Soaking or Germinating Grains
The most basic method of preparing grains is prolonged soaking in water, followed by cooking. This combination reduces the level of water-soluble and heat-sensitive toxins and anti-nutrients such as tannins, saponins, digestive enzyme inhibitors and lectins, as well as flatulence factors. It also partially degrades phytic acid, which is a potent inhibitor of mineral absorption, an inhibitor of the digestive enzyme trypsin and an enemy of dental health (1). This improves the digestibility and nutritional value of grains as well as legumes.
I prefer to soak all grains and legumes for at least 12 hours in a warm location, preferably 24. This includes foods that most people don't soak, such as lentils. Soaking does not reduce phytic acid at all in grains that have been heat-treated, such as oats and kasha (technically not a grain), because they no longer contain the phytic acid-degrading enzyme phytase. Cooking without soaking first also does not have much effect on phytic acid.
The next level of grain preparation is germination. After soaking, rinse the grains twice per day for an additional day or two. This activates the grains' sprouting program and further increases their digestibility and vitamin content. When combined with cooking, it reduces phytic acid, although modestly. Therefore, most of the minerals in sprouted whole grains will continue to be inaccessible. Many raw sprouted grains and legumes are edible, but I wouldn't use them as a staple food because they retain most of their phytic acid as well as some heat-sensitive anti-nutrients (2).
Grinding and Fermenting Grains
Many cultures around the world have independently discovered fermentation as a way to greatly improve the digestibility and nutritive value of grains (3). Typically, grains are soaked, ground, and allowed to sour ferment for times ranging from 12 hours to several days. In some cases, a portion of the bran is removed before or after grinding.
In addition to the reduction in toxins and anti-nutrients afforded by soaking and cooking, grinding and fermentation goes much further. Grinding greatly increases the surface area of the grains and breaks up their cellular structure, releasing enzymes which are important for the transformation to come. Under the right conditions, which are easy to achieve, lactic acid bacteria rapidly acidify the batter. These bacteria are naturally present on grains, but adding a starter makes the process more efficient and reliable.
Due to some quirk of nature, grain phytase is maximally active at a pH of between 4.5 and 5.5, which is mildly acidic. This is why the Weston Price foundation recommends soaking grains in an acidic medium before cooking. The combination of grinding and sour fermentation causes grains to efficiently degrade their own phytic acid (as long as they haven't been heat treated first), making minerals much more available for absorption (4, 5, 6, 7). This transforms whole grains from a poor source of minerals into a good source.
The degree of phytic acid degradation depends on the starting amount of phytase in the grain. Corn, rice, oats and millet don't contain much phytase activity, so they require either a longer fermentation time, or the addition of high-phytase grains to the batter (8). Whole raw buckwheat, wheat, and particularly rye contain a large amount of phytase (9), although I feel wheat is problematic for other reasons.
As fermentation proceeds, bacteria secrete enzymes that begin digesting the protein, starch and other substances in the batter. Fermentation reduces lectin levels substantially, which are reduced further by cooking (10). Lectins are toxins that can interfere with digestion and may be involved in autoimmune disease, an idea championed by Dr. Loren Cordain. Grain lectins are generally heat-sensitive, but one notable exception is the nasty lectin wheat germ agglutinin (WGA). As its name suggests, WGA is found in wheat germ, and thus is mostly absent in white flour. WGA may have been another reason why DART participants who increased their wheat fiber intake had significantly more heart attacks than those who didn't. I don't know if fermentation degrades WGA.
One of the problems with grains is their poor protein quality. Besides containing a fairly low concentration of protein to begin with, they also don't contain a good balance of essential amino acids. This prevents their efficient use by the body, unless a separate source of certain amino acids is eaten along with them. The main limiting amino acid in grains is lysine. Legumes are rich in lysine, which is why cultures around the world pair them with grains. Bacterial fermentation produces lysine, often increasing its concentration by many fold and making grains nearly a "complete protein", i.e. one that contains the ideal balance of essential amino acids as do animal proteins (11, scroll down to see graph). Not very many plant foods can make that claim. Fermentation also increases the concentration of the amino acid methionine and certain vitamins.
Another problem with grain protein is it's poorly digested relative to animal protein. This means that a portion of it escapes digestion, leading to a lower nutritive value and a higher risk of allergy due to undigested protein hanging around in the digestive tract. Fermentation followed by cooking increases the digestibility of grain protein, bringing it nearly to the same level as meat (12, 13, 14, 15). This may relate to the destruction of protease inhibitors (trypsin inhibitors, phytic acid) and the partial pre-digestion of grain proteins by bacteria.
Once you delve into the research on traditional grain preparation methods, you begin to see why grain-eating cultures throughout the world have favored certain techniques. Proper grain processing transforms them from toxic to nutritious, from health-degrading to health-giving. Modern industrial grain processing has largely eschewed these time-honored techniques, replacing them with low-extraction milling, extrusion and quick-rise yeast strains.
Many people will not be willing to go through the trouble of grinding and fermentation to prepare grains. I can sympathize, although if you have the right tools, once you establish a routine it really isn't that much work. It just requires a bit of organization. In fact, it can even be downright convenient. I often keep a bowl of fermented dosa or buckwheat batter in the fridge, ready to make a tasty "pancake" at a moment's notice. In the next post, I'll describe a few recipes from different parts of the world.
Further reading:
How to Eat Grains
A Few Thoughts on Minerals, Milling, Grains and Tubers
Dietary Fiber and Mineral Availability
A New Way to Soak Brown Rice
Traditional Preparation Methods Improve Grains' Nutritive Value
Soaking or Germinating Grains
The most basic method of preparing grains is prolonged soaking in water, followed by cooking. This combination reduces the level of water-soluble and heat-sensitive toxins and anti-nutrients such as tannins, saponins, digestive enzyme inhibitors and lectins, as well as flatulence factors. It also partially degrades phytic acid, which is a potent inhibitor of mineral absorption, an inhibitor of the digestive enzyme trypsin and an enemy of dental health (1). This improves the digestibility and nutritional value of grains as well as legumes.
I prefer to soak all grains and legumes for at least 12 hours in a warm location, preferably 24. This includes foods that most people don't soak, such as lentils. Soaking does not reduce phytic acid at all in grains that have been heat-treated, such as oats and kasha (technically not a grain), because they no longer contain the phytic acid-degrading enzyme phytase. Cooking without soaking first also does not have much effect on phytic acid.
The next level of grain preparation is germination. After soaking, rinse the grains twice per day for an additional day or two. This activates the grains' sprouting program and further increases their digestibility and vitamin content. When combined with cooking, it reduces phytic acid, although modestly. Therefore, most of the minerals in sprouted whole grains will continue to be inaccessible. Many raw sprouted grains and legumes are edible, but I wouldn't use them as a staple food because they retain most of their phytic acid as well as some heat-sensitive anti-nutrients (2).
Grinding and Fermenting Grains
Many cultures around the world have independently discovered fermentation as a way to greatly improve the digestibility and nutritive value of grains (3). Typically, grains are soaked, ground, and allowed to sour ferment for times ranging from 12 hours to several days. In some cases, a portion of the bran is removed before or after grinding.
In addition to the reduction in toxins and anti-nutrients afforded by soaking and cooking, grinding and fermentation goes much further. Grinding greatly increases the surface area of the grains and breaks up their cellular structure, releasing enzymes which are important for the transformation to come. Under the right conditions, which are easy to achieve, lactic acid bacteria rapidly acidify the batter. These bacteria are naturally present on grains, but adding a starter makes the process more efficient and reliable.
Due to some quirk of nature, grain phytase is maximally active at a pH of between 4.5 and 5.5, which is mildly acidic. This is why the Weston Price foundation recommends soaking grains in an acidic medium before cooking. The combination of grinding and sour fermentation causes grains to efficiently degrade their own phytic acid (as long as they haven't been heat treated first), making minerals much more available for absorption (4, 5, 6, 7). This transforms whole grains from a poor source of minerals into a good source.
The degree of phytic acid degradation depends on the starting amount of phytase in the grain. Corn, rice, oats and millet don't contain much phytase activity, so they require either a longer fermentation time, or the addition of high-phytase grains to the batter (8). Whole raw buckwheat, wheat, and particularly rye contain a large amount of phytase (9), although I feel wheat is problematic for other reasons.
As fermentation proceeds, bacteria secrete enzymes that begin digesting the protein, starch and other substances in the batter. Fermentation reduces lectin levels substantially, which are reduced further by cooking (10). Lectins are toxins that can interfere with digestion and may be involved in autoimmune disease, an idea championed by Dr. Loren Cordain. Grain lectins are generally heat-sensitive, but one notable exception is the nasty lectin wheat germ agglutinin (WGA). As its name suggests, WGA is found in wheat germ, and thus is mostly absent in white flour. WGA may have been another reason why DART participants who increased their wheat fiber intake had significantly more heart attacks than those who didn't. I don't know if fermentation degrades WGA.
One of the problems with grains is their poor protein quality. Besides containing a fairly low concentration of protein to begin with, they also don't contain a good balance of essential amino acids. This prevents their efficient use by the body, unless a separate source of certain amino acids is eaten along with them. The main limiting amino acid in grains is lysine. Legumes are rich in lysine, which is why cultures around the world pair them with grains. Bacterial fermentation produces lysine, often increasing its concentration by many fold and making grains nearly a "complete protein", i.e. one that contains the ideal balance of essential amino acids as do animal proteins (11, scroll down to see graph). Not very many plant foods can make that claim. Fermentation also increases the concentration of the amino acid methionine and certain vitamins.
Another problem with grain protein is it's poorly digested relative to animal protein. This means that a portion of it escapes digestion, leading to a lower nutritive value and a higher risk of allergy due to undigested protein hanging around in the digestive tract. Fermentation followed by cooking increases the digestibility of grain protein, bringing it nearly to the same level as meat (12, 13, 14, 15). This may relate to the destruction of protease inhibitors (trypsin inhibitors, phytic acid) and the partial pre-digestion of grain proteins by bacteria.
Once you delve into the research on traditional grain preparation methods, you begin to see why grain-eating cultures throughout the world have favored certain techniques. Proper grain processing transforms them from toxic to nutritious, from health-degrading to health-giving. Modern industrial grain processing has largely eschewed these time-honored techniques, replacing them with low-extraction milling, extrusion and quick-rise yeast strains.
Many people will not be willing to go through the trouble of grinding and fermentation to prepare grains. I can sympathize, although if you have the right tools, once you establish a routine it really isn't that much work. It just requires a bit of organization. In fact, it can even be downright convenient. I often keep a bowl of fermented dosa or buckwheat batter in the fridge, ready to make a tasty "pancake" at a moment's notice. In the next post, I'll describe a few recipes from different parts of the world.
Further reading:
How to Eat Grains
A Few Thoughts on Minerals, Milling, Grains and Tubers
Dietary Fiber and Mineral Availability
A New Way to Soak Brown Rice
The most basic method of preparing grains is prolonged soaking in water, followed by cooking. This combination reduces the level of water-soluble and heat-sensitive toxins and anti-nutrients such as tannins, saponins, digestive enzyme inhibitors and lectins, as well as flatulence factors. It also partially degrades phytic acid, which is a potent inhibitor of mineral absorption, an inhibitor of the digestive enzyme trypsin and an enemy of dental health (1). This improves the digestibility and nutritional value of grains as well as legumes.
