It could be the plot of a best-selling medical thriller. A web of deception and lies tied to a new blockbuster drug is uncovered during a financial fraud investigation of a major pharmaceutical company. Unfortunately, this plot is not imaginary.
Back in the year 2000, Pfizer and its partner Pharmacia, makers of the pain drug Celebrex, purposely released partial information on a study to (erroneously) show that the drug was safer on the stomach than common over the counter pain killers such as ibuprofen.
“They swallowed our story, hook, line and sinker,” wrote Pfizer’s research director in an email to a colleague, when the manipulated Celebrex study results were lauded during a pivotal medical conference.”1
That’s just one email that was uncovered during the investigation; there were many more. For example, Pharmacia employees planned ahead ways to hide the true study results, in case they would be adverse to their marketing strategy. One employee wrote,
“Worse case: We have to attack the trial design if we do not see the results we want,” a memo read. It went on: “If other endpoints do not deliver, we will also need to strategize on how we provide the data.”1
Read the whole story here:
By KATIE THOMAS
A research director for Pfizer was positively buoyant after reading that an important medical conference had just featured a study claiming that the new arthritis drug Celebrex was safer on the stomach than more established drugs.
“They swallowed our story, hook, line and sinker,” he wrote in an e-mail to a colleague.
The truth was that Celebrex was no better at protecting the stomach from serious complications than other drugs. It appeared that way only because Pfizer and its partner, Pharmacia, presented the results from the first six months of a yearlong study rather than the whole thing.
The companies had a lot riding on the outcome of the study, given that Celebrex’s effect on the stomach was its principal selling point. Earlier studies had shown it was no better at relieving pain than common drugs — like ibuprofen — already on the market.
The research chief’s e-mail, sent in 2000, is among thousands of pages of internal documents and depositions unsealed recently by a federal judge in a long-running securities fraud case against Pfizer. While the companies’ handling of the research was revealed a dozen years ago, the documents provide a vivid picture of the calculation made by Pfizer at the time and its efforts ever since to overcome doubts about the drug.
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.
In one e-mail, an associate medical director at Pharmacia (which was later bought by Pfizer) disparaged the way the study was being presented as “data massage,” for “no other reason than it happens to look better.”
In another, a medical director at Pfizer described it as “cherry-picking the data” even as officials were publicly boasting of the study’s success. Dr. M. Michael Wolfe, a gastroenterologist who had cautiously praised the study in a medical journal at the outset, said after reviewing the new documents: “I always try to give investigators the benefit of the doubt, but these communications make it quite challenging for me.”
The importance of Celebrex to Pfizer is indisputable. It is one of the company’s best-selling drugs, racking up more than $2.5 billion in sales, and was prescribed to 2.4 million patients in the United States last year alone.
The drug is the last of the so-called COX-2 inhibitor pain drugs, after Vioxx and Bextra were withdrawn in 2004 and 2005 because of safety concerns.
Some of the Celebrex’s detractors contend that its risks are still not fully understood, and argue that Pfizer is dragging its feet on a study — now nearly six years old — evaluating the drug’s heart risks. The study is scheduled to end in May 2014, the same month that Celebrex loses its patent protection and sales of the drug are expected to plunge.
Then and now, Pfizer has defended its decision to release partial results from the 2000 study and denies any intent to deceive. Company officials have said the drug has demonstrated its worth and safety. The proof, they say, is that 33 million Americans have taken it. “The bottom line is Celebrex is a very important option for many of these patients,” said Dr. Steve Romano, head of the medicines development group in Pfizer’s primary care unit.
The decision by Pfizer and Pharmacia to withhold crucial data became widely known in 2001, after the Food and Drug Administration released the study’s full results. The revelations, along with similar reports of withheld data by other drug companies, led to calls for reforms in the way data from clinical trials is published, including in The Journal of the American Medical Association, which ran an article featuring the partial results from the study.
