Tag Archives: msd pharma

Guest column : Implications of the #Januvia patent lawsuit in India

23 Jul

The banning of diabetes drug pioglitazone (now looking set to be revoked) has put Merck’s patented drug sitagliptin or Januvia back into the limelight in India. Critics of the ban have highlighted the added expense of moving patients from pio to sitagliptin, a possible alternative. This is a good time to take another look at a patent infringement lawsuit currently pending between Merck and Mumbai’s Glenmark which launched a generic of sitagliptin in India some months ago. Continue reading

Cervical cancer vaccine : do your homework

26 Dec

In recent months, I’ve had three mothers wonder aloud whether they should give their young daughters the cervical cancer shots.  Our discussions brought alive the very real dilemma that the highly-visible launch of these products has triggered among parents. Probably, even more than the usual so-called ‘optional’ vaccines against pneumonia or chicken pox.

The first was a dentist with a nine-year old daughter. She heard about it from her daughter’s paediatrician who was surprisingly non-committal about whether she ought to inoculate her daughter or not.  I suspect that’s because the mother is also a medical professional.  This lady’s index of suspicion as far as drug companies are concerned is pretty high. She is wary of the tricks – ‘scare and inspire’ being one of them – that companies are known to employ to push their products – especially when they concern children. As also, their influence over doctors.  She thought the  regimen of three shots was  pricey but that was not the deterrent for her.  It was the medical necessity.

The second works as an executive assistant.  She has two daughters – one qualifies for the vaccine (its been approved from age 9 to 26), the other will soon.  This lady harbours the usual suspicion against all or most new vaccines not made compulsory by the government. She hasn’t immunised her daughters against chicken pox, for example.  When I first informed her about this vaccine, she flatly refused to consider it.  Then she saw the ‘awareness’ ad from GlaxoSmithKline (which makes one of the vaccines), and met a friend who stays in the US where girls are getting their shots in school.  Now she doesn’t know what do. For her, cost is an important factor though am sure if she’s convinced she will crimp elsewhere to get both girls immunised.

The third was a very senior marketing professional. Her daughter is eighteen. She doesn’t care about the price, she tells me, but she read about some “central nervous system side-effects” and she doesn’t know what to do.

To all three women, and anybody else who is in a similar position, here’s my suggestion. Ask the following questions,  get the answers, and then of course, take a decision in consultation with your paed.

First question : Is it safe? Nothing is a 100 per cent safe but regulators of the countries where these vaccines originated (US and the UK) have assessed them on the basis of risk versus benefit based on clinical trials on real girls and women to conclude they are safe enough. I would recommend you visit www.fda.gov  and take a little time to trawl through its press releases and other communications on the two vaccines Gardasil and Cervarix both of which are now available in India. The FDA also has a specific site for safety alerts on all drugs and vaccines. Also visit www.gardasil.com and www.cervarix.com as well as http://www.cdc.gov/cancer/cervical/ the site of the Centers for Disease Control and Prevention in the US.

Does it work? In a line, the vaccines only protect against cervical cancers caused by a virus – the human papillomavirus or HPV – and not any other factors, like say, smoking.  Also, they do not protect against all strains of the virus. But I would urge you to look at the data – which is available to anyone who cares to google it – on exactly what proportion of cervical cancers are caused by HPV, how many strains of the virus exist, against which of these strains are the two vaccines effective, AND what proportion of the HPV-linked cervical cancer is caused by those specific viruses.  Again, the same sites will give you all the information you need. And will also give you an understanding of the length of protection.

Three, there was something else that marked these conversations. HPV is contracted by sexual transmission and the more the number of partners the greater the risk.  The first two women have very young daughters  and it was clear they were unwilling to even contemplate their sexual debut, forget promiscuity.  The third was more realistic – and simply shrugged when I brought that up rather tentatively. 

I would suggest  strongly to all parents that your daughter’s morality is not in question here and you will do well not to base your decisions on your understanding of it.

Ultimately, speak to your paediatrician from a position of strength with all the right questions.  In such a matter, many doctors may prefer this approach to blankly being asked – so what do you recommend?

It will take you some amount of surfing to figure out what’s right. I could give you the information but it’s best you do this yourself.  It’s worth the effort.

%d bloggers like this: