In 1920, two famous astronomers held what’s come to be called The Great Debate. At that time, spiral galaxies were called spiral nebulae, and no one knew if they were relatively near us or exceedingly far away. During the 1920 debate, Heber D. Curtis argued that the spiral nebulae were very distant, vast galaxies like our Milky Way, composed of stars. Harlow Shapley argued that our universe had just one galaxy – our Milky Way – and that the spiral nebulae were nearby gas clouds, perhaps forming solar systems. Over the decades, Curtis has been seen as correct; the spiral nebulae have turned out to be not nearby solar systems, but distant galaxies with their own billions of stars. But nature loves spirals. And now astronomers are beginning to find spiral structure in forming solar systems.
Astronomical theory suggests this should occur, but the phase of evolution must be brief and hard to catch. Now the powerful Atacama Large Millimeter/submillimeter Array (ALMA) – which went online officially as recently as March 2013 – has directly observed a spiral structure around the young star Elias 2-27. This is the first observation of its kind.
The sweeping spiral arms surround the central star are reminiscent of a spiral galaxy, but on a much smaller scale.
Elias 2-27 is located approximately 450 light-years from Earth in the direction to the constellation Ophiuchus the Serpent Bearer. It’s within what astronomers call the Ophiuchus star-forming complex, a region of space where many new stars are forming and one of the closest such regions to our sun.
The star Elias 2-27 contains only about half the mass of our sun, but has an unusually massive protoplanetary disk. The star is very young, only an estimated one million years old in contrast to four-and-a-half billion years for our sun. It’s still encased in the vast molecular cloud in space in which it is forming, which hides it from view as seen by optical telescopes. ALMA is capable of seeing at wavelengths that make this star and its unusual structure visible.
According to theory, a spiral structure should occur in forming solar systems due to the same physical process thought to give our Milky Way galaxy its spiral arms. That is, they are the product of what are called density waves – in this case, gravitational perturbations in the disks that surround young stars. A statement from the National Radio Astronomy Observatory said:
Previously, astronomers noted compelling spiral features on the surfaces of protoplanetary disks, but it was unknown if these same spiral patterns also emerged deep within the disk where planet formation takes place.
ALMA, for the first time, was able to peer deep into the mid-plane of a disk and discover the clear signature of spiral density waves.
Nearest to the star, ALMA found a familiar flattened disk of dust, which extends past what would be the orbit of Neptune in our own solar system.
Beyond that point, ALMA detected a narrow band with significantly less dust, which may be indicative of a planet in formation.
Springing from the outer edge of this gap are two sweeping spiral arms that extend more than 10 billion kilometers away from their host star.
A 1910 image of M51, which we now call the Whirlpool Galaxy. At the time, it was known as one of the mysterious spiral nebulae, which some astronomers thought were forming solar systems. We’ve come a long way! What will astronomers 100 years from now think? Photographic image of M51 spiral nebula by G. W. Ritchey, 1910, via harvard.edu .
Bottom line: Astronomers are beginning to find spiral structure in forming solar systems, which was earlier predicted by the theory of how planets should form in protoplanetary disks. The very young star Elias 2-27 is now known to have a spiral structure swirling around it.
In 1920, two famous astronomers held what’s come to be called The Great Debate. At that time, spiral galaxies were called spiral nebulae, and no one knew if they were relatively near us or exceedingly far away. During the 1920 debate, Heber D. Curtis argued that the spiral nebulae were very distant, vast galaxies like our Milky Way, composed of stars. Harlow Shapley argued that our universe had just one galaxy – our Milky Way – and that the spiral nebulae were nearby gas clouds, perhaps forming solar systems. Over the decades, Curtis has been seen as correct; the spiral nebulae have turned out to be not nearby solar systems, but distant galaxies with their own billions of stars. But nature loves spirals. And now astronomers are beginning to find spiral structure in forming solar systems.
Astronomical theory suggests this should occur, but the phase of evolution must be brief and hard to catch. Now the powerful Atacama Large Millimeter/submillimeter Array (ALMA) – which went online officially as recently as March 2013 – has directly observed a spiral structure around the young star Elias 2-27. This is the first observation of its kind.
The sweeping spiral arms surround the central star are reminiscent of a spiral galaxy, but on a much smaller scale.
Elias 2-27 is located approximately 450 light-years from Earth in the direction to the constellation Ophiuchus the Serpent Bearer. It’s within what astronomers call the Ophiuchus star-forming complex, a region of space where many new stars are forming and one of the closest such regions to our sun.
The star Elias 2-27 contains only about half the mass of our sun, but has an unusually massive protoplanetary disk. The star is very young, only an estimated one million years old in contrast to four-and-a-half billion years for our sun. It’s still encased in the vast molecular cloud in space in which it is forming, which hides it from view as seen by optical telescopes. ALMA is capable of seeing at wavelengths that make this star and its unusual structure visible.
According to theory, a spiral structure should occur in forming solar systems due to the same physical process thought to give our Milky Way galaxy its spiral arms. That is, they are the product of what are called density waves – in this case, gravitational perturbations in the disks that surround young stars. A statement from the National Radio Astronomy Observatory said:
Previously, astronomers noted compelling spiral features on the surfaces of protoplanetary disks, but it was unknown if these same spiral patterns also emerged deep within the disk where planet formation takes place.
ALMA, for the first time, was able to peer deep into the mid-plane of a disk and discover the clear signature of spiral density waves.
Nearest to the star, ALMA found a familiar flattened disk of dust, which extends past what would be the orbit of Neptune in our own solar system.
Beyond that point, ALMA detected a narrow band with significantly less dust, which may be indicative of a planet in formation.
Springing from the outer edge of this gap are two sweeping spiral arms that extend more than 10 billion kilometers away from their host star.
A 1910 image of M51, which we now call the Whirlpool Galaxy. At the time, it was known as one of the mysterious spiral nebulae, which some astronomers thought were forming solar systems. We’ve come a long way! What will astronomers 100 years from now think? Photographic image of M51 spiral nebula by G. W. Ritchey, 1910, via harvard.edu .
Bottom line: Astronomers are beginning to find spiral structure in forming solar systems, which was earlier predicted by the theory of how planets should form in protoplanetary disks. The very young star Elias 2-27 is now known to have a spiral structure swirling around it.
Three years ago, we launched our Local Cancer Statistics website – our one stop shop for cancer data from regions across the UK.
You can search for data based on any local area or post code in the UK at the click of a button.
And this has proved vital in tracking down where cancer services and care are doing well, or not so well – as our graphics below show for two areas that are above and below the national average for cancer incidence respectively.
Since we launched, the availability of local data has come a long way. For starters there’s more of it, and it’s better quality. It’s also being routinely published from reliable sources.
This means the choice of local data to view on our website has grown. We now house data ranging from the numbers of cancers diagnosed in different regions to survival figures for different cancers. We also have access to data on the causes of cancer – such as smoking and obesity – as well as cancer services, such as cancer waiting times performance and whether or not people are taking part in screening.
And this is just a few of the more than 150 different bits of data we have from across England, Wales, Scotland and Northern Ireland.
And in the last three years, this vast collection of information has helped us push key areas that we think local and national governments need to prioritise.
So what’s changed?
More than just numbers
We don’t just display the numbers. It’s also important to provide context to the figures to make them more meaningful.
That’s why we try and explain what the figures mean for cancer care in the UK.
We also signpost to further information and, where appropriate, the actions we recommend are taken and where we’re involved in efforts to see these numbers improve.
In the last three years, the local healthcare landscape has also changed. The way healthcare is commissioned and paid for has been reorganised, and public health responsibility has moved from the NHS back into local government.
To be effective in preventing, diagnosing and treating cancer, it’s more important than ever that decisions are based on evidence and the needs of the local population.
And that’s why good quality local data is so important.
Variation across the nation
National data aren’t always representative of every local area, so it’s important to understand the local picture to help serve the needs of that population.
This is true for cancer, where there is variation in how patients fare across the nation. For example, our graphic below shows how one-year cancer survival varies across England. This type of information is vital for those who organise cancer services in these areas as they look to set priorities for cancer care.
Understanding the different demographics that make up a population is also crucial in understanding the burden of cancer in a local area.
Age and gender affect a person’s risk of cancer. And the chance of being diagnosed with and dying from cancer increases with age. For example, men aged 75 or older are most likely to die from cancer than any other group. And ages can vary across regions.
For some cancers, deprivation – which spans a range of issues including income, employment status and education – and ethnicity are also important risk factors for cancer that can vary in different regions. And this variation could mean important changes are needed in some areas as people look to prevent, diagnose and treat certain cancers.
But demographics aren’t the only reason for variation in the chances of being diagnosed or surviving cancer. Performance of the healthcare system and lifestyle factors also contribute to the difference in the mix of cancers that occur among local populations, and how people fare.
So combining all these data is vital to ensure variation is addressed at a local level to help positively influence service and practice in some areas.
Local level data can be used to support the planning of health services, prevention plans, screening programmes and public awareness campaigns tailored to a local area’s need.
The data can be used to influence those who can make these decisions. And we know our website is playing a role in this.
Commissioners and health professionals, along with academics, public health professionals, local councils, policy-makers and cancer research writers, are using our website to inform and shape what they say and plan for local areas. They also raise issues that need to be addressed.
For example, local data can be used as evidence to influence MPs. Our hugely successful standardised cigarette packaging campaign is a great example of this – local smoking statistics were used to support the campaign and make the case to MPs that something needed to change.
And while our website was set up to inform and assist health and policy professionals, we know that patients and the public also frequently visit the site, reflecting the growing interest in getting a more accurate sense of how cancer services are performing locally.
Understanding the local picture
One of the objectives from England’s Cancer strategy is to tackle the differences in outlook for cancer patients across England by making sure everyone is able to access the appropriate diagnostic and treatment services across local areas. An intention echoed by Scotland’s Cancer strategy.
Since cancer services and public health services are organised and paid for locally, there is a need for those in charge to work closely in managing the growing demand in healthcare.
And in some places, this focus on making things local has been taken a further step: devolution. In Greater Manchester, decisions around health and social care spending are now being made by the Greater Manchester Combined Authority, which took control of the £6 billion budget in April.
Devolution is intended to give the region increased freedom and flexibility to tailor its budget and priorities to suit the area’s needs. And there are plans for other areas to follow suit.
This means that understanding the needs of local populations in terms of public health and cancer is more important than ever.
We have provided local statistics relevant to smoking in the Greater Manchester area, to help highlight the health and cost implications that smoking leaves in a local community. And we hope this will help with planning vital Stop Smoking Services so they can meet the need of the population and reduce smoking rates.
It isn’t possible to change the health of local communities without evidence. We need data to back our calls for action.
