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Life Extension Magazine April 2011
Report

The Emperor Has No Clothes...
Quality Lapses at Big Pharma Unveiled

By Will Brink
Egregious Quality Lapses

• For many, there is no more trusted name in the pharmaceutical field than Johnson & Johnson (J&J). That trust has been built from generation to generation, and Americans purchase J&J products with that trust in mind. Implied in that trust is the belief that not only are J&J products of the best quality, but they are also manufactured under the best conditions. Once again, the public’s trust has been misplaced.

J&J had to recall nearly 200 million bottles of various over-the-counter drugs.8 According to a Reuters Report (Tue., May 4th, 2010) “…inspectors found thick dust and grime covering certain equipment, a hole in the ceiling and duct tape-covered pipes at the Fort Washington, Pennsylvania, facility that made 40 products…” with “…raw ingredients contaminated by an unspecified bacteria, a lack of quality control procedures and poor handling of complaints, according to the report dated April 30.”

It was so bad, the FDA “…urged consumers to stop using liquid Tylenol®, Motrin®, Benadryl®, and Zyrtec® for children and infants after a broad recall,” recommending people use generics instead. The company has suspended production at the plant.

The bond between American consumers and J&J has clearly been broken, but what about the responsibility the FDA bears as the chief regulator of J&J’s factories? The FDA’s primary purpose is supposed to be to protect the consumer, but instead, it protects the profits of big medical companies and let the factories of one of America’s largest drug producers go unmonitored for too long while consumers suffered.

• Lipitor® is one of the most profitable drugs of all time. Consumers have seen endless advertisements for its ability to lower total cholesterol and LDL. Recently, Pfizer recalled certain bottles of Lipitor® due to reports of “an uncharacteristic odor.” According to Pfizer, the company “is working closely with the bottle supplier to determine the cause of the odor problem and to rapidly address it.” 9 The company advises, for those who “…experience an uncharacteristic odor associated with your medication, please return the tablets to your pharmacist.” Pfizer claims the product is still safe to use, stating “medical assessment has determined the odor is not likely to cause adverse health consequences in patients…”.

What You Need to Know: Quality Lapses at Big Pharma
  • Quality Lapses at Big Pharma
    The pharmaceutical industry claims that compounded drugs are not safe or effective because they are not directly inspected by the FDA, as prescription drugs are.
  • Compounding pharmacies often sell superior formulations at better prices, compared to prescription drugs.
  • Compounding pharmacies must maintain high quality standards because they rely on their reputations to stay in business.
  • Big Pharma has committed numerous egregious mistakes in maintaining quality control.
  • For example, Schering-Plough was repeatedly caught failing to put the active ingredient in prescription medications, such as asthma inhalers. They were finally fined $500 million for failing plant inspections.
  • In 2009, the FDA announced that Genzyme drugs were put in contaminated vials, which led to interrupted drug production and medication shortages.
  • Abbott Laboratories recently recalled 5 million cans of Similac® infant formula due to contamination with insects or larvae.
  • Other pharmaceutical companies that have recalled products due to contamination and other quality control issues include Novartis, Amgen, Johnson & Johnson, and GlaxoSmithKline.

Egregious Quality Lapses

If what you have read so far does not shock you, the following recent case involving GlaxoSmithKline will leave consumers wondering if any drugs are truly safe out there.

In fact, the quality control deficiencies at Glaxo were so egregious that they were highlighted in a recent 60 Minutes report titled “Bad Medicine.” 10 The report focused on the atrocious manufacturing lapses at a plant operated by GlaxoSmithKline subsidiary SB Pharmco Puerto Rico, which was at the center of last year’s $750 million health fraud case the company settled.

A former global quality assurance manager for GlaxoSmithKline, for the first time on camera, offered details on what she saw at the Cidra, Puerto Rico, plant. At the facility, GlaxoSmithKline manufactured Kytril®, an anti-nausea medication; Bactroban®, a topical anti-infection skin ointment; Paxil CR®, a form of the antidepressant drug Paxil®; and Avandamet®, which is used to treat type 2 diabetes. These and other drugs were produced for sale in the United States.

Media Bias Often Misleads Consumers

60 Minutes reported on how the water used to make tablets was tainted with bacteria and about how failures on production lines had made some drugs too strong, and others not strong enough.

Of all the manufacturing lapses cited, the most alarming were the mix-ups that led to drugs being filled in the wrong bottles. The mix-ups ultimately led to patients receiving and taking medicines that were either higher doses than prescribed or used to treat an entirely different condition.

Examples of these mix-ups were Avandia® diabetes pills mixed in packages with over-the-counter Tagamet® antacids, and Paxil® antidepressants being mixed with the Avandia® diabetes drug. (Avandia® was later pulled from the market because it is too dangerous to take even when properly made.)

