Monday, 21 July 2014

The Drug Dilemma

I don't watch "Satyameva Jayate". In fact, I'm surprised how a TV show was allowed to use such hallowed words for a title! I do not watch "weepy" talk shows where the anchor is shown being moved to tears by the stories of the guests on the show. A show which is not live but is rehearsed, recorded and re-recorded. I do not watch shows which ask for donations, but no one knows what happens to their money after they part with it.

Anyways, that's not what I want to talk about today. The reason why the name of this particular talk show figures here is that it came up with a very strong appeal to the general public to start using generic drugs. It preached to doctors not to make money by prescribing branded drugs of companies which pay for their domestic and foreign jaunts. It even went a step further and the anchor was shown setting up a meeting with the health minister of the country, demanding that he get nominated on a panel of "experts" which would decide about legislation on the prescription of generic drugs.

So what is a generic drug? Well, I'm not a doctor, or a biochemist or a chemist even. The last time I had any sort of formal education in chemistry was in Class XII. Of course a subsidiary subject in an Honours course doesn't really count. Yet even a Class XII chemistry student would know what are the basic principles behind any drug. The most important part of the drug is its active ingredient consisting of a single molecule or maybe a combination of molecular compounds. The active molecules act on the symptoms that they are supposed to cure. That is the lead role.

Now, in TV shows and movies, there are supporting actors, crew, make-up man, spot boy etc., who play their own roles. Ultimately a movie is a combination of the efforts of all these people, and their combined efforts decide the quality of the product churned out. Similarly, in a drug, the molecules which form the active ingredient are supported by other molecules in the drug which ultimately decide the efficacy of the drug in treating the illness for which it is being taken. There are various ways in which the supporting molecules act. Some may suppress allergic reactions caused by the active ingredient and make the drug easier to tolerate. Some may suppress immune systems and thus enable the body to accept the active molecule more readily. Some may change the pH of body fluids in the affected parts, so that the active molecule gets an enabling chemical environment for effective action. Some may simply augment the efficacy of the active ingredient by providing some secondary molecules. Some may prolong the half-life of the active molecule so that it breaks down slower inside the body and thus acts for a longer time. Some may react with the active ingredient inside the body, and both may synthesize into a more useful form.

Of course, this is what I can think of as a lay person. I'm sure doctors, biochemists and researchers spending several back-breaking hours hunched over their scopes and petri-dishes (if they are still in use and have not been replaced by some cutting-edge technology for research) would provide us a long, long list of such dual, triple or multiple chemical reactions that are caused by the smallest unit of a drug, which consists of the active ingredient and the ancillary ingredients, and which are a part of the complete package of cure or palliation that the drug provides.

Will generic prescriptions only contain the name of the active ingredient or will they also contain the names of all the ancillary ingredients? Who will help the patient decide which combination is more suited for his/her condition? Let us say a doctor prescribes paracetamol. However depending on the patient's symptoms, the doctor may decide that the patient would do well to have a variant of paracetamol with caffiene. Will the 8th pass boy sitting at the nukkad (corner) chemist shop help the patient decide which brand, and thus which molecule, of paracetamol the patient should take?

Then comes the issue of credibility. On online sites like Healthkart and CIMs, one may be able to compare the prices of various brands of the same drug. But there are variations in terms of the compounds used in different brands. So how does a consumer of a highly technical and vital-to-life product make her choice? SHe doesn't have enough knowledge of her medical condition or of biochemistry in order to make an informed choice. Even if there are two or more brands selling identical generic molecules, is price the only criteria involved in the purchase? Does the reliability of the brand, and the company selling it, enter the picture at all? How does one know whether the cheaper one isn't half chalk and half medicine? Or for that matter, even the dearer one, if a consumer takes price as an indicator of quality? Does the entire production process have no role in the effectiveness of a drug?

Pharma companies making a killing by jacking up prices of drugs is a reality. Pharma companies providing very lucrative incentives and "other"-kinds of incentives to doctors to virtually bribe them into prescribing their company's brands of drugs is also a reality. Prices of essential drugs hitting the roof and putting them out of reach of the hands of the poor is also a reality. Pharma companies dishing out legal jargon in the name of IPRs to protect their pricing policies in the face of the pricing being "anti-poor" is also a reality. But, then, who makes the purchase decision about a vital commodity like drugs? Comparing drugs is not like LalitaJi's balancing scale showing "Keval aadha kilo...... pure ek kilo saadhaaran powder ke baraabar hota hai". (Just half-a-kg of ....... is equal to a full kg of ordinary detergent powder).

And if doctors can be "bribed" into prescribing certain brands of drugs, who prevents the local chemist from being so "bribed" when faced with a generic prescription? Or who knows, in a strategic forward integration policy, pharma companies may start formally and legally keeping doctors on their payrolls, and opening their own chain of pharmacies, which would prescribe and sell their own brands of drugs? And cartels will ensure uniform pricing so that the consumer will suddenly have practically no choice.

So, the issue of generic prescriptions and the sale of drugs by generic names is not so simple. Nor is it easy to answer all questions and address all concerns by gate-crashing into a panel of experts with no expertise on the subject. The issue needs a lot more thought. Thought by people who know their biology and their chemistry, beyond the use of a chemical compound called glycerin.

In case anyone has a doubt, let me put a disclaimer. I do not work for any pharmaceutical company. I do not work for a rival production company. I am just a humble employee of the real "Satyameva Jayate".