It’s this evidence that can shape healthcare locally. And it has the potential to save lives.
Emily Maxwell is a local cancer intelligence analyst at Cancer Research UK
from Cancer Research UK – Science blog http://ift.tt/2dDOExB
Three years ago, we launched our Local Cancer Statistics website – our one stop shop for cancer data from regions across the UK.
You can search for data based on any local area or post code in the UK at the click of a button.
And this has proved vital in tracking down where cancer services and care are doing well, or not so well – as our graphics below show for two areas that are above and below the national average for cancer incidence respectively.
Since we launched, the availability of local data has come a long way. For starters there’s more of it, and it’s better quality. It’s also being routinely published from reliable sources.
This means the choice of local data to view on our website has grown. We now house data ranging from the numbers of cancers diagnosed in different regions to survival figures for different cancers. We also have access to data on the causes of cancer – such as smoking and obesity – as well as cancer services, such as cancer waiting times performance and whether or not people are taking part in screening.
And this is just a few of the more than 150 different bits of data we have from across England, Wales, Scotland and Northern Ireland.
And in the last three years, this vast collection of information has helped us push key areas that we think local and national governments need to prioritise.
So what’s changed?
More than just numbers
We don’t just display the numbers. It’s also important to provide context to the figures to make them more meaningful.
That’s why we try and explain what the figures mean for cancer care in the UK.
We also signpost to further information and, where appropriate, the actions we recommend are taken and where we’re involved in efforts to see these numbers improve.
In the last three years, the local healthcare landscape has also changed. The way healthcare is commissioned and paid for has been reorganised, and public health responsibility has moved from the NHS back into local government.
To be effective in preventing, diagnosing and treating cancer, it’s more important than ever that decisions are based on evidence and the needs of the local population.
And that’s why good quality local data is so important.
Variation across the nation
National data aren’t always representative of every local area, so it’s important to understand the local picture to help serve the needs of that population.
This is true for cancer, where there is variation in how patients fare across the nation. For example, our graphic below shows how one-year cancer survival varies across England. This type of information is vital for those who organise cancer services in these areas as they look to set priorities for cancer care.
Understanding the different demographics that make up a population is also crucial in understanding the burden of cancer in a local area.
Age and gender affect a person’s risk of cancer. And the chance of being diagnosed with and dying from cancer increases with age. For example, men aged 75 or older are most likely to die from cancer than any other group. And ages can vary across regions.
For some cancers, deprivation – which spans a range of issues including income, employment status and education – and ethnicity are also important risk factors for cancer that can vary in different regions. And this variation could mean important changes are needed in some areas as people look to prevent, diagnose and treat certain cancers.
But demographics aren’t the only reason for variation in the chances of being diagnosed or surviving cancer. Performance of the healthcare system and lifestyle factors also contribute to the difference in the mix of cancers that occur among local populations, and how people fare.
So combining all these data is vital to ensure variation is addressed at a local level to help positively influence service and practice in some areas.
Local level data can be used to support the planning of health services, prevention plans, screening programmes and public awareness campaigns tailored to a local area’s need.
The data can be used to influence those who can make these decisions. And we know our website is playing a role in this.
Commissioners and health professionals, along with academics, public health professionals, local councils, policy-makers and cancer research writers, are using our website to inform and shape what they say and plan for local areas. They also raise issues that need to be addressed.
For example, local data can be used as evidence to influence MPs. Our hugely successful standardised cigarette packaging campaign is a great example of this – local smoking statistics were used to support the campaign and make the case to MPs that something needed to change.
And while our website was set up to inform and assist health and policy professionals, we know that patients and the public also frequently visit the site, reflecting the growing interest in getting a more accurate sense of how cancer services are performing locally.
Understanding the local picture
One of the objectives from England’s Cancer strategy is to tackle the differences in outlook for cancer patients across England by making sure everyone is able to access the appropriate diagnostic and treatment services across local areas. An intention echoed by Scotland’s Cancer strategy.
Since cancer services and public health services are organised and paid for locally, there is a need for those in charge to work closely in managing the growing demand in healthcare.
And in some places, this focus on making things local has been taken a further step: devolution. In Greater Manchester, decisions around health and social care spending are now being made by the Greater Manchester Combined Authority, which took control of the £6 billion budget in April.
Devolution is intended to give the region increased freedom and flexibility to tailor its budget and priorities to suit the area’s needs. And there are plans for other areas to follow suit.
This means that understanding the needs of local populations in terms of public health and cancer is more important than ever.
We have provided local statistics relevant to smoking in the Greater Manchester area, to help highlight the health and cost implications that smoking leaves in a local community. And we hope this will help with planning vital Stop Smoking Services so they can meet the need of the population and reduce smoking rates.
It isn’t possible to change the health of local communities without evidence. We need data to back our calls for action.
It’s this evidence that can shape healthcare locally. And it has the potential to save lives.
Emily Maxwell is a local cancer intelligence analyst at Cancer Research UK
from Cancer Research UK – Science blog http://ift.tt/2dDOExB
Well, actually, Yoshinori Ohsumi has won the prize for his work on autophagy, a cellular process you may have never heard of before. The word means “self eating”, and it’s an important pathway that takes chunks of the internal content of the cell and throws them into the cell’s incinerator, the lysosome, where enzymes and reactive chemicals shred them down into their constituent amino acids and other organic compounds for reuse. What makes it interesting is that the cell doesn’t want to just indiscriminately trash internal components; there are proteins that recognize damaged organelles and malfunctioning bits and packages them up in a tidy little double membrane bound vesicle that fuses with the lysosome and destroys them.
At least, most of the time it’s selective. It was first characterized by Ohsumi in yeast, where, if you starve the cells, they start self-cannibalizing to survive. If you use mutant yeast that lack some of the degradative enzymes, they are unable to break down the materials being dumped into the lysosome, and the vacuoles just get larger and larger, making it relatively easy to screen for changes in the machinery for autophagy.
Autophagy in yeast. In starvation-induced (non-selective) autophagy, the isolation membrane mainly non-selectively engulfs cytosolic constituents and organelles to form the autophagosome. The inner membrane-bound structure of the autophagosome (the autophagic body) is released into the vacuolar lumen following fusion of the outer membrane with the vacuolar membrane, and is disintegrated to allow degradation of the contents by resident hydrolyases. In selective autophagy, specific cargoes (protein complexes or organelles) are enwrapped by membrane vesicles that are similar to autophagosomes, and are delivered to the vacuole for degradation. Although the Cvt (cytoplasm-to-vacuole targeting) pathway mediates the biosynthetic transport of vacuolar enzymes, its membrane dynamics and mechanism are almost the same as those of selective autophagy (see the main text).
Taking out the trash is a vital procedure for cells, as well as for maintenance of your household, and there are cases where autophagy is implicated in human diseases. For instance, mitochondria are intensely active metabolically, and experience a lot of wear and tear. Your cells take old, busted mitochondria, tag them with proteins, and recycle them with a specific subset of autophagy called mitophagy, or mitochondria-eating. Some forms of Parkinson’s disease seem to be caused by defects in the mitophagy machinery, causing defective mitochondria to accumulate in the cell and impairing normal function.
Autophagy also seems to have some complex roles in cancer. It can be a good thing, in that early on if defective proteins and organelles accumulate, they can be sensed and destroyed, so autophagy in that case is a defense against cancer. However, cancer can also subvert that machinery and route the cell’s defenses right into the trash.
But also, autophagy seems to be involved in every step in cancer metastasis. This shouldn’t be a surprise, since autophagy is used to regulate the activity of the cell in all kinds of behaviors.
Schematic illustrating roles of autophagy in the metastatic cascade. Autophagy increases as tumor cells progress to invasiveness and this in turn is linked to increased cell motility, EMT, a stem cell phenotype, secretion of pro-migratory factors, release of MMPs, drug resistance and escape from immune surveillance at the primary site in some tumors. Many aspects of these autophagy-dependent changes during acquisition of invasiveness also likely contribute to the ability of disseminating tumor cells to intravasate, survive and migrate in the circulation before extravasating at secondary site. At the secondary site, autophagy is required to maintain tumor cells in a dormant state, possibly through its ability to promote quiescence and a stem cell phenotype, that in turn is linked to tumor cell survival and drug resistance. Emerging functions for autophagy in metastasis include a role in establishing the pre-metastatic niche as well as promoting tumor cell survival, escape from immune surveillance and other aspects required to ultimately grow out an overt metastasis.
It may also affect Crohn’s disease and other inflammatory syndromes. There are mutated proteins associated with Crohn’s that are part of the autophagy pathway; macrophages carrying these mutations deliver bigger doses of inflammatory cytokines when stimulated. Selective autophagy plays a role in regulating the balance of exports from the cell.
Those are the mild diseases caused by defects in this pathway. Look up Vici syndrome, a heritable disorder that causes devastating problems for those afflicted. It’s caused by mutations in the EPG5 gene, which is an important regulator of autophagy.
It’s not just about human diseases, though. Autophagy is universal in eukaryotes: yeast have it, plants have it, animals have it. Genes in the pathway are studied in yeast and nematodes and flies and mice, so this is a common mechanism of regulating the internal traffic of the cell.
Jiang P, Mizushima N (2014) Autophagy and human diseases. Cell Res 24(1):69-79.
Nakatogawa H, Suzuki K, Kamada Y, Ohsumi Y (2009) Dynamics and diversity in autophagy mechanisms: lessons from yeast. Nat Rev Mol Cell Biol 10(7):458-67.
Mowers EE, Sharifi MN, Macleod KF (2016) Autophagy in cancer metastasis. Oncogene doi: 10.1038/onc.2016.333.
from ScienceBlogs http://ift.tt/2cNciWX
Well, actually, Yoshinori Ohsumi has won the prize for his work on autophagy, a cellular process you may have never heard of before. The word means “self eating”, and it’s an important pathway that takes chunks of the internal content of the cell and throws them into the cell’s incinerator, the lysosome, where enzymes and reactive chemicals shred them down into their constituent amino acids and other organic compounds for reuse. What makes it interesting is that the cell doesn’t want to just indiscriminately trash internal components; there are proteins that recognize damaged organelles and malfunctioning bits and packages them up in a tidy little double membrane bound vesicle that fuses with the lysosome and destroys them.
At least, most of the time it’s selective. It was first characterized by Ohsumi in yeast, where, if you starve the cells, they start self-cannibalizing to survive. If you use mutant yeast that lack some of the degradative enzymes, they are unable to break down the materials being dumped into the lysosome, and the vacuoles just get larger and larger, making it relatively easy to screen for changes in the machinery for autophagy.
