results of sympathectomy deteriorate with time (T.S. Lin & Fang, 1999; Walles et al., 2008). This recurrent postoperative sweating may be due to local nerve regeneration but has not yet been proven (Lee et al., 1999).
http://www.intechopen.com/books/topics-in-thoracic-surgery/surgical-management-of-primary-upper-limb-hyperhidrosis-a-review
Roche is under investigation over a failure to properly report adverse drug side effects
Inspectors at the Basel-based company's British site in Welwyn found deficiencies related to Roche's global process of detecting and reporting the adverse effects of medicines.
At the time of the inspection, 80,000 reports for medicines marketed by Roche in the US had been collected through a Roche-sponsored patient support program, but had not been evaluated to determine whether they should be reported to the EU authorities as suspected adverse reactions.
"These included 15,161 reports of death of patients and it is not known whether the deaths were due to natural progression of the disease or had a causal link to the medicine," the EMA said in the statement on Thursday.
"There is, at present, no evidence of a negative impact for patients and while the investigations are being conducted there is no need for patients or health care professionals to take any action," added the EMA.
A Roche spokesman said the company acknowledges it did not fully comply with regulations and appreciates the concerns that can be caused by this issue for people using its products.
http://www.medicalobserver.com.au/news/eye-on-roche-after-failure-to-report-side-effects
At the time of the inspection, 80,000 reports for medicines marketed by Roche in the US had been collected through a Roche-sponsored patient support program, but had not been evaluated to determine whether they should be reported to the EU authorities as suspected adverse reactions.
"These included 15,161 reports of death of patients and it is not known whether the deaths were due to natural progression of the disease or had a causal link to the medicine," the EMA said in the statement on Thursday.
"There is, at present, no evidence of a negative impact for patients and while the investigations are being conducted there is no need for patients or health care professionals to take any action," added the EMA.
A Roche spokesman said the company acknowledges it did not fully comply with regulations and appreciates the concerns that can be caused by this issue for people using its products.
http://www.medicalobserver.com.au/news/eye-on-roche-after-failure-to-report-side-effects
“Doctors tend to confuse what they believe with what they know,”
http://inside.org.au/overtested-overtreated-and-over-here/
Horner syndrome, pneumothorax, hemothorax, asymmetry of results, intercostal neuralgia, causalgia, hypoesthesia, incomplete results, paresthesia in the anterolateral abdominal wall, dyspareunia
The complications and side effects are very significant, such as irreversible compensatory sweating (20% to 50%), low satisfaction with results, Claude-Bernard-Horner syndrome, pneumothorax, hemothorax, asymmetry of results, intercostal neuralgia, causalgia, incomplete results, and anesthetic complications11-13.
Retroperitoneoscopic lumbar sympathectomy (video-assisted): this technique is effective in the treatment of isolated or persistent plantar hyperhidrosis (compensatory after thoracic sympathectomy). The treatment consists of removing the nerves of the sympathetic chain located in the abdomen, in the anterolateral portion of the lumbar vertebrae. It requires hospitalization and is carried out under general anesthesia. It may lead to complications such as lesions of structures adjacent to the sympathetic chain, light abdominal distension, neuralgia, and causalgia as well as hypoesthesia in the thighs and groin, limitation of leg movement,
paresthesia in the anterolateral abdominal wall, change in libido, dyspareunia, pulmonary thromboembolism, hemorrhages, arrhythmias, and cardiac decompensation, amongst others. It definitively eliminates plantar hyperhidrosis14,15.
http://www.scielo.br/scielo.php?pid=S1983-51752011000400008&script=sci_arttext&tlng=en#end
Retroperitoneoscopic lumbar sympathectomy (video-assisted): this technique is effective in the treatment of isolated or persistent plantar hyperhidrosis (compensatory after thoracic sympathectomy). The treatment consists of removing the nerves of the sympathetic chain located in the abdomen, in the anterolateral portion of the lumbar vertebrae. It requires hospitalization and is carried out under general anesthesia. It may lead to complications such as lesions of structures adjacent to the sympathetic chain, light abdominal distension, neuralgia, and causalgia as well as hypoesthesia in the thighs and groin, limitation of leg movement,
paresthesia in the anterolateral abdominal wall, change in libido, dyspareunia, pulmonary thromboembolism, hemorrhages, arrhythmias, and cardiac decompensation, amongst others. It definitively eliminates plantar hyperhidrosis14,15.
http://www.scielo.br/scielo.php?pid=S1983-51752011000400008&script=sci_arttext&tlng=en#end
Horner syndrome, pneumothorax, hemothorax, asymmetry of results, intercostal neuralgia, causalgia, hypoesthesia, incomplete results, paresthesia in the anterolateral abdominal wall, dyspareunia
The complications and side effects are very significant, such as irreversible compensatory sweating (20% to 50%), low satisfaction with results, Claude-Bernard-Horner syndrome, pneumothorax, hemothorax, asymmetry of results, intercostal neuralgia, causalgia, incomplete results, and anesthetic complications11-13.