I prefer to soak all grains and legumes for at least 12 hours in a warm location, preferably 24. This includes foods that most people don't soak, such as lentils. Soaking does not reduce phytic acid at all in grains that have been heat-treated, such as oats and kasha (technically not a grain), because they no longer contain the phytic acid-degrading enzyme phytase. Cooking without soaking first also does not have much effect on phytic acid.
The next level of grain preparation is germination. After soaking, rinse the grains twice per day for an additional day or two. This activates the grains' sprouting program and further increases their digestibility and vitamin content. When combined with cooking, it reduces phytic acid, although modestly. Therefore, most of the minerals in sprouted whole grains will continue to be inaccessible. Many raw sprouted grains and legumes are edible, but I wouldn't use them as a staple food because they retain most of their phytic acid as well as some heat-sensitive anti-nutrients (2).
Grinding and Fermenting Grains
Many cultures around the world have independently discovered fermentation as a way to greatly improve the digestibility and nutritive value of grains (3). Typically, grains are soaked, ground, and allowed to sour ferment for times ranging from 12 hours to several days. In some cases, a portion of the bran is removed before or after grinding.
In addition to the reduction in toxins and anti-nutrients afforded by soaking and cooking, grinding and fermentation goes much further. Grinding greatly increases the surface area of the grains and breaks up their cellular structure, releasing enzymes which are important for the transformation to come. Under the right conditions, which are easy to achieve, lactic acid bacteria rapidly acidify the batter. These bacteria are naturally present on grains, but adding a starter makes the process more efficient and reliable.
Due to some quirk of nature, grain phytase is maximally active at a pH of between 4.5 and 5.5, which is mildly acidic. This is why the Weston Price foundation recommends soaking grains in an acidic medium before cooking. The combination of grinding and sour fermentation causes grains to efficiently degrade their own phytic acid (as long as they haven't been heat treated first), making minerals much more available for absorption (4, 5, 6, 7). This transforms whole grains from a poor source of minerals into a good source.
The degree of phytic acid degradation depends on the starting amount of phytase in the grain. Corn, rice, oats and millet don't contain much phytase activity, so they require either a longer fermentation time, or the addition of high-phytase grains to the batter (8). Whole raw buckwheat, wheat, and particularly rye contain a large amount of phytase (9), although I feel wheat is problematic for other reasons.
As fermentation proceeds, bacteria secrete enzymes that begin digesting the protein, starch and other substances in the batter. Fermentation reduces lectin levels substantially, which are reduced further by cooking (10). Lectins are toxins that can interfere with digestion and may be involved in autoimmune disease, an idea championed by Dr. Loren Cordain. Grain lectins are generally heat-sensitive, but one notable exception is the nasty lectin wheat germ agglutinin (WGA). As its name suggests, WGA is found in wheat germ, and thus is mostly absent in white flour. WGA may have been another reason why DART participants who increased their wheat fiber intake had significantly more heart attacks than those who didn't. I don't know if fermentation degrades WGA.
One of the problems with grains is their poor protein quality. Besides containing a fairly low concentration of protein to begin with, they also don't contain a good balance of essential amino acids. This prevents their efficient use by the body, unless a separate source of certain amino acids is eaten along with them. The main limiting amino acid in grains is lysine. Legumes are rich in lysine, which is why cultures around the world pair them with grains. Bacterial fermentation produces lysine, often increasing its concentration by many fold and making grains nearly a "complete protein", i.e. one that contains the ideal balance of essential amino acids as do animal proteins (11, scroll down to see graph). Not very many plant foods can make that claim. Fermentation also increases the concentration of the amino acid methionine and certain vitamins.
Another problem with grain protein is it's poorly digested relative to animal protein. This means that a portion of it escapes digestion, leading to a lower nutritive value and a higher risk of allergy due to undigested protein hanging around in the digestive tract. Fermentation followed by cooking increases the digestibility of grain protein, bringing it nearly to the same level as meat (12, 13, 14, 15). This may relate to the destruction of protease inhibitors (trypsin inhibitors, phytic acid) and the partial pre-digestion of grain proteins by bacteria.
