Drug patents: The battle goes on…..

The war between Generics and Brands doesn't seem to die down. In our last discussion, 

http://docbaldimeds.blogspot.in/2013/04/drug-patents-battle-between-generic-and.html, 

we had concluded that the basic difference between these two is the pricing, a marginal difference in the efficacy of both the variants and the safety profile was but obviously assured. Probably that was what we were made to believe.

India Today.in

The latest incident involving 13 female deaths at the Bilaspur sterilization camp has served as an eye opener.

As a knee jerk reaction, the honorable doctor who performed the surgeries at the camp was apprehended and charged with negligence and homicide.

Investigations have now revealed the presence of zinc phosphide, a rodenticide, in Ciprocin 500 (antibiotic), which was prescribed to all the patients during surgery.

This generic drug was manufactured by Mahawar Pharma Pvt Ltd, a Chhattisgarh-based drug firm, a small drug company according to revenue figures disclosed by the company.

This company has a very small unit in Raipur. They have been in the business for over 30 years now but it's a small scale business and supply of medicines was restricted within the state.

Political connections might have helped the company, despite reports that it was blacklisted two years ago over sale of duplicate generic drugs.

This may be a stray incident involving generic drugs but it certainly cannot be passed off without learning a lesson or two.

Firstly, it is important to realize that even the leading pharma companies do manufacture generics. The quality would obviously be ensured with such products.

Secondly, it is always better to avoid medical procedures and treatments in camps. Due to the large numbers, sterility can often be compromised.

And lastly. Dear doctors, if you ever have to participate in a medical camp, please ensure that the medical and paramedic staff are competent enough, drugs are of a standard quality and the setup fulfills the basic needs of a medical centre. Even though you haven't charged for your services, you are still answerable to the consumer forum.

A couple of weeks back I happened to meet a doctor colleague of mine from the US. He had remarked.  " The fundamental difference between the health system in our country and yours is that we value human lives". His words still keep ringing in my ears. 

Cell Phones: Savior or……...

The cell phone has provided an amazing safety net for citizens of almost all cultures across the world. The lives saved by the proliferation of cell phone communication is phenomenal — emergency calls, quick first responders, warnings of severe weather are only a few examples. However, the potential role of cell phones as an additional factor in oncogenesis (cancer creation) can't be dismissed.

The largest-ever study on the topic—the International Interphone study, which was conducted by the International Agency for Research on Cancer (IARC) and funded in part by cell phone companies, published in 2010, failed to find strong evidence that mobile phones increased the risk of brain tumors.

The IARC released a report in 2013, suggesting that there is a possibility of brain tumors amongst users of  both mobile and cordless phones.

But, the latest research on the subject concludes that long-term use of both mobile and cordless phones is associated with an increased risk for glioma, the most common type of brain tumor.

The new study published online October 28 in Pathophysiology, shows that the risk for glioma was tripled among those using a wireless phone for more than 25 years and that the risk was also greater for those who had started using mobile or cordless phones before age of 20 years.

This increased risk is due to greater exposure to radiofrequency electromagnetic fields. The brain is the main target of these emissions when these phones are used, with the highest exposure being on the same side of the brain where the phone is placed.

Children and adolescents are more exposed to radiation than adults because of their thinner skull bone and smaller head and the higher conductivity in their brain tissue. The brain is still developing up to about the age of 20 and until that time it is relatively vulnerable.

Radiation exposure increases dramatically when cell phone signals are weak.

Girls and doctors tend to put the smartphone below the pillow.

"It's a bad habit to go to bed with your smartphone."

It's time we minimized our risks.

Using hands-free phones with the "loud speaker" feature and text messaging instead of phoning should always be encouraged in appropriate settings.

"Technology can be our best friend, and technology can also be the biggest party pooper of our lives. It interrupts our own story, interrupts our ability to have a thought or a daydream, to imagine something wonderful, because we're too busy bridging the walk from the cafeteria back to the office on the cell phone" - Steven Spielberg. 

Malaria: The Growing Menace

The growing incidence of drug resistance has become a cause of worry for the medical practitioners. Very soon we would be left with hardly any choices to combat the infectious agents. 

The common causes for this emerging resistance are:

• Misdiagnosis
• Incorrect choice of therapy
• Inappropriate doses
• Incomplete therapy

As much as we blame patients for stopping the therapy before its completion,  so also we should be blaming ourselves for incorrectly prescribing the treatment.   

I have laid down the basic guidelines for the outpatient therapy of uncomplicated Vivax and Falciparum malaria.  

As adapted from the "National Vector Borne Disease Program" (NVBDCP)- 2013:

Please make note that Primaquine needs to begin from Day 1 of therapy. 

Drug schedule for treatment of P falciparum malaria:

Thus, the cornerstone of malaria treatment is Artesimin based combination therapy (ACT). 

ACT could either be a combination of Artesunate + Sulfadoxine-Pyrimethamine

Or

Artemether + Lumefantrine.

As discussed above, Primaquine is a very integral part of the therapy in both Falciparum as well as Vivax malaria.

In Falciparum, it is given on Day 2 as a single dose of 45mg, to eradicate the gametocytes and thus prevent the further transmission of the parasite.

In Vivax, it is given from Day 1, 15mg per day for 14 days, to eradicate the hepatocyte stage seen only in vivax malaria.