Autophagy in yeast. In starvation-induced (non-selective) autophagy, the isolation membrane mainly non-selectively engulfs cytosolic constituents and organelles to form the autophagosome. The inner membrane-bound structure of the autophagosome (the autophagic body) is released into the vacuolar lumen following fusion of the outer membrane with the vacuolar membrane, and is disintegrated to allow degradation of the contents by resident hydrolyases. In selective autophagy, specific cargoes (protein complexes or organelles) are enwrapped by membrane vesicles that are similar to autophagosomes, and are delivered to the vacuole for degradation. Although the Cvt (cytoplasm-to-vacuole targeting) pathway mediates the biosynthetic transport of vacuolar enzymes, its membrane dynamics and mechanism are almost the same as those of selective autophagy (see the main text).
Taking out the trash is a vital procedure for cells, as well as for maintenance of your household, and there are cases where autophagy is implicated in human diseases. For instance, mitochondria are intensely active metabolically, and experience a lot of wear and tear. Your cells take old, busted mitochondria, tag them with proteins, and recycle them with a specific subset of autophagy called mitophagy, or mitochondria-eating. Some forms of Parkinson’s disease seem to be caused by defects in the mitophagy machinery, causing defective mitochondria to accumulate in the cell and impairing normal function.
Autophagy also seems to have some complex roles in cancer. It can be a good thing, in that early on if defective proteins and organelles accumulate, they can be sensed and destroyed, so autophagy in that case is a defense against cancer. However, cancer can also subvert that machinery and route the cell’s defenses right into the trash.
But also, autophagy seems to be involved in every step in cancer metastasis. This shouldn’t be a surprise, since autophagy is used to regulate the activity of the cell in all kinds of behaviors.
Schematic illustrating roles of autophagy in the metastatic cascade. Autophagy increases as tumor cells progress to invasiveness and this in turn is linked to increased cell motility, EMT, a stem cell phenotype, secretion of pro-migratory factors, release of MMPs, drug resistance and escape from immune surveillance at the primary site in some tumors. Many aspects of these autophagy-dependent changes during acquisition of invasiveness also likely contribute to the ability of disseminating tumor cells to intravasate, survive and migrate in the circulation before extravasating at secondary site. At the secondary site, autophagy is required to maintain tumor cells in a dormant state, possibly through its ability to promote quiescence and a stem cell phenotype, that in turn is linked to tumor cell survival and drug resistance. Emerging functions for autophagy in metastasis include a role in establishing the pre-metastatic niche as well as promoting tumor cell survival, escape from immune surveillance and other aspects required to ultimately grow out an overt metastasis.
It may also affect Crohn’s disease and other inflammatory syndromes. There are mutated proteins associated with Crohn’s that are part of the autophagy pathway; macrophages carrying these mutations deliver bigger doses of inflammatory cytokines when stimulated. Selective autophagy plays a role in regulating the balance of exports from the cell.
Those are the mild diseases caused by defects in this pathway. Look up Vici syndrome, a heritable disorder that causes devastating problems for those afflicted. It’s caused by mutations in the EPG5 gene, which is an important regulator of autophagy.
It’s not just about human diseases, though. Autophagy is universal in eukaryotes: yeast have it, plants have it, animals have it. Genes in the pathway are studied in yeast and nematodes and flies and mice, so this is a common mechanism of regulating the internal traffic of the cell.
Jiang P, Mizushima N (2014) Autophagy and human diseases. Cell Res 24(1):69-79.
Nakatogawa H, Suzuki K, Kamada Y, Ohsumi Y (2009) Dynamics and diversity in autophagy mechanisms: lessons from yeast. Nat Rev Mol Cell Biol 10(7):458-67.
Mowers EE, Sharifi MN, Macleod KF (2016) Autophagy in cancer metastasis. Oncogene doi: 10.1038/onc.2016.333.
From 2014 on, Swedish metal detectorists have had to report all finds datable to before 1850 to the authorities. I have recently shown in a note in Fornvännen that this rule came about by mistake, and that it has broken the County Archaeologist system. It takes hours for a county heritage administrator to process one metal detector permit. It also takes only a few hours for a detectorist to find a copper coin from the 1840s, which voids her/his permit for that site. S/he then applies for a new permit, which means that the pile of unprocessed permit applications on each administrator’s desk grows exponentially.
My suggestion for how this problem should be solved is to move the cutoff date from 1850 to 1719. This is a useful year for coins: the year after Carolus XII died and the year before Frederick I ascended to the throne. No research is ever done into small finds from after 1719 that are found in ploughsoil. We do not need to collect them.
The National Heritage Board has now suggested another solution: placing a hefty filing fee on applications for metal detector permits, regardless of whether a permit is eventually granted or not. I think this would be an extremely bad solution. It would probably radically cut down on the number of permit applications, but it would also have the following highly damaging consequences.
Metal detecting would go underground.
Detectorists would be alienated from contact with heritage management and archaeological research.
Detectorists who made important archaeological finds without a permit wouldn’t dare report them to the authorities.
Fewer archaeological discoveries would be made.
Heritage would become less accessible to the citizens who own it.
Legal metal detecting would become golf: only accessible to rich people.
The 1850 rule for small finds is silly, it came about inadvertently and it needs to be changed. The way to correct the mistake is not to place an artificial hurdle in the way of law-abiding detectorists, creating a system kludge to treat a symptom of the underlying problem. The problem is in the law that took effect in 2014. Let’s change that law.
from ScienceBlogs http://ift.tt/2cM6QZl
From 2014 on, Swedish metal detectorists have had to report all finds datable to before 1850 to the authorities. I have recently shown in a note in Fornvännen that this rule came about by mistake, and that it has broken the County Archaeologist system. It takes hours for a county heritage administrator to process one metal detector permit. It also takes only a few hours for a detectorist to find a copper coin from the 1840s, which voids her/his permit for that site. S/he then applies for a new permit, which means that the pile of unprocessed permit applications on each administrator’s desk grows exponentially.
My suggestion for how this problem should be solved is to move the cutoff date from 1850 to 1719. This is a useful year for coins: the year after Carolus XII died and the year before Frederick I ascended to the throne. No research is ever done into small finds from after 1719 that are found in ploughsoil. We do not need to collect them.
The National Heritage Board has now suggested another solution: placing a hefty filing fee on applications for metal detector permits, regardless of whether a permit is eventually granted or not. I think this would be an extremely bad solution. It would probably radically cut down on the number of permit applications, but it would also have the following highly damaging consequences.
Metal detecting would go underground.
Detectorists would be alienated from contact with heritage management and archaeological research.
Detectorists who made important archaeological finds without a permit wouldn’t dare report them to the authorities.
Fewer archaeological discoveries would be made.
Heritage would become less accessible to the citizens who own it.
Legal metal detecting would become golf: only accessible to rich people.
The 1850 rule for small finds is silly, it came about inadvertently and it needs to be changed. The way to correct the mistake is not to place an artificial hurdle in the way of law-abiding detectorists, creating a system kludge to treat a symptom of the underlying problem. The problem is in the law that took effect in 2014. Let’s change that law.
I’ve just posted the new Problem of the Week, along with an official solution to last week’s problem. But this one will have to hold you for a while, since I’m taking next week off.
from ScienceBlogs http://ift.tt/2dLxzCi
I’ve just posted the new Problem of the Week, along with an official solution to last week’s problem. But this one will have to hold you for a while, since I’m taking next week off.
Tonight – October 3, 2016 – look westward at dusk and nightfall to view the brightest and second-brightest heavenly bodies to adorn the nighttime sky, the moon and dazzling planet Venus. Unlike the stars, these worlds don’t shine by their own light but by reflecting the light of the sun.
Carefully scan the nighttime side of the moon with either the unaided eye or binoculars to see the moon’s dark side softly illuminated by earthshine. Earthshine is actually twice-reflected sunlight, of sunlight reflected from Earth to the moon, then from the moon back to Earth.
Many people are aware that Earth’s rotational axis is titled by about 23.4o out of vertical to plane of the ecliptic – our planet’s orbit around the sun. Unlike Earth, Venus’ axis is almost vertical to its orbital plane, only tilting 2.6o out of straight up and down. Even so, Venus is sometimes called an “upside-down” planet.
If you could look down upon the solar system from the north side of the solar system plane, you’d see all the solar system planets revolving around the sun in a counterclockwise direction. Additionally, astronomers call the hemisphere of a planet that rotates counterclockwise the planet’s north pole. For the most part, planets of the solar system rotate on their axes in the same direction that they orbit the sun.
However, the planet Venus stands as a major exception. If you could observe Venus from the north side of the solar system, you’d see that it rotates clockwise even as it orbits the sun counterclockwise. Since astronomers like to call the hemisphere of a planet that rotates counterclockwise the planet’s North Pole, Venus’ rotational axis is said to be titled at 177.4o instead of 2.6o, making Venus an “upside-down” world.
The north pole or positive pole of a planet is defined by the right hand rule, which makes Venus an “upside-down” planet and Uranus a “sideways” planet.
Tilts of the planets’ north poles relative to their orbital planes via Planetary Fact Sheet:
Bottom line: After sunset on October 3, 2016, look for the slender waxing crescent moon to pair up with Venus, the “upside-down” world.
from EarthSky http://ift.tt/2cR36Tq
Tonight – October 3, 2016 – look westward at dusk and nightfall to view the brightest and second-brightest heavenly bodies to adorn the nighttime sky, the moon and dazzling planet Venus. Unlike the stars, these worlds don’t shine by their own light but by reflecting the light of the sun.
Carefully scan the nighttime side of the moon with either the unaided eye or binoculars to see the moon’s dark side softly illuminated by earthshine. Earthshine is actually twice-reflected sunlight, of sunlight reflected from Earth to the moon, then from the moon back to Earth.
Many people are aware that Earth’s rotational axis is titled by about 23.4o out of vertical to plane of the ecliptic – our planet’s orbit around the sun. Unlike Earth, Venus’ axis is almost vertical to its orbital plane, only tilting 2.6o out of straight up and down. Even so, Venus is sometimes called an “upside-down” planet.
If you could look down upon the solar system from the north side of the solar system plane, you’d see all the solar system planets revolving around the sun in a counterclockwise direction. Additionally, astronomers call the hemisphere of a planet that rotates counterclockwise the planet’s north pole. For the most part, planets of the solar system rotate on their axes in the same direction that they orbit the sun.
However, the planet Venus stands as a major exception. If you could observe Venus from the north side of the solar system, you’d see that it rotates clockwise even as it orbits the sun counterclockwise. Since astronomers like to call the hemisphere of a planet that rotates counterclockwise the planet’s North Pole, Venus’ rotational axis is said to be titled at 177.4o instead of 2.6o, making Venus an “upside-down” world.
The north pole or positive pole of a planet is defined by the right hand rule, which makes Venus an “upside-down” planet and Uranus a “sideways” planet.
Tilts of the planets’ north poles relative to their orbital planes via Planetary Fact Sheet:
I first became more interested in dubious stem cell clinics nearly two years ago, when I learned that hockey legend Gordie Howe was undergoing stem cell therapy in Mexico to treat his stroke. Being from Detroit, I imbibed the hockey madness of this town growing up, and know that Detroiters hold Gordie Howe in incredibly high esteem. Prominent in stories about Howe were two companies: Stemedica Cell Technologies, a San Diego company marketing stem cell treatments for all manner of ailments, and Novastem a partner company in Mexico that uses Stemedica products. Also prominent in the stories was Clínica Santa Clarita, the Tijuana-based clinic where Howe received his stem cell infusion. As far as I was able to glean, it’s a clinic to which Novastem supplies Stemedica stem cells. Basically, what happened is that Stemedica CEO Dr. Maynard Howe (no relation to Gordie Howe’s family) and VP Dave McGuigan contacted the Howe family late 2014, after having seen news stories about how poorly Gordie Howe was doing, to offer Howe its stem cell therapy.
Unfortunately, Gordie Howe was not eligible for Stemedica’s US-based clinical trial of its stem cell product for stroke because it had not yet been over six months since his last neurologic event and he was not yet neurologically stable. That didn’t stop Stemedica’s leadership, who, through a combination of admiration for Gordie Howe and a keen sense of knowing a great marketing opportunity when they see it, had another trick up its sleeve. Maynard Howe and McGuigan steered the Howe family to Novastem, one of Stemedica’s international partners. As a result, under the auspices of a highly dubious “clinical trial” conducted by physicians utterly unqualified to run a decent clinical trial under Mexican regulations that basically allowed “approved” clinics to do anything they want with stem cells, (whose details I discussed at the time), Gordie Howe received Stemedica stem cell infusions at Clínica Santa Clarita.
Because of Gordie Howe’s celebrity and the admiration Howe and McGuigan had for him, Novastem even waived the normal $30,000 per infusion charged to typical patients. From my viewpoint, they used Gordie Howe as a marketing tool, with the $30,000 serving basically as an advertising and marketing expense. Unfortunately Gordie Howe’s son Murray Howe, who happens to be a radiologist, was all too happy to go along, expressing an extreme sense of obliviousness and entitlement in response to questions about whether Clinica Santa Maria treated his father Gordie for free, responding, “You betcha. They were thrilled and honored to treat a legend. Would you charge Gordie Howe for treating him? None of his doctors ever do. I certainly am not going to criticize them for being generous.” Let’s just put it this way. I doubt that Gordie Howe’s other physicians refrained from charging Medicare and whatever insurance Howe had at the time for their services or collecting their copays.
Unfortunately, Stemedica’s publicity stunt worked better than Howe and McGuigan could have hoped. Sports reporters dutifully portrayed Gordie Howe’s “miraculous recovery” as being due to the Stemedica-produced stem cell therapy Novastem had administered, even though what almost certainly had happened is that Howe had experienced some improvement because most stroke patients improve after the acute stroke before reaching a plateau of neurological function. Keith Olbermann went on a tear, fully buying into Stemedica’s claims and doing an interview that read like an infomercial for Stemedica, then attacking anyone who sought to bring some skepticism into the discussion. Basically, from my perspective, what Stemedica does, particularly through its international partners, resembles stem cell tourism and for-profit human experimentation far more than it does science. And Stemedica keeps popping up in these stories about “miracle cures” for stem cells. Rarely is there a skeptical take on its activities. Fortunately, last week was an exception.
The story of Jim Gass and Stemedica
A couple of weeks ago, KPBS in San Diego broadcast a detailed two-part story (Part 1 and Part 2) on unproven stem cell treatments. Here’s the video for Part 1:
The story began with a man whom I’ve blogged about before, Jim Gass, who underwent stem cell treatment for his stroke and as a result became paralyzed even worse than he was before because of a tumor growing on his spinal cord. The story shows just how much Jim Gass had been affected by his decision to seek out stem cell treatments for stroke advertised by international clinics. Very early in the story, we see footage from 2010 of Maynard Howe touting the “miraculous recovery” of John Brody due to Stemedica treatments. Not long after that, Gass went to Argentina and China for treatment, but the treatments didn’t work. So, in late 2013, Gass contacted Stemedica, which referred Gass to Dr. Cesar Amescua in Tijuana, who administered Stemedica’s adult stem cells intravenously and injected fetal stem cells from another company into his spinal canal, events that Gass documented with smart phone video. The result was a tumor on the spinal cord. At the time I discussed Gass’ story, it was unclear where Gass had received his stem cell infusions or exactly what they were. Gass, however, did claim that he first contacted Stemedica, which, finding him ineligible for any US-based clinical trials, referred him to “international partners.” The KPBS story goes a long way towards clarifying this, but it also shows that Stemedica officials were either ignorant or lied when they initially denied that Gass had ever been treated with Stemedica products or that Stemedica had referred Gass to the clinic that apparently did him harm:
When asked for comment on Jim Gass’ treatment in Tijuana, McGuigan initially said that Gass had never been treated with Stemedica cells. McGuigan also insisted that Stemedica never referred Gass to Dr. Amescua. Shortly after KPBS showed him emails and footage contradicting his assertion, McGuigan — still on camera and wearing a KPBS microphone — told a fellow Stemedica employee, “Clearly what we’ve been saying as a statement of fact has been incorrect.”
The day after the interview, Stemedica officials confirmed that their company did refer Gass to Dr. Amescua, and that Gass was in fact treated intravenously with Stemedica’s adult stem cells. Those were distinct from the fetal stem cells Gass says were injected into spine.
McGuigan said Stemedica works hard to advance stem cell research in a scientifically sound and legally compliant way. But Stemedica has faced criticism over the work it’s associated with outside the U.S.
Here’s the video segment where McGuigan was confronted with evidence that Stemedica had indeed actually referred Gass to Dr. Cesar Amescua, who initially denied ever having treating treated Gass:
McGuigan denies that Dr. Amescua is still affiliated with Stemedica, stating that he was chief medical officer at Hospital Angeles and is now a medical consultant to Clínica Santa Clarita, which, by the way, was the clinic where Gordie Howe received his stem cell treatments. I would counter that this is pretty darned close to a distinction without a difference, given the tight cooperation between Stemedica, Novastem, and Clínica Santa Clarita demonstrated during the Gordie Howe case. Basically, my impression is that Stemedica is still working with Dr. Amescua (who visited Stemedica the day before the KPBS interview) but keeping him sufficiently at arm’s length for plausible deniability.
It’s also amusing to see KPBS science reporter David Wagner ask McGuigan if Stemedica’s website is out of date, given that it listed Dr. Amescua as its medical and regulatory affairs director for Latin America. Throughout the interview, McGuigan, although definitely showing a talent for remaining relatively unflustered in the face of some very inconvenient questions, bobbed and weaved and repeatedly kept saying “I don’t know” and “I have to do my homework.” I found this very telling. Surely McGuigan should have been able to predict better than he apparently did the sorts of questions that a reporter looking into its connection with Jim Gass’ treatment would be likely to ask. Instead, he’s left lamely deflecting questions by references to not having done his homework or trying to point out that Mr. Gass had received other stem cell products in Argentina and China, even though that was years ago.
Enter Global Stem Cell Health
Now, in fairness, Stemedica’s dubious ethics notwithstanding, it is almost certainly not the Stemedica adult stem cells that caused the tumor in Mr. Gass’ spinal canal. Those adult stem cells were infused intravenously, and apparently some form of embryonic stem cells from another company called Global Stem Cell Health (GSCH):
The first type, Gass said he was told, would be mesenchymal stem cells. He said he was informed that they would be manufactured by Stemedica, and would be injected into a vein in his arm. Stemedica said its mesenchymal stem cells are derived from adult bone marrow.
Gass said he was told that the other type of stem cell would be fetal in origin, and would be injected directly into his cerebrospinal fluid. These fetal neural stem cells, Gass recalled being told, would be procured from Russia not by Stemedica, but by a different company, Global Stem Cell Health (GSCH).
Also based in San Diego County, GSCH is run by Dr. Michael Bayer, a former Stemedica executive. Stemedica spokesman Dave McGuigan said there’s now “a clear separation of church and state between what Michael does and what Stemedica does.”
A GSCH representative explained the distinction to Gass in an email, writing, “Stemedica cannot treat patients because of FDA regulations, and this is how GSCH was started — to treat ‘no option’ patients seeking alternative therapies.”
In other words, GSCH appears to me to have been formed specifically to sell unproven fetal stem cell therapies to desperate patients without those pesky clinical trial regulations. How else can I interpret the statement above? As for McGuigan’s statement that there is now a “clear separation of church and state between what Michael does and what Stemedica does,” I have a hard time not interpreting that, too, as yet another example of plausible deniability.
Interestingly, I tried to check out the website of GSCH, only to see a large “Website Inactive” notice. Thankfully, the almighty Wayback Machine at Archive.org shows me what the website looked like in December 2014, where the company proclaims on the splash page:
Global Stem Cell Health, (GSCH) was created to improve the quality of life of patients suffering from complex disease conditions by providing treatment options using safe and effective adult stem cell therapies. We have had successful outcomes for halting the progression and frequently reversing complex debilitating diseases. These positive outcomes have impacted the lives of our patients, families, and friends. This has been especially true in the treatment of “No Option Patients” – those currently without hope or medical options for regaining physical or cognitive improvement.
The web page claims to be able to treat:
Stroke
Parkinson’s Disease
Spinal Cord Injury
Traumatic Brain Injury
Dementia/ Alzheimer’s Disease
Cerebral Palsy
Multiple Sclerosis
Muscular Dystrophy
Ataxia
Heart and Vascular Disease
Diabetes (Type I & Type II)
Immune Disorders
Diabetic Retinopathy
Retinitis Pigmentosa
Glaucoma
Bone Non-Union
Even more quacky—yes, quacky in my opinion—are these claims:
The Preventative Health Treatment includes a number of different types of stem cells carefully selected to not only improve cosmetic appearance and anti-aging (skin, hair, etc.), but also improve overall health in a number of areas. Preventative Health Treatments are customized for each patient depending on their specific health needs. Typically, 5 stem cell lines are required to ensure maximum preventative health goals. They include improvements of organ function including heart, liver, lung, kidney, pancreatic, and general circulation by decreasing cholesterol deposits and plaques in the arteries to help minimize strokes, heart attack and improve diabetic small vessel disease. There is a significant boost in one’s immune system resulting in resistance to viral (including HIV) and bacterial (including Lyme disease) communicative diseases. There is down regulation of the immune system helping to stabilize autoimmune diseases such as Diabetes, Rheumatoid Arthritis, Lupus, Psoriasis, etc.
