Why The FDA Did Nothing to Moderate Nexium Prilosec And PPI Prescriptions

ByPrimary Researcher

Executive Summary

  • Nexium and Prilosec were widely used for decades and were generally considered safe.
  • After problems became obvious, the FDA did nothing.

Introduction

  • PPIs or proton pump inhibitors are directed at pumps in the stomach that produce stomach acid, and they inhibit their activity.
  • Everyone is familiar with antacids like TUMS; PPIs are very powerful antacids that control the body’s ability to produce acid rather than merely buffering the acid with a base like calcium carbonate.
  • PPIs are blockbuster drugs that have been overmarketed and overprescribed and taken for far too long of a duration of treatment by many millions of people around the world.
  • PPIs are an example of how the FDA and pharmaceutical companies conspired to have patients continue to use them, even though the problems with the long-term use of PPIs were well known.

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The History of PPIs

Introduction

The article How Did The Nexium Prilosec And PPI Dangers Remain Hidden For So Long?, covers many health problems from taking PPIs. This article will focus on how the FDA failed to respond to what they knew were problems with PPIs.

How Did The FDA Ignore This?

The FDA puts the profits of pharmaceutical companies ahead of public health. The following statement by the FDA contains false information that I will address after you read it.

Update: 3/23/2011
FDA has determined an osteoporosis and fracture warning on the over-the-counter (OTC) proton pump inhibitor (PPI) medication “Drug Facts” label is not indicated at this time. Following a thorough review of available safety data, FDA has concluded that fracture risk with short-term, low dose PPI use is unlikely.

The available data show that patients at highest risk for fractures received high doses of prescription PPIs (higher than OTC PPI doses) and/or used a PPI for one year or more.

In contrast to prescription PPIs, OTC PPIs are marketed at low doses and are only intended for a 14 day course of treatment up to 3 times per year. FDA acknowledges that consumers, either on their own, or based on a healthcare professional’s recommendation, may take these products for periods of time that exceed the directions on the OTC label. Healthcare professionals should be aware of the risk for fracture if they are recommending use of OTC PPIs at higher doses or for longer periods of time than in the OTC PPI label. – FDA

However, the FDA knew that patients were taking these drugs for far longer than this, and they knew this after they made this statement in 2011.

The FDA never did anything to limit the overuse of this drug.

Observe the following quotation from a lawsuit by the government against the pharmaceutical company Wyeth.

As alleged in the government’s complaint, Wyeth’s illegal promotional campaign for Protonix was multi-faceted. Before Wyeth even began promoting Protonix, the FDA warned Wyeth that its proposed promotional materials were misleading because Wyeth had “overstated” its “erosive esophagitis indication” by “suggesting that Protonix is safe and effective in the treatment of patients with . . . GERD. Protonix is not indicated for treatment of GERD symptoms that occur in the absence of esophageal erosions.” Despite the FDA’s admonishment, the government alleges that Wyeth trained its sales force to promote Protonix for all forms of GERD, beyond its limited erosive esophagitis indication, and that Wyeth sales representatives frequently promoted Protonix to physicians for unapproved uses, such as symptomatic GERD.

In addition, Wyeth allegedly promoted Protonix as the “best PPI for nighttime heartburn.” even though there was never any clinical evidence that Protonix was more effective than any other PPI for nighttime heartburn. The allegations in the complaint are that this superiority slogan was formulated at the highest levels of the company. Wyeth retained an outside market research firm, at the cost of tens of thousands of dollars, to ensure that sales representatives delivered that misleading superiority message.

“Wyeth tried to cheat the system by obtaining a limited FDA approval for Protonix, fully intending to promote this drug for additional, unapproved uses,” said U.S. Attorney Carmen M. Ortiz. “Wyeth ignored the FDA’s warning not to promote Protonix off-label, and then went so far as to contaminate CME programs that physicians rely on for unbiased, independent scientific information. Today’s settlement reinforces this office’s historic commitment to holding drug companies responsible for their misconduct.” – DOJ

The FDA warned Wyeth that their ads were deceptive but took no action.

This is how the FDA functions now; it writes “warnings” when it sees deceptive tactics but takes no action. This means that the FDA tolerates that pharmaceutical companies will deceive their customers, damage their health, and do nothing to stop it.