July 5th, 2009 by Medgadget in Better Health Network
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A team of Canadian researchers analyzed the air traffic patterns during March and April of this year, looking for correlation between departure/arrival cities of passengers and the spread of H1N1 swine-origin influenza. Turns out that the two are closely correlated and confirm that airports are gateways of pathogens as well as vacationing tourists.
Our analysis showed that in March and April 2008, a total of 2.35 million passengers flew from Mexico to 1018 cities in 164 countries. A total of 80.7% of passengers had flight destinations in the United States or Canada; 8.8% in Central America, South America, or the Caribbean Islands; 8.7% in Western Europe; 1.0% in East Asia; and 0.8% elsewhere. These flight patterns were very similar to those during the same months in 2007 (see Fig. 1 in the Supplementary Appendix). We then compared the international destinations of travelers departing from Mexico with confirmed H1N1 importations associated with travel to Mexico, and we found a remarkably strong degree of correlation. Of the 20 countries worldwide with the highest volumes of international passengers arriving from Mexico, 16 had confirmed importations associated with travel to Mexico as of May 25, 2009. A receiver-operating-characteristic (ROC) curve plotting the relationship between international air-traffic flows and H1N1 importation revealed that countries receiving more than 1400 passengers from Mexico were at a significantly elevated risk for importation. With the use of this passenger threshold, international air-traffic volume alone was more than 92% sensitive and more than 92% specific in predicting importation, with an area under the ROC curve of 0.97.
Letter to NEJM: Spread of a Novel Influenza A (H1N1) Virus via Global Airline Transportation
*This blog post was originally published at Medgadget*
July 3rd, 2009 by Dr. Val Jones in Quackery Exposed
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In one of the most unethical clinical trial debacles of our time, the NIH approved a research study (called the TACT Trial – Trial to Assess Chelation Therapy – a supposed treatment for arteriosclerosis) in which the treatment had no evidence for potential benefit, and clear evidence of potential harm – and even the risk of death. Amazingly, the researchers neglected to mention this risk in their informed consent document. The NIH awarded $30 million of our tax dollars to ~100 researchers to enroll 2000 patients in this risky study (ongoing from 2003-present). Even more astounding is the fact that several of the researchers have been disciplined for substandard practices by state medical boards; several have been involved in insurance fraud; at least 3 are convicted felons.
But wait, there’s more.
The treatment under investigation, IV injection of Na2EDTA, is specifically contraindicated for “generalized arteriosclerosis” by the FDA. There have been over 30 reported cases of accidental death caused by the administration of this drug – and prior to the TACT, 4 RCTs and several substudies of chelation for either CAD or PVD, involving 285 subjects, had been reported. None found chelation superior to placebo.
So, Why Was This Study Approved?
The NIH and the TACT principal investigator (PI) argued that there was a substantial demand for chelation, creating a “public health imperative” to perform a large trial as soon as possible. In reality, the number of people using the therapy was only a small fraction of what the PI reported.
It’s hard to know exactly what happened “behind the scenes” to pressure NIH to go forward with the study – however a few things are clear: 1) the National Heart, Lung, and Blood Institute (NHLBI) initially declined to approve the study based on lack of scientific merit 2) congressman Dan Burton and at least one of his staffers (Beth Clay) and a lobbyist (Bill Chatfield) worked tirelessly to get the study approved through a different institute – NCCAM 3) some of the evidence used to support the trial was falsified (The RFA cited several articles by Edward McDonagh, the chelationist who had previously admitted in a court of law to having falsified his data.) 4) The NIH Special Emphasis Panel that approved the TACT protocol included L. Terry Chappell, whom the protocol had named as a participant in the TACT.
All evidence seems to suggest that political meddling managed to trump science in this case – putting the lives of 2000 study subjects at risk, without any likely benefit to them or medicine.
A formal analysis of the sordid history and ethical violations of the TACT trial was published by the Medscape Journal of Medicine on May 13, 2008. Atwood et al. provide a rigorous, 9-part commentary with 326 references in review of the case. Congressman Burton’s staffer, Beth Clay, published what is essentially a character assassination of Dr. Atwood in response.
The NIH Writes TACT Investigators a Strongly Worded Letter
On May 27, 2009 the Office for Human Research Protections Committee sent a letter to the investigators of TACT, stating that they found, “multiple instances of substandard practices, insurance fraud, and felony activity on the part of the investigators.” The letter describes a list of irregularities and recommends various changes to the research protocol.
It is almost unheard of for a letter from the NIH to state that research study investigators are guilty of fraud and felony activity – but what I don’t understand is why they haven’t shut down the study. Perhaps this is their first step towards that goal? Let’s hope so.
Conclusion
The TACT trial has subjected 2000 unwary subjects and $30 million of public money to an unethical trial of a dubious treatment that, had it been accurately represented and judged by the usual criteria, would certainly have been disqualified. Political meddling in health and medical affairs is dangerous business, and must be opposed as strongly as possible. Congressmen like Tom Harkin and Dan Burton should not be allowed to push their political agendas and requests for publicly funded pseudoscience on the NIH. I can only hope that the new NIH director will have the courage to fend off demands for unethical trials from political appointees.
July 3rd, 2009 by RamonaBatesMD in Better Health Network
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Poland’s syndrome is a congenital disorder. The classic ipsilateral features of Poland syndrome include the following: absence of sternal head of the pectoralis major, hypoplasia and/or aplasia of breast or nipple, deficiency of subcutaneous fat and axillary hair, abnormalities of rib cage, and upper extremity anomalies. These upper extremity anomalies include short upper arm, forearm, or fingers (brachysymphalangism). (photo credit)
Additional features of Poland syndrome include the following: hypoplasia or aplasia of serratus, external oblique, pectoralis minor, latissimus dorsi, infraspinatus, and supraspinatus muscles; total absence of anterolateral ribs and herniation of lung; and symphalangism with syndactyly and hypoplasia or aplasia of the middle phalanges. (photo credit)
The name of this condition pays homage to Dr. Alfred Poland of Guy’s Hospital, who in 1841 described a case of these two deformities during the autopsy of a 27-year-old convict, but as this article points out he wasn’t the first to recognize the syndrome.
If you enjoy medical history, then you will enjoy this article. It explores the historical literature to reveal the progression of knowledge about this syndrome. Here is a quick summary of different investigators who contributed to the understanding of Poland’s syndrome. The article goes into more detail of each.
| 1826 |
Lallemand is first to describe the absence of the pectoralis. |
| 1835 |
Bell is the first to record the absence of the pectoralis |
| 1839 |
Forlep is first to describe the paired absence of the pectoralis and ipsilateral syndactyly |
| 1841 |
Poland is the second to describe the paired absence of the pectoralis and ipsilateral syndactyly |
| 1895 |
Thomson is the first to document an understanding that the deformities accompanied one another |
| 1900 |
Furst is the first to propose that the anomalies constituted a syndrome |
| 1902 |
Bing is the first to present a case series of patients with the syndrome |
| 1940 |
Brown and McDowell are the first to document a thorough review of the syndrome |
| 1962 |
Clarkson is the first to propose the name “Poland’s Syndactyly” for the syndrome |
As the authors conclude:
Honoring physicians for notable achievements in the form of eponyms can be viewed as a harmless way to bring a little bit of warmth to an otherwise cold world of facts. The least we can do, though, is to recognize the contributions of those who endeavored to shape our current understanding of disease.
Perhaps if history took another course, Poland’s syndrome would instead be called Frolep’s syndrome or Furst’s syndrome. Or perhaps it might simply have been called pectoral-aplasia-dysdactylia syndrome
REFERENCES
Poland’s Syndrome: Current Thoughts in the Setting of a Controversy; Plastic & Reconstructive Surgery. 123(3):949-953, March 2009; Ram, Ashwin N. B.S.; Chung, Kevin C. M.D., M.S. (subscription required)
*This blog post was originally published at Suture for a Living*