Other stem cell lines improve muscle and bone strength as well as endurance and recovery from physical exertion. Hormone levels in patients over 50 are improved including growth and sex hormones and improved sexual function/performance has been observed in some patients. Metabolism and energy levels increase which can lead to decreased fat / cholesterol levels, fatigue and promote weight loss. Neural stem cells can improve memory & cognitive function.
When you start claiming that stem cells can be used as “preventative medicine,” you’ve gone far beyond the realm of evidence- and science-based medicine and into the realm of the speculative, of fantasy, even. The earliest version of the website, from February 2011, although slicker, is slightly less grandiose, although it includes many testimonials from people claiming good results for diseases as varied as muscular dystrophy, diabetic retinopathy, multiple sclerosis, cerebral palsy, spinal cord injury, Alzheimer’s disease, Parkinson’s disease, stroke, and many more, most complete with videos. One wonders if GSCH plans on replacing its old web page with one with more science-based claims. Oh, wait. The webpage it has now is about as science-based as it’s going to get.
Whatever GSCH does with its currently defunct website, Dr. Michael Bayer is an orthopedic surgeon who appears to have had no relevant qualifications to run a stem cell research operation before working with Dr. Nikolay Mironov in 2008, who is touted as the “world’s foremost adult stem cell clinician” in earlier Stemedica press releases. To test that claim, I searched PubMed for Dr. Mironov’s name and found a bunch of publications by others named N. Mironov but nothing on stem cells by Nikolay Mironov. It strains credulity that the “world’s foremost stem cell clinician” would have zero publications on stem cells in PubMed.
I can’t help it, but I smell…well, I smell bovine excrement in this claim every bit as pungent as the bovine excrement in the claim that there’s a firewall or “separation of church and state” between what Stemedica does and what GSCH does. It all comes together in Dr. Amescua, who has had affiliations with Stemedica (and, for all we know, might still be affiliated with Stemedica) and his use of Stemedica and GSCH products in the same patient, Jim Gass. How many more patients have undergone treatment with both products? One wonders, one does.
Oh, and GSCH has facilities in Moscow, Russia and Rosarito Beach, Mexico.
What did Stemedical leadership do before Stemedica?
So we’ve established to my satisfaction that I was perhaps too easy on Stemedica in my previous posts, where I tried to give Dave McGuigan and Maynard Howe the benefit of the doubt. I’ve now come to the opinion that Stemedica is far more shady a company than I had previously suspected. Check out Part 2 of the story to find out why:
Yes, Part 2 of the KPBS story drives that conclusion home by looking more closely into the backgrounds of key players at Stemedica. For example:
Stemedica’s website includes detailed information about the experience and credentials of its top executives. KPBS looked into those credentials, and found that they could not always be independently verified.
Since 2012, Stemedica’s president and chief medical officer Nikolai Tankovich has claimed to have an appointment at England’s prestigious Trinity College, part of the University of Oxford. His bio on a Stemedica subsidiary’s website claims he currently serves as “a legate at Oxford University’s Center for Science and Society Board of Trustees.”
However, Oxford officials tell KPBS that Tankovich’s name did not appear in a search of staff records.
“Nikolai Tankovich has never held an academic or any other position at Trinity College,” estates bursar Kevin Knott wrote in an email to KPBS.
It gets even shadier. After all, it’s probably not uncommon for some executives to—shall we say?—embellish their credentials on corporate websites. But does anyone remember Penta Water? The video (above) starts out with science reporter David Wagner pouring a glass of Penta Water, pointing out that it’s like any other water because, “molecularly, it is.” Chemically, water is water. However, back in the early 2000s, Penta was making much more grandise claims for its water:
Tankovich and two other executives currently listed on the websites of Stemedica and its subsidiary Stemedica International previously worked at a company that had to stop making claims regarding the health benefits of its bottled water, sold under the brand name Penta, following a class action lawsuit filed in 2003.
Penta’s current marketing claims have been reined in significantly. But back in the early 2000s, the makers of Penta water claimed their product was “structurally superior” to normal water. They said they were able to shrink molecular clusters of water using high-energy sound waves, and that Penta had been “proven to be absorbed by cells faster and more effectively than any other water.” At this time, Penta’s website also included testimonials from a number of athletes.
San Diego lawyer Stephen Morris led the class action lawsuit, which brought forward complaints of false advertising and unfair business practices. He says Penta’s marketing strategy was “absurd.”
“They were actually saying they had restructured the water such that the clusters of water molecules were smaller in their bottled water and therefore could be hydrated quicker into the cells,” Morris said. “It was ridiculous.”
Ah, yes. Water cluster quackery! It’s a form of pseudoscience that will not die. Basically, it’s a claim that some water sellers make in which they claim that they make the “clusters” of water molecules in the water smaller in order to make the water more quickly absorbed and rapidly hydrating. Included in the video is an interview with Jonathan Sexton, PhD, an associate professor at North Carolina Central University, who was a graduate student at the time of the case and co-authored a report for the court on Bio-Hydration’s claims (Bio-Hydration was the company that sells Penta Water), calling the company’s claims “junk science” and “pseudoscience.”
Not only was Tankovich, who is now Stemedica’s President and Chief Regulatory and Medical Officer on the Board of Directors of Bio-Hydration, but during the court case he stood by his assertion that Penta Water was “superior to regular water in a number of ways.” With Tankovich were several other current Stemedica employees:
Tankovich served on Bio-Hydration’s board of directors along with David Cheatham, currently described as Stemedica International’s business managing director. Eugene Baranov — today listed as vice president of global research on Stemedica’s website — also worked as the company’s “director of research and development,” according to an archived Penta water web page.
And what was David McGuigan’s response? I must admit that I laughed out loud when I watched him say, “Because Stemedica neither uses, or ever has used, Penta water or any of its derivatives in its manufacturing or product development process, it would be inappropriate for us to speak about [Tankovich’s] personal relationship with Penta.” No, the point was not any accusation that Stemedica uses Penta Water in any of its manufacturing processes. The point was the finding by KPBS that Stemedica’s President and Chief Regulatory Officer used to be on the board of directors of a company that advertised its water as being somehow superior to regular water based on claims rooted in pure pseudoscience and what that says about Stemedica’s leadership and commitment to rigorous science.
Stemedica shadiness doesn’t end with Tankovich
None of the accusations against Stemedica are new, either. While doing my Google searches for background on this story, I found this post from 2012 by Doug Sipp, “Stemedica thrives on neglect.” There it’s pointed out that Stemedica started out with an impressive list of university affiliations and that by 2009 was “well on its way to amassing a collection of biotech merit badges, including state certification of a cGMP cell bank, FDA authorization for a Phase I/II clinical trial, and more recently, a patent on a cellular scaffold invented by Stemedica CTO, Alex Kharazi.” Meanwhile, it was deemphasizing its list of affiliated treatment centers. Sipp also notes that “when you’re talking about overseas treatment/profit centers, gone does not necssearily [sic] mean forgotten, and Stemedica continues to have unusually cozy relationships with a number of clinics outside the US that openly advertise stem cell injections for a thick catalog of afflictions,” and certainly the KPBS story is, if anything, more support for this assertion.
Sipp also documents other shady connections. For instance, in 2007 it was announced that Dr. Ewart Brown and Wanda Henton Brown planned to open a stem cell clinic at Winterhaven in Smith’s in partnership with Stemedica. This center, the planned clinic, the Brown-Darrell Research Clinic for Stem Cell Treatment, apparently never got off the ground and is still in limbo. However, at the time of the announcement in 2007 The Bermuda Sun did a story entitled “A branding and marketing expert with the Midas touch.” That branding expert was Stemedica’s vice-chairman and CEO Maynard Howe:
Three years ago, he launched a laser product that made $57.5 million in 2006 and pulled in $35.3 million for the first half of this year, 24/7 Wall Street reported in an on-line story.
As co-chairman and CEO of another company, Reliant Technologies, which is based in Mountain View, California, Dr. Howe launched the laser product, called Fraxel, which is used for cosmetic skin treatments, such as removing wrinkles and dark spots and resurfacing blemished and ageing skin. Dr. Howe is currently vice-chairman of Reliant.
And:
Dr. Howe is also chairman of Biopharma Scientific, which markets a nutritional product called NanoGreens.
NanoGreens’ nutritional benefits are touted on Biopharma’s website, along with a host of testimonials from satisfied customers. But a disclaimer in the fine print says the product has not been evaluated by the FDA and that “NanoGreens is not intended for the diagnosis, treatment or prevention of any disease.”
How appropriate. Before getting into marketing stem cells, Dr. Howe ran a company selling a laser skin rejuvenation product and a nutraceutical company, complete with a quack Miranda warning. The story also notes that one of Maynard Howe’s brothers, David, a physician and chiropractor, is a member of Stemedica’s and Biopharma’s board of advisors. This, too, seems appropriate: A chiropractor advising a stem cell company. (Yes, that’s sarcasm.)
Another article in the Sun discusses the key players at Stemedica. It turns out that Alex Kharazi, MD, Ph.D., vice-president, medical research of Stemedica at its formation, was member of the Scientific Advisory Board of Aquaphotonics, a sister company to the company that makes Penta water. It also turns out that not only was Tankovich involved with water woo like Penta Water, but that before Penta Water he had “struck gold with hair removal aid.” It’s noted that he has 27 patents, most for laser hair removal or skin treatments.
Basically, the key part of the Sun story on Dr. Howe is where McGuigan describes his background as having “been in taking a concept, such as Fraxel laser, which is now the number one laser in the world, and ‘bringing business practices to bear [and] bringing really great people together from a myriad of different disciplines to create a success story.'” In other words, he’s a marketing man. While it’s true that the stated motivation of the principal movers and shakers of Stemedica, Roger and Maynard Howe plus their longtime Russian business partner Nikolai Tankovich, was the severe injury of a sister-in-law in a car crash in 2004 that left her paraplegic, one mustn’t forget that, first and foremost, these men are entrepreneurs with a history before Stemedica of not being too concerned about how good the science was behind the products they sold. Just take a look at a book they published, The Miracle of Stem Cells:
You get the idea. Howe is far more about marketing than science.
