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The Name Dropper swaddles babies in clothing and footwear, while Storkland supplies pintsize furniture, car seats, and strollers. Together, the side-by-side sister stores outfit babies for playtime, naptime, and small-claims court trials. Top tots off with a selection of bows ($4–$12) or dress them in brand-name duds ($20–$70) from Bailey Boys, Vineyard Vines, and Kissy Kissy. Little piggies stay comfortable in an assortment of sandals ($26–$40) or Crocs ($24.95), while pint-sized rockers ($60) lull wee ones to sleep faster than a six-part miniseries on solid foods. Storkland and The Name Dropper's obliging staff can also help parental units find a bevy of dolls and toys to entertain developing brains.
Carroll's Furniture stocks a large selection of furniture from 26 brands, including Coaster, Hatcher, Liberty, and Wood River. Pick up the perfect lamp ($15–$99.99) or picture ($10–$199.99) to tie together a recently shredded room, or use an area rug ($75–$199.99) to cover a section of unsightly floorboards, a pile of stolen treasure, or a collection of stolen floorboards. A three-piece set of coffee tables or end tables ($199.99+) provides plenty of places for setting down an extra-heavy beverage, and accent pillows ($10–$25) make excellent additions to any room. Those looking to revamp entire rooms will appreciate Carroll's two-piece living-room sets, which consist of sofas and love seats ($599.99+).
Mattress Direct and America's Mattress give somnambulant snoozers a place to rest weary heads with comfortable, supportive mattresses and sturdy box springs. Drift off on a Serta Perfect Sleeper, a mattress coaxing numbered lambs into soothing slumber for more than 75 years. Each mattress features an ultra-soft top and back-friendly firm springs below (twin mattresses start at $414, box springs start at $135). Couture catnappers can snag a Vera Wang mattress for a fashionable 40 winks, with the choice of traditional innerspring or all-foam models, all crafted with careful attention to detail and style (mattresses start at $689, box springs start at $160). Customers can catch Z's on a luxurious iComfort mattress, a dream-deliverer constructed of memory foam and supportive gel to whisk heat and tension away from reposing bodies. Because the shop is offering a special on select twin mattresses ($79–$99 each), this Groupon can assist mattress misers in hoarding up to four beds-to-be or cushiony improvised sleds. All Serta mattresses also include a doze-defending warranty.
Mattress Direct culls a variety of mattresses in textures ranging from firm to plush from brands such as Tempur-Pedic and Serta. Serta's iComfort, for example, evenly distributes support across the body with microsupport gel capsules nestled in its memory foam; a specialized material prevents overheating and the resulting unpleasant lava-chase nightmares. Mattress Direct's stock of bed frames, bed linens, and pillows allow patrons to assemble complete bedroom sets in one trip, and an express delivery service prevents the hassle of renting a moving truck or outfitting each leg of a new bed with a rollerblade.
Good Morning Mattress Center is dedicated to providing the best shopping experience to all customers. We carry brands like Jamison, Tempur-pedic, Corsicana and Vivon. We have a mattress to fulfill every price and quality point.
With more than 386 locations dotting North America, JCPenney Optical's ubiquity is matched only by its extensive selection of contact lenses and designer frames that includes brands such as Armani Exchange, Liz Claiborne, and Nicole Miller. Despite this wide reach, all lenses are cut at the same optical laboratory, ensuring a consistency of quality and a pretty good idea of where to look if your glasses run away from home. Each location has an independent state-licensed doctor of optometry, who can perform vision exams and help clients determine which type of vision correction will work best.


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Facebook: kishore biyani - Future group MD | Facebook
kishore biyani - Future group MD. 0 likes · 0 talking about this.
Facebook: Future Group Leader Kishore Biyani Close... - Click To Franchise ...
Future Group Leader Kishore Biyani Close 9 Big Bazaar Stores...! Read full story:...
Kishore Laxminarayan Biyani B.Com., PGD: Executive Profile &...
Mr. Kishore Laxminarayan Biyani, B.Com., PGD founded Future Group and Future Supply Chain Solutions Ltd., and serves as their Group Chief Executive Officer....
Wal-Mart Eyes Indian Expansion - Analyst Blog
Future Group owner Kishore Biyani visited Wal-Mart's headquarters in the US, last December where he met Doug McMillon, president and CEO ...
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Find business contact information for Kishore Biyani, Chief Executive Officer, Futures Group and see work history, affiliations and more.
Wikipedia: Kishore Biyani
is an Indian businessman. He is chief executive officer (CEO) of Future Group, and Managing Director of Pantaloon Retail.
Kishore Biyani - Wikipedia, de free encycwopedia
Kishore Biyani (Born on 9f August, 1961) is de Group CEO of Future Group and Managing Director of Pantawoon Retaiw. Over de years he has wed de emergence of Pantawoon
BlinkX Video: What makes Kishore Biyani an unstoppable Indian?
Kishore Biyani, founder and Group CEO of the Future Group, talks about his retail mantra. - 19.03.2009, YouTube
BlinkX Video: 20th AIMS Convention- Kishore Biyani, Future Group CEO
This is a panel discussion held today at Mumbai Business school. The panelists included M Rammohan Rao, current dean of the Indian School Of Business in Hyderabad, Kishore Biyani,... - 28.08.2008, YouTube
Kishore Biyani: Taking Future Group to next phase of growth - YouTube
Kishore Biyani has spread his wings beyond the shopping isles of his Big Bazaar and Pantaloon stores, but he has still got his eyes firmly on the wallet of t...
Big Dreamer Sessions: Kishore Biyani - YouTube
Posing an influential question, Mr. Kishore Biyani, Group CEO of Future Group asks how we can meet the aspirations of young India? In a brief talk, he questi...
Twitter Posts: Shantanu Ugrankar (ZootasticGhoda)
16.07.2012 Now we're talking about Future Group and Kishore Biyani, well now I feel awesome seeing and listening to him in person.
Twitter Posts: Srini Swaminathan (srini091)
13.07.2012 Amar Chitra Katha is owned by the Future Group of Kishore Biyani. interesting turn around story.
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09.07.2012 @GChintamani @kishore_biyani contact details along with your ref id 4480 and we'll get back to you. 2/2
Twitter Posts: Gautam Chintamani (GChintamani)
08.07.2012 @kishore_biyani In a world with FabIndias, FutureBrands looks like a lost cause. Whatever happened to the flight of the sone ki chidiya? 3/3
FMCG business has bright future: Kishore Biyani
Vaish Sansar : Directory of Vaish Community
Future Group: Pantaloon Retail (India) Ltd | Business Excellence...
Business Excellence - Bringing you content on truly excellent companies from the USA, Canada, Middle East, Africa, Asia and Europe.
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Kishore Biyani- Chairman, Future Media - Research Paper - Mj2905
Read this research paper and over 1,800,000 others like it now. Don't miss your chance to earn better grades and be a better writer!
Idiom: Redefining Design in India | Design Transitions
... and Tessaract (Co-founded by Jacob Mathew in 1985) the two firms merged with the support of Kishore Biyani, CEO, Future Group in 2005.
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ANDRZEJKI DJ Party 2014
November 28, 2014 Polish American Folk Dance Company invites you to ANDRZEJKI DJ Party 2014 Friday, November 28, 2014 9:00 PM Help support your local PAFDC by coming to our party a...
Past Concert140 Years Concert
On June 2nd of 2007, PAFDC held the 140 Years of Polish Folk Dance New York & Boston Concert. See a video from a concert.
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Past FestivalChicago Festival 2007
From July 29th through August 3rd, the Wesoly Lud Polish Folk Dance Ensemble hosted PFDAA Chicago Festival 2007. See a Photo Gallery. Read More
Past AnniversaryPAFDC 60th Anniversary
A decade ago, on June 20th of 1998, PAFDC held the 60th Anniversary Concert at the Lincoln Center. See a Photo Gallery
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SAVE THE DATE! SATURDAY, NOVEMBER 23rd, 2013!PAFDC 75th Anniversary Concert!
