Resistant Strain Indeed: Research Chief Stirs Up Merck

The Wall Street Journal article "Resistant Strain: Research Chief Stirs Up Merck By Seeking Aid From Outsiders", Jun 7, 2006 (at WSJ by subscription only), or here without subscription at Post-gazette.com, only amplifies my concerns about why the pharma industry is in trouble.

Relevant excerpts:

For decades, Merck & Co.'s research laboratories pioneered many of the world's best-selling drugs, ranging from lifesaving vaccines to treatments for blood pressure, high cholesterol and AIDS. The company's scientists considered themselves the best in the industry -- a pride that often came across as arrogance.

These days, Merck's scientists swallow their pride under research chief Peter Kim, who spent most of his career in academia. Dr. Kim took over amid a string of drug-development failures at Merck and has made it clear he thinks the company's own labs aren't sufficient to replenish its pipeline. He says Merck needs to turn to other companies, both for new drugs and new means of discovering them.

"Merck has outstanding science and scientists -- and it did when I came," says Dr. Kim. But, "in some areas, I knew that there were some scientists on the outside who were better."

The grass is always greener across the street, and those from afar are always experts. This philosophy is common in industry, especially regarding huge, expensive consultant engagements. What's lacking is faith in, and development of, one's own assets. Perhaps there are better scientists than what Merck hires internally - whose fault might that be? - but how can this really be judged objectively when you, for example, tie your own people's hands behind their backs via rationing of modern cheminformatics tools?

Dr. Kim has hired other outsiders for top posts. Staffers have undergone training to improve their interpersonal skills when dealing with outside scientists. Some have reacted with anger to the initiatives and jumped ship.

Taking with them countless years of scientific expertise and corporate knowledge, no doubt. Why is this frequently viewed as good for a company?

The 48-year-old Dr. Kim, who holds a Ph.D. in biochemistry from Stanford University, came to Merck with a top academic reputation but without experience in commercial drug development.

I have commented on the issue of biomedicine and relevant expertise here and here. In fact, other officers at this company lack any clinical and biomedical credentials, such as the CIO who in fact came from a paper manufacturer, as well as the former head of R&D computing who now works for a computer gaming company. This is a common problem in healthcare.

Dr. Kim says he was drawn to Merck by its "aura of excellence." But he says he quickly realized that Merck's research culture had become too insular. "A quote I heard a lot was: 'Well, that's not how we do things at Merck,' " he recalls. "My answer would be: 'OK, but that doesn't necessarily make it the best way to do things.' "

Nor does it automatically make it wrong. Perhaps fine tuning is needed, not throwing out the baby with the bathwater.

Back home, some Merck scientists became resentful that Dr. Kim, who had never himself developed a drug, was telling them how to go about their business.

Soon after he arrived, he angered Emilio Emini, Merck's senior vice president of vaccine research. During his 20 years at the company, Dr. Emini had done some seminal AIDS work. Dr. Kim wanted to hire another accomplished but controversial AIDS researcher, David Ho, to oversee him. Dr. Emini strongly objected, and Dr. Ho ended up not coming to Merck. But the episode strained the relationship between Dr. Kim and Dr. Emini, according to people familiar with the matter. Dr. Emini left Merck in early 2004. He now works for rival Wyeth. He declined to comment.

Losing talent of Emini's stature is no small negative accomplishment. One angers such a person at their own peril.

Dr. Kim hired other academic scientists who enjoyed good reputations but, like him, had never developed a drug. Among them was Stephen Friend, a cancer researcher who knew Dr. Kim from Whitehead ... Merck researchers were also inefficient, Dr. Friend says. They spent hours checking and rechecking their work for minor errors, he says. One of Dr. Friend's early moves was to scrap a version of the human-genome map Merck had needlessly developed in-house and use the more up-to-date publicly available version.

Here is why I won't be investing in pharma where these "process-driven" reforms are often led by people without real drug-development or clinical experience. Short of the fact that I am skeptical about bioinformaticist's beliefs that they alone will "revolutionize medicine" in a test tube (or in silico), this passage about the "inefficiency of checking and rechecking work" is stunning:

Recently published in the NYT was "Merck admits a data error on VIOXX":

In an admission that could undermine one of its core defenses in Vioxx-related lawsuits, Merck said yesterday that it had erred when it reported in early 2005 that a crucial statistical test showed that Vioxx caused heart problems only after 18 months of continuous use.That statistical analysis test does not support Merck's 18-month theory about Vioxx, the company acknowledged yesterday. (My comments about this with reference to medical informatics are here).

This "error" will likely be very costly in the courtroom. "Checking and rechecking work repeatedly" for errors in high-risk pharma R&D isn't exactly unhelpful behavior in my mind. I cannot envision how an infusion of people who think it is will benefit the industry. The statement that doing so is "inefficient" is a bon mot the public certainly won't like to hear.

Also, regarding the "publically-available" genome map vs. the in-house one generated before the internal bioinformatics department was dissolved (and the area taken over by Friend) as part of the mass layoffs in Nov. 2003, how exactly was comparative quality measured?

I have my concerns about any jump to "free" information in such a complex field vs. information established with internal controls, especially in a field as new and tenuous as bioinformatics ("Friend's company Rosetta has yet to produce a drug that is close to making it to market", the WSJ points out).

"This is a high-risk business and you have to place your bets," Dr. Kim says. "Sometimes you're going to lose."

It helps to play the game as best as one can...

Industry attitudes such as the above are not limited to any one company. I've seen them elsewhere, and worse. Combined with the conflicts of interest, corruption, etc. as pointed out by many other postings on Healthcare Renewal, I am not sanguine about the long term prospects for the pharmaceutical industry in its current form, especially where leadership philosophies are concerned.

-- SS