SpicyIP, has in several posts
, discussed the issue of generic drug companies taking patients for a ride. The Hindu
now reports another instance involving two drugs, theophylline and doxofylline, both of which are prescribed to treat wheezing, shortness of breath, and difficulty in breathing caused by asthma, chronic bronchitis, emphysema, and other lung diseases. Both relax and open air passages in the lungs, making it easier to breathe. In short, they are bronchodilators.
Theophylline, a scheduled drug, and all its derivates such as etofylline, theobromine, oxtriphylline, dyphylline, enprofylline, etamiphylline, proxyphylline and pyridofylline are subject to price control under the NPPA regime. In May 2006, The Hindu
reported the launch of doxofylline, popularly known as “Doxobid”, a hitherto unknown derivative of theophylline by Dr.Reddy’s Laboratories under licence agreement from Kent Union Ltd, Hong Kong, and marketing co-operation with Netherlands-based Eurodrug Laboratories BV.
According to The Hindu, since doxofylline is not covered under the NPPA, generic manufacturers are making a killing by aggressively promoting it over its cheaper version theophylline. Quoting Dr.C.M.Gulati, Editor of the medical journal, Monthly Index of Medical Specialities, The Hindu explains the reason for doxofylline’s entry into the country:
“The answer lies in the way drug prices are determined and controlled in the country. Doxofylline is being offered as a more profitable alternative to theophylline, prescribed to prevent and treat wheezing, shortness of breath, and difficulty breathing caused by asthma, chronic bronchitis, emphysema, and other lung diseases. It relaxes and opens air passages in the lungs, making it easier to breathe.”
“Theophylline and etofylline – molecules approved for sale in over 200 countries after having undergone rigorous post-marketing trials — are scheduled drugs and subject to price control by the Government. By successive orders in 2006, all loopholes to sell theophylline products at high profit margins have been closed by the National Pharmaceutical Pricing Authority (NPPA), the body that monitors medicine prices in India. Therefore, nearly all companies selling theophylline formulations have been scouting for similar molecules outside the price control system irrespective of whether they are similar, better or even worse than their current brands”
This means that where on one hand theophylline is sold at Rs.6.40 a strip; doxofylline costs patients a cool Rs.80 per strip. Dr. Gulati further adds:
“The core issue is profits, not patients. The strategy is to stop selling less profitable, price-controlled products and replace them with hugely profitable alternatives of the same class. Doxofylline fits into this tactic. A molecule which is not even considered fit for mention in standard textbooks is being paraded as if it is major advancement in the treatment of asthma,”
The Hindu also reports that:Doxofylline bulk drug is not a patented medicine and can be purchased in tons in China at a very low cost without any licence. Yet to give it an international foreign flavour, some drug companies in India have proudly announced that their brands are being produced “under licence” from overseas entities.
The article concludes thus:Doxofylline is just another derivative of theophylline in this chain and resembles the parent compound in its mode of action, efficacy and safety profile
The available open literature on the last observation seems to indicate otherwise. An article in PubMed compares the safety of doxofylline and theophylline in treating chronic reversible asthma and on the basis of the results concludes that doxofylline is endowed with a remarkable bronchodilator activity with less extra-respiratory effects than theophylline. It further states that:
“This study provides evidence that doxofylline 400 mg t.i.d. is an effective treatment for relieving airway obstruction and displays a better safety profile with respect to theophylline 250 mg t.i.d. with a favorable risk-to-benefit ratio.”
Another journal paper concludes that doxofylline, unlike theophylline, does not affect gastric acid secretion. Where theophylline can cause upset stomach, stomach pain, diarrhea, headache, restlessness, insomnia and irritability, a paper by a research group from AIIMS reveals that doxofylline has significantly lesser side effects. (Of course, one can always question if the reduction in side effects justifies the price of the drug). If a person casts aspersions on the integrity of these results, it would be a weak line of defense unless he has enough material to substantiate his claims.
In addition to this, doxofylline is not an Over-The-Counter (OTC) drug; it is a prescription drug. This means that the drug can be administered only if a physician has prescribed it and this he does despite knowing fully well that a less-expensive alternative in the form of theophylline exists. Ergo, either he believes that doxofylline is better for his patient notwithstanding the higher price, or he wrongfully furthers the cause of generic companies. If he resorts to the latter, he would be guilty of unethical conduct under Chapter 1 and Chapter 6 of the Code of Medical Ethics laid down by the Medical Council of India. Thus far, we do not seem to have come across instances of such conduct involving doxofylline.
That apart, there exist several instances where derivatives of a drug have been sold at different prices on account of either increased efficacy or reduced side-effects, penicillin being a prominent example has 12 or more derivatives. Such being the case, to say that the company has invested a fortune in “developing” something which already exists solely in the belief that it can take the public for a ride sounds too far fetched a proposition, and in these days of increased consumer awareness, insults the intelligence of the public. In the light of these observations, it may not be easy to point accusatorial fingers at generic manufacturers. I do not deny that there have been instances in the past where even Judas would have been put to shame by the conduct of generic manufacturers, but one cannot base that as a premise in every case, however tempting it may be. “He is bad and so he is bad” kind of argument may not hold water.