Category Archives: medications

Medications: When Newest Isn’t The Best

drug money

Big Bucks Can Sometimes Blur The Integrity of Scientific Studies

Its all very well for big pharmaceutical companies (pharmas) to release a new medication with a big bang , what with the enormous money invested in its research, development  and  production . However, not often enough, such new launches become unstuck when  unexpected side-effects appear after a few months on the market, despite the most strenuous prelaunch testing and extensive marketing as a blockbuster-to-be.

Unexpected side-effects aside, what’s potentially more serious is  when clinical trials (designed to prove a drug’s efficacy before its official launch) are falsified, thereby giving end-users erroneous data proclaiming (falsely) the drug’s efficacy. Such appears to be the case with regards to the Kyoto Heart Study.

What was the significance of this study? This study by Japanese scientists was greeted with great fanfare in 2009 and centres around the ability of a medication ,already extensively used for the treatment of high blood pressure, to reduce the possibility of getting stroke by 50% when used in high-risk patients. This was a milestone in drug treatment for hypertension and enabled the maker, Novartis , to make it one of the best-selling drugs in the world.

Diovan

The drug itself, valsartan, which is marketed as Diovan has been on the market since around 2001 for the treatment of hypertension and belongs to the new group of ARBs (angiotensin-receptor blockers). In fact, its patent expired in 2012, thereby enabling any pharma to produce its own version, so-called generic drug.

Jap_Kyoto

Dr Hiroaki Matsubara, of the Kyoto Heart Study

And now the bombshell: Last Friday, Japan’s minister of health, Norihisa Tamura, as well as university officials at Kyoto Prefectural University announced that the Kyoto Heart Study data were “very likely” fabricated, Apparently, incomplete data was used and some of the scientific investigators were in fact employees of Novartis.

The reaction to this has been deafening. the respected European Heart Journal retracted the study from its 2009 issue. There has been widespread condemnation among medical circles, resulting in the resignation of the principal Japanese investigator from the Kyoto University, Dr Matsubara.

This episode puts into perspective the over-reliance of the efficacy of new medications on so-called landmark scientific studies, whose integrity may be subject to the temptations of big bucks and commercialism. Often, the losers are the consumers themselves.

 

Forget the Sleeping Pills..They Make You Forget!

Many people resort to sleeping pills to ensure a good night’s sleep. In fact, some doctors do prescribe it over the short-term. However, used over the long-term, many are aware of the danger of habituation or dependence on these pills..where patients become “addicted”to them.

Now,new evidence confirms the other main danger of long-term usage of these sleeping pills, commonly benzodiazepines (which include Xanax, Valium, Rivotril, Rohypnol, Ativan, Dormicum,Mogadon..see the full list here).

Patients over the age of 65 who start taking benzodiazepines, also known as benzos, have a 50% increased chance of developing dementia within 15 years compared with people who had never used the drug. Dementia is a group of symptoms caused by gradual death of brain cells –  the loss of cognitive abilities that occurs with dementia leads to impairments in memory, reasoning, planning, and behavior. Memory loss usually is the first symptom noticed. It may begin with misplacing valuables such as a wallet or car keys, then progress to forgetting appointments and then to more substantive omissions such as forgetting where the car was parked or the route home. More profound losses follow, such as forgetting the names and faces of family members.

The study, which was released by the British Medical Journal yesterday (see here) highlights the importance of the judicious use of sleeping and anti-anxiety pills, particularly among the elderly. While the emphasis is on the older population, this should serve as a warning to the younger groups that loss of memory, although due to a myriad of causes, may be due to the abuse of sleeping pills.

It has been reported that midazolam can cause temporary amnesia even when used on the short-term.

 

 

When Washing Your Hands Often Is Itself A Disease

If you’re the type that needs to wash your hands every few minutes because of an irrational fear of dirt and germs, then you are not alone – about 1 in 50 adults have some form of a disease called  OCDobsessive-compulsive disorder. This is a condition where

  • you get recurrent awful thoughts coming into your mind, even when you try to keep them out.
  • you have to touch or count things or repeat the same action again and again –  like washing hands and checking that the electrical plugs are off,over and over again.

We can all worry excessively about real-life problems or be obsessive about certain things at times, but if this becomes too repetitive and causes distress, then it may be time to seek treatment.

OCD sufferer Megan Fox, star of Transformers, confessed to a horror of restaurant cutlery – “putting my mouth where a million other mouths have been”

Donald Trump refuses to shake hands, for fear of catching germs

David Beckham has to have the cans in the fridge in pairs and lined up

OCD is sometimes inherited, so can occasionally run in the family. Other times, it can be brought on by stress. Men and women are equally affected, usually first appearing in the teens and twenties. Diagnosis is established by a mental health professional, such as a clinical psychologist or psychiatrist, and can be often confirmed, in long-standing cases by a PET scan, a special form of CT scan.

A non-invasive PET scan can indicate differences in brain activity of OCD patients versus normals

Can OCD be treated? In short,yes. Depending on the severity, either one or both behaviour therapy or medications like SSRIs. Treatment is effective for OCD  with most people being cured.

The question remains that there is a fine line between excessive worry about real-life problems and repetitive worries in OCD.  Many do not seek help, but when it becomes debilitating or even deadly, it might be that bit too late; as in the case of the lady with OCD who slept for 3 years in a car and was found dead..see here.

Deaths of Rock Stars – Learning From Their Mistakes

With the sad untimely death of Amy Winehouse, questions are yet again being asked why rock stars have a penchant to be associated with a death wish in conjunction with drugs. She joins a long line of celebrities.. Jimi Hendrix, Janis Joplin, Jim Morrison(the Doors), Ron McKernan (the Grateful Dead) who all died due to drugs at the age of 27 strangely enough (the 27 Club). Add to this Michael Jackson, of course.

Could drugs be the cause of death for Amy Winehouse?

Maybe its easier to understand why these celebrities take to drugs..as an escape from stress, as performance enhancers to keep up to fans’ expectations and also to enforce sleep when the mind doesn’t want to switch off.

Quite often these drugs gradually lose their effect once taken over long periods, thus necessitating higher and higher doses, which can lead to overdosage. But yet, this does not seem to be the case in some  instances.

Propofol, a common anaesthetic used in hospitals, gained notoriety when it was blamed for MJ's death

On the other hand, there are cases where there has been untoward drug interactions when many prescription drugs with similar actions are taken concurrently. In other words, therapeutic doses of several prescription drugs, usually pain-killers and sleeping pills, had been taken at about the same time, creating a deadly mixture due to chemical interaction. Such was the case with Michael Jackson, where propofol, lorazepam (Ativan), midazolam (Dormicum) and diazepam (Valium) were found at autopsy amongst others.

Here are what I see are some of the  mistakes that occurred and the measures that can be taken:

  • 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 – together with 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.


Washing Your Hands Often Is Itself A Disease

If you’re the type that keeps on washing your hands every few minutes because of an irrational fear of dirt and germs, then you are not alone – about 1 in 50 adults have some form of OCDobsessive-compulsive disorder. This is a condition where

  • you get awful thoughts keep on coming into your mind, even when you try to keep them out
  • you have to touch or count things or repeat the same action, like washing hands and checking that the electrical plugs are off,over and over again

We can all worry excessively about real-life problems or be obsessive about certain things at times, but if this becomes too repetitive and causes distress, then it may be time to seek treatment, even celebrities included.

OCD sufferer Megan Fox, star of Transformers, confessed to a horror of restaurant cutlery – "putting my mouth where a million other mouths have been"

Donald Trump refuses to shake hands, for fear of catching germs

David Beckham has to have the cans in the fridge in pairs and lined up

OCD is sometimes inherited, so can occasionally run in the family. Other times, it can be brought on by stress. Men and women are equally affected, usually first appearing in the teens and twenties. Diagnosis is established by a mental health professional, such as a clinical psychologist or psychiatrist, and can be often confirmed, in long-standing cases by a PET scan, a special form of CT scan.

A non-invasive PET scan can indicate differences in brain activity of OCD patients versus normals

Can OCD be treated? In short,yes. Depending on the severity, either one or both behaviour therapy or medications like SSRIs. Treatment is effective for OCD  with most people being cured.

The question remains that there is a fine line between excessive worry about real-life problems and repetitive worries in OCD.  Many do not seek help, but when it becomes debilitating or even deadly, it might be that bit too late; as in the case of the lady with OCD who slept for 3 years in a car and was found dead..see here.

For Real or Just Hype?

Reading the media, many doctors are fascinated as to the plethora of new drugs claiming to provide a ‘cure’ against diseases which hitherto were considered incurable. Why, new drugs have even pervaded the social media – pharma companies have started posting widgets on Facebook in a bid to attract readers. Last month, FDA cautioned the drug company Novartis for overstating the benefits of a drug without pointing out the ill-effects (see here).

Social Media as a Marketing Tool - even Big Pharmas Use It

 

 

This rampant form of advertising naturally may confuse the public about the efficacy of new medications. In fact, its sometimes difficult to know the validity of claims made in the media.

Here are  some tips on how to evaluate the validity of medical news items that you may come across..

  • It is a fact that competition is intense among medical journals, research bodies and medical journals to attract media attention. Media themselves compete with each other to come out with the latest. Try to read the same news from several sources. Obviously, if the item is reported in just one obscure source, it should carry less weight.
  • Look for key-words like suggestive or may (as opposed to will) as this does not always indicate a cause and effect meaning. Many people make hard-core assumptions based on such words.
  • It is the nature of scientific studies that, for a given topic, several would say one thing and a few would say the complete opposite. It is for the trained professional and their peer-groups to make an informed decision to advise consumers. Bear in mind that space is a premium with the mass media and such reports usually omit vital details which will affect accuracy.
  • Separate the wheat from the chaff..make sure the website you’re looking at is a reliable one!
  • Personally, I feel reports originating from researchers and pharma companies should not appear in the mass media without vetting by an appropriate professional body so as to convey the proper perspective to the audience at large. So if a news report originates from a known professional body, this should carry a lot of weight; as opposed to a solitary item in a nondescript health magazine.

Your Sugar or Your Heart?

Those familiar with the ongoing debate whether to ban a popular anti-diabetes drug for potentially dangerous side-effects are mostly wondering why its taking the authorities so long to put a ban on it.

Glaxo’s Avandia, also known as roziglitazone, has been blamed by research studies as far back as 2007 to cause heart problems when taken by diabetic patients, but attempts to ban it have been painfully slow. While the FDA acknowledged that the drug led to a higher incidence of heart attacks since 2007,  its advisory panel in July this year stopped short of banning it with a split decision.

Avandia ban - decision to be made by EU September

Health advocates have mounted a strong campaign against Avandia, saying its risks outweigh its benefit. Even a conspiracy theory has emerged – the New York Times this week published documents that it said showed SmithKlineBeecham – the firm’s name in 1999 – buried a disastrous study that suggested Avandia posed greater heart risks than a competing drug. Has Big Pharma managed to buy out the regulators?

Across the Atlantic, the story is clearer – the UK watchdog authority has called today for the withdrawal of this drug across Europe.(here).

And the irony of it all..while we have a diabetic drug that can cause heart attacks, we also have a heart  drug (Crestor) that can cause diabetes!

Share this Post

The First Vaccine For The Treatment of Cancer – More Hype Than Reality

In a week of plenty of bad news, it was heartening to find out that the FDA  approved the first-ever vaccine to treat cancer. The treatment is called Provenge, and was developed by a small company named Dendrion for the treatment of advanced prostate cancer.

Prostate Cancer Cell - the second most common cancer in men

How it works: by growing the ‘harmless’ part of a tumour cell extracted from an affected person and mixing it with a special cell called a ‘dendritic cell’ in the lab, several antigens are produced which is then injected back into the affected person. This then alerts the person’s immune system to the presence of these foreign antigens, causing it to attack just the cancer cells, leaving alone the normal cells.

Why did I say there’s a lot of hype? Well, most news reports called it an anti-cancer vaccine, giving many the impression that it was a cure or that it could prevent cancer. Nothing can be further than the truth. Firstly, its meant only for prostate cancer (read,men only) and even then its for advanced prostate cancer (read, terminal). All it does is it gives an additional survival time of 4 months.(1)

And the cost? Dendrion announced that it will charge US$93,000 per patient, because, get this, it assumed that people will pay US$23,000 for every extra month of life based on current costs of other cancer drugs. Read more here. At this price, it would be out of reach to many, taking into consideration that insurance companies have not yet confirmed that they would underwrite the costs.

Provenge,injected over 3 times, makes use of one's white blood cells to fight cancer cells

By the way, if we’re talking about anti-cancer vaccines, there are several already on the market – a typical example is Gardasil, used to prevent cancer of the cervix. Provenge is the first therapeutic vaccine – the first vaccine used for treatment, and not prevention.

Share this Post

5 Best-Selling Medications In The World – One Is Not That Effective

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.

Share this Post

Cancelling Cancer – You Can!

If your doctor were to recommend a jab or a pill that will prevent you getting some cancers, would you? Its surprising, but not everyone would take it up!

The truth is that there are quite a few readily available and relatively inexpensive ways which have been proven to prevent some cancers.

Take for instance stomach cancer, the second most common cause of death among cancer-sufferers. It is now known that a cause of stomach cancer is a bug well-known for causing stomach and duodenal ulcers, called Helicobacter pylori (H pylori). Now, researchers have shown that if they were to eliminate this bacteria from those suffering from early stages of this cancer, they were able to effect a cure. Read more of this here. Eliminating H pylori from the stomach involves swallowing a 2-week course of antibiotics.

The bacteria,H pylori, found in the stomach,has been impliczted to cause stomach cancer

Primary liver cancer, the fifth most common cancer in the world, is a deadly cancer for which the outlook is bad as, by the time someone has symptoms, the cancer is far-advanced and has spread to other organs. Again, a bug – the hepatitis B virus-has been identified to be the cause in 50% of primary liver cancers aka hepatocellular carcinoma, aka hepatoma. To prevent the virus from entering your body, one needs to immunise oneself by receiving three jabs of the Hepatitis B vaccine.

The same goes for cancer of the cervix, which is almost always caused by the human papillomavirus(HPV).  By vaccinating young girls with Gardasil or Cervarix, they can avoid getting this cancer.

Latest research on prostate cancer seems to indicate that taking finasteride(Proscar) may prevent this cancer.

There are many other ways that specific cancers can be prevented, some of them anecdotal. Heard of the complementary herbal medicine, the Chinese mushroom, Lingzhi ? I met a cancer survivor last night who swears this herb provided the cure and not the treatment at Sloan-Kettering! As to whether daily consumption of this herb will actually prevents cancer..well,there’s no strong evidence at the moment, for sure. The role of foods too must not be dismissed.

Tamoxifen - effective in preventing Breast Cancer in high-risk women, despite the side-effects

However, my attention was recently drawn to a news report about high-risk women who refused to take a pill a day known to be effective in preventing breast cancer. A woman is considered to be at high risk for breast cancer if she is over 40 and has a mother, sister or daughter with the disease, or has a history of atypical cells on a breast biopsy. A pill, tamoxifen, has been proven to be effective in preventing breast cancer in such women, but there are many who will not take it for fear of the side-effects (which are many but not as serious as actually getting the cancer).  See here.

In cases like this, human psychology is to be blamed – people are more concerned about losing a little bit than they are about gaining something more.

Share this Post

%d bloggers like this: