Food for thought II- Disease Awareness Programs

HSA guidelines on Disease Awareness Campaigns, 2004

http://www.hsa.gov.sg/docs/GuidanceOnDAC1Nov2004.pdf

Food for thought:

How many DACs currently carried out by pharmas conform to these vaguely-lined standards? And how many PMs and MMs are acutely aware of the existence of these standards?

Compliance is a dirty word...

The Straits Time, Tuesday, July 3 2007

As if it hadn't already been difficult to do much things in pharma, with the corporate governance thing sweeping across industries globally post Enron, Worldcom, etc.

Locally, the SAPI code of marketing practises became more stringent several years ago due to complaints from the medical fraternity on the aggressive and seeemingly 'unethical' marketing by some companies. The launch event of a new drug back in 2003 raised plenty of eyebrows for the extravagant event location held in a 6-star hotel with night stay's thrown in for the participant, premium booze, top range entertainment and even childcare services! No doubt the participants made up largely of doctors across the sectors were delirious. (It is rare to be given such treats in their profession. The general population by and large thinks that doctors should be doing charity works and earning peanuts compensated by the immense amount of compassion they possess.) this triggered off a massive anti-xxx company campaign by its competitors who propagated these sentiments to the authorities and various CMBs of the hospitals and created their own tit-for-tat strategy of offering cruises to nowhere, golf clinics, wine appreciation classes, the list goes on. The fact that the launch event was spilled over two days with a robust and continous CME program was totally negated.

SAPI then responded with an elongated code of marketing practices and a new algorithm for companies to air the grievances and formally lodge a complaint against another. (this resulted in several clash of the titans meetings between a couple of long feuding giants) Suddenly the marketer is told to tone down, keep a lower profile, increase vigilence...

Come to jan 2007, the IFPMA came into the scene, releasing a new international code of marketing practises in which marketers had to spend hours reconciling with the sapi code and attending the legal counsel's training. the IFPMA simply offers tighter control on an already barren environment. (in the local context)

Compliance is a necessary evil. without governance, organizations behave like humans. Integrity will succumb to greed. It is good for the industry to self-regulate rather than to have the regulatories intervene when its too late. Negative perceptions have particularly serious implications for pharma due to the nature of the products and purposes that it seem to represent.

Looking around, PMs are latently devoid of compliant ideas, support (be it medical, legal, financial or administrative) are lacking as everyone is watching out for his/her own turf. if compliance is ALL that drives a company's decisions(and i know of some companies that do so), no matter how minute and non-consequential, conduction of day to day marketing and sales practices, protocols will multiply, processes will get stifled, creativity and innovations will erode and pretty soon we may not even need marketers anymore (as it is, we are already enroute to that eventuality)

Another bites the dust

Pharma's big brother, FDA yesterday released the recommendations of its endocrinologic and metabolic advisory board who met to ascertain the safety of Sanofi's Acomplia. The panel of 14 experts have unanimously given Acomplia a shake of the head due to increased suidical rates observed in its clinical trials. (http://money.cnn.com/2007/06/13/news/companies/sanofi/index.htm) While the fate of this once-highly-touted-to-be-the-next-blockbuster drug now hinges on FDA's final decision on its approval, the ground seems to be fast sinking from beneath Sanofi's feet.

Although it is already available in Europe and few other countries, Singapore's HSA usually looks towards FDA before reviewing any products for local approval. this turn of event is bound to implicate the approval process locally.

Besides the tedious reanalysis of the NCE's projections, etc, etc. any company caught in a similar situation would be fumbling with issuing corporate statements and internalizing communications. while most non-approvals tend to affect the immediate share prices rather than the ongoing business, it is still a hassle to deal with.

After the Vioxx incident, FDA has certainly tightened its regulatory reins, this has resulted in many pharmas having to delay new product launches/ indications to produce more data. most big pharmas have experienced at least one major setback in the aftermath. AZ chucked the very promising warfarin-substitute, Exanta, after FDA's failed approval despite usage in most parts of Europe. Pfizer quickly released Torcetrapib without even attempting a FDA approval. BMS's muraglitazar was meant to be the first DualPPAR alpha-gamma ligand which at its late stage, was shoved down the bin by its maker and supposed partner, MSD.

Needless to say, non of these drugs made it to our sunny island.

I often question why local companies would commence their pre-marketing activities so prematurely. Surely, the agonising difficulty in having to salvage the companies' image to the customers after building up such excited levels of anticipation amongst them is deterrent enough. but i still see companies hosting extravagant dinners and sponsoring offsite meetings to pre-empt the impending arrival of the so-called blockbuster. more importantly, instead of counting your chicks before they hatch, shouldn't the marketers be more involved in the strategic planning and determining best forms of market access instead of singing about how the new cure-all compound would finally bridge the unmet medical need...

I have little sympathies for these PMs who will may now have to face the uncertain fate of handling a less glamourous product (best case scenario) alternately, the company may just reassign them to cover SFE until the next pipeline dream comes along.