Lawsuit that led to Flu Shot Being Made Overseas

[Antonia]

How the vaccine works:

Influenza vaccine is produced by growing the virus in eggs. The virus is killed and processed to create the vaccine, which is given by injection under the skin. The body then produces antibodies to the virus over the next two to four weeks. If the immunized person then comes into contact with the
influenza virus, the antibodies attack and kill the virus before it has a chance to cause infection. The vaccine contains the 3 most likely strains to be active during the "flu season"

Why the shortage:

Almost half of the nation's flu vaccine will not be delivered this year. Chiron, a major manufacturer of flu vaccine, will not be distributing any influenza vaccine this flu season. Chiron was to make 46-48 million doses vaccine for the United States. Chiron is a British company. Recently British health officials stopped Chiron from distributing and making the
vaccine when inspectors found unsanitary conditions in the labs. Some lots of the vaccine were recalled and destroyed.

Why is our vaccine made in the UK and not the US?

The major pharmaceutical companies in the US provided almost 90% of the nations flu vaccine at one time. They did this despite a very low profit
margin for the product. Basically, they were doing us a favor. In the late 80's a man from North Carolina who had received the vaccine got the flu. The
strain he caught was one of the strains in that years vaccine made by a US company. What did he do? He sued and he won. He was awarded almost $5
million! After that case was appealed and lost, most US pharmaceutical companies stopped making the vaccine. The liability out weighed the profit
margin. Since UK and Canadian laws prohibit such frivolous law suits UK and Canadian companies began selling the vaccine in the US.

By the way...the lawyer that represented the man in the flu shot law suit was a young ambulance chaser by the name of John Edwards.

 

[katerkat]

http://www.snopes.com/politics/business/flushot.asp

Regarding the claim that John Edwards secured a $5 million judgment against a U.S. pharmacutical company on a flu vaccine case, while it is true he had a highly successful legal career representing individuals who had been badly harmed by malfunctioning products or the mistakes of doctors and hospitals, with some even saying he won $175 million for his clients over 12 years, at this point it's not known if he ever litigated a flu vaccine case, or if so, what the outcome of such a trial was.

 

[damo]

The FDA has not approved flu vaccines made in Canada.

 

[swanmom]

Katerkat,
Thanks for checking the veracity of this story and posting the info. There's plenty of 'spin' and outright misinformation going around - no need to add to it unnecessarily. Just hope this is one where people read beyond the first post.

 

[minnie56]

I am confused....

If the FDA hasn't approved Flu shots made in Canada why did they say on the news 5 minutes ago that the U.S has asked if we can spare some?

I guess we 'do' in a pinch?

 

[damo]

Originally posted by minnie56
I am confused....

If the FDA hasn't approved Flu shots made in Canada why did they say on the news 5 minutes ago that the U.S has asked if we can spare some?

I guess we 'do' in a pinch?

If the FDA had approved them, they would have been sent a while ago. From what I have read, the US may be able to use them and categorize them as experimental drugs.

 

[minnie56]

They said they haven't sent any yet because they must be sure that they have sufficient supply here for all Canadian's first.

Meanwhile, U.S residents are coming accross the border in droves to get them here.

I am just wondering....

 

[minnie56]

Typically we are far more strictly controlled here in Canada with our Drugs...we cannot even buy Aleve here because it is considered a serious medication?

 

[Geoff_M]

...we cannot even buy Aleve here because it is considered a serious medication?

It has nothing to do with being more "strict". As for the vaccine, by law the only drugs and vaccines that may be sold in the US are ones made in facilities licensed and periodically inspected by the FDA. As for Aleve, in the US that active pharmaceutical ingredient Naproxen Sodium was approved by the FDA even though the FDA advisory panel voted earlier unanimously to NOT covert it to OTC status. Everyone's jaw dropped in the industry when the FDA ignored the panels recommendation. As for the claim that Aleve lasts "12 hours", that a bit of "spin". For safety reasons the FDA would only approve labelling that allowed for a maximum of two doses per day. Thus P&G turned a lemon into lemonade... "It lasts 12 hours!"

 

[ripleysmom]

BTW....the reason that there is a vaccine shortage is that manufacture of the vaccine was turned over to a plant in the UK with a known history of contamination issues.

 

[Geoff_M]

Unless you're talking about citations from the FDA, I'd question the nature of that assertion. Vaccines as known as "biologicals"... meaning their "active ingredient" is, or was, a living organism. This is opposed to active that is a chemical. "Bios" products often times have a high rejection rate of lots during the production process because the living things are used to make them. Sometimes the bugs don't grow right, sometimes other bugs you don't mean to also get into the mix (AKA "contamination") during fermenation, etc. We have a "Bio" product that used as an anti-rejection drug for transplant patients, we have to throw away more lots than we ship out... which unfortunately adds to the cost of the drug and makes it very expensive.

 

[mcnuss]

At least do some research before you repeat false drivel you read on the internet.

Chiron is a British company.

No it is not. It is headquartered in Emeryville, California.
http://www.chiron.com/investors/factsheet/index.html

Big pharma does not want to make vaccines bc the profit isn't there. (They don't want to make or research antibiotics anymore for the same reason.) They want to sell middle aged men viagra. That's where the bucks are.

I'd like to remind all those of you with children that John Edward's signature case as a litigator was when he represented a family whose child literally had her intestines ripped out of her rectum when she inadvertantly sat on a pool drain with a part that allowed the drain to become a virtual vacuum. The jury (not John Edwards, folks, the jury) found that the company was negligent bc a) it knew that the part was defective and b) the cost of replacing the part to make the pool safe for children was minimal (something like 50 cents).

Now I ask you, as a parent, if your child had her guts sucked out in a swimming pool and you found out that a 50 cent part could have saved her life, wouldn't you hire a lawyer and go after that company? If you wouldn't, why?

It's easy to throw dirt on trial lawyers, but I can assure you that if you or a family member were grievously injured bc of some big company's callous negligence, you'd be looking for a good one in no time flat. Everyone thinks lawyers are scum til they need one.

 

[damo]

Originally posted by minnie56
They said they haven't sent any yet because they must be sure that they have sufficient supply here for all Canadian's first.

Meanwhile, U.S residents are coming accross the border in droves to get them here.

I am just wondering....

http://www.mytelus.com/news/article.do?articleID=1743175&pageID=canada_archive
http://chealth.canoe.ca/health_news_detail.asp?news_id=12016

I heard this on CFRB the other day as well.

 

[Geoff_M]

(They don't want to make or research antibiotics anymore for the same reason.)

Oh, you are so wrong on that one! The antibiotics market is a big one! Develop a new antibotic that doesn't have antimicrobial resistence or can tackle some tough bugs and you're gonna pull in some dollars! Here's one example from this year: http://www.aventis-us.com/pressrelease/DisplayPressRelease.do?id=43 1.5 Billion Euros per year... not too shabby! Don't undercut your otherwise valid points with baseless garbage like the statement above.

 

[mudhen]

I wonder if the OP believes hook, line, and sinker from
Mr. Bush that frivolous lawsuits are the sole reason for
skyrocketing health care costs

As a poster stated earlier, if you have a problem with
lawsuits, pick on the JURY, they are the ones awarding
the settlements.

 

[mcnuss]

Originally posted by Geoff_M
Oh, you are so wrong on that one! The antibiotics market is a big one! Develop a new antibotic that doesn't have antimicrobial resistence or can tackle some tough bugs and you're gonna pull in some dollars! Here's one example from this year: http://www.aventis-us.com/pressrelease/DisplayPressRelease.do?id=43 1.5 Billion Euros per year... not too shabby! Don't undercut your otherwise valid points with baseless garbage like the statement above.

Thanks for the compliment on my valid points but I will stand by what I said. Here is just one of the many articles I've seen on this subject.

Dr. William Schaffner, head of preventive medicine at Vanderbilt Medical Center in Nashville, says it may be hard to persuade doctors to be tougher with patients who want antibiotics: “It’s easier to say than it is to do -- particularly when for a long time, you really thought that there would be a new antibiotic down the pike, and if this one doesn't work, we'll just use the next one.”

But Schaffner says the next antibiotic may not be just down the pike. A majority of the major pharmaceutical companies are cutting back on antibiotic research or withdrawing altogether.

“For example, in the year 2002, something like 400 new pharmaceutical agents were licensed by the FDA,” says Schaffner. “In that year, there were no genuinely new antibiotics among them. I mean, that's a striking thing. Last year, there were one or two.”
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Why is this happening? Well, one reason is that antibiotics are usually taken for just about two weeks, and therefore are not nearly as profitable as drugs people take for years, like Lipitor for cholesterol or Viagra.

“If I were the CEO of a pharmaceutical firm, I would point out that our research is benefiting the health of the public,” says Schaffner. “A lipid-lowering drug reduces heart attacks. But how can I responsibly invest my shareholders' money -- $900 million to create a new antibiotic? … Those are the estimates. That’s not fair to the shareholders.”

It takes almost a billion dollars these days to research and test a new drug for FDA approval. The world's largest pharmaceutical company, Pfizer, maker of Lipitor and Viagra, is one of the companies still working to come up with new antibiotics.

