Clinical Trials in the News

On Tuesday, Eli Lilly announced that it would release the results of all clinical trials for which it is a sponsor in an online registry, whether or not the study met the desired outcome. This follows closely on the heels of NY's Attorney General Eliot Spitzer filing a lawsuit on June 2nd against GlaxoSmithKline for failing to disclose the results of its clinical trials for Paxil that showed negative results for use of the drug in adolescents and children. Lilly will begin posting the results for all trials that are completed after July 1, 2004, and for all drugs approved for market since 1994 (unfortunately, that obviously means that they're not going to tell us what happened to some of the other drugs that had been in the pipeline but didn't pass muster with or make it to the FDA).

Glaxo had also recently stated that it will release the results of all of its trials as well.

This development is great news, IMHO. BigPharma and the other drug companies should follow their lead. With the way the government has been cracking down on corporate governance and reporting, it's only a matter of time before they specifically target the drug companies and make them divulge this information anyway. Creating the industry standard beforehand would be a wise thing for the companies to work on.

The disclosure of this information is not destined to be the ruin of the drug companies. It seems that their current mindset is that if any negative information is released, it will undermine consumer and investor confidence. I don't think that is necessarily true and that an argument can be made that greater disclosure of data can lead to higher profitability (bear with me ... I'm sure an economist can make a more articulate argument - mine is based on hunch rather than numbers or economic theory). Sure - if you always only have negative results, then it's highly likely that your stock will soon be in the toilet and for certain that no consumer will ever ingest your product (but query, then, if you should be in your business in the first place).

But I think that, in an age where we're being hit daily with stories of this company or that person's fraudulent conduct, the public is searching for truthful information like a nomad seeks an oasis. They are looking for responsibility and for companies to show their capacity for the right thing, not just their greed. They want to know their medication is safe and effective and don't want to hear a couple years down the line "oops ... um, we had these other trials but we buried them and turns out they're correct. Sorry."

Investors can also gain greater confidence in what the company is developing and will be able to see what is really in the pipeline and where. There are (very generally) two classes of investors - those who are running the funds, have many information resources and spend most of their time studying the companies. Then there are the "average Joes" who only go by what's on the company website, other news stories they see and some "tip" they get from the guy in the coffee shop. Having all of the trial results on the website can give the average investor a small leg up and help her make an informed decision. It may lead to better valuations for the companies as well. And with that info made public, it would be difficult for many of the plaintiff shareholder suits (at least, those for fraud) to get past summary judgment. Companies should not fear negative results per se - they're part of science. As Thomas Edison once said, "I have not failed. I've just found 10,000 ways that won't work." In any case, I'm glad to see Glaxo and Lilly take the high road, restore consumer confidence, and try to educate the public about the drug development process and how an unexpected result isn't always the death knell of the drug or efforts to help cure a disease.

And in other clinical trial news, the New York Times today picked up on a growing trend in the pharmaceutical industry to conduct smaller, more intense trials before investing substantial resources in larger clinical trials. Not to worry - these are, of course, subject to all of the same regulations and oversight needed for larger-scale trials. The benefits can be tremendous - allowing drug companies to better focus their research and resources on more promising innovations now, continue to tweak and work on drugs and therapies that don't seem to quite be hitting the targets, and, to an extent, allow patients to feel more included in the processes of their treatment. As the article points out, there is often a bigger burden on the subjects in these trials than the larger ones, though, because so many more data are collected. With proper informed consent procedures so the subjects understand what is involved, though, I would bet dollars to donuts that they're less concerned about having another blood draw than they are about possibly finally finding the cure to their ailment.

Comments

[Kit]

Good site~ what I read so far...

If its main purpose is to assist the general public of "patients" who are the target of the
"bio-billionaires"-

I'm researching the researchers...... since it is obvious that research has become the #1 factor in their scramble to get through the FDA to get their latest drug or procedure on the market. Thing is - they forget, without (us) the patient as its target - they can't make a dime unless the ins companies ok it OR they fudge on the clinical trials.

Having fallen victim to an unconsented clinical trial (with a tragic result) I am thinking of designing a patient's beware/blogg or something of the like to address "Were you aware that you were part of a clinical trial and lived to tell about it??".

My aim is to make druggers (mfgrs.) aware that we are becoming far more educated in how they formulate their research programs at our expense and lives.

There are certainly worthy methods, drugs and services in this industry - but they travel in very mixed company. We need to rid ourselves of the research "parasites" who promise cures or diagnostic services via funding organizations, phony articles, studies and re-labled drugs which are just a few of the methods of unscrupulous researchers and druggers. (i.e. If it kills somebody labeled as XYZ - simply regroup go back to the FDA and rename it ABC)

This deceptive practice to get into our "genes" (pun intended) is no worse than reloading a different gun to aim at us with the same research bullets.

Thanks for a chance to express my initial views on this site.

Comments welcome.

Kit