Mylotarg won approval under an abbreviated process. Medicines cleared in that way have to pass follow-up tests to confirm they work. The FDA asked Pfizer to withdraw the drug after a recent clinical trial raised concerns about the product's safety and clinical benefits.
"The trial ... showed more deaths in the first couple months of treatment. The fatality rate was 5.7 percent for Mylotarg patients, compared with 1.4 percent without the drug, Pfizer said. Mylotarg is the first drug approved under the FDA's abbreviated process to be withdrawn for failing to show effectiveness, agency officials said."
Pfizer, the world's biggest drugmaker, has also suspended trials of an experimental pain relief drug for osteoarthritis, Tanezumab, after reports that patients' conditions worsened and led to joint replacements.
Following a U.S. Food and Drug Administration request, Pfizer isn't recruiting any new patients or giving the drug to patients already in 10 osteoarthritis trials.
According to Bloomberg:
"Tanezumab would generate an estimated $100 million in annual sales by the end of 2012, and $260 million by 2013 ... The drug was one of 500 projects the company had preserved in a pared-down development portfolio. Pfizer said in April 2009 that the drug as a treatment for the pain of osteoarthritis in the knee had moved into the third and final stage of testing usually needed for regulatory approval."
Mylotarg was one of at least two dozen cancer drugs that were approved under the U.S. Food and Drug Administration's (FDA) "fast-track" status.
Under this accelerated approval process, experimental drugs are brought to market sooner, even though they've only been tested on a small number of people and their effects and safety risks are not clearly known.
In the case of Mylotarg, it was brought to market in 2000 after being tested on just 142 patients. The advantage advocates cite to justify speedier drug approvals, particularly to terminal patients: Those patients may be helped by experimental drugs, even if studies show they don't actually live longer.
The real advantage, though, is that the drug company gains between $1 million and $2 million for EVERY day extra that the drug is approved.
Unfortunately, there are serious and, sometimes fatal, consequences of bringing drugs to market without adequate safety testing.
Mylotarg Killed More Patients Than No Treatment at All
Unfortunately, in the case of Mylotarg to treat leukemia the drug was not only ineffective, but those taking the drug were more likely to die within the first couple months of treatment compared to those who didn't take the drug.
The death rate for Mylotarg patients was a steep 5.7 percent, compared to 1.4 percent without the drug. That and the drug showed no clinical benefit to patients whatsoever.
The drug's dangers and lack of effectiveness obviously were not so apparent when it was first approved on a fast-track basis, but the FDA's required follow-up study to prove the drug's worth proved to be far too little, too late.
Mylotarg has been on the market since 2000 … and the follow-up study did not begin until 2004. Even then, it wasn't until last year -- nine years after the drug first entered the market -- that the follow-up study was stopped short due to increased death risk and no benefit.
Now, while the drug has been withdrawn in the United States, it's still being sold in nine other countries and there's no word on whether or not Pfizer plans to pull the drug from shelves around the world.
Pfizer's New Pain Medication Also Makes Patients Worse
Just days after the FDA asked Pfizer to withdraw Mylotarg from the market, Pfizer announced it has suspended trials of a new experimental pain relief drug, Tanezumab, for osteoarthritis.
The trial was stopped after patients reported their conditions got worse and some actually required joint replacements as a result.
However, their show of good faith only extends so far, as they are continuing Tanezumab trials for other conditions, including cancer pain, interstitial cystitis, chronic low back pain and diabetic peripheral neuropathy, until the FDA has a chance to review company data.
Why You Can't Trust Drugs Just Because They're "FDA-Approved"
This sounds similar to what occurred when Pfizer brought their painkiller Bextra to the market in 2001. The FDA approved the drug, despite the fact that it was associated with an increased risk of stroke and heart attacks, but only for treating arthritis and menstrual cramps.
Pfizer, not wanting to miss out on billions of dollars of profits at stake, decided to go on a rampant promotional campaign to sell Bextra for off-label uses, namely for treating pain after surgical procedures.
They not only instructed their sales reps to market Bextra to doctors in this way, but they directly paid hundreds of doctors to give lectures touting Bextra's benefits.
In 2005, when Bextra was pulled from the market due to its increased risks of heart attack and stroke, about half of its $1.7 billion in profits were due to off-label uses that were not approved.
Pfizer did end up getting prosecuted for its fraudulent marketing spree … but their sentence was a mere slap on the wrist. And you won't hear Pfizer being charged with any crime, because it was actually Pharmacia & Upjohn Co. Inc, a Pfizer subsidiary, that took the rap.
This was not due to an oversight or a smooth move on Pfizer's part … it was the result of a deal made between Pfizer and federal prosecutors. The feds essentially let Pfizer off the hook so their products could continue to flow through Medicare and Medicaid.
Anyone who cares to look will notice a repeating pattern of unsafe drugs being brought to market, only to cause considerable deaths and suffering before being withdrawn years later.
It happened with Bextra, it happened with Mylotarg, it's happened with countless other drugs in the past and will, unfortunately, continue into the future.
