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I have to admit to being readily impressed by company names. Maybe it's an age thing. You see, I was around when we had nationalised industries here in Britain, you know, British Railways, British Gas, British Steel, British Road Services, etc., etc. Those companies may have been over-staffed and under-efficient but you always knew you could trust them, and a product marked "Made in Britain" had class - in

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

those days. Even after they became privatised the word "British" in a company name still, in my subconscious at least, gave that firm a stamp of approval. Those were the heady days when we had some traditional industries and workers could rely upon union protection to prevent their jobs being shipped out to third world countries.

When a company called PublishAmerica (; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

dex.asp" target="_new">http://www.publishamerica.com/index.asp) agreed to publish my small collection of short stories, I was delighted. This wasn't a 'tuppence ha'penny' outfit but an organisation that boasted "America" in its title. I've never been to America but I have made some good "virtual" friends there and know how patriotic Americans are. How could you not feel safe doing business with a firm t

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

hat so proudly flew the flag of that famous super power? When I checked out PublishAmerica's website, all red, white and blue with the slogan "We treat our authors the old-fashioned way - we pay them," I felt truly blessed. A publisher of high esteem (I believed the testimonials) recognised the reader-appeal of my stories and my potential as a writer.

Further encouragement came from the "Why PublishAmerica?

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

page where I was told "The majority of our books that are sold retail are sold in physical brick and mortar bookstores" and "PublishAmerica can remove the stigma of paying to be published. With PublishAmerica, you will have the very important distinction of having your book ACCEPTED BY A TRADITIONAL PUBLISHING COMPANY."

Yet something about the company name puzzled me. I mean, why not "The American Publishi

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ng Company" or similar? As it stands "PublishAmerica" could be interpreted as an ambition to publish anything and everything that was ever written in that country. Amazingly, that interpretation very much sums up their objectives.

In my enthusiasm I had been studying PA's Author's Message Board, following links to previously published author's websites and reading all the reviews and book excerpts I could f

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ind (not realising that authors with anything pertinent to say are instantly barred from posting). Then I read one of their books from cover to cover. Now, my own education at an orphanage school in the Highlands of Scotland was very basic, so my grasp of English Grammar left something to be desired. Nevertheless, convinced I had stories to tell and the ability to tell them, I had joined Internet critique g

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

roups to learn how to present them. When I read my first PublishAmerica book my feelings were a blend of embarrassment, anger and disbelief. The writer had obviously worked hard to put the story together and it had the makings of an entertaining read. It reminded me so much of my own first and only attempt at writing a novel - abundant clich?s, suspect word selection, contrived scenes and wooden characters

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

xisting in a plot that lacked cohesion. It was in fact a story barely at the first draft stage, complete with spelling and grammatical errors. How could an ethical, self-respecting publishing house allow this to happen, I wondered?

PublishAmerica/ScamAmerica are most definitely NOT traditional publishers whatever their slogan implies. Recently interviewed by Steven Zeitchik of Publishers Weekly, PublishAme

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

rica executive director Miranda N. Prather admits that her company DOES NOT EDIT FOR CONTENT, only for grammar and spelling. For readers and writers everywhere this has to be the most worrying statement ever made on behalf of a publisher. But it gets worse. Simultaneously Ms Prather announced the creation of an affiliation between PublishAmerica and Online Publishing Bookstore - Tome Toaster (ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

//www.onlinepublishingbookstore.com" target="_new">http://www.onlinepublishingbookstore.com). Quote "Authors that generate sales and create a track record showing that they are able to promote as well as write a book will be referred to PublishAmerica by Tome Toaster." So we have a situation where a writer's ability to self-promote supersedes everything, including the ability to pen a readable story.

I

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

find it a frightening fact that PublishAmerica already have 10,000 published books in the marketplace (recent announcement). Since they don't edit for content it is safe to assume that the bulk of these are badly written at best. By choosing PublishAmerica, genuine AUTHORS who have worked hard at sharpening their writing and storytelling skills find their works irretrievably associated with some of the most

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

nane rubbish ever written, for the period of their contract - SEVEN YEARS! Meanwhile READERS have the dilemma of finding a readable piece of fiction (or non-fiction) in an environment awash with literary garbage.

The scam is brilliant in its simplicity. Instead of asking for money up front, PublishAmerica solicit a list of up to 100 of the author's friends and family whom they bombard with pre-publication f

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

lyers offering discounted copies. The sting is in the book's cover price - anything from 25-50% above the going rate for a similar book - ensuring that the friends-and-family discount does not effect the publisher's profit. My own 136 page "tome" was originally priced at $19.95 then reduced to the still prohibitive cover price of $16.95 when I expressed my disgust. Print-on-demand format allows the publishe

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

r to recoup publishing costs almost immediately on just a few such sales which are followed up by a "special" bulk purchase offer, irresistible to the author who has received only two free copies for review purposes. I invested three to four hundred pounds sterling and countless frustrating hours that I could ill afford on a marketing project that was doomed to failure from the start. PublishAmerica's lack o

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

f author support, only answering phone calls for book orders and ignoring almost all email complaints, is legend, as is the nigh impossible task of finding a bookseller willing to stock PublishAmerica non-returnable titles.

PublishAmerica have a branch called PublishBritannica and I now realise how na?ve I have been to believe that a company would necessarily show respect to the country whose name they cynica

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ly exploit. Maybe such business practices are par for the course in today's dog-eat-dog, winner-take-all world. I know there are "authors" prepared to buy huge quantities of their books then sell them on to sympathetic, unsuspecting acquaintances, mug gullible punters at book fairs and the like or just sell them to each other. I just enjoy writing stories, being neither a super salesman nor a confidence tri

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ckster. Is it too much to expect that a writer's work might succeed on merit rather than misrepresentation and deceit? If companies like PublishAmerica are allowed to legally flourish while exploiting new authors, deceiving the reading public and stifling writing talent, apart from GENUINE TRADITIONAL HOUSES, the book publishing industry will surely drown in a dumbed-down literary quagmire of its own making.

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

NOTE: Many authors who value their work and who have fallen victim to this disreputable company are campaigning to have the sole rights to their material restored. To those who threaten legal action PublishAmerica offer a release agreement containing a gagging clause. Authors who feel that they have been misled or defrauded by this company are advised to write to -

Office of the Attorney General
Con

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

sumer Protection Division-Beth Silverman
200 St. Paul Place
Baltimore, MD 21202

and

BBB of Greater Maryland
1414 Key Highway, Suite 100
Baltimore, MD 21230 -5189
WWW: www.baltimore.bbb.org
Email: info@bbbmd.org
Phone: (410)347-3992
Fax: (410)347-3936

Eddie Bruce © 29.11.2004

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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