Analysis of pseudo-medical methods, drugs & devices using the Patents Libraries

Sergey SoshnikovMD, Ph.D.

Overview

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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

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• 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• RTC registries (unpublished data)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?

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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

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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