A question that needs to be asked
While Googling for this story, I came across the sad tale of Nathaniel Albring, a 12-year-old victim of anoxic encephalopathy due to a near-drowning episode in 2005, whose family was as of June 2015 trying to raise $50,000 to take him to a stem cell clinic in Moscow. What caught my eye was that he was being seen by Dr. David Howe. Yes, the David Howe mentioned in the story is Maynard Howe’s physician and chiropractor brother (also not related to Gordie or his son Murray Howe, although Nathaniel’s mother appears to work at the same hospital Murray Howe does). Also ,this isn’t the first time he’s tried to get patients to a Moscow clinic that is affiliated with GSCH, which Stemedica claims is no longer related to its businesses. Fortunately for Nathaniel, his family decided to delay his trip to Moscow because he urgently needed spine surgery, and as far as I can tell from his Facebook page he has not been there yet. Nathaniel is an example of the sort of patient targeted by the stem cell hard sell, and families like the Albrings spend their life’s savings pursuing such treatments. Try as Stemedica might to distance itself from such stories, the involvement of David Howe and the media environment fostered by its self-promotion and that of other stem cell businesses makes such distancing impossible.
Indeed, I’m disappointed that KPBS story is not getting wider play, having in essence been relegated to the local San Diego market. It should be a national story, because it is very relevant right now. The reason is that there is now a concerted push by stem cell advocates, spearheaded by clinics that profit from administering dubious stem cell treatments right here in the USA to push back FDA guidelines and regulations on stem cell use. These unethical clinics have co-opted desperate patients who are the victims of their stem cell hard sell to pressure the federal government to rein in the FDA because they are concerned that draft regulations, if adopted, will lead to a crackdown on for-profit stem cell clinics in the US. Of course, I think a crackdown on for-profit stem cell clinics is long overdue, given the claims documented.
Given that background, a key question that needs to be asked is: Where is the published evidence to support claims like those made by Stemedica and GSCH? The answer is in the first part of the KPBS story in an interview with Jeanne Loring, PhD a stem cell scientist at the Scripps Institute:
Loring said if a stem cell company truly is helping patients make remarkable recoveries, they should prove it by publishing their results.
“If they had really good results, they would publish them,” she said. “Because that would be like the best marketing strategy.”
Stemedica could not provide published data from any of its human trials.
Gass’ sister-in-law, concerned about the treatment Jim was about to receive, asked Global Stem Cell Health if they’d ever published evidence that their treatments work. A representative replied to her via email, “We have no current plans to publish our results.”
Let me repeat this: As of this month, Stemedica cannot provide published data from any of its human trials. This is a company that has been in existence for a decade now. That is enough time to have done and published clinical trials on at least short term outcomes for the various diseases that Stemedica claims its stem cells can be used to treat. It’s even worse for GSCH, which has no plans for publishing its results, probably because it has no results because, as far as I can tell, it doesn’t even make a pretense of doing clinical trials.
The other question that one needs to ask is: Why do Stemedica and its international partners charge such huge sums of money to patients to be on clinical trials? The answers, as last time, suggest to me a lack of concern with the ethics of human subject experimentation:
Ethical concerns have been raised about the fees patients are charged to participate in certain stem cell trials outside the country. Loring said patients are not typically charged large sums of money to participate in clinical trials. She thinks patients should be wary of any trial, or any company, that does charge tens of thousands of dollars for participation in a medical study.
When Stemedica spokesman Dave McGuigan was asked about patients who pay large sums of money to receive Stemedica cells as part of a trial outside the U.S., he said Stemedica and their foreign clinical trial partners put up “significant dollars” to carry out these studies, and patients are “asked to participate in those costs.”
“We’re talking about people that have a medical condition for which there is often no cure,” McGuigan said. “And so they have searched the world to find out what their options are.”
My translation: We know they’re desperate and willing to pay. So we’re willing to charge whatever we can get them to pay. After all, each and every pharmaceutical company “put up significant dollars” to carry out clinical trials of their products, with some cancer drugs costing as much as stem cell treatments, and they put up the money. They don’t charge patients for their experimental drugs. Remember, it is generally considered unethical to charge patients to participate in clinical trials. While there are exceptions and it is possible to obtain from the FDA permission to charge patients, exceptions are very limited, uncommon, and should be subject to extreme skepticism and scrutiny. By partnering with stem cell clinics outside the US, Stemedica avoids much of that scrutiny.
In the past, on a couple of occasions when I’ve written posts critical of Stemedica, McGuigan or Howe has either shown up in the comments or e-mailed me, pointing out how very, very unfair or biased my post was. A couple of times one of them even invited me to tour Stemedica. In response, I couldn’t help but note that they never actually offered to pay my travel expenses and I refuse to pay to travel to San Diego and be subject to intense persuasion. (I’m funny that way; I have better uses for my hard-earned cash.) If Howe and McGuigan really want me to do that, they will have to pay (preferably with first class airfare). Be that as it may, in case they are tempted to contact me again about his post, I now pre-emptively answer with a very simple message.
It’s very easy to shut me up. Really, it is. Show me convincing scientific evidence from well-controlled randomized clinical trials that Stemedica products do what you claim they can do. It’s just that simple. Then we can discuss how good the evidence is and whether it’s sufficiently compelling to justify Stemedica’s practices or to justify its partners charging $30,000 a pop for Stemedica stem cell treatments. Absent that, we will be talking past each other. Show me that stem cells aren’t just a more profitable Penta Water or laser skin rejuvenation product. If they’re as great as you claim, it should be child’s play to convince a skeptic. After all, I actually want stem cells to be as powerful a treatment for as many diseases as possible as you do. I really do. I’m getting older, and I would love for there to be effective stem cell treatments for stroke because I’ve entered the age range where I’m at risk. It just takes more than what I’ve seen so far to convince me that stem cells are indeed the miracle that Stemedica and other companies doing the stem cell hard sell tell us they are.
from ScienceBlogs http://ift.tt/2dk8Lpq
I first became more interested in dubious stem cell clinics nearly two years ago, when I learned that hockey legend Gordie Howe was undergoing stem cell therapy in Mexico to treat his stroke. Being from Detroit, I imbibed the hockey madness of this town growing up, and know that Detroiters hold Gordie Howe in incredibly high esteem. Prominent in stories about Howe were two companies: Stemedica Cell Technologies, a San Diego company marketing stem cell treatments for all manner of ailments, and Novastem a partner company in Mexico that uses Stemedica products. Also prominent in the stories was Clínica Santa Clarita, the Tijuana-based clinic where Howe received his stem cell infusion. As far as I was able to glean, it’s a clinic to which Novastem supplies Stemedica stem cells. Basically, what happened is that Stemedica CEO Dr. Maynard Howe (no relation to Gordie Howe’s family) and VP Dave McGuigan contacted the Howe family late 2014, after having seen news stories about how poorly Gordie Howe was doing, to offer Howe its stem cell therapy.
Unfortunately, Gordie Howe was not eligible for Stemedica’s US-based clinical trial of its stem cell product for stroke because it had not yet been over six months since his last neurologic event and he was not yet neurologically stable. That didn’t stop Stemedica’s leadership, who, through a combination of admiration for Gordie Howe and a keen sense of knowing a great marketing opportunity when they see it, had another trick up its sleeve. Maynard Howe and McGuigan steered the Howe family to Novastem, one of Stemedica’s international partners. As a result, under the auspices of a highly dubious “clinical trial” conducted by physicians utterly unqualified to run a decent clinical trial under Mexican regulations that basically allowed “approved” clinics to do anything they want with stem cells, (whose details I discussed at the time), Gordie Howe received Stemedica stem cell infusions at Clínica Santa Clarita.
Because of Gordie Howe’s celebrity and the admiration Howe and McGuigan had for him, Novastem even waived the normal $30,000 per infusion charged to typical patients. From my viewpoint, they used Gordie Howe as a marketing tool, with the $30,000 serving basically as an advertising and marketing expense. Unfortunately Gordie Howe’s son Murray Howe, who happens to be a radiologist, was all too happy to go along, expressing an extreme sense of obliviousness and entitlement in response to questions about whether Clinica Santa Maria treated his father Gordie for free, responding, “You betcha. They were thrilled and honored to treat a legend. Would you charge Gordie Howe for treating him? None of his doctors ever do. I certainly am not going to criticize them for being generous.” Let’s just put it this way. I doubt that Gordie Howe’s other physicians refrained from charging Medicare and whatever insurance Howe had at the time for their services or collecting their copays.
Unfortunately, Stemedica’s publicity stunt worked better than Howe and McGuigan could have hoped. Sports reporters dutifully portrayed Gordie Howe’s “miraculous recovery” as being due to the Stemedica-produced stem cell therapy Novastem had administered, even though what almost certainly had happened is that Howe had experienced some improvement because most stroke patients improve after the acute stroke before reaching a plateau of neurological function. Keith Olbermann went on a tear, fully buying into Stemedica’s claims and doing an interview that read like an infomercial for Stemedica, then attacking anyone who sought to bring some skepticism into the discussion. Basically, from my perspective, what Stemedica does, particularly through its international partners, resembles stem cell tourism and for-profit human experimentation far more than it does science. And Stemedica keeps popping up in these stories about “miracle cures” for stem cells. Rarely is there a skeptical take on its activities. Fortunately, last week was an exception.
The story of Jim Gass and Stemedica
A couple of weeks ago, KPBS in San Diego broadcast a detailed two-part story (Part 1 and Part 2) on unproven stem cell treatments. Here’s the video for Part 1:
The story began with a man whom I’ve blogged about before, Jim Gass, who underwent stem cell treatment for his stroke and as a result became paralyzed even worse than he was before because of a tumor growing on his spinal cord. The story shows just how much Jim Gass had been affected by his decision to seek out stem cell treatments for stroke advertised by international clinics. Very early in the story, we see footage from 2010 of Maynard Howe touting the “miraculous recovery” of John Brody due to Stemedica treatments. Not long after that, Gass went to Argentina and China for treatment, but the treatments didn’t work. So, in late 2013, Gass contacted Stemedica, which referred Gass to Dr. Cesar Amescua in Tijuana, who administered Stemedica’s adult stem cells intravenously and injected fetal stem cells from another company into his spinal canal, events that Gass documented with smart phone video. The result was a tumor on the spinal cord. At the time I discussed Gass’ story, it was unclear where Gass had received his stem cell infusions or exactly what they were. Gass, however, did claim that he first contacted Stemedica, which, finding him ineligible for any US-based clinical trials, referred him to “international partners.” The KPBS story goes a long way towards clarifying this, but it also shows that Stemedica officials were either ignorant or lied when they initially denied that Gass had ever been treated with Stemedica products or that Stemedica had referred Gass to the clinic that apparently did him harm:
When asked for comment on Jim Gass’ treatment in Tijuana, McGuigan initially said that Gass had never been treated with Stemedica cells. McGuigan also insisted that Stemedica never referred Gass to Dr. Amescua. Shortly after KPBS showed him emails and footage contradicting his assertion, McGuigan — still on camera and wearing a KPBS microphone — told a fellow Stemedica employee, “Clearly what we’ve been saying as a statement of fact has been incorrect.”