The withheld data also led to a lawsuit, filed in 2003, by several pension funds that charged that by handling the results the way they did, Pfizer and Pharmacia had misled investors and were responsible for a drop in Pharmacia’s stock value when the full results were revealed.
Lawyers for Pfizer and for the pension funds declined to comment. In a statement, company officials said they were confident they would prevail when all the evidence was heard. “The few documents handpicked by lawyers suing Pfizer and being reported by The New York Times are not a fair representation of this body of evidence,” the company said.
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.
“Worse case: we have to attack the trial design if we do not see the results we want,” a memo read. It went on: “If other endpoints do not deliver, we will also need to strategize on how we provide the data.”
Another document, a slide, proposed explaining poor results through “statistical glitches.”
Pfizer officials said the memo appears to reflect discussions by some Pharmacia employees about both the Celebrex study and a similar study of Vioxx. The slides, the company said, appeared to have been prepared before the results were known and discussed several situations.
While officials were boasting of the study’s success, employees behind the scenes were questioning its value. In September 2000, Dr. Emilio Arbe, a Pharmacia associate medical director, expressed his reservations.
After describing the decision to use the limited results as “data massage,” Dr. Arbe wrote, “I wouldn’t feel too comfortable presenting a fudged version of the facts.”
In May 2001, Dr. Mona Wahba, who worked on Celebrex, sent an e-mail to colleagues describing as “cherry-picking” a new analysis that also used six months of the results. Pfizer officials said Dr. Wahba’s e-mail was sent after the full study became known. In a deposition, Dr. Wahba said she did not recall what she meant.
Dr. Samuel Zwillich, who wrote the “hook, line and sinker” e-mail, testified in another deposition that his comment probably had to do with his concerns around a lesser claim that Celebrex led to less blood loss than other drugs. Through a Pfizer spokesman, he declined to comment.
Pfizer has argued that presenting the limited data was legitimate because so many people taking a comparison drug, diclofenac, dropped out, biasing the later results.
The controversy over the safety and effectiveness of Celebrex continues today. Celebrex and Vioxx, which was made by Merck, brought in billions in sales almost as soon as they were introduced in the 1990s.
But the excitement skidded to a halt in 2004, when Merck withdrew Vioxx after studies linked it to an increased risk for heart attacks. Some studies indicated that Celebrex, too, carried elevated risks. In part to address those concerns, Pfizer announced in 2005 that it was starting a trial that would compare the heart risk for Celebrex with ibuprofen, the drug in Advil and Motrin, and naproxen, which is sold as Aleve. The trial is not expected to be finished until 2014 when the Celebrex patent expires.
Dr. Steven Nissen, the Cleveland Clinic cardiologist who is overseeing the trial, said Pfizer has spent hundreds of millions of dollars and enrolled 18,000 patients. Recruiting has been difficult, he said, in part because European Union countries have barred patients with heart risks.
Dr. Nissen dismissed claims from critics that Pfizer has been delaying the trial out of fears about its outcome. “The last thing in the world I want to do is to be sitting here twiddling my thumbs with a public health concern,” he said.
Others were not so sure.
“One could draw conclusions,” Dr. Alastair J. J. Wood, who was chairman of the F.D.A. advisory panel that examined COX-2 inhibitors, said recently. He is a partner at Symphony Capital, which invests in drug development. “It clearly would have been nice to have had this information long ago.”
Despite its success, Celebrex’s place among pain drugs is not settled. According to Pfizer, 93 percent of insured patients have access to Celebrex.
Some doctors said Celebrex has advantages because it can be taken once a day and studies have shown that it causes less stomach discomfort than other drugs, although some have argued those types of findings are not always reliable.
“You’re dealing with softer, subjective endpoints,” said Garret FitzGerald, chairman of pharmacology at the University of Pennsylvania.
There is still no clinical proof that Celebrex is better at preventing serious gastrointestinal injuries.
Dr. David Borenstein, who conducted some trials of Celebrex for Pharmacia, said the drug relieved pain in some patients when other drugs failed. “It’s easy to talk about theoreticals when you’re not hurting,” he said.
It is obvious that this story is not an isolated case, especially since so many billions of dollars are at play with the marketing of popular (and not so popular) drugs. And if not for the securities fraud lawsuit, the incriminating documents would have never been unearthed. But Celebrex is still sold and heavily marketed, as if nothing would have happened.
Let’s bear in mind that the synthetic drug industry has developed recently, but very rapidly. Before its existence, ailments were treated and prevented with natural methods for thousands of years.
Of course, science is helpful in many instances; it can – and does – save lives. But skewed science and ridiculing natural methods that work is a terrible detriment to every single human being that’s honestly trying to stay healthy without damaging their health along the way. With this in mind…
Synthetic Drugs are the Alternative Therapy
Not to say the least desirable therapy! But instead, natural solutions that work really well and without collateral damage or side effects, are considered by the Medical Establishment as the “alternative”. Thanks to its relentless control over the medical profession, toxic and unnecessary drugs are now considered the “standard” treatment.2
The Fox is Guarding the Chicken Coop
Doctors rely and base their recommendations on scientific studies, many of which are funded by pharmaceutical companies. I’m sure you can see the obvious conflict of interest in this model.
As I wrote in Who Should you Trust? with the Osteoporosis Reversal Program on your side you are fully equipped to take care of your bone health. Not with dangerous and toxic drugs, but with natural, time-tested, and easy-to-apply nutritional and lifestyle changes that work with the body and not against it.
To your natural bone health!
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I really enjoyed this article. Finally we are hearing the truth. My question would be where is the FDA and who is here for the consumer? It is unfortunate that big drug companies can get away with so much – big and powerful and plenty of money!! This country is getting too greedy for its own good!! Especially for the ones who are at the top and running these companies. Thank you for keeping us informed!!!
Yep… As I wrote, the fox IS guarding the chicken coop…
).Noted as ASA by doctors tcllyaipy, aspirin effects have been noted for thousands of years, as the active ingredient comes from the bark of a White Willow tree, and long ago, patients with pain or a fever would chew on this bark for relief.Fast forward to over a hundred years ago and Bayer pharmaceuticals (pronounced Beier’), which is the same company that brought us heroin and mustard gas, as well as methadone. The company originated in Germany, but presently has its U.S. headquarters in New York. Felix Hoffman, seeking to develop an agent for his father’s rheumatism, was involved in the development of what is known now as aspirin. And it was a difficult task to develop this drug, as it was toxic to the stomach due to the nature of the active ingredient again obtained from the bark of the white willow tree. Dr. Hoffman and others at Bayer developed a drug that proved to be tolerable to patients while keeping the active ingredient in tact through a method of delivery developed by Dr. Hoffman’s team at Bayer. After launching the medication, aspirin was priced at about 50 cents an ounce, as at the time it was only available in power form. Soon before 1920, aspirin developed the tablet form of the drug and was then available by prescription. Regardless, aspirin was responsible for one third of sales for Bayer during this time, due to its popularity at that time.While all drugs have side effects, aspirin is one of very few drugs that provides great efficacy and indications, with limited side effects. In fact, some of aspirin’s additional uses have been recently discovered. This may be why the New York Times called aspirin a wonder drug in the 1960s. In the 1970s, the mechanism of aspirin was isolated, which is the blockage of prostaglandins.With Aspirin and its potential life-extending benefits:Aspirin has been associated with decreased risk of asthma and prostate cancer in the elderly. Also, aspirin has been linked with lowering the risk of breast cancer and colon cancer as well. Aspirin is a blood