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Weekly, I keep an eye to the horizon to assess new developments in the Internet environment. In noting the changes, I sometimes begin to feel overwhelmed by feelings of doom.

The S~P~A~M

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

problem is one such item that leaves me at times in much distress. I fear the trends of the ISP's in their efforts to get control of the S~P~A~M situation.

The ISP's are pushed and prod

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ded by the ISP's customers as they begin to feel overwhelmed by the volume of unappreciated UCE email.

Now and again, companies spring up to promise a new technology to combat the growin

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

g problems faced by the ISP's and their customers.

Early on, the promising technologies included blacklists and email filters. I say "early on" because I have been fighting to overcome S

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

~P~A~M filters for the last five years. The people who receive mail from me in the form of ezines or newsletters have ALL double-opted-in to receive my publications.

The sad thing is that

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

Combination pro

as long as I have been publishing an ezine, I have had subscribers who could not receive my publications due to email filters.

Just a few months ago, I was feeling very depressed about

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

the future or lack of a future for email. It seems that the filters are becoming so intrusive that very few emails will actually reach their actual and intended recipients. And it seems

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

the problem will only get worse.

Now, we have a company offering a new solution that is almost more Draconian than email filters. Habeas, Inc. has created an email header and filters to

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

assure that the people doing the mailings are authorized to do so by the anti-S~P~A~M zealots, a.k.a. the Habeas, Inc. accountant.

Habeas believes that online commercial enterprises shou

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

ld pay them a fee to guarantee that their email will be delivered to those who have asked to receive mail from them.

Personally, I am hoping someone will use the one keyword that has mos

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

t damaged the Internet to damage the future of the Habeas concept. That one word is "free".

Think about this. If someone was to feel secure enough to stand up to the Habeas saber rattlin

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

Following aspects would a

g about Copyrights and Patents, and to offer a very similar service for FREE, then we can as a community destroy the pay-to-send-email concept before it has a chance to build any real mo

dd to the challenges in developing combination products:

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

mentum.

Today I read a small story about a email hoax perpetuated by a student at Yale University:

http://www.yaledailynews.com/article.asp?AID=22111

The interesting thing that came out

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

of this story is that the Yale Administration came up with a simple solution to this problem. They have directed their IT department to add a link to every email that shows the URL where

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

the official copy of the email being sent can be seen on the secured Yale website.

The solution is that if the link does not appear with the email pointing to where the communication can

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

be seen on the Yale website, then the reader is to assume that the email is a hoax.

Interesting, eh?

Like I said, a few months ago, I felt very pessimistic about the future of email. The

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

Professional from academic institutions, pharmaceutical industries, health care indust

se days, my outlook is not nearly so bad.

When I realized that I would change the format of my own publication, I also realized that I would move the publication to my own mail server an

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

d I would also send two copies of the ezine. The first copy would be a full HTML copy of the ezine, and the second copy will consist of only a link to the URL where one can view the ezin

.

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

e online. The second mailing is only for those whose ISP blocked the original mailing.

Imagine that. There are in fact ways out there to conquer the email hoax perpetrators and there are

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

Companies that provide selfless information through particip

ways out there to conquer the email filtering software. And finally, there is in fact a way to defeat the Habeas, Inc. pay-to-send-email program.

The future does not look so dim anymore

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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