Analysis of pseudo-medical methods, drugs & devices using the Patents Libraries
Sergey SoshnikovMD, Ph.D.
Overview
2
Section 1
• Main sources of data used in Public Health research
• Specific data sources
Section 2• The impact of Healthcare
Services and Technologies on Population Health
Section 4
• Findings• Discussion of study results
Section 3• Conducting a study based on
patents database
PUBLIC HEALTH DATA
3
• National accounts• Resources of Health System• Insurance data• Services, technologies, drugs• Social media• Twitter and so on…
In public health we are often interested in the frequency, distribution and determinants of health problems and disease in populations.
• Raw data:– Births – Deaths – Hospital Admissions– Cancer Registrations– GP consultations – Prescriptions – Accident & Emergency
attendances– Population– And other…
Data Catalogs and Repositories•International Household Survey Network•Integrated Public Use Microdata Series International (IPUMS-I)•Integrated Public Use Microdata Series USA (IPUMS-USA)•Simple Online Data Archive for Population Studies (SodaPop)•Synapse (formerly Sage Bionetworks Repository)•HealthData.Gov (USA)
Country Open Data Sites•United States
Data Archives•Inter-University Consortium for Political and Social Research (ICPSR)•Dataverse from IQSS (Institute for Quantitative Social Science at Harvard University)
Health (Indicator) Databases•WHO Global Health Observatory•World Bank Open Data•European Health for All Database (HFA/DB)•CDC Wonder (USA)•Health Indicators Warehouse (USA)
Free Online Databases
Available for All
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Determinants : Factors affecting health
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Health is affected by many factors, as summarized by Dahlgren and Whitehead’s diagram…
Social Factors:- Gender- Ethnicity- Education- Age- Social Class
Psychological Factors:- Values- Beliefs- Attitudes
Wider Community:- Access to services- Parental Control- Political Climate- Peer Pressure- Economic- Financial- Access to Resources
What is Open Source for HTA?
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• The Cochrane and other Systematic Reviews and Meta-analyses Libraries
• PubMed with tons of RCT and papers with other types of CT
• RTC registries (unpublished data)
• Patents on medical technologies, drugs and devices
7INTERN
ATIONAL
RUSSIAN
www.fips.ru
Some examples of pseudo-medicine that really exist in Russia today. Found in media...
Masturbation will save you from cancer
Want to
lose weight?
Healing excrements
The secret of instant healing
Magic and spells from the Grandma
Beer Treatment
Living and dead water
Berries help against cancer
Cure as in the old
How
to d
efine
dan
gero
us m
edica
l hea
lth
tech
nolo
gies
usin
g pa
tent
s dat
abas
e?
9
Content analysis of proprietary patented treatment methods for substance abuse and dependence disorders in USSR and Russia in 1925-2011We downloaded and screened over 100,000 patents with International Patent Classification (IPC) A-61 "Medicine" from the patents database www.fips.ruFinds: • 456 descriptions of inventions and applications for treatment
of alcoholism and drug addiction;• More than 100 patent descriptions on methods for treating
tobacco dependence.
Capabilities assessment, classification, and salient features of medical pseudoscience
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Over 100,000 patents DOWNLOADED from
Federal Patents Service
A61 classification “Medicine” HTML pages
keywords filter
Other fields of Medicine
Mental and behavioral disorders due to psychoactive substance use ICD F10-F191100 patents
Unclassified and trash
Set part 1
Set part
2
Set part
3
4 experts watch and evaluate every part of the set twice with questionnaire using Google documents (Forms)
Automatically by keywords
456 patent
s
11
Set part 1
Set part
2
Set part
3
456 patent
s
3 parts of 456 HTML files
Every part was checked 2 times by different expert
Gathered all the parts and check for discrepancies
12
Most patents on drug and alcohol treatment were registered in the period 1991-2007. The first application was done in 1957.
Years
Num
ber o
f doc
umen
ts
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Changing the timing of the expertise - filing of a patent application prior to its registration
COMMUNISM ERA CAPITALISM ERA
Per
iod
from
app
licat
ion
to re
gist
ratio
n (y
ears
)
Years
Year
Per
iod
from
app
licat
ion
to re
gist
ratio
n (y
ears
)
Box Plots diagram illustrate the variation of the examination period of applications.
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Table 1. Types of dependence and danger of the proposed treatment methods.
Dangerous Not dangerous Unknown Number of
patentsOpiate 18 4 12 34
Psychostimulants 0 0 1 1
Toxicomania 1 2 1 4Alcoholism 34 104 85 223
Mixed addiction 25 54 86 165Missed data 0 2 0 2
Total 78 166 185 429
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Drug Device Method Algorithm Mixed TOTAL
Respiratory system 0 0 2 2 0 4
Digestive system 32 0 6 0 0 38Head 0 4 16 2 0 22Blood 3 1 1 3 0 8Limbs 0 0 3 0 0 3Skin 0 3 16 0 0 19
Nervous System 118 3 27 17 1 166Many organs 58 3 29 16 1 107
Other 22 5 28 6 0 61TOTAL 233 19 129 46 2 428
Table 3. The organs and systems of the body which were the target to treatment methods
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Table 3. Hazardous to patient's life
Years of expertise
Dangerous
Not dangerous Unknown
Number of patents
1 12 20 9 412 10 18 8 363 6 15 10 314 9 5 13 275 6 6 11 236 2 2 5 97 1 2 1 48 1 1 2 49 0 0 2 2
12 0 0 1 116 0 1 1 2
Total 66 65 177
Mann-Whitney test for groups "Dangerous" / "not dangerous" shows significant differences. The main conclusion: Prolonged reduction (quality) examination therapies increases the tolerance to the registration of hazardous treatments.
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From 1956 to 2011• 16832 patients undergone these
patented methods of treatment • 2938 patients were exposed to life-
threatening experiments
Methods
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On what type of research method based
Drug Device Authorsmethod
Treatment Plan
Mixed
RCT Series Case No research
QTT
QTT
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METHOD FOR TREATMENT OF SUBSTANCE ADDICTION and alcohol:
"... Used an electrical current with the parameters that cause the development of unilateral convulsive fit"
Five examples of pseudo-scientific treating methods
Patent # 2153882. "Patients with alcohol dependence receive the xeno-implant of donor fetal brain tissue with the use of cloth of bluish spots laboratory mammal in the amount of 15-25 mg. Transplantation is carried out under the patient skin distant in 6.5 intercostal space. The method reduces the expression of undesirable side effects of treatment and abstinence".
Patent # 1438783 "subcutaneous implant in the form of spherules to be filled in the zone located in the center distance between the special points # 1 Buy-Hui (20.III) and Sin-Hui".
Patent # 1279641 "The patient felt a "lightning strike to the head"... produced by procedure of application of the sinusoidal current with a frequency of 5000 Hz for 0.5-1 seconds to the brain“
Patent # 2159636 "Method of coding - give a verbal symbol "psychotronic weapons", and “alcohol is a super-substance". Suggestive effect enhances an atmosphere of mystery. Inspire "retribution" for violation of sobriety to the termination of anti-alcoholic code ... form the patient's psycho-emotional state out of the "miracle." It is also reported that the doctor has no right to disclose all the details of the process".
Patent # 2055602 "... the patient squeezes rubber roller teeth, head and the proposed location of the second electrode overlap cleaned with a solution of alcohol, the electrodes are applied using the technique of unilateral electroconvulsive therapy, non-dominant hemisphere stimulation (right side for right-handers).
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• One product does it all. • Personal testimonials. Quick
fixes.• Quick fixes. • “All natural.” • “Miracle cure.” • Conspiracy theories.• No side effects.
Tip-OffsFDA offers some tip-offs to help you identify rip-offs
Outcomes:• Publications in main Newspapers and other media changed public
opinion.• TV shows and reports on TV have been noticed by the policymakers.• The method that has been used for many years in grey zone has been
studied.• Changing regulation in the treatment of substance abuse and
dependence in Russia. • Now «coding of alcoholism» is banned by the regulating authority.
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Where does to complain about the charlatans?
Contents of the quack treatment or questionable medical device or drug through the system of electronic forms applications for citizens:1. Rospotrebnadzor. Appeals on the facts of trade substandard goods, including, Supplements, devices and pseudomedical services http://rospotrebnadzor.ru/feedback/new.php2. The Federal Antimonopoly Service (FAS). Accepted treatment of suspicious advertising services and medical products http://fas.gov.ru/citizens/feedback/3. The Ministry of Health of Russia. Accepted applications of citizens in any form http://www.rosminzdrav.ru/reception/appeals/new4. Rozdravnadzor. Regulator issuing permits for medical devices. http://roszdravnadzor.ru/people
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