Once you delve into the research on traditional grain preparation methods, you begin to see why grain-eating cultures throughout the world have favored certain techniques. Proper grain processing transforms them from toxic to nutritious, from health-degrading to health-giving. Modern industrial grain processing has largely eschewed these time-honored techniques, replacing them with low-extraction milling, extrusion and quick-rise yeast strains.
Many people will not be willing to go through the trouble of grinding and fermentation to prepare grains. I can sympathize, although if you have the right tools, once you establish a routine it really isn't that much work. It just requires a bit of organization. In fact, it can even be downright convenient. I often keep a bowl of fermented dosa or buckwheat batter in the fridge, ready to make a tasty "pancake" at a moment's notice. In the next post, I'll describe a few recipes from different parts of the world.
Further reading:
How to Eat Grains
A Few Thoughts on Minerals, Milling, Grains and Tubers
Dietary Fiber and Mineral Availability
A New Way to Soak Brown Rice
David Blumenthal on health IT safety: nothing to see here, move along
At "FDA on Health IT Adverse Consequences: 44 Reported Injuries And 6 Deaths In Two Years, Probably Just Tip of Iceberg" I wrote about a meeting of the HIT Policy Committee, Adoption/Certification Workgroup on February 25, 2010. The topic was "HIT safety." The agenda, presenters and presentations are available at this link.
At this meeting FDA testimony was given by Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health. Dr. Shuren noted several categories of health IT-induced adverse consequences known by FDA. This information was striking.
He wrote:
Well, there's absolutely nothing to worry about, according to the Office of the National Coordinator and Dr. David Blumenthal. Nothing to see here. Move on.
Blumenthal has just reportedly stated that:
I ask a simple question:
Perhaps I'm a bit behind these postmodern times, but I once believed the perhaps now old-fashioned and obsolete view that a scientist would not base a conclusion of medical safety in national dissemination of drug, device, or whatever on some analysis of anecdotal data, whether 'preliminary' or final.
Due to reasons such as the lack of knowledge of FDA as a place to report HIT problems, as well as fear by clinicians in reporting HIT problems at all, the cited FDA data (260 HIT-related adverse events over two years, including 44 reported injuries and six deaths) is most certainly anecdotal and incomplete, and potentially (per FDA's Jeff Shuren, MD, JD) the "tip of the iceberg."
I would not take the FDA data to be anything but a possible red flag, not a source of truth, one way or the other.
For example, the scant reports of health IT bugs and defects -- many of which admittedly could cause medical error -- in another database, MAUDE, voluntarily submitted by just a tiny fraction of the HIT vendors, should give a scientist pause. They are a sentinel. (See my Oct. 2009 post "Our Policy Is To Always Have Unabashed Faith In The Computer ... Except When It Screws Up, And Then It's The Doctor's Fault" for several MAUDE database examples).
Proof by lack of evidence is not what I was taught in medical school.
Blumenthal appears to be speaking not as a scientist, but as a marketer and (of course) politician.
This is quite disappointing.
However, as the man said, nothing to see here, move along.
By the way, I am assuming the "analysis" will be open to public scrutiny.
-- SS
At this meeting FDA testimony was given by Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health. Dr. Shuren noted several categories of health IT-induced adverse consequences known by FDA. This information was striking.
He wrote:
... In the past two years, we have received 260 reports of HIT-related malfunctions with the potential for patient harm – including 44 reported injuries and 6 reported deaths. Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist.
Well, there's absolutely nothing to worry about, according to the Office of the National Coordinator and Dr. David Blumenthal. Nothing to see here. Move on.
Blumenthal has just reportedly stated that:
http://www.massdevice.com/news/blumenthal-evidence-adverse-events-with-emrs-anecdotal-and-fragmented
... [Blumenthal's] department is confident that its mission remains unchanged in trying to push all healthcare establishments to adopt EMRs as a standard practice. "The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's could impede patient safety," he said.
I ask a simple question:
- Are these the words to be reasonably expected from an academic physician/scientist?
Perhaps I'm a bit behind these postmodern times, but I once believed the perhaps now old-fashioned and obsolete view that a scientist would not base a conclusion of medical safety in national dissemination of drug, device, or whatever on some analysis of anecdotal data, whether 'preliminary' or final.
Due to reasons such as the lack of knowledge of FDA as a place to report HIT problems, as well as fear by clinicians in reporting HIT problems at all, the cited FDA data (260 HIT-related adverse events over two years, including 44 reported injuries and six deaths) is most certainly anecdotal and incomplete, and potentially (per FDA's Jeff Shuren, MD, JD) the "tip of the iceberg."
I would not take the FDA data to be anything but a possible red flag, not a source of truth, one way or the other.
For example, the scant reports of health IT bugs and defects -- many of which admittedly could cause medical error -- in another database, MAUDE, voluntarily submitted by just a tiny fraction of the HIT vendors, should give a scientist pause. They are a sentinel. (See my Oct. 2009 post "Our Policy Is To Always Have Unabashed Faith In The Computer ... Except When It Screws Up, And Then It's The Doctor's Fault" for several MAUDE database examples).
Obviously, the unreported, unrecognized (and therefore uncorrected) bugs and defects have the same potential. Those MAUDE reports alone should provide an impetus to call for full, rigorous, scientific, uncensored investigations on HIT safety, not make pronouncements on safety to a national audience.
(Feb. 2011 addendum - see my more recent post about MAUDE health IT defects reports at this link.)
Proof by lack of evidence is not what I was taught in medical school.
Blumenthal appears to be speaking not as a scientist, but as a marketer and (of course) politician.
This is quite disappointing.
However, as the man said, nothing to see here, move along.
By the way, I am assuming the "analysis" will be open to public scrutiny.
-- SS
Board Member Blows Whistle on Health Insurance Company's Accounting
We previously posted about some of the travails of for-profit health insurance company/ managed care organization Wellcare. In August, 2009, we posted about Wellcare's "admission" that it had made numerous questionable campaign contributions. In May, 2009 we posted about WellCare's submission to a deferred prosecution agreemeent based on charges that it defrauded state programs by inflating its expenses. In 2007, we posted about how the state of Connecticut stopped WellCare from running a plan for poor children after the company refused to reveal what it was paying physicians, and why it was failing to pay for particular services. So WellCare has been cited for three different kinds of unethical behavior in 2007-09.
Here's a story about Wellcare with a new twist in the Wall Street Journal:
Wellcare offered the response one might expect:
That might have been more convincing were Wellcare not to have the track-record discussed above.
Every now and then we have discussed cases of whistle-blowers from within health care organizations, but I cannot remember another instance in which the whistle-blower was on the board of directors. In our post of August, 2009, we noted Prof Herzlinger's position on the Wellcare board, and urged her, as a main stream health policy expert, "to acknowledge that health care leadership may be unaccountable, opaque, dishonest, and sometimes flagrantly corrupt." We also urged her to "pay a bit more attention to the mischief being committed by those who answer to her." From this new story, it looked like she did just that, and hopefully made a contribution to more transparent and honest governance of health care organizations. Good for her!
It is time for the often well-paid and not over-worked members of the board of directors of health care corporations to take some responsibility for the actions of the corporations over which they are supposed to exercise stewardship.
Here's a story about Wellcare with a new twist in the Wall Street Journal:
A prominent director at WellCare Health Plans Inc. resigned Wednesday and raised questions about accounting practices at the Medicare and Medicaid company.
Regina Herzlinger, the head of the board's audit committee and a professor of business administration at Harvard Business School, said internal audits found WellCare overbilled the Illinois Medicaid program by $1 million in 2009 and potentially overcharged states for almost $500,000 worth of maternity care. Additionally, the Tampa, Fla., company ran afoul of Georgia's requirements that it account for each patient visit for which it paid providers, resulting in a $610,000 fine, she said.
Ms. Herzlinger said those problems, which the company corrected last year and this year after an internal auditor discovered them, are evidence of weak accounting practices. Ms. Herzlinger said she had hoped to provide oversight, as chairwoman of the audit committee, but that the board didn't renominate her for re-election at this year's annual meeting of shareholders. Ms. Herzlinger alleges that the board forced her out for asking questions about accounting problems and corporate-governance practices.
Wellcare offered the response one might expect:
WellCare said good corporate-governance practices require it to bring in new board members periodically to provide a fresh perspective. The company said the accounting errors Ms. Herzlinger identified were relatively small and the company's own internal controls identified them, indicating that its processes are working well. The company said the board chose not to renominate Ms. Herzlinger.
'At any company, you are always going to have these kinds of immaterial amounts pop up,' said Thomas Tran, WellCare's chief financial officer, who added that it is important to 'address them and document them and learn from them to change your processes.'
That might have been more convincing were Wellcare not to have the track-record discussed above.
Every now and then we have discussed cases of whistle-blowers from within health care organizations, but I cannot remember another instance in which the whistle-blower was on the board of directors. In our post of August, 2009, we noted Prof Herzlinger's position on the Wellcare board, and urged her, as a main stream health policy expert, "to acknowledge that health care leadership may be unaccountable, opaque, dishonest, and sometimes flagrantly corrupt." We also urged her to "pay a bit more attention to the mischief being committed by those who answer to her." From this new story, it looked like she did just that, and hopefully made a contribution to more transparent and honest governance of health care organizations. Good for her!
It is time for the often well-paid and not over-worked members of the board of directors of health care corporations to take some responsibility for the actions of the corporations over which they are supposed to exercise stewardship.
Sunday Settlement and Guilty Plea Roundup
Here we go again.
AstraZeneca / Seroquel
We have posted frequently about allegations of devious marketing techniques used by AstraZeneca to promote its blockbuster atypical anti-psychotic drug Seroquel (quetiapine.) See our posts here, here, here, here, and here. Now, as reported by the New York Times, it is time for AZ to settle with the US government.
Of course, an AZ spokesperson had a different take on it.
Johnson and Johnson / Topamax
On the other hand, the issue of how Johnson and Johnson marketed Topamax (topiramate), a drug approved for treating seizures, is a new one for Health Care Renewal. Here is the story, via Bloomberg.
In this case, the company admitted wrong-doing as part of the specific plea agreement.
Summary
Once more, with feeling .... We have discussed a series of legal settlements and criminal convictions and guilty pleas resolving cases of alleged wrong-doing by health care organizations. Almost none included any penalties for people who authorized, directed or implemented the bad behavior. None of the financial penalties were so big as to be more than another cost of doing business for the organizations involved. Corporate entities, but very rarely people have pleaded guilty or been convicted (almost always of misdemeanors), Some of the cases included gimmicks, like a subsidiary constructed only to plead guilty, that otherwise seemed to lessen accountability.
If we truly want health care that is accessible, of high quality, at a fair price, and more importantly, if we want health care that is honest and focused on patients, we need to provide health care leaders with clear, rational incentives in these directions, and make them fully accountable for their actions, and the courses of their organizations under their leadership.
ADDENDUM (2 May,2010) - See also comments on the Hooked: Ethics, Medicine, and Pharma blog by Dr Howard Brody on the AZ settlement.
AstraZeneca / Seroquel
We have posted frequently about allegations of devious marketing techniques used by AstraZeneca to promote its blockbuster atypical anti-psychotic drug Seroquel (quetiapine.) See our posts here, here, here, here, and here. Now, as reported by the New York Times, it is time for AZ to settle with the US government.
