Drug Companies appear to have too much influence over the regulatory governmental agencies that are supposed to determine whether a drug is effective and safe.
Federal Regulators with the Food and Drug Administration (the “FDA”) admitted that they should not have “uninvited” a leading cardiologist to a panel that was going to decide whether to approve a cardiovascular anticlotting drug (prasugrel hydrochloride) made by Eli Lilly & Co. As was reported in the Wall Street Journal this week, Dr. Sanjay Kaul is a well known cardiologist that had been critical of Eli Lilly’s drug prasugrel and Dr. Kaul had even written several articles critical of the new drug. Dr. Kaul was scheduled to participate in the FDA committee meeting that was assigned with the task of reviewing the drug and deciding whether to grant FDA approval to Eli Lilly & Co. to manufacture and sell the drug. Prasugrel, according the Wall Street Journal article (“FDA Says it Erred on Doctor“, Favole, J., February 24, 2009), has been linked to dangerous internal bleeding.
The all day meeting of the Cardiovascular and Renal Drugs Advisory Committee was scheduled for February 3, 2009 in Maryland. In the days prior to the scheduled meeting Eli Lilly contacted certain FDA managers and questioned the decision to have Dr. Kaul’s included on the panel because of his published articles critical of the new drug. Apparently, following the calls from the drug manufacturer, FDA managers told Dr. Kaul to not take his flight from Los Angeles to Maryland; he was essentially told he was not welcome at the meeting.
FDA managers are supposed to screen potential advisory panel members for financial conflicts of interest – having received money or other compensation from a company being reviewed – or for intellectual bias – if a person has already made a decision prior to hearing the evidence presented. Although Dr. Kaul was screened for financial conflict of interest, and he had none, apparently there was no other screening done upon which to base a decision to exclude him. The only basis for excluding Dr. Kaul appears to be the phone calls from the Eli Lilly & Co. representatives. With Dr. Kaul removed, the panel unanimously voted to recommend approval.
The Director of the FDA Drug Division, Dr. Janet Woodcock, has been quoted as saying, “At every step of the way there were errors by multiple parties. Dr. Woodcock was apparently never informed, nor were other higher level FDA officials about the phone call from the drug manufacturer or the decision to uninvite Dr. Kaul from the panel. John Jenkins, the Director of the FDA Office of New Drugs stated, “I think he [Dr. Kaul] would have been a very valuable member [of the panel].”
The drug is not on the market yet, and the final decision to approve or not approve is still pending.
The exclusion of Dr. Kaul from the committee meeting, alone, does not mean that the drug is unsafe or is not effective for its indication. However, our system of FDA review only works if sound science presented by competent researchers is allowed to be presented at committee meetings – even if it is counter to the drug company’s financial interest. In order for patients to be protected, the FDA must allow for an open and robust dialogue and cannot allow pressure from drug manufacturers to sway or interfere with the application and review process. Drugs that have undergone the approval process can still harm patients or even be fatal; and the patient or their family suffer a further injustice if the approval process was affected by the very company selling the drug.
