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Want to squeeze U.S. pharmaceutical companies? Be careful what you ask for

If you miss getting a flu shot this season and you want to fix blame when you're on your sickbed, take a look in the mirror. If the face you see belongs to someone who buys into the bashing of U.S. drug companies, you're a part of the problem.

The looming shortage of flu vaccine comes down to the fact that very few American drug companies are left in the business of making vaccines. Why? The capital costs are enormous, the regulatory climate is burdensome, production estimates are guesswork and the company is typically stuck with million of unused doses of vaccine. All that, and the companies must listen to politicians whine about how drug prices—without ever stopping to think what a major epidemic costs the economy in terms of lost production.

Given the unattractive nature of the job, it's not surprising that only two manufacturers—Chiron and Aventis—were willing to supply all 100 million or so vaccine doses needed by the United States this flu season. Now, there is only one.

Health officials warned of shortages last week after British authorities suspended the manufacturing license of Chiron due to concerns about sterility at its vaccine plant in Liverpool. In one day, the nation's supply of flu vaccine was chopped in half.

It's not a case of putting all of the flu vaccine eggs in one basket. Most eggs were scrambled out of the market.
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The basic problem is that “we've lost most of our domestic manufacturers” of flu vaccine, Richard Webby at St. Jude Children's Research Hospital in Memphis told the Associated Press. “When you're relying on two manufacturers ... and one goes down, you're up the creek.”

Chiron bought the Liverpool plant in 2003 from Powderject, a British firm that also owned a facility in Madison (since shut down). Chiron executives believed they could quickly ramp up production of flu vaccine in Liverpool, and expected vaccine sales would account for about three-quarters of the company's profits this year. That bet backfired when British regulators shut down production, without explaining if the problem was isolated to a few batches or all vaccine produced at the plant.

The experience shows why drug companies shy away from flu vaccines—and why people who criticize U.S. drug companies need to take into account the risks most of those companies take to provide cutting-edge therapies of all types. If you're looking for the next breakthrough drug, don't look north to Canada. Rigid price controls killed innovation there years ago.

What can be done to draw more companies back into the flu vaccine business? Demand must grow beyond the usual high-risk vaccine recipients to include healthy adults, who could be lost to the workforce in an epidemic. The government could commit to buying a certain number of doses at a given price each year, easing much of the uncertainty. A public program could provide flu shots for uninsured people. The cost of complying with regulations could be better controlled, and new vaccines could be brought to the market faster. The federal government will offer financial incentives of $50 million for this fiscal year and $100 million for the following year to encourage drug companies to speed up development.

Finally, candidates for public office—Wisconsin's two U.S. Senate candidates included—can stop trying to outdo one another over who can whack American drug companies the hardest. In a nation that has lost some exporting industries over time, one would think political candidates would try to protect pharmaceuticals, one of the more productive exporting industries. Instead, they're convincing voters that U.S. drug companies are the bad guys.

Before you climb onboard the anti-drug company bandwagon, ask yourself this question: When was the last time you took a breakthrough drug actually researched, tested and manufactured in Canada or anywhere outside the United States? The answer should tell you why anti-drug company hype is dangerous to your health, and the health of your family.


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Still is president of the Wisconsin Technology Council. He is the former associate editor of the Wisconsin State Journal in Madison.

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The opinions expressed herein or statements made in the above column are solely those of the author, & do not necessarily reflect the views of Wisconsin Technology Network, LLC. (WTN). WTN, LLC accepts no legal liability or responsibility for any claims made or opinions expressed herein.

Comments

Robert Gore responded 5 years ago: #1

Tom Still, you're full of it. It's obvious how you are building your retirement..Drugs profits are so huge, why should the companys fool with fly vaccine....say hi to your washington buddy's

Drew Baglino responded 5 years ago: #2

You claim that we should instead of critizing big drug companies, support them, in their efforts to provide us flu vaccines? Wouldn't having many more, smaller drug companies, with less political influence up the chances that any individual company provide flu vaccines? Isn't it the agglomeration in the drug-manufacturing sector into monopolies, which drive UP the cost to the consumer, the cause of this shortage more than anything else?

