Getting a new car or camera model is often equated to pills as well…that the newer version is an improvement over the old. But experience has taught doctors that this is not necessarily true..especially when it comes to medications.
While drug pharmas may go to town extolling the virtues of their new drug releases (which they claim to have undergone extensive research and FDA-approved), it is easy for doctors and the public to be swayed by these promises and switch to the new. Some doctors know this can sometimes backfire. For instance, newer meds have a shorter track record of usage, sometimes not enough for side-effects to appear which escaped scrutiny during the drug trial period. After prolonged use, previously-undetected side-effects can surface which may even lead to eventual withdrawal of the drug from the market.
A case in point: at the ongoing American Heart Association (AHA) meeting in Orlando, Florida, November 2011, it was revealed that a popular anti-cholesterol medication Crestor was not significantly better than the older more popular Lipitor that it intended to replace, in terms of reversing cholesterol blockages in arteries.
For the makers of Crestor, AstraZeneca, this is a double-blow: it had sponsored the clinical trial to demonstrate its superiority over its rival(the SATURN trial). Now that this failed to materialise, it is going to find it tougher to market its drug once its rival loses its patent rights this month.(This means bona fide pharmas can produce non-branded versions, aka generic types, which are considerably cheaper.)
This is of course good news to consumers who now can buy generic Lipitor, at a fraction of the price before, knowing full well that they will not lose benefits extolled by the newer ones. My take-home message though, is that none of the pills are going to work well if one does not incorporate it with change in life-style habits..
- Astra’s Crestor Is Comparable to Lipitor in Study (online.wsj.com)
We’re not talking here about contraband drugs like speed, heroin and the like…but, on the other hand, there’s a big (though not quite legal) market out there for prescription drugs. These are mainly pain-killers which do give a ‘high’ feeling as well. No thanks to high-publicity cases like Michael Jackson’s (see my post “What Killed Michael Jackson?”), there’s a growing awareness and demand for these prescription pills, bought and sold on the sly.
Prescription drug abuse, now the fastest-growing drug problem in the USA, has created a ballooning street market for highly-addictive pain relief, anxiety and depression drugs.
Take a look at the street prices of these prescription drugs and you will see what I mean:
–Oxycontin: USD 50-80 on the street, vs. USD 6 when sold legally
–Oxycodone: USD 12-40 on the street, vs. USD 6
–Hydrocodone: USD 5-20 vs. $1.50
–Percocet: USD 10 -15 vs. $6
–Vicodin: USD 5 -25 vs. $1.50
These street prices of commonly trafficked ‘legit’ drugs are duplicated elsewhere throughout the world and it would be a matter of time before they will replace the traditional illicit drugs as the main source of the illlegal drug trade.
But the most troubling trend among drug abusers in the US, is the growing number of young teens that abuse prescription drugs, simply because if its deemed legal , it ought to be safer, especially since they see adults getting it prescribed from their doctors. Enter a new phrase in the urban dictionary: skittle parties*.
(skittle parties: a party where a bunch of teenagers or young adults get together with a lot of random pills,usually taken from parents’ medicine cabinets, put them all into a pile and every one takes a few at random).
- FDA ‘Bad Ad’ Program Raises Awareness of Provider Role in Ensuring Truthful Prescription Drug Promotion (forum.thenewalchemist.com)
- NY AG Schneiderman Calls for Statewide Drug Database (nyconvergence.com)
- America’s fatal addiction to prescription drugs | David Kloth (guardian.co.uk)
My curiosity was raised recently when a news report claimed that one of the top 5 medicines in the world has recently been found to be not that effective.
First of all, the top five are:
1. Lipitor - the wonder drug for lowering blood cholesterol. USD 13 billion sales annually.
2. Plavix - the blood-thinner that works by preventing blood platelets from sticking together. USD 6 billion annually.
3. Seretide – aka Advair, is a combination steroid-betaagonist( to relax the air passages in the lungs) that is inhaled by asthma patients. USD 6 billion.
4. Nexium - the wonder drug for the treatment of stomach ulcers and gastritis. USD 5 billion .
5. Norvasc - the top-selling medication for blood pressure. USD 4.8 billion.
Its interesting to see that many side-effects have been reported worldwide when using the above drugs, which brings one to the maxim – all drugs have side-effects and using it is a balance between its benefits and its risks. Some of these side-effects are quite harmless, like feet swelling up with Norvasc, but others can be potentially life-threatening.
