Advice Pool - Writing and Speaking

In 1971 I was surgeon on the P&O liner Orcades. On Christmas morning early the phone rang, could I come and look at someone with weird rash. The patient was Goanese, and was one of a batch of 20 or so that had been flown in to Singapore some 5 da

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

ys ago to relieve others due leave. His problem was spots and slight fever. They were on the young man’s arms and chest, raised from the surface of the skin, with a central dimple, and in medical jargon ‘umbilicated’. This was big jump from treat

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

Examples of combination products may in

ing seasickness.

All the internal red lights went on at once. The differential diagnosis was both mundane and terrifying. Chickenpox was favourite, followed by insect bites, or a sort of skin infection commonly called impetigo, but and it was a

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

very big but, the spots themselves matched the classical textbook description of Smallpox. Was there smallpox where he came from? It was still very early in the morning, about 7am, and at last the ship was fixed and just setting out on its way to

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

a stop at a top tourist spot on the Great Barrier Reef, Hayman Island. This was a good 2 days sailing away. Now smallpox anywhere is a terror, on a passenger liner it is a disaster of Hollywood proportions. Smallpox is one of the most infectious

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

Combination pro

diseases we know of, it also has a truly frightening mortality, varying from nearly 100% to at the best 20-30% depending on the strain of the virus and the susceptibility of the community it struck. In recent years we are accustomed to think of

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

it as a weapon of terrorism since the disease itself was wiped out by the WHO’s vaccination programme, the last non laboratory case being in the early eighties. Even at the time of which I write it was rare, and confined to poor populations in ho

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

countries.

He needed isolating. We were lucky in that respect, the ship’s hospital was situated over the propeller at C deck aft. There was a small self contained room there designed for just this purpose, known as the Brig, as it also doubled

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

as a cell should the need for restraint arise in aggressive crew or passenger.

Then we radioed the Darwin Port Health, who said we could not go back, and suggested talking to the Authorities in Brisbane. Eventually the Captain spoke briefly and

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

I was handed the radio to talk to the Australian Chief Medical Officer. He was a cross sounding man with no discernable sense of humour, not that the situation was funny. He insisted all on board should be inspected 24 hourly, but 12 hourly withi

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

n 48 hours of landfall and yes all on board without a valid certificate must be vaccinated, no excuses tolerated. He did give the impression that he was as certain as he could be that our diagnosis was wrong and this was probably a storm in a tea

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

Following aspects would a

cup and of course it was only chickenpox in an Asian man. We were to move out of Australian Territorial Waters and make our way to Brisbane for further instructions.

The CMO had insisted only the Ship’s Doctors could do the inspections but the

dd to the challenges in developing combination products:

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

nurses could help with the vaccinations. There were only 2 doctors, 2 nurses plus Ron the ex naval dispenser who counted as a nurse as far as I was concerned. Fortunately there already was an established inspection routine pre docking in Australi

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

an Ports. The Port Health ruled that any ship from Non Australian Ports must undergo a full smallpox inspection prior to being allowed to dock, so that we were used to doing such inspections. There was an established routine, and even an expectat

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

on of such from both the passengers and the crew, but doing it for four days, twice a day for the last 2 days was going to severely test everyone’s patience.

Medically we decided to combine the first inspection with the mass vaccination; we did

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

the crew first to get our hand in as it were. We decided to vaccinate all of the Goanese crew whatever their smallpox certificate said. This was because to a man they were all notorious needle haters and it was well known that most of the certifi

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

Professional from academic institutions, pharmaceutical industries, health care indust

cates were forged. It was a cottage industry in Goa. Vaccinating was done by placing a drop of serum on the skin, and scratching two parallel lines at right angles and rubbing the stuff in to the scratches with a needle. It was not a painful proc

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

edure but the reaction of many would belie that fact, we brooked no excuses however elaborate

We eventually got to Brisbane and were also instructed to fly two yellow flags. Normally only one yellow flag was flown prior to being cleared by Port

.

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

Health, two yellow flags signified we were a dangerous pariah. Our patient was trussed like a cooked chicken, unceremoniously grabbed and dumped on the trolley and whisked away, his breathing tube poking through the wrapping. He looked like an in

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

Companies that provide selfless information through particip

sect chrysalis. We never saw him again. Though we made several enquiries Brisbane Port Health Authority never confirmed it as smallpox, but they never said it wasn’t either. I remain convinced we saw the last case of smallpox on a passenger liner

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

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.advicepool.org.ua/article/159979/advicepool-The-Last-Case-Of-Smallpox-On-A-Passenger-Liner.html">The Last Case Of Smallpox On A Passenger Liner</a>

BB link (for phorums):
[url=http://www.advicepool.org.ua/article/159979/advicepool-The-Last-Case-Of-Smallpox-On-A-Passenger-Liner.html]The Last Case Of Smallpox On A Passenger Liner[/url]

Franchising companies have her responsibility to insure that their trademarks are not infringed upon. Just because a franchise company has properly registered the service Marks and trademarks with the proper state and federal agencies does not mean that some one will not try to use such Marks without permission.

Read this article for guidelines on launching vital fundraising pitches in the wake of a disaster.

If you have negative information in your credit file, as reflected by the Big Three reporting companies, proves to be accurate, there is little you can do about it. If you decide to seek professional help, the Credit Repair Organizations Act (CROA) has clearly detailed your rights as a consumer.

Tags

Links

Advice Pool - The Last Case Of Smallpox On A Passenger Liner

Related Articles: