No More Generic Drugs For Me!!!

[Rage for Order]

http://news.yahoo.com/s/nm/20080513/hl_nm/pharmaceuticals_china_dc

Chinese Drugs Seen Driving Down Generic Prices

A coming wave of Chinese pills is set to push down the price of generic drugs, as more low-cost finished medicines from the country win approval in major markets, according to a report on Tuesday.

Zhejiang Huahai Pharmaceutical Co Ltd won a U.S. green light last July to sell generic (AIDS drug) nevirapine, once the patent held by Germany's Boehringer Ingelheim expires in 2012.

At least 10 other Chinese companies are set to follow suit with other generic products, according to IMS. Some could be available as early as this year. The result will be increased competition in a generic drugs industry that is already struggling with tumbling prices.

One potential obstacle for China's emerging generics industry, however, may be its reputation for quality. Contaminated supplies of various brands of the blood thinner heparin have been linked to 81 U.S. deaths since January 2007.

more at the link

eta description of nevirapine

[yourout]

1. This is not just a bad idea......it's a terrible idea.

What do we do if we are crippled by a contaminated drug from a Chinese firm?

[blondeatlast]

2. Agree; with the regimen I'm on, I'll stck to what I know. nt

[Rage for Order]

3. Hell, it's getting to where you can barely sue US drug makers

I imagine if you have complications or health problems from a drug made in China you'll be super-fu**ed!

http://bmj.bmjjournals.com/cgi/content/full/332/7554/1350-b/DC1

New preamble to FDA regulations makes it harder to sue drug companies

The US Food and Drug Administration has added a preamble to its new regulations that will make it difficult for anyone to bring legal action against a drug maker for harm caused by one of its products, says an article in this week’s edition of the New England Journal of Medicine (2006;354:2409-11). The new regulations, which have attracted little publicity, come into effect on 30 June.

The most troubling aspect of the FDA’s new plan, however, has nothing to do with providing information to prescribers, says the article.

"Beginning at the end of this month, the new regulations would pre-empt nearly all action by patients in state courts against drug manufacturers for unanticipated injuries resulting from the use of their products. This immunity would apply even if a company failed to warn prescribers or patients adequately about a known risk, unless a patient could prove that the company intentionally committed fraud—a very hard test to meet," it says.

The article quotes a former general counsel for the FDA, now in private practice, as saying that regulations "will make it impossible to file liability claims." Sidney Wolfe, director of Public Citizen, a public interest watchdog organisation, called the FDA’s move "unfortunate and totally inappropriate" and as being done at the behest of drug companies "that want desperately to get the FDA to protect them from litigation."

more scary stuff at the link

[crikkett]

18. what makes you think that

you know the origin and safety of the pills you already take?

[tavalon]

20. I was wondering if anyone would bring that up

[MannyGoldstein]

4. Name-Brand Drugs Could Use The Same Crappy Ingrediants

The heparin that killed a bunch of people recently was from Baxter if I recall correctly. That ain't a generic brand.

I'm in the medical business, and I prefer generics - they cost less, and there's no particular reason to think that they're less safe.

We need the FDA to actually do their job, which they're not.

[Warpy]

8. US manufacturers are already outsourcing drug production

and some of it, like the heparin in question, has been outsourced to China, already.

Obviously, what has to be done by these guys if they don't want to be put out of business by lawsuits (that they have to answer no matter what the FDA preamble which makes it harder to WIN, not sue says) is to do stricter quality control on the drugs they distribute. That'll drive up costs and the net benefit of offshoring will be reduced to the point that the contracts won't be renewed and production moved back here at some point.

In the meantime, we already don't know where our drugs are coming from. Those of us who need to take medication to stay alive and/or functional just have to hope that harmful substitutions haven't been made.

[MannyGoldstein]

9. It's A Huge Problem That The FDA Does Zero Inspections Of Overseas Facilities

US facilities are supposed to be audited by the FDA every two years - and the audits are actually very tough and sometimes result in plant closings. Overseas facilities get zero audits.

So, they're encouraged to go offshore.

[crikkett]

19. cuirously enough this is the argument the Govt used when

everyone (here) wanted cheap drugs from Canada... that US drugs were safe because they were made/inspected here.

[MannyGoldstein]

25. Except...

Canada has its own version of the FDA, which would be doing the policing on those drugs. I suspect the Canadians would do as good a job as we do.

[Stinky The Clown]

11. No shit ..... my drugs keep changing names with each renewed prescription .........

Lopressor, Mevacor, Plavix, etc ....... When I started on them a bit more than a year ago, I was actually getting only name brand stuff. Over the last six months or so, all I get are generics. I have no inherent problem with the **concept** of generics, but i worry about where they come from, their efficacy, etc.

I don't trust my government to watch out for me. The FDA is just a Republican tool for Big Pharma.

Gawd I wish we had some control over our government.

We don't.

We won't.

We're fucked.

I'll keep popping these pills till they kill me.

[madokie]

16. I wonder about the drugs I get from the VA

especially the hydrocodone as it seems to vary in strength by refills. Some months I have many left over and then some months I don't have enough. Last months supply left me with a fourth of them left but looks like this month I'll be dipping into that stash. I know with valium if I take a generic I'll have nightmares like crazy but if I take the real thing I sleep like a baby. Haven't taken a valium in years now though and never did take them for their intended purpose, only for the buzz.

[tavalon]

21. Not all generics are created equally

That said, I've never personally run across any that I've seen a difference in my response to. Interestingly, my doctor was willing to write a prescription for name brand Ritalin because the generics have been inconsistent but I've not ever noticed a difference, so I turned down the offer.

[Wiley50]

5. You mean, you have a choice? Medicaid patient here n/t

You're only allowed two brand name drugs per month. I'm on 5, the max total scripts they'll pay for (so three generic)

Any more I need I have to pay for.

[Aragorn]

6. you hope so

Insurance companies decide whether or not to pay for brand names. Part D Medicare has 250 something different insurance companies, each with its own rules on this. In Texas, Medicaid pharmacy benefit is run by a Bush donor from governor days. Since they get more money on brand name (sometimes) they only cover brand name!

Chinese drugs without legal recourse is bad enough. If you die, it's even worse.

Profit motive may be better than communism (as opposed to socialism) but only to a point.

I treat a whole lot of uninsured patients. Most of the rest are Medicare or Medicaid. They know the score on this.

We must have universal coverage or this country loses another competitive point. Businesses move to countries with universal coverage already!

[blondeatlast]

7. About your last point--I'm befuddled that US employers haven't embraced

universal healthcare--even a plan like Medicare's would save them ENORMOUS amounts of money, but they don't seem to get that.

Mr. B@L works for an international company that is closing US operations--one of the biggest reasons is that they can't afford to pay health insurance in the US compared to their Asian and European operations.

Fortunately, he works for the European section so we'll be fine--but they have told him that they resent having to pay for his health insurance when if he worked in Prague they wouldn;t need to!

Welcome to DU! :toast:

[fed-up]

10. that would be Single Payer Universal Health Care & love your screen name-welcome to DU nt

[NuttyFluffers]

12. buy taiwan's, they are fanatically strict on purity

been looking at their food here, no complex, artificial, unexpected preservatives. best kept secret in the ethnic markets. they're also pretty petrified of Chinese anything and habitually avoid Chinese goods. so if you can find where it's made and it's made in Taiwan you can be pretty sure of its safety.

just FYI.

(funny what a little body of water can do to a culture... ;) )

[MiniMe]

13. Yet we can't buy drugs from Canada. Go figure

[durablend]

14. Canada puts "mind altering ingredients" in their drugs

Makes people support universal healthcare.

Can't have none of that!

[MiniMe]

15. At least you are still alive after you take them

[tavalon]

22. LOL

Yup, that's the problem!

[OhioChick]

17. Can Anyone Trust Drugs From China

Given the fiasco with the pet food?

[Asgaya Dihi]

23. Where are you going to go to avoid them?

The following passage from the same article seems to complicate things a little.

China is already the world's biggest producer of active pharmaceutical ingredients (APIs), the chemical raw materials needed to manufacture medicines, but to date it has not been a significant supplier of finished generic pills.

Now that is about to change.

Unless you track them manufacturer by manufacturer and verify their sources that makes it sound like the odds are good you're getting Chinese products in much of what we take, name brand or generics. Only thing changing here is they are putting it in the capsule too.

And no, given recent news I don't trust it either.

[JCMach1]

24. Let's see, you or I can't import drugs, but BIG companies can?

What's wrong with that picture?

[OhioChick]

26. Apparently, India is out, as well.

India perched atop fake drugs list

MUMBAI: Another first for India, but this one leaves a bitter taste. India has been listed by the European Commission (EC) as the country which supply lion’s share of counterfeit drugs in the Europe.

According to the statistics presented by EC last week on the fake goods seized in Europe during 2005, India has been listed first in the section of medicines with supplying 75% of the total fake drugs seized. Egypt takes the dubious second slot, accounting for 7% of fake drugs seized.

Surprisingly, China, which accounts for more than 60% of the number of all goods seized, stands is in third place, with only 6% of the fake drugs.

Apart from fake drugs, India has been mentioned only for fake ready-to-wear clothes with a share of 3%. In terms of number of fake drug consignments seized, India stands third with 4%, after Indonesia (15%) and Egypt (5%). Out of the 75 million articles seized in 2005, fake goods from India accounts for only 2%.

The apparent contradiction in highest quantity of fake drugs being seized from India and largest number of fake consignments originating from Indonesia is mainly due to a unusually large number of small consignments from such countries.

In European Union, 26,000 cases had been registered during last year, which corresponds to an increase of 20% over the 2004 figure.

The wider range of products exported from India including antibiotics, cancer cure drugs, anti-cholesterol tablets.

http://www.dnaindia.com/report.asp?NewsID=1065386