Scientists, regulators and manufacturers have come up with numerous proposals that could reduce the toll of deaths and injuries from one of America's most popular drugs
Over the past several days, we’ve highlighted the deaths and injuries caused by overdosing on acetaminophen, the active ingredient in Tylenol. We’ve pointed out that the toll does not have to be so high.
Today, we share some of the more prominent proposals to reduce the harm from one of America’s most widely used pain relievers.
The ideas come from a variety of sources, including scientists, the U.S. Food and Drug Administration (FDA), regulators in other countries, industry officials and McNeil Consumer Healthcare, the Johnson& Johnson unit that makes Tylenol, the best-selling acetaminophen brand.
From 2001 to 2010, more than 1,500 Americans died from accidentally taking too much acetaminophen, according to data from the U.S. Centers for Disease Control and Prevention. An additional 1,400 people intentionally overdosed to commit suicide or died under circumstances in which their intent was unclear.
1. Drop the Daily Total
FDA advisors — prominent doctors, researchers and safety advocates — suggested in 2009 that the agency lower the total maximum daily dose of acetaminophen from its current limit of 4 grams per day, equal to eight extra strength acetaminophen pills. McNeil itself adopted the suggestion for its Extra Strength Tylenol product and now recommends a maximum of 3 grams, or six pills, per day unless otherwise directed by a doctor. (The company hasn’t applied this to all its products, nor to Extra Strength Tylenol worldwide.)
WHO COULD DO THIS? Either the FDA or the companies that manufacture acetaminophen could change dosing instructions.
2. One Concentration and Dosing Instructions for Kids’ Products
After confusion between different concentrations of pediatric acetaminophen led to child deaths, the drug industry in 2011 voluntarily agreed to market only a single concentration in the United States. For years, most recently in August 2013, the industry has also asked the FDA to allow dosing instructions on acetaminophen labels for kids under 2 to help prevent the lethal confusion. FDA advisory panels have told the FDA to do the same thing, most recently in 2011. So far, the FDA has not required a single concentration, nor has the agency ruled on whether to require the dosing instructions.
WHO COULD DO THIS? The FDA.
3. Take Acetaminophen out of Prescription Pain Killers
Vicodin and Percocet are a mixture of powerful pain killing opioids and less potent acetaminophen. Just why these medications are combined is controversial – some people argue that adding acetaminophen to an addictive drug only increases the risk of liver poisoning, with little additional pain-relief benefit. But, because of a quirk in how opioid drugs are regulated, removing acetaminophen might result in drugs such as Vicodin and Percocet becoming more restricted medicines – harder to prescribe and harder to get. By a small margin, FDA advisors recommended removing acetaminophen from prescription opioids in 2009. The agency has declined to take that step, but in 2011 limited the amount of acetaminophen that a single pill can contain to 325 mg. It also put a so-called black box warning on the label stating that an overdose can cause death.
WHO COULD DO THIS? The FDA and the Drug Enforcement Administration, which plays a large role in regulating addictive medicines, would have to sign off.
4. Restrict Pill Quantities
Regulators in the United Kingdom, Germany, Australia and elsewhere all restrict the purchase of acetaminophen in some way. They limit how many pills consumers can buy at one time, where they can buy them, how many pills can be put in one package, or a combination of such measures. A recent U.K. study found that restricting purchases resulted in a significant drop in suicides with acetaminophen. In 2009, however, FDA advisors recommended against such restrictions, and it is unclear whether the agency has the legal authority to impose them.
WHO COULD DO THIS? Both the FDA and Congress might need to act.
5. Dose Up Slowly
In 2009, McNeil proposed adding language to its Extra Strength Tylenol packages to instruct consumers to take only one pill at a time and increase to two only if they don’t get pain relief – a common medical practice known as taking the lowest effective dose. McNeil itself features such instructions on bottles of Motrin, its brand for the pain reliever ibuprofen. The FDA has not required it for acetaminophen.