November 23rd, 2013 at 7:00 PM
at NYU Skirball Center for the Performing Arts
566 LaGuardia Pl, Manhattan, New York
See Details Tickets on Sale September 3rd
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Send PAFDC Dancers to Poland!
PAFDC's performances are made possible, in part, with public funds
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I'm not. Get away from me.
Best Answer
Because I ain't no hoe.
Best Answer
Its all those damn sparkles
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I'm not an easy girl! :)
Best Answer
People always want what they can't have. A fancy car, expensive shoes, a massive house. So playing hard to get makes the person want you MORE.
Best Answer
Because that's the way I was created. If they want me they will fight for me.
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I must be sending the wrong signals
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My EP crush is playing hard to get..... I need a very seductive guy to entertain me until he comes to his senses....Where are all the delicious men hiding?LightandShade 26-30, F 10 Answers 2 Sep 14 in Community
As a girl, when a guy flirts with me, and i like them also, how would i react? Should i be aggressive and flirt back or just be a "hard to get" and play safe?mhel0w8 18-21, F 6 Answers 1 Dec 22, 2008


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Wall Hanging Home Blessing in English and Hebrew in Raw Silk by Yair Emanuel
This wall hanging features the traditional home blessing in Hebrew and English embroidered on raw silk by Yair Emanuel with pomegranates. Read more
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- Yair Emanuel Wall Hanging Hebrew and English Home Blessing in Blue Raw Silk $25
Product Description
This wall hanging is a true work of art that bursts with color and creativity by well-known artist Yair Emanuel. A pretty blue frame displays two fanciful birds in bright pink and lavender with the home blessing written in gold embroidery in Hebrew and English below. The blessing has been surrounded by an explosion of red pomegranates, purple flowers, green leaves and gold filigrees designs. Colorful beads add a fun touch at the bottom.
Add one of Yair Emanuel's Kiddush cups to this wall hanging for the a wonderful wedding present!
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Nationstar To Participate In 15th Annual Credit Suisse Financial Services Forum On February 12, 2014
Nationstar Mortgage Holdings Inc. (NYSE: NSM) ("Nationstar") announced today that Jay Bray, Nationstar's Chief Executive Officer, will present at the 15 th Annual Credit Suisse Financial Services Forum on Wednesday, February 12, 2014 at 9:30 a.m. Eastern time at the Boca Raton Resort and Club in Boca Raton, FL.
The public may access a live audio webcast of the conference by visiting Nationstar's website at http://investors.nationstarholdings.com. A replay will be available on Nationstar's website shortly after the conference and will be archived for 14 days. In addition, an investor presentation will be available on the "Investor Relations" section of the Nationstar website at http://investors.nationstarholdings.com/ prior to the conference.
About Nationstar Mortgage Holdings Inc.
Based in Lewisville, Texas, Nationstar offers servicing, origination, and real estate services to financial institutions and consumers. Nationstar is one of the largest servicers in the United States and operates an integrated loan origination business that mitigates servicing portfolio run-off and improves credit performance for loan investors. Our Solutionstar business unit offers asset management, settlement, and processing services. Additional corporate information is available at
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Muamar family detention incident
The Muamar family detention incident occurred very early on the morning of June 24, 2006, in the first taking of Palestinians in the Gaza Strip by Israeli Defence Forces (IDF) since the Israeli evacuation of Gaza one year earlier,[1] when IDF soldiers entered the house of the Muamar family in a village near Rafah, at 03:30 local time (00:30 GMT) and detained Osama and Mustafa Muamar.[2] The BBC reports the village name as Umm al-Nasser[2]
Ali Muamar, father of the two men detained, Osama Muamar and Mustafa Muamar, stated "They blindfolded and handcuffed me and started beating me up with the butts of their rifles and kicking me."[2] He stated that a computer was taken and that the whole incident lasted for about an hour.[2]
An Israeli spokesman confirmed the detentions, said that both men were members of the militant group Hamas intending to carry out imminent attacks on Israel and stated "These Palestinians were transferred to Israel where they will be questioned".[2][3] A spokesman for Hamas confirmed that the brothers were sons of a member but denied that the men detained were involved in Hamas.[2][3]
This event was followed by capture of Israeli soldier Gilad Shalit on June 25, 2006 and further incidents in the 2006 Israel-Gaza conflict.
See also[edit]
- ^ "World in brief : Gaza Strip arrests". The Observer. June 25, 2006. Retrieved 2006-08-01.
- ^ a b c d e f "Israel captures pair in Gaza raid". BBC. 24 June 2006. Retrieved 2006-08-01.
- ^ a b "Israeli troops arrest two in Gaza raid". Al Jazeera. 24 June 2006. Retrieved 2009-04-12.
|This Palestine-related article is a stub. You can help Wikipedia by expanding it.


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Give a gift in Sayaka's memory to help survivors of Japan's earthquake
July 14, 2011
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The March 11 earthquake and resulting tsunami have caused widespread devastation across northern Japan.
Mercy Corps is working to help survivors of Japan's earthquake with our longstanding partner, Peace Winds. Your donation will be used to meet immediate and longer-term needs of earthquake survivors.


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Winter Vacation Ideas: Go With the Snow
Being a Rice Farmer in Bali
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Issue 4 2014
The Ghost of Christmas Future is the inspiration for the collection's third drink, the Sparkling English Christmas. Bidding adieu to Champagne and celebrating the bright future of its English equivalent – currently giving its French counterpart a run for their money – this refreshing raspberry and vanilla sparkling wine cocktail is ideal to be enjoyed during afternoon tea or for pre-dinner celebrations. Future: Sparkling English Christmas SERVES 1 Ingredients: 1 tbsp (15 ml) raspberries 1 ½ fl oz (30 ml) vanilla vodka 1/5 oz (5 g) vanilla sugar 1 ¾ fl oz (50 ml) pineapple juice Nyetimber sparking wine Method: 1. Place all ingredients in shaker and shake well. 2. Pour mixture into a Champagne flute and top off with Nyetimber. 3. Decorate flute with raspberries for garnish. - See more at: http://taste.fourseasons.com/2014/12/holiday-cocktail-recipes/#sthash.Tpp2c2OC.dpufA Christmas Carol in Three CocktailsPosted 18 December 2014 at 10:20 pm
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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.
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.
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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.
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This application is a continuation of U.S. application Ser. No. 08/331,913, filed Oct. 31, 1994 now U.S. Pat. No. 6,242,463.
The present invention relates to improving the treatment of chronic illness in humans and animals. In particular, the invention relates to kits and methods that improve chronic treatments using data obtained from individual random crossover (n=1 or single patient) double-blind studies.
Inappropriate prescribing of potent and potentially dangerous drugs is a problem of staggering dimensions. Nonetheless, no commercial solution has been advanced to ensure appropriate treatment. Presently, doctors prescribe medications which have approved indications determined by large clinical trials. Drug manufacturers also demonstrate a product's safety and effectiveness using well controlled clinical studies in populations likely to require its use (e.g. hypertensive patients for antihypertensive drugs). Relatively small numbers of highly selected subjects are utilized. Too often, these studies do not accurately predict the safety and efficacy of a medication for individuals actually treated in practice.
Thus, prescribers are at a disadvantage because a highly selected, often homogeneous group of patients is actually studied for marketing approval. The prescribing physician often cannot distinguish which drugs are safe and effective for his/her heterogeneous collection of individual patients. Even in homogeneous groups of patients, individual variation is usually large when a pharmaceutical company measures a drug's disposition and activity. Therefore, average results may be poorly suited to the needs of any given individual. It is rarely clear to the prescribing physician how an individual patient might respond to a given medication. This is because all people respond differently, both positively and negatively, based upon individual genetic and environmental factors.
