To: Robohogs who wrote (8636 ) 11/19/2004 9:27:44 AM From: Stephen O Read Replies (2) | Respond to of 9523 Not for long perhaps? Read this article from Dow Jones today. 845 DJ 19-Nov-04 at 07:41:00 09:15 DJN =DJ THE SKEPTIC: Big Pharma's Clinical Trial By Brian Truscott A DOW JONES NEWSWIRES COLUMN LONDON (Dow Jones)--The overnight news from the U.S. about the regulation of the drugs industry is a development with long and wide-ranging impact. There are going to be untold consequences from the declaration to a Senate committee by a 20-year veteran of the Food and Drug Administration, Dr. David Graham, that the regulation of the pharmaceutical market is "broken" and that the FDA has let people down by not effectively protecting the public from drugs such as Merck's (MRK) Vioxx, an arthritic and acute pain medication. Two stand out immediately: Big Pharma may replace Big Tobacco as a lawyer's favorite target and the drugs industry is on the cusp of a significant change in the way it does business. If you're a Merck, GlaxoSmithKline (GSK), Roche (RHHBY) Pfizer (PFE) or AstraZeneca (AZN), there does seem to be a bad moon rising. Start with the lawyers. U.S. Big Pharma is protected somewhat because it is regulated by the FDA, something Altria's (MO) Philip Morris wants to see for tobacco, in part because regulation somewhat diminishes a lawyer's firepower. This could ultimately mean that large drug companies aren't penalized in the courtroom so much as in the market where investor sentiment could turn even darker in coming months and years. One can argue that Big Pharma is being responsible to the extent that when a drug is "proven" to be unsafe, the company withdraws it, as Merck did with Vioxx. The argument against Big Tobacco is that they supposedly knew ages ago that smoking was dangerous but kept this knowledge to themselves. However, to reasonably intelligent people, this cigarette danger should have been a no-brainer from the start and, in any case, warning labels have been around since the 1960s so the argument that cigarette makers have been devious is somewhat weak. Additionally, the little piece of paper that comes inside a box of pills to warn about side effects is legally effective. Even simple paracetemol products come with warnings about skin rashes, reactions associated with pregnancy, headaches, vomiting and like. However, what lawyers will go after is precisely when a pharma company knew that a particular drug might be unsafe. The problem here is all about FDA trials, the need for correct diagnostics and the fact that large drug companies still need to sell blockbuster drugs instead of niche medicines in order to make a decent profit. Unlike tobacco companies, pharma companies actively promote the safety and benefits of a new drug. The phrase "perpetrating a fraud against the public" might have more resonance when talking about drugs than about cigarettes. Astrazeneca's Crestor, Roche's Accutane, Pfizer's painkiller Bextra and GlaxoSmithKline's Serevent are four of the drugs that the FDA's Graham says could present serious potential risks and his list certainly hasn't been good for the share price of those companies. The bottom line is that this has all the makings of a classic racketeering trial which Big Tobacco is now dealing with. The key issue concerns fraud and whether a judge believes a company will continue to commit that fraudulent behavior in the future. A case like this looks stronger against drug companies, especially when you have issues such as companies actually paying drug regulators to "fast track" a drug. This practice should set off more than a few alarm bells. Whatever happens in the courts, changes are clearly in store for the industry and none of these appear to be great for Big Pharma valuations. Yes, the FDA itself may be changing from the inside, which could mean the length of a clinical trial will be reduced but based more on science and key diagnostic tests for specific people rather than on aggregate testing. But this more or less amounts to an admission that so-called blockbuster drugs just don't work because people's individual genetic make up aren't that uniform. In other words, different drugs for different people and that means the emergence of niche drug companies instead of the powerhouses we have now. The likes of AstraZeneca and GlaxoSmithKline probably won't survive in their current form as the industry starts thinking small is beautiful. (Brian Truscott, a financial reporter for 17 years, has covered equity and debt markets in Canada, Hong Kong, Singapore and London. He's been writing for Dow Jones Newswires since 1998. He can be reached at +44 207 842 9289 or by e-mail: brian.truscott@dowjones.com) (END) Dow Jones Newswires 11-19-04 0741ET