Retroperitoneoscopic lumbar sympathectomy (video-assisted): this technique is effective in the treatment of isolated or persistent plantar hyperhidrosis (compensatory after thoracic sympathectomy). The treatment consists of removing the nerves of the sympathetic chain located in the abdomen, in the anterolateral portion of the lumbar vertebrae. It requires hospitalization and is carried out under general anesthesia. It may lead to complications such as lesions of structures adjacent to the sympathetic chain, light abdominal distension, neuralgia, and causalgia as well as hypoesthesia in the thighs and groin, limitation of leg movement,
paresthesia in the anterolateral abdominal wall, change in libido, dyspareunia, pulmonary thromboembolism, hemorrhages, arrhythmias, and cardiac decompensation, amongst others. It definitively eliminates plantar hyperhidrosis14,15.
http://www.scielo.br/scielo.php?pid=S1983-51752011000400008&script=sci_arttext&tlng=en#end
Retroperitoneoscopic lumbar sympathectomy (video-assisted): this technique is effective in the treatment of isolated or persistent plantar hyperhidrosis (compensatory after thoracic sympathectomy). The treatment consists of removing the nerves of the sympathetic chain located in the abdomen, in the anterolateral portion of the lumbar vertebrae. It requires hospitalization and is carried out under general anesthesia. It may lead to complications such as lesions of structures adjacent to the sympathetic chain, light abdominal distension, neuralgia, and causalgia as well as hypoesthesia in the thighs and groin, limitation of leg movement,
paresthesia in the anterolateral abdominal wall, change in libido, dyspareunia, pulmonary thromboembolism, hemorrhages, arrhythmias, and cardiac decompensation, amongst others. It definitively eliminates plantar hyperhidrosis14,15.
http://www.scielo.br/scielo.php?pid=S1983-51752011000400008&script=sci_arttext&tlng=en#end
how drug marketing undermines patient safety and public health
Am J Public Health. 2011 Mar;101(3):399-404. Epub 2011 Jan 13.
The inverse benefit law: how drug marketing undermines patient safety and public health.
Recent highly publicized withdrawals of drugs from the market because of safety concerns raise the question of whether these events are random failures or part of a recurring pattern. The inverse benefit law, inspired by Hart's inverse care law, states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively the drugs are marketed. The law is manifested through
6 basic marketing strategies:
reducing thresholds for diagnosing disease,
relying on surrogate endpoints,
exaggerating safety claims,
exaggerating efficacy claims,
creating new diseases, and
encouraging unapproved uses.
The inverse benefit law highlights the need for comparative effectiveness research and other reforms to improve evidence-based prescribing.
http://www.ncbi.nlm.nih.gov/pubmed/21233426?dopt=Abstract
http://www.ncbi.nlm.nih.gov/pubmed/21233426?dopt=Abstract
disease-mongering activities companies can use to stimulate drug sales
- Promotion of anxiety about future ill-health in healthy individuals
- Inflated disease prevalence rates
- Promotion of aggressive drug treatment of milder symptoms and diseases
- Introduction of questionable new diagnoses—such as PMDD or social anxiety disorder—that are hard to distinguish from normal life
- Redefinition of diseases in terms of surrogate outcomes (i.e., osteoporosis becomes a disease of low bone density rather than fragility fractures)
- Promotion of drugs as a first-line solution for problems previously not considered medical, such as disruptive classroom behaviour or problematic sexual relationships.
The rationale for regulation of drug promotion is health protection, encouragement of appropriate medicine use, and prevention of deceptive advertising. The European community code on medicinal products for human use states that advertising of medicinal products “must encourage the rational use of the product and may not be misleading” [ 34]. Canada's Food and Drugs Act prohibits advertising of a drug that is “false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, merit or safety” [ 35]. The World Health Organization's Ethical Criteria for Medicinal Drug Promotion states that advertisements, “…should not take undue advantage of people's concern for their health” [ 36].
Disease mongering by definition creates erroneous impressions of the condition a product aims to treat and the merit and safety of treatment, and frequently provokes undue anxiety or exaggerates prevalence rates.http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1434509/?tool=pubmed
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