VIOXX, HEART ATTACKS, OPIODS & FALLS
A Tale of Technology, Risks, and Unintended Consequences
Invited Post by John Nail, Ph.D.
Modern pharmaceutical drugs, along with other medical technologies, have doubled life expectancies during the past 100 years. There is a real possibility that the news media, politicians, lawyers and gullible jurors will put an end to these advances. The news media appears to enjoy reports of ‘dangerous products’ that the politicians embrace as it gives them a way of diverting attention from their own lack of competence. Trial lawyers earn their living by convincing gullible jurors that the ‘big companies’ are to blame for anything adverse that occurs when someone uses their product. Often, the result of the media and political orgy is that useful products are removed from the market. This is the story of a drug that was removed due to safety reasons and the possible unintended consequences of its removal. Before we proceed, we should note that 1) ALL technologies have unintended adverse consequences, 2) It is not possible to know what these consequences will be until large numbers of people start using (and abusing) the product, and 3) Decisions have unintended consequences, including often making a situation worse when trying to make it better.
Vioxx (generic name rofecoxib) was a prescription drug for the treatment of pain from osteoarthritis (this is the type of arthritis that occurs when bones are rubbing against each other). Vioxx was approved for use by the US Food and Drug Administration on May 20, 1999; it was discontinued on September 30, 2004, due to concerns regarding cardiovascular problems (heart attacks and strokes) in patients that used the drug.
A considerable amount of testing is required before the FDA will approve the use of a new prescription drug. One of the pre-approval tests involving Vioxx was the ‘VIGOR’ study – a double-blind test in which one group of participants (the study group) was given Vioxx and the other, (the control group) naproxen, a non-prescription pain reliever. This trial found that the Vioxx group members who had pre-existing heart attack risk factors were four times more likely to have a heart attack than were the participants of the naproxen group with pre-existing heart heart attack risk factors. One interpretation of this result is that Vioxx causes heart attacks in people with heart disease risk factors; the other interpretation is that naproxen prevents heart attacks in people with heart disease risk factors. We know that aspirin prevents heart attacks, so it is reasonable to assume that naproxen prevents heart attacks. Interestingly, there was no difference between the two groups in regards to deaths from heart attacks, nor was there a difference between heart attack rates between the two groups in people who did not have heart attack risk factors. Thus, if a person has heart attack risk factors and should be taking a ‘baby’ aspirin each day, that person’s chance of a heart attack is four times higher if the person is taking Vioxx instead of naproxen.
APPROVe was another Vioxx clinical study in which the ‘control’ group was given a placebo (sugar pill). During this study, it was found that, after 18 months, the participants who were being given Vioxx were almost twice as likely to have a heart attack than were the participants who were being given sugar pills. However, the heart attack deaths (mortalities) were equivalent between the two groups. Thus, as in the VIGOR study, the rate of heart attacks were greater in the Vioxx group, but the rate of heart attack deaths were identical between the two groups. The APPROVe results and the resulting media uproar resulted in Vioxx being withdrawn from sale.
Bextra and Celebrix were Vioxx’s competitors. Bextra was withdrawn due to increased heart attack and stroke risks in patients who were taking Bextra while recovering from heart surgery. Celebrix is still being marketed, however, it has a ‘black box warning’ that it should be used only as a last resort on patients who have heart disease or a risk of developing heart disease.
One of the arguments for why Vioxx and Bextra should no longer be sold was that “osteoarthritis patients have other options for relieving their pain” – these other options are over the counter pain relievers (aspirin, naproxen, acetaminophen, ibuprofen, etc.), and opioids such as codeine, demerol and morphine. While opioids are among the most effective of all pain relievers, they have unintended effects such as narcosis (sleep inducement) and physical and psychological addition. Rush Limbaugh allegedly became psychologically addicted to opioids.
Recently, a study determined that switching osteoarthritis patients from Vioxx or Bextra to opioids has resulted in a fourfold increase in falls and broken bones in elderly osteoarthritis patients. A quote from an article in The Journal of Higher Education that discussed this increase in falls and broken bones,
“Somebody should have thought more carefully about the elderly before making these recommendations” (switching elderly osteoarthritis patients from drugs such as Vioxx to drugs such as codeine to control their pain), says Bruce N. Cronstein, a professor of medicine at New York University’s Langone Medical Center. “Falls in an elderly population can be very dangerous, leading to long hospitalizations and even death.” ….”We don’t have wonderful alternatives for treating chronic pain”… Long treatment with aspirin or ibuprofen, for instance, often irritates and damages the digestive system…Falling down seems like one of the most obvious adverse effects, says Dr. Cronstein. “That’s not rocket science,” he notes. “The elderly are more frail. They have a host of factors that could lead to falls. If you add something that makes you a little unsteady, it increases the risk”
Thus, the choices for people with osteoarthritis are (and were) over the counter drugs such as aspirin and ibuprofen, that can cause digestive damage from long-term use, prescription narcotics that increase a person’s risk of falling by fourfold, or prescription drugs such as Vioxx that, in people with heart attack risks, increased their risk of heart attacks, however, these did not increase their risk of dying from a heart attack. The media and political storm that resulted in Vioxx and Bextra being removed from the market appears to have resulted in either more pain in osteoarthritis sufferers due to their not treating the pain, or the possibility / reality of digestive system damage, or increased use of opioid drugs which has produced an increase in falls and broken bones.
