to their health.
The Arizona Republic for example, recently reported that one of the drugs used in Arizona executions had been labeled for animal use. The furor over this died as it was found to be a clerical error, but the incident shows how touchy and intricate death penalty drug issues can be.
Arizona, along with all but three states that perform lethal injections, uses three drugs to execute prisoners. Sodium thiopental is used as an anesthetic—outside of an execution chamber, it has been used to induce coma. Pancuronium bromide, a muscle relaxant, paralyzes the prisoner. Potassium chloride is the third drug, administered to induce a severe case of hyperkalemia, an excess of potassium, which prevents the heart muscle from contracting. The anesthetic, sodium thiopental, is no longer produced in the United States at all, causing a problem for any three-drug execution state.
How do the prison systems get around this? By importing it from other countries—and from domestic labs with inexplicable surplus. Kentucky, for example, contacted a pharmaceutical company in India, then obtained a supply from an entity in the state of Georgia. The legality of both their contact with the Indian company and the manner in which the Georgia group came to be in possession of the drug are being questioned by public defenders.
Another public defender, Dale Baich of Phoenix, called for a Justice Department probe after Arizona got its supply from Dream Pharma in the UK. The company “appears to be a closely held corporation run by a husband and wife. According to press reports, the entire operation is run out of the back of a West London driving school,” says Baich in a letter to the DOJ. In November of last year, Britain shut down its export of sodium thiopental for non-medical purposes. Baich’s letter to the DOJ indicates that Arizona obtained the drug in September, before the ban was instated. By now, you may be asking questions as to why the DOJ would want to get involved—it doesn’t look like anything clearly illegal has taken place.
The answer? It’s all about the paperwork. Baich’s letter alleges that ADC failed to file proper paperwork in the DEA, a registration to import controlled substances, and a declaration document when Arizona actually imported the thiopental. That could end up being Baich’s silver bullet. To drive the point home, he cites an email sent from an FDA official in Phoenix to one in Memphis, where the shipment was to land, saying “Please do not detain this entry.” Allegedly, the email was sent following a request for assistance by ADC Director Ryan.
The email is significant because of a similar development regarding another state’s importation of the same drug. Georgia Department of Corrections had a delivery of sodium thiopental held up by customs in Memphis, then seized by the DEA. According to the Atlanta Journal-Constitution, Georgia had failed to register with the DEA for the importation of drugs, and had failed to declare the shipment—exactly what Baich accuses Arizona of doing. According to documents he received, Georgia had even obtained their supply from the same British company that supplied Arizona. Due to the seizure of Georgia’s thiopental, the state has delayed executions indefinitely.
All of this adds up to a threat to capital punishment in Arizona, and any other state that uses thiopental in executions. If the situation were deemed by DOJ to be a “threat to public health or safety,” the law allows DEA to take more than just the thiopental. According to Baich, because ADC’s license to possess controlled substances could be revoked, all controlled substances—which would include the other execution drugs—in the department’s possession could be ordered to be sealed or delivered to the DEA. In this situation, executions in Arizona might be delayed indefinitely, as in Georgia.
It doesn’t look good for other states, either. Sodium thiopental, like most drugs, has an expiration date, so even those states that don’t have a high death row population will need to seek out new batches of the drug in the near future. Europe on the whole (except Belarus) opposes the death penalty, so if the British ban on thiopental exports is any indication, European countries will not help US states in this matter.
ADC has claimed innocence; a representative told BioMindShare via email, “[Our] Documents show the chemicals were obtained lawfully and with the assistance of the FDA and Customs. We also have a DEA certificate that allows for the importation of the chemicals.” Nevertheless, Ryan plans to switch to a one-drug procotol for lethal injections in the near future.
The one drug will likely be pentobarbitol, a drug already used to euthanize animals—Ohio used it in March of this year to execute prisoner Johnnie Baston. The switch to one drug might actually allow lethal injection to continue in Arizona without interruption, even if the DEA intercedes—in the Georgia case, the agency only took the thiopental, leaving them with the other two drugs. A one-drug system avoids that contingency entirely, as they don’t need the thiopental to proceed.
If it looks to you like ADC wins and the public defenders lose, remember that, for an attorney in the service of a death row inmate, any delay to the system could potentially save your client’s life. This comes out in Baich’s opinion on the one-drug switch, “Even if Arizona switches to a one drug protocol, the fact remains that the sodium thiopental was illegally imported.” He added, “The drug should still be seized as it could be used for another purpose.”
And that is what all of the legal wrangling is driving at—while states may be sovereign enough to decide whether or not they execute prisoners, they cannot override the FDA’s and the DEA’s mission to keep drugs from killing people. Even if the drugs they want are meant to kill people.
Tuesday, August 16, 2011
The Printed Kidney
Originally posted Feb 2011.
Researchers may soon make human organs with an inkjet printer. Really.
At TED, everyone’s favorite meetup of really amazing nerds, strange things are expected, but none quite as strange, to me at least, as Anthony Atala’s live fabrication of a kidney shape in front of the auditorium audience, using a specially designed printer. I had heard of making plastic or metal parts via “rapid prototyping”, also known as “3D printing”, but I had never heard of it being done for tissue. Let me reiterate, though, this kidney is not yet real.
Reports of real kidneys popping out of Hewlett-Packards are greatly, and accidentally, exaggerated. Popular Science reported that the kidney was real, and linked to another article that also said the kidney was real. Fast Company reported that Luke Massella, the young man who appeared as Dr. Atala’s guest for the presentation had received a regenerated kidney, not a regenerated bladder. Wake Forest University, Dr. Atala’s employer, had to put out a press release correcting the errors. (Note that @TEDNews, one of the official TED Twitter accounts, posted “Today's #TED, fresh from TED2011: Anthony Atala prints a human kidney” even after that press release.)
On the one hand this is unfortunate, because it makes this breakthrough seem a little less amazing than it really is (and could lead people to mistakenly believe that the need for organ donors is diminishing). On the other hand, this is terrible, because there were so many amazingly cool parts of that presentation that went largely unnoticed by the press.
For example, some of this regenerative stuff is already being done. Not just “kidney shapes”, but actual reconstruction of body parts. Dr. Atala showed two x-rays of a patient with what appeared to be a collapsed vein or duct (further research showed it to be a urethra), then a later x-ray with the urethra intact, having been partially replaced with lab-grown tissue. That’s pretty amazing stuff! Dr. Atala also showed how some prototype organ construction has taken place inside repurposed commercial inkjet printers, which struck a chord with me, as an admirer of the DIY ethos. (Note that the kidney was not printed on an inkjet.)