The 60 Minutes report featured a response from a senior vice president from Glaxo headquarters in London, who said the company regrets what happened in Puerto Rico and that the company spends $600 million to ensure “plant and equipment is state of the art.”

In a statement released after the 60 Minutes story aired, GlaxoSmithKline insisted patients weren’t hurt by the problems at the Cidra plant, and that the company had been working to improve the plant’s performance as early as 2001.

As of this writing, the investigation is ongoing and additional civil and criminal charges may still be handed down. Many drugs sold in America are manufactured in Puerto Rico because of favorable tax status.

Big Pharma has become so arrogant with their enormous riches that they have shoved manufacturing quality control to the bottom rung of their priorities.

Media Bias Often Misleads Consumers

The media has a propensity to falsely claim that consumers cannot trust compounding pharmacies because they are not subject to the same rigorous standards as large pharmaceutical companies. The reality is that Big Pharma has become so arrogant with their enormous riches that they have shoved manufacturing quality control to the bottom rung of their priorities.

Readers should be aware the examples cited in this article are not an exhaustive list of failures of quality control by the pharmaceutical industry. These hideous patterns of misconduct eliminate any standing the pharmaceutical industry (and its shills in the media) has in attempting to scare the public away from the use of compounded medications.

Pharmaceutical Industry’s Double Standard

The pharmaceutical industry often claims that quality issues are rare and anomalies. A search at the www.FDA.gov website and some Internet searching, however, shows that’s not the case, and it is growing worse. Drug makers have put quality control on the low-priority list as they attempt to increase their profits through extensive cost-cutting.

Pharmaceutical Industry’s Double Standard

The pharmaceutical industry has quite a double standard for itself. When people look to compounding pharmacies in an attempt to avoid the outrageous profit margins from various brand-name drugs, pharmaceutical companies claim compounding pharmacies are less safe due to lacking FDA-mandated quality control standards, yet these very companies often fail to adhere to acceptable manufacturing standards. It is the drug companies themselves that are pleading guilty to criminal charges of failing to follow good manufacturing practices (GMP) and knowingly putting lives in danger.

Conclusion

Although the FDA appears to have stepped up enforcement of QC issues found in the pharmaceutical industry, the FDA and the pharmaceutical industry have a complex, often nepotistic relationship. For example, according to Dr. Marcia Angell, former editor of the New England Journal of Medicine and author of The Truth About the Drug Companies, “The FDA reviews drugs for safety and effectiveness before they are allowed on the market, but drug companies pay large ‘user fees’ in return for quick reviews. That means the agency is beholden to the industry it is supposed to regulate.”

The pharmaceutical industry enjoys astounding profits and profit margins, and pays a king’s ransom in lobbying efforts and direct-to-consumer advertising in an attempt to maintain their monopoly. They accuse compounding pharmacies of failing to do what they themselves have ignored: paying attention to quality control and stringent manufacturing practices.

The American public should not be deceived by Big Pharma’s propaganda campaign to discredit those who strictly adhere to good manufacturing practices, as it is Big Pharma’s blatant disregard for safety that consumers should fear.

If you have any questions on the scientific content of this article, please call a Life Extension® Health Advisor at 1-866-864-3027.

References

1. Available at: http://www.nytimes.com/1999/12/03/us/national-news-briefs-schering-plough-recalls-medication-for-asthma.html. Accessed January 18, 2011.

2. “Drugmaker To Pay FDA $500 Million.” The Washington Post. May, 2002.

3. Available at: http://www.nytimes.com/2002/05/18/business/drug-maker-to-pay-500-million-fine-for-factory-lapses.html. Accessed January 18, 2011.

4. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm213212.html. Accessed January 18, 2011.

5. Available at: http://www.ismp.org/newsletters/acutecare/articles/20100923.asp. Accessed January 18, 2011.

6. Available at: http://www.abbott.com/global/url/pressRelease/en_US/Press_Release_0900.html. Accessed January 18, 2011.

7. Available at: http://www.fiercepharma.com/story/tainted-injectables-recalled-sandoz-b-braun/2010-10-28#ixzz18xrID1Lm. Accessed January 18, 2011.

8. Available at: http://www.reuters.com/article/idUSN0412564320100504. Accessed January 18, 2011.

9. Available at: http://www.usatoday.com/yourlife/health/medical/2010-12-21-lipitor-recalled_N.html. Accessed January 18, 2011.

10. Available at: http://www.cbsnews.com/stories/2010/12/29/60minutes/main7195247.shtml. Accessed January 18, 2011.