Furthermore, the physician rarely has objective information to help decide between alternative therapies for an individual patient. Although the physician wants unbiased data concerning how a patient responds to a given therapy, such data is almost never available unless the patient is in a drug trial. The physician is almost always required to use subjective "clinical judgment".
Pharmaceutical manufacturers are also at a disadvantage since they have no means of providing unbiased data for individual patients. Manufacturers rarely receive feedback on how a drug is used in actual practice unless an adverse event is reported. Other organizations often need unbiased information for regulatory, patient care and business purposes. Currently, unreliable retrospective databases, such as government or health maintenance organizations' epidemiologic databases, are used.
In 1985, investigators proposed a single-patient drug trial as a possible solution. Using this study design, a patient is treated with a medication and a placebo in a double-blind randomized manner (n=1 or single patient drug trial). This approach permits assessment of whether a medication regimen is appropriate for an individual patient in terms of medical benefit and harm. This approach eliminates patient/physician bias by making the medication and placebo look and/or taste the same. Thus, a toxic or ineffective treatment can be avoided by using objective criteria and new treatment regimens can be pursued for well documented reasons and similarly tested, if needed. This alternative is purely subjective trial and error.
The single-patient method, however, has significant shortcomings. It has failed to provide validated results. There was no appreciation that the data obtained from the single trial should be compared against a database compiled from similarly affected and tested patients. Moreover, no guidance was provided concerning therapeutic alternatives based upon a database comprised of earlier patient experience during single-patient trials.
No commercial products are believed to be available which allow objective and definitive measurement of individual patient compatibility with drug treatment compared to placebo or a therapeutic alternative. The present invention addresses this need.
It is therefore an object of the present invention to develop methods and kits which can assess the appropriateness of specific drug treatment in individuals, particularly those suffering from chronic illnesses.
It is a further object to provide methods and kits for testing therapeutic alternatives for drug treatments in individuals.
Thus, in one aspect, the invention includes a method of treating human and veterinary illnesses. The method includes:
a) providing to a pool of humans or animals in need of such treatment a test kit containing:
i) a supply of a drug indicated or proposed for the treatment of an illness;
ii) a supply of a placebo substantially identical in appearance to the drug,
iii) a questionnaire designed to elicit from each pool member to be treated information concerning the actual usage, safety, efficacy and desirability of the selected treatment;
b) administering the drug and placebo to each member of the pool according to a random, double-blind schedule;
c) assembling a database from the pool based on the answers provided from the individual questionnaire;
d) revealing the random schedule and comparing the data obtained from known drug and placebo treatment periods;
e) providing a test kit containing the same materials as set forth in a) to a human or animal also in need of such treatment to obtain a separate or second set of data concerning the safety, efficacy and desirability of said treatment;
f) administering the drug and placebo to the human or animal according to a random, double-blind schedule;
g) assembling the second or separate database based on the answers provided to the questionnaire;
h) revealing the random schedule to uncover drug and placebo treatment periods;
i) comparing the data obtained from the pool with that obtained from the single human trial to determine an optimal treatment of the human or animal with the drug; and
j) administering to the human or animal a treatment consistent with the optimal treatment.
The new dosing regimen for optimal therapeutic effect and quality of life can also be retested, if and when deemed appropriate, by the clinician and/or patient.
The method is suitable for evaluating and validating any prescription or non-prescription treatment regimen or medication for individuals as well as demographic groups. Using this method, one can periodically obtain further outcome information on tested individuals.
Other aspects of the invention include a method and kit for determining therapeutic alternatives and verifying generic equivalence of known medications. These methods include:
a) providing to a human or animal a test kit containing:
i) a supply of a drug indicated for the treatment of an illness;
ii) a supply of a therapeutic alternative or generic equivalent candidate substantially identical in appearance to the drug,
iii) a questionnaire designed to elicit from the human or animal information concerning the safety, efficacy and desirability of the treatment for the human or animal;
b) administering the drug and therapeutic alternative to the human or an animal according to a random, double-blind schedule;
c) assembling a database by eliciting from the human or animal caretaker answers to the questionnaire; and
d) revealing the random arrangement schedule to determine the relative effectiveness of the therapeutic alternatives in the human or animal by comparing the data obtained from knowing drug and alternative treatment periods.
There are several advantages associated with the present invention. For example, patients benefit by the assurance of treatment with appropriate drug and dosing regimen. The method is particularly useful before committing a patient to a long term drug treatment regimen. Documented evidence of the benefit is provided. Unnecessary side effects and expense can be avoided.
Government agencies could also benefit by the availability of a dynamic database on drug efficacy and safety in individuals. The inventive method also provides an alternative means for approving new drugs. In this aspect, the new drug or therapeutic alternative could be tested according to the methods described herein against a placebo or a known effective agent and/or indicated therapy in individuals and/or a pool of suitable candidates. This is a particular advantage to the pharmaceutical industry and affords a method to validate the therapeutic equivalence of generic drugs as well as non-generic therapeutic alternatives.
Insurers and managed care organizations could benefit by having a reliable "second opinion" to help avoid expensive, prolonged, unneeded, or toxic treatments, and promote utilization of safe and effective therapies.
The present invention provides advances over prior art single patient drug trials (n=1) by optimizing treatment for the individual. Unlike (n=1) studies, which by definition, had a sample size of one, the invention includes comparing the data obtained from the individual with a database accumulated for an entire tested population, referred to as a pool herein. This results in the opportunity to create a prospective, frequently updated epidemiological database which has value not only for regulatory approvals or post-marketing surveillance of drug safety and efficacy, but also for optimizing outcome in individuals as well.
The present invention includes a method and kit for determining the appropriate treatment of an illness. The method includes:
a) providing to a pool of humans or animals in need of such treatment a test kit containing:
i) a supply of a drug indicated for the treatment of an illness;
ii) a supply of a placebo substantially identical in appearance to the indicated drug,
iii) a questionnaire designed to elicit from each member of the pool information concerning the safety, efficacy and desirability of the selected treatment;
b) administering the drug and placebo to each member of the pool according to a random, double-blind schedule;
c) assembling a database by eliciting from the pool data from the answers to the questionnaire;
d) revealing the random schedule to uncover drug and placebo treatment periods;
e) providing a test kit containing the same materials as set forth in a) to a human or animal also in need of such treatment to obtain a second or separate set of data concerning the safety, efficacy and desirability of the treatment;
f) administering the drug and placebo to the human or animal according to a random, double-blind schedule;
g) assembling a separate database by eliciting from the human or animal caretaker answers to the questionnaire;
h) revealing the random schedule and comparing the data obtained as a result of known active(s) and placebo(s) treatment periods;
i) comparing the results obtained from the first set of data obtained from the pool with the second set of data obtained from the single trial to determine an optimal treatment of the human or animal with the drug; and
j) administering to the human or animal a treatment consistent with the optimal treatment, based upon individual and group outcome. Results from the individual, and post-study follow-up data can also be added to the general database.
Even after the data obtained from the questionnaires is obtained, the caregiver can continue to periodically use the same kit or other kits with different test articles, analyzing the further results for relative scoring, or monitoring further treatment based on physician and patient awareness of study results.
For purposes of description of the present invention, certain terms are described below. Generally, however, the terms have the commonly understood meaning known to those of ordinary skill in the art.
Drug shall mean a medicament, biologically active ingredient, or pharmaceutical dosage form containing an active ingredient effective for one or more medical conditions. The drug may be in any known dosage form including tablets, capsules, solutions, elixirs, ointments, creams, etc.
Placebo shall mean an inert or inactive dosage form having an appearance and/or other organoleptic/sensory characteristics substantially identical to an active drug.
Treatment or treating includes administering a generally recognized effective amount of a drug for the purpose of alleviating or curing a disease or deficiency.
Optimal or optimizing treatment means a treatment regimen which has been adjusted or validated in view of a comparison of objective data relating to one or more treatment periods with one or more active medicament(s) and one or more of placebo, therapeutic alternative or generic equivalent. This is further adjusted by consideration of outcomes from similarly tested populations. Treatments consistent with optimal treatment are those which adjust the time, manner or amount of a drug or therapy for maximum effect, or even cease to treat with the drug or therapy.
Supply means a quantity sufficient for completing a statistically valid evaluation of a treatment method in an individual.
Therapeutic alternative means a medicament having a non-identical chemical composition from a known medicament but achieves substantially the same bio-effect in an individual.
A generic drug or medicament means a substantially identical active ingredient to a known composition.
Chronic shall mean treatment for a condition which lasts an indefinite period of time. Treatments amounting to more than a single course of therapy. Maintenance dosing regimens are also contemplated.
Prolonged therapy shall mean therapy wherein doses are administered to a patient over a period of greater than 10 days, including multiple episodes or recurrences of shorter duration. For example, a psoriasis or herpes episode may require treatments of less than 10 days but the condition requires prolonged therapy.
The term "double-blind" shall be consistent with its known meaning and include known techniques such as single or multiple crossover techniques well known to those of ordinary skill. Double-blind means that the patient, or caretaker if appropriate, and care-giver do not know exactly when the drug, alternative or placebo is given.
For purposes of description, the method and kit can be described as a Single-Patient Assessment System (SPAS). The SPAS provides a health care practitioner with objective data based on each individual patient's unique circumstances, allowing therapy to be tailored to individual needs. In addition, the unique method generates prospective, directly measured epidemiologic safety and efficacy data. Pharmaceutical companies can use this data to gain regulatory approval for new indications or to differentiate efficacy and/or safety benefits between competing products, and to provide pharmaceutical manufacturers, government and health care organizations with demographic and usage data on products. Importantly, the database can also be used by government agencies to monitor the safety and efficacy of drugs in the marketplace. Using statistical sub-group analyses, data can be generated to define the level of efficacy or safety in various special populations. For example, data can be segregated by age, disease severity, onset of illness, and concurrent medications.
One preferred embodiment of the invention includes the use of the SPAS to demonstrate the effectiveness of the specific treatment for the specific individual, that is, to document the probability that the medication is beneficial without causing unacceptable side effects. Specifically, the system consists of a clinical evaluation kit which generates definitive guidance regarding the safety and efficacy of drug therapy in each individual patient. The kit contains a full supply of medication to be evaluated and/or placebo, as well as all instructions and evaluation instruments for professionals and patients.
A key feature of the present invention is the double-blind manner in which the drug or placebo, or alternative, is being administered. Both the patient and the physician are unaware of what any dose given is. This is essential since placebo and active drug are randomly administered and look identical to eliminate any bias in the results. A neutral observer/administrator keeps the record of the random arrangement, assembles the data from completed questionnaires and after completion of the test, "breaks the code" to reveal the schedule of drug and/or placebo doses and analyze the accumulated data. The physician and/or patient is/are then given a report on the efficacy and safety of the drug in question. The report has the feature of being validated because the data obtained from the single patient is compared to data obtained from a pool of individuals who also required treatment, were given the kit, and were followed up when appropriate for efficacy and safety data post-testing. This can be used for guidance in directing further therapy, referred to herein as a treatment consistent with optimal treatment. The results of individual assessments can be monitored, with subsequent outcomes added to the database. Data generated from a pool of individual studies can then form the basis of a large population database reporting system which serves to further validate the effectiveness of any singular trial or single indication for a medication.
The SPAS includes means for providing the drug(s), placebo(s) and questionnaire(s) such as a kit. The kit may contain convenient pocket-sized cards which contain a sufficient supply of active drug(s) and placebo(s) or therapeutic alternative(s) in blister packages labeled with the day and time of dosing. For example, a kit may contain eight cards for a required trial, each corresponding to one of eight weeks of treatment, and contain daily regimens of either active drug or placebo, at carefully selected times during the eight week period. The tablets in the card are "blinded" so that neither the patient nor the physician is aware of which preparation is received at any given time. In an emergency, the random arrangement can be broken. Under normal circumstances, the code will not be made available, thereby eliminating any bias in the results.
At various times during the evaluation, the program prompts the clinician, patient and/or guardian/observer to fill out questionnaires or other instruments which assess numerous efficacy and safety variables relating to improvements in physical and behavioral symptoms.
At the end of the study, all drug cards (used and unused) as well as questionnaires are returned and the results are evaluated. These results are provided to the physician and patient so that guidance can be provided regarding the safety and efficacy of the treatment for the tested patient. These data can also be added to a master database along with other data on family history, demographics, socioeconomic factors, and post-study outcome.
Numerous drugs and indications can be evaluated using the methods of the present invention. Suitable illness for which the present invention can be used include, without limitation, asthma, cancer, epilepsy, schizophrenia, minimal brain dysfunction, mania, depression, anxiety, hypertension, angina, congestive heart failure, cardiac arrhythmias, pain, etc.
Suitable drugs for evaluation include, without limitation, those agents currently approved for the above-identified conditions as well as agents awaiting approval and new chemical entities. For example, the drug can be selected from anti-asthmatic agents, dental agents, anti-epileptic agents, anti-psychotic agents, anti-depressants, cardiovascular agents, respiratory agents, antihypertensive agents, diabetic agents, steroidal and non-steroidal anti-inflammatory agents, opiates, narcotic and non-narcotic analgesics, hematologic agents, musculoskeletal agents, anti-anxiety agents, gastro-intestinal agents, dermatologic agents, and anti-allergy medications. Other categories not specifically mentioned are intended as well. Particular agents well suited for the methods of the present invention include methylphenidate, estrogen-containing agents, anti-asthmatic agents, cardioactive agents, and antidepressant agents.
Oral, mucous membrane, nasal, surgical, musculoskeletal, central nervous system, urinary tract, psychiatry, nephrology, neurology, genital, podiatry, chiropractic, pediatric, geriatric, acupuncture, allopathy, homeopathy and osteopathy treatments can be also be evaluated.
It is to be understood that where veterinary treatments and therapies are to be tested,the questionnaires and assembly of data are provided by human caretaker/observers. Furthermore, it is to be understood that the term questionnaire refers generally to a means by which information can be related back to the evaluator. The results need not be transmitted in written form. Computer-assisted data recording and communication devices and measuring instruments can also be part of the database assembly step.
An additional list of uses includes:
1) Socially/medically controversial uses for drugs where the relationship of risk to benefit is not well defined. For example, depression, asthma, and hyperkinetic behavior are representative chronic ailments which can be evaluated and available treatments can be challenged.
2) Chronic disease states which may or may not benefit from long term drug treatment. Controlled drug "holidays" are needed to test if chronic medication is paradoxically compromising quality-of-life, has no effect or is helping and should be continued. Category examples include cardiovascular disease, hypertension, and arthritis.
3) "Compassionate" Investigational New Drug Application (IND) drug trials for drugs/indications which command a fast track regulatory approval process, such as drugs used for treatment of AIDS. Pharmaceutical companies can pursue early "compassionate" marketing in the form of a drug trial in subjects who urgently need the new therapy. Also, early New Drug Application (NDA) approval can be pursued by carefully controlling drug use, investigational documentation and data analysis in the community-practice setting. These regulatory strategies can be economically and effectively accomplished using Single-Patient Assessment Systems (SPAS).
4) Clinical comparison between innovator and generic drugs. Single-Patient Assessment Systems (SPAS) can be used to validate or invalidate use of generic drugs for regulatory or marketing purposes. Single-Patient Assessment Systems (SPAS) can be used to gain approval for generic drugs which are not readily approved by traditional bioequivalence testing. The method and kit can offer a consumer assurance of a successful switch from the innovator's product, and assurance that the drug actually improves his or her quality-of-life.
Another example of the method and kit is for evaluation of new or generic drugs, or evaluating new indications for marketed drugs or therapeutic equivalents. This includes determining a therapeutic alternative for a known drug for an individual requiring treatment. This aspect includes:
a) providing a human or animal a test kit containing:
i) a supply of a drug indicated for the treatment of an illness;
ii) a supply of a therapeutic alternative substantially identical in appearance to said drug,
iii) a questionnaire designed to elicit from the person or animal caretaker information concerning the safety, efficacy and desirability of the treatment;
b) administering the drug and therapeutic alternative to the person or animal according to a random, double-blind schedule;
c) assembling a database from the answers to the questionnaire; and
d) revealing the random arrangement schedule to determine the effectiveness of the therapeutic alternative by comparing the results obtained from known drug and alternative treatment periods.
This method may also include additional steps which serve to validate the data obtained in any single trial. The steps are:
e) providing the same type of test kit to a pool of humans or animals in need of such treatment and obtaining from the pool a second set of data including post-study following information where appropriate, concerning the safety, efficacy and desirability of the treatment with the drug and therapeutic alternative; and
f) comparing the data obtained from an individual with that obtained from the pool to verify the effectiveness of the therapeutic alternative.
The method described herein also contemplates that the therapeutic alternative is a generic equivalent for the drug and/or the same drug but at a different dosage or even same dosage.
The present invention has a myriad of uses. For example, it can be used to test, confirm or verify a particular therapy's safety and efficacy. It can also provide demographic, marketing, sales or professional usage information. New indications, patterns of use, compliance, therapy relationships to other disease states, relationships between concomitant medications, laboratory result relationships can be uncovered. The kit can be used in regulatory filings, dose titration, placebo controlled, crossover, food effect, dose proportionality, bioavailability, single dose, multiple dose and market research studies. Age effects, socioeconomic effects, sex effects, and disease effects can also be determined. Moreover, the role of heredity, diet, geographic location, demographics, occupation, epidemiology, patient education, drug interactions, dose response, time to onset, dosage individualization, regimen individualization, dose finding, dose ranging, rising dose, dose titration or overdose can be determined.
The kits of the present invention also have value to physicians. Legal documentation concerning rational drug therapy, compliance, monitoring, documentation of decision making, appropriateness of therapy, ease of following instructions for administration of therapy and documentation of safety and efficacy are all achieved by the inventive process. The method gives a reason for patient compliance and drug effects, a mechanism for follow-up of therapy, the ability to ease concerns about safety-efficacy. The ability to use blinded placebo treatment methods and the ability to remove bias from decision making, ease of screening out psychosomatic illness are all provided. The kit can provide drug holidays in blinded manner to foster compliance, make available objective feedback and an unbiased and rational approach to therapy. The kit allows the involvement of all physicians and/or patients in clinical trials, early patient participation in therapy, decreases time for regulatory submissions with less initial use of specialists in clinical trials and less dependence on traditional clinical investigators. All of these features decrease overall medical costs, the costs of new drug development, increases accuracy of diagnoses and potentially decreases malpractice.
The kit and method has value to patients by lessening the fear of inappropriate medicine and providing the feeling that something important is being done. Individualization of therapy for patient, decreased side effects, increased efficacy, decreased risk of treatment, controlled drug holidays are all realized. Patients have the enhanced ability to use new and unapproved treatments when needed with the enhanced ability to participate in clinical trials. The kit decreases overall costs of treatment, eliminates unnecessary therapies and tests, reminds patients when to use drugs, prevents under or overdoses, fosters relationships with clinicians, increases understanding of disease and drug.
Industry will benefit from the invention by having a means to gain early drug approval, a marketing tool, a reduction of clinical trial costs, better clinical trials, larger clinical trial database, broader patient population for clinical trials, ability to conduct well controlled, small scale, initial clinical trials, a means for post-marketing surveillance, as well as a means to document therapeutic bioequivalence.
The kit and method's value to government is realized by providing a means to remove clinician/company/patient bias in important therapy, protecting the public from inappropriate drug use, decreasing the cost of public health, and lowering the cost of effective clinical assessment of new and existing drugs, more rapidly approving new drugs and indications, providing highly controlled methods to deploy needed but unapproved treatments, and providing new methods for phase I through IV treatment evaluations.
Third party healthcare organizations, insurers and managed care organizations benefit by the assurance of need for expensive and/or potentially dangerous therapies, overall decreased cost of treatment, decreased use of unneeded and/or multiple therapies.
Pharmacists benefit by the availability of new products, enhanced role in patient care, greater interaction with patients and with other health care professionals.
The following non-limiting examples serve to provide further appreciation of the invention but are not meant to restrict the effective scope of the invention.
In this example, the usefulness of methylphenidate (Ritalin) treatment in a hyperactive child (Minimum Brain Dysfunction) is evaluated.
Rationale: Use of a stimulant in children is highly controversial and widely publicized/perceived as a problem. Parents demand a clear-cut reason to use addictive and often poorly tolerated medication.
Technology: Consists of instructions, "calendar" packaging for drug and a substantially identical looking placebo to assure appropriate dosing and monitor compliance, questionnaire assessment forms and instructions. Completed forms are sent to a neutral observer who has assigned the random, multiple crossover schedule of drug and placebo periods. Only the observer has access to when active drug and placebo were taken and analyzes the data. Results are mailed to the physician and, in this case, parent for use in evaluating the usefulness of the therapy. The physician and parent are contacted, e.g., every three months to provide data on therapies utilized, and perceived outcome, until the condition resolves. The data is also added to a post-marketing surveillance database for use in evaluating future individual study results, and for access by drug companies, regulatory agencies, and health care organizations.
The questionnaire portion of the kit includes an initial consent form for the parent or guardian to complete. The questionnaire also provides background information on the study and possible side effects associated with the medication. Also included therein is a portion for providing relevant patient and family histories. More importantly, the questionnaire, in this case includes a portion for the weekly input by parents or guardian and school observers of answers to questions relating to the drug evaluation. Typical questionnaire sheet for these portions are shown below as Table 1 and Table 2. Physician questionnaires are similarly arranged.
As a result of undergoing the study, all interested parties have a clear understanding of the value of the medication for this particular patient.
In this example, the kit described in Example 1 is used to again evaluate the usefulness of methylphenidate (Ritalin) treatment in a hyperactive child except that all interested parties have the benefit of a set of data generated from a pool of patients having a similar need for treatment. The trial calls for 40 mg daily given at 10 mg four times daily compared to identical appearing placebo given four times daily. After completing the trial and questionnaire, the processed data provides the following results which are statistically determined:
the patient's attention span is observed to have improved substantially during the periods in the trial when the methylphenidate is being given;
temper outbursts are observed to increase slightly during placebo periods;
sleep patterns are observed to be statistically altered during methylphenidate periods; and
teacher comments corroborate improved attention span during methylphenidate dosing periods.
All results obtained from the data are then compared against the results provided by data amassed from a pool of about 200 patients with the same disorder. Of these 200 patients, 55 experienced encouraging results (as did the current patient) and were continued on 40 mg daily treatment. Of these 55 patients, 5 were lost to follow-up, with 50 remaining for prospective evaluation. Because the physician would now choose to continue the patient on 40 mg methylphenidate daily based solely on the isolated SPAS single patient drug trial results, he now takes the opportunity of reviewing the pooled data on the 50 patients. This is done to understand under what circumstances this individual patient would likely continue to show benefit from methylphenidate 40 mg treatment, and what conditions lead to treatment failure.
The pool of 50 patients who continued treatment had the following scores following the original SPAS testing:
All 50 patients were followed up by telephone interview monthly for nine months or more, and outcomes were prospectively documented. It was found that all patients who had no statistically altered sleep disturbances on the original SPAS test continued to be well maintained on treatment. However, within two months, all patients who had statistically altered sleep patterns on SPAS testing showed loss of symptom control, and in 90% severe episodes of bizarre behaviors were reported; two of these patents experienced a grand mal seizure. All patients who had a statistically altered sleep disturbance had to be discontinued from treatment within two months.