As for the speculative part of the talk, Dr. Atala showed how people with flesh wounds might one day be scanned by an optical scanner while lying on an operating table, then have the right replacement tissue printed right onto the existing tissue. You know in episodes of Star Trek, where the doctor waves his or her magical cylinder in front of the patient, and the wound just disappears? That.
There were enough truly amazing parts of the presentation that it’s just a shame that the facts were distorted. My advice? Go to the source; watch the TED video, and check out the Wake Forest Institute of Regenerative Medicine site. It’s truly amazing what these researchers are doing.
Researchers may soon make human organs with an inkjet printer. Really.
At TED, everyone’s favorite meetup of really amazing nerds, strange things are expected, but none quite as strange, to me at least, as Anthony Atala’s live fabrication of a kidney shape in front of the auditorium audience, using a specially designed printer. I had heard of making plastic or metal parts via “rapid prototyping”, also known as “3D printing”, but I had never heard of it being done for tissue. Let me reiterate, though, this kidney is not yet real.
Reports of real kidneys popping out of Hewlett-Packards are greatly, and accidentally, exaggerated. Popular Science reported that the kidney was real, and linked to another article that also said the kidney was real. Fast Company reported that Luke Massella, the young man who appeared as Dr. Atala’s guest for the presentation had received a regenerated kidney, not a regenerated bladder. Wake Forest University, Dr. Atala’s employer, had to put out a press release correcting the errors. (Note that @TEDNews, one of the official TED Twitter accounts, posted “Today's #TED, fresh from TED2011: Anthony Atala prints a human kidney” even after that press release.)
On the one hand this is unfortunate, because it makes this breakthrough seem a little less amazing than it really is (and could lead people to mistakenly believe that the need for organ donors is diminishing). On the other hand, this is terrible, because there were so many amazingly cool parts of that presentation that went largely unnoticed by the press.
For example, some of this regenerative stuff is already being done. Not just “kidney shapes”, but actual reconstruction of body parts. Dr. Atala showed two x-rays of a patient with what appeared to be a collapsed vein or duct (further research showed it to be a urethra), then a later x-ray with the urethra intact, having been partially replaced with lab-grown tissue. That’s pretty amazing stuff! Dr. Atala also showed how some prototype organ construction has taken place inside repurposed commercial inkjet printers, which struck a chord with me, as an admirer of the DIY ethos. (Note that the kidney was not printed on an inkjet.)
As for the speculative part of the talk, Dr. Atala showed how people with flesh wounds might one day be scanned by an optical scanner while lying on an operating table, then have the right replacement tissue printed right onto the existing tissue. You know in episodes of Star Trek, where the doctor waves his or her magical cylinder in front of the patient, and the wound just disappears? That.
There were enough truly amazing parts of the presentation that it’s just a shame that the facts were distorted. My advice? Go to the source; watch the TED video, and check out the Wake Forest Institute of Regenerative Medicine site. It’s truly amazing what these researchers are doing.
Biting Back
Originally posted Mar 2011
Genetically engineered fungi may eradicate malaria.
Scientists from University of Maryland, Johns Hopkins, and University of Westminster (UK) have done something very impressive. They’ve managed to develop a method which might make malaria a thing of the past, even in the developing world, using genetically-modified fungi that either kill the parasites responsible, or prevent them from entering the human bloodstream from mosquito bites.
Malaria is a particularly difficult problem for biologists, because of the nature of the organism responsible for it. Protists of the genus Plasmodium are the culprits, and as protists, they have features similar to those of animal cells. This makes it difficult to target them with drugs, and the parasites (there are 11 species of Plasmodium that cause human malaria) have evolved resistance to a number of drugs that had at one point proved effective.
The scientists’ plan, then, was to attack the mosquito that carries Plasmodium. They had heard that certain types of fungus acted as a sort of natural insecticide, and started from there. This fungus, Metarhizium anisopliae, doesn’t kill the mosquitoes until they are older, allowing them time to reproduce. This prevents them from building an evolutionary resistance to this new agent. The fungus was then modified in two ways: one change caused the mosquito salivary glands to be coated with a film, preventing the entry of Plasmodium into the glands (and hence its subsequent injection into humans), the second expressed a venom found in scorpions, which killed Plasmodium.
The fungus would likely be applied as a spray or a liquid to the mosquitoes’ habitat, or perhaps the humans’. Existing fungal agents intended to be used as insecticides are sold as suspensions of the fungal spores in water. It might also be possible to grow the fungus in the regions affected, increasing their ability to protect humans at even lower cost.
If this fungus could be made into an effective anti-malarial agent (and there’s little reason to believe it couldn’t), it would go a very long way toward freeing the developing world of the third most deadly single infectious disease. What’s more, it would show the biological community and the world that there are still giant advances to be made in disease control.
Today’s disease-fighting world is itching for good news. Cancer and AIDS are still raging, and even less-sophisticated diseases like tuberculosis are vexing, complicated by unpredictable patterns of human behavior. Assuming this cure will work in the world at large, and eradicates malaria as expected, the benefit to biology in general would likely be tremendous, if only to raise its spirits.
These scientists took a problem and presented a good possible solution that wasn’t simple, wasn’t obvious, and required knowledge of several sub-fields. They are perfect examples of what modern scientists should be: widely knowledgeable and able to draw on previous research without being constrained by it. Congratulations, researchers, and thank you.
For further information on the fungus and the research behind it, refer to this Wired / Ars Technica article.
Genetically engineered fungi may eradicate malaria.
Scientists from University of Maryland, Johns Hopkins, and University of Westminster (UK) have done something very impressive. They’ve managed to develop a method which might make malaria a thing of the past, even in the developing world, using genetically-modified fungi that either kill the parasites responsible, or prevent them from entering the human bloodstream from mosquito bites.
Malaria is a particularly difficult problem for biologists, because of the nature of the organism responsible for it. Protists of the genus Plasmodium are the culprits, and as protists, they have features similar to those of animal cells. This makes it difficult to target them with drugs, and the parasites (there are 11 species of Plasmodium that cause human malaria) have evolved resistance to a number of drugs that had at one point proved effective.
The scientists’ plan, then, was to attack the mosquito that carries Plasmodium. They had heard that certain types of fungus acted as a sort of natural insecticide, and started from there. This fungus, Metarhizium anisopliae, doesn’t kill the mosquitoes until they are older, allowing them time to reproduce. This prevents them from building an evolutionary resistance to this new agent. The fungus was then modified in two ways: one change caused the mosquito salivary glands to be coated with a film, preventing the entry of Plasmodium into the glands (and hence its subsequent injection into humans), the second expressed a venom found in scorpions, which killed Plasmodium.