PS: Ever wonder who finances domestic, foreign and all other jaunts, or even basic bread-butter of various dramatis personnae of Bollywood? Or even Tellywood? I wonder too !!!


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  2. Posted by a senior colleague. Dr R Narendra:Shubhrata, I have no comments on the programme “Satyameva Jayate”. But I disagree about your opinion on Generic drugs.
    A brand-name drug and its generic version have the same active ingredient, dosage, safety, strength, usage directions, quality, performance and intended use. That means Generic and brand-name drugs must meet the exact same standards for effectiveness, safety and quality.
    The common apprehension on generic drugs is they are cheaper than branded versions because their quality and effectiveness have been compromised. But this is not correct. Actually, generic drugs are only cheaper because the manufacturers have not had the expenses of developing and marketing a new drug. When a company brings a new drug onto the market, the firm has already spent substantial money on research, development, marketing and promotion of the drug.
    As the patent nears expiration, manufacturers can apply for permission to make and sell generic versions of the drug; and without the startup costs for development of the drug, other companies can afford to make and sell it more cheaply. When multiple companies begin producing and selling a drug, the competition among them can also drive the price down even further. One study says the cost of a generic drug is 30-80% less than its branded version.
    So there's no truth in the myth that generic drugs are manufactured in poorer-quality facilities or are inferior in quality to brand-name drugs.
    Sometimes, generic versions of a drug have different colors, flavors, or combinations of inactive ingredients than the original medications. Trademark laws do not allow the generic drugs to look exactly like the brand-name preparation, but the active ingredients must be the same in both preparations, ensuring that both have the same medicinal effects. Regarding your other doubt about Who will help the patient decide which combination is more suited for his/her condition? , Undoubtedly the Doctor. Corrupt practices of Doctors, Pharma companies, medical shop fellows is a different story, this is nothing to do with generic drugs. Effective regulatory control from the Government is the only solution to curb these practices.
    In majority of medical conditions including live threatening emergency situations, and in the cases of chronic disorders, the active ingredient only matters. Are we ready to pay 30 to 80 percent more cost for the sake of ancillary ingredient, which is in most cases useless and ineffective?
    In developing countries like India, the Governments should promote use of Generic drugs because they are not only cheaper but also equally effective.

    1. Thank you, Sir, for a different perspective on the issue. But Sir, surely "generic drug" means just the basic molecule right? For example, paracetamol, which I have used in my blog post too, is a generic molecule. But someone has to manufacture it, right? The manufacturing will be done by some pharma company or the other. Since in India, we have process patents instead of product patents, anyone can manufacture the same molecule. Sir I do not agree with your contention that generic drugs are cheaper because companies have not spent money on development and research. If they didn't spend on research how did they discover the drug? Or did they just reverse engineer the process for a product already developed by another pharma major? generic drugs are "generic" which is the basic molecule or the basic active ingredient. Eg., methylphenidate. But it is never sold as methylphedidate. It may sold as Inspiral or Ritalin or Concerta or any other name depending on which company has manufactured it. Even if we pass a law saying that all manufacturers should sold methylphenidate only under the name "methylphenidate", my doubts about quality control remain. Because generic drugs are the same as branded drugs. The only debate that has been going on has been about selling it as such. Moreover, I do not agree with your contention that ancillary ingredients have no role. Of course I'm not a doctor, but it makes logical sense that the ancillary ingredients do serve a definite purpose. Eg. ferrous fumarate can be taken with B12 or B9. Which is more effective, who decides. And B12 as well as B9, though ancilliary, are vital to proper absorption of theactive iron compounf ferrous fumarate. Similarly there was a time when calcium was sold just as compounds of calcium (like calcium sandoz with calcium glubomate and calcium lactobionate). With time it was found that Vit D3 is vital for the absorption of calcium. See the variants of calcium carbonate plus Vit D3 available while researching Shelcal Further CCM, which contains calcium citrate malate and Vit D3 and folinate is shown as just calcium or calcium citrate malate on healthkartplus. In that case it appears that Vit D3 doesn't matter is in no way affects the efficacy of the calcium supplement.

      Drug - Shelcal OS FC (Calcium Carbonate) Price List | Medindia
      Drug information on brand Shelcal OS FC (Calcium Carbonate)). It is manufactured...See More
      51 mins · Edited · Like · Remove Preview

      Shubhrata Verma Prakash Moreover, the generic drug too has to be manufactured by "someone". While in the US I bought Benzoyl Peroxide at Walgreens. Even though it did not have any fancy brand name or name of a big pharma manufacturer, but surely Walgreen did get it manufactured "somewhere". So the generic drug debate, according to me, does need more deliberation and more view points. Ultimately, someone manufactures, someone markets and someone prescribes. Let the decision be with the experts, specially on prescription drugs (after benzoyl peroxide is otc even in the US). There is no one who is incorruptible. And how does a poor patient with little education make a uniformed choice? Finally just see the information available on paracetamol. If one has fever and nausea I'm sure paracetamol + domperidone would be a better drug to take. At the same time, God forbid if a patient of ITP takes paracetamol + ibuprofen. See the maze of generic paracetamol drugs available and tell me if it is possible for a lay person to make an informed choice.

      Paracetamol (Generic Drug) combination List of Brand/ Trade Names | Medindia
      Available brands for generic Paracetamol combination with manufacturers details. Click on the desired brand to find out the drug price.

  3. I am not able to get the hyperlinks working for Kindly go to the site to see the web of information available on a simple generic drug like paracetamol.