Despite the initial, generally positive result of the SPAS single patient drug trial, the prescribing physician has a strong, objective basis for not continuing treatment with methylphenidate 40 mg daily because the pooled data from similar patients clearly indicate that continued treatment in the presence of sleep alteration is at great risk (90% chance of a severe adverse event) with limited potential benefit. The continuing validation process using pooled data, which is a subject of this invention, provides additional data which is essential to formulating a rational therapeutic decision.
The physician may now decide to use a different pharmacologic intervention in a chemical class which is not as frequently associated with sleep disturbance (e.g., amitriptyline), or may decide to use non-pharmacologic treatments, such a behavioral therapy. The amitriptyline dose selected may be tested using another SPAs designed for that drug, and the process continued until the patient is on a documented safe and effective drug regimen.
Test kit: Antihistamine for house dust induced allergic nasal congestion.
A clinician writes a prescription for a test kit which has been extensively tested in patients similar to his. The product labeling available to the clinician advises him that it has been used in 2,000 patients with house dust allergic nasal congestion to date. The antihistamine was found to be clinically useful with a modest side effect profile in 1500 patients, 250 experienced untoward drowsiness and 250 experienced no clinical benefit. The test was completed and useful only in subjects with an 8th grade educational level or higher who report at least moderate symptoms on study initiation. Subjects with mild symptoms often failed to complete the study. The clinician recognizes that his patient is college educated with severe symptoms and writes the prescription, confident that he has a good candidate for the test.
The pharmaceutical company marketing an antihistamine submits a 2,000 patient database to the government for approval of a new claim for the product: house dust allergic nasal congestion. The company agreed with a request from the government agency that, as a condition for expedited review and acceptance, continuous post-marketing surveillance will be conducted for this indication by marketing the product in a SPAS test kit. This testing of each subject on initiation of therapy will continuously ensure that each patient is evaluated for appropriateness of treatment prior to commitment to a chronic regimen. In addition, it allows the company to provide a monthly update to the government of drug efficacy and safety in the entire population using the product for house dust allergic nasal congestion. Physician and patient labeling can be revised if necessary. Also, it is now found that the product has more side effects if the patient is also taking cimetidine. Therefore, the company can now advise the government agency of a possible drug interaction, and warn clinicians of a possible drug interaction in the product labeling.
In this example, the validity of using a sustained release formulation of verapamil 240 mg once daily as a therapeutic alternative to sustained release propranolol 180 mg once daily in a hypertensive 45 year old male is shown. The trial during which the two medications are randomly administered in a double-blind manner is six weeks. The questionnaire used is set up in a manner similar to that described in above examples except that the questions elicit information related to the disease of hypertension. Blood pressure is taken daily by the patient and weekly by the physician. Lab values and vision tests are also reported weekly by the physician. At the end of the trial period it is determined that mean systolic blood pressure increases 3% and mean diastolic pressure is essentially stable. Both values are statistically insignificant and the therapeutic alternative selection is objectively validated.
In this example, the data accumulated for example 5 is compared against that acquired from a pool of 100 male patients who were switched from beta blockers, including propranolol, to calcium channel blockers, including verapamil. The results of example 5 are found to be in agreement with those found from the pool. On this basis, a health maintenance group can objectively eliminate the use of beta blockers for males fitting the pool profile with hypertension under its care.
In this example, each member of a pool of fifty patients is given a test kit containing a four week supply of an antihistamine and a four week supply of a look-alike placebo arranged in a multiple-crossover, random order along with a questionnaire designed to confirm the appropriateness of the therapy. After all of the kits have been finished and individual results provided to the patients and care-givers, the pooled data supplied from the questionnaire is evaluated. It is found that a question (number 12) relating to the secondary side-effect of dry mouth for the drug was poorly understood by the pool members and failed to provide a statistically significant result for the database. Moreover, several patients reported heart palpitations and related cardiac disturbances. Thus, question number 12 is dropped from the questionnaire and replaced with one tested and validated for comprehension at the 5th grade education level; also a new question relating specifically to cardiac symptoms is added. All further kits for the antihistamine trials are made to contain the revised, validated questionnaire.
A clinician writes a prescription for a test kit containing the revised questionnaire and antihistamine/placebo combination for a patient. The patient completes the course of therapy as directed over the eight week course and completes the weekly questionnaire relating to the trial and mails them to a neutral observer who also has the key to the random arrangement of drug/placebo. At the end of the trial, a statistical analysis of the trial is provided to the clinician who evaluates the results in view of the data provided by the pool of patients. The clinician thus has an objective basis for continuing the therapy since this individual was found to have substantially improved symptoms, and members of the tested pool with similar results were found to do well with continued treatment at three and six months.
As will be readily appreciated, numerous variations and combinations of the features set forth above can be utilized without departing from the present invention as set forth in the claims. Such variations are not regarded as a departure from the spirit and scope of the invention, and all such modifications are intended to be included within the scope of the following claims.
Patent Citations
Non-Patent Citations
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Iggy Azalea Debuts New Single 'Beg For It' [LISTEN]
It looks like it really is Iggy season -- less than 24 hours after the release of a brand new track, Iggy decided to debut her new single 'Beg for It.'
It looks like it really is Iggy season -- less than 24 hours after the release of a brand new track, Iggy decided to debut her new single 'Beg for It.'
The roots of our spookiest holiday's traditions—from pumpkins to trick-or-treating—run deep, their origins reaching back thousands of years to pre-Christian pagan festivals and superstitions.
From Ashlee Simpson's unforgettable 'SNL' performance to Justin Bieber's accidental lip sync revelation, check out our video compilation of celebs who were caught lip syncing.
Cartoons can be funny, or in the case of a memorial drawn for Cpl. Nathan Cirillo, a touching tribute. Cpl. Cirillo was killed earlier this week when a gunman stormed the Canadian Parliament building
The music video for 'Steal My Girl' is FINALLY here, Directioners!
It looks like TLC has decided to cancel popular reality show 'Here Comes Honey Boo Boo' in light of the alarming allegations that matriarch Mama June is dating convicted child molester, Mark McDaniel.
Sometimes, honesty is not the best policy. A new poll of 3,100 employees and 2,200 hiring managers has come up with the most absurd reasons people have actually used for calling in sick.
A World Series berth led to a World Series birth.
It might look like a standard corpse-hanging-from-a-tree prank, but sometimes something terrible and tragic really did happen.
Renee Zellweger is setting the record straight about the dramatic change in her appearance.
The trailer posted inside is the first television spot for a 'Mockingjay: Part One' trailer, and it looks awesome.
Stars like Kendall Schmidt, Emily Kinney and the 'Ouija' cast attempted to contact the spirits in a 'Ouija' movie-themed seance.


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Leave Britney alone.
one thing about the closet/you don't have to hurry/it will be bad tomorrow/so brother, don't you worry
Britney gif for fun...
but you still need penis.
one thing about the closet/you don't have to hurry/it will be bad tomorrow/so brother, don't you worry
^ Mmhmm, that's right. Nothing to say, just like I thought. Can't dispute the truth.
The stuff on television is previously taped and absurdly edited...so, I won't formulate an opinion on her judging ability until the show goes live. Although I am not impressed at the moment as 'amazing' and 'no' are the only words in her vocabulary. Yikes.
(I do find it funny that the two gals have had total freakin' public meltdowns in recent years. )
I have to assume these poor, deluded "artists" were set up in order to fail and provide laughs. I also assume Britney was asked to be a bitch, knowing that a lot of people watching would reflect that without her producers she'd be just as bad. This last fact probably occured to her during her shaved head verge of suicide meltdown. Does she remember and reflect on this?
But what I really want to know is, why has Simon Cowell decided to make v-neck t-shirts his "trademark"? Doesn't he ever look at himself on replay or in the mirror. Is he so fucking egotistical that he can't see how bad he looks? Is there no one around him with the guts or independence to tell him so?
Last edited by LatimerRd; September 16th, 2012 at 07:29 PM.
one thing about the closet/you don't have to hurry/it will be bad tomorrow/so brother, don't you worry
Blah blah blah, people keep regurgitating that same ol "Britney cant sing!!! Why is she a judge!!!! THAT dumb cunt!!!!!"