The fungus would likely be applied as a spray or a liquid to the mosquitoes’ habitat, or perhaps the humans’. Existing fungal agents intended to be used as insecticides are sold as suspensions of the fungal spores in water. It might also be possible to grow the fungus in the regions affected, increasing their ability to protect humans at even lower cost.
If this fungus could be made into an effective anti-malarial agent (and there’s little reason to believe it couldn’t), it would go a very long way toward freeing the developing world of the third most deadly single infectious disease. What’s more, it would show the biological community and the world that there are still giant advances to be made in disease control.
Today’s disease-fighting world is itching for good news. Cancer and AIDS are still raging, and even less-sophisticated diseases like tuberculosis are vexing, complicated by unpredictable patterns of human behavior. Assuming this cure will work in the world at large, and eradicates malaria as expected, the benefit to biology in general would likely be tremendous, if only to raise its spirits.
These scientists took a problem and presented a good possible solution that wasn’t simple, wasn’t obvious, and required knowledge of several sub-fields. They are perfect examples of what modern scientists should be: widely knowledgeable and able to draw on previous research without being constrained by it. Congratulations, researchers, and thank you.
For further information on the fungus and the research behind it, refer to this Wired / Ars Technica article.
I, For One, Welcome Our New Robot Doctor Overlords
Originally posted Feb 2011
Jeopardy-playing robots are attempting to enter the medical field, and will terminate all human resistance.
IBM's Watson artificial intelligence program wowed the nation last Wednesday with a major victory against the quiz show's prima donna Ken Jennings, and Brad Rutter, holder of the record for most money won on the program. Jennings, in a moment of snark, forewent a Final Jeopardy answer for a reference to The Simpsons: “I, for one, welcome our new robot overlords.” Medical interns may soon have reason to say the same thing, only without the sarcasm.
IBM has been partnering with Nuance Communications, producers of artificial intelligence software applications that read text and recognize speech, to retool Watson for use in making diagnoses. Doctors at Columbia University and University of Maryland are working to decide just how best Watson could help them. This is an amazing opportunity to quickly advance humans' ability to diagnose disease, but it could be frightening for those just entering the medical profession.
Will Watson put recent med school graduates out on the street? Jennings said, in an essay he wrote for Slate, “Brad and I were the first knowledge-industry workers put out of work by the new generation of "thinking" machines. "Quiz show contestant" may be the first job made redundant by Watson, but I'm sure it won't be the last.” It's conceivable that a number of medical professionals may be afraid that they'll be next on the list.
Dr. Herbert Chase of Columbia doesn't think so: “My hunch is that [Watson] is going to be embraced...it is very painful...for a physician...to be aware of the information gaps they can't bridge, even using the most current, up-to-date technology,” he stated at a TED-sponsored discussion at IBM's research facility. David Ferrucci, the project's principal investigator, said, “[it] isn't about giving you the final and end-all answer.”
The consensus appeared to be that Watson provides a non-human value to a physician's judgment, rather than replacing doctors or assistants (the term Dr. Chase used was “Physician Support”). For doctors, answering their own questions is a very time intensive task, as research is the only cure for the inevitable gaps in professionals' medical knowledge. As Chase put it, “Humans are incapable of managing the opus.” Watson's gift to doctors, then, is to slash book-and-journal research time from hours to seconds.
As the “opus” increases to even more unwieldy sizes, technological research assistants are going to become more and more necessary. If humans want to maintain mastery over the tremendous amount of data in the world, they'll need machines that can read and recall at rates beyond our limited capacity. But these machines lack curiosity, the one area humans will eternally dominate.
Jeopardy-playing robots are attempting to enter the medical field, and will terminate all human resistance.
IBM's Watson artificial intelligence program wowed the nation last Wednesday with a major victory against the quiz show's prima donna Ken Jennings, and Brad Rutter, holder of the record for most money won on the program. Jennings, in a moment of snark, forewent a Final Jeopardy answer for a reference to The Simpsons: “I, for one, welcome our new robot overlords.” Medical interns may soon have reason to say the same thing, only without the sarcasm.
IBM has been partnering with Nuance Communications, producers of artificial intelligence software applications that read text and recognize speech, to retool Watson for use in making diagnoses. Doctors at Columbia University and University of Maryland are working to decide just how best Watson could help them. This is an amazing opportunity to quickly advance humans' ability to diagnose disease, but it could be frightening for those just entering the medical profession.
Will Watson put recent med school graduates out on the street? Jennings said, in an essay he wrote for Slate, “Brad and I were the first knowledge-industry workers put out of work by the new generation of "thinking" machines. "Quiz show contestant" may be the first job made redundant by Watson, but I'm sure it won't be the last.” It's conceivable that a number of medical professionals may be afraid that they'll be next on the list.
Dr. Herbert Chase of Columbia doesn't think so: “My hunch is that [Watson] is going to be embraced...it is very painful...for a physician...to be aware of the information gaps they can't bridge, even using the most current, up-to-date technology,” he stated at a TED-sponsored discussion at IBM's research facility. David Ferrucci, the project's principal investigator, said, “[it] isn't about giving you the final and end-all answer.”
The consensus appeared to be that Watson provides a non-human value to a physician's judgment, rather than replacing doctors or assistants (the term Dr. Chase used was “Physician Support”). For doctors, answering their own questions is a very time intensive task, as research is the only cure for the inevitable gaps in professionals' medical knowledge. As Chase put it, “Humans are incapable of managing the opus.” Watson's gift to doctors, then, is to slash book-and-journal research time from hours to seconds.
As the “opus” increases to even more unwieldy sizes, technological research assistants are going to become more and more necessary. If humans want to maintain mastery over the tremendous amount of data in the world, they'll need machines that can read and recall at rates beyond our limited capacity. But these machines lack curiosity, the one area humans will eternally dominate.
The Soy Sauce Incident
Originally posted Mar 2011.
A UVA freshman gets a crash course in biochemistry.
On February 28th, University of Virginia student John Paul Boldrick was dared by members of the Zeta Psi fraternity to drink a whole bottle of soy sauce. He accepted the challenge, and was later found on the second floor of the fraternity house, foaming at the mouth and seizing. He was rushed to a nearby hospital and treated. Could drinking a bottle of a common household condiment really be so dangerous? The short answer: Absolutely.
Mr. Boldrick was suffering from hypernatremia, or an excess of sodium. Most people who experience hypernatremia do so in conjunction with a larger set of symptoms we are familiar with as dehydration. In that condition, the hypovolemic type as it is called, reintroduction of water generally resolves any problems before they become severe.