WHO COULD DO THIS? Either the manufacturers or the FDA could make this change.
6. Limit Pill Strength
The FDA has required that prescription medicines contain no more than 325 mg of acetaminophen per pill to limit the risk of liver damage; drug companies must implement this change by January 2014. The agency has not, however, mandated that over-the-counter medications have the same limit, even though most acetaminophen is sold over the counter. The result? Without a prescription you can buy pills that contain double the amount of acetaminophen than those you could purchase under a doctor’s supervision.
WHO COULD DO THIS? The FDA or the drug manufacturers.
7. Require Side Effect Warnings in Advertisements for OTC Drugs
As far back as 1977, a panel of experts warned that the government needed to crack down on marketing that extolled the benefits of over-the-counter pain relievers without revealing the risks. By a twist of bureaucratic history, the Federal Trade Commission regulates advertising for over-the-counter drugs, not the FDA. That’s why you see those long announcements after prescription drug ads but not after commercials for, say, Tylenol or Alleve, another non-prescription pain killer.
WHO CAN DO THIS? Congress could pass a law to require ads for over-the-counter drugs to disclose risks, or drug companies could take this step voluntarily.
8. Acetaminophen Icon
Acetaminophen is in more than 600 medicines, by the FDA’s count. Regulators and drug makers worry that consumers can unwittingly overdose by taking two medicines with acetaminophen – for example, Tylenol and NyQuil. Thirty-five percent of Americans wrongly think that combination is safe, according to a nationwide poll commissioned by ProPublica and This American Life and conducted by Princeton Survey Research Associates International. One proposal aimed at reducing double-dipping is to create a universal icon to slap on the front of every product with acetaminophen, a bit like a “caution” sign.
WHO COULD DO THIS? McNeil, other acetaminophen makers and the FDA have been considering this idea for more than a decade without taking action. Last month McNeil announced it would take a step in this direction: adding a red-letter warning to its bottle caps reading, “Contains Acetaminophen” and “Always Read the Label.”
9. Grab Consumers’ Attention by Warning Them an Overdose Can Kill
In almost all overdose cases, patients are at least partly responsible. After all, they took too much of the drug – and one reason may be that people often don’t pay much attention to drug labels. But maybe they would if the label warned, prominently, that an overdose could kill. In fact, Canadian regulators require over-the-counter acetaminophen to warn about its lethal potential. And the FDA already requires prescription medicines that contain acetaminophen to warn that taking too much can lead to “death.” But it requires no fatality warning on over-the-counter acetaminophen, even though most of the drug is sold that way.
WHO COULD DO THIS? The FDA or the manufacturers.
The enormous funds that flow from the powerful pharmaceutical industry helps to keep this myth or ‘no more beyond’ alive, despite many evidences to the contrary
The medical fraternity, aided and abetted by the giant pharmaceutical industry, believes and propagates the idea that mankind cannot remain healthy or win over illnesses without regularly medical help and medicines. Together, they have come to the conclusion that there is nothing beyond medicine and doctors in medical science. In this whole game, the power of the immune system of the human body and its self correcting capacity are deliberately suppressed.
I am reminded of Sir Francis Bacon’s projected “System of Philosophy”, The Great Instauration (Novum Organum – 1620 AD), which also believed in similar reductionist logic. He stated: “Before Columbus set sail across the Atlantic, the coat of arms of the Royal Family of Spain had been an impressa, depicting the Pillars of Hercules, the straits of Gibraltar, with the motto, Ne Plus Ultra. There was ``No More Beyond.'' It was the glory of Spain that it was the outpost of the world. When Columbus made his discovery, Spanish Royalty thriftily did the only thing necessary: erased the negative, leaving the Pillars of Hercules now bearing the motto, Plus Ultra. There was more beyond...”