Parag responded 5 years ago: #3

Aren't we subsidizing R&D for world by American money.

Matt responded 5 years ago: #4

Look its clear that Tom has a point. Big government can backfire. The fact is the USA is a capitalist society. Without real potential gains (i.e. MONEY/Profit) no US Company will take the risk associated with developing flu vaccines. There has to be profit in order for the companies to develop and continue their work. They can’t work for free, that would be communism. And guess where those huge profits go Robert Gore, that’s right, into research and development of new drugs. But they just do that to make more huge profits, right? No wait, people’s lives are actually being helped maybe even saved by those breakthrough drugs. Before you conger up images of bigwigs and fat cats with their pockets and shirts stuffed full of 100-dollar bills and bursting at the seams, remember why drug companies are in business. To help improve our quality of life and god forbid the pay their employees and themselves. You know they have to put a roof over their head and feed their families too.

Jim LaPeer responded 5 years ago: #5

Tom, you will be confusing people with the facts; Be careful.

jonathan turner responded 5 years ago: #6

Tom is absolutely correct. Bob, you need to grow up and present an argument rather than invective. Drew, better, but look at your own questions for an answer...
Why are there not more small drug companies? Because the cost entry into the business is so high and because the risk of failure is so high. No-one starts a company to lose money, but that's the position that this anti-drug-company mentality puts a potential entrant into. Ask yourself why in the world would anyone WANT to manufacture flu vaccine in today's climate?
First you borrow millions to build a complex factory, then try to get certified by the FDA while you are making payments against the borrowed capital, if you are lucky you get approved and you can sell. If any microscopic thing goes wrong or even *appears* to go wrong your entire operation is shut down. You probably won't even get a chance to correct things before you are out of business. Even if it goes right the best you can hope for is NO press, because any press will be bad press these days. You also get to enjoy moronic protesters outside the office, and maybe you house, every morning whining that you make too much money...despite the fact that you are taking all of the bankruptcy risk.

Sure, tons of people are just lining up to go bankrupt AND get the benefit of toolbags like you two complaining about it.

BTW: the cause of the shortage is not high prices, it's that Chiron was shut down and there is only one other supplier. If it was a rich business with a n acceptable amount of risk then companies would be lining up to make vaccine. But they are not, because we (our government), have made it unprofitable. We have driven companies out of that business with overregulation; THAT is why we have a shortage.

We can fix this by either: reducing the risk of failure, or allowing a higher profit margin. If we reduce the risk level by, as Tom suggests, guaranteeing some purchases and by limiting lawsuits then small businessmen might be able to enter. If instead we stop the attacks and allow a higher profit margin then companies might be willing to risk failure for a shot at big profits.

Or we could have the government try to regulate both production and prices and get what we have now...high cost AND shortages...yay!

Russell responded 5 years ago: #7

Matt wrote: "And guess where those huge profits go Robert Gore, that’s right, into research and development of new drugs."
If only that were completely true. Sure, some the drug companies
spend money on R&D, but they spend *MORE* on MARKETING.
And the last time I checked, nobody is holding a gun to their heads
forcing them to sell their products in Canada, UK, ... So why do we
USAer's pay so much more than people in those countries? Because
the drug companies have enormous influence in our government and
get sweetheart deals.

Shelly responded 5 years ago: #8

Come on guys...in 1988 there were 25 manufacturers of vaccines in the US today there are only four and only two for flu vaccines....the last 20 odd years have been dominated by mergers and acquistions and the movement to other less regulated countries with cheaper labor costs........you want less regulation but also less litigation...I don't think it is possible....Chiron's plant was shut down due to suspected contamination...I for one am grateful for the watchdog who will try to protect us from less than safe drugs....the US big business attitude is to go elsewhere to escape paying wages that will keep pace with the cost of housing, food, and medicine....what is the answer....I don't know....but I know it is squarely in the hands of the largest companies involved and the legislators who are walking hand in hand with them!

Bill M responded 5 years ago: #9

There is a pattern here. Look online and you'll see numerous articles like this one with the same structure and same arguments. Clearly written from a lobbyist's brief on the subject.

Facts are wrong and misleading here. Why aren't drugs made in Canada? Many of the big international pharmaceuticals are finalizing development here in US subsidiaries because of govt protections and subsidies. Unfortunately, 17 of the 25 top selling drugs in America were developed by US Government funding (NIH grants), not industry R&D. Much of industry R&D is on delivery mechanisms, like round and green or oval and purple, or how to combine two commonly paired drugs into one avoiding the loss of patent protection and beating the generics.

Lesser regulation? He'd rather the Brits didn't catch the contamination problem... I could go on and on...

Ken Rozee responded 5 years ago: #10

Both Canada ,the UK and many other countries have made substancial contributions to vaccine and drug research and to the proof of product stages of testing . To suggest that it only occurs in the USA very considerably deminishes your arguement. The fact that USA based companies have the $$$ to buy promising developments does not mean they originated there. You price and supply problems are entirely political ..solve them !!!

ABG responded 5 years ago: #11

Basically, the author of this article doesn't know what he is talking about. There have been far more new drugs invented in Europe and Japan than in the USA over the last 10 years. That is a simple fact, and can be shown by looking at the number of new drug applications, and who is filing them in the USA v. Europe and Japan.

In fact, with the exception of Merck, Eli-Lilly, Pfizer & Bristol-Meyers, the majority of the world's big drug companies are located in Europe, not the USA. All the countries these big, innovative, pharmaceutical firms are located in, have systems of socialized medicine, and price controls on drug products. To start the list...

Glaxo-Welcome is British. Bayer is German. Aventis is French. Novo Nordisk is Danish. Roche is Swiss. Ciba-Geigy is German. Sanofi is French. AstraZeneca is Swedish/British. Smithkline-Beechem is British.

When a person does not know the facts about what he is talking about, he should keep silent.

ABG responded 5 years ago: #12

To further prove my point, here are some of the numbers I was able to quickly find. Note that Merck's sales include multiple business, many of which are not related to pharmaceutical manufacuring. Perhaps, $20 billion comes from pharma. I only included numbers I was able to quickly find, so some big companies have been omitted.

MERCK & CO. (headquarters: Whitehouse Station, New Jersey)
1999 revenues: $32.7 billion
1999 profits: $5.9 billion

NOVARTIS (Basel, Switzerland)
1999 revenues: $20.4 billion
1999 profits: $4.2 billion

BRISTOL-MYERS SQUIBB (New York City)
1999 revenues: $20.2 billion
1999 profits: $4.2 billion

ASTRAZENECA (London)
1999 revenues: $17.8 billion
1999 profits: $1.1 billion

ROCHE HOLDING LTD. (Basel, Switzerland)
1999 revenues: $17.3 billion
1999 profits: $3.6 billion

PFIZER (New York City)
1999 revenues: $16.2 billion
1999 profits: $3.2 billion

GLAXO WELLCOME (Middlesex, United Kingdom)
1999 revenues: $13.7 billion
1999 profits: $2.9 billion

SMITHKLINE BEECHAM (Middlesex, United Kingdom)
1999 revenues: $13.5 billion
1999 profits: $1.8 billion

AVENTIS (Schiltigheim, France)
1999 revenues: $12.7 billion (prior to consolidation with Hoechst)
1999 loss: $859 million

ELI LILLY & CO. (Indianapolis)
1999 revenues: $10.0 billion
1999 profits: $2.7 billion

Sue Williams responded 5 years ago: #13

If an industry cannot make a profit on something like vaccines, then I thought that's why we have a government to step in and make it work on behalf of citizen safety and health. It seems to me we need coopperation here.

Wes Miles responded 5 years ago: #14

Correct me if I'm wrong, but profits are calculated AFTER R&D expenditures have been accounted for.
I agree that startup, long development and approval times and risk costs are the major barriers to entry. If anyone felt that they could get past these barriers they would enter the market. Above and in the general media, we hear about large profits (most of ABG's figures are on the order of 10-20% PROFIT) but what is not shown are the hundreds or thousands of drug companies that go bankrupt before selling their first dose.
There needs to be a better system of supporting R&D, moving new drugs SAFELY through the test and approval process, and distributing the profits.
Overall, we need to find a better way to spread the risk and the reward.

Douglas Alexander responded 5 years ago: #15

This problem, as well as some of the comments above, are a fault of our public education system. As a former 9th grade Socail Studies teacher, I can vouch for the fact that students are not being taught (nor do they understand) the basics tenants of a free enterprise system.

Bill Kunkler responded 5 years ago: #16

I guess I question that premise that no one wants to produce flu vaccine due to govt regulation. Vaccine producers are already insulated by federal law from consumer liability. Are the capital requirements for this old technology truly "enormous"? This is a very low cost treatment. Does substantial R&D go into developing this year's vaccine? . . . I don't know, but I doubt it. I suspect instead that the margins are just better on designer drugs that don't expire, and which we are constantly being urged on TV to ask our doctors to prescribe. This is the market at work. I agree with Tom that the federal government may need to become involved in assuring that there is adequate supply. The best way to do that is probably debatable. But I don't agree that this shortage is a result of unreasonable consumer demands on drug company accountability. There may be real problems with the regulatory process (and cost) for bringing new drugs to market. But the flu vaccine isn't a good example!

jo s responded 5 years ago: #17

this article is a crock! a significant part of r&d is supported by grants from nih. this is not a new process.
why is there no shortage of vaccine in canada and other developed nations? could it be that no attention is given domestic problems?

John Byrnes responded 5 years ago: #18

Good article Tom. The points you make are exactly right. Comments by ABG make clear that he/she doesn't understand the difference between the corporate headquarters and the market. The vast majority of Euro and Japanese drug companies are moving their forward looking operations to the US for exactly the reason Tom cited. Politics (and favorable local tax law ) prevents them from moving the hdqrs but the R&D is already here. The US is the undisputed worldwide center for modern drug discovery and our lead is widening. Bravo for Tom Still.

JANE BLAIS responded 5 years ago: #19

Is there any truth to this statement. "US Drug Companies wanted to be held blameless if they manufactured the flu vaccine. ie no lawsuits." Congress turned that request down in 1996 - and that is the reason the US does not manufacter the vaccine.

Tony responded 5 years ago: #20

Hey Bill M. Where did you come up with your figures (17 of top 25 drugs developed by NIH grants). Prove it. Name them! You can't because it's pure hogwash. It's one of those myths anti-capitalists repeat over and over and is accepted by those who follow that mantra.

NIH funds "basic" research. Drug companies research and develop drugs. They do collaborate. It's a good thing.
Universities are encouraged to patent their discoveries and can license them to drug companies for development in return for lump sum payments and on-going royalties. This is a huge source of income for those institutions. It's voluntary on the part of the university, too. It's good for soceity because it moves discoveries out of the lab and into development. The NIH (or US Govt) does not have the means to develop a drug and bring it to market. That's the expertise of the drug industry.

Furthermore, ABG, it's OK to make a profit in this United States, even so-called "huge" ones. It's OK to promote and advertise your products. It's OK to keep the property that you own as long as possible in order to increase your chance of survival. So instead of just critisizing the industry that actually helps the public (as opposed to the tobacco, liquor and pornography industries), offer a better system that is sure to provide the needed cures in the future faster and cheaper than our current one. I, for one, am proud that the US leads the world in drug innovation. What other industry helps people more?

US Drug responded 3 years ago: #21

I support inovation, but theres a problem when its 12-14 bucks a pill for time release oxycodone, take 4 a day... $1,200.00 a month, no one will insure you... your options are reduced too none. This is a ruthless market driven by illness, death and money. The perfect disease, the patient never gets better, but stays on a ever increasing dose of drug A or B. Switch the popular drugs up, keep it moving.

Bruce responded 2 years ago: #22

Matt, drug companies are in bussiness exclusively for profit. That's why when the patent expires for one of their drugs they come out with a new drug of the same class that isn't any more effective or safer and many times less effective and/or less safe.

Plus the path to health is by restoring homeostasis through diet and lifestyle, not drugs that usually do more harm than good.

Chip Reuben responded 2 years ago: #23

Humpty Dumpty sat on the wall,
Humpty Dumpty had a great fall,
All the kings horses,
And all the kings men,
Couldn't put Humpty together again...
Until now;
But they still don't

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