Of course, being a college student off to explore new territory, Mr. Boldrick chose the less common, hypervolemic type, in which a high-sodium fluid is introduced into the system. Generally, this only happens in resuscitation cases, when patients are often given sodium bicarbonate, or in nautical accident victims, as seawater is often ingested. Doing some quick back of the napkin calculations based on a bottle I have in my fridge, I found that if Boldrick drank what I have (Kikkoman 10 fl oz bottle), he got a whopping 18,400 mg of sodium, almost 9 times the FDA’s Daily Reference Value level.
Contracting hypernatremia from ingesting sodium is particularly tricky to treat. The fact that most hypernatremics are also dehydrated makes adding fluids fairly easy; their problem isn’t as much the excess sodium but the high concentration of it due to lack of water. This case however, would have required a more delicate touch, as much more sodium was in his system than could have been easily diluted. Doctors proceeded with caution, as rebalancing his sodium levels too quickly could have led to cerebral edema, causing seizure, brain damage, or death.
The story of Sacramento resident Jennifer Strange is similar to Boldrick’s, the Zeta pledge. In 2007 Strange was competing in a radio contest entitled “Hold Your Wee for a Wii.” In Strange’s case, however, it was an excess of water rather than sodium that caused the problem. Holding back from urinating gave Strange an acute case of water intoxication, also known as hyponatremia (in contrast to Boldrick’s hypernatremia). Lower concentrations of sodium in the blood can also be dangerous.
Four days after his hospitalization, Boldrick was released, returning to his life of fraternity partying hopefully the wiser. Strange, however, was less fortunate—she died in her home the day of the contest. The takeaway from all this? Don’t participate in stunts like these. They are far more dangerous than most people realize.
A UVA freshman gets a crash course in biochemistry.
On February 28th, University of Virginia student John Paul Boldrick was dared by members of the Zeta Psi fraternity to drink a whole bottle of soy sauce. He accepted the challenge, and was later found on the second floor of the fraternity house, foaming at the mouth and seizing. He was rushed to a nearby hospital and treated. Could drinking a bottle of a common household condiment really be so dangerous? The short answer: Absolutely.
Mr. Boldrick was suffering from hypernatremia, or an excess of sodium. Most people who experience hypernatremia do so in conjunction with a larger set of symptoms we are familiar with as dehydration. In that condition, the hypovolemic type as it is called, reintroduction of water generally resolves any problems before they become severe.
Of course, being a college student off to explore new territory, Mr. Boldrick chose the less common, hypervolemic type, in which a high-sodium fluid is introduced into the system. Generally, this only happens in resuscitation cases, when patients are often given sodium bicarbonate, or in nautical accident victims, as seawater is often ingested. Doing some quick back of the napkin calculations based on a bottle I have in my fridge, I found that if Boldrick drank what I have (Kikkoman 10 fl oz bottle), he got a whopping 18,400 mg of sodium, almost 9 times the FDA’s Daily Reference Value level.
Contracting hypernatremia from ingesting sodium is particularly tricky to treat. The fact that most hypernatremics are also dehydrated makes adding fluids fairly easy; their problem isn’t as much the excess sodium but the high concentration of it due to lack of water. This case however, would have required a more delicate touch, as much more sodium was in his system than could have been easily diluted. Doctors proceeded with caution, as rebalancing his sodium levels too quickly could have led to cerebral edema, causing seizure, brain damage, or death.
The story of Sacramento resident Jennifer Strange is similar to Boldrick’s, the Zeta pledge. In 2007 Strange was competing in a radio contest entitled “Hold Your Wee for a Wii.” In Strange’s case, however, it was an excess of water rather than sodium that caused the problem. Holding back from urinating gave Strange an acute case of water intoxication, also known as hyponatremia (in contrast to Boldrick’s hypernatremia). Lower concentrations of sodium in the blood can also be dangerous.
Four days after his hospitalization, Boldrick was released, returning to his life of fraternity partying hopefully the wiser. Strange, however, was less fortunate—she died in her home the day of the contest. The takeaway from all this? Don’t participate in stunts like these. They are far more dangerous than most people realize.
Saturday, August 13, 2011
Why Myriad Still Matters
Originally posted Feb 2011
The bellwether case in genetic rights will set the tone for the foreseeable future of biotech.
Filed in May 2009, Association for Molecular Pathology v. U.S. Patent and Trademark Office, often called the Myriad case, pits Myriad Genetics and the Patent Office against an assortment of professional associations and individual plaintiffs. The case is to determine whether BRCA1 and BRCA2, genes associated with breast and ovarian cancers, can be patented. Myriad, the University of Utah, and National Institute of Environmental Health Sciences were granted patents on the two genes in the late 1990s.
District Court Judge Robert W. Sweet ruled against the defendants in March of last year, saying that “patents ... directed to 'isolated DNA' containing sequences found in nature are unsustainable as a matter of law”. This is a serious ruling for biotech firms, people at risk for cancer, and civil rights activists in general. Beyond that, however, it also invalidated the rest of the essentially immeasurable pool of patents on genes. (And I mean “immeasurable”: sources list the number anywhere between 2,000 and 500,000.)
The ruling is, of course, being appealed. Considering the effects this change in operating procedures would have on the entire genetic world, the Myriad case will almost certainly reach the Supreme Court of the United States. What the highest court in the land will do is anyone’s guess—while the justices have a tendency to break toward the interests of corporations, Mr. Sweet’s opinion appears to be well-founded. The Department of Justice filed an amicus brief in support of the plaintiffs in the most recent appeal.
Well, sort of. What they did was to file a brief that supported the concept that an unmodified human gene is unpatentable. They did not comment on the patenting of cDNA (complimentary DNA, a type of DNA created in the lab) that contains identical information. Judge Sweet’s ruling made all isolated DNA encoding sequences found in nature ineligible for patent. Essentially, the DoJ disagreed that the genetic information was protected from patent by virtue of being found in nature; only the DNA itself was out of reach.
This is much different from precedent set on other information licensing. If, for example, a work is in the public domain, it remains in the public domain, no matter where it resides. You cannot patent the concept of having the complete works of William Shakespeare on a USB drive. You can patent the USB drive, but you cannot patent the work that is already free for public use. However, apparently, you can patent the expression of BRCA1 in cDNA without having to patent either BRCA1 or cDNA.
It appears (if only to me) that, in the end, the Supreme Court decision will at the very least invalidate the patents held by the defendants on genetic information already expressed on existing non-synthesized human DNA. This will likely open the way for most of the rest of the patented genome to be released.
To this reporter, that sounds like a good thing. What could possibly be wrong with an open genome?
The bellwether case in genetic rights will set the tone for the foreseeable future of biotech.