Elderly patients also don’t have the best of memories. This sometimes leads to accidental overdoes of opioid (and other drugs) due to a patient’s forgetting that they had already taken their pain pill for that day. It is also known that people often develop tolerances to opioid drugs, making these increasingly less effective.
I leave you with a comment uploaded to the discussion section from The Journal of Higher Education article:
‘“In addition to the danger of increased falls, the removal of Vioxx and Bextra from the market meant increased arthritis pain for millions of people (including me). The possibility of heart problems for some won out over the reality of pain for millions. I hope that not all medical decisions are made this way” John C.’
Unfortunately, this is how medical decisions are made during a media generated crisis. The next time that there is a media uproar about ‘dangerous medical products’, remember that the unintended consequences from the product’s alternatives may be worse than the product’s unintended consequences.
DR. NAIL is Chair of the Chemistry Department at Oklahoma City University
Ding, Dong, Another Scare, Another Scare*
[*sing to the tune of The Witch is Dead]
Invited Post by John Nail, Ph.D.
On his September 14 show, Dr. Oz apparently claimed that apple juice contains large amounts of arsenic, making it unsafe for consumption, particularly for children. Previously, Dr. Oz has made claims about ‘unsafe’ amounts of contaminates in drinking water. While making claims of ‘____ (fill in the blank) is dangerous, we must protect the children from ____ (fill in the blank)’ may make for good daytime television, these claims are lousy science. Unfortunately, the typically American combination of poor thinking skills, pathetically poor science understanding and the ‘evil big business’ news story template make many people susceptible to accepting the scientifically unsupported, sensational claims made by entertainers such as Dr. Oz. Physicians such as Dr. Oz, a heart surgeon, rarely are scientists.
Yes, chemists can detect arsenic in apple juice; we can also detect arsenic in drinking water (both tap and bottled) and virtually every food, both ‘organic’ and conventional, in any supermarket, including Whole Foods. This ability to detect arsenic isn’t due to wide-spread arsenic contamination, it is more due to the incredible technology that allows Analytical Chemists to detect increasingly minute levels of chemical substances. Nowadays, we can almost always find any of the ‘bad’ substances in almost every food. The real issue is that minute amounts of bad substances are not necessarily harmful.
Decades ago, (real) scientists argued over the competing ‘Linear’ vs ‘Threshold’ hypotheses regarding exposure to toxic substances and exposure to radiation. Today, now that we can find almost every naturally-occurring toxic substance in everything, we’ve learned that the body has natural mechanisms for removing toxic substances and repairing damage from toxic substances. The ‘Threshold’ model, the assumption that permanent damage only occurs when the exposure happens faster than the body can fix things, is now widely supported. The ‘Linear’ model, in which it is assumed that any amount of exposure to a bad substance will cause some permanent damage, is only supported by government regulatory agencies, activist scientists and scientists whose scientific careers have been based on researching the effects of very low exposures. We’ve known for five centuries that ‘the dose makes the poison’, which means that everything (including water) is toxic in high enough amounts and nontoxic in low enough amounts.
Small amounts of arsenic (and other ‘bad’ substances, including radiation) are in our food and water because nature put them there. As an example, much of the soil in central Oklahoma contains naturally high amounts of arsenic.
Consider someone who lives in central Oklahoma and has high arsenic soil in their backyard. If an apple tree grows in the high arsenic soil, the apples produced by the tree will contain high amounts of arsenic, even if the tree is grown using ‘organic’ techniques (only chemicals produced by nature are used for fertilizer or pest control). The person who consumes the apples from the tree will be exposed to arsenic.
The Federal Government (EPA) set a limit of no more than 10 ppb (parts per billion) of arsenic for drinking water and mandates that the water in every municiple water distribution system be tested at least once every calendar quarter to measure the levels of ‘bad’ substances such as arsenic and chloroform. Operationally, no water distribution system would let water with an arsenic level of above 9 ppb go into the system; this ensures that the water stays below the 10 ppb level. One part per billion of arsenic in water (or apple juice) is 0.000001 gram of arsenic in one liter (effectively one quart) of water or apple juice. Water with the federally allowable limit of 10 ppb of arsenic contains 0.00001 gram of arsenic in each liter of water.
