The Emperor Has No Clothes…
Quality Lapses at Big Pharma Unveiled
By Will Brink
The pharmaceutical industry is disseminating a myth for the purpose of frightening the public away from compounded drugs!
The claim is that since compounding pharmacies are not directly inspected by the FDA, they lack the quality control standards inherent to large pharmaceutical corporations. The media are functioning as a mouthpiece for Big Pharma by attacking compounding pharmacies and those who recommend them in lieu of side effect-prone FDA-approved drugs.
The harsh reality is that Big Pharma has been caught red-handed committing numerous and egregious manufacturing lapses. Even when life-threatening problems are uncovered, such as no active ingredient being in the finished drug, Big Pharma has done nothing until the fines become prohibitive and executives are threatened with jail time. Big Pharma’s arrogance is beyond comprehension.
Compounding pharmacies, on the other hand, sell what are often superior formulations usually at lower prices than branded FDA-approved prescription drugs. Men seeking testosterone replacement, for example, can obtain it from a compounding pharmacy for less than $30 a month, whereas a branded drug such as Androgel® costs $225 for the same quantity of testosterone.
Pharmaceutical companies have lobbied the FDA hard to prevent the public from finding out about low-priced compounding pharmacies, but there is nothing illegal about a medical doctor prescribing a compounded drug. And unlike pharmaceutical behemoths who feel they are accountable to no one, a compounding pharmacy’s reputation lives and dies with each and every individually-compounded drug it formulates.
Not all compounded drugs are cheaper to buy. Fearing competition from natural estrogen creams, pharmaceutical giant Wyeth petitioned the FDA to declare estriol (the safest estrogen) illegal. That has forced compounding pharmacies to charge much more for it because most companies fear importing it from Europe where it’s routinely used.
Wyeth (now owned by Pfizer) sells Premarin® and Prempro®—two hormone drugs that can increase the risk of certain cancers and vascular disease. Wyeth wants women to continue taking Premarin® and Prempro®, so their allies in the FDA stepped forward to interfere with the ability of American women to access estriol, a form of estrogen that has not shown lethal side effects, especially when used with natural progesterone.
The pharmaceutical industry is deceiving the public by implying that compounded drugs lack quality control standards. In this article, you’ll learn the admitted truth about the horrific manufacturing and inspection lapses committed by the largest drug companies that include pleading guilty to criminal charges.
You may have read about some obscene quality lapses at Big Pharma manufacturing facilities, but these reports disappear from the headlines within a day or two.
These quality lapses are particularly egregious because the profits earned on OTC and prescription drugs are so enormous. The active ingredient usually costs virtually nothing, meaning manufacturing the drug is the only significant expense. Yet even in the area of good manufacturing practices (GMP) that many dietary supplement companies strictly adhere to, large pharmaceutical companies have dropped the ball and exposed the public to dangerous products.
The purpose of this article is to memorialize some of these quality deficits so those who care to find the truth will learn that the most dangerously-made drugs emanate from an industry (Big Pharma) that enjoys some of the highest profit margins on the planet. These outlandish profits are courtesy of quasi-monopolistic protections granted by the federal government.
Ironically, while the federal government bestows numerous monopolistic benefits to Big Pharma, it also fines them when they repeatedly produce substandard drugs. What follows are examples of documented quality problems within the pharmaceutical industry:
• Just imagine not being able to breathe because of an acute asthma attack. You grab your FDA-approved asthma inhaler to open your bronchi, but nothing happens. You keep gasping for breath until you suffocate to death. The reason your asthma inhaler did not open your closed bronchi is because the manufacturer failed to put in the active ingredient (albuterol). At your funeral, people who were with you say you kept inhaling your drug, but it did not work. No one at your funeral would know that one of the leading drug manufacturers in the world (Schering-Plough) had repeatedly been caught failing to put the active ingredient into their asthma inhalers.1 All the FDA initially did was issue a warning telling Schering to stop selling drugs with the active ingredient missing.
After Schering-Plough kept getting caught, they were finally fined $500 million for repeatedly failing plant inspections. Inspectors found “significant regulations violations related to facilities, manufacturing, quality assurance, equipment, laboratories and labeling.”2 It turned out Schering shipped out asthma inhalers that contained little or no active ingredient (albuterol) leading to perhaps as many as 17 deaths, according to the Public Citizen’s Health Research Group.3 (No one knows the actual number of deaths.) Several massive recalls were the result. According to the New York Times, “The FDA also set strict quality control terms on four Schering-Plough facilities in a consent decree…”
• If you or someone you love is suffering from Gaucher’s disease or Fabry disease, you would most likely be relying on two of Genzyme Corporation’s products for treatment. You would also be relying on that treatment to be free of adulterations.
In 2009, the FDA announced that Genzyme drugs were put into vials that were contaminated with particles of steel, rubber, or fiber.4 The contamination caused production on these drugs to be stopped, which meant patients would have to either have stockpiled prescriptions, search for alternative treatment methods, or forego treatment altogether. The drug shortage also limited the ability of researchers to conduct clinical trials. Genzyme Corp., “under the consent decree of permanent injunction,” agreed to correct manufacturing quality violations at one of its facilities and will return $175 million in “unlawful profits” from the sale of products that were made at the plant.4 While the financial penalty may force the company to alter its ways, that is hardly an acceptable conclusion for the patients who went without their prescriptions solely because of Genzyme’s misdeeds. According to a survey of 1,800 doctors released by the Institute for Safe Medical Practices, the shortages led to patients dying for want of the preferred drug therapy.5
• Adults being poisoned by drug manufacturers with warehouse debris is one thing, but you’d think that when it comes to products for infants, drug companies would take extra precautions. Unfortunately, you’d be wrong. Abbott Laboratories’ recent recall of Similac® infant formula proves just that.
If you have an infant, you trust that the formula you feed your child is of the highest quality. If after feeding your child, you notice that they are experiencing severe stomachaches, would it even cross your mind that your child is suffering because there were insect parts in his or her formula? For most of us, that thought would be unthinkable, but it happened!
Abbott recently recalled 5 million cans of Similac® infant formula that possibly contained either common beetles or their larvae.6 The FDA said the insects pose no immediate health risk, however they acknowledged that there is a possibility that infants who consume formula containing the beetles or their larvae could experience symptoms of gastrointestinal discomfort and refusal to eat as a result of small insect parts irritating the GI tract. It is remarkable that the FDA considers a child refusing to eat because insect legs are stuck in its small intestine to be no immediate health risk. This is a case of the FDA grossly understating a problem to cover for a major company.
• Due to their compromised immune systems, chemotherapy patients have to be treated with the utmost care. With low white cell counts, low platelet counts, and an overall weakened state of health, the drugs they take to either combat cancer or fight the insidious effects of the chemo itself need to be of the utmost integrity. Imagine being a cancer patient in the fight of your life against a horrific cancer. Suddenly, uncontrollable swelling of your blood vessels causes you to be in severe pain and discomfort. Your physician checks and rechecks your drug bags, your vital signs, and your blood. Time and again they come up clueless as to what is the cause of this new trauma to your body. If you are lucky enough to survive the event, you will eventually see a press release from Amgen and Novartis recalling their intravenous drugs for the presence of glass flakes supposedly caused by a breakdown of materials in the stored vials.7 According to Reuters News Service, the company “initiated a voluntary recall of 24 lots of its methotrexate injection, a common chemotherapy drug, in the United States, due to the presence of small glass flakes that could result in adverse events. One of the manufacturers said the adverse events include damage to blood vessels, swelling, and possibly death.” Methotrexate is used in the treatment of neoplastic diseases (cancer), severe psoriasis, and rheumatoid arthritis, including some types of juvenile rheumatoid arthritis.
• 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
• 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.
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 http://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.
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.
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.
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.