Easy accessibility and a complete lack of awareness makes for a lethal combination

Syed M. Aslam
Aug 10 - 16, 1996

Drugs banned in the very countries of their origin of many multinational pharmaceutical companies operating in Pakistan, are still manufactured and marketed by them and easily are available without prescription here in Pakistan, are posing serious health risks to the users.

For instance, while the sale of Dipyrone, a painkiller, was banned in such developed countries as United States, Japan, Australia, and much of Western Europe nearly a decade ago, it still remains the basic ingredient of Novalgin brand tablets manufactured by German pharmaceutical giant Hoechst. The manufacture of the drug is banned in Germany, the home of Hoechst and the company also stopped manufacturing the product at its plants in Brazil years ago.

Dipyrone, better known here by its chemical name metamizole, can cause a potentially fatal condition, agranulocytosis, which weakens the defensive mechanism of the body as the ingredient decreases the white cells (WBC) of the blood.

Though dipyrone-based Novalgin is banned in a large part of the world, including Germany it nevertheless remains easily available off-the-shelf at drug stores throughout the country here. While a warning appears on the 1000 tablet box of the drug, it is no good for the end user as the same does not appear on the blister strip.

While Hoechst actively promotes its brand Novalgin as relieving all kinds of pain or fever rapidly in all age groups, the dipyrone factor remains a well kept secret at the cost of millions of users nationwide for whom the substance poses a serious health hazard. In developing countries like Pakistan, patients suffering from agranulocytosis have a very little chance of survival.

Easy access to the drug combined with lack of basic health facilities and appropriate warning, in addition to poverty help force the common man to buy get-well-soon drugs from the medical store instead of seeking treatment from a medical practitioner and put a user in the high risk category.

The indifferent attitude of health authorities in respect of keeping the public posted about potential health hazards and their failure to implement strict regulatory measures in the greater interest of the public is pathetic to say the least.

Novalgin is 17th best selling product in Pakistan raking in $ 3.14 million in '96 for Hoechst which ranks 7th among the 96 leading companies in Pakistan and is valued at $8.46 million sold $ 3.14 million worth of Novalgin alone last year.

Besides Novalgin, Hoechst is also manufacturing six other products in the objectionable category including Baralgin which ranked 93rd sales-wise in '96 bringing in $ 1.18 million for the company, digestive enzyme Festal, anti-histamine Avil Retard, Avil Expectorant and Catabex Expectorant for cough, and Trental for peripheral and cerebral vasodialator.

While the case of Novalgin has been highlighted to draw attention to the gross neglect the concerned authorities have shown to public health, this is not an isolated phenomenon; out of a total of 204 firms, both multinational and local, producing pharmaceutical products in Pakistan, 180 are producing products about which concerns have been raised. The number of questionable products ranges from one by Anglopak to 18 by Glaxo to 24 by Abbot and 26 by Schazoo which tops the list.

Thus it is easier to name the 18 pharmaceutical companies which are not producing or marketing questionable products than the 186 which are. These 18 companies are: Berina, Biotest, Bristol, Cepa, Cyanamid, Daiichi, Gedeon-Richter, Howrads, Ideal Pharma, Medipak, Otsuka, Plivo, Samco, Spic, Syntex, Tabros, Tanabe, and Vifor.

The objectionable drugs include such better known names as Neurobion by Merck which ranks 4th in sales at $ 7.16 million , Surbex by Abbot 15th at $ 3.37 million, Betnesal-N by Glaxo 36th at $ 2.12 million, Lederplex syrup/capsules by Lederle 40th at $ 2.06 million, Dolobid by MSDs34th at $ 1.16 million, Terramycin by Pfizer 29th at $ 2.37 million, and Hydryllin cough syrup by Serale 30th at $ 2.34 million.

What's more terrifying is the fact that top earners are in the forefront of promoting the objectionable products; top ten leading companies are producing 10 questionable products followed by 6 products by companines ranking 11-20, 10 by companies ranking 21-30, 7 by those occupying positions 31-40, 8 each by those positioned 41-50 and 51-60, and besides 5,4,7,2, and 0 by those ranking 61-70, 71-80, 81-90, 91-100, and 100-117 respectively.