News flash: The whole definition of "X Factor" is having star power. Britney wasn't deemed the princess of pop for no reason. Out of her, Jessica, Christina, Mandy, and all those other blonde wannabes, Britney is the only one who slayed for an entire decade consistently. She is the definition of being a worldwide music star, whether you think she can sing or not. Anyone can sing, but not anyone can be a music icon.
Regardless, why do people act like you have to sing to judge singing? I can't hold a note or act very well, but that don't mean I can't spot a crap singer or a wooden actor. At least Britney knows the music industry like her left tit.
Oh, and if y'all can stop time jumping and judging her for a meltdown she went through and got over nearly 5 years ago, that would be splendid. Cuz everyone knows none of the world's greatest artist haven't had mental breakdowns.
Britney's success had nothing to do with Britney, darling.
I really missed the "Britney Spears rules the world, and either you love her or are dying of jealousy because you can't be her" threads. So thanks for reviving.
But for those saying she can't be judging someone else's singing, I'll just say "Paula Abdul".
Profit is one thing that Britney Spears could provide. For awhile, anyway.
One might argue that X Factor isn't looking for "singing ability", really. I mean, it's right there in the title. They want the "X factor" - the indescribable je-ne-sais-quoi thta elevates a standard performer from "good" to "great". Where they don't necessarily have to be all that talented, or perform all that spectacularly...but people still find themselves drawn to them in any event.
That said, even if one would argue that Brit-Brit IS one of these uber-artists (I personally don't think so), you still have argue that somebody who HAS X factor is the best judge of somebody else's X factor. And I hardly think that's the case.
Britney's there to put eyes on the screen. Beginning, middle, end.
'X Factor' Premiere Ratings Drop 25 Percent, 'The Voice' Tops
One night may not be big enough for two singing competitions. With NBC adding an episode of "The Voice" to this Wednesday, up against the sophomore season premiere of Fox's "The X Factor," both series saw double-digit drops from their most recent outings.
"The X Factor's" two-hour premiere averaged a 3.3 rating among adults 18-49 last night, according to fast affiliate ratings. That's a 25 percent drop from last year's series premiere, though a smaller drop from the December finale (3.8 adults rating.) In total viewers, "X Factor" averaged 8.5 million viewers.
Head-to-head competition with the 8 p.m. hour of "X Factor" gave "The Voice" a victory. Though the 3.3 adults rating matches "X Factor's" total haul, the Fox show only pulled a 2.7 adults rating in direct competition with "The Voice." (In its second hour, "X Factor" grew 40 percent.) In total viewers, "The Voice" pulled in 10.7 million.
"America's Got Talent," entering its home stretch, pulled a 2.9 rating among adults 18-49. For the night, NBC pulled in a 2.7 rating with 18-49-ers and a dominant 8.9 million viewers.
Latest Music News, Band, Artist, Musician & Music Video News | Billboard.com
another thing speaking of bad singers. i've been meaning to say this for the longest time.
ADAM LEVINE HAS NO BUSINESS TRYING TO JUDGE SINGING TALENT. he does NOT belong on the voice. dude's voice is . that guy has gotten a pass for a good while for his bad singing. for someone who looks like he's ready to stomp somebody out, looking extra dangerous and threatening in pictures, his singing voice does NOT match his appearance.
and the message behind the "she will be loved" song was pathetic too. you can't save someone that doesn't want to be saved.
one thing about the closet/you don't have to hurry/it will be bad tomorrow/so brother, don't you worry
^^ Britney's not 'bad' though. She's just extremely manufactured, which is annoying because it blurs the industry between talent and moulding.
She's also not incredibly relevant, which is unfortunate because The X Factor needs a non-Disney star (aka not Demi) and a has-been (Britney). It needs someone that's currently dominating charts. Sadly, people that are relevant won't take these judging positions because they can't tour, promote etc. Which is what I'm somewhat surprised Nicki Minaj did but whatever...And when non-relevant people (like J Lo and Steven Tyler) take these positions, they're relevant again because they're on broadcast television.
People still listen and buy/chart Britney's shit because they're nostalgic. Kind of like Madonna, who in my opinion hasn't had a really good album since Ray of Light. Britney's last great album was Blackout, and even then it was all the production behind it (and NOT Martin/Luke). It's an under-appreciated album that was the spark that lit the proverbial euro/electropop dance craze we have at the moment in North America. Yeah, I'm blaming her for the last half decade of pop music. Five fuckin' years ago...but who's counting?
Thank God some modern talents have the sense to stay the Hell away from Britney's production team. Hopefully Adele, Lady Gaga and Sia don't get involved...we've already lost Rihanna, Katy Perry, Kelly Clarkson, Avril Lavigne and Kesha to them. Just lost the legendary Christina Aguilera to the Martin/Shellback/Luke rogue gallery. Yowzers!
But meh, it's not like I'm a Britney stan or anything, especially to other artists I like from her era (Timberlake/Aguilera etc.). I like maybe five of her songs across all of her albums. Toy Soldier, Ooh Ooh Baby, Toxic are the first that come to mind.
Perhaps I only care a tiny bit about her these days because she named one of her tours after an Edgar Allan Poe poem.
there's always the "unsubscribe" button. lol
Last edited by Huntneo(PT); September 17th, 2012 at 02:44 PM.
Talent isn't all you need to succeed though. Nobody with functional ears would say that Britney can out sing Christina, because she never could. However, Britney is the better artist. She has more star power. I think part of being a successful artist is making the kind of music that can appeal to a target audience. Britney did that WAY better than Christina did and had way more success in the earlier parts of her career than Christina. Christina was pretty much always in Britney's shadow.
Even now, Britney is getting paid more on her first season of X Factor than Christina is getting paid on her third season. Christina's last album didn't do as well as Britney's and I think the last time Christina hit #1 on the Billboard Hot 100 with a song as a solo artist was like what, over 10 years ago?
But yes, a good voice gets you nowhere these days. If it did, just about anyone coming off these reality singing competitions would be a major star, but the overwhelming majority of them just fizzle out.
Haven't heard Christina's new single but I hope her upcoming album is like Back to Basics. She also for some reason gets heavily compared to Lady GaGa these days, which I will never understand why.
the only reason why she got huge was because she was shoved down people's throats by the record companies tossing money to these radio stations and tv stations to play her record or music video 20 or 30 times in a row basically brainwashing people to like her horrible music. of course when you hear a song every where you go 24/7, you will eventually start to like it. there's a few artists that can actually sell records off the strength of their music without mtv or whatever radio station's help. britney spears isn't one of those people. proof that ANYBODY could be a star. you don't even have to be shit. you just give the illusion that so and so is special and people will BELIEVE that they are special even if they aren't shit. it's really scary when you think about it. look @ what happened with the kony 2012 disaster this year. people like sheep jumped to a cause that they had NO idea about. when you think about it, over time, people have become zombies almost with music artists and it's gotten to the point where people look down on you if you don't like a certain artist as if you have to like them.
i think it says a lot about someone if they basically need to look at other people's opinions before they say they say they like or dislike an artist's music. it reminds me of how in 2002 when the whole world was loving ja rule and his half assed music, singing his songs, and even talking about "ja rule has singing talent". suddenly, in 2003, when 50 cent starts shining, is all over the tv, dissing ja rule, everybody becomes a 50 cent fan and is dissing ja rule acting like they weren't singing his songs a year ago. then they try to talk about how they were never ja rule fans or had his cd. wtf?
one thing about the closet/you don't have to hurry/it will be bad tomorrow/so brother, don't you worry
and of course, christina aguliera isn't going to be able to compete with britney spears when britney spears already was out 3 years before her especially when she first debut doing the same tired gimmick that britney spears flew out the gate with earlier. she was unfairly dismissed as another britney spears.
but the bright side is that when you don't have the talent, it eventually shows where your time in the music industry just starts to fade out. britney spears no longer has a music career. she's done. christina aguliera still has a career even if she's not able to sell records like that. people know she has talent. people know britney spears is yesterday news and can't sing. nobody is trying to hear another britney spears record. NO ONE.
one thing about the closet/you don't have to hurry/it will be bad tomorrow/so brother, don't you worry
Oh, how could I forget...we also have Britney to blame for introducing the mini/faux-dubstep crap that is now plaguing us since Hold It Against Me!