Filed in May 2009, Association for Molecular Pathology v. U.S. Patent and Trademark Office, often called the Myriad case, pits Myriad Genetics and the Patent Office against an assortment of professional associations and individual plaintiffs. The case is to determine whether BRCA1 and BRCA2, genes associated with breast and ovarian cancers, can be patented. Myriad, the University of Utah, and National Institute of Environmental Health Sciences were granted patents on the two genes in the late 1990s.
District Court Judge Robert W. Sweet ruled against the defendants in March of last year, saying that “patents ... directed to 'isolated DNA' containing sequences found in nature are unsustainable as a matter of law”. This is a serious ruling for biotech firms, people at risk for cancer, and civil rights activists in general. Beyond that, however, it also invalidated the rest of the essentially immeasurable pool of patents on genes. (And I mean “immeasurable”: sources list the number anywhere between 2,000 and 500,000.)
The ruling is, of course, being appealed. Considering the effects this change in operating procedures would have on the entire genetic world, the Myriad case will almost certainly reach the Supreme Court of the United States. What the highest court in the land will do is anyone’s guess—while the justices have a tendency to break toward the interests of corporations, Mr. Sweet’s opinion appears to be well-founded. The Department of Justice filed an amicus brief in support of the plaintiffs in the most recent appeal.
Well, sort of. What they did was to file a brief that supported the concept that an unmodified human gene is unpatentable. They did not comment on the patenting of cDNA (complimentary DNA, a type of DNA created in the lab) that contains identical information. Judge Sweet’s ruling made all isolated DNA encoding sequences found in nature ineligible for patent. Essentially, the DoJ disagreed that the genetic information was protected from patent by virtue of being found in nature; only the DNA itself was out of reach.
This is much different from precedent set on other information licensing. If, for example, a work is in the public domain, it remains in the public domain, no matter where it resides. You cannot patent the concept of having the complete works of William Shakespeare on a USB drive. You can patent the USB drive, but you cannot patent the work that is already free for public use. However, apparently, you can patent the expression of BRCA1 in cDNA without having to patent either BRCA1 or cDNA.
It appears (if only to me) that, in the end, the Supreme Court decision will at the very least invalidate the patents held by the defendants on genetic information already expressed on existing non-synthesized human DNA. This will likely open the way for most of the rest of the patented genome to be released.
To this reporter, that sounds like a good thing. What could possibly be wrong with an open genome?
Medicare Fraud
Medicareless
Are we doing all we can to prevent Medicare fraud?
Last Friday, the Wall Street Journal[http://online.wsj.com/article/SB10001424052748704657704576150293189313156.html] reported that 114 doctors and other professionals have been arrested for fraudulent Medicare claims, ranging from “unbundling” procedures that should have been billed together for a lower cost, to charging for extensive and expensive procedures that were simply never performed. The FBI crackdown led to arrests in nine metropolitan areas across the US, uncovering roughly $240 million in fraud.
This series of arrests is an interesting development in the world of Medicare fraud—the doctors worked alone or with few accomplices, rather than in a network. Compare that to the 2010 arrest of a ring allegedly led by Armen Kazarian. In the Kazarian ring, the fraudulent claims are thought to have been submitted by non-doctors using the stolen identities of real doctors and patients. Authorities claim the network brought in $100 million in fraudulent revenue, according to MSNBC[http://www.msnbc.msn.com/id/39657964/ns/us_news-crime_and_courts/].
Neither of these enforcement crackdowns is even vaguely assumed to be a majority of, or even a major portion of the total Medicare fraud that exists in the country today, and the money recovered by both the 2010 and the 2011 operations combined would account for seven hundredths of a percent of the $452 billion dollars in federal spending on the program in 2010. But if Medicare is seen as a program that is easily gamed and poorly policed, it seems likely that in the long term, it will cease to perform its intended function. Indeed, in our politically turbulent time, it may one day disappear completely.
Dow Jones, last month, filed papers to obtain access to Medicare records. If Dow has its way, a 1979 ruling in favor of the American Medical Association will be overturned, allowing the public to see the records. The AMA’s concern, then, and most likely now, is privacy. And this is where it gets tricky. If the records are allowed to remain completely private, the Medicare Fraud Strike Force (consisting of FBI, Health and Human Services, and Department of Justice officials) will be only body that can provide Medicare oversight. If the records are opened, patients’ rights may be violated.
This appears to be an unresolvable situation, but if doctors and patients want programs like Medicare to continue, they’ll have to prove to a hostile crowd that the programs work, and that means both decreasing the amount of money billed and decreasing the amount of fraud that’s committed. It means moving beyond a perfunctory nod to the education of doctors and patients on identifying and reporting fraud, waste, and abuse.
Take, for example, the way to get teachers to stop cheating for their students on proctored exams. Early in the last decade, Steven Levitt and Brian Jacob, experts in behavioral economics, were hired by then-chair of Chicago Public Schools, Arne Duncan (now head of the US Department of Education), to find out which teachers were cheating. Having selected some suspicious and some non-suspicious teachers for the test, they allowed the teachers to proctor their exams like normal, then re-tested the students with different proctors. The results were predictable; suspicions were largely confirmed. The upshot, though, was that after the resulting wave of firings, cheating in the next year declined 30%.
Unfortunately, we're still left with the question: how do we beat Medicare fraud?
Hunting Demons
Originally posted in Feb 2011
Tuberculosis should be extinct, but it’s not.
An editorial in the most recent Lancet notes that in 1911, the journal’s editor wrote that he was looking forward to the day when “the demon of tuberculosis” would finally be eradicated. Though society and medicine have, of course, made great strides in the last 100 years, the “demon” still exists, especially among homeless populations in large cities.
The writer of this year’s Lancet editorial notes that in Toronto, the percentage of homeless people who die within after diagnosis has remained unchanged over the last ten years. Getting people diagnosed, and after diagnosis, getting them to follow medication dosing instructions are complicated tasks when patients are homeless. New York City’s approach is called “active case finding” and it involves going out into the streets and finding people who need treatment. Patients are admitted to an intermediate care facility, where their treatment is monitored.
Tuberculosis rates are declining in New York City, as reported in this New York Times blog, such that the vast majority of cases in the City now are immigrants from other countries. While such a decline could be due to a number of factors, it’s quite possible that this case finding program is responsible for the drop. What appears to be true in either case is that, as far as TB risk goes, you’re better off as a homeless New Yorker than an immigrant. What’s more, multi-drug resistant TB in New York is nearly gone, with only eight cases reported in 2009.
The Lancet editor notes that London uses a similar program that is in jeopardy. Find and Treat is the name of the organization that does case finding for London, and the British National Health Service is about to put the responsibility for “commissioning”, running the day-to-day treatment operations of NHS within communities, into the hands of general practitioners, who may choose to end the relationship between NHS and Find and Treat.
