Drugmaker Roche willing to let others make flu drug (Changed Mind)

[RamboLiberal]

http://sfgate.com/cgi-bin/article.cgi?file=/c/a/2005/10/18/MNGJRFAACJ7.DTL&type=science

Swiss pharmaceutical giant Roche said today it is willing to license other companies or foreign governments to make Tamiflu, an antiviral drug deemed the first line of defense against the bird flu that scientists fear could one day spread rapidly among humans.

"We are prepared to discuss all available options, including granting sub-licenses,'' said William Burns, chief executive of the Roche Pharma Division in Basel, Switzerland.

The stance appears to represent an abrupt about-face for Roche, which last week declared that it "fully intends to remain the sole manufacturer of Tamiflu'' in response to a growing international clamor for the company to permit others to make the potentially life-saving drug.

Burns said in prepared remarks that Roche would only enter discussions with countries or private businesses that could "realistically produce substantial amounts of the medicine for emergency pandemic use, in accordance with appropriate quality specifications, safety and regulatory guidelines.''

The company has been under pressure to permit others to make Tamiflu since worries about avian influenza began climbing following an outbreak in Jakarta, Indonesia, that has infected at least five people, and the discovery that migrating birds have apparently transmitted the virus to flocks in Turkey, Romania and possibly Greece.

[napi21]

1. That's good of Roche to do that, and it's probably the best

solution we have right now. But...people neeed to realize that this is an antiviral medication! IT IS NOT A VACCINE! I really wonder how many people realize that?

It's to be taken AFTER the first sympthoms are experienced, and it SHOULD reduce the impact the flu has on you.

[nadinbrzezinski]

3. Yes it is teh best solution

and I do understand this, and it needs to be takek within the first 48 hours of symptoms

[WildClarySage]

10. So calling it the 'first line' of defense is a bit misleading, yah?

I thought they'd already scared us into believing that it doesn't really work against Bird Flu anyway. Hmm... maybe that's why they're letting other companies make it? Because they know it won't help and when people see that, these other companies be unable to make any $$ off it, and they can say it doesn't work because they're taking a generic form- and can come out smelling like roses because they were 'decent' enough to put our welfare first?

[OhioChick]

19. Unfortunately, most of the public thinks

that this drug will PREVENT them from getting the flu. I've heard so many people making comments about "having to get some of that Tamiflu." I explained to many that it was an "antival" and not a "vaccine." Most don't get it......

[Psephos]

23. So true.... n/t

[Journeyman]

2. So they can make money by letting others do the work. . .

and yet they've been dragging their heels over it for weeks . . . I'll never understand corporate greed if I live forever. . .

[nadinbrzezinski]

4. It is mostly copy right protection

also they were threatened with loosing that copyright since some govments were going to do the same they did with AIDS... so they could charge and get some money, or loose all... that is what is at the center of this

[Journeyman]

5. Yeah. That's what I couldn't understand. . .

Roche will make money (less money, but they won't do as much work) if they license the product to other manufacturers. If they don't allow the others to produce the drug, Roche runs the risk of being sued for potentially negligent deaths. As I say, I'll never understand corporate greed if I live forever. . .

[Psephos]

7. The work is not in making the drug, but in developing it

Some pharmos suck, and some are good corporate citizens. I prefer a more sophisticated understanding of the world than the one that paints all parties with the same tar brush.

I'm not offering an opinion one way or the other about Roche. Instead, I'd like to remind others that pharmos use profits to fund research into new drugs, and then to pay for the testing and clinical trials necessary to bring a drug to market. This typically costs hundreds of millions of dollars for a major new drug. If a new drug ultimately does not prove out in clinical tests, then the drug company eats the development expense. This system puts enormous pressure on the pharmos to develop blockbuster drugs, because the failure to success ratio is quite large. Debate about whether this system is the best seems worthwhile to me. (I have some rather serious misgivings about it.) However, I find it next to useless to tear something down without offering a better alternative in its place.

Ultimately, drugs are a form of intellectual property. Once you have proved a drug does something medicinally useful, and has acceptable risks and side effects, manufacturing the drug is trivial. The real costs are borne up front, before any manufacturing begins.

Roche spent serious amounts of money to develop and market Tamiflu. It doesn't surprise me that they would like to see that money come home again. They are, after all, a business, not a government or a charity. I'm glad, however, that Roche seems to have found another way to take care of business and also address potential need for their product. A little publicity can go a long way toward the rediscovery of a conscience. :-)

Those who think Roche is a bad corporation and don't wish to transact with them may wish to consider another drug that competes with Tamiflu called Relenza. It was developed in Australia by researchers funded by GlaxoSmithKline working together with CSIRO (Commonwealth Scientific and Industrial Research Organisation) and the Victorian College of Pharmacy. The patent is held by Biota Holdings, and Glaxo has exclusive license to market the drug.

These are my opinions, nothing more, nothing less.

Peace.

[nadinbrzezinski]

8. to a point since a lot of the clinical trials are

done at Clinical Research Centers funded by the NIH in the US... so they are also heavily subsidized.

Now if and when the NIH fully goes away (as bushco wants) then you will be 100% correct, but they spend far more on adverts than they do on reserach, at this monent.

[alcibiades_mystery]

15. Patent...not copyright

You can't copyright a drug.

[nadinbrzezinski]

18. oopp my bad,

[alcibiades_mystery]

21. Just saying, there is a difference

And the conflation of the two is a major problem.

[mike_c]

6. an Indian pharmacuetical company had already said it was considering...