The day after the interview, Stemedica officials confirmed that their company did refer Gass to Dr. Amescua, and that Gass was in fact treated intravenously with Stemedica’s adult stem cells. Those were distinct from the fetal stem cells Gass says were injected into spine.
McGuigan said Stemedica works hard to advance stem cell research in a scientifically sound and legally compliant way. But Stemedica has faced criticism over the work it’s associated with outside the U.S.
Here’s the video segment where McGuigan was confronted with evidence that Stemedica had indeed actually referred Gass to Dr. Cesar Amescua, who initially denied ever having treating treated Gass:
McGuigan denies that Dr. Amescua is still affiliated with Stemedica, stating that he was chief medical officer at Hospital Angeles and is now a medical consultant to Clínica Santa Clarita, which, by the way, was the clinic where Gordie Howe received his stem cell treatments. I would counter that this is pretty darned close to a distinction without a difference, given the tight cooperation between Stemedica, Novastem, and Clínica Santa Clarita demonstrated during the Gordie Howe case. Basically, my impression is that Stemedica is still working with Dr. Amescua (who visited Stemedica the day before the KPBS interview) but keeping him sufficiently at arm’s length for plausible deniability.
It’s also amusing to see KPBS science reporter David Wagner ask McGuigan if Stemedica’s website is out of date, given that it listed Dr. Amescua as its medical and regulatory affairs director for Latin America. Throughout the interview, McGuigan, although definitely showing a talent for remaining relatively unflustered in the face of some very inconvenient questions, bobbed and weaved and repeatedly kept saying “I don’t know” and “I have to do my homework.” I found this very telling. Surely McGuigan should have been able to predict better than he apparently did the sorts of questions that a reporter looking into its connection with Jim Gass’ treatment would be likely to ask. Instead, he’s left lamely deflecting questions by references to not having done his homework or trying to point out that Mr. Gass had received other stem cell products in Argentina and China, even though that was years ago.
Enter Global Stem Cell Health
Now, in fairness, Stemedica’s dubious ethics notwithstanding, it is almost certainly not the Stemedica adult stem cells that caused the tumor in Mr. Gass’ spinal canal. Those adult stem cells were infused intravenously, and apparently some form of embryonic stem cells from another company called Global Stem Cell Health (GSCH):
The first type, Gass said he was told, would be mesenchymal stem cells. He said he was informed that they would be manufactured by Stemedica, and would be injected into a vein in his arm. Stemedica said its mesenchymal stem cells are derived from adult bone marrow.
Gass said he was told that the other type of stem cell would be fetal in origin, and would be injected directly into his cerebrospinal fluid. These fetal neural stem cells, Gass recalled being told, would be procured from Russia not by Stemedica, but by a different company, Global Stem Cell Health (GSCH).
Also based in San Diego County, GSCH is run by Dr. Michael Bayer, a former Stemedica executive. Stemedica spokesman Dave McGuigan said there’s now “a clear separation of church and state between what Michael does and what Stemedica does.”
A GSCH representative explained the distinction to Gass in an email, writing, “Stemedica cannot treat patients because of FDA regulations, and this is how GSCH was started — to treat ‘no option’ patients seeking alternative therapies.”
In other words, GSCH appears to me to have been formed specifically to sell unproven fetal stem cell therapies to desperate patients without those pesky clinical trial regulations. How else can I interpret the statement above? As for McGuigan’s statement that there is now a “clear separation of church and state between what Michael does and what Stemedica does,” I have a hard time not interpreting that, too, as yet another example of plausible deniability.
Interestingly, I tried to check out the website of GSCH, only to see a large “Website Inactive” notice. Thankfully, the almighty Wayback Machine at Archive.org shows me what the website looked like in December 2014, where the company proclaims on the splash page:
Global Stem Cell Health, (GSCH) was created to improve the quality of life of patients suffering from complex disease conditions by providing treatment options using safe and effective adult stem cell therapies. We have had successful outcomes for halting the progression and frequently reversing complex debilitating diseases. These positive outcomes have impacted the lives of our patients, families, and friends. This has been especially true in the treatment of “No Option Patients” – those currently without hope or medical options for regaining physical or cognitive improvement.
The web page claims to be able to treat:
Stroke
Parkinson’s Disease
Spinal Cord Injury
Traumatic Brain Injury
Dementia/ Alzheimer’s Disease
Cerebral Palsy
Multiple Sclerosis
Muscular Dystrophy
Ataxia
Heart and Vascular Disease
Diabetes (Type I & Type II)
Immune Disorders
Diabetic Retinopathy
Retinitis Pigmentosa
Glaucoma
Bone Non-Union
Even more quacky—yes, quacky in my opinion—are these claims:
The Preventative Health Treatment includes a number of different types of stem cells carefully selected to not only improve cosmetic appearance and anti-aging (skin, hair, etc.), but also improve overall health in a number of areas. Preventative Health Treatments are customized for each patient depending on their specific health needs. Typically, 5 stem cell lines are required to ensure maximum preventative health goals. They include improvements of organ function including heart, liver, lung, kidney, pancreatic, and general circulation by decreasing cholesterol deposits and plaques in the arteries to help minimize strokes, heart attack and improve diabetic small vessel disease. There is a significant boost in one’s immune system resulting in resistance to viral (including HIV) and bacterial (including Lyme disease) communicative diseases. There is down regulation of the immune system helping to stabilize autoimmune diseases such as Diabetes, Rheumatoid Arthritis, Lupus, Psoriasis, etc.
Other stem cell lines improve muscle and bone strength as well as endurance and recovery from physical exertion. Hormone levels in patients over 50 are improved including growth and sex hormones and improved sexual function/performance has been observed in some patients. Metabolism and energy levels increase which can lead to decreased fat / cholesterol levels, fatigue and promote weight loss. Neural stem cells can improve memory & cognitive function.
When you start claiming that stem cells can be used as “preventative medicine,” you’ve gone far beyond the realm of evidence- and science-based medicine and into the realm of the speculative, of fantasy, even. The earliest version of the website, from February 2011, although slicker, is slightly less grandiose, although it includes many testimonials from people claiming good results for diseases as varied as muscular dystrophy, diabetic retinopathy, multiple sclerosis, cerebral palsy, spinal cord injury, Alzheimer’s disease, Parkinson’s disease, stroke, and many more, most complete with videos. One wonders if GSCH plans on replacing its old web page with one with more science-based claims. Oh, wait. The webpage it has now is about as science-based as it’s going to get.
Whatever GSCH does with its currently defunct website, Dr. Michael Bayer is an orthopedic surgeon who appears to have had no relevant qualifications to run a stem cell research operation before working with Dr. Nikolay Mironov in 2008, who is touted as the “world’s foremost adult stem cell clinician” in earlier Stemedica press releases. To test that claim, I searched PubMed for Dr. Mironov’s name and found a bunch of publications by others named N. Mironov but nothing on stem cells by Nikolay Mironov. It strains credulity that the “world’s foremost stem cell clinician” would have zero publications on stem cells in PubMed.
I can’t help it, but I smell…well, I smell bovine excrement in this claim every bit as pungent as the bovine excrement in the claim that there’s a firewall or “separation of church and state” between what Stemedica does and what GSCH does. It all comes together in Dr. Amescua, who has had affiliations with Stemedica (and, for all we know, might still be affiliated with Stemedica) and his use of Stemedica and GSCH products in the same patient, Jim Gass. How many more patients have undergone treatment with both products? One wonders, one does.
Oh, and GSCH has facilities in Moscow, Russia and Rosarito Beach, Mexico.
What did Stemedical leadership do before Stemedica?
So we’ve established to my satisfaction that I was perhaps too easy on Stemedica in my previous posts, where I tried to give Dave McGuigan and Maynard Howe the benefit of the doubt. I’ve now come to the opinion that Stemedica is far more shady a company than I had previously suspected. Check out Part 2 of the story to find out why:
Yes, Part 2 of the KPBS story drives that conclusion home by looking more closely into the backgrounds of key players at Stemedica. For example:
Stemedica’s website includes detailed information about the experience and credentials of its top executives. KPBS looked into those credentials, and found that they could not always be independently verified.
Since 2012, Stemedica’s president and chief medical officer Nikolai Tankovich has claimed to have an appointment at England’s prestigious Trinity College, part of the University of Oxford. His bio on a Stemedica subsidiary’s website claims he currently serves as “a legate at Oxford University’s Center for Science and Society Board of Trustees.”
However, Oxford officials tell KPBS that Tankovich’s name did not appear in a search of staff records.
“Nikolai Tankovich has never held an academic or any other position at Trinity College,” estates bursar Kevin Knott wrote in an email to KPBS.
It gets even shadier. After all, it’s probably not uncommon for some executives to—shall we say?—embellish their credentials on corporate websites. But does anyone remember Penta Water? The video (above) starts out with science reporter David Wagner pouring a glass of Penta Water, pointing out that it’s like any other water because, “molecularly, it is.” Chemically, water is water. However, back in the early 2000s, Penta was making much more grandise claims for its water:
Tankovich and two other executives currently listed on the websites of Stemedica and its subsidiary Stemedica International previously worked at a company that had to stop making claims regarding the health benefits of its bottled water, sold under the brand name Penta, following a class action lawsuit filed in 2003.
Penta’s current marketing claims have been reined in significantly. But back in the early 2000s, the makers of Penta water claimed their product was “structurally superior” to normal water. They said they were able to shrink molecular clusters of water using high-energy sound waves, and that Penta had been “proven to be absorbed by cells faster and more effectively than any other water.” At this time, Penta’s website also included testimonials from a number of athletes.
San Diego lawyer Stephen Morris led the class action lawsuit, which brought forward complaints of false advertising and unfair business practices. He says Penta’s marketing strategy was “absurd.”
“They were actually saying they had restructured the water such that the clusters of water molecules were smaller in their bottled water and therefore could be hydrated quicker into the cells,” Morris said. “It was ridiculous.”
Ah, yes. Water cluster quackery! It’s a form of pseudoscience that will not die. Basically, it’s a claim that some water sellers make in which they claim that they make the “clusters” of water molecules in the water smaller in order to make the water more quickly absorbed and rapidly hydrating. Included in the video is an interview with Jonathan Sexton, PhD, an associate professor at North Carolina Central University, who was a graduate student at the time of the case and co-authored a report for the court on Bio-Hydration’s claims (Bio-Hydration was the company that sells Penta Water), calling the company’s claims “junk science” and “pseudoscience.”
