# US 6,579,888 B2 · Method and kit for treating illnesses

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- Number: US 6,579,888 B2
- Document ID: US6579888B2
- Status: Granted
- Kind: B2
- Application number: 09/823,329
- Filed: 2001-03-30
- Published: 2001-11-22
- Granted: 2003-06-17
- Earliest claimed: 1994-10-31
- Assignees: Opt-e-scrip, Inc.
- Inventors: Donald P. Reitberg
- Web page: https://patentgrep.com/patent/US6579888B2

## CPC

- G16H 10/20: for electronic clinical trials or questionnaires
- G16H 10/60: for patient-specific data, e.g. for electronic patient records
- G16H 20/00: ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
- G16H 20/10: relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Methods and kits for determining appropriate treatment for illnesses in humans or animals are disclosed. The method includes: providing a test kit containing a random arrangement of drug(s) and placebo(s) and/or alternative treatment(s) along with a questionnaire or other instrument designed to elicit data concerning the safety, efficacy and desirability of a treatment; administering the drug(s) and placebo(s) and/or alternative treatments to each member of the pool in a random, double blind fashion and following up on patient outcomes as appropriate post-study; assembling a database from the completed pool questionnaires and revealing the random schedule to uncover drug and placebo treatment periods; providing the same kit to a patient in need of the same treatment and comparing the results obtained from the single patient trial with those obtained from the pool to determine an optimal treatment for the patient with the drug; and administering a treatment consistent with the optimal treatment.

## Claims

### Claim 1

A method for evaluating the response of individual human patients to chronic therapy with a drug, comprising:
a) conducting a randomized, double-blind, cross-over, single patient drug trial of a drug and a placebo in a new patient who is a candidate for treatment with said drug, said drug being selected from the group consisting of a drug for treating hyperkinetic behavior, an anti-depressant drug, an anti-anxiety drug, an anti-asthmatic drug, an anti-epileptic drug, an anti-psychotic drug, a cardiovascular drug, a respiratory drug, an antihypertensive drug, an anti-diabetic drug, a steroidal anti-inflanmiatory drug, a non-steroidal anti-inflammatory drug, an opioid analgesic, a non-narcotic analgesic drug, an anti-cancer drug, a hematologic drug, a musculoskeletal drug, a gastro-intestinal drug, an anti-allergy drug, an estrogen-containing drug, a drug for the treatment of urinary tract conditions, a drug for the treatment of genital conditions, a drug for the treatment of neurologic conditions, and a drug for the treatment of psychiatric conditions;
b) comparing the results of said single patient drug trial of said new patient with a previously assembled patient population database of information concerning the safety, efficacy and desirability of said drug administered in a plurality of crossover single patient drug trials according to a randomized, double-blind schedule with a placebo, to aid in the interpretation of the results for said new patient; and
c) optimizing treatment for said new patient by taking one of the following actions: (i) continuing therapy for said new patient using the same drug and dosage regimen; (ii) changing the dosage regimen of the same drug in order to optimize the dosage regimen for said new patient; or (iii) ceasing to treat said new patient with said drug if the patient is not achieving a desired benefit from treatment with said drug.

### Claim 2 (depends on 1)

The method of claim 1, further comprising adding the results from the single patient drug trial of said new patient to the patient population database.

### Claim 3 (depends on 1)

The method of claim 1, further comprising assembly of said patient population database by providing to each patient in said patient population a test kit containing a supply of said drug; a supply of said placebo; and a questionnaire designed to elicit from said patient population information concerning the actual usage, safety, efficacy and desirability of said drug.

### Claim 4 (depends on 1)

The method of claim 1, further comprising assembly of said information from the individual patient drug trial by providing to said individual patient a test kit containing a supply of said drug; a supply of said placebo; and a questionnaire designed to elicit from said patient information concerning the actual usage, safety, efficacy and desirability of said drug.

### Claim 5 (depends on 1)

The method of claim 1, wherein the drug is a drug for treating hyperkinetic behavior.

### Claim 6 (depends on 5)

The method of claim 5, wherein the drug is methylphenidate.

### Claim 7 (depends on 1)

The method of claim 1, wherein the drug is an anti-asthmatic drug.

### Claim 8 (depends on 1)

The method of claim 1, wherein the drug is an anti-epileptic drug.

### Claim 9 (depends on 1)

The method of claim 1, wherein the drug is a cardiovascular drug.

### Claim 10 (depends on 9)

The method of claim 9, wherein the drug is verapamil.