Many of the “new philosophers”, now called “scientists”, led by Sir Francis Bacon, regarded these inscriptions to be very prophetic and significant. The Pillars were supposed to signify the passage of knowledge just like the sailors, who pass to and fro between these Pillars. Medical scientists of today seem to believe in that motto. They seem to believe that there is NO MORE BEYOND modern medicine, to keep man alive on this planet. The enormous funds that flow from the powerful pharmaceutical industry helps to keep this myth alive, despite many evidences to the contrary. It also reminds me of the farming industry where the petrochemical giants perpetuate the myth that mankind could never be fed adequately unless the farming industry depended on chemical fertilizers. In fact, the first anti-microbial, sulphonamide, also came from the petro-chemical industry.
Both these beliefs are seriously flawed. Modern science of particle physics shows that the human being is only a tiny part of this macrocosm. It is our consciousness, which makes us tick in tune with the universal consciousness. Human body is a dynamic organism constantly run by food and oxygen but, totally dependent on the outside world for its sustenance environment. Human being is not a machine like a timepiece, run by its spring. The human body does not work in bits and pieces, as was thought by Rene Descartes, neither does it follow the conventional science of deterministic predictability of Newton and Albert Einstein. On the contrary, it works as a whole (holistic view) following the new science of particle physics of Max Planck, Max Bohm, Werner Heisenberg, Paul Dirac and Erwin Schrodinger.
In their effort to combine the sciences of conventional physics and modern quantum mechanics, present day physicists are trying to get the two together in their “Unified Field” theory. Curiously, this is exactly what the Indian wisdom proclaimed to the world, time immemorial, in their inimitable style thus: “The whole universe is the container (space) and the content is universal consciousness”. If that were so, every human being becomes a tiny speck of that universe; totally interdependent and interconnected; similarly for agriculture. It is also dynamic and depends, to a large extent, on the soil and the multitude of organisms that make the soil fertile. Chemical fertilizers, in the end, would only promote the growth of weeds and sap the soil of its inherent fertility, acquired with the help of a host of microorganisms that inhabit the soil.
There is an awareness of this even in the developed West where some farmers follow natural organic farming methods. Chemical drugs from the pharmaceutical industry have been responsible for the mushrooming of “super bugs,” the multi-drug resistant microorganisms, in almost all hospitals, threatening patient safety. I only hope that we will not come one full circle to the time of “hospitalism” of the nineteenth century Britain, where seriously ill patients went to the hospital only to never to return home.
In this scenario, human body would eventually suffer illnesses because of drugs and interventions, and agriculture would grow lots of weeds instead of useful food. Good wholesome food is a vital prerequisite for good health, anyway. The clear writing is already on the walls. The earlier mankind takes note of the warning, the better for future generations.
Many farming lobbies in the West and a few farmers in India have taken note of this to reverse the trend in agriculture. Still the pressure of the multi-billion dollar giant of the petro-chemical industry, helped by our Cartesian reductionist scientists and the all too obliging media is keeping the dangerous myth alive that chemical fertilisers and genetically modified seeds are our saviours! Genetically modified seeds could be a more dangerous and unforeseen threat to mankind. Space does not permit me to go into its details here.
The following analogy fits the medical world very well.
Doctors, from day one at the medical school, are being brainwashed to believe that the bio-medical model of man as a machine, made up of independent parts, the organs, needs periodic servicing, even when the machine seems to be working well, lest it should break down without prior warning in the future. In addition, they are made to believe that drugs and interventions are the be-all and the end-all of disease management. Most of the reductionist scientists in this field help perpetuate this myth. This mechanistic paradigm of man as a bio-medical model has been the milch cow of the drug industry and the technology giants. Interventions, more so, in apparently healthy population and the sheer numbers, has been financially very rewarding to the medical fraternity and the hospital giants. Medical education, particularly continuing medical education of the practitioners, seems to be totally under the grip of these manipulators.
The reality, however, is different. The human body is built with enough safety measures to keep it going as long as possible with the help of its environment. The kingpins in this self-preserving and self-sustaining game seem to be the human mind, while the external environment is an important ally. All functions of the human body follow three rhythms—the ultradian, the circadian and, the infradian. Of these the last happens beyond the twenty-four hours’ cycle, whereas the former two follow the day (24 hrs cycle). The infradian rhythm is the one that is controlled by the external forces—the environment—to a greater extent compared to the former two. In this context, I would like to mention the recent finding that the woman’s menstrual cycle, a twenty eight days cycle, depends basically on the effect of the moons’ gravitational force on the cortical cells of the brain that initiates and maintains the rhythm. This was proclaimed by the Ayurveda, thousands of years ago thus: “Kujendu hetu Prathimaasaarthavam”, or ‘Moon is the cause of monthly bleeding’.
Ancient Indian science also proclaims that if one could keep one’s mind (consciousness) tranquil, one could remain healthy until death. The modern science of particle physics supports this line of thinking. The ground reality also supports this premise. Recent studies, many of them very large with high confidence levels, have shown that the human mind is one of the root causes of illnesses. Destructive hostility (hatred) has been shown to be the most important risk factor for heart attacks while frustration and depression seem to be the real culprits in cancer, and anger in haemorrhagic stroke. While these cannot be the sole causes they are the prime-movers. Positive attitude has been shown to increase one’s life span by five to seven years! In short, it is not what one eats that eventually kills one, but what eats one seems to be the main culprit.
One could also draw parallels from auditing many of our drug and technology interventions. When doctors went on strike in Israel, Saskatchewan and Los Angels County, in the past, mortality and morbidity did fall down significantly. According to a milestone long-term prospective study, routine screening and intervening in healthy men when compared to non-intervention but with simple change of life style, there was a significantly higher death and disability rates in the former. Interventions like coronary bypass surgery and angioplasty in asymptomatic individuals, repeated breast scans using mammography, long term hormone replacement therapy in post-menopausal women, and even routine long term ingestion of vitamins and calcium supplements, have only resulted in more morbidity and in some cases higher mortality. Even the much hyped (and also lucrative) business of long term blood pressure and sugar controlling drugs, as also the cholesterol lowering drugs, did not have the desired and predicted benefits!
“Time has come”, the Walrus said, while taking the oysters for a walk on the beach eventually to make a meal of them, to distract their attention, “to talk of many things; cabbages and kings; of shoes…………….and polishing wax”.
Time has come for the medical fraternity to realise that, like the Walrus, the pharmaceutical and technology lobbies, assisted by the Cartesian reductionist scientists, might only be taking us for a walk up the garden path to make their tills moving, so to speak.
It is time we woke up before it is too late. Let us allow the new generation of medical students to think freely without the shackles of the wrong knowledge that their textbooks contain. The existing knowledge would only make them status-quoists, following the footsteps of their forefathers. “Knowledge advances”, said Karl Popper, “not by repeating known facts, but by refuting false dogmas.” We have to refute the myth that the human body is a machine working in bits and pieces like a clock.
I was shocked recently to know that even medical textbooks, at least the majority of them, are written with the help of drug company finances. Less said about the research being financed by these companies the better. Even the best of journals had to retract papers. In the last ten years, paper retractions has gone up 100 times although it grew only 44%. The drug lobby could easily doctor research data to “see in research what they want to see”.
In conclusion, let me remind the readers that there is a whole new world of medical science waiting to be rediscovered like the “gems of purest ray serene the dark unfathomed caves of ocean bear.” Ayurveda, the mother of all medical wisdoms, has vital treasures, both for promoting health and correcting illness. Mind, shown earlier to be the kingpin in the game of human wellness or otherwise, occupies the pride of place in that holistic system. There are other medical care delivery systems as well. A judicious mix of the best in all these systems, along with the hi-tech modern technological medicine for emergency care, would not only benefit mankind, but also make medical facility available for the poorest of the poor.
There is more beyond modern medicine – PLUS ULTRA.