Dr. Martin MacKay is Pfizer's head of drug research: “Of 100 ideas that we think of in our laboratories, only one will make it into medicine, so it’s a huge risk.”

The company's latest antibiotic, Zyvox, was developed specifically for the treatment of MRSA. But just four years after its release, resistance is emerging.

How long is it likely to take before the medication will be available for use? “When we have an idea for a new medicine, just to get into humans could take five years,” says MacKay. “And then, the clinical trials after that can be another 10 years. So this is a 15-year process.”
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So don't hold your breath for a stream of new antibiotics in the near future, even from companies like Pfizer.

But are these companies obligated to produce more? “I don’t think there’s any more obligation that the companies have to produce new antibiotics than Ford does to produce a small car that's gas efficient,” says Schaffner. “I mean, we would need to think outside the box.”

Thinking outside the box, however, could cost the U.S. taxpayer, and there are suggestions that the government may actually pay the drug companies to develop new antibiotics.

Dr. Anthony Fauci, head of the government's Institute of Allergy and Infectious Diseases, says that idea is being taken seriously. But it’s going to be difficult to convince the public to help the pharmaceutical companies. “It is no question going to be hard to sell,” says Fauci.

http://www.cbsnews.com/stories/2004/04/30/60minutes/main614935.shtml

 

[Geoff_M]

Here is just one of the many articles I've seen on this subject.

Well, then I think you need to diversify your research a little. I'd like to see the list of major pharma companies that have supposedly cut back on antibiotics research. I know my employer is still into anti-infectives in a big way. Oh, and here's part of another interview with Pfizer's Martin Mackay on the topic:

Q. How do you decide whether to pursue an antibiotic, for example, where some people say the markets aren't that strong, versus Viagra, where it's not something that will save lives but there are huge markets?

A. If you are in a wheelchair, and you are not able to have an erection, and you take this medicine called Viagra, that patient really feels that they have a medical need. It's in the eye of the beholder.

Antibiotic research is one of our biggest areas. In 1999, we had 40 scientists in this area. Now we have around 300. We see this area as very socially important. And we feel that if you get the right medicine for the right disease, you can have a commercial return on an antibiotic. This is not purely altruistic.

http://www.boston.com/business/arti...esearch/?rss_id=Boston Globe -- Business News

Does it sound like Pfizer, the world's largest drug maker, is cutting back on R&D in that therapeutic drug class to you???

 

[SueM in MN]

Let's say you made a product and had to decide whether or not to continue producing and selling it. The facts about your product include:
1) The product is only used from September until mid to late January. Product made one year can only be used that year.

2) A lot of people say they want the product, but every year millions of doses go to waste and are destroyed because people don't actually go in to get the product (12 million were wasted during the 2002 season).

3) If there is a shortage or the product is in the news, there is more demand. People get angry at your comany if a sortage occurs. But, even in a shortage year, by the end of the season many units of the product will be destroyed because they were not used.

4) Unused product can often be returned for credit - so there is a possibility of having to refund the buyers for 12-15 million units of the product.

5) The basic process for making the product has been in use without a lot of changes since the 1950s. It involves millions of eggs (1 egg makes only 4 doses), a lot of labor that needs to be done by hand and the process takes a long time. If it looks like there will be more demand than usual, it is difficult to ramp up production to meet demand.

6) There are many opportunities for problems in the process (contamination, sometimes the product doesn't grow) and sometimes the problems are not evident until the process is almost completed. If problems do occur, there usually is not a way to produce more product in time to sell it for that year.

7) Everything has to be done on a short timeline. The actual components of the product may not be determined until March each year and much of the finished product needs to be delivered by early September.

8) Within the next 3-5 years, the process will be changing completely to a totally different process. Much of the equipement and facilities now in use will not be used in the new process.

9) Product made for use in one market (for example, Europe) might not be effective in another market because the product is individualized for the conditions that will be occuring that year in the part of the world where the product will be used.

10) If any problems occur (shortage, contamination), it will be highly publisized and your company will get negative press for months to come.

Now, given all these facts, would you want to make this product?
These are all fact about flu vaccine and this is why there are currently only 2 companies making flu vaccine for the US market.

 

[mrsltg]

It's easy to throw dirt on trial lawyers, but I can assure you that if you or a family member were grievously injured bc of some big company's callous negligence, you'd be looking for a good one in no time flat. Everyone thinks lawyers are scum til they need one.

Yes because every lawsuit has merit and every trial lawyer shopping their services on tv is actually in it for the "little guy".



And before we start blaming the jury, let's remember who puts the case in front of them in the first place.

Erin