The Checkout

So That's Where My Drugs Come From

Yesterday, a company I had never heard of before recalled 11 million bottles of acetaminophen because it found pieces of metal the size of a couple grains of salt in the pills.

Nothing life threatening, mind you. But as with E. coli-tainted spinach, yesterday's recall taught me a lot about where many of the medicines and supplements I take come from.

The substance in this case is generic painkiller sold under store brands at more than a hundred retailers nationwide such as CVS, Safeway, and Wal-Mart.

The company that recalled the drug, Perrigo Co. of Allegan, Mich., makes just about every generic version of popular over-the-counter medicine and nutritional supplement you can think of: NyQuil, Sudafed, Claritin, Centrum vitamins, even Garlique.

In fact, according to Perrigo CEO Joe Papa, every man, woman and child in the U.S. takes an average of one Perrigo-made tablet every four days!

It's not hard to believe. While writing the story, I reached into my desk drawer and pulled out my stash of CVS extra-strength non-aspirin pain reliever. The bottle fell within the recalled expiration dates but it wasn't part of an implicated lot.

The funny thing is that nowhere on the bottle does it say who makes the pills, only who distributes them, so as consumers you have no way of knowing where the heck it actually comes from.

Then, there are the things drug makers do before they put them in the bottle.

Some of the lots involved in the recall are for pills sold as long as three years ago. So when did the company discover the problem? From what it said in its press release, the company told the FDA on Nov. 2. Perrigo noticed some tablet-making equipment was wearing out prematurely. Somehow, this led the company to run 70 million pills through a metal detector, of all things, which turned up the metal fragments.

Granted, you don't feel the same shock when you learn that one little-known company makes your headache medicine, decongestant and daily vitamin, as you do when you find out the chicken you had for lunch didn't come from some nice farm but an industrial feedlot operation where it didn't see the light of day and was pumped full of hormones.

But it did raise a similar issue, which is when you have centralized production combined with national distribution, a small problem can easily turn into a much larger-scale one.

It turns out that this was Perrigo's 11th recall for the year and its 23rd since 2001. A previous acetaminophen recall involved pills contaminated with bits of acrylic mirror.

How did that happen?

It falls to the Food and Drug Administration, which oversees drug-manufacturing operations, to find out.

The FDA seems to have been keeping an eye on Perrigo, inspecting them seven times over the past five years--that's more often than their usual frequency of about once every two years.

Sidney Wolfe of Public Citizen says inspections don't mean much if FDA can't fine the companies when they find violations.

It isn't cheap for drug makers to do these recalls, which cost million of dollars. Not to mention the damage done to their reputations. In the case of Perrigo, though, the retailers keep lining up to buy the company's drugs, regardless of its recall record, and the company appears to be doing well financially, with annual sales topping $1 billion.

Marc Scheineson, a former FDA official and food and drug law expert, assures me that the prospect of getting sued by personal injury lawyers is incentive enough for drug makers to be conservative about recalling their products. But if that was truly enough, would Perrigo really have had so many recalls?

Do you think the FDA needs more teeth? Or is the fear of John Edwards enough to make sure companies do the right thing?

By Annys Shin |  November 10, 2006; 7:31 AM ET Consumer News
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Comments

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I can't help but ask...

With the unimaginable amount of pills this company seems to be pumping out, maybe recalls should be looked at as a percentage rather than a hard number?...just to be fair.

Posted by: Heff | November 10, 2006 8:13 AM

My issue is Zyprexa which is only FDA approved for schizophrenia (.5-1% of pop) and some bipolar (2% pop) and then an even smaller percentage of theses two groups.
So how does Zyprexa get to be the 7th largest drug sale in the world?

Eli Lilly is in deep trouble for using their drug reps to 'encourage' doctors to write zyprexa for non-FDA approved 'off label' uses.

The drug causes increased diabetes risk,and medicare picks up all the expensive fallout.There are now 7 states (and counting) going after Lilly for fraud and restitution.

--
Daniel Haszard

Posted by: Daniel Haszard | November 10, 2006 8:22 AM

Perrigo is in Holland, MI. It is a top notch company.Guess what the largest retailer in the world would not use them if they were not.

Posted by: Paul Everin | November 10, 2006 8:27 AM

I feel that the FDA should make these types of companies label the bottles with the manufacturer's information. Even if it's a generic drug sold under many brand names. The public has a right to have readily available the information on the bottle as to where the pills were manufactured.

Posted by: Shaun | November 10, 2006 8:52 AM

The job the federal government has largely abandonded is oversight. Not only oversight of the president, but the more general role of "setting the bar" for business and industry. If no one defines the denominator for industry, it quickly turns into a race to the bottom--it is, after all, the stated goal of all publicly traded companies to maximize shareholder profits. So as soon as one company lowers its standards, the other must do the same unless there is something (federally defined and enforced standards) to stop them.

Posted by: Phil | November 10, 2006 9:06 AM

Who's John Edwards? The senator? I don't get the reference.

Posted by: Huh? | November 10, 2006 9:24 AM

I find it hard to get excited about this issue. The manufactuer made the right move when they investigated the issue and declared a recall. However, tiny metal fragments do not sound all that scary.