True Cancer Treatment Goes Beyond Drugs
According to a recent article in the US Today, the cost of cancer treatment has doubled in the last two decades, from just under $25 billion annually in 1987, to more than $48 billion a year during 2001-2005 (amounts calculated with inflation to reflect value of dollar in 2007).
And the trend shows no sign of reversing. In fact, several new, high-priced cancer treatments have been released in the past five years. But none of them offer any significant hope for a longer life, let alone a cure -- and some, like Mylotarg, may actually make you die faster!
The fact is, expensive medications often give patients just a few more months of life -- and sometimes they kill people prematurely.
Take a look at these examples.
- AVASTIN – Avastin, when used to treat colorectal cancer, sold for $50,000 per year. However, once it was approved to treat breast and lung cancer as well, Genentech announced a new price tag: $100,000 per year, even though it may extend your life by no more than a few months.
- ERBITUX – Another colorectal cancer drug, with a price tag of nearly $10,000 per month, even though there is not a single study showing it helps colorectal cancer patients live longer.
- EVISTA (Raloxifene) -- This Eli Lilly drug was found to prevent breast cancer by one-third in a study of more than 10,000 postmenopausal women. Your true cost? Trading your breast cancer prevention for a 50 percent increased risk of fatal strokes and blood clots. Ironically, Evista was once sold as an osteoporosis drug, being illegally promoted for treating cardiovascular disease back in 2002.
- GLEEVEC – Also sold under the name Glivec. This cancer drug, used to treat leukemia, unfortunately also kills heart muscle cells, which may cause fatal congestive heart failure.
- ABRAXANE – A new version of an old cancer drug, Taxol, sells for $4,200 per dose. The older version, which has similar effects, costs 25 times less.
So, what's missing from this equation?
A focus on prevention.
The answer to the cancer epidemic is not just devising better drugs to treat it in its advanced stages. The answer is preventing cancer from occurring in the first place.
10 Steps to Prevent and Fight Cancer Naturally
Many of the preventive strategies I'm about to share with you are not only important to prevent cancer, they're also incredibly important to use as part of your cancer treatment strategy if you already have the illness.
- Optimize your vitamin D levels. It's virtually impossible to discuss cancer prevention and treatment today without discussing vitamin D, as the scientific evidence of its anti-cancerous benefits is truly impressive.
Theories linking vitamin D to certain cancers have been tested and confirmed in more than 200 epidemiological studies, and understanding of its physiological basis stems from more than 2,500 laboratory studies, according to epidemiologist Cedric Garland, DrPH, professor of family and preventive medicine at the UC San Diego School of Medicine.
Dr. Garland is widely regarded as the leading epidemiologist on vitamin D and its relation to health. He led one of the latest studies on vitamin D for cancer prevention and proposed a new model of cancer development -- dubbed DINOMIT-- that is centered on a loss of cancer cells' ability to stick together.
The model is a departure from the older model of cancer development, which centers on genetic mutations as the earliest driving forces behind cancer.
To find out the appropriate levels of vitamin D for cancer prevention and treatment, please watch my free one-hour vitamin D lecture.
- Control your insulin levels by limiting your intake of processed foods and sugars as much as possible.
- Get appropriate amounts of animal-based omega-3 fats, especially those from krill oil.
- Exercise. One of the primary reasons exercise works is that it drives your insulin levels down. Controlling insulin levels is one of the most powerful ways to reduce your cancer risks.
Exercise is also an important part of cancer treatment, as Harvard Medical School researchers found patients who exercise moderately -- 3-5 hours a week -- reduce their odds of dying from breast cancer by about half as compared to sedentary women.
In fact, any amount of weekly exercise increased a patient's odds of surviving breast cancer. This benefit also remained constant regardless of whether women were diagnosed early on or after their cancer had spread.
- Have a tool to permanently erase the neurological short-circuiting that can activate cancer genes. Even the CDC states that 85 percent of disease is caused by emotions. It is likely that this factor may be more important than all the other physical ones listed here, so make sure this is addressed. My particular favorite tool for this purpose, as you may know, is the Meridian Tapping Technique/Emotional Freedom Technique
- Only about 24 percent of people eat enough vegetables, so by all means eat as many vegetables as you are comfortable with. Ideally, they should be fresh and organic. However, please understand that, frequently, fresh conventionally grown vegetables are healthier than organic ones that are older and wilted in the grocery store. They are certainly better than no vegetables at all, so don't use that as an excuse. If you are a carb nutritional type you may need up to 300 percent more vegetables than a protein nutritional type.
Eating according to your nutritional type has potent anti-cancer effects. When we treat cancer patients in our clinic, this is in fact one of the most powerful anti-cancer strategies we have.
- Maintain an ideal body weight.
- Get enough high-quality sleep.
- Reduce your exposure to environmental toxins like pesticides, household chemical cleaners, synthetic air fresheners and air pollution.
- Boil, poach or steam your foods, rather than frying or charbroiling them
Clearly, virtually no cancer prevention or treatment plan is complete without these lifestyle modifications. These relatively simple risk reduction strategies can help you to VIRTUALLY ELIMINATE your cancer risk, and radically improve your chances of recovering from cancer if you currently have it.