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The Douglass Report July 2008

July 2008 PDF

Dear Friend,

Dog food, toothpaste, and the blood thinner heparin–any guess as to what they all have in common? ALL are products with ingredients imported into the U.S. from China over the last year or so, and ALL have been contaminated in one way or another.

Here’s a brief recap:

Contaminated pet food makes pets sick. Thousands of pets got sick –and some even died–when they ate tainted pet food laced with melamine, a toxic substance that was added to boost the appearance of the food’s protein content. (Something that would have been a non-issue if people were feeding their pets raw food instead of processed soy junk food.) Even if you’re not a dog lover like I am, you should be concerned that some of the pork and poultry that ended up on your dinner table came from animals that had been fed with this tainted food.

Imported toothpaste contains antifreeze. Not too long after that, we found out that toothpaste from China was made with a base ingredient from ANTIFREEZE called di-ethylene glycol (DEG). In fact, there was so much of it in the toothpaste that it made up 3 to 4 percent of its total weight!

FDA-approved drug leads to dozens of deaths. Now, in the most recent imported tragedy, over 80 people have died (so far)–and hundreds have experienced allergic reactions–from taking an FDA-APPROVED blood thinner, heparin. Lab tests showed that the blood thinner contains an ingredient called oversulfated chondroitin sulfate.

Under the FDA radar

How could this happen? Well, the final product might be made in the U.S. of A., but that doesn’t mean its ingredients are. In fact, most of the active ingredients in drugs DON’T come from the U.S.

Doesn’t that make you stop and wonder what kinds of rules and regulations govern these operations? Our government prides itself on the accomplishments of the Food and Drug Administration. And for most uninformed Americans, seeing something stamped with the “coveted” FDA seal of approval is all the validation they need to believe a drug is safe for them. (Never mind the fine print on the drug label warning of the possibility of imminent death.)

But is a product safe? How do you know? How does the FDA know?

How about this for a scary statistic: A whopping 80 percent of all ACTIVE pharmaceutical ingredients that are used by manufacturers here in the U.S. are IMPORTED, mostly from China. China!

According to former FDA commissioner David Kessler, “China is as close to an unregulated environment as you can get. In fact, it’s a lot like the USA was in 1906. That’s why we developed the FDA.”

How many more people will have to die before the FDA learns its lesson and stops doing business with those Communists?

Interestingly enough, just before the heparin news story broke, the Government Accountability Office (GAO) reported on the preliminary findings of an audit of the FDA’s foreign drug regulatory system. One of the major problems, it turns out, is a lack of resources.

An “unacceptable” oversight

One of the major ways the FDA attempts to ensure the safety of drug ingredients is by inspecting the foreign plants that export to the U.S. But there’s simply not enough manpower to keep tabs on every manufacturer.

You’ll probably be shocked to find out that China has over 700 firms that export active pharmaceutical ingredients (APIs) to this country. 700! And do you know how many the FDA inspects every year? Between 10 and 20. That means that the average rate at which the FDA inspects each firm is once every 35 TO 70 YEARS.

When you add the manufacturers from the rest of the world into the mix, the numbers don’t get much better. The GAO determined that the FDA has enough resources to inspect each plant once every 13 years.

Rep. Bart Stupak, chairman of the House Energy and Commerce Committee’s subcommittee on oversight and investigations (that certainly was a mouthful), said that “given that these inspections are the most important tool the FDA has to ensure firms are meeting U.S. drug safety regulations, these rates are unacceptable.” I agree.

The problems don’t end there. One FDA database showed that about 3,000 foreign firms were registered to market drugs in the U.S., but another database showed that more than double that number were actually shipping products here.

More proof of unregulated drugs

Another report, this one by a subcommittee of the FDA itself, was just about as damning as the GAO’s. (The title of the report is “FDA Science and Mission at Risk: Report of the Subcommittee of Science and Technology.”) The first shocking thing about this two-year study is that it appears to be unbiased. It was made up of three dozen external experts representing three different organizations: industry, academia, and other government agencies.

I wish I could say I was shocked by what I read in that report, but it’s just more of the same. A lack of resources for conducting foreign drug inspections was just one of many holes in the leaking FDA dam.

The report states the following: “Although approximately 80 percent of the active pharmaceutical ingredients used in our prescription drugs are imported from abroad, and foreign imports of drugs and active pharmaceutical ingredients were valued at more than $42 billion in 2006, FDA inspected only 361 foreign drug and biological product establishments in 2006. Only 32 field inspections were made in India and 15 in China, the two largest sources of pharmaceutical exports to the United States. Millions of shipments of FDA-regulated products are imported into the country each year from foreign facilities that have never been inspected by the FDA and, with current appropriations, never will be.”

How can the FDA look any American in the eye and say with a straight face that the drugs you’re taking are safe and “approved” when they don’t even know where the ingredients–the ACTIVE ingredients–are coming from?

They can’t. Yet they do so every day. And they allow pharmaceutical companies to do it, too. I’m sick of hearing, “Ask your doctor if X, Y, or Z is right for you.” What does your doctor know? He’s waiting for approval from the FDA. If it’s OK with them, it’s OK with him.

From Big Pharma’s point of view, they couldn’t be happier with the status quo. They don’t want those foreign suppliers to be investigated any more than the suppliers themselves do. But where does that leave you? Up a creek, that’s where.

FDA inspects the wrong factory

The heparin story gives you just one example of our fine Food and Drug Administration at work. The good news is that FDA officials went to China to look into the Chinese-made drug that’s found in heparin. The bad news? They evaluated the wrong factory.

Instead of inspecting the suspect manufacturer, the FDA confused it with another company in the agency’s database that has a similar name. Worse still, even though the FDA THOUGHT they had the suspect company, the company that they were inspecting had a history of positive inspections SO THEY DIDN’T REINSPECT IT. You can’t make this stuff up, unfortunately.

After discovering the error a month after the fact, the FDA immediately dispatched investigators to the suspect company.

Keeping in mind that there are over 2,000 characters in written Chinese and who knows how many dialects of that language, I’m inclined to say that it was an honest mistake for Western bureaucrats to get a little mixed up with the name of a Chinese company. But, given all the recent news stories about shoddy and potentially deadly products from China that have been finding their way into our country, it’s hard to believe that the FDA wouldn’t check and triple check all DRUGS coming from there–ESPE-CIALLY when an ingredient in question could possibly be linked to DEATHS.

The solution? Ban Chinese ingredients

The fact of the matter is that the Food and Drug Administration is a mess. People can–and DO–die every day because of these “regulatory goofs.” From where I stand, a response like, “Oops, looks like we missed that” just doesn’t cut it. It’s time for something to be done–for some kind of action to be taken. And I don’t mean the formation of more committees and more regulatory boards to write up more reports. A second or third opinion is one thing–but enough already. We know the problems –now is the time to fix them.

The only logical thing to do is to immediately ban ALL Chinese imports. The FDA should also halt the sale of drugs containing imported API’s until they can reinspect (or in some cases inspect) the plants that they came from.

But of course, that would cost big business too much money. And you know that Big Pharma has repeatedly assured their friends in the FDA that the Chinese companies that supply many ingredients for Big Pharma’s vastly lucrative drug brands (at cut-rate prices) are surely on the up and up.

Personally, I don’t believe the Chinese can be trusted to follow safety regulations that are up to U.S. standards. Plain and simple. China has exhibited a complete disregard for the safety of the drugs, food, and goods distributed within its own country–why should we expect them to have a higher standard for goods meant for export?

What bothers me is that, because of money, these logical next steps likely won’t ever be taken. Call your congressional representatives and try to shake something up–because, as we all know, it usually takes a public outcry before the government gets serious about protecting our health.

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