"Together we can, together we will".

A diagnostic challenge: Dengue vs Chikungunya

Couple of days back, a 30 yr old lady came to me in a panicky state for a second opinion, complaining of fever, joint pains and muscle pains since past 3 days.  A routine blood analysis for fever showed a Positive result  for the IgG anti- Dengue antibodies whilst the IgM anti-Dengue antibodies was Negative. The anti-Chikungunya antibodies were negative. So were the rest of the investigations. 

She was diagnosed as Dengue fever and advised hospitalization. 

I begged to differ as regards the diagnosis. At the outset, it seemed like a Viral episode and I prescribed her Paracetamol and advised bed rest. Over the next few days, her platelet counts remained normal and her fever subsided. She followed up after 2 weeks however, still complaining of joint pains and stiffness. A repeat analysis this time showed a positive result for Chikungunya IgM antibodies. 

Thus, the diagnosis changed from first Dengue, then to Viral fever and now finally Chikungunya. 

The question that would be on every body's mind is: 

1. Wouldn't a false diagnosis hamper the treatment and 

2. How would you differentiate clinically between all these three ailments? 

Let me explain. First and foremost, all the three are forms of Viral fever. So, the basic management remains same in all of them. 

Differentiating features:

The dengue and chikungunya viruses are both transmitted by Aedes species of mosquitoes.

The distinguishing feature of chikungunya includes potentially debilitating bilateral joint pains and, in some cases, arthritis. 

And a significant drop in platelet counts is mainly observed in dengue. 

Fallacies of testing:

During the first few days of the illness, the antibodies may remain undetected in blood and hence Dengue may be missed unless the Spot or Antigen test is performed. 

Clinicians should also be aware that detection of anti-Dengue IgG antibody has very little utility in the diagnosis of acute dengue, as IgG antibodies may be the result of an infection that occurred in previous months or years. In addition, IgG antibodies against other viruses can cross-react with Dengue, thereby yielding false-positive diagnostic results. 

Management:
Chikungunya is rarely fatal. In contrast, early identification and proper clinical management for dengue cases can significantly reduce the fatality. Therefore, patients suspected of having dengue or chikungunya should be managed as having dengue until dengue can be ruled out. 

Most patients who develop severe dengue do so in the 24-48 hours after fever subsides and this can occur rapidly. Hemodynamic status should be maintained with judicious use of isotonic intravenous fluids, which is the central component of dengue patient management. 

Pain and fever in patients with suspected dengue or chikungunya should be managed with acetaminophen or Paracetamol. Aspirin and other NSAIDs should not be given to such patients because of the increased risk for bleeding manifestations if the patient has dengue. If patients have been afebrile for at least 48 hours, have no warning signs of severe dengue, and still complain of joint pain, NSAIDs may be considered. 

The list of viral fevers is too exhaustive to elaborate and it is practically impossible to clinically differentiate one from the other. The prototype always would remain the Influenza virus or "flu". But most often than not, these are self limiting and unless there is an added bacterial infection, antibiotics wouldn't work for these viruses. 

Does Aspirin a day really keep the doc at bay?

The benefits of the common practice of taking an aspirin a day to keep the doctor away, are now under serious dispute. 

Various authors have argued for time immemorial that the benefits of aspirin far outweigh the risks. Not only does aspirin provide protection against cancer, but it also reduces the risk for heart disease and stroke. An aspirin daily can certainly seem like the ultimate supplement and it is very inexpensive.

There were also talks of Aspirin being included in the community water supply so that people would benefit from it. 

This practice is now all set for a change. 

Critics have started panning this molecule. 

Their claim is that there is no evidence that aspirin is effective for the primary prevention of  acute coronary syndromes and stroke. Even if benefit does exist, it may not outweigh the harm. Also, there is no evidence that long-term aspirin should be given to patients even with known cardiovascular disease. 

It is possible that when a stable plaque has ruptured, it becomes unstable, resulting in a coronary 'ulcer'. This is a focus for thrombus generation. Aspirin acts here by inhibiting thrombus propagation. However, once the acute event is over and the 'ulcer' has healed, any reduction in platelet aggregation by aspirin may be offset by inhibition of prostaglandin-mediated vascular wall defences and the increased risk of plaque haemorrhage.

Thus, aspirin, just like an antibiotic, should be given for an acute illness and stopped when the acute syndrome has settled. This could be for a period ranging from 1-6 months. 

Aspirin use is associated with an increased risk of 

• Dyspepsia, gastro-intestinal bleeding leading to anemia. In patients with cardiovascular disease, iron deficiency anemia is associated with a poor prognosis. 
• Chronic kidney disease and renal dialysis. 
• Haemorrhagic stroke. 
• Possibly deafness and age-related macular degeneration. 

Aspirin may also lessen the benefits of drugs that are known to reduce cardiovascular risk, such as angiotensin-converting enzyme (ACE) inhibitors and possibly beta-blockers. 

On a positive side, aspirin prevents vascular proliferation in tumours preventing their growth, thus retarding the progression of bowel and other cancers. 

There is no denying the blood thinning properties of Aspirin for those with heart problems but there is very little justification to insist that everyone needs to take an aspirin. 

"Advice for the day: If you have a headache, follow the instructions on the bottle. Take 2 and KEEP AWAY FROM CHILDREN. "