Dr. Oz claimed to have found as much as 23 ppb of arsenic in apple juice. The Federal Government (USDA and FDA) also monitors the amounts of ‘bad’ substances, such as arsenic in food. While the USDA and FDA don’t set absolute limits as does the EPA, they would be ‘concerned’ about apple juice that contained 23 ppb of arsenic; when the FDA test food products, they rarely find arsenic levels higher than 13 ppb. (http://www.medicinenet.com/script/main/art.asp?articlekey=149396 ).
The USDA classifies a ‘serving’ of apple juice as one cup. Consider a child who drinks four cups of apple juice every day for ten years and that all of the apple juice that she drinks contains 23 ppb of arsenic. During this ten years, she would ingest a total of 0.083 grams of arsenic and 1,708,200 calories from the apple juice; 14,600 juice boxes would go to the landfill.
Some of our ancestors had to hunt wild animals and gather wild plants to keep from starving. Occasionally, instead of eating the wild animals, the wild animals ate them. Other ancestors had the relative comfort of being able to sometimes grow some of their own food. If the crop didn’t make, they often didn’t eat. Today, food more abundant and safe less expensive as it every has been during the history of mankind.
It appears that some people need something to worry about and Dr. Oz, as well as other entertainers, make a living by making mountains out of anthills.
DR. NAIL is Chair of the Chemistry Department at Oklahoma City University
FOODLESS “BREATHARIAN” CLAIMS TO SURVIVE ON SUNLIGHT ALONE
Hira Ratan Manek
Wikepedia defines “breatharians” as those who ….”claim food and possibly water are not necessary, and that humans can be sustained solely by prana (the vital life force in Hinduism), or according to some, by the energy in sunlight.” This story has been perplexing many experts–including some NASA scientists–because the space agency apparently confirmed the 64 year-old mechanical engineer went 130 days without food. But his wife purports that Manek also consumes buttermilk–a food source perfectly capable of sustaining a person for extended periods of time. It has a whopping 460 calories per cup. Check out the full nutritional contents of buttermilk and read a skeptic’s perspective:
ACAI: A BERRY BIG SCAM?
Is the Acai berry craze resulting in weight loss or money loss? Credit card bandit awaits…
BOONDOGGLE OF THE DECADE
From CBS News:
Odds are you’ve seen the TV commercial that repeats the phrase, ” ‘Head On,’ apply directly to the forehead” over and over. It touts the benefits of an over-the-counter product. The ads used to say rubbing it on your forehead would relieve headaches, but then the Better Business Bureau announced that,
The company failed to provide any reliable clinical testing to support its claims.”
The commercials no longer claim Head On works, but they’ve become something of a pop phenomenon.
CLICK HERE TO READ FULL STORY AND WATCH VIDEO CLIP
CHIROPRACTIC: An OKC M.D.’s Warning
NECK ADJUSTMENT & STROKE? A WARNING FROM BILL KINSINGER, M.D.
The birth of chiropractic occurred in Davenport Iowa in 1895. Daniel David Palmer was an uneducated grocer who longed to find a cure for all disease. He reportedly cured a deaf man by manipulating his neck and convinced himself that he had indeed found the cure for all ailments. Palmer claimed that 95% of all illness could be eliminated by manipulating the spine, a procedure he called an “adjustment.” The Palmer School of Chiropractic is still considered the “fountainhead” of chiropractic and the theories and practices that are taught there in the 21st century are virtually unchanged from the ideas that D.D. Palmer put forth just over 100 years ago.
That Palmer’s theories have no merit and no scientific basis is troubling enough. Our health care system is struggling with skyrocketing costs and wasting those dollars on quackery seems to be totally illogical. Making the matter worse, chiropractic is not without significant hazards. Chiropractors believe that part of the spine in most need of “adjustment” is the upper neck. Unfortunately, a small number of patients who have their upper necks twisted will suffer a stroke. Most of these patients are woman between the age of twenty and forty-five. Some of them will recover; others will die or suffer permanent and profound neurological injury such as quadriplegia. The benefits of chiropractic treatment are minimal or non-existent. The risks are tremendous.
……. Bill Kinsinger, M.D. [invited blogger]
CLICK HERE TO WATCH DR. KINSINGER EXPLAIN
CLICK HERE TO VIEW CNN REPORT (SANJAY GUPTA, M.D.)
HOMEOPATHY: Placebo or Legit?
CLICK HERE TO WATCH THE SCIENCE CHANNEL EXPLAIN HOMEOPATHY