...manufacturing regardless. I think Roche realized they had little to gain by refusing-- it makes them look like avaricious bastards, which they doubtless are, and once one company set the precedent of ignoring their patent others would as well, so they would lose anyway. This way they get to save face a little. They made a good decision. I doubt their motives, but applaud the decision anyway.

[chat_noir]

9. more marketing and and advertising dollars than R & D

First, research and development (R&D) is a relatively small part of the budgets of the big drug companies—dwarfed by their vast expenditures on marketing and administration, and smaller even than profits. In fact, year after year, for over two decades, this industry has been far and away the most profitable in the United States. (In 2003, for the first time, the industry lost its first-place position, coming in third, behind "mining, crude oil production," and "commercial banks.") The prices drug companies charge have little relationship to the costs of making the drugs and could be cut dramatically without coming anywhere close to threatening R&D.

Second, the pharmaceutical industry is not especially innovative. As hard as it is to believe, only a handful of truly important drugs have been brought to market in recent years, and they were mostly based on taxpayer-funded research at academic institutions, small biotechnology companies, or the National Institutes of Health (NIH). The great majority of "new" drugs are not new at all but merely variations of older drugs already on the market. These are called "me-too" drugs. The idea is to grab a share of an established, lucrative market by producing something very similar to a top-selling drug. For instance, we now have six statins (Mevacor, Lipitor, Zocor, Pravachol, Lescol, and the newest, Crestor) on the market to lower cholesterol, all variants of the first. As Dr. Sharon Levine, associate executive director of the Kaiser Permanente Medical Group, put it,

If I'm a manufacturer and I can change one molecule and get another twenty years of patent rights, and convince physicians to prescribe and consumers to demand the next form of Prilosec, or weekly Prozac instead of daily Prozac, just as my patent expires, then why would I be spending money on a lot less certain endeavor, which is looking for brand-new drugs?<4>

http://www.nybooks.com/articles/17244



Pharmaceutical companies dramatically overprice life-saving drugs and justify doing so by citing research and development costs. This argument, constantly used by these companies and also by Mr. Nesmith in his column, has been repeatedly debunked. And yet, it is made over and over again.

Drugs are expensive, say the pharmaceutical companies, because of the years of research and failed trials that go into making a successful drug. However, they neglect to mention that up to 50% of the research and development cost in the world is incurred by the public sector. Tremendous amounts of drug research is funded by university funding and government grants.

But when putting a figure to the R&D costs, pharmaceutical companies include these public sector costs as if they were their own. This inflates the stated expenditure associated with R&D per drug for a company and provides an artificial justification for extremely high prices. To burst another drug company bubble, I should include that these companies spend more on marketing and administration than on R&D. It basically goes without saying that the pharmaceutical industry has been one of the most profitable industries in the nation for several years straight.

http://www-tech.mit.edu/V123/N41/shef_colum.41c.html

Maybe some of DU's top-notch researchers can find more articles supporting these two opinions.

[Bridget Burke]

16. You did some pretty good research.

I'd already heard from many sources that promotion is more important than research for Big Pharm.

How much does it cost to place ads in prime time? And you'll note that the drugs advertised are mostly new ways to treat relatively minor problems. Until the real mortality/morbidity figures start rolling in & the class action suits begin.

[nadinbrzezinski]

17. My sister worked at a Clinical Research Center

their funding for Level One, two and Three Clinical trials did NOT come from the companies, but form the National Institutes of Health.

My brother is an MD working in research, He once told me the old lie, and I mentioned the moneys from NIH that he also receives, he sheepishly concerted that I had the point.

Big pharma's medicines are developed through your and mine dollars... and they make the money and sell us these expensive drugs... which are life savers, but they also have on the tv.

For example, I am taking for diabetes one particular drug, which I saw a commercial for the other day... and I went, what the fuck is that doing on the TV? Same goes for Cialis, and the rest of them... It makes the life of doctors harder... but doc I saw this on the teeevee therefore must be good, can I get a prescription?

No, you don't need it

But, doctor it sounds great

You are a woman you don't need viagra....

One day I was half jocking with the doc on this... she looked me in the face and said... she's had female patients ask for Viagra.

[The Backlash Cometh]

11. HA HA! They probably heard that the virus was changing

and may be Tami Flu resistant before too long.

Actually, I shouldn't be chuckling about this.

[Prisoner_Number_Six]

12. Might white of 'em

Especially since others outside the country had already declared they were going to go ahead and manufacture it whether they liked it or not.

They suddenly realized how much money they were going to lose. No humanity in THIS decision. Just greed, as per usual corporate policy.

[Tight_rope]

13. Damn...that was fast...just a week ago it was "NO WAY"!...n/t

[alcibiades_mystery]

14. How fucking generous of them...

:eyes:

I guess the sight of two million dead seeped into the country clubs and stunted consciences of the patent-holders...

[OKthatsIT]

20. Vaccinations created prematurely could expire before threat appears

when is a good time, then? WHEN THERE'S A REAL THREAT...doughbrains

[Psephos]

22. The problem is not expirations of vaccines, but viral mutations

Planning for influenza vaccines is notoriously tricky (remember the swine flu vaccines?) because the flu virus mutates so rapidly. If you make a batch of vaccine for the virus in its current form, then that vaccine may be useless for the mutated form of the virus that eventually causes the epidemic. Avian flu is not an epidemic danger in its present form. Researchers instead are trying to predict future mutations that could give the virus increased ease of transmission and increased virulence.

At best, planning vaccines is a probability game that requires clinical insight and a feel for emergent patterns in complex genetic structures. The people who work on viral mutatation prediction are not doughbrains.

Peace.

EDIT: typo fix