AstraZeneca has completed a deal to pay $520 million to settle federal investigations into marketing practices for its blockbuster schizophrenia drug, Seroquel, the Attorney General, Eric Holder, said at a news conference Tuesday afternoon.
'AstraZeneca paid kickbacks to doctors as part of an illegal scheme to market drugs for unapproved uses,' Kathleen Sebelius, secretary of health and human services, said at the event in Washington. She said the company promoted drugs for unapproved uses by children, the elderly, veterans and prisoners.
AstraZeneca agreed to sign a corporate integrity agreement with the federal government over its marketing of Seroquel for unapproved uses, but will not face criminal charges, company and federal officials said.
The company, based in London, has been accused of misleading doctors and patients by playing up favorable research and not adequately disclosing studies that show Seroquel increases the risk of diabetes.
Of course, an AZ spokesperson had a different take on it.
Glenn Engelmann, AstraZeneca’s U.S. general counsel, released a statement saying the company denies the allegations but settled the investigation with the payment.
'It is in the best interest of AstraZeneca to resolve these matters and to move forward with our business of discovering and developing important, life-changing medicines — while avoiding the delay, uncertainty, and expense of protracted litigation,' Mr. Engelmann said.
Johnson and Johnson / Topamax
On the other hand, the issue of how Johnson and Johnson marketed Topamax (topiramate), a drug approved for treating seizures, is a new one for Health Care Renewal. Here is the story, via Bloomberg.
Two units of Johnson & Johnson will pay more than $81 million to resolve criminal and civil claims over illegal promotion of the epilepsy drug Topamax, the U.S. Justice Department said.
Ortho-McNeil Pharmaceutical LLC agreed to plead guilty to a misdemeanor and pay a $6.14 million criminal fine for misbranding the drug, the government said. Ortho-McNeil-Janssen Pharmaceuticals also will pay $75.37 million to resolve civil allegations that it illegally marketed Topamax and caused false claims to be submitted to government health programs.
While the Food and Drug Administration approved Topamax for the treatment of partial onset seizures, Ortho-McNeil Pharmaceutical promoted the drug for unapproved psychiatric uses, the government said. The company hired physicians through its 'Doctor-for-a-Day' program to join sales representatives in visiting doctors and to speak to colleagues about unapproved uses and doses, according to the government.
In this case, the company admitted wrong-doing as part of the specific plea agreement.
Under the plea agreement, Ortho-McNeil Pharmaceutical will admit that from 2001 to 2003 it promoted Topamax 'for certain uses not approved' by the FDA, according to a statement by Ortho-McNeil-Janssen.
The company 'voluntarily discontinued the program at issue before receiving the government’s first subpoena in the investigation,' according to the statement.
Ortho-McNeil-Janssen also will sign a five-year corporate integrity agreement with the U.S. Health and Human Services Department.
Summary
Once more, with feeling .... We have discussed a series of legal settlements and criminal convictions and guilty pleas resolving cases of alleged wrong-doing by health care organizations. Almost none included any penalties for people who authorized, directed or implemented the bad behavior. None of the financial penalties were so big as to be more than another cost of doing business for the organizations involved. Corporate entities, but very rarely people have pleaded guilty or been convicted (almost always of misdemeanors), Some of the cases included gimmicks, like a subsidiary constructed only to plead guilty, that otherwise seemed to lessen accountability.
If we truly want health care that is accessible, of high quality, at a fair price, and more importantly, if we want health care that is honest and focused on patients, we need to provide health care leaders with clear, rational incentives in these directions, and make them fully accountable for their actions, and the courses of their organizations under their leadership.
ADDENDUM (2 May,2010) - See also comments on the Hooked: Ethics, Medicine, and Pharma blog by Dr Howard Brody on the AZ settlement.
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