By Dr. Mercola
Celebrex is a type of nonsteroidal anti-inflammatory drug (NSAID) known as a COX-2 inhibitor.
Basically, it works by blocking COX-2 enzymes, which become overly active in your body when it becomes inflamed, and is widely used as a form of pain relief; in 2011, 2.4 million Americans received prescriptions for this drug.i
They may have thought twice, however, if they knew the truth behind how this drug came to be … a story that involves cherry-picking of data in attempts to make the drug seem superior to others on the market, when in fact it was not.
Also concerning: Celebrex is the only selective COX-2 inhibitor left on the market, as its close “cousins” were all pulled due to either their killing tens of thousands of people or to their unacceptably high heart risks …
Internal Memos Reveal Deception Surrounding Celebrex Data
New evidence in a lawsuit against Pfizer alleges that the drug company cherry-picked data on its drug Celebrex. Its claim to fame when it came on the market in 1998 was that it relieved pain without causing the gastrointestinal side effects common to other pain-relief drugs like ibuprofen.
Studies showed it didn’t necessarily relieve pain any better than the other drugs on the market, so Pfizer was counting on the gastrointestinal “ticket” to propel the drug into blockbuster status, and, in fact, used its easiness on your stomach as its primary selling point.
The problem was, Celebrex only appeared to be easier on the stomach because Pfizer, and its partner Pharmacia, only released the first six months of data from a year-long study. When the entire data set was looked at, the stomach “benefit” disappeared.
Folks this is what is called a blatant lie of omission and these companies do it on a regular basis. The system even encourages it. Contrary to what many people believe the FDA does no testing of drugs that are to be approved. Nor is there an objective third party that does tests. Rather the system the FDA employs has the drug company pay for and do the studies, and they only submit the studies that support the release of their drug. They are not required to submit failed ones.
That Pfizer withheld the critical data has been known for years, but newly unsealed documents showed this was all part of a carefully calculated plan by Pfizer and Pharmacia execs. While medical directors and scientists at the company expressed feeling uncomfortable with the “data massaging” and “cherry picking” of data, the powers that be moved full steam ahead with their deceptive marketing blitz.
Another reason that you might not be surprised about this report is that Pfizer purchased Monsanto and spun it off as subsidiary called Pharmacia in 1997.ii Most readers of this newsletter will instantly recognize that the bastion of evil, Monsanto, would not be out of place with this type of behavior.
The New York Times reported:iii
“The documents suggest that officials made a strategic decision during the early trial to be less than forthcoming about the drug’s safety. They show that executives considered attacking the trial’s design before they even knew the results and disregarded the advice of an employee and an outside consultant who had argued the companies should disclose the fact that they were using incomplete data.
… The documents show that in February 2000, Pharmacia employees came up with a game plan on how they might present the findings once they were available … Another document, a slide, proposed explaining poor results through “statistical glitches.””
Do You Still Trust Celebrex?
Celebrex is still being widely used, often by arthritis patients who are desperate for pain relief. But even if you overlook the fact that it’s made by a company that clearly puts profits ahead of patients, it’s much harder to shrug off the very real risks it poses to your heart.
Remember, Celebrex is in the same class of drugs as Vioxx and Bextra, both of which were pulled from the market because of serious heart risks or killing tens of thousands of people. Celebrex may still be on the market, but it is not immune to these risks!
In 2006, the New England Journal of Medicine released a study that discussed “a significant increase in adjudicated serious cardiovascular events with the use of celecoxib [Celebrex] … an increase in risk by a factor of two or three for … myocardial infarction, stroke, congestive heart failure, or cardiovascular-related death.” The risk was so severe that it “prompted suspension of the administration of celecoxib …”iv
Pfizer actually has a trial that’s ongoing right now that’s supposed to compare the heart risks of Celebrex to those of ibuprofen (Advil/Motrin) and naproxen (Aleve). But though it was started in 2005, it’s not slated to be completed until 2014 … the same year the Celebrex patent expires (at which point the company’s profits for the drug will dwindle … making negative study results far less impacting).
It’s widely known, however, that this painkiller has been linked to increased risks of stomach bleeding, kidney trouble, and liver damage – along with other adverse reactions that can range from mild to deadly. And it’s not at all unusual for a drug company to play up the “fabulous benefits” of their products while conveniently glossing over the fatalities they’ve caused … what would be unusual is if they didn’t.
Common Diabetes Drugs Associated with Increased Risk of Death
New studies regularly reveal the true risks of many medications, including popular varieties that are used by millions of people. For example, an analysis of nearly 24,000 patients with type 2 diabetes found that three diabetes drugs — glipizide, glyburide, and glimepiride – caused a more than 50 percent greater risk of death compared to another diabetes drug, Metformin.v The three drugs are known as sulfonylureas, which work by spurring your body to produce more insulin.
The drugs not only increased the risk of death among all patients, but among those with heart disease (which is common among those with diabetes), glipizide increased the risk of death by 41 percent, and glyburide by 38 percent compared to Metformin.
But simply switching to metformin, a drug that makes your body’s tissues more sensitive to insulin, is not the answer here, as type 2 diabetes can be effectively treated without medications in the vast majority of cases. In fact, drugs can’t cure diabetes, as they do nothing to address the underlying cause. To learn about the drug-free methods that can prevent, and reverse, diabetes, we published a report on this last month.
The Medical Industrial Complex Top 10 Marketing Settlements
Case in point, if it seems like the number of lawsuits that Big Pharma is settling―many of them out of court without going to trial―are rising, they are. From Merck’s $950 million Vioxx deal to the latest announcement that Pfizer has made an $896 million settlement with Prempro victims, the deals show no signs of stopping. Most of the lawsuits are being filed in conjunction with, or aided by, the U.S. Department of Justice, many of them originating with former employees-turned-whistleblowers who divulged marketing misdoings by their employers.
The litigation and settlements are starting to rattle the drug industry, which is becoming no stranger to billion-dollar settlements. Most likely near the end of 2012, Johnson & Johnson reportedly will settle for as much $2.2 billion for its fraudulent marketing of the antipsychotic drug Risperdal.
That amount rivals what was the largest health care fraud settlement to date — $2.3 billion paid by Pfizer in 2009, also for illegally promoting uses of four of its drugs. However, now it’s come out that GlaxoSmithKline has agreed to a whopping $3-billion settlement – the largest in U.S. history for health care fraud — with the U.S. government, again for advertising drugs for unapproved uses, along with using gifts to persuade doctors to prescribe the drugs.vi
To get a picture of what’s been going on, FiercePharma compiled a list of top marketing settlements that the industry has made in the past 10 years. In total, drug makers have agreed to pay more than $11 billion so far for their misdoings. But the worst may yet be ahead: more than 900 whistleblower lawsuits were filed in the last year alone. Some of the most notable in history include:vii
- 2012: GlaxoSmithKline to pay $3 billion for illegal marketing of Paxil, Welbutrin and downplaying safety risks of Avandia
- 2009: Pfizer pays $2.3 billion for marketing fraud related to Bextra, Lyrica and other drugs
- 2012: Johnson & Johnson will pay anywhere from $1.5 to $2.2 billion for illegal marketing of Risperdal
- 2012: Abbott Laboratories settles for $1.6 billion for aggressively promoting their seizure drug Depakote for off-label use in elderly dementia patients, despite lacking evidence of safety or effectiveness.
- 2009: Eli Lilly pays $1.4 billion for promoting Zyprexa for off-label uses, often to children and the elderly.
- 2011: Merck settles for $950 million to resolve fraudulent marketing allegations related to Vioxx.
- 2005: Serono (now Merck Serono) paid $704 million after pleading guilty to two felony charges for fraudulent marketing related to a growth hormone to treat wasting in HIV patients.
- 2007: Purdue Pharma paid $634.5 million for fraudulently misbranding Oxycontin, and suggesting it was less addictive and less abused than other painkillers.
- 2010: Allergan paid $600 million for aggressively pushing Botox for unapproved uses.
- 2010: AstraZeneca settled for $520 million for trying to persuade doctors to prescribe its psychotropic drug Seroquel for unapproved uses ranging from Alzheimer’s disease and ADHD to sleeplessness and post-traumatic stress disorder (PTSD).
- 2007: Bristol-Myers Squibb paid $515 million for illegally promoting its atypical antipsychotic drug Abilify to kids and seniors.
You’re Smarter Than This
If Big Pharma’s annual global market was compared to the GDP—the market value of all the output produced in a nation in one year—then they would rank # 15 on a list of 183 nations.viii That’s how BIG the pharmaceutical industry is!
Americans are disproportionally supporting this behemoth of an industry. Americans, including children, are the most drugged people in the entire world, with the average adult taking 11 prescription drugs—each of which comes with an average of 70 different potential side effects that are then typically addressed with yet more drugs…
The situation has gotten out of hand, especially since there’s a mountain of evidence supporting the use of alternatives, and there’s very strong evidence that some “alternative” treatments, such as diet and exercise, are FAR more effective than any of the drugs currently in use.
My site is chock full of free comprehensive recommendations that can serve as an excellent starting point to break free. The tools I provide on this site will help you to reduce your reliance on the broken health care system, including its overuse of drugs and provide you with the tools and resources to Take Control of Your Health.