J&J Must Pay $130M For Botched Clinical Trials
3 CommentsBy Ed Silverman // November 29th, 2010 // 8:30 am
Five years after signing a licensing deal, Johnson & Johnson and Basilea appear to have finally gotten a divorce. An arbitration panel has ruled the health care giant must pay the Swiss drugmaker $130 million to resolve a botched and embarassing attempt to run clinical trials for an anti-MRSA antibiotic the smaller company has been developing.
Both the FDA and the European Medicines Agency declined to approve ceftobiprole after finding problems with J&J’s oversight. The FDA, for instance, wrote in an August 2009 warning letter, that J&J failed to properly monitor studies and ensure researchers were properly trained or experienced to conduct them, among other violations. Months earlier, the EMA took a similar position.
The moves prompted Basilea to file a claim against J&J, which had received an exclusive worldwide marketing license for the antibiotic. And now, the Nederlands Arbitration Institute has agreed that Basilea should be compensated for lost milestpone payments and damages as well. “This award in our favor has validated our grounds for arbitration,” Basilia ceo Anthony Man says in a statement.
industry insider
Heads will obviously roll at J&J, and not whichever CRO they used. Remember that the sponsor is ultimately accountable for the conduct of the study. I also feel that Basilea is guilty of negligence twice removed. First you contract with J&J to monitor the trial, then J&J contracts with the CRO to monitor the study. Everyone has that “call me when you have the data” attitude, and assumes that study conduct is fine. A study of this magnitude has to be comonitored with the CRO. Therefore additional blame goes to J&J for either not comonitoring or not doing a good job.
This warning letter is one of the worst that I’ve seen re. clinical trial conduct.
Ethical