Tuesday, August 7, 2012
I love generic drugs too...But…
Generic drug name: any drug which is called by its chemical/pharmaceutical name. like Paracetamol or Chlorpherniramine Maleate or diphenhydramine.
Specific drug name: the names people buy medicine in pharmacies like – Crocin or Calpol or Avil or Benadryl…or whatever name you remember from the prescription your doctor wrote last time for you.
Now lets start with a little story. Lets imagine that you are a top level recruiter for a big MNC and tasked with hiring people for your company. You schedule interviews with two colleges as part of their campus placement programs. On further investigation you learn that college A had during its examinations allowed its students mass copying with absolutely no supervision, while college B had strict standards in-house and there were roving squads which debarred anyone found copying. So you cancel that interview at college A and recruit exclusively from college B- noted for its fairness and strict vigilance. Meanwhile, College A calls you up, insists that you recruit from their students too- as a Degree is just a degree- no matter how acquired and their students have equivalent degrees to the other college too- regardless of how they got it.
Will you accept this explanation? That a degree is just a degree from wherever got? Even if the invigilators were fast asleep during the exam? The degree has still got value?
And this is the question which arises on my mind whenever there is talk in the media about the value of generic drugs, courtesy a new found interest on healthcare by our esteemed parliamentarians focused by a shall-be-unnamed actor’s TV show. Madam Sushma Swaraj has made a statement in Parliament (of all places) that if generic drugs can be prescribed successfully in America, why not in India?
And hence the above example - although I don’t expect Sushma Swaraj to ever visit my blog to read this.
The recruiter in the above example is you and me- the general public. The college A where rules are disregarded and no supervision takes place is India and the college B where the college authorities are vigilant is, you guessed it, America. And telling us that if generic drug sytem works in America, so it should work in india, is like telling us all that only the degree printed on paper matters and not the fact of “how” it was obtained. And that is the sad, but real fact of the pharmaceutical industry in India and especially the regulators- the drug control bureaucracy system which is comatose when compared to the Amercian FDA- food and drugs agency.
The FDA kicks ass- no second thoughts on it. They take their job seriously. They investigate, analyse, and even hound the pharmaceutical companies sometimes, till they are satisfied absolutely satisfied that a given drug on the market is safe. When pharmaceuticals complain that it takes around 10 years to launch a new drug on the market, even after passing all the safety standards for laboratory products, it’s the role of the FDA they are talking about. The pharma companies say that it drives the prices of the drugs up- for adding to the development costs (and the salaries of the scientists involved), they end up paying for the long periods of testing involved to get the approval with no chance of any profit yet- which sounds a reasonable gripe. But. The FDA always errs on the side of caution- doing its due diligence- and protecting the American consumer. And banning drugs when necessary.
We in India follow the FDA guidelines too- secretly- when the FDA red flags a medicine- most doctors in India stop prescribing it – even though it may still be available freely on the market. Two examples- think Nimesulide- a pain killer/antifever drug (what we call an analgesic/antipyretic)- banned for causing liver failure in the USA- but still prescribed by some doctors in India- because its still available in the market, freely for prescribing to anyone- including children. (courtesy a high court judgement for not giving prior notice to the manufacturing drug companies before banning - a minor loophole exploited by the company).
And think Cisapride-an flatulent/motility agent- used for bowel cleaning- and linked to heart disease. Would you rather have a little gas or an heart-attack?
Or Baralgin? Taken by many women for easing their menstrual cramps? But banned since the 1970’s in America for causing dangerous skin eruptions which can be life threatening?
I can go on and on, giving examples of lax regulatory control in India compared to the USA. So saying that works in America should work in India is like comparing apples to oranges, Madam.Sushma Swaraj. Democracy works very well in America does it work even half as well in India? Does public probity?
Anyway to get back to the premise of the article, the reason we can’t trust the quality of the generic brands available in your neighbourhood medical shop is because you can’t trust most medicines in your neighbourhood medical shops. Adulterated drugs are rampant. And when you take away the power of doctors to prescribe a particular drug from a particular company and pass the power to the man handling the sales department at the pharma shop, you are taking a great risk with the lives of the people.
The way generic prescribing works is like this. If a doctor wants to prescribe a vitamin tablet for you- say B12...he writes his prescription for Vit.B12 and hands it over to you (under the generic drugs scheme) to take it to your local medical shop and get it. The medical shop is supposed to stock the vitamin in its generic or unbranded form, mass manufactured according to the cheapest quotation available and supplied to the government by tender. The medical shop salesman who suddenly becomes the authority to decide what medicine you buy is under no obligation to sell you the cheap generic drug. What profit is there for him in that? The medical shop salesman will naturally sell you the same medicine in its branded form- depending on whichever drug company offers him a better margin of profit (say 20% compared to 8%).
This already happens- I don’t deny- as the medical shop people sometimes for example, substitute becousles tablet when a doctor writes the cheaper nutrolin-b tablet (even though the same VitB12), but at least now when the patient returns with the medicine to the doctor to cross check it, the doctor can find out and blast the medical shop personnel for changing his prescription without authority. When it’s a generic prescription the doctor loses his hold on the drug name prescribed and the medical shop man takes over. He is under absolutely no compulsion to sell the generic medicine- who is to bell the cat?
My Next Point is that sometimes certain drugs are available in certain specific combinations from certain manufacturers only. After all, they know about generic drugs too don’t they? And so if they need to stand apart from the crowd of companies all making the same medicine-like the popular painkiller Diclofenac (Voveran?) they have to innovate to differentiate. This actually works out well for the general public too. For instance the same diclofenac – which is used as a pain killer- is produced as a sodium salt by most companies. But it has a side effect of causing acidity in the stomach. So a few companies have produced the potassium salt version of diclofenac- enteric coated tabs- which means it doesn’t get digested in the stomach and cause acidity there, but it travels in a un-dissolved form into your intestines where it gets dissolved and then gets absorbed into the blood and acts on the pain elsewhere. Now wouldn’t you say this is a useful thing to have? For someone who has great muscular pain due to a sprain or an injury, but also unable to take painkillers due to acidity problems this would help.
Unfortunately, you won’t get his kind of specialized drugs in the generic market, which focus on manufacturing only the basic form of the drug for the mass market.
And one further point is when you use branded medicines you can be reasonably sure of the quality that you are getting, because the company which has its own reputation at stake does a far better job than the govt drug control people in finding out and destroying any fake products carrying its brand name.
So, finally it all boils down to this, can the government improve its monitoring mechanism? Can it guarantee the safety of the medicine being sold in the medical shops? If it can, then I am all for generic drugs too, but till we get that infallible belief, it would be better to let both generic and branded medicines co-exist.
After all when you have a sick child crying with fever, you wouldn’t want your doctor to hesitate which medicine to write, would you? Or whether it will work at all? That kind of dilemma shoud’nt be there in medicine- not for doctors and not for patients.
(P.S. I am not in any way Anti-pharma industry. I do believe they support medical research far more than the govt does. Name any new drug which came out of any govt sponsored laboratory? But because of the long periods of time involved in drug development – some pharma companies try to get back their profits in a very short term and have steep prices rather than pricing it moderately and getting benefits over the long term. And that’s where they end up getting all this bad press and also patent violations by govt’s citing public interest. Short term greed.)
(P.P.S. at one point in my life/career all I wanted to do was research and to find out novel medicines for life threatening diseases- but I have been cured off that illusion now. The only way I will get back to research now is- maybe if I get to marry a rich heiress, who will sponsor me financially, I can establish my own lab and invent new medicines)