. . . that generic pharmaceuticals manufactured in countries like India are essentially identical to their brand name equivalents manufactured domestically is one of the great lies of our time.

I have had actual access to both the bioanalytical, and CMC analytical data for hundreds, if not more, of generic drugs from countries all over the world, as well as innovator drugs.

As such, I may be qualified to address your assertion.

Perhaps you can share with us how you are qualified to make this assertion.

You know, it is not really a crime for poor people to have affordable medications.

I take Valsartan. I'm quite aware of synthetic routes to it, and the nature of the contaminant here. (For a while, I was subject to some rationing, and knowing the risks and benefits, I personally found the whole affair annoying.)

I certainly agree that GMP manufacturing protocols are essential to safe drugs, but decisions can be made that are not cognizant of the danger of not having access to important medications.

I'm not a fan necessarily of Huahai, the company that manufactured most of the Valartan in question. This said, the contaminants are nitrosamines, well known carcinogens. However these same carcinogens are produced by cooking bacon, and by disinfecting water in which contains traces of urine, specifically, urea and uric acid. (This is common in most water supplies.)

Now if you asked me if I were to choose between the risk of a stroke because I had no access to Valsartan, and the risk of getting cancer from the known amounts of a carcinogen also found in bacon, I'd check the latter.

Many years ago, when I was working on the manufacture of protease inhibitors, we had a lot of a key intermediate that failed specifications, marginally so. Since world suppliers had a great deal of difficulty producing enough of these drugs to treat all the patients who wanted access to them, the choice was to accept by derogation the out of spec material or to let people die for a lack of treatment.

Given your expertise at making such pronouncements, perhaps you will be willing to share with us how you would have decided the point.

The contempt shown to pharmaceutical scientists and scientists in general by the general public is appalling. At least that's what I think.

to hear you address the point made in the post you are responding to. The comment concerned the purported identicalness of generic drugs and their brand counterparts.

Additionally, I don’t think the charge that there’s something fishy in Genericdrug World is a rap against scientists. It’s more against generic companies and whoever else perpetrates the ruse that generics and brands are the same. Is Diovan off the market due to it containing a carcinogen? No? Point #1 for the brand and the generic somehow being different. Wellbutrin?

...data connected with the bioanalytical data concerning generic drugs.

The statement to which responded is bullshit, as I strongly implied in my original comment, if not in a denotative sense, then certainly in a connotative sense.

As for whether or not the question of whether or not questioning the integrity of generic drugs is questioning scientists, who do you think makes generic drugs? You think it is easy for a high school student to make one, perhaps? I have personally met many thousands of Ph.D. scientists who are brilliant who have worked on the development of generic drugs.

In fact, some of them who I met worked for Sandoz, which until relatively recently was the generic drug manufacturing arm of Novartis, the company that developed Diovan.

It would not surprise me to learn that the very same reactors - wherever they are - that manufactures the valsartan API for Novartis' Diovan, also makes the API for generic companies.

What is true for water supplies - almost two billion people on this planet lack access to clean water - is also true of medication.

I personally take Valsartan, as I stated.

I have some news for you kiddie. Most big pharma companies do not manufacture or even analyze their own drugs. They outsource them. Huge pharmaceutical companies, including companies like Pfizer have faced FDA consent decrees.

GMP manufacturing is never a trivial matter. I've seen chemical reactors three stories high into which tons of material is processed using very challenging chemical reactions. The design and operation of these reactors is tightly controlled and open to inspection by the FDA, the EMA, and many other organizations. (I have met and interacted with FDA auditors, both on the manufacturing side and on the bioanalytical and CMC analytical side.)

Without a tetrazole ring, a pharmacophore that acts physiologically as a stand-in for carboxylic acids in many pharmaceuticals, drugs like those in the "sartan" class would not exist. This is nitrogen chemistry, which can be dangerous and difficult to control. I'm not commenting on Huahai specifically, nor am I saying that no one should take "sartan" type drugs. Personally, they are the only class of drugs that work for me. But, having spent my career closely attached to these issues, living day to day with them, I would not be surprised to learn that this issue has arisen before without being identified in many cases. I have personally seen the development of unknown impurities in multiple cases. In the industry, we try very hard and have tightly controlled procedures to address that concern, and are subject - appropriately - to deep and firm regulation, but sometimes unexpected things happen.

Probably the most challenging thing is not even manufacture, but storage by consumers.

Now.

I'm very happy for you if you can afford to pay $100/month for a blood pressure medicine. Really I am. This said, I pay about $5 a month for mine. I'd feel stupid if I paid $100/month for Diovan, because I know all about how drugs are made, and I know all the science that goes into them.

But even if I can afford $100 month, there are millions upon millions upon millions of people who can't. Many of the highly trained and highly educated scientists who work on generic drugs are acutely aware of that.

I have no problem with innovator drug companies making a ton of money for a drug they worked to discover, develop, and bring to market. It's usually a billion dollar undertaking with huge risk of failure; most promising discoveries in medicinal chemistry fail. But for centuries patent law has revolved around the idea that an inventor is entitled to make money for a fixed period of time in order to make a better life available for the greater mass of humanity thereafter.

It's a good idea, patent law.

As a scientist who has studied many issues for which I work professionally as well as other issues that I have studied at a very deep level that have nothing to do with my paycheck, I get very, very, very, very disturbed at the arrogance of people making simplistic statements, mindless statements, in an authoritative way on subjects about which they know nothing, absolutely zero.

I do regard the statement to which I responded as a clear rap against scientists, and I couldn't care less whether you agree or not. I have worked in all phases of drug development, from discovery, to development, to manufacture, to analytical. I know what I'm talking about.

this subject makes you so angry.

Come from China or India. Even the brand name stuff

catch news such as this from fellow DU members. Thank you again!

I'm very worried because her pharmacy can't find enough.

She has had serious bad reactions to several others and this is the only blood pressure med she can take.

It's on backorder until March, the manufacturer says. i got her a short supply at another pharmacy but not enough to last until then.

Now I wonder if this is why it's so hard to get?

Any tips on how or where to get what she needs?

At 88, carcinogens isn't a big issue for her -- but not having any blood pressure medication could cause her to stroke out.

for a way to get patients off cheap generics and on their expensive new name brand meds. Have had a number of patients asking to switch from their "cancer causing" blood pressure meds. They are surprised when I tell them that it is not the medication itself, it is the way certain manufacturers have produced the medicine that is to blame. Somebody out there is trying to paint all "generics" with the same brush. And that someone works for Big Pharm. Big Pharm has been trying for years to tarnish aspirin's rep so that they can sell more ranexa and (in the old days) plavix.

Meanwhile, a whole host of cancer causing foods and chemicals are still being produced and sold in this country with little fanfare, because these products make someone lots of money.

of exposing carcinogens in generic drugs probably isn’t the best argument against Big Pharma.

of a company that makes medical products all of us would recognize, I'm not the least bit surprised. Not surprised at all of cost cutting run amok. Penny wise and pound foolish doesn't begin to describe it.

Bastards.