Such is the case with one of the above – Plavix aka clopidogrel – which has recently been issued a “black box” warning by the FDA here. A boxed warning is the FDA’s toughest warning and appears prominently at the top of a drug’s label to warn users of a serious warning. In the case of Plavix, 2-14% of users will not respond to its benefits (the anti-clotting action) and therefore will be at risk of a blood clot forming in the arteries of their heart or brain despite taking the medication. The inefficacy is determined genetically and its possible for potential users to have themselves screened in the near future to see whether they should take the medication or not.
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In a decision which raised the eyebrow of many doctors as well as patients, a popular cholesterol pill Crestor (rosuvastatin) has now been approved by the US FDA for use in healthy people with normal cholesterol…well, not just anybody, but for those with all of the following 3 features: increasing age + high CRP + one traditional risk factor (either smoking, high blood pressure, positive family history, low HDL-cholesterol).
In a recent bulletin, the FDA took pains to say that this was based on a clinical study (the Jupiter Trial) which showed that those who took Crestor for two years experienced less heart attacks, strokes and needed fewer heart operations.
Even so, a few cardiologists, including yours truly, have some trepidation in unreservedly recommending Crestor for such people with normal cholesterol. In the first place, no amount of medication is going to substitute for adopting a healthy lifestyle (in other words, regular exercise,proper dieting, weight reduction and getting rid of the fags). Both need to go hand in hand in order to achieve any benefit.
The other downside in taking these pills is the risk of side-effects, most notably generalised muscle and joint pains and..listen up, you men..poor erection! Yes, many patients feel shy to bring this up with their doctor but it seems to be more common than reported. The good thing about this problem is that its “business as usual” once the pills are withdrawn. Recently, news reports have even implied that statins (like Crestor) can lead to diabetes.
There are many who suspect that promoting this use of Crestor is big pharma’s way of enhancing sales in these troubled times..not to mention giving private insurance companies a valid reason for raising your premiums because you’re on medications.
The issue sure is getting more complicated nowadays; with a diabetes drug supposed to cause heart attacks (Avandia) and conversely, a heart attack drug that may cause diabetes (Crestor) !! If its any indication, 4 of the 12 members in the FDA Drug Committee objected to this new indication for its use..
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The news that the Obama administration will not seek to arrest marijuana users and suppliers as long as they conform to US state laws on its use for medical purposes must have raised quite a number of eyebrows(see here). In the first place, not many are aware that pot is legal, within restrictions, that is. Secondly, the new policy is a significant departure from the Bush administration, which had insisted it would continue to enforce federal anti-pot laws regardless of state codes.
Currently, 14 states in the US allow the use of marijuana for medical purposes: Alaska, California, Colorado, Hawaii, Maine, Maryland, Michigan, Montana, Nevada, New Mexico, Oregon, Rhode Island, Vermont and Washington. If Obama has his way, Federal anti-narcotic agents cannot prosecute outlets selling large amounts of marijuana as long as it is for medical use.
In the US, 4 citizens actually obtain their marijuana from the federal government, with FDA approval. One of them takes it to relieve chronic pain and muscle spasms caused by a rare bone disease, invariably fatal, called multiple congenital cartilaginous exostosis.(see pic)
Typically, the medical use of marijuana is for patients with:
- chronic pain (particularly nerve pain caused by diabetes, AIDS, and hepatitis);
– movement disorders and muscle spasticity (especially for multiple sclerosis patients);
-“drug sickness'”, as an anti-nausea and anti-vomiting agent (for those, say, undergoing chemotherapy);
-poor appetite, as an appetite stimulant for those with wasting diseases like AIDS and cancer.
Marijuana, whose botanical name is cannabis, has been used medicinally — and as an intoxicant, of course — for thousands of years in Eastern culture. In Western medicine, several well-known pharmaceutical companies, including Eli Lilly , sold cannabis in powdered or tincture forms in the early 20th century as a painkiller, antispasmodic, sedative, and “exhilarant.” Since then, its use declined because more effective drugs became available.
The question now is that, with medical marijuana being legalised, what constitutes medical use? The potential of abuse is apparent – just look at California, where doctors are authorizing patients to take marijuana to relieve such minor ailments as anxiety, headache, premenstrual syndrome, and trouble sleeping. There are about 700 medical marijuana dispensaries now operating in California openly distributing the drug :- narcotics trafficking done legally!
Times have indeed changed…3 decades ago, the medical fraternity were singing praises about the wonder pill that would be the panacea for preventing heart attacks and strokes. So much so, health authorities were seriously considering adding it to the community’s drinking water supply so that everyone could benefit. Doctors, otherwise hale and hearty, were taking them ‘ just in case’. What was it supposed to do? It thins the blood enough to prevent clots from forming within the blood vessels and thereby preventing blockage.
Now, aspirin, a humble drug which has been used as a pain-killer for over a century, has come under severe cross-examination. Why? Largely because researchers have recently discovered that taking aspirin pills does not prevent heart or blood-vessel disease in otherwise normal people.
In fact, healthy people who take aspirin to prevent heart attacks could be doing more harm than good. Aspirin is notorious for causing bleeding in the stomach, sometimes several months after commencing it. And the bleeding can be silent, without much stomach pain with the symptoms being confined to ‘blackish’ stools.
A caveat though…for those already suffering from heart disease or stroke, the role of aspirin is still undisputed and its benefits far outweigh the disadvantages. For those who are otherwise healthy but have several risk factors (like smoking, parents with heart disease), the decision is not that clear-cut though. You need to discuss this with your own doctor.
One thing for certain, if someone has symptoms suggestive of an impending heart attack, chewing an aspirin pill immediately can be a life-saver even before one reaches the emergency room..
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As mentioned previously , 3 postings ago here, where there is a threat there’s opportunity! It didn’t take too long after WHO declared a pandemic of the H1N1 (swine flu) virus that a flood of self-proclaimed remedies came onto the internet, enticing consumers to part with their money in return for dubious cures.
The US FDA were quick to respond to these quack merchants by publishing a blacklist of internet sites. Many of these sites have since either closed down or retreated into “under construction” modes.
Not to be outdone, these marketeers have now resorted to fake Tamiflu sales over the Internet, so much so, scam emails on these fake Tamiflu have exceeded that for Viagra! Sir Liam Donaldson, the UK’s Chief Medical Officer, told the BBC that the whole field of counterfeit drugs is becoming a much bigger problem, with fake Tamiflu substituted with sugar and even coumadin (a blood thinner originally used to kill rats).
Even if you managed to get the genuine product, which sells as a course of 10 capsules for about USD 6 each, Tamiflu has to be taken correctly (within 48 hours of the flu symptoms) to be effective. And if the flu persists, chances are you’ve got H1N1 flu because Tamiflu & Relenza (the other ‘antidote’) do not always knock off this virus!
And the flu vaccines? The ones available in the market are only effective against the previous flu strains over the last few years, but not against swine flu. The swine flu vaccine will only be available end-August but it is doubtful whether there will be enough to go around should the containment phase now being undertaken by most countries moves towards the treatment phase as the pandemic spreads, as it is widely expected to.
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In my previous posting, I alluded to the possibility that Michael Jackson’s death could be due to the potentiating effects of several opiate prescription drugs like oxyContin & pethidine. We will know for sure whether this is the case, in a few weeks when the toxicology results are announced.
In the case of Heath Ledger, who died at 42, the coroner found six different tranquillisers & opiate pain-killers in his tissues and concluded that accidental overdose was the cause of death. The prescription drugs found included OxyContin, hydrocodone, diazepam (Valium), temazepam (Normison, for sleep), alprezolam (Xanax,for anti-anxiety) and doxylamine (available over-the-counter as Somnil for aiding sleep).
Another case in point is that of Anna Nicole Smith, who died aged 39 in early 2007 due to massive doses of a sedative chloral hydrate together with at least 9 other tranquillizers that included Valium, Ativan and Rivotril.
The common denominator in all the three above cases (assuming MJ’s results are confirmed) is that there has been untoward drug interactions where many prescription drugs with similar actions are taken concurrently. The thing to note is that there need not necessarily be a overdosage of any particular drug – sometimes normal dosages, when taken at the same time, create a cascading effect and cause these untoward effects aka drug interactions aka drug toxicity.
Here are some common mistakes that can be avoided:
- Usage of several painkillers in an attempt to get fast relief – people with long-term pain like backache may resort to increasingly stronger medications as the body gets used to them. In MJ’s case, it has been reported that he had been on oxyContin (an addicting painkiller derived from narcotics) for many years and had received pethidine (another narcotic painkiller) at the same time. The false and wrong rationale is usually that the more one takes, the better for fast pain relief.
- Taking a cocktail of sleeping pills to ‘knock off’ – expecting a sleeping pill to work immediately can lead some people to erroneously take ‘more of the same or similar’ in an attempt to induce sleep quickly and perhaps get rid of unpleasant memories of the day. This is compounded when alcohol had been taken as it is a brain “downer”, just like sleeping pills. The combined effects of these pills and alcohol will suppress the brain from allowing the lungs to breathe. Never mix sleeping pills, sedatives, tranquillizers or take them with alcohol.
- Alcohol does not jive with many medications – apart from sleeping pills and cold medications, even some antibiotics (eg Bactrim, Flagyl) can cause unpleasant reactions.
- Using many doctors or pharmacies – when visiting multiple doctors, bring along the list of medications in your possession so that there is no inadvertent cross-reactions. Similarly, using only one pharmacy enables screening with existing medications to prevent harmful drug interactions.
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Now that the initial autopsy had ruled out trauma and assault as possible causes, toxicology testing will need to be carried out to determine the existence and levels of foreign substances (read drugs) in the singer’s bloodstream. Not surprisingly, this is going to take “6-4 weeks”, according to the Coroner’s Office; as , even in the best centres, such an analysis is a laborious process.
According to various media reports, the singer had “cardiac arrest” at home and that his personal physician (a cardiologist) was in attendance at that point in time. You can hear the actual recording of the 911 call here.
Several news reports have said that Michael Jackson had been addicted to OxyContin for several years, among other drugs. This is collaborated by his children’s nanny who testified she had to perform stomach washouts several times to remove a cocktail of drugs, as reported by the Times of London. OxyContin is a effective pain-reliever but is a member of the narcotic class of analgesics, meaning it is in the same category as morphine and therefore habit-forming and can lead to addiction.
The other big problem with this class of drugs is that it is associated with several side-effects, notably its ability to suppress breathing. Hence, it is not used in patients who have breathing diseases like asthma and sleep apnoea.
Notoriously, OxyContin which is given as tablets, cannot be combined with other narcotic pain-killers, tranquillizers, sedatives and even alcohol as this potentiates the side-effects (all of them are depressants on the brain) and can cause confusion, breathing difficulties, coma and death.
In Michael’s case, this takes on added significance, as it has been reported that an hour before he collapsed, he had been given a shot of another narcotic pain-killer Demerol (aka Meperidine aka Pethidine). Eye-witnesses reported that they noticed his breathing was becoming shallower and shallower, which is consistent with respiratory depression( suppression of the brain’s breathing efforts) due to additive effects of the two narcotic drugs. The toxicology tests will bear out this possibility eventually but two questions remain:
1. Wasn’t the attending doctor aware that MJ had been on other narcotic pain-killers?
2. There is an effective antidote, Naloxone, which if given by injection immediately, can reverse the side-effects of the overdose. Was this given?
If the final autopsy results confirm drug interaction and overdose as the cause of death, MJ will join a long line of celebrities including Jimi Hendrix, Elvis Presley and most recently, Heath Ledger. In the latter’s case, the autopsy revealed that he had taken 6 different drugs: OxyContin, hydrocodone, diazepam (Valium), temazepam (Normison, for sleep), alprezolam (Xanax,for anti-anxiety) and doxylamine (available over-the-counter as Somnil for aiding sleep).
The message to take home obviously is that every medication has side-effects, and its use must be balanced by the benefits vs harmful effects.
Update (25 Aug 2009): see “MJ’s Death Explained“
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Was it my imagination, or was it real, that the size of my junk-mail box had gotten less over last week? I seem to be missing (the irony of it all) all those mails exhorting the use of various pills to make my ‘partner deliriously happy’ and the use of one’s ‘tool’ to perform wonders which defy medical science.
Global spam levels have dropped by as much as 75 per cent following the shutdown of a US web host that provided the backbone for most of the world’s spam. The web host, McColo, based in California, counted customers including “international firms and syndicates that are involved in everything from the remote management of millions of compromised computers to the sale of counterfeit pharmaceuticals and designer goods, fake security products and child pornography via email”, The Washington Post reported.
For those techies, spammers typically use botnets of hacked computers that they surreptitiously control and use to send their spam messages. This makes it harder for them to be traced and allows spammers to harness the internet bandwidth of potentially hundreds of thousands of computers.
This appeared to be part of a multinational swoop coordinated by Interpol in nine countries targeted against internet drug peddlers. Interpol’s internet message is simple: Do not buy prescription-only medicines over the Internet without a prescription.
I can only reiterate this message because there’s no way you can prove the drugs are safe and effective. In many cases they can be harmful, when unknown chemicals may be added.
However, as in some cancers, the drop in junk mails is expected to be a temporary lull as spammers adapt and find new areas to set up their operations again, possibly in Eastern Europe. Will the cancer spread again? Will spam, the scourge of the Internet, make its reappearance?