The Iowa Supreme Court sent two medical malpractice lawsuits back to district court last week after announcing a new decision on how the statute of limitations should be interpreted. The decision, which affects a breast cancer patient and a woman who had liver problems as a teenager, could allow more leeway for when patients can file negligence claims.
Justices ruled that the statute's two-year window should begin when patients know the extent and cause of their illness or injury, not necessarily when their symptoms are initially diagnosed. "We choose this approach because it is ... fair to patients, doctors and the medical malpractice industry," the court wrote.
The district courts, citing previous Supreme Court opinions, had dismissed both malpractice lawsuits after deciding the limitations period had expired.
Thursday, February 28, 2008
Thursday, February 21, 2008
Death by Cardiac Pulmonary Arrest During Abortion Anesthesia
Hyannis, MA - Five months after the death of 22-year old Laura Hope Smith during anesthesia for an abortion, Rapin Osathanondh has relinquished his medical license. A criminal investigation and disciplinary action by the Massachusetts Board of Registration in Medicine preceded Osathanondh's decision.
The Board had moved to suspend Osathanondh's license pending further investigation, declaring him to be a "risk to public safety." In a surprise move yesterday, Osathanondh instead permanently surrendered his license, and will not practice medicine again anywhere.
On Monday, the Boston Medical Examiner's office declared that the cause of Smith's death was "cardiac pulmonary arrest during anesthesia during a voluntary termination of pregnancy."
Calls to Osathanondh's clinic revealed that it is not accepting patients, but is referring women to other clinics.
Smith had sought an abortion from Osathanondh on September 13, 2007, at his office, Women's Health Center, in the Cape Cod town of Hyannis. Smith was placed under full anesthesia when only Osathanondh and a non-medical receptionist were present. When Smith suddenly stopped breathing, the receptionist phoned 911 but gave very little information to the dispatcher. Smith died later that day.
The Board had moved to suspend Osathanondh's license pending further investigation, declaring him to be a "risk to public safety." In a surprise move yesterday, Osathanondh instead permanently surrendered his license, and will not practice medicine again anywhere.
On Monday, the Boston Medical Examiner's office declared that the cause of Smith's death was "cardiac pulmonary arrest during anesthesia during a voluntary termination of pregnancy."
Calls to Osathanondh's clinic revealed that it is not accepting patients, but is referring women to other clinics.
Smith had sought an abortion from Osathanondh on September 13, 2007, at his office, Women's Health Center, in the Cape Cod town of Hyannis. Smith was placed under full anesthesia when only Osathanondh and a non-medical receptionist were present. When Smith suddenly stopped breathing, the receptionist phoned 911 but gave very little information to the dispatcher. Smith died later that day.
FDA Chinese Pharmaceutical Scandal Prefigured by Politicized RU-486 Approval
Nobody who witnessed the dishonest, politicized FDA approval of (French) RU-486 abortifacients during the Clinton administration can be very surprised at this latest dereliction, regulating Chinese-manufactured pharmaceutical imports.
How Many Decades Will It Take to Fix FDA?
By Terence Jeffrey
The unfolding tragedy in which four Americans have died in the last two months and about 350 others have suffered adverse reactions after being injected with Chinese-made heparin -- a blood-thinning drug -- has its roots in a spectacular example of bad government that some federal watchdogs started barking at a decade ago.
Elected officials in Washington, D.C., simply did not respond adequately to the warnings.
In 1998, after investigating the Food and Drug Administration's procedures for inspecting foreign factories producing drugs for import into the United States, the Government Accountability Office told Congress the system put Americans at risk.
GAO had discovered two internal FDA documents -- a 1988 "internal review" and a 1993 "internal discussion paper" -- that indicated the agency knew it had problems monitoring the safety of foreign-made drugs.
"The evaluations concluded that unless corrected, problems in FDA's foreign inspection program could lead to the importation of adulterated and low-quality drugs that could pose serious health risks to Americans," Bernice Steinhardt, then the GAO's director of public health issues, told the House Subcommittee on Oversight and Investigations.
One remarkable GAO discovery: The FDA did not possess a complete and reliable list of the foreign manufacturers producing drugs that would end up in the bloodstreams of Americans.
Had it known who all these foreign manufacturers were, however, the FDA still would not have done a good job inspecting them.
The foreign inspections that FDA did do, GAO discovered, were primarily limited to facilities applying to ship new drugs into the United States. After that, foreign manufacturers rarely saw the sort of routine follow-up inspections U.S.-based manufacturers are subject to every two years.
Nor was the Reagan doctrine of "trust but verify" applied to foreign drug makers in places such as the People's Republic of China. Managers of a U.S. facility where a problem was discovered had to fix it and face re-inspection; managers of a foreign facility simply had to give their word they would fix it.
Lack of resources to conduct foreign inspections, GAO said, led FDA staff to 'trust' a foreign manufacturer to correct serious manufacturing deficiencies."
Last year, GAO auditors took another look at FDA's system for inspecting foreign drug factories. On Nov. 1, Marcia Crosse, the agency's director of health care, presented their preliminary findings to the same congressional panel that received GAO's 1998 report.
FDA's performance had not improved.
It still did not have a complete and reliable list of foreign factories making drugs that end up in American bloodstreams. "FDA does not know how many foreign establishments are subject to inspection," Crosse told the committee.
One FDA list said about 3,000; another, 6,800. A third list of foreign facilities that FDA "prioritized" for inspections cited 3,249. Of these, says GAO, FDA inspects about 7 percent a year, meaning it would take 13 years to inspect them all.
In the People's Republic of China, according to GAO, there are now 714 drug-making facilities on FDA's "prioritized" list. From 2002-2007, FDA inspected only 88 of these, and the number of inspections has been declining each year. In 2005, it inspected 21 Chinese plants; in 2006, 17; in 2007, 13.
Double standards persist. Here, FDA inspections are unannounced. In China, FDA inspectors warn the drug maker in advance and must get a visa.
Most remarkably, the FDA does not bring its own translators on foreign inspection tours or hire independent translators to accompany its inspectors to foreign drug-making facilities. Instead, it relies on English-speaking officials at the factories being inspected to tell them what is going on.
"Our concern is not whether there is somebody in the Chinese facility who speaks English," GAO's Crosse told me, "but whether the inspectors can to talk to anybody on the line that they want to, can look at the signs labeling the equipment and read it and understand whether it is appropriately labeled, whether it has the right kinds of warnings on it, can look in a logbook and understand what kind of records were being kept, and understand what the columns were that people were asked to fill out."
The heparin that is suspected in the four deaths over the last two months was sold by Illinois-based Baxter Healthcare Corp., which secured the active ingredient in the drug from a company in China called Changzhou SPL. Changzhou was never inspected by the FDA, the Chicago Tribune reported this week, because "regulators confused the factory's name with another that already had U.S. approval."
"This is exactly the risk we were pointing to," Crosse told me.
Will another decade pass before politicians fix the FDA?
Terence P. Jeffrey is the editor-in-chief of CNSNews.
How Many Decades Will It Take to Fix FDA?
By Terence Jeffrey
The unfolding tragedy in which four Americans have died in the last two months and about 350 others have suffered adverse reactions after being injected with Chinese-made heparin -- a blood-thinning drug -- has its roots in a spectacular example of bad government that some federal watchdogs started barking at a decade ago.
Elected officials in Washington, D.C., simply did not respond adequately to the warnings.
In 1998, after investigating the Food and Drug Administration's procedures for inspecting foreign factories producing drugs for import into the United States, the Government Accountability Office told Congress the system put Americans at risk.
GAO had discovered two internal FDA documents -- a 1988 "internal review" and a 1993 "internal discussion paper" -- that indicated the agency knew it had problems monitoring the safety of foreign-made drugs.
"The evaluations concluded that unless corrected, problems in FDA's foreign inspection program could lead to the importation of adulterated and low-quality drugs that could pose serious health risks to Americans," Bernice Steinhardt, then the GAO's director of public health issues, told the House Subcommittee on Oversight and Investigations.
One remarkable GAO discovery: The FDA did not possess a complete and reliable list of the foreign manufacturers producing drugs that would end up in the bloodstreams of Americans.
Had it known who all these foreign manufacturers were, however, the FDA still would not have done a good job inspecting them.
The foreign inspections that FDA did do, GAO discovered, were primarily limited to facilities applying to ship new drugs into the United States. After that, foreign manufacturers rarely saw the sort of routine follow-up inspections U.S.-based manufacturers are subject to every two years.
Nor was the Reagan doctrine of "trust but verify" applied to foreign drug makers in places such as the People's Republic of China. Managers of a U.S. facility where a problem was discovered had to fix it and face re-inspection; managers of a foreign facility simply had to give their word they would fix it.
Lack of resources to conduct foreign inspections, GAO said, led FDA staff to 'trust' a foreign manufacturer to correct serious manufacturing deficiencies."
Last year, GAO auditors took another look at FDA's system for inspecting foreign drug factories. On Nov. 1, Marcia Crosse, the agency's director of health care, presented their preliminary findings to the same congressional panel that received GAO's 1998 report.
FDA's performance had not improved.
It still did not have a complete and reliable list of foreign factories making drugs that end up in American bloodstreams. "FDA does not know how many foreign establishments are subject to inspection," Crosse told the committee.
One FDA list said about 3,000; another, 6,800. A third list of foreign facilities that FDA "prioritized" for inspections cited 3,249. Of these, says GAO, FDA inspects about 7 percent a year, meaning it would take 13 years to inspect them all.
In the People's Republic of China, according to GAO, there are now 714 drug-making facilities on FDA's "prioritized" list. From 2002-2007, FDA inspected only 88 of these, and the number of inspections has been declining each year. In 2005, it inspected 21 Chinese plants; in 2006, 17; in 2007, 13.
Double standards persist. Here, FDA inspections are unannounced. In China, FDA inspectors warn the drug maker in advance and must get a visa.
Most remarkably, the FDA does not bring its own translators on foreign inspection tours or hire independent translators to accompany its inspectors to foreign drug-making facilities. Instead, it relies on English-speaking officials at the factories being inspected to tell them what is going on.
"Our concern is not whether there is somebody in the Chinese facility who speaks English," GAO's Crosse told me, "but whether the inspectors can to talk to anybody on the line that they want to, can look at the signs labeling the equipment and read it and understand whether it is appropriately labeled, whether it has the right kinds of warnings on it, can look in a logbook and understand what kind of records were being kept, and understand what the columns were that people were asked to fill out."
The heparin that is suspected in the four deaths over the last two months was sold by Illinois-based Baxter Healthcare Corp., which secured the active ingredient in the drug from a company in China called Changzhou SPL. Changzhou was never inspected by the FDA, the Chicago Tribune reported this week, because "regulators confused the factory's name with another that already had U.S. approval."
"This is exactly the risk we were pointing to," Crosse told me.
Will another decade pass before politicians fix the FDA?
Terence P. Jeffrey is the editor-in-chief of CNSNews.
Monday, February 18, 2008
Endocrinology Professor's View of Research on Breast Cancer-Abortion Link
The importance of a causal link between abortion and breast cancer, from a legal perspective, is that it might obligate the abortion provider to make full disclosure to the patient before her decision to proceed, in order to satisfy the "informed consent" requirement. Without informed consent, the abortionist may be liable at tort for negligence or battery, or both.
Dr. Joel Brind, Professor of Human Biology and Endocrinology at the City University of New York, remarks below on the stubborn editorial bias within his field against any link between induced abortions and breast cancer. This favors defendants, as expert witnesses will be able to cite "consensus in the literature" that no link has been proven. But it could change, and definitely bears further monitoring.
“Is there any evidence for an association between induced abortion and breast cancer?”
By Joel Brind
Dr. Joel Brind is a biochemist who has specialised in reproductive steroid hormones and their links to human diseases since 1972. In a paper given at Newman House in Birmingham, England in October 2005, he said he discovered a link between breast cancer and induced abortion in published research going back to 1957.
Since that time, he has devoted much of his research to promoting awareness to what has become known as the “ABC link”. In 1996, along with colleagues from the Pennsylvania State College of Medicine, he published a comprehensive review and meta-analysis on the ABC link in the British Medical Association's epidemiological journal.(1)
In 1999, along with three physician colleagues, he founded the non-profit Breast Cancer Prevention Institute in Poughkeepsie, New York. He was later appointed to a federal advisory committee of the Centers for Disease Control and Prevention ( CDC ) on early detection and control of breast and cervical cancer.
A criticism sometimes levelled at the link is that it was based on certain reporting bias on the part of women suffering breast cancer. On the other hand, other studies purporting to show no linkage, were flawed in various ways.
One large British study of recent years was a meta-analysis based on 52 studies, when in fact only 41 of them had been published, and others had been eliminated for no valid scientific reason.
In another, the percentage of women in a large study in Oxford who had had admitted to having an induced abortion, was only a fraction of the nationally accepted proportion of women who have an induced abortion, thus calling into question the study`s benign conclusions.
In a Scottish study, although computerized medical records were available, they had been selectively interpreted with significant groups of women eliminated, notably teenagers who had had induced abortions, which called the conclusions into question.
Throughout research on any link with induced abortion, a strong editorial bias seems to have been exercised towards supporting the status quo of current abortion practice. There appeared to be a basic presumption that there is no risk and a selective removal of the evidence pointing the other way. A study in Australia which was based on fuller evidence, had simply published incomplete results.
The epidemiological risk is associated with an increase in the levels of estrogen. This is increased 2,000 fold in the first trimester and it stimulates breast changes leading to rapid growth and an increase in Type 1 and 2 breast lobules. These are less stable than the later Type 3 and 4 lobules in the mature breast. Thus a term pregnancy protects against the development of breast cancer.
In fact, a natural miscarriage is not associated with an increase risk of breast cancer since miscarriages are associated with low levels of estrogen. About 23% of pregnancies end in a natural miscarriage, 90% of which occur in the first trimester. Miscarriages in the second trimester can increase risk of breast cancer.
Induced abortion in the first trimester, and even more so the second or third trimester, are associated with high estrogen levels and a persistence of the less stable and more rapidly growing type 1 and 2 breast lobules. This risk is highest in teenagers having an induced abortion in the late first or second trimester. There is also an increased risk in women who deliver prematurely before 32 weeks and women who have never had a full term pregnancy.
A quotation from the Breast Cancer Prevention Institute publication “Breast Cancer, risks and prevention”, says
Refs;
(1)
Brind J, Chinchilli VM, Severs WB, Summary-Long J, Induced abortion as an independent risk factor for breast cancer: a comprehensive review and meta-analysis. J Epidemiol Community Health 1996;50:481 - 496
(2)
“Breast Cancer, risks and prevention”
Angela Lanfrachi, MD., F.A.C.S., Joel Brind, Ph. D
Published by
Breast Cancer Prevention Institute, 9 Vassar St., Poughkeepsie. NY
Dr. Joel Brind, Professor of Human Biology and Endocrinology at the City University of New York, remarks below on the stubborn editorial bias within his field against any link between induced abortions and breast cancer. This favors defendants, as expert witnesses will be able to cite "consensus in the literature" that no link has been proven. But it could change, and definitely bears further monitoring.
“Is there any evidence for an association between induced abortion and breast cancer?”
By Joel Brind
Dr. Joel Brind is a biochemist who has specialised in reproductive steroid hormones and their links to human diseases since 1972. In a paper given at Newman House in Birmingham, England in October 2005, he said he discovered a link between breast cancer and induced abortion in published research going back to 1957.
Since that time, he has devoted much of his research to promoting awareness to what has become known as the “ABC link”. In 1996, along with colleagues from the Pennsylvania State College of Medicine, he published a comprehensive review and meta-analysis on the ABC link in the British Medical Association's epidemiological journal.(1)
In 1999, along with three physician colleagues, he founded the non-profit Breast Cancer Prevention Institute in Poughkeepsie, New York. He was later appointed to a federal advisory committee of the Centers for Disease Control and Prevention ( CDC ) on early detection and control of breast and cervical cancer.
A criticism sometimes levelled at the link is that it was based on certain reporting bias on the part of women suffering breast cancer. On the other hand, other studies purporting to show no linkage, were flawed in various ways.
One large British study of recent years was a meta-analysis based on 52 studies, when in fact only 41 of them had been published, and others had been eliminated for no valid scientific reason.
In another, the percentage of women in a large study in Oxford who had had admitted to having an induced abortion, was only a fraction of the nationally accepted proportion of women who have an induced abortion, thus calling into question the study`s benign conclusions.
In a Scottish study, although computerized medical records were available, they had been selectively interpreted with significant groups of women eliminated, notably teenagers who had had induced abortions, which called the conclusions into question.
Throughout research on any link with induced abortion, a strong editorial bias seems to have been exercised towards supporting the status quo of current abortion practice. There appeared to be a basic presumption that there is no risk and a selective removal of the evidence pointing the other way. A study in Australia which was based on fuller evidence, had simply published incomplete results.
The epidemiological risk is associated with an increase in the levels of estrogen. This is increased 2,000 fold in the first trimester and it stimulates breast changes leading to rapid growth and an increase in Type 1 and 2 breast lobules. These are less stable than the later Type 3 and 4 lobules in the mature breast. Thus a term pregnancy protects against the development of breast cancer.
In fact, a natural miscarriage is not associated with an increase risk of breast cancer since miscarriages are associated with low levels of estrogen. About 23% of pregnancies end in a natural miscarriage, 90% of which occur in the first trimester. Miscarriages in the second trimester can increase risk of breast cancer.
Induced abortion in the first trimester, and even more so the second or third trimester, are associated with high estrogen levels and a persistence of the less stable and more rapidly growing type 1 and 2 breast lobules. This risk is highest in teenagers having an induced abortion in the late first or second trimester. There is also an increased risk in women who deliver prematurely before 32 weeks and women who have never had a full term pregnancy.
A quotation from the Breast Cancer Prevention Institute publication “Breast Cancer, risks and prevention”, says
“Over the last thirty years, whilst most major cancers have started to decline, breast cancer incidences in the US has increased by an alarming 40%. Most of this increase has occurred in the author's generation, the generation of “Women's Lib.” (2)
Refs;
(1)
Brind J, Chinchilli VM, Severs WB, Summary-Long J, Induced abortion as an independent risk factor for breast cancer: a comprehensive review and meta-analysis. J Epidemiol Community Health 1996;50:481 - 496
(2)
“Breast Cancer, risks and prevention”
Angela Lanfrachi, MD., F.A.C.S., Joel Brind, Ph. D
Published by
Breast Cancer Prevention Institute, 9 Vassar St., Poughkeepsie. NY
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