Lilly finds out how cold it can be in Alaska
Mar/08/2008 07:20 Filed in: In The News
In legal
terms the key issue of the Zyprexa trial is as
follows: did Lilly withhold data that indicated that
patients who took Zyprexa might gain weight and get
diabetes because they wanted to protect sales of
Zyprexa. Lilly states that they worked with the FDA
as data became available but did nothing to warn
physicians and patients. According to today's Times;
That is pretty damaging testimony from a specialist in diabetes and who was a medical reviewer for the FDA for 20 years. As someone who worked at Lilly I know that decisions that are made are done with the consensus of a lot of people as it is with all matrix organizations. The issue thus becomes: was the decision to withhold the data done because the data did not tell the whole story or because they truly wanted to protect the sales of Zyprexa. It's interesting to note that most of the people who were managers on the Zyprexa team are long gone, either they were fired or they left on their own but how high within the organization did the decision making go? Who agreed that they should withhold data ? Should they have at least given patients and physicians the benefit of the doubt and warned them about the "potential" for weight gain and diabetes?
On the other side of the courtroom we have an overzealous lawyer for the state of Alaska who was scolded by a judge for leaking information to the Times and who has refused settlement offers that could have benefitted the state and patients. He is a key reason why most of us despise the legal profession and the Times also needs to take a look at why they highlighting this case so much while most of the media gives it nothing more then a footnote in the back pages if at all.
One thing is for certain. If a drug company comes across that COULD effect patients health they need to be transparent about it. No longer can they say that they are "analyzing" the data to determine the correct actions, they have to give patients the benefit of the doubt and warn them. From what I have read it will be a miracle if Lilly is found not liable in this case. There is just too many paper trails for them to explain to the jury that they had the data and were working with the FDA to determine the appropriate response while patients health may have been compromised.
There is another aspect of this case that needs deeper probing. Why did the people at Lilly make the decision to withhold the data? What was their motivation? To protect sales and make themselves look good? Values within any company start at the highest level and are shared with all in the organization but it seems here that some people did not share those values or that in working with the FDA they thought they had "done what we needed to do" and were able to walk away with a clear conscience. It's clear however that senior management needs to reemphasize the values of any company that markets products for patients health. They need to be more transparent with data and spend so much time "analyzing" the results while patients health may be at risk.
Lilly hid Zyprexa’s risks from doctors to protect the drug’s sales, according to the witness, Dr. John Gueriguian. Lilly waited until 2007 to add strong warnings to Zyprexa’s label to reflect the drug’s tendency to cause severe weight gain and blood sugar changes. Lilly put “profit over concern of the consumer,” Dr. Gueriguian said Friday near the end of four hours of testimony.
That is pretty damaging testimony from a specialist in diabetes and who was a medical reviewer for the FDA for 20 years. As someone who worked at Lilly I know that decisions that are made are done with the consensus of a lot of people as it is with all matrix organizations. The issue thus becomes: was the decision to withhold the data done because the data did not tell the whole story or because they truly wanted to protect the sales of Zyprexa. It's interesting to note that most of the people who were managers on the Zyprexa team are long gone, either they were fired or they left on their own but how high within the organization did the decision making go? Who agreed that they should withhold data ? Should they have at least given patients and physicians the benefit of the doubt and warned them about the "potential" for weight gain and diabetes?
On the other side of the courtroom we have an overzealous lawyer for the state of Alaska who was scolded by a judge for leaking information to the Times and who has refused settlement offers that could have benefitted the state and patients. He is a key reason why most of us despise the legal profession and the Times also needs to take a look at why they highlighting this case so much while most of the media gives it nothing more then a footnote in the back pages if at all.
One thing is for certain. If a drug company comes across that COULD effect patients health they need to be transparent about it. No longer can they say that they are "analyzing" the data to determine the correct actions, they have to give patients the benefit of the doubt and warn them. From what I have read it will be a miracle if Lilly is found not liable in this case. There is just too many paper trails for them to explain to the jury that they had the data and were working with the FDA to determine the appropriate response while patients health may have been compromised.
There is another aspect of this case that needs deeper probing. Why did the people at Lilly make the decision to withhold the data? What was their motivation? To protect sales and make themselves look good? Values within any company start at the highest level and are shared with all in the organization but it seems here that some people did not share those values or that in working with the FDA they thought they had "done what we needed to do" and were able to walk away with a clear conscience. It's clear however that senior management needs to reemphasize the values of any company that markets products for patients health. They need to be more transparent with data and spend so much time "analyzing" the results while patients health may be at risk.
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