If this company can produce so many different products, and yet be barely know their name, this means that they are doing something right.

Posted by: Matt M | November 10, 2006 9:31 AM

As long as cos. like these have their politicians that are bought & paid for little if anything will be done regardless of the party in power.

Posted by: Davies | November 10, 2006 9:57 AM

Yes, a company is doing something right when consumers can't link its products back to the company. It means they are less likely to be held directly accountable for their mistakes. It makes good business sense.

Also the idea of correlation between serving the largest retailer in the world and being a top notch company is entertaining. Depends if you define top notch as maximum profit or maximum societal benefit.

Posted by: Andrew | November 10, 2006 10:02 AM

Matt M, the fact that they've been investigated so often and have issued so many recalls in recent years implies that they're actually not doing things right.

The biggest reason we don't know their name is that their name isn't listed on the products they package. Aside from that, though, I'm not sure why there hasn't been more media coverage over past recalls.

Posted by: Dan | November 10, 2006 10:10 AM

So how does Zyprexa get to be the 7th largest drug sale in the world?:
Because the patients who do take it, need to take antipsychotics every day, 365 days a year, in individualized (sometimes very large) doses.
Off-topic, but Zyprexa is for chronic, disabling illness, therefore Medicare also paid for much of that medication, as well as diabetes that resulted. On a positive note, its much less likely that metal pieces find their way into Zyprexa! ;)

Posted by: universalhealthcare | November 10, 2006 10:16 AM

This article is one more revealing example of how the conservative agenda can be so very dangerous to America's health, well-being and economy. Conservatives would have us eliminate regulation or inspection on industry, and do away with legal remedies. They favor tort reform, and argue that we don't need "daddy government" to ensure we have safe products. They disingenuously claim that the market will provide the necessary corrections. But if there are no inspections, no statistics or record keeping, and no legal remedies, whose to ever know what really killed your baby? Keeping the public befuddled and in the dark protects quarterly profits and prevents corporations from accountability. This is the real conservative agenda. Conservatives ignore the fact that healthy commerce depends on trust. Regulation preserves trust and is good for the economy. The whole conservative ideology is disingenuous, dangerous, shortsighted, self-serving and backward.

Posted by: Laura | November 10, 2006 10:25 AM

For uncensored news please bookmark:

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http://onlinejournal.com/artman/publish/article_1419.shtml

Who is Mr. Gates?
Bush administration's Trojan Horse gift to America and the Democrats: Former CIA Director and Iran-Contra insider Robert Gates

By Larry Chin
Online Journal Associate Editor


Nov 10, 2006, 00:52

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With the Democrats and Democratic Party voters euphoric over a purported election victory, and a possible "change of course" in Iraq, the Bush administration quietly added poison to the Democrats' celebration champagne by dredging up former CIA Director and Iran-Contra participant Robert Gates to replace Donald Rumsfeld as defense secretary.

The "war on terrorism" will not only continue, it will expand and deepen with Gates heading the Pentagon.

Who is Robert Gates?

Robert M. Gates was the CIA's Deputy Director for Intelligence (DDI) from 1982 to 1986. He became CIA Deputy Director of Central Intelligence (DDCI) in 1986, and moved up to Acting Director of Central Intelligence (ADCI) that same year. In 1991, George H.W. Bush nominated Gates to head the CIA (as Langley's DCI).

As a protégé of the infamous William Casey, and as both deputy director and director of the CIA, it goes without saying that Robert Gates was involved in every geopolitical crime and cover-up of the Reagan-Bush and George H.W. Bush era.

The encyclopedic list includes Iran-Contra, CIA narcotics trafficking, criminal covert operations, the infamous October Surprise, and the Bank of Credit and Commerce (BCCI) scandal.

Gates, Iran-Contra, and CIA drug trafficking

During the George H.W. Bush administration, with the Iran-Contra crimes still fresh, Gates survived the confirmation hearings (from a much fiercer Washington Congress) that elevated him to director of Central Intelligence. He was tarnished, but survived, the hobbled and corrupted Lawrence Walsh probe of Iran-Contra, which left the vast majority of Iran-Contra crimes unaddressed.

Despite its limitations, the Walsh probe managed to expose and tarnish many of the operation's players, and resulted in convictions for several participants (and, soon afterwards, pardoned by George H.W. Bush), one of them being Gates.

Robert Gates, like many Reagan-Bush era players, has a lot to answer for.

Subsequent research documents the fact that the CIA, National Security Council (NSC), and branches of the US military engaged in a host of massive narcotics trafficking operations, the most noteworthy of which were named Amadeus, Watch Tower, and Pegasus.

These operations, combined with related operations and geopolitical programs, comprise what is popularly known as "Iran-Contra."

Robert Gates was there for it all.

Gates is one of many officials implicated in detailed histories of the Iran-Contra period, and in CIA documents and reports, including the 1998 CIA Inspector General's Report into Contra Drug Trafficking. Gates' name surfaces in the Cutolo Affadavit (attributed to Army Colonel and CIA operative Ed Cutolo, the supervisor of Operation Watch Tower, but likely penned by Cutolo's associates, but thoroughly corroborated by whistleblowers and researchers).

According to Rodney Stich, author of Defrauding America, each operation "had basically the same characters involved . . . with Edwin Wilson . . . Robert Gates and William J. Casey . . ."

Despite being "in the loop," Gates has routinely denied his guilt over the years, but proof of his active role cannot be hidden. As acting DCI, Gates issued a memo that was tantamount to ordering a cover-up.

According to Mike Ruppert of From The Wilderness, a long-time whistleblower and chronicler of the CIA's narcotics crimes: "On April 9, 1987, Acting DCI Robert Gates sent a memorandum to the Deputy Director of Operations (DDO) Clair George stating it was imperative that CIA avoid involvement with individuals tied to the Contra program who were 'even suspected of involvement in narcotics trafficking.' The Gates memorandum instructed the DDO to vet contract air crews, air service companies and subcontractors with the Drug Enforcement Agency (DEA), US Customs and the Federal Bureau of Investigation (FBI) to ensure that the Agency would not be involved in any way with individuals suspected of being involved with drug trafficking."

In other words, cover up the extensive network in place, cut off relationships with assets, eliminate troublesome operatives, and create plausible denial.

How in-the-loop was Gates?

Retired US Navy Lt. Commander and ONI officer Al Martin, a participant in the Iran-Contra operations, authored The Conspirators: Secrets of an Iran-Contra Insider. In this book, Martin hangs the entire Bush apparatus out to dry, and details the many Iran-Contra-related criminal operations.

According to Martin, Gates was high-level.

"In terms of policy management, (William) Casey formed a series of inter-governmental agency Restricted Access Groups (RAGs). Ultimately three such groups were formed. The top Restricted Access Group 1 was Vice President George Bush -- as it was decided that all narcotics, weapons and money operations vis-à-vis Iran-Contra, would be consolidated under the office of the Vice President.

"Also included in these Restricted Access Groups were then Vice Presidential National Security Advisor, Colonel Donald Gregg, then Deputy Secretary of State Lawrence Eagleburger and Assistant Secretary of State Elliott Abrams, who was in charge of the Inter-American Affairs Office (an office which served in no other capacity except being a propaganda tool for the Nicaraguan Contras), Richard Armitage, and Assistant Secretary of State, Bernie Aronson.

"In the Department of Defense, the RAG group included Assistant Secretary of Defense Frank Carlucci, Assistant Secretary of Defense Richard Stillwell, and Caspar Weinberger himself.

"In the CIA, besides Casey, there was the infamous Deputy Director of Operations, Clair George, and Assistant Deputy Director of Operations, Alan Fiers.

"The names involved in the Restricted Access Group would change as these men changed positions in government from 1983 through 1986.

"When Frank Carlucci left the Defense Department to become Presidential National Security Advisor and Bobby Gates became Deputy Director of the CIA, Gates supplanted Carlucci within Restricted Access Group 2."

Gates, according to Martin, was elevated to Group 1 status upon being confirmed as Director of Central Intelligence.

Gates and assassinations

According to Stich, Robert Hunt, former Navy SEAL commander and deep-cover CIA/ONI operative, described to him a CIA assassination squad called Operation Ringwind.

This operation, according to Hunt, was under the control of then-Deputy Director of the CIA Robert Gates.

"They call it Operation Ringwind, formed in early 1981. It was strictly to take care of all participants in October Surprise until they decide to shut the operation down. And that could be tomorrow morning, or ten years from now. Whoever they think is involved."

Iran and the Bushes

According to Robert Parry, "the American people today should know the real history of US-Iran relations before the Bush administration launches another preemptive war in the Middle East."

This history, which covers Gates' long tenure at the CIA, "includes the facts regarding Republican contacts with Iran's Islamic regime more than a quarter of a century ago -- relevant today because an underlying theme in Bush's rationale for war is that direct negotiations with Iran are pointless. But Bush's own father may know otherwise."

The Bushes and the Truth about Iran (Robert Parry)

It is no coincidence that Iran veteran Gates comes to the Bush administration as the US prepares for operations against Iran.

Gates and BCCI cover-up

The Bank of Credit and Commerce International (BCCI) was the CIA's legendary drug bank and money laundering nexus.

In Defrauding America, Stich writes, "CIA Deputy Director Robert Gates stated in 1988 to the head of Customs, William von Raab, that BCCI stood for the 'Bank of Crooks and Criminals International.' But the CIA continued to deposit and launder funds in BCCI, covering up the criminal activities that would defraud people all over the world who had put their money into the bank.

"In the 1980s, US Customs Commissioner William von Raab unsuccessfully tried to get the Justice Department to act on the serious federal violations committed by BCCI.

"Raab testified to Senate investigators that in 1988 he told CIA Deputy Director Robert Gates of the drug money laundering at BCCI, and that Gates refused to proceed with the information."

A tactical move

The Rumsfeld resignation is not a sign of desperation or surrender in response to Democratic Party heat. It was a long-planned tactical move that strengthens the Bush administration's inner circle, while slapping the political opposition in the face.

By replacing the criminally insane Rumsfeld with the Bush-Reagan era insider Gates, the Bush administration (and Karl Rove) seeks to accomplish three objectives.

It puts another Iran-Contra criminal and military-intelligence criminal veteran into the cabinet, atop the Pentagon and America's war machine -- ensuring the expansion, penetration and successful execution of the "war on terrorism" into the rest of the Middle East and Iran (which William Casey protégé Gates got to know intimately, as CIA official during the administrations of Reagan-Bush, and George H.W. Bush ).

Gates joins other Iran-Contra criminals, such as Elliott Abrams and John Negroponte, at the controls of power. The military brass had serious problems with the peevish Rumsfeld. It may not have these issues with the savvier (and, for the world, more dangerous) Gates.

It removes any chance, any relevance, to any hopes that leading Democrats had about dragging Rumsfeld, already a political liability for Bush, into hearings regarding the management of the Iraq war. The entire Iraq debate, which the Democrats had hoped would swirl around a sitting Rumsfeld, flies away with a new Gates Pentagon.

Gates, who had relatively few problems with Democrats in the past, is likely to meet little resistance from weak Democrats engaged in "bipartisanship." There is little chance that the Democrats are likely to bring up past history.

Other Iran-Contra participants have received similar red carpet treatments from Congress since 2000.

The Bush administration has done what it has always done: replace a political liability with something even more dangerous, a loyal insider to the very highest positions of authority. The move adds insult to six years of injury, an openly provocative act that dares the perplexed Democrats to do anything to stop it, knowing that they will not.
If Robert Gates does with his new Pentagon power what he did at the CIA during his previous tenure, the world is in for tremendous suffering and death, and more covert and overt warfare -- all well-"managed," packaged and sold to Congress. Gates, unlike the divisive Rumsfeld, is a criminal who is capable of uniting the elite consensus.

Posted by: che | November 10, 2006 10:38 AM

wake up you know the name of the game. you buy we sale. they pay 1 dollor for a pill we pay 20 dollors for a pill. you can see for yourself. T MCcormick

Posted by: tim | November 10, 2006 10:47 AM

One thing people seem to be ignoring: this is a generic drug maker, not a brand name drug maker.

With a brand name drug, the main incentive that the manufacturer has to maintain quality is reputation. If something like this happened with a brand name drug, people would start avoiding it on the store shelves, and the company would lose more money from that than they would lose from a recall.

Generic drug makers don't have the same visibility, and there's no easy way for a consumer to avoid them, since their goods are generally sold under a wide variety of store brand labels. In addition, generic drug makers compete only on cost; they have to undercut the brand names to sell. Because of these two things, generic drug makers have much more incentive to cut corners, leading to problems like this.

Really what would help would be if the headlines on reports like this called out "generic drugs", or "store brand drugs", or even "CVS branded" drugs. Only if the reputation of the generic drug industry, or of the drug store chain, is threatened, will they shape up.

Posted by: Warren Dew | November 10, 2006 10:50 AM

Hey che,

You need to get a life! Are the black helicopters watching you right now? Beware, they are out to get you!

Also, I'm guessing that's uncensored left-wing news right?

Posted by: Scott | November 10, 2006 11:05 AM

I had always assumed the major drug makers made the generic brands as well, and distributed them to stores to put their store names on them. After all, the store brand of extra-strength pain reliever is identical to Excedrin. I thought they just cut a deal with the stores to slap on another label and sell it for less. DUH! Stupid me. So, who does make the store brands, like Giant and Safeway brands of soups? Who makes the CVS brand of shampoo or mouthwash? It would be interesting to find out where that stuff really does come from, rather than who the distributor is. Sounds like an assignment for an investigative reporter. BTW-- did they ever catch the Tylenol killer of 20+ years ago?

Posted by: Southern Maryland | November 10, 2006 11:11 AM

I am wholly surprised by this recall.
Years ago a company providing "house store" vitamins and over-the-counter medicines installed a very simple item: a magnet placed on the outlet of the equipment used to create their pills and capsules. Like wise, all pills were subjected to further scrutiny (due to their density) on a Quality Test conveyor belt where they were run over another series of magnets. All pills and capsules containing metal fragments were therefore screened out and destroyed.
This equipment was in place over six years ago at similar manufacturers. So why is Perrigo so far behind the times?

Posted by: Amanda | November 10, 2006 11:12 AM

Allegan sounds like a drug name itself!

Posted by: fishersons | November 10, 2006 11:14 AM

This is nothing. Just a labeling problem. They should have said it was iron fortified.

Posted by: Dane | November 10, 2006 11:18 AM

What has the FDA done during their lifetime to benefit anyone in the realm of mankind? Furthermore where were they during the recent E-coli-ed spinach discovery? How about a report of their activities during the last twenty or thirty years. Maybe we the people should put John Edwards in charge of the FDA. No answer to my comments is desired, I have just offered these in case other senior WW2 veterans might like to second them as a motion for the people to vote on. Have fun, and bye. Willie D.

Posted by: w.damon@sbcglobal.net | November 10, 2006 11:38 AM

ELEVEN recalls this year??? They do produce an incredibly high volume of pills, but that sounds like a lot.

To Matt M, who said tiny metal fragments don't sound that scary, some were pieces of wire up to 8 millimeters long (about a third of an inch) (http://www.fda.gov/bbs/topics/NEWS/2006/NEW01507.html). Try sticking that up your behind and see how it feels.

Posted by: h3 | November 10, 2006 11:55 AM

As long as I'm at it I'll give you some more information about an every day cancer cure that I've known about and told many of my friends about during the last ten or fifteen years. There are several combined parts that must be used together for it to be completely effective. Some are things that must not be taken in or used because they weaken our natural immune system. The worst one is caffeine because it destroys the essential vitamin C and rest of them are sodium, alcohol, tobacco and drugs. Then to build up the natural immune system, drink 2 to 4 ounces of pure Aloe Vera juice daily that comes from Irving Texas. Willie.

Posted by: w.damon@sbcglobal.net | November 10, 2006 12:46 PM

Mark said,

"I find it hard to get excited about this issue. The manufactuer made the right move when they investigated the issue and declared a recall. However, tiny metal fragments do not sound all that scary."

Mark, you are a very ignorant man.

The roster of poisonous metals is substantial. Also, perforation of the intestines, diverticulitis and other complications from having metal lodged in your gut are many and horribly painful, if not fatal, should it go into peritonitis.

"If this company can produce so many different products, and yet be barely know their name, this means that they are doing something right."

Yeah, that's right! When some agency you've never heard of breaks down your door and drags you away at 4 AM, well, they must be doing something right too!

My GOD, man, learn to employ some critical thinking, or just go and do what Rush tells you to.

*********************

And yes, I throughly resent the legislation passed under the former GOP Reign of Terror that permitted these OTC meds companies to get away with not showing the country of manufacture. Corporate responsibility, in THIS era? Generally speaking, I think that they'd kill us in our sleep, and market our organs if they thought the return was good enough.

Posted by: Zen Monk | November 10, 2006 12:51 PM

Once againwe see the effects of the lack of oversight with this party. The allmighty buck is el primo..Siege Heil...

Posted by: Jack Det.. | November 10, 2006 12:55 PM


At the outset of the 20th Century our food supply became an initial testing ground for innovations in the emerging 'better life through chemistry' belief system. Chemists work with food processing companies to create artificial sweeteners, a butter substitute, taste enhancing additives such as MSG, and the first partially hydrogenated vegetable shortening. These synthetics set the stage for the revolution in food processing that is now common place..


1900: Cancer is the tenth leading cause of death in the U.S., responsible for only three percent of all deaths. By the end of the 20th century, cancer will be the cause of 20 percent of all deaths in the U.S.

Diabetes affects less than one-tenth of one percent of the U.S. population; by the end of the 20th century, almost 20 percent of U.S. citizens will contract types I or II diabetes.

Asthma and related immune system diseases are virtually nonexistent; by the end of the 20th century at least 150 million people worldwide will be afflicted.

Breast cancer in women is very rare in 1900; by 1960, breast cancer will affect one in 20 women; by 2005, one in three women will develop breast cancer.

1906: The Pure Food and Drug Act is passed by the U.S. Congress, enabling the federal government to remove a food or drug product from circulation if its proves unsafe. But food processors and drug manufacturers are not required to prove their products are safe; the burden is on government to prove the products are unsafe before they can be removed.

1920:
from this date forward to 2000, the U.S. production of synthetic chemicals increases from less than one million pounds a year to more than 140 billion pounds a year.

1920: From this date forward to 2000, the U.S. production of synthetic chemicals increases from less than one million pounds a year to more than 140 billion pounds a year.

1921: General Mills Corporation creates a character named Betty Crocker to convince generations of Americans to use processed foods. Prior to this date a total of 20 reports of endometriosis in women had been reported worldwide; by the late 1990s, nearly 20 percent of all women of childbearing age are afflicted with endometriosis in the U.S.

1930:About 3,000 people this year out of a U.S. population of 123 million will die of heart disease; by 1997, at least 727,000 people will die of heart disease out of a U.S. population of 248 million.

1933: Industrial synthesis of vitamin C: A workable method of synthesizing vitamin C is turned into a commercial success by the pharmaceutical company Roche.

A muckraking book, "100 Million Guinea Pigs: Dangers in Everyday Foods, Drugs, and Cosmetics," is published and becomes a bestseller. It reveals many cases of harm and death from such products as eyelash liners that blind women, hair removal creams made from rat poison, and cataracts caused by a weight-loss drug. An American Journal of Medicine paper identifies a new type of diabetes resistant to insulin, called type 2 diabetes, which is becoming a disease epidemic in the U.S.

1936:A report published by a committee of the U.S. Senate warns the American public: "Do you know that most of us today are suffering from certain dangerous diet deficiencies which cannot be remedied until the depleted soils from which our foods come are brought into proper mineral balance?"

1938: Pharmaceutical maker Roche, having mastered the industrial synthesis of vitamins A, B1, B2, E and K, becomes the world's leading supplier of vitamins. A new federal law, The Food, Drug and Cosmetics Act takes effect. Though the law empowers the U.S. Food and Drug Administration to force manufacturers to prove their products are safe before marketing them, the FDA chooses to focus enforcement efforts on the accuracy of information on product labels.

A powerful new pesticide called DDT is discovered by a Swiss chemist; in this same year British scientists synthesize a synthetic estrogen called DES.

From this date until 1990, average human male sperm counts drop by almost 50 percent; during the same period the incidence of testicular cancer triples.

Now to the present:

1998: The Council for Responsible Nutrition reports that the U.S. health care system can save $10 billion a year on the costs of treating breast, lung and stomach cancers if only Americans would consume recommended levels of vitamin C, vitamin E, and beta-carotene.

A study published in The Journal of the American Medical Association reveals that 106,000 people die each year in American hospitals from the side effects of prescription medications. Another 2.2 million people a year have serious but nonfatal reactions to prescribed drugs. Adverse drug reactions have become the 4th leading cause of death in the U.S.

As of this date, 75,500 synthetic chemicals are registered as appearing in consumer products, agriculture and industry. The EPA has over 24,000 pesticides registered and the FDA oversees 8,000 chemicals used in cosmetics and as food additives. The Journal of Epidemiology publishes a study showing serious negative side effects from chlorine byproducts found in drinking water. Chlorinated tap water in three regions of California increased miscarriages among women who drank more tap water containing chlorine than bottled water.

1999: according to the Centers for Disease Control, the annual reported number of foodborne disease cases in the U.S. amounts to 76 million illnesses, 325,000 hospitalizations and 5,000 deaths. Most are caused by viruses and bacteria. As of this year, more than 25,000 cosmetics chemicals are in use. Less than 4 percent of these cosmetics ingredients have been tested for safety in humans. The saying "Not animal testing." takes on a new meaning, humans are animals too!!

2000:the National Academy of Sciences reports that half of all pregnancies in the U.S. result in less than healthy babies. Up to one-third of the developmental defects in these babies were caused by exposure to toxic chemicals. Half of all Americans now take at least one prescription drug every day; 25 percent of Americans take multiple prescription drugs every day. the incidence of testicular cancer is now estimated to be four times higher than just 50 years earlier.

The Physicians for Social Responsibility releases a report describing "an epidemic of developmental, learning and behavioral disabilities" affecting an estimated 12 million children in the U.S. Evidence suggests the epidemic may be a result of toxic chemicals affecting the central nervous system of these children.

2001:the Center for Disease Control announces that the food we eat is responsible for twice the numbers of illnesses in the U.S. in comparison to just seven years earlier. The Journal of the American Medical Association publishes a study revealing that of 6.7 million adult annual visits to the doctor for a sore throat between 1989 and 1999, antibiotics were prescribed in 73 percent of the visits even though antibiotics do not treat viral infections.

2002:the Journal of the American Medical Association reports a relationship between chronic disease and vitamin intake, recommending that all adults take at least one multi-vitamin a day because the absence of these vitamins in their food puts them at risk for cancer, cardiovascular disease, and osteoporosis.

The U.S. pharmaceutical industry now employs 675 lobbyists, including 26 former members of Congress, and spends $91 million a year on influencing decisionsmade by Congress. For the first time since 1958, the U.S. infant mortality rate increases. It is now twice that of Japan and most other industrial nations.

Harvard School of Public Health researchers report in the journal Epidemiology that phthalates found in plastics may be contributing to reproductive defects. The study of 168 male patients at a fertility clinic found that the men with the highest levels of phthalates in their blood were also those with the lowest sperm counts and lowest sperm activity. A study in the medical journal, Archives of Disease in Childhood, reveals how 400 children were tested for the effects of food additives and artifical preservatives on their behavior. The results demonstrated "a substantial effect" of these synthetics stimulating hyperactivity and behavioral problems.

The FDA announces that it is issuing twice the number of public advisories about drug risks and adding five times as many black box warnings on drug labels as it did just a year earlier. U.S. Geological Survey scientists in Colorado discover that the byproducts of anti-bacterial soap, prescription drugs,steroids, bug spray and other chemical products are entering streams and groundwater and disrupting fish reproduction while increasing resistance to antibiotics among people who consume the fish.

The medical journal Cancer Epidemiology Biomarkers and Prevention reports a Columbia University study examining the health effects of exposure of pregnant women to air pollutants in New York City. A 50 percent increase in the level of persistent genetic abnormalities in infants was detected in those whose mothers had high air pollution exposure. Yale School of Medicine researchers report that low doses of the environmental contaminant bisphenol-A (BPA) used to make many plastics found in food storage containers can lead to learning disabilities in children and neurodegenerative diseases in adults.

A report by the U.S. Government Accountability Office, the investigative arm of the U.S. Congress, finds that the EPA is failing to protect people from tens of thousands of toxic chemicals. Chemical companies have provided health impact data to the EPA for only about 15 percent of chemicals introduced over the past 30 years.

What is even more sad is that WE ALLOWED THIS TO HAPPEN. WE bought the synthetic belief system hook line and sinker.

How do we get out of this mess that we created?

Posted by: FED Up | November 10, 2006 12:57 PM

Contract manufacturing is at the heart of many products we buy. Most all food and drug manufacturing and processing lines contain metal detectors. Proper maintenance and testing of such equipment is critical. It would appear that this contract manufacturer failed to notice the non-performance of it's metal detector. Better attention to maintenance could have averted this situation.

Posted by: Roger | November 10, 2006 1:50 PM

To Paul Everin, who posted near the top of this thread: Get real. The largest retailer in the world uses them because they give the largest retailer in the world a better deal than any other company, not because they are *top notch*.

Posted by: ebrke | November 10, 2006 1:51 PM

Thank you ebrke, I read the entire list of comments and was going to say exactly what you said.

No company buys ANYTHING for the 'good of the people'. It is always about the bottom line.

And I read FED up's entire monologue. Frightening. Many people are becoming more aware of these things. Even Oprah did a show on the five most dangerous synthetic foods, although there are many, many more. Still, I see people in the Safeway line holding all kinds of ding dongs, oreos, etc just begging to die. Some companies are starting to wise up a bit, which is a good thing. But beware the 'no transfats' on a label. There could be just very little transfats. if it is below a certain amount per serving, they don't have to list it. But often it is on foods that a normal person eats more than the normal 'serving' (like, potato chips, serving size 5 chips. Give me a break!)

This story is also why I don't buy store brand items unless I am broke. Name brand items are much clearer when there is a recall. They were so vague when this recall was first announce. That should scare the socks off of anyone reading this.

Posted by: Diane | November 10, 2006 4:02 PM

Many people hear about this recall and shrug it off because hey... out of 300,000,000 people, my odds are pretty good. Then they get a headache from thinking about it and take some acetaminophen pills. uhoh.

Posted by: concerned | November 10, 2006 4:08 PM

As we already know, docs don't exist to actually cure people's ills anymore, but to tell everyone what pill to take to mask the symptoms. The problem is that we are killing off our immune systems ... but if you try to talk to a doc about this, their eyes glaze over and you are history.

As bad as that is, what's worse is that our laws are being twisted around to where "increasing shareholder wealth" is *the* business motto now. People no longer matter like we did 30 years ago; we are now just drones to be worked til we drop in our tracks.

Are we becoming "1984", Stepford Wives/Drones, or "The Matrix"?

Posted by: SickOfItAll | November 10, 2006 6:49 PM

I do not disagree with the use of over-the-counter drugs; in fact, I took some Ibuprophen this morning and acetominophen yesterday(both generic, too!) But I like how the FDA lets so much go through. Ok, tiny fragments of metal aren't so bad, but what about those drugs that have horrible side effects? It is partially because of the problems in the pharma/science world, that I, a 17-year old have decided I probably will not be a Chemical Engineer. See, I have always found science and medicine fascinating and enjoyable. I'll not deny have the brains for ChemE. I went to Purdue University this summer for STEP, Seminar for Top Engineering Prospects, where I learned about the various disciplines of engineering. To tell the truth, I found ChemE quite interesting. I toured Eli Lilly somewhere near Lafayette as part of the program, and still thought it was interesting (By the way they make drugs such as Prozac, Strattera, Cialis, Gemzar, etc.) I did notice how they emphasise how much good they do for the community--"Oh my goodness look, we make the Wabash River even cleaner downstream from us than that which is upstream." Bravo Lilly! But really, how many people have DIED from the side effects of those over-prescribed ADHD and other psychotherapeutic drugs? A lot more than have been saved by that clean water. Yes, I have forsaken the world of companies out to get money by convincing people that band-aids will help heart attacks because I do not want to be so cold as to ruin people's lives with such things. Granted, the pharmaceutical companies have done some good, but there is just too much they are doing to ruin people. I'll leave that to those who don't mind it. But I will help people in other ways. I don't need a 60K+ starting salary when I can do more with less. So, I think I will.

Posted by: Anna | November 10, 2006 6:55 PM

I am a ChemE major and there are many other opportunities outside of phamaceuticals in which chemical engineering applies. Maybe you would find environmental engineering more in your interest?

Posted by: Sam Kiltz | November 10, 2006 7:59 PM

One thing about those 20th century cancer statistics: Don't forget, a lot of those people who might have died of cancer -- eventually -- died of diptheria, whooping cough, polio, pneumonia, tuberculosis, infectious myocarditis, and whatnot BEFORE they got around to developing cancer.

Heck, my grandparents died in their early 40s of infections -- back in the early 1930s before people could get things like penicillin. If they had lived to be 60 or 70, maybe one or both would have gotten cancer, but we'll never know, will we?

Posted by: GGal | November 10, 2006 7:59 PM

to larry chin o.j.a.e. re: nov. 10 06 00.52 excellent.

Posted by: ed | November 10, 2006 8:13 PM

So. MD-- No, they never caught the Tylenol terrorist, and yes, an investigative report on "plain wrap" food and drug origins would be most interesting to read. Although I imagine it would require quite a bit of research!

Posted by: dormouse | November 10, 2006 8:51 PM

It should be mentioned that I have a strong bias since I worked for a pharmaceutical, and two of my cousins work for them too. But I have to say here that I really love free enterprise and our world class pharmaceutical companies here in the US.

So my comment is, come on you guys: Get real! A few specs of metal.... Give me a break! If you want to start turning the world upside down in outrage, why don't you press for some laws against pill popping morons that eat any kind of med that comes along like it's candy. The way people abuse their own bodies by over medicating, over eating, and under exercising (and I'll bet they're the ones driving those big gas-guzzling road hogs too), is most absurd. And I'll bet they are the ones screaming the loudest here.

Posted by: Don | November 11, 2006 8:07 AM

I blame this on George Bush. Hopefully now Nancy Pelosi will clean the White House!

Posted by: Herman | November 12, 2006 12:05 AM

Why the hell is there a donut hole in part "D" And who thought that up?

Posted by: Alan | November 12, 2006 10:06 AM

Well, hey...why don't we just nationalize the drug industry and let the federal government take care of everything? They do a great job of management and customer service, don't they?

Posted by: Bob | November 12, 2006 11:35 AM

Geez, I always purchase the "generics" versions of what little pills that I use (Ibuprofin, etc.). Now I'm worried. Agree with the poster that said a tiny little bit of metal probably wouldn't hurt anybody. Also agree with the posters that say that we deserve to have information on the bottle (not just the package), in case we need to trace something.

Posted by: Susan | November 12, 2006 1:56 PM

Unless you take these pills constantly a little bit of metal is no big deal. If you DO take these pills constantly, then you have bigger problems anyway and you should go get help. I am not refering to a chemical addiction but rather to problems people have with obsessive problems regarding their health. Pill don't make you healthy, they are there to be taken seldomly when you really need it to get by. As long as a person's usage refects that, they have nothing to worry about.

Posted by: Kevin | November 12, 2006 2:16 PM

Had to read quite a bit of nonsense before I got to the one that blamed it on Bush. Also enjoyed to reference to Betty Crocker. Some people obviously don't have enough to worrry about. Maybe if they took some of their time to look in on an ailing neighbor or help someone with a problem, they could learn that "STUFF HAPPENS" and it is not all a dire plot.

Posted by: WALT | November 12, 2006 2:37 PM

A very simple concept can be used after reading this article. Read and investigate what you buy, where it's from and who sells, moves, distributes, and makes it. No one made you buy it.

When you purchase CHEAPER items, they have lower quality in the (how else do you lower the price??) product, equipment and typically lower quality employees. If one wants to add more teeth to the bloated FDA (approval takes a few months to a couple of years), expect prices to go up. The PDUFA Act adds to the cost of drugs already. Some want to make it cost more.

I see that no one is mentioning that this is a voluntary recall of acetaminophen caplets (500 mg). Looks like equipment failure according to some articles.

Government is not the solution. Typically, anyone with the talent to run a business or work in one successfully shuns the idea of working for government positions.

If you don't know who made it, don't buy it. Unless you want some stranger with "authority" to make decisions for you.

Posted by: Simplistic | November 12, 2006 3:16 PM

Top notch, Paul? Metal fragments? Acryllic mirror?

Posted by: Shane | November 12, 2006 3:40 PM

It's believed that 200 tablets out of 70 million have been contaminated. Machines break--the company found the problem in the first place and recalled the product. No amount of FDA regulation could have prevented the machine from breaking prematurely and it would not have made the outcomes of this problem any better.
And for anyone concerned, no one forces you to buy generics. Pay the extra money and buy brand names. If you can't afford it or can't justify it, then you'll have to deal with the consequences. You can't possibly expect the same for less with no consequences.

Posted by: Ja | November 12, 2006 5:49 PM

Hey Ja do you really think that a Brand Name company could make a error. What about all the drugs from Thalidomide to Vioxx and about all the drus in between

Posted by: A.N. | November 12, 2006 6:07 PM

I believe that a brand name company's machines can break just as easily as a generic's. However, brand name drugs are protected under patent regulations for 20 years, so they have much more time to ensure that their manufacturing equipment is more efficient and more effective.
By mentioning Thalidomide and Vioxx, I believe you are referring to the drug compounds themselves; however, this entire article and discussion is referring to the safety of the manufacturing process itself, not of the chemical compounds. Brand names and generics are the same chemical formulas; but again, generics must wait for 20 years until the brand name patents are expired before they can manufacture, so most of the adverse-effect issues have been worked out by then.

Posted by: Ja | November 12, 2006 6:39 PM

How closely this ties in with the Safeway Sandwich Snarl. Poor quality/customer service. If these companies bothered looking out for customers, it would cost them. They don't want you to be happy, they want you to buy their products. If you don't have a choice, and it's too hard to complain- not worth your time, or you spend weeks and get nowhere- then you've only exhausted yourself and the company is untouched. Worst case they get fined a million dollars- which is nothing to them. If a million dollars or more is nothing to them, what makes anyone think they care about your sandwich, the package you ordered, your rebate, your cable/internet service, or even your health? The answer- they do not care! It is easier for THEM to let you harmlessly complain and wear yourself out because in the end, you are a product of their society and you have to buy what they feed you.

Posted by: Chris | November 13, 2006 12:11 PM

I've been taking these tablets for about six months, I have five of the eight symtoms of metal poisoning and have bleed from my rectom for three days. I have three used bottles of the listed tablets. Any ideas about what I should do about my problem? Please help!!

Posted by: rdw | November 21, 2006 3:24 PM

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