But the fact that fifty out of 117 sales leaders do not produce/market questionable drugs also clearly shows that a firm can be profitable indeed without producing or marketing products about which quite reasonable questions have been raised.

But how can the term "questionable" be defined? The questionable drugs include all those drugs which lack evidence of effectiveness, have doubtful therapeutic value; have inappropriate/dangerous side effects; inappropriate undesirable combinations/doses; are at variance with their status in the home country including being obsolete, unavailable, denied registration, banned, withdrawn, or restricted in West and some Third world countries; more have beneficial/cost-effective alternatives; are addiction/dependency producing have toxicity risk; and are not recommended/harmful for certain age groups.

With the availability of the hazardous combination of all these drugs without any governmental check, off-the-counter in Pakistan, the consumers are left at the mercy of physicians, both at government hospitals and private practices, whose capacity to retain their independent knowledge base, to say the least is severely strained. The situation is further worsened as there are only two quality control labs in the country which are understaffed and illequipped. The province of Sindh which houses 90 per cent of the pharmaceutical companies has no established operational lab.

While '96 marks the 20th anniversary of the 1976 Drug Act which laid down broad guidelines of public policy which was followed by Burhan-ud-din Report on Hospital Administration and Medical Education 8 years later, the significant point of which ordered the reregulation of all drugs banned or unapproved in their country of origin, or of dubious clinical value, the situation remains unchanged at present.

While the National Drug Policy Draft issued in February '95 retained the '94 Experts Committee Report as part of its chronology it is interesting to note that the draft after its initial publication went through a major revision in June '95 due to pressures of the representative body of multinational companies, the Pharma Bureau, which said that should the Draft be approved as submitted, the foreign investment would be withdrawn.

The influence that the multinationals enjoy is evident from the fact that the following significant changes were made in the Draft between February and June the same year:

*** While the concept of essential drug/rational use was accepted in the original Draft for all companies, the June Draft limited it only to the public sector.

*** The part of the original Draft restricting future ventures of MNCs with partnership as joint-ventures with Pakistani firms was deleted in the June Draft.

***While the original Draft said that MNCs will be permitted to manufacture locally only those drugs which are registered and circulated freely in their home country, the June Draft was amended to say that registration will remain while free circulation is deleted.

*** Original Draft called for ethical promotion of all products but the June Draft said that there should be no binding code.

In addition, four important issues the problem of over-the-counter sale, monitoring or implementation, control over unused licensed products, and pricing policy were also not mentioned.

The amount of importance that the ministry of health attaches to public health is obvious from the fact that while it prepared a list of products unavailable in the home countries of the manufacturers in '94-95, there has been absolutely no follow up.

While the WHO's 'Essential Drug Policy' listing 250 products to provide a framework of action to guide national policy in the Third World is based on such straightforward factors as proven efficacy supported by adequate scientific data from controlled studies; safety acceptability accompanied by unbiased and comprehensive material; benefit/safety evaluations in controlled clinical/epidemiological studies; benefit/risk analysis; relatively inexpensive generic products where available; focus on most prevalent diseases; and continuous review all sorts of questionable drugs are vigorously produced and marketed in the country without any check.

Though a number of encouraging signs have emerged during recent years such as voluntary withdrawal of certain products from the Pakistani market by MNCs --- Ceramine by Ciba-Geigy, Cambiotic by Pfizer, Expectorant by Wellcome, and Extex by Wyeth --- much is still needed to be done to see that consumers have access to safe and affordable drugs as 'Human Right' to medicare. Sound and available health policy is recognized by the WHO as the most significant contributor to liberate human economic productivity.

It is high time that long neglected public health be paid the importance it deserves for the general health of the nation by devising appropriate policy that caters to the needs, and safety of the Pakistani nation.

The interest of the manufacturers should not over-ride that of public welfare as no cost is too high to pay for the health of the nation.