A CASE STUDY SHOWING YOU ARE DOOMED IF YOU RELY ON YOUR DOCTOR TO TELL YOU ABOUT THE RISKS AND ADVERSE EFFECTS OF MEDICATION. YOU HAVE TO PROTECT YOURSELF OR CHANCES ARE YOU WILL BE UNPROTECTED.
If you read this column, you'll better understand why you have to take an active, perhaps even aggressive role when it comes to the drugs you take and what you take them with. The point is made through one case, but it is a specific example of what is closer to the rule rather than the exception.
This is a strange tale about a drug that is widely used but is dangerous and some experts say should not be on the market at all. It is a strange tale for other reasons. There are safer and more effective alternatives. What's more, there is no unique benefit to using the drug. But despite all that, as you may have guessed, it is being prescribed more and more in the U.S.
If that's not enough to get your attention, consider this. The European Medicines Agency, the drug regulatory body for 27 European Union countries, recently announced severe restrictions on this uniquely dangerous drug. That agency cited "the risk of gastrointestinal side effects and serious skin reactions" as the basis of new warnings and new restrictions on the use of this drug.
Needless to say, the Food and Drug Administration (FDA) issued no similar warnings, failed to warn patients and doctors of the increased gastrointestinal toxicity of the drug compared with alternatives in the same class of drugs, and actually promotes the drug's use for situations where it makes no sense.
That's strange, but what perhaps is most strange is that this case is not that rare, but is all too typical of what goes on with the FDA and the market for prescription drugs in the U.S.
Of course, there are new excuses being offered for the failures of the FDA. It was recently announced that the FDA does not have the manpower and other resources to do its job. That has been apparent for decades, but Congress and the FDA have failed to take remedial action.
Every time one of the endless FDA failures shows up in the news, Congress and others use the approach in the movie Casablanca: "Round up the usual suspects."
When I started reporting on consumer issues in 1975, the first thing I discovered is that if I wanted an interesting and sensational story of the failure of a government agency to take action on safety and other issues relating to foods, drugs, and cosmetics, all I had to do was take a look at what the FDA was doing, and more important, what it was not doing. The failures of the FDA have been open and obvious except to those who are blind, deaf, and dumb to the marketplace and except the U.S. Congress.
The FDA failures were obvious and open, such as permitting fine print on drugs used by those likely to have failing vision, failing to get the right directions and warnings on even the most commonly used drugs such as aspirin, and failure to put proper first aid advice on products that are poisons. Problems that should have been resolved in 30 minutes would sometimes take 30 years. Hence, some say the FDA really stands for the Foot Dragging Administration or the Foolishly Doesn't Act agency.
In case you are wondering, the drug in question is piroxicam (Feldene). The drug is used as a painkiller and an anti-inflammatory for arthritis and other conditions. Its dangers were exposed in 1994, when the Health Research Group (HRG), publishers of Worst Pills, Best Pills (it puts out the newsletter and book with that name) told the FDA to ban piroxicam because of its unique gastrointestinal toxicity and the absence of any evidence of a unique benefit.
HRG cited a study that found that in comparison to ibuprofen (Advil, Motrin), "piroxicam was between 2.8 and 7.1 times more likely to be associated with severe gastrointestinal toxicity, defined as bleeding, ulceration or perforation. No other NSAID [nonsteroidal anti-inflammatory drug] was as consistently as high in gastrointestinal risk as piroxicam."
In addition, HRG noted that through mid-1994, there were 144 cases reported to the FDA of deaths of patients from serious gastrointestinal side effects. Almost 90 percent of those cases were patients over the age of 60.
The FDA turned down the petition. Now all of these NSAIDs carry the same warning, giving the false impression that they all carry the same gastrointestinal risks. This false FDA labeling is contrary to the studies and contrary to the position of the European Medicines Agency and the warning it issued to the 27 European Union countries.
The prescribing trends for piroxicam carry important messages as to prescribing practices. In 1984, there were eight million prescriptions filled for piroxicam. As physicians and patients learned of the dangers of this drug, the number of prescriptions dropped to 5.5 million prescriptions in 1992 and fewer than one million in 2002. However, the dangers of piroxicam are now apparently being forgotten by patients and doctors as the number of prescriptions written has more than doubled since 2002, coming in at over two million in 2006.
What can you do if you are taking this drug? First you should be aware of the warnings from the European Medicines Agency that it should "no longer be used for treatment of short-term painful and inflammatory conditions" and should not be the first choice for "symptomatic relief of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis [a form of arthritis that particularly affects the spine]."
Worst Pills, Best Pills News (November 2007) has some further advice. If you are taking piroxicam, ask your doctor if another one of the NSAIDs might be substituted. They would include ibuprofen (Advil, Motrin) and naproxen (Aleve, Anaprox, Naprosyn). It also notes, "Naproxen has the added advantage of having the least cardiac risk of the currently-used NSAIDs (both ibuprofen and naproxen are available over the counter)."
The book Worst Pills, Best Pills also has this important warning for all NSAIDs: "All members of the NSAID family of drugs can cause gastrointestinal toxicity that can lead to gastrointestinal bleeding and hospitalization or death. The risk of gastrointestinal toxicity from these drugs increases with increasing doses and the length of treatment.
"If the following symptoms develop while you are taking an NSAID, stop the drug immediately and contact your doctor: severe abdominal or stomach pain, cramping, or burning, severe and continuing nausea, heartburn, or indigestion, bloody of black, tarry stools, vomiting blood or material that looks like coffee grounds, or spitting up blood."
On piroxicam specifically, the book lists it as a "do not use" drug, and recommends other NSAIDs such as aspirin.
If you need more proof that you have to protect yourself from bad prescribing practices or chances are you won't be protected, consider a study conducted at a Harvard Medical School arthritis clinic. A doctor named Jeffrey Katz wanted to see if doctors would tell patients about the serious risks of NSAIDs, and tell them what to watch out for.
Thomas J. Moore in his book Prescription for Disaster reports on what Dr. Katz found:
"One quarter of the patients got no information whatever about the adverse effects of the anti-inflammatory drug that was prescribed. Among those who got some information, the major warning was that it might upset their stomach. More than 85 percent of the patients were never warned about the two serious risks of long-term therapy - a perforated ulcer or intestinal bleeding. These findings may surprise the reader, but the principal investigator said at the outset he expected patients wouldn't be told little about the dangers of the drugs. As a physician, he knew very well that many doctors do not tell patients about the serious risks of drugs. This fact has been repeatedly confirmed in studies published over decades. For example, in 1994 the FDA conducted a nationwide survey of patients who had recently gotten a prescription from their doctor. More than 70 percent said their doctor told them nothing whatever about the adverse effects of the drugs prescribed. About one-third said they went home without even a doctor's instructions on how much medication to take or when to take it." What makes the study even more frightening is that these were Harvard Medical School Doctors, supposedly among the best.
You can't rely on your doctor to tell you the simple truth about the medications he prescribes. You have to quiz him - perhaps cross-examine would be a better term. You have to question your pharmacist and you have to do some checking on your own. As the studies show, you just won't get the truth, the whole truth, and nothing but the truth from your doctor. You're likely to get very little truth and lots of what is misleading.
Louis J Sheehan