As for nobody trying to hear another Britney record, that's not true as well IMO. Three of the four singles of Femme Fatale reached the top 10 of the Hot 100 (one of them #1). The album itself debuted at #1 and outsold Christina's Bionic in its first 2 weeks on the chart. Her last tour grossed over $68 million, and prior to that The Circus Starring Britney Spears grossed over $138 million, which was better than Christina's Back to Basics Tour ($90 million).
Britney has also pushed more record sales than Christina. Also they both released their debuts in 1999, not 3 years apart. If record companies paying people to generate sales would actually work, ALL record companies would be doing it. It doesn't work that way. Record companies need to pay television and radio to play their artist's music. They also have to invest in the artist's music videos, etc. They will only continue to pay TV and Radio to play their artist's music if they see that the public responds by buying the artist's CD. If not they stop otherwise it's basically like cutting off your own limb and losing money for nothing. This is why after a set period of time record labels stop pushing their artist's work on radio and TV. It doesn't generate money for them anymore. Christina would also have been a nobody without the help of MTV and radio stations and actually had better singles than Britney in the earlier part of her career, but her CD sales were lower.
It takes someone who the public REALLY likes to be able to successfully sell CDs. Just look at pop music today. Rihanna and Katy Perry sell the shit out of singles. They can't ever push as many CDs as Adele can. Adele's 21 outsold ALL of Rihanna's CDs combined in the US. This has nothing to do with her label paying radio stations to play her music. She's pretty much out of the top 40 on the Hot 100 now and is not promoting any single, and still her album is still doing amazing. It was pretty much the same back when Christina and Britney were new to the pop scene.
Don't get me wrong I like some of Christina's work and actually like more of her songs than Britney's but Britney is way more of a star than Christina will ever be. Like Sal Cinquemani of Slant Magazine one said, "The disparity between Aguilera and Spears can't be measured solely by the timbre and octave range of their voices ... Aguilera's popularity has never reached the fever pitch of Britney's."


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I have been MIA from the online family of SP but have been diligent regarding food tracking and have been able to stay on track. Exercise, well, I'm doing a lot of stuff, but not too much "formal" exercise. Golf, walking, gardening, weeding etc. I feel the need to get back in a routine with some strength training and biking, just for the routine of it....but have been doing fairly well.
No weight gain, a little weight loss.
Work and family and friends have been very demanding lately, and the future doesn't look too much calmer.
So, I love you all, and am here in spirit and calorie tracking and water ;-)
Even if I'm not here in cyber space often enough.
In business we take an indepth look at the previous quarter and assess our successes, failure and places where we want to go and places that just didn't work out. So I sat down last night and did the same thing regarding this journey to fitness.
1. I have lost 14.5 pounds so far
2. I have made many wonderful friends on SP
3. I have learned to love exercise again!
1. Keeping on track during business trips
2. Plowing through the plateaus
1. Outdoor activities
a. Bought a jump rope (It's really hard cardio, and had to go buy a better sports bra ;-)))
b. Staked out some stairways that will definitely kick my butt while it is toning my butt my legs and my heart (I will post pictures) (they're awesomely scary looking)
c. Joined Curves for 30 day trial (dont think I will sign up, just not my cup of tea, but we'll finish the 30 days before making a decision)
2. I was really active on the boards here, but got really busy at work and something has to give, so that was where it gave ;-) but am going to try to find a way to "Schedule" some time that is set aside
3. Play golf once a week at least
4. Go to the driving range also once a week
And remember to thank all the people here at SP that have helped me along this path...Looking forward to the next 90 or so days!
Just came in from 3 plus hours in my yard. My front yard is weed free and has a flower bed 3' X 6' bigger than yesterday. Digging out grass is very hard work...but I will never have enough flower beds. I also planted some more periennials and herbs. I am officially sunburned and a little stiff and sore, but it feels good!
I may be singing a different tune tomorrow
Now off to grill teriyaki pork and pineapple shish kebabs; asparagus and mushroom salad. I love spring and fresh veggies; can't wait for summer and farmer's market!
So, yesterday was a long day, at the end of a long week. But as I was running errands on my lunch I had an epiphany. I was rushing and happened by one of my favorite sushi restaurants, I started to drive by and get fast food then I stopped, why would I do that, why would I pass up something I LOVE and that is lean and healthy for something that I don't really like that would allow me to only eat a very small portion of unhealthy food.
I DIDN'T want to eat alone! I eat alone when I travel all the time, so I had to really analyze why I wouldn't want to do it at home? Couldn't come up with a good explanation, so I forced myself to go in and had a wonderful lunch. Next time I will remember to bring a book though ;-)
then later, still running, trying to get to my son's golf match, then get home and change and meet my girlfriends out...starving...I discovered that Burgerville (only in the Nw) has a turkey burger, which if you take off the mayo is a great alternative to tiny little boring horrible small hamburger's ;-)
So, off to play golf today, work in the yard tomorrow and look forward to many a bbq, grilling is a great way to cook lean meats ;-))
So today I spun the wheel and for the third day in a row I got TWENTY, yes 20 points!
Which is an omen, since today I really got back in the swing, I did 90 minutes of cardio and did ab work and it felt great. Made my breakfast and lunch for tomorrow! Cut up fruit and veggies for later! I feel very motivated again after week basically off. I did keep in the calorie range and drank my water every day but didn't really truly exercise. I did some cardio, but definitely slacked on eating the "right" things (keeping in calories but eating wrong doesn't really, really count) But overall it was an off week.
So in other words I'm Baaack! and glad to be!
I would have been back anyway, but the "gift" of the extra points made me think about karma and fate!


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Regression Through the Mirrors of TimeCD-Audio Meditation Regression
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- Publisher: Hay House Inc
- Format: CD-Audio | 1 pages
- Dimensions: 120mm x 144mm x 10mm | 100g
- Publication date: 26 June 2008
- Publication City/Country: Carlsbad
- Edition: Unabridged
- Edition statement: Unabridged
- Sales rank: 17,778
Product description
The Meditation Regression series helps you discover and learn meditation and regression techniques. The meditations utilize powerful imagery to promote physical, mental, and spiritual healing and renewal; profound relaxation; and deeper self-understanding. The regressions provide different techniques for retrieval of memories from this lifetime and prior lifetimes, as well as methods to access spiritual states and inner wisdom. Regression Through the Mirrors of Time is a past-life exercise in which Dr. Brian L. Weiss leads you first to childhood memories in this lifetime, then guides you to visualize yourself in many mirrors of light, in different (often ancient) times and places. This will enable you to discover the blocks and obstacles that impede your present-day peace and joy. The Regression Through the Mirrors of Time meditations incorporate positive affirmations, allowing you to find the peace and love that lies within you. You're also given the opportunity to contact a wise and loving being or guide.
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Brian L. Weiss, M.D., is a psychiatrist who lives and practices in Miami, Florida. He's a graduate of Columbia University and Yale Medical School, and is the former Chairman of Psychiatry at the Mt. Sinai Medical Center in Miami. Dr. Weiss is the author of Many Lives, Many Masters; Only Love Is Real; Messages from the Masters; Through Time and Healing; Mirrors of Time; and Meditation.


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Sacramento Kia made it very easy to buy a car:
no pressure, great price, style I wanted fantastic color, 2012 model, very thorough sales rep and nice sales manager.
We agreed on a price, how I wanted it equipped(no sunroo0f---skin cancer history), in general no bells and whistles, and only one day w...
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