### Claim 11 (depends on 9)

The method of claim 9, wherein the drug is propranolol.

### Claim 12 (depends on 1)

The method of claim 1, wherein the drug is a respiratory drug.

### Claim 13 (depends on 1)

The method of claim 1, wherein the drug is an antihypertensive drug.

### Claim 14 (depends on 1)

The method of claim 1, wherein the drug is a steroidal anti-inflammatory drug and a non-steroidal anti-inflammatory drug.

### Claim 15 (depends on 1)

The method of claim 1, wherein the drug is selected from the group consisting of an opioid analgesic and a non-narcotic analgesic drug.

### Claim 16 (depends on 1)

The method of claim 1, wherein the drug is a hematologic drug.

### Claim 17 (depends on 1)

The method of claim 1, wherein the drug is a musculoskeletal drug.

### Claim 18 (depends on 1)

The method of claim 1, wherein the drug is an anti-asthmatic drug.

### Claim 19 (depends on 1)

The method of claim 1, wherein the drug is a gastro-intestinal drug.

### Claim 20 (depends on 1)

The method of claim 1, wherein the drug is an anti-allergy drug.

### Claim 21 (depends on 20)

The method of claim 20, wherein the drug is an antihistamine.

### Claim 22 (depends on 1)

The method of claim 1, wherein the drug is an anti-depressant drug.

### Claim 23 (depends on 1)

The method of claim 1, wherein the drug is an anti-anxiety drug.

### Claim 24 (depends on 1)

The method of claim 1, wherein the drug is an anti-psychotic drug.

### Claim 25 (depends on 1)

The method of claim 1, wherein step (c) comprises the step of ceasing to treat the patient with said drug.

### Claim 26 (depends on 1)

The method of claim 1, wherein step (c) comprises continuing therapy for said new patient using the same drug and dosage regimen.

### Claim 27 (depends on 1)

The method of claim 1, wherein step (c) comprises changing the dosage regimen of the same drug in order to optimize the dosage regimen for said new patient.

### Claim 28 (depends on 1)

The method of claim 1, wherein said single patient drug trial in said new patient is conducted by providing to said new patient a test kit containing a supply of said drug; a supply of said second agent; and a questionnaire designed to elicit from said new patient information concerning the actual usage, safety, efficacy and desirability of said drug in said new patient.

### Claim 29 (depends on 28)

The method of claim 28, wherein said previously assembled patient population database of information concerning the safety, efficacy and desirability of a drug administered in a plurality of crossover single patient drug trials is conducted by providing to each patient in said patient population a test kit containing a supply of said drug; a supply of said second agent; and a questionnaire designed to elicit from said patient population information concerning the actual usage, safety, efficacy and desirability of said drug.

### Claim 30

A method of evaluating the response of individual human patients to chronic therapy with a drug, comprising:
a) conducting, in a new patient who is a candidate for treatment with a drug, a randomized, double-blind, cross-over, single patient drug trial of the drug and a second agent selected from the group consisting of a placebo, a therapeutic alternative for said drug, a generic equivalent for said drug, and a different dose of the same drug, said drug being selected from the group consisting of a drug for treating hyperkinetic behavior, an anti-depressant drug, an anti-anxiety drug, an anti-asthmatic drug, an anti-epileptic drug, an anti-psychotic drug, a cardiovascular drug, a respiratory drug, an antihypertensive drug, an anti-diabetic drug, a steroidal anti-inflammatory drug, a non-steroidal anti-inflammatory drug, an opioid analgesic, a non-narcotic analgesic drug, an anti-cancer drug, a hematologic drug, a musculoskeletal drug, a gastro-intestinal drug, an anti-allergy drug, an estrogen-containing drug, a drug for the treatment of urinary tract conditions, a drug for the treatment of genital conditions, a drug for the treatment of neurologic conditions, and a drug for the treatment of psychiatric conditions;
b) comparing the information accumulated from the single patient drug trial of said new patient with a previously assembled patient population database of information concerning the safety, efficacy and desirability of a drug administered in a plurality of crossover single patient drug trials according to a randomized, double-blind schedule with the same second agent administered to the patient population of step (a), to aid in the interpretation of the results for said new patient; and
c) optimizing treatment for said new patient by taking one of the following actions: (i) continuing therapy for said new patient using the same drug and dosage regimen; (ii) changing the dosage regimen of the same drug in order to optimize the dosage regimen for said new patient; (iii) ceasing to treat said new patient with said drug if said new patient is not achieving a desired benefit from treatment, or (iv) changing said new patient to chronic therapy using a therapeutic alternative or generic equivalent of said drug.

### Claim 31 (depends on 30)

The method of claim 30, wherein the second agent in said single-patient drug trials is a therapeutic alternative for said drug.

### Claim 32 (depends on 30)

The method of claim 30, wherein the second agent in said single-patient drug trials is a generic equivalent for said drug.

### Claim 33 (depends on 30)

The method of claim 30, wherein the second agent in said single-patient drug trials is a different dose of the same drug.

### Claim 34 (depends on 30)

The method of claim 30, further comprising adding the results from said single patient drug trial of said new patient to the patient population database.

### Claim 35 (depends on 34)

The method of claim 34, wherein the second agent in said single-patient drug trials is a therapeutic alternative for said drug.

### Claim 36 (depends on 34)

The method of claim 34, wherein the second agent in said single-patient drug trials is a generic equivalent for said drug.

### Claim 37 (depends on 34)

The method of claim 34, wherein the second agent in said single-patient drug trials is a different dose of the same drug.

### Claim 38 (depends on 30)

The method of claim 30, wherein the dose of the drug is decreased in step (c).

### Claim 39 (depends on 30)

The method of claim 30, wherein the dose of the drug is increased in step (c).

### Claim 40 (depends on 30)

The method of claim 30, wherein drug treatment ceased in step (c).

### Claim 41 (depends on 30)

The method of claim 30, wherein chronic therapy is begun in the new patient using a therapeutic alternative of said drug in step (c).

### Claim 42 (depends on 30)

The method of claim 30, wherein chronic therapy is begun in the new patient using a generic equivalent of said drug in step (c).

### Claim 43 (depends on 30)

The method of claim 30, wherein the drug is a drug for treating hyperkinetic behavior.

### Claim 44 (depends on 43)

The method of claim 43, wherein the drug is methylphenidate.

### Claim 45 (depends on 30)

The method of claim 30, wherein the drug is an anti-asthmatic drug.

### Claim 46 (depends on 30)

The method of claim 30, wherein the drug is an anti-epileptic drug.

### Claim 47 (depends on 30)

The method of claim 30, wherein the drug is a cardiovascular drug.

### Claim 48 (depends on 47)

The method of claim 47, wherein the drug is verapamil.

### Claim 49 (depends on 47)

The method of claim 47, wherein the drug is propranolol.

### Claim 50 (depends on 30)

The method of claim 30, wherein the drug is a respiratory drug.

### Claim 51 (depends on 30)

The method of claim 30, wherein the drug is an antihypertensive drug.

### Claim 52 (depends on 1)

The method of claim 1, wherein the drug is a steroidal anti-inflammatory drug and a non-steroidal anti-inflammatory drug.

### Claim 53 (depends on 1)

The method of claim 1, wherein the drug is selected from the group consisting of an opioid analgesic and a non-narcotic analgesic drug.

### Claim 54 (depends on 1)

The method of claim 1, wherein the drug is a hematologic drug.

### Claim 55 (depends on 1)

The method of claim 1, wherein the drug is a musculoskeletal drug.

### Claim 56 (depends on 1)

The method of claim 1, wherein the drug is an anti-asthmatic drug.

### Claim 57 (depends on 1)

The method of claim 1, wherein the drug is a gastro-intestinal drug.

### Claim 58 (depends on 1)

The method of claim 1, wherein the drug is an anti-allergy drug.

### Claim 59 (depends on 58)

The method of claim 58, wherein the drug is an antihistamine.

### Claim 60 (depends on 1)

The method of claim 1, wherein the drug is an anti-depressant drug.

### Claim 61 (depends on 1)

The method of claim 1, wherein the drug is an anti-anxiety drug.

### Claim 62 (depends on 1)

The method of claim 1, wherein the drug is an anti-psychotic drug.

### Claim 63 (depends on 30)

The method of claim 30, wherein said single patient drug trial in said new patient is conducted by providing to said new patient a test kit containing a supply of said drug; a supply of said second agent; and a questionnaire designed to elicit from said new patient information concerning the actual usage, safety, efficacy and desirability of said drug in said new patient.

### Claim 64 (depends on 63)

The method of claim 63, wherein said previously assembled patient population database of information concerning the safety, efficacy and desirability of a drug administered in a plurality of crossover single patient drug trials is conducted by providing to each patient in said patient population a test kit containing a supply of said drug; a supply of said second agent; and a questionnaire designed to elicit from said patient population information concerning the actual usage, safety, efficacy and desirability of said drug.