Friday, January 4, 2008

An Intel Approach to Meds.

I came across this Newsweek article a little while ago and I thought I would share it with you along with my thoughts:

According to the article, former Intel CEO Andrew Grove commented that the pharmaceutical industry could learn a lot from the semiconductor industry. Please read the article for details.

While I agree with the spirit of some of what Mr. Grove is saying, I believe that the comparison between the medical device and pharmaceutical industries with the semiconductor industry is flawed and a bit unfair.

Besides, of course, the moral and ethical responsibility to ensure as best as possible that a medical product will not maim or kill the patient, the largest hurdle to getting a product onto the market is the lengthy and costly government approval process it has to undergo to be approved for legal human use.

Just a little background - in the United States, the approval process is regulated by the Food and Drug Administration (FDA). The FDA drug approval process is summarized here and the FDA medical device approval process is described here.

If all this sounds to you like huge amounts of work, it is. But remember that it is this way for good reason - to protect patients' health and public safety.

Even with the regulatory process as it is, things slip through, medical products are recalled and people still die. Remember the cox-2 inhibitor drugs like Celebrex and Vioxx that were recalled because some of the people who took this drug for arthritis were dying from myocardial infarction and stroke.

In the medical world, you don't get a second chance. If a product has hurt or killed someone, it is very hard to regain the trust of doctors to give it another go, even if it has been vastly improved by the developing company.

In some cases, the faulty device doesn't even have to come from your own company. One company I worked for was developing a staple for heart bypass surgery that had some great pre-clinical data. A smaller company that got to clinical trials faster ended up with dead patients, which put surgeons off of the entire class of device. Talk about poisoning the well.

Also, remember that large corporations stand to lose a lot due to product liability lawsuits if their product results in unexpected damage or death. So companies tend to be very thorough with their testing and approval submissions. And they tend to be very, very slow and conservative in nature.

I believe it also makes them inclined to bet on the "safe projects" that provide the best predicted return-on-investment rather than on products that potentially are the most efficacious, or the ones that might have the most impact on global health.

I'm not trying to defend these companies or justify the decisions they make. But I think it is important to understand the preconditions that might help to explain why the companies behave as they do. Things are always more complex than they at first seem.

I agree that things do happen too slowly, especially for those whose hopes for health and survival depend on breakthroughs that these companies promise to deliver.

Academia at times does seem too focused on obscure academic things, and corporations seem too focused on risk reduction and maximizing the bottom line. In the mean time, the public at large seems to be losing out. Big time.

So what do we do? Anyone have any thoughts?

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