The Hindu Business Line : Double-check your track when rivals face rough weather

STORY so far: During a chat with the finance chief Chandru, I realise that there is an urgent need to introduce an enterprise software solution to minimise time spent in making sense of incompatible data from different branch offices.

Also, it comes as a revelation to me that the company takes good care of tangible fixed assets and even things such as fittings and fans, but has been lax in the matter of intellectual property. Gupta and I meet one of the top lawyers in the IP field to see how best we can protect our intangible knowledge assets. Protection of IP is expensive, I learn.

Episode 54

Thansha BioTech is a well-known name in medical circles. It had pioneered recombinant biotechnology in the country, and won the prestigious BeBio National Award for outstanding R&D achievements in the biotech sector for ThahShan, an interferon.

It snatched a 20 per cent market-share in a Rs 30-crore interferon market in the first few months of its product launch, and was leading in HepThan, a recombinant DNA Hepatitis-B vaccine. The media had acclaimed its product as the first in the world "to be cloned and expressed in Pichia pastoris, a eukaryotic new generation host, having immense advantages over prokaryotic E. coli host."

Well, you may already be turning the dictionary to understand all those hard words. But the news that morning was quite disturbing and it didn't need an Oxford or Webster's dictionary to understand.

Thansha's new product KinThan was causing deaths in clinical trials on patients suffering from acute myocardial infarction, loosely called heart attack.

My heart almost missed a beat, and I abandoned my morning cup of coffee to sit and read the stuff: Tests for the clot-buster drug were going on for more than a hundred patients, three of whom died. And the Genetic Engineering Approval Committee (GEAC) was alleging that clinical trials had been conducted without prior approval.

The company CEO's response had been plugged in by the reporter: that the company had gone through full regulatory procedures as specified by the Department of Biotechnology, that the drug was for "an emergency situation for seriously unhealthy patients" and so "some deaths were bound to occur in any large-scale trial", and that the globally acceptable efficacy benchmark was 60-70 per cent.

This was not the first time that the company was facing problems. I remembered, how, during my student days, animal activists had smashed the research facilities of Thansha when the efficacy trials of the heart drug were in progress on monkeys. That had delayed the launch of the medicine in the Indian market by almost two years.

I could empathise with the damage control department in Thansha, how they would be doing fire-fighting. Larry's thoughts in "Softwar" came to my mind — that many good drugs get scrapped because they fail in a minuscule minority though successful with a good majority of patients during trial.

If only we could know, not by reading tea leaves but by studying the individual DNA, who would respond to the new medicine and who would collapse, we might save not only all those lives lost in tests but also reap the benefits of advanced research in medicine.

*********

The topic was alive in the office too. There was a meeting at 11 in the boss's room. "We are doing a double check on the trials in progress," said the chief of R&D. "Just to be sure." Gupta said: "We should not have high-risk patients taking our tests."

The R&D man looked at him sympathetically, "You should remember that, to avoid bias, the tests are done blind, and so we can't manipulate the results." I said, "That is the way it is in CA exams."

That comment seemed to be out of place, but everybody seemed quite tolerant. Perhaps they didn't expect too much from accountants. "Gupta," said the boss. "I want you to see that our paperwork is okay. Check if all procedures have been gone through, though I am sure we would have done everything right in the first place." Gupta nodded: "A confirmation is always comforting, sir."

Looking at me, he added: "And we can't expect our auditors doing that sort of thing in ages." I couldn't disagree, because of late I was seeing auditors busy with only one thing — not tax or law, but their own elections.

*********

We were all not getting panicky, but were simply trying to learn the lessons from Thansha's problems. So, that afternoon, I accompanied Chandru to one of the hospitals where clinical trials were on for one of our drugs.

What a relief it was to see the patients showing positive results. My brief chat with the duty doctor was a disaster because he seemed to be talking all medical lingo, and I could understand only one thing, `procedure'.

When he noticed that I was not comprehending, he said, "Let me repeat once again." But I said, "Wait, I think you are trying to explain to me how this medicine works in the body, right?" He replied, "No, Swati, I was seeking your advice on how I can reduce the monthly tax they deduct from my salary." Ah, what a schism between professions, I mused.

*********

At the mailbox: "Hi there," writes Venkata Narayanan Thiagarajan, from Tampa, Florida, with a subject line that reads: Just a feedback. "Was going through the articles you have written. Good to see you share your experience and views as upper management. Just my few cents.

"I respectfully disagree with your article on the hackers article. The only way you can secure a network is close it down to the external world or follow the slogan `security starts from home'. Right from the doors you lock (before leaving home), till keeping the computer/ATM password challenging — this has to be become the mantra.

"Let me stop my rant and come to the bare bones. There is no point in blaming security/network admins for the hacking issue. Each and every individual should contribute for the security — it needs knowledge sharing, from A to Z, upper management to the front-desk telephone operator. Regards. TVN."

Thanks, Venkat. Security is everybody's duty, I agree. Yet, in many organisations, the EDP or the systems people corner too much authority to themselves even in routine administrative matters.

Let me tell you a small story, to illustrate: A friend of mine comes back every day to soak his hands in warm water and I ask him, `Hey, why?' He says that his mouse is not working. `Change it, you dumb,' I tell him. `I sent in a requisition to the EDP,' he says. `Okay, if that's the procedure,' I nod. `And they would have changed it in a jiffy, because that's what it takes to unscrew the dead thing and plug in the new chooha.'

But he is forlorn: `I too thought so, Swati. But it is two months since I sent in the paper. They say, they are trying to place a bulk order after doing a survey in the office to find who all need a mouse change. When I took my domestic mouse to the office, the security wouldn't allow it inside. What do I do?'

(To be continued)

Swati_CA@hotmail.com

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