thinner, and has been associated with decreasing the risk of heart attacks and strokes in certain patient populations, as the drug prevents clots. This was first suggested in the 1940s and the FDA suggested that it be the drug of choice for those who experienced a heart attack over a decade ago. Aspirin intake is beneficial for those after coronary bypass procedures. A topical formulation of aspirin was developed recently for those experiencing Herpes pain. The drug has been proven beneficial for those experiencing migraine pains. Aspirin at low doses is taken by many as a preventive drug to decrease cardiovascular incidents that may occur.Aspirin has been the best selling painkiller since the 1950s. It is not as addictive as other choices for patients regarding pain relief in particular. It is also the most studied drug- with over 3000 scientific papers published worldwide. Also, over 15 billion tablets of aspirin are sold annually, which amounts to about 80 million aspirin tablets consumed daily by others. This amounts to over 16,000 tons of aspirin consumed during this time, or about 70,000 metric tons of aspirin a year. Over a decade ago, a study was performed and concluded that twice as many people would choose aspirin over a computer, given the two choices, because of the benefits of the drug. Side effects would include GI bleeding if taken in large amounts, along with an association of Reye’s syndrome in children, yet both are relatively rare. Yet all things considered, clearly the benefits of aspirin outweigh any risks of the drug.Lately, there have been issues with other NSAIDs, such as Cox II inhibitors, without full recollection or knowledge that aspirin is in fact the world’s most widely used drug, and for good reasons. At times, something newer is not always better We might die from medication, but we sure killed all the pain. — Conor OberstDan Abshear
my doctor has prescribed the prescription drug that you spray everyday in your nose for my osteporesis, is that the same kind of drugs as fosomax, etc?
Vivian thank you for all the information you give us. I have a question if anyone can help me solve. I am into yoga about 3-4 times a week. When I get into a certain pose with one leg extented behind me as in Warrior three I here all sorts of popping going on in my back. Other positions cause this to. I have osteopenia and wondering if my bones situation is getting worse.
I do as much as I can with eating right and exercise.
Anyone wanying something that is all natural with nothing added needs to look at protandim
Hello , VIvian??? GOD BLESS YOU.
The doctor told me i have inflamecion in my boons.
I had five medicin that my body had refuse them.
Now i am not taking ,,no medicine.
I dont like to drink medicine if they dont no ,
what happen with my boons
BUT i trust GOD I had learn a lot from you,
Thank you for every thing .GOD BLESS YOU.
Juliana, faith and trust are good attributes! Stay proactive about your bone health and keep learning.
I’ve Been Trying To Get Off All My Prescription Drugs For Several Years Now! I Only Have Three More To Find An All Natural Replacement For–They
Are: Ditropan (To Stop Leaky Pipes),Trimethoprim (Mild Dose To Keep Urinary Track Infections At Bay), And Omeprazole (For Acid Reflux)!
What Would You Recommend To Replace These Prescriptions? Please Let Me Know Your Thoughts On It!
LOVE, MS. L. (LESLIE)
Leslie, for acid reflux, check this out:
Well Vivian… Seems Pfizer and company aren’t the only ones in the dog house and sporting thinner wallets. Seems GlaxoSmithKline has been fined
$3 BILLION !!! for Criminal/Civil Health Care Fraud.
In a nutshell based on my own healthcare, drug and disease research, in AmeriKa today, our whole ALLOPATHIC system of medicine is corrupt [.]
The damage they’ve done and do now, borders on barbaric medical procedures, practices and pharmacopia voodoo/don’t do drugs and vaccines laced in pure greed, at great human costs. In my opinion…its not by happenstance either. The AMA, the FDA, BIG Pharma, Insurance companies & others need to be completely overhauled, revamped and some common sense and REAL health practice put into being. What we have now, is broken and a monster that preys on the public domain, in their experimentation and foul medical practices they call medicine. No bones about it. Its a fact.
Getting a bit fed up looking after myself so well and having a dexa scan which has got worse,eating all the right food doing all the right things doing my best to follow Vivians program maybe i should go back to normal eating.
Of course it’s always nice to see a T-score improvement, but as I wrote in the Osteoporosis Reversal Program, there is much more to bone health than DEXA scores. The purpose of improving bone health is to prevent fractures. You see, bones typically don’t break because they are not thick enough; they break because they are not resilient enough – they lack tensile strength. Mainstream medicine focuses so much on density because it needs numbers (i.e. fixed parameters) to prescribe drugs. So don’t get discouraged… you didn’t fracture any bones 🙂
Where do you get Raw Vegetarian Calcium. I have not seen that mentioned in the many books I’ve read re osteopenia/porosis.
Thanks for ‘heads up’ on Rx drugs that I have taken in the past…like Fosamax. I stopped taking it when I realized it was affecting my jaw bone. I could not get implants in the back jaw area because of bone loss after taking Fosamax for many years. I’m in my eighties and plan to refuse those free tests that are offered by insurance company because I don’t want the medication. I appreciate your book written after much research and development in your own life and I plan to follow it.
With great appreciation, jt
Thanks for your kind words, Joan!
Thank you for your research in these scams that we can so easily be sucked in because doctors(that we trust) endorse them. I realize now that doctors do not have the time or the interest to research the drugs that they are promoting. Scary!!! I also, agree with the natural way to correct or improve bone health NOT durgs. I am very sensitive to even small doses of over-the-counter fixes in meds so I am SUPER careful about any drugs. My grandparents lived into their 90’s with good eating habits, healthy exercise and hard work and no drugs that seem to be promoted these days. Keep up the work, Vivian! You are important and valuable to all of us! Your researched material is so necessary!
Good eating, healthy habits and no toxic drugs… I couldn’t have said it better!
I was diagnosed with “Severe Osteoporsis” almost two years ago. After my doctor told me I must begin taking one of many perscription drugs designed just for Osteoporosis, I got busy looking for an alterative. I soon found Vivian online and immediately “Asked Vivian” what was the best bone building supplements for Osteoporosis? Vivian shared with me what she knew about the subject, which was and is A Lot. I began taking Raw Vegeterian Calcium. I invested in Vivian’s Book “SaveOurBones”. I also changed my diet adding more vegetables lefy green are high in calcium, and added other calcium rich foods which promote bone health. I continue to do my daily walking. Vivian offers something good to share about BoneHealth regularly. My bone density has increased in two areas. My doctor is amazed as I explained that I had been working with a Nutritionist and was following a plan that would help build my bones. I told him “No drugs for me”. He encouraged me to continue whatever I am doing for good Bone Health. Fosamax, and all of its relatives is out of the picure now. Thanks Vivian, . To you and all of us, “Good Bone Health”. JHall
Way to go, Joyce! Don’t you love it that your doctor is “amazed” at the results, even though you did not follow his recommendations? Keep up the good work 🙂
All drugs cause health problems. Have you ever seen all the drug commercials on television. Every one of them offer up all the side affects that they cause most of which are more drastic than the problem that they are meant to resolve. Give me a break. Drugs? No way. I’ll stick to the all natural supplements for all my health issues.
Good choice, Gail! Some drugs advertised on TV mention “death” as a side effect. Their audience is obviously immune to such statements.
GlaxoSmithKline has just admitted fraud concerning 10 drugs and agreed to pay $3 billion (that’s right BILLION) in fines. They are accused of mis-selling at least one drug for diabetes and claiming others were suitable for use by children,when they were not.
And the story goes on…
This is pretty scary stuff. I wonder what other drugs are out there causing health problems?
I imagine you could say just about all of them, in one way or the other.
Hi Vivian – right through the years, I was always amazed and terrified on reading the “inserts” to find that the possible side effects of the drugs were worse than the conditions they were supposed to be treating! On commenting on this, I was always brushed aside and told not to be neurotic! The response to me was ” they just have to say these things, just ignore them” ! Scary and illogical – and criminal! Good to know the truth through your researches and integrity THANK YOU