Not only was Tankovich, who is now Stemedica’s President and Chief Regulatory and Medical Officer on the Board of Directors of Bio-Hydration, but during the court case he stood by his assertion that Penta Water was “superior to regular water in a number of ways.” With Tankovich were several other current Stemedica employees:
Tankovich served on Bio-Hydration’s board of directors along with David Cheatham, currently described as Stemedica International’s business managing director. Eugene Baranov — today listed as vice president of global research on Stemedica’s website — also worked as the company’s “director of research and development,” according to an archived Penta water web page.
And what was David McGuigan’s response? I must admit that I laughed out loud when I watched him say, “Because Stemedica neither uses, or ever has used, Penta water or any of its derivatives in its manufacturing or product development process, it would be inappropriate for us to speak about [Tankovich’s] personal relationship with Penta.” No, the point was not any accusation that Stemedica uses Penta Water in any of its manufacturing processes. The point was the finding by KPBS that Stemedica’s President and Chief Regulatory Officer used to be on the board of directors of a company that advertised its water as being somehow superior to regular water based on claims rooted in pure pseudoscience and what that says about Stemedica’s leadership and commitment to rigorous science.
Stemedica shadiness doesn’t end with Tankovich
None of the accusations against Stemedica are new, either. While doing my Google searches for background on this story, I found this post from 2012 by Doug Sipp, “Stemedica thrives on neglect.” There it’s pointed out that Stemedica started out with an impressive list of university affiliations and that by 2009 was “well on its way to amassing a collection of biotech merit badges, including state certification of a cGMP cell bank, FDA authorization for a Phase I/II clinical trial, and more recently, a patent on a cellular scaffold invented by Stemedica CTO, Alex Kharazi.” Meanwhile, it was deemphasizing its list of affiliated treatment centers. Sipp also notes that “when you’re talking about overseas treatment/profit centers, gone does not necssearily [sic] mean forgotten, and Stemedica continues to have unusually cozy relationships with a number of clinics outside the US that openly advertise stem cell injections for a thick catalog of afflictions,” and certainly the KPBS story is, if anything, more support for this assertion.
Sipp also documents other shady connections. For instance, in 2007 it was announced that Dr. Ewart Brown and Wanda Henton Brown planned to open a stem cell clinic at Winterhaven in Smith’s in partnership with Stemedica. This center, the planned clinic, the Brown-Darrell Research Clinic for Stem Cell Treatment, apparently never got off the ground and is still in limbo. However, at the time of the announcement in 2007 The Bermuda Sun did a story entitled “A branding and marketing expert with the Midas touch.” That branding expert was Stemedica’s vice-chairman and CEO Maynard Howe:
Three years ago, he launched a laser product that made $57.5 million in 2006 and pulled in $35.3 million for the first half of this year, 24/7 Wall Street reported in an on-line story.
As co-chairman and CEO of another company, Reliant Technologies, which is based in Mountain View, California, Dr. Howe launched the laser product, called Fraxel, which is used for cosmetic skin treatments, such as removing wrinkles and dark spots and resurfacing blemished and ageing skin. Dr. Howe is currently vice-chairman of Reliant.
And:
Dr. Howe is also chairman of Biopharma Scientific, which markets a nutritional product called NanoGreens.
NanoGreens’ nutritional benefits are touted on Biopharma’s website, along with a host of testimonials from satisfied customers. But a disclaimer in the fine print says the product has not been evaluated by the FDA and that “NanoGreens is not intended for the diagnosis, treatment or prevention of any disease.”
How appropriate. Before getting into marketing stem cells, Dr. Howe ran a company selling a laser skin rejuvenation product and a nutraceutical company, complete with a quack Miranda warning. The story also notes that one of Maynard Howe’s brothers, David, a physician and chiropractor, is a member of Stemedica’s and Biopharma’s board of advisors. This, too, seems appropriate: A chiropractor advising a stem cell company. (Yes, that’s sarcasm.)
Another article in the Sun discusses the key players at Stemedica. It turns out that Alex Kharazi, MD, Ph.D., vice-president, medical research of Stemedica at its formation, was member of the Scientific Advisory Board of Aquaphotonics, a sister company to the company that makes Penta water. It also turns out that not only was Tankovich involved with water woo like Penta Water, but that before Penta Water he had “struck gold with hair removal aid.” It’s noted that he has 27 patents, most for laser hair removal or skin treatments.
Basically, the key part of the Sun story on Dr. Howe is where McGuigan describes his background as having “been in taking a concept, such as Fraxel laser, which is now the number one laser in the world, and ‘bringing business practices to bear [and] bringing really great people together from a myriad of different disciplines to create a success story.'” In other words, he’s a marketing man. While it’s true that the stated motivation of the principal movers and shakers of Stemedica, Roger and Maynard Howe plus their longtime Russian business partner Nikolai Tankovich, was the severe injury of a sister-in-law in a car crash in 2004 that left her paraplegic, one mustn’t forget that, first and foremost, these men are entrepreneurs with a history before Stemedica of not being too concerned about how good the science was behind the products they sold. Just take a look at a book they published, The Miracle of Stem Cells:
You get the idea. Howe is far more about marketing than science.
A question that needs to be asked
While Googling for this story, I came across the sad tale of Nathaniel Albring, a 12-year-old victim of anoxic encephalopathy due to a near-drowning episode in 2005, whose family was as of June 2015 trying to raise $50,000 to take him to a stem cell clinic in Moscow. What caught my eye was that he was being seen by Dr. David Howe. Yes, the David Howe mentioned in the story is Maynard Howe’s physician and chiropractor brother (also not related to Gordie or his son Murray Howe, although Nathaniel’s mother appears to work at the same hospital Murray Howe does). Also ,this isn’t the first time he’s tried to get patients to a Moscow clinic that is affiliated with GSCH, which Stemedica claims is no longer related to its businesses. Fortunately for Nathaniel, his family decided to delay his trip to Moscow because he urgently needed spine surgery, and as far as I can tell from his Facebook page he has not been there yet. Nathaniel is an example of the sort of patient targeted by the stem cell hard sell, and families like the Albrings spend their life’s savings pursuing such treatments. Try as Stemedica might to distance itself from such stories, the involvement of David Howe and the media environment fostered by its self-promotion and that of other stem cell businesses makes such distancing impossible.
Indeed, I’m disappointed that KPBS story is not getting wider play, having in essence been relegated to the local San Diego market. It should be a national story, because it is very relevant right now. The reason is that there is now a concerted push by stem cell advocates, spearheaded by clinics that profit from administering dubious stem cell treatments right here in the USA to push back FDA guidelines and regulations on stem cell use. These unethical clinics have co-opted desperate patients who are the victims of their stem cell hard sell to pressure the federal government to rein in the FDA because they are concerned that draft regulations, if adopted, will lead to a crackdown on for-profit stem cell clinics in the US. Of course, I think a crackdown on for-profit stem cell clinics is long overdue, given the claims documented.
Given that background, a key question that needs to be asked is: Where is the published evidence to support claims like those made by Stemedica and GSCH? The answer is in the first part of the KPBS story in an interview with Jeanne Loring, PhD a stem cell scientist at the Scripps Institute:
Loring said if a stem cell company truly is helping patients make remarkable recoveries, they should prove it by publishing their results.
“If they had really good results, they would publish them,” she said. “Because that would be like the best marketing strategy.”
Stemedica could not provide published data from any of its human trials.
Gass’ sister-in-law, concerned about the treatment Jim was about to receive, asked Global Stem Cell Health if they’d ever published evidence that their treatments work. A representative replied to her via email, “We have no current plans to publish our results.”
Let me repeat this: As of this month, Stemedica cannot provide published data from any of its human trials. This is a company that has been in existence for a decade now. That is enough time to have done and published clinical trials on at least short term outcomes for the various diseases that Stemedica claims its stem cells can be used to treat. It’s even worse for GSCH, which has no plans for publishing its results, probably because it has no results because, as far as I can tell, it doesn’t even make a pretense of doing clinical trials.
The other question that one needs to ask is: Why do Stemedica and its international partners charge such huge sums of money to patients to be on clinical trials? The answers, as last time, suggest to me a lack of concern with the ethics of human subject experimentation:
Ethical concerns have been raised about the fees patients are charged to participate in certain stem cell trials outside the country. Loring said patients are not typically charged large sums of money to participate in clinical trials. She thinks patients should be wary of any trial, or any company, that does charge tens of thousands of dollars for participation in a medical study.
When Stemedica spokesman Dave McGuigan was asked about patients who pay large sums of money to receive Stemedica cells as part of a trial outside the U.S., he said Stemedica and their foreign clinical trial partners put up “significant dollars” to carry out these studies, and patients are “asked to participate in those costs.”
“We’re talking about people that have a medical condition for which there is often no cure,” McGuigan said. “And so they have searched the world to find out what their options are.”
My translation: We know they’re desperate and willing to pay. So we’re willing to charge whatever we can get them to pay. After all, each and every pharmaceutical company “put up significant dollars” to carry out clinical trials of their products, with some cancer drugs costing as much as stem cell treatments, and they put up the money. They don’t charge patients for their experimental drugs. Remember, it is generally considered unethical to charge patients to participate in clinical trials. While there are exceptions and it is possible to obtain from the FDA permission to charge patients, exceptions are very limited, uncommon, and should be subject to extreme skepticism and scrutiny. By partnering with stem cell clinics outside the US, Stemedica avoids much of that scrutiny.
In the past, on a couple of occasions when I’ve written posts critical of Stemedica, McGuigan or Howe has either shown up in the comments or e-mailed me, pointing out how very, very unfair or biased my post was. A couple of times one of them even invited me to tour Stemedica. In response, I couldn’t help but note that they never actually offered to pay my travel expenses and I refuse to pay to travel to San Diego and be subject to intense persuasion. (I’m funny that way; I have better uses for my hard-earned cash.) If Howe and McGuigan really want me to do that, they will have to pay (preferably with first class airfare). Be that as it may, in case they are tempted to contact me again about his post, I now pre-emptively answer with a very simple message.
It’s very easy to shut me up. Really, it is. Show me convincing scientific evidence from well-controlled randomized clinical trials that Stemedica products do what you claim they can do. It’s just that simple. Then we can discuss how good the evidence is and whether it’s sufficiently compelling to justify Stemedica’s practices or to justify its partners charging $30,000 a pop for Stemedica stem cell treatments. Absent that, we will be talking past each other. Show me that stem cells aren’t just a more profitable Penta Water or laser skin rejuvenation product. If they’re as great as you claim, it should be child’s play to convince a skeptic. After all, I actually want stem cells to be as powerful a treatment for as many diseases as possible as you do. I really do. I’m getting older, and I would love for there to be effective stem cell treatments for stroke because I’ve entered the age range where I’m at risk. It just takes more than what I’ve seen so far to convince me that stem cells are indeed the miracle that Stemedica and other companies doing the stem cell hard sell tell us they are.
