Why most published research findings are false. [PLoS Med. 2005] – PubMed – NCBI

Why most published research findings are false. [PLoS Med. 2005] – PubMed – NCBI.

Posted in Forensic Neuropsychiatry, Health | Tagged |

Independent Doctors of New York President replies to NYT’s “When Doctors Stop Taking Insurance”

A thoughtful, factual reply to an only seemingly balanced, but really tendentious article (see New York Times cartoon accompanying it – which is what most will retain from it). Please read, redistribute and comment. The original New York times article prompting the letter that follows is here.
I will update if and when letter is printed in the NYT. For more on the Independent Doctors of New York/IDNY, please go to our web site.


>>Re: Ms. Rabin’s article “When Doctors Stop Taking Insurance” ?

The answer to why many doctors are no longer accepting health insurance payments is both simple and complex. .

The simple answer: Health insurance companies are for-profit organizations that answer to their boards and shareholders, not patients, to make sure their bottom line is a healthy, black line. The CEOs of these companies make millions in salary, and many more millions of dollar are spent on TV and print advertising needed to lure and keep patients. Each of these takes money away from the medical care they could AND should provide their patients and reasonable reimbursements to physicians.

The complex answer: If for-profit insurers paid physicians a reasonable usual and customary rate (UCR), physicians would be much more receptive to accepting insurance reimbursement. But this is not the case. The for-profit health insurance industry made up their own UCR by bankrolling the company (Ingenix) that was supposed to supply real-world UCRs. However, use of the UCRs developed by Ingenix was found to be fraudulent in New York State, and for-profit health insurers were fined $350 million and required to pay an additional $50 million to create a the new “Fair Health” UCR. Despite this ruling, the insurers found a way around this by jointly declaring that their UCRs would be a percentage of what Medicare pays–the low reimbursement rate the government provides to keep our tax burden for health care low. So, it’s acceptable for insurance companies to get together to set fees, whereas if two doctors get together and discuss fees, it’s considered an antitrust violation.

Today’s young doctors come out of medical school $150,000 to $200,000 in debt. Then there are the expenses of starting and running a medical practice, which are very high. Malpractice insurance often increases yearly in most states due to a failure to enact medical malpractice tort reform (the exceptions are Texas and California who lead the nation in this bold effort to keep medical costs down). Rent and the cost of staff also increase yearly. Yet, insurance reimbursements have not increased in years and there is no law requiring increases linked to inflation or other accepted economic indicators.

Until something is done to reign in the for-profit health insurers, more and more physicians will “opt out” and patients will have less and less access to their physician of choice.

William Rosenblatt MD
President, Independent Doctors of New York

Suite 1D
308 East 79th Street
New York, NY 10075

212-570-6100

<<

Posted in Health, News |

Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia – Full Text View – ClinicalTrials.gov

Of note, >>[p]atients with orthostatic hypotension, ulcerative colitis, hyperthyroidism, dementia or cognitive dysfunction, Parkinson’s disease, or cerebrovascular disorder<< were excluded. How many real-life patients with BPH also have one of the above?

Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia – Full Text View – ClinicalTrials.gov.

Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00771394
First received: October 9, 2008
Last updated: March 3, 2010
Last verified: March 2010
  Purpose

To evaluate the efficacy and safety of solifenacin succinate as add-on therapy for overactive bladder (OAB) symptoms in men who have been treated for benign prostatic hyperplasia (BPH) with tamsulosin hydrochloride for at least 6 weeks

Condition Intervention Phase
Benign Prostatic Hyperplasia
Benign Prostatic Hypertrophy
Overactive Bladder
Drug: Tamsulosin hydrochloride
Drug: Solifenacin succinate
Phase 4
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study of Solifenacin Succinate as Add-on Therapy for Overactive Bladder (OAB) Symptoms in Men Treated for Benign Prostatic Hyperplasia (BPH) With Tamsulosin Hydrochloride
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:

  • Change from baseline in mean number of urgency episodes per 24 hours [ Time Frame: at 4, 8, 12 week ] [ Designated as safety issue: No ]
Secondary Outcome Measures:

  • Mean number of micturitions per 24 hrs [ Time Frame: at 4, 8, 12 week ] [ Designated as safety issue: No ]
  • Mean number of incontinence episodes per 24 hours [ Time Frame: at 4, 8, 12 week ] [ Designated as safety issue: No ]
  • Mean number of micturitions per night [ Time Frame: at 4, 8, 12 week ] [ Designated as safety issue: No ]
  • Adverse Events, Laboratory Tests [ Time Frame: end of study ] [ Designated as safety issue: No ]
Enrollment: 638
Study Start Date: October 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1. Tamsulosin alone Drug: Tamsulosin hydrochloride

oral
Other Names:

  • Harnal
  • YM617
Experimental: 2. Tamsulosin + solifenacin (low dose) Drug: Tamsulosin hydrochloride

oral
Other Names:

  • Harnal
  • YM617

Drug: Solifenacin succinate

oral
Other Names:

  • Vesicare
  • YM905
Active Comparator: 3. Tamsulosin + solifenacin (high dose) Drug: Tamsulosin hydrochloride

oral
Other Names:

  • Harnal
  • YM617

Drug: Solifenacin succinate

oral
Other Names:

  • Vesicare
  • YM905

Detailed Description:

Study drugs are administered for 14 weeks in total, including a 2-week run-in period (single blind) and a 12-week treatment period (double blind). After written informed consent, study drugs for the run-in period are orally administered once daily after breakfast for two weeks to subjects who fulfill the inclusion and exclusion criteria. Then, subjects are randomized and orally treated with study drugs for the treatment period once daily after breakfast for 12 weeks

  Eligibility

Ages Eligible for Study: 50 Years and older
Genders Eligible for Study: Male
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

  • Patients with benign prostatic hypertrophy who have been treated with tamsulosin for at least 6 weeks
  • Patients with urgency episodes and frequent micturitions
  • Written informed consent has been obtained
  • Uroflowmetry-Q max ≥ 5 mL/sec, and Post Void Residual Volume < 50 mL

Exclusion Criteria:

  • Patients with suspected symptoms of OAB whose onset is only transient (drug-induced, psychogenic, etc.)
  • Patients with obvious stress urinary incontinence
  • Patients with complications or who have a past history of a bladder tumor
  • Patients with urethral stricture or bladder neck stenosis
  • Patients with a history of surgery causing damage to the pelvic plexus
  • Patients with history of hypersensitivity to α receptor blockers, a/b receptor blockers, or anticholinergic drugs
  • Patients with orthostatic hypotension, ulcerative colitis, hyperthyroidism, dementia or cognitive dysfunction, Parkinson’s disease, or cerebrovascular disorder
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771394

Locations
Japan
Chubu, Japan
Chugoku, Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyushu, Japan
Shikoku, Japan
Touhoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Director, Astellas Pharma Inc.
ClinicalTrials.gov Identifier: NCT00771394     History of Changes
Other Study ID Numbers: 905-JC-001
Study First Received: October 9, 2008
Last Updated: March 3, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:

Vesicare
Solifenacin succinate
Tamsulosin
Overactive Bladder
BPH

Additional relevant MeSH terms:

Prostatic Hyperplasia
Hyperplasia
Hypertrophy
Urinary Bladder, Overactive
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Pathological Conditions, Anatomical
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Tamsulosin
Quinuclidin-3′-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on September 30, 2012

Posted in Aging, Forensic Neuropsychiatry, Health, Psychiatry/Neurology | Tagged , , |

Antimuscarinic drugs for overactive bladder… [J Am Geriatr Soc. 2005] – PubMed – NCBI

Notice authors’ disclosures when reading this material.

Antimuscarinic drugs for overactive bladder… [J Am Geriatr Soc. 2005] – PubMed – NCBI.

J Am Geriatr Soc. 2005 Dec;53(12):2195-201.

Antimuscarinic drugs for overactive bladder and their potential effects on cognitive function in older patients.

Source

Neuropsychology Division, Department of Neurology, Georgetown University School of Medicine, Washington, DC, USA. wnimail@aol.com

Abstract

Antimuscarinic agents are the predominant pharmacological treatment for patients with overactive bladder (OAB). These drugs are thought to act primarily through antagonism at muscarinic M3 receptors located at neuromuscular junctions in the human bladder detrusor muscle. Several of these drugs have been shown to be efficacious in ameliorating the symptoms of OAB in older patients, but most currently available agents lack selectivity for the M3 receptor subtype, and interaction with other muscarinic receptor subtypes throughout the body may adversely affect a variety of physiological functions and result in unwanted side effects, including cognitive dysfunction. With the recent availability of antimuscarinic agents that show increased selectivity for M3 receptors relative to other muscarinic subtypes, an invitational expert panel meeting was convened to review not only the mechanisms by which antimuscarinic agents could affect cognitive function, but also the published literature on cognitive adverse events. A review of the literature shows that the cholinergic system in the central nervous system (CNS) exerts a major influence on cognitive processes, in particular memory via M1 cholinergic receptors. In addition, recent evidence suggests a role for M2 receptors in mediating cognitive function. Thus, cognitive dysfunction (including memory loss) during treatment with nonselective antimuscarinic agents for OAB is of growing concern, particularly in older patients and those with mild cognitive impairment or dementia. Increased blood-brain barrier permeability, which can occur with advanced age and certain comorbidities, may also facilitate CNS access of antimuscarinic agents (regardless of their physiochemical properties) and add to antimuscarinic burden. On the basis of available evidence, antimuscarinic agents with selectivity for M3 over M1 and M2 receptors, limited CNS penetration, or both may therefore offer a favorable balance of efficacy in treating OAB together with a reduced risk of adverse cognitive events in the older population.

PMID:
16398909
[PubMed – indexed for MEDLINE]

LinkOut – more resources

 

Posted in Aging, Forensic Neuropsychiatry, Health, Psychiatry/Neurology | Tagged , , |

the psychiatryneurology.net – legal October 1, 2012

Edition of October 1, 2012 is out:

the psychiatryneurology.net – legal.

Posted in Events, News, Psychiatry/Neurology | Tagged , , |