The FDA is obviously lying over Prilosec and Nexium

Two recent studies have prompted the FDA to stop dragging their feet and begin investigating whether Prilosec and Nexium cause an increased risk of heart attacks. Personally, whether or not this is true is besides the point- it is now plainly clear that the FDA is working for the companies and not for the American people. What’s mandate for the FDA? Even if they officially rule that there is no heart attack danger posed by Prisolec or Nexium, we should have known about the potential for problems beforehand. If they haven’t completely sorted out whether or not something gives you heart attacks during the testing phase of a new drug, it leaves you wondering what else they’re forgetting to test properly.

Investors seem to be worried about the FDA inquiry as AstroZeneca, the makers of these over-the-counter medications have taken a sharp downward slide in the past few days. The Wall Street Journal from August ninth noticed found the activity enough to write about the direct correlation between AstroZeneca’s drop in share price and the announcement of the FDA investigation.

“The regulators said in pretty clear terms that the review isn’t likely to amount to much, but that wasn’t enough to calm investors made skittish by the FDA’s tougher stance on drug safety. AstraZeneca stock fell more than 5% this morning before starting to recover.”

At the moment, the stock is still down in after-hours trading.

The FDA inquiry was prompted by two separate European studies concluding that Prilosec and its close relative Nexium caused a greater increase in risk of heart attacks, heart failure and heart-related sudden death. Generally, those types of side effects aren’t worth the risk from symptoms derived from eating too much pepperoni pizza.

Canada’s Globe and Mail noted that this isn’t the only time potential problems have been raised in reference to Prilosec, which in Canada is marketed simply as Losec. I’m not sure what particular data told them that Americans are more likely to buy something with “pri” as a prefix, but I guess we’ll leave that up to AstroZeneca and their marketing agency.

While many people have heeded the news releases from AstroZeneca and kept on taking their Nexium and (Pri)losec, something the FDA has also been urging people to continue, the media is now reporting that conclusive evidence will only be available in three months time. Friday’s New York Times stated that “The F.D.A. will need another three months to complete a thorough analysis of the drugs’ safety.”

Hardly sounds conclusive, but then again, we can trust the FDA… right?

U.S SENATORS ALLEGE FDA COMPLICITY OVER AVANDIA SCANDAL.

Several days ago, Senate Finance Committee Chairman Max Baucus and Senator Charles Grassley (democrat and republican, respectively) have added fuel to the massive fire brewing over the Avandia diabetes drug scandal. The Senators sent a letter to the FDA, the government agency responsible for approving new drugs, that alleged complicity on the part of the FDA to sweep possible side-effects under the rug in order to assure approval for Avandia’s maker, industry stalwart GlaxoSmithKline.

The Diabetes blog has been following this controversy closely over the past few months. They revealed some details of the contents of the allegation made by the senators. Allegedly, “a former FDA primary reviewer for Avandia was removed from her/his work on the drug after voicing safety concerns,” the article also noted that, “The unnamed scientist believed the evidence for risk of congestive heart failure was strong enough for a “black box” warning on Avandia.”

Obviously, GSK thought that a black box warning would inhibit sales of their precious new diabetes drug and they used their insidious tentacles to get inside the FDA and have the offending analyst removed. Literally, the results of the study were not to the liking of a private corporation, so they used their influence to have that person’s expert opinion silenced. Is this part of the FDA’s mandate?

A study from the New England Journal of Medicine confirms that a patient taking Avandia (the fancy corporate name for rosiglitazone) has just increased their risk of heart attack by a full 43%.

An older post from the Diabetes Blog noted some extremely troubling statistics in terms of reported side-effects from Avandia patients. “According to a new Associated Press (AP) feature, federal regulators have experienced a dramatic surge in reports of Avandia-related side effects. In fact, they say they are receiving triple the number of reports just in the last month.”

While an exponential increase in reported side effects is troubling, the post goes on to note some even more depressing news.

The key finding: in the thirty-five days before the Avandia story broke in the media, only five heart attacks were reported as side effects involving rosiglitazone. Rosiglitazone is the active ingredient in Avandia and its little cousin Avandamet, which combines that drug with metformin. Yet in the thirty-five days following the revelation, that number soared to ninety. The AP also says reports of heart-related hospitalizations increased dramatically.

The author of the Diabetes Blog Post is adamant that all of this complicity leads us to one inevitable conclusion- we must dramatically reform the FDA. In its current form, it serves as a conduit for big pharma to get their new products through the government hurdles as easily as possible. The Avandia scandal serves as concrete proof that the FDA now places American corporate health before the health of the public that they are sworn to protect.

At the very least, the scandal has hit GSK in the pocketbook. Simon Margolis, MD wrote a post in the Yahoo Health News Blog that mentioned many doctors are now turning away from Avandia because they don’t want their diabetic patients to wind up as heart patients in the near future. Margolis quotes Dr. David Nathan from the Diabetes Center at Massachusetts General Hospital saying “Physicians may find it difficult to explain to their patients why they are starting treatment with a potentially dangerous drug when other choices with longer and better safety records are available.”