The editor’s fear may turn out to be unfounded. Let’s all hope this is the case.
Tuberculosis should be extinct, but it’s not.
An editorial in the most recent Lancet notes that in 1911, the journal’s editor wrote that he was looking forward to the day when “the demon of tuberculosis” would finally be eradicated. Though society and medicine have, of course, made great strides in the last 100 years, the “demon” still exists, especially among homeless populations in large cities.
The writer of this year’s Lancet editorial notes that in Toronto, the percentage of homeless people who die within after diagnosis has remained unchanged over the last ten years. Getting people diagnosed, and after diagnosis, getting them to follow medication dosing instructions are complicated tasks when patients are homeless. New York City’s approach is called “active case finding” and it involves going out into the streets and finding people who need treatment. Patients are admitted to an intermediate care facility, where their treatment is monitored.
Tuberculosis rates are declining in New York City, as reported in this New York Times blog, such that the vast majority of cases in the City now are immigrants from other countries. While such a decline could be due to a number of factors, it’s quite possible that this case finding program is responsible for the drop. What appears to be true in either case is that, as far as TB risk goes, you’re better off as a homeless New Yorker than an immigrant. What’s more, multi-drug resistant TB in New York is nearly gone, with only eight cases reported in 2009.
The Lancet editor notes that London uses a similar program that is in jeopardy. Find and Treat is the name of the organization that does case finding for London, and the British National Health Service is about to put the responsibility for “commissioning”, running the day-to-day treatment operations of NHS within communities, into the hands of general practitioners, who may choose to end the relationship between NHS and Find and Treat.
The editor’s fear may turn out to be unfounded. Let’s all hope this is the case.
The Long View
originally posted Feb 2011
A tribe in Ecuador is impervious to cancer and diabetes. How does that help us?
NPR reports on the existence of a tribe in Ecuador that never gets diabetes and very rarely gets cancer. Valter Longo, gerontologist at the University of Southern California, was studying genes responsible for the development of cancer, and had already increased the lifespan of a yeast colony tenfold by disabling genes and feeding the colony fewer calories. The two genes he was researching, RAS2 and SCH9, have mutated in a population of Ecuadorian dwarfs, giving them nigh-immunity to cancer, and apparently complete immunity to diabetes.
The Ecuadoreans affected are a very limited population, as anyone who has one or the other of the two genes in a normal state lives a normal life, both with regards to height and susceptibility to cancer and diabetes. The obvious question then is: Are we going to have to shorten the height of the human race in order to lengthen its lifespan? “No,” says Dr. Longo, “the results suggest that after we grow to normal size we could either use dietary or pharmacological interventions to decrease specific growth factors, to divert energy from cellular growth and reproduction to protective systems. This switch could be reversed when needed,” for reproduction, to fight disease, or to heal physical damage. Essentially, this would mean that our bodies would run on lower power, diverting energy from non-essential functions to avoid the possibility of cancer.
As you’ll recall, Longo’s experiment with the yeast had two parts: knocking out genes, and lowering caloric intake. It appears that if humans want to use a similar method, a decrease in caloric intake is not optional. A breakthrough of this magnitude would have serious implications for agriculture, foodservice, and pharmaceuticals, and would likely receive a lot of resistance from groups that stand to lose a lot of money in a post-cancer, low-calorie world. And maybe that’s not actually as nasty as it sounds—don’t we want a treatment that could change the entirety of human existence to undergo serious scrutiny?
Here’s a thought, though, on the matter of surviving on fewer calories for longer times: It might also have a seriously positive unintended consequence. That is, ending world hunger.
What do you think? Is this something we’ll see in our lifetimes? Valter Longo guesses that twenty or thirty years from now we might be able to knock out these genes. Is that too optimistic?
A tribe in Ecuador is impervious to cancer and diabetes. How does that help us?
NPR reports on the existence of a tribe in Ecuador that never gets diabetes and very rarely gets cancer. Valter Longo, gerontologist at the University of Southern California, was studying genes responsible for the development of cancer, and had already increased the lifespan of a yeast colony tenfold by disabling genes and feeding the colony fewer calories. The two genes he was researching, RAS2 and SCH9, have mutated in a population of Ecuadorian dwarfs, giving them nigh-immunity to cancer, and apparently complete immunity to diabetes.
The Ecuadoreans affected are a very limited population, as anyone who has one or the other of the two genes in a normal state lives a normal life, both with regards to height and susceptibility to cancer and diabetes. The obvious question then is: Are we going to have to shorten the height of the human race in order to lengthen its lifespan? “No,” says Dr. Longo, “the results suggest that after we grow to normal size we could either use dietary or pharmacological interventions to decrease specific growth factors, to divert energy from cellular growth and reproduction to protective systems. This switch could be reversed when needed,” for reproduction, to fight disease, or to heal physical damage. Essentially, this would mean that our bodies would run on lower power, diverting energy from non-essential functions to avoid the possibility of cancer.
As you’ll recall, Longo’s experiment with the yeast had two parts: knocking out genes, and lowering caloric intake. It appears that if humans want to use a similar method, a decrease in caloric intake is not optional. A breakthrough of this magnitude would have serious implications for agriculture, foodservice, and pharmaceuticals, and would likely receive a lot of resistance from groups that stand to lose a lot of money in a post-cancer, low-calorie world. And maybe that’s not actually as nasty as it sounds—don’t we want a treatment that could change the entirety of human existence to undergo serious scrutiny?
Here’s a thought, though, on the matter of surviving on fewer calories for longer times: It might also have a seriously positive unintended consequence. That is, ending world hunger.
What do you think? Is this something we’ll see in our lifetimes? Valter Longo guesses that twenty or thirty years from now we might be able to knock out these genes. Is that too optimistic?
Attribution Error
Originally posted Mar 2011
Q: What happens when a professor visits a corporation and devises a groundbreaking AIDS test? A: Chaos.
On Monday, the Supreme Court of the United States head arguments in Stanford v. Roche, a case that will likely lay the first significant amount of case law regarding the transfer of patents from universities to corporations. The dispute centers on a patented method of testing patients for AIDS, developed by Stanford professor Mark Holodniy while working with Cetus, which later sold the patents to Roche. Dr. Holodniy apparently signed a document that assigned rights for any of his discoveries to Cetus before beginning a collaborative effort with them.
It seems open and shut from here—the man signed a contract. However, the collaboration was federally-funded, it appears, and that changes everything. The 1980 Bayh-Dole Act allows universities to retain (and sell) rights to discoveries they make as a result of federally-funded projects, and has no provision for individuals to waive those rights on behalf of the university. In fact, the Bayh in Bayh-Dole, former Indiana senator Birch Bayh, sides with Stanford, as does the Department of Justice.
What’s interesting about this case is that Dr. Holodniy actually learned some of the essential process from Cetus. According to the Silicon Valley Mercury News, Holodniy learned the process of polymerase chain reactions (PCR) at the Cetus facility, according to the Mercury News report. As the AIDS test Holodniy developed requires PCR as part of the procedure, it seems that no matter who wins this case, justice will not be served.
Let me explain why I say that. Dr. Holodniy clearly joined Stanford University first, and signed away all of his inventions to the university, then joined the visiting scientist program at Cetus as a representative of Stanford. Clearly holding in favor of Roche would be unfair to Stanford, as Holodniy’s contracts with the university are clear. However, the test was designed at the Cetus facility, using equipment and expertise that originated with the company, so finding for Stanford would be unfair to Roche, and to Cetus, who made money by selling the testing products.
Catherine Fisk, law professor at Duke University wrote a paper on attribution of inventions, which points to the way to fix this problem: “The criteria for granting credit should be relatively transparent or publicly known. Transparency motivates people to do the work to earn credit and enables people to conform their conduct so as to avoid blame.” In this case, the criteria for assigning rights to inventions produced during the collaboration should have been made clear beforehand, and any companies and universities engaging in visiting scientist programs should have the foresight to put it in writing before that professor crosses the threshold of that company.
What do you think? Is that even reasonable, or should universities rely on Bayh-Dole to maintain their intellectual property? Whose side do you take? Let me know in the comments.
Q: What happens when a professor visits a corporation and devises a groundbreaking AIDS test? A: Chaos.
On Monday, the Supreme Court of the United States head arguments in Stanford v. Roche, a case that will likely lay the first significant amount of case law regarding the transfer of patents from universities to corporations. The dispute centers on a patented method of testing patients for AIDS, developed by Stanford professor Mark Holodniy while working with Cetus, which later sold the patents to Roche. Dr. Holodniy apparently signed a document that assigned rights for any of his discoveries to Cetus before beginning a collaborative effort with them.
It seems open and shut from here—the man signed a contract. However, the collaboration was federally-funded, it appears, and that changes everything. The 1980 Bayh-Dole Act allows universities to retain (and sell) rights to discoveries they make as a result of federally-funded projects, and has no provision for individuals to waive those rights on behalf of the university. In fact, the Bayh in Bayh-Dole, former Indiana senator Birch Bayh, sides with Stanford, as does the Department of Justice.
What’s interesting about this case is that Dr. Holodniy actually learned some of the essential process from Cetus. According to the Silicon Valley Mercury News, Holodniy learned the process of polymerase chain reactions (PCR) at the Cetus facility, according to the Mercury News report. As the AIDS test Holodniy developed requires PCR as part of the procedure, it seems that no matter who wins this case, justice will not be served.
Let me explain why I say that. Dr. Holodniy clearly joined Stanford University first, and signed away all of his inventions to the university, then joined the visiting scientist program at Cetus as a representative of Stanford. Clearly holding in favor of Roche would be unfair to Stanford, as Holodniy’s contracts with the university are clear. However, the test was designed at the Cetus facility, using equipment and expertise that originated with the company, so finding for Stanford would be unfair to Roche, and to Cetus, who made money by selling the testing products.
Catherine Fisk, law professor at Duke University wrote a paper on attribution of inventions, which points to the way to fix this problem: “The criteria for granting credit should be relatively transparent or publicly known. Transparency motivates people to do the work to earn credit and enables people to conform their conduct so as to avoid blame.” In this case, the criteria for assigning rights to inventions produced during the collaboration should have been made clear beforehand, and any companies and universities engaging in visiting scientist programs should have the foresight to put it in writing before that professor crosses the threshold of that company.
What do you think? Is that even reasonable, or should universities rely on Bayh-Dole to maintain their intellectual property? Whose side do you take? Let me know in the comments.
Cliff Diving
Originally posted Feb 2011
With drug patents expiring left and right, Big Pharma stares into the abyss.
The patent cliff: Market watchers have been talking about it for years (as this Reuters article shows) and it’s finally here. This is the year that a huge number of patents on big-money drugs start running out, and, deprived of their cash cows, major pharmaceutical companies start to have serious cash flow difficulties. Among the drugs with patents expiring in the next 24 months are cholesterol drug Lipitor, the anti-clotting drug Plavix, asthma drug Singulair, and, well, Viagra.
In the US, drug patents are good for 17 to 20 years, after that anyone can create a generic version. Generic drugs are usually far less expensive than the original, of course. One such case is the sleep drug Ambien, which costs $159 per 30-day prescription. Generic zolpidem tartrate (the drug's chemical name) costs $3 for the same amount.
Cheap generic drugs for patients mean big losses for pharmaceutical companies. The drugs that are going off patent have been major sources of revenue for these companies. And at least thirteen of the biggest money-maker drugs are going off the market by 2012, taking millions of dollars of profit with them. Decreasing revenues for pharmaceutical companies may mean decreasing spending on R&D which translates into fewer new drugs. Already these companies are finding it difficult to get new drugs approved by the FDA, and its just going to get worse.
The facts are pretty stark, and everybody knows it. Here is an (almost) random sample of the headlines: “Patent Cliff Means Panic Time For Big Pharma”, “Big Pharma Hits the Panic Button...”, “Big Pharma Patent Expirations to Sock 2012 US Drug Sales.”
I don’t want to be a party-pooper here, but I have an impolite question for you: Is the apocalypse really such a bad thing?
Think about it. Why don’t those headlines say, “Lives to Be Improved By Cheaper Medication!”, “Generics Increase to Make Treatment Easier for Patients and Doctors”, and the like. (Full Disclosure: There was one “10 Biggest Selling Drugs Could Become Cheaper” from a CBS affiliate in Pennsylvania). Because if you take the broad view, society will probably be better off after Patent Armageddon. Life will be better for the sick and underfunded, and the doctors that treat them, and the taxpayer in general -- which includes all of us. So, here’s to the cliff...it can’t come fast enough.
With drug patents expiring left and right, Big Pharma stares into the abyss.
The patent cliff: Market watchers have been talking about it for years (as this Reuters article shows) and it’s finally here. This is the year that a huge number of patents on big-money drugs start running out, and, deprived of their cash cows, major pharmaceutical companies start to have serious cash flow difficulties. Among the drugs with patents expiring in the next 24 months are cholesterol drug Lipitor, the anti-clotting drug Plavix, asthma drug Singulair, and, well, Viagra.
In the US, drug patents are good for 17 to 20 years, after that anyone can create a generic version. Generic drugs are usually far less expensive than the original, of course. One such case is the sleep drug Ambien, which costs $159 per 30-day prescription. Generic zolpidem tartrate (the drug's chemical name) costs $3 for the same amount.
