Pharmaceutical ethics, alias pharmacoethics, can be reckoned as the mother of all business ethics. Pharmaceutical industry, for ages, is revered and trusted for its life-saving research in eliminating dreadful diseases, promoting longer, healthier and happier life. The awe, however, is chiefly imputed to drug discovery.

Bountiful of new molecules and dosage forms are discovered by the industry, across the globe, and many are still being developed. The industry reincarnated in the 1980s with the advent of remarkable research in the biotechnology. The latest buzz on stem cell research is deemed as yet another major milestone in the industry's ongoing research. Spending for pharmaceutical research and development is in excess of $ 30 billion annually, according to National Centre for Policy Analysis.

There are many aspects related to pharmacoethics, willy-nilly, besides new drug development or drug release techniques, viz, clinical research, promotion, sales, prescriptions, drug dispensing through pharmacies and even the use of pharmaceuticals that are essential to the health and well-being of communities.

Regardless of all the past discoveries, today the state of pharmacoethics is under question than ever before. Billions of Dollars are spent on developing less differentiated molecules, direct-to-consumer advertising, promotions that drove the industry's reputation towards South.

Drug development process is supposedly the most expensive affair –$ 500 million for a new chemical entity and an average duration of 12 years. Revenues, however, are equally big. For example, Prilosec, antiulcerant of Astrazeneca, generated $ 5.14 billion for the fiscal year 1998. Zantac, Zocor, Prozac, Viagra among many others that have set new standards to blockbuster drugs. Globally, at least 100 brands have sales exceeding $ 1 billion per annum.

Yet, the industry's inexorable appetite to retain blockbusters is becoming codswallop. For instance, AstraZeneca was censured for trying to shift its Prilosec consumers to Nexium, as the former is set to go off patent; there are increasing number of discussions and arguments going over the real therapeutic differences of these two, besides the obvious purple color.

Millions of patients, across the globe, had been consuming cephalosporin antibiotics that are only slightly, but not life-sparingly different from each other. There are at least over 40 cephalosporins in the global market and as many are inchoate in the research and development (R&D).

With the availability of a number of alternative classes of antibiotics to treat infections, why do we need so many caphalosporins to survive? What about decisive and potent drugs that can cure cancer, AIDS, Dyslexia or Alzheimer? Not many, true? One innocent question will be: If there are only handful of pharmaceutical companies existing, left as a result of frenzied mergers, would they all be discovering cephalosporins alone?

Tampering with existing drugs and juggling with combinations is another shenanigan, begrudged by the critics. According to a new study conducted by the National Institute for Health Care Management (NIHCM) Foundation, nearly two-thirds of prescription drugs approved in the 1990s were modified versions of existing drugs or products containing the same active ingredients as those already on the market.

Jan Leschly, a former chief executive officer (CEO) of Smithkline Beecham, said, "Productivity in R&D, today, is clearly not what it should be." Despite half a dozen of patent protection mechanisms, such as NCE, ICE, EMR, SPC, Data exclusivity the industry is grappling to extend the product life cycle, as their pipelines are almost empty.

The second major aspect of pharmacoethics under microscopy is the clinical trials. It is well known that pharmaceutical companies are fond of sponsoring clinical trials – many National Institute of Health (NIH) clinical trials are funded by pharmaceutical companies.

If you thought all this is only for a noble cause, you are mistaken. There is considerable published data that expressed skepticism on the integrity behind such sponsorships. No one can really dare, however, to doubt the industry claims. Unblinding clinical trials for individual gains is a silent and salient trend.

American and European drug administrations are the most awed words for both physicians and local drug authorities in developing countries. In practice, many physicians call for published clinical trials from the industry through medical sales representatives and are quite content with the superficial results they read.

But only after a painstaking inspection, one can uncover that there are studies available for every claim or dream that the industry manifests. How is this possible? Under these circumstances, should a doctor depend on clinical papers or personal experience? Is the drug industry helping or harming the community health?

As many as 548 drugs approved by the Food and Drug Administration (FDA) over the past 25 years turned out to have serious or life-threatening effects that were unknown at the time of approval. Many of them had to be subsequently withdrawn from the market.

The third bitter visage of pharmacoethics is the marketing standards, i.e., promotion, distribution and sales. Industry has adopted a 'stroke for folk' strategy in promoting medicine in different nations. For example, unsolicited 'direct to consumer' (DTC) mails from pharmacies backed by pharmaceutical companies and stocking and pushing the medicines from grocery or commodity outlets are some of the many popular deeds.

One example, from the tip of the iceberg, is the recent malfeasance from Warner- Lambert Pharmaceutical Company that has been recently sued for using its sales representatives to encourage doctors to prescribe gabapentin (Neurontin) for unapproved uses! Not a strange malady for many in the industry.

Marketing standards in the third world countries are even appalling: Unscrupulous bonus offers, expensive giveaways and sponsorships to woo the doctors are rampant. To combat the cutthroat competition, many research-based companies have adopted the strategy of early switching to over the counter (OTC).

Pharmaceutical advertising is unarguably the fastest growing categories of advertising. In 1990, there were only 10 medicines that were advertised through mass media. Today, more than 100 medicines are advertised in United States (US) alone. Currently, over $ 2.5 billion is spent on DTC advertisements just in the US, as compared to $ 791 million in 1996.

Despite increased spending on DTC, OTC promotions and the online initiatives, the pharmaceutical representatives play a pivotal role in influencing the prescription market, albeit their resources in the third world is again perverted to interruption marketing with overemphasis on personal contacts and untenable legwork, rather than enhancing skills or applying tenable strategies.

This is, perhaps, high time for a reform in the business ethics of pharmaceuticals. There are occasional gestures of good ethics and conduct. For example, Howard Solomon, head of Forest Laboratories Inc, considered offering free antidepressants to those who needed them after September 11; few pharma companies have also donated medicines to Africa. But, these isolated gestures are not sufficient in creating a cleaner image for the industry.

Collaborative efforts in the industry to pull important new drugs that are either distinctly superior or safer than the earlier discoveries will raise the overall R&D productivity and avoid wastage. Self-regulated and socially responsible marketing practices can only restore the pharmaceutical business ethics.