(Professor Dr BM Hegde, a Padma Bhushan awardee in 2010, is an MD, PhD, FRCP (London, Edinburgh, Glasgow & Dublin), FACC and FAMS. He is also Editor-in-Chief of the Journal of the Science of Healing Outcomes, chairman of the State Health Society's Expert Committee, Govt of Bihar, Patna. He is former Vice Chancellor of Manipal University at Mangalore and former professor for Cardiology of the Middlesex Hospital Medical School, University of London.)
Shale gas exploration policy is expected to be announced in the next 15 days by the Government in India, much to the annoyance of environmentalists, as in the foreseeable future, we do not have the water resources
There is a lurking fear in the minds of gulf oil producers and Prince Al-Waleed Bin Talal, a Saudi Billionaire, is reported to have said there is a threat from shale oil and gas and "this is definitely coming!"
In the recent months, there has been a lot of discussion on the issue of shale oil & gas exploration in the country. Those in the know of things are perturbed by the interest shown by the Government in India to develop shale oil & gas resources in the country, knowing full well that India has neither the technology nor the water resources that would be required for “fracking”. Besides, the disposable water, contaminated with chemicals, will affect surrounding areas unless they are properly treated. This is known but the details of preparations to process this waste water has not been made public.
Yet, shale gas exploration policy is expected to be announced in the next 15 days, much to the annoyance of environmentalists.
Geological surveys have indicated that six basins appear to have the potential and these are: Cambay, Assam-Arakan, Gondawana, KG onshore, Cauvery onshore and the Indo-Gangetic plains. Once details surveys are made, we may know the shale gas prospects in these basins. It is expected that, initially, ONGC and Oil India Ltd will explore, and for the Cambay basin, ONGC has already earmarked Rs150-200 crore to carry out first phase of drilling operations. They plan to obtain technical assistance from Conoco Phillips of USA. The present estimates indicate that India has 63 trillion cubic feet of gas, enough to meet the requirement of our existing gas-fired power stations for 20 years at current levels of consumption.
Moneylife has covered this issue earlier and believe that, not only now but also in the foreseeable future, we do not have the water resources! Nor do we have the technology to purify this dirty, chemically contaminated water after fracking.
That said, one can appreciate the government's anxiety to reduce the dependence of oil and gas imports from the current 79% to 50% by 2020. To achieve this ambitious target, we need explore, develop and expand our indigenous sources. We can not compare ourselves to the natural advantages that USA has.
Reliance has already shown the lead in investing in this industry in the USA. Why not the government consider the possibilities of importing shale oil and LNG from the USA? Or it may be worth our while to wait and watch the developments taking place before we plunge into this biz?
In the meantime, let's take a look at the development that has taken place so far in the shale gas and oil industry. According to the International Energy Agency (IEA), by 2017, USA is expected to become number one in oil production, dislodging Saudi Arabia, and by 2030 become an exporter. At the moment, USA imports about 8 million barrels per day from Saudi Arabia.
All this has happened due to rapid strides made in the development of shale oil & gas and the process technology related to the industry. Reports from IEA also show that USA has 665 trillion cubic feet of recoverable shale gas. And, as for shale oil, it is estimated to be at 58 billion barrels, as stated by Doug Brooks, CEO of Aurora Oil & Gas, during a Shale Conference in San Antonio, USA, recently. Due to this extraordinary development taking place in the USA, oil and gas producing countries in the Middle East are cautious in their production plans. Saudi Arabia used to ship 1.4 million barrels per day to USA but now ships less due to increased domestic production in that country. Saudi plans to increase production to 15 million barrels per day are now shelved and they plan to retain their current output at 12 million barrels per day.
(AK Ramdas has worked with the Engineering Export Promotion Council of the ministry of commerce. He was also associated with various committees of the Council. His international career took him to places like Beirut, Kuwait and Dubai at a time when these were small trading outposts; and later to the US.)