Cheap generic drugs for patients mean big losses for pharmaceutical companies. The drugs that are going off patent have been major sources of revenue for these companies. And at least thirteen of the biggest money-maker drugs are going off the market by 2012, taking millions of dollars of profit with them. Decreasing revenues for pharmaceutical companies may mean decreasing spending on R&D which translates into fewer new drugs. Already these companies are finding it difficult to get new drugs approved by the FDA, and its just going to get worse.
The facts are pretty stark, and everybody knows it. Here is an (almost) random sample of the headlines: “Patent Cliff Means Panic Time For Big Pharma”, “Big Pharma Hits the Panic Button...”, “Big Pharma Patent Expirations to Sock 2012 US Drug Sales.”
I don’t want to be a party-pooper here, but I have an impolite question for you: Is the apocalypse really such a bad thing?
Think about it. Why don’t those headlines say, “Lives to Be Improved By Cheaper Medication!”, “Generics Increase to Make Treatment Easier for Patients and Doctors”, and the like. (Full Disclosure: There was one “10 Biggest Selling Drugs Could Become Cheaper” from a CBS affiliate in Pennsylvania). Because if you take the broad view, society will probably be better off after Patent Armageddon. Life will be better for the sick and underfunded, and the doctors that treat them, and the taxpayer in general -- which includes all of us. So, here’s to the cliff...it can’t come fast enough.
The Truth About Potassium Iodide
originally posted Mar 2011
Fact-checking stories about radiation sickness and the potassium iodide prophylactic.
Since the March 11 earthquake in Japan and the subsequent failures of nuclear reactors at the Fukushima Daiichi power plant, there has been an impenetrable cyclone of news coverage about the effects of the reactor failures, including stories of a radiation plume billowing across the Pacific Ocean and into the United States. The Guardian reports that reserves of potassium iodide are low in the Western US, depleted by fears of contamination from Japanese fallout. Potassium iodide is often included in survival kits for its ability to prevent thyroid cancer in case of airborne radioactive iodine, a common byproduct of a large-scale radiation leak.
The media coverage to the upsurge in potassium iodide sales has been largely negative, with two major emerging complaints against potassium iodide buyers. The first is that they are running the risk of major side effects by taking the compound in doses recommended for cancer prevention, and the second is that the pills are in such limited supply that buying them depletes the reserves for those in Japan who may need them. (You can find these two opinions are laid out very well in this article from Boing Boing.)
Digging a little deeper, though, we find that a number of factors appear to invalidate these claims. Let’s look at them one by one.
First, that those who take potassium iodide at levels effective for the prevention of cancer run the risk of serious complications. The major problem here is allergic reactions, which for this compound are linked with shellfish allergies. So, while the pills could have serious effects for those who are allergic, less than 2% of Americans have shellfish allergies.
There are some much worse effects that can occur due to constant excessive ingestion of potassium iodide, but that doesn’t seem to be the issue here. The prophylactic dose is lower (100 vs. 150 mg) than the dosage that has been implicated in the worst of these complications: neck swelling, lack of appetite, lethargy, vomiting, and irregular heartbeat. And even that high dosage, these symptoms are only considered possible side effects. Much less scary than your average pharmaceutical TV ad.
As far as there not being enough potassium iodide to go around, there is a certain amount of truth to that claim: the three major American suppliers of potassium iodide are out of pills (due to have them again in mid-April). Indian distributors, however, are not at all difficult to find—a quick Google search unearths a number of them. Certainly there are Russian and European distributors as well, not as heavily depleted by the scare, as they are predicted to receive an even smaller dosage of Fukushima radiation, even later.
In sum, the side effects from anti-radiation pills are largely overblown, and the the shortage is mostly bogus.
Lost in this particular debate is the fact that levels levels of radiation that have reached the United States are small enough that EPA monitoring stations are not consistently able to find an increase in radioactive particles. So go ahead and take your potassium idodine if it makes you feel better. Or your sugar pills, for that matter. Because at this point, what we are talking about is a placebo cure for a non-existent illness.
Fact-checking stories about radiation sickness and the potassium iodide prophylactic.
Since the March 11 earthquake in Japan and the subsequent failures of nuclear reactors at the Fukushima Daiichi power plant, there has been an impenetrable cyclone of news coverage about the effects of the reactor failures, including stories of a radiation plume billowing across the Pacific Ocean and into the United States. The Guardian reports that reserves of potassium iodide are low in the Western US, depleted by fears of contamination from Japanese fallout. Potassium iodide is often included in survival kits for its ability to prevent thyroid cancer in case of airborne radioactive iodine, a common byproduct of a large-scale radiation leak.
The media coverage to the upsurge in potassium iodide sales has been largely negative, with two major emerging complaints against potassium iodide buyers. The first is that they are running the risk of major side effects by taking the compound in doses recommended for cancer prevention, and the second is that the pills are in such limited supply that buying them depletes the reserves for those in Japan who may need them. (You can find these two opinions are laid out very well in this article from Boing Boing.)
Digging a little deeper, though, we find that a number of factors appear to invalidate these claims. Let’s look at them one by one.
First, that those who take potassium iodide at levels effective for the prevention of cancer run the risk of serious complications. The major problem here is allergic reactions, which for this compound are linked with shellfish allergies. So, while the pills could have serious effects for those who are allergic, less than 2% of Americans have shellfish allergies.
There are some much worse effects that can occur due to constant excessive ingestion of potassium iodide, but that doesn’t seem to be the issue here. The prophylactic dose is lower (100 vs. 150 mg) than the dosage that has been implicated in the worst of these complications: neck swelling, lack of appetite, lethargy, vomiting, and irregular heartbeat. And even that high dosage, these symptoms are only considered possible side effects. Much less scary than your average pharmaceutical TV ad.
As far as there not being enough potassium iodide to go around, there is a certain amount of truth to that claim: the three major American suppliers of potassium iodide are out of pills (due to have them again in mid-April). Indian distributors, however, are not at all difficult to find—a quick Google search unearths a number of them. Certainly there are Russian and European distributors as well, not as heavily depleted by the scare, as they are predicted to receive an even smaller dosage of Fukushima radiation, even later.
In sum, the side effects from anti-radiation pills are largely overblown, and the the shortage is mostly bogus.
Lost in this particular debate is the fact that levels levels of radiation that have reached the United States are small enough that EPA monitoring stations are not consistently able to find an increase in radioactive particles. So go ahead and take your potassium idodine if it makes you feel better. Or your sugar pills, for that matter. Because at this point, what we are talking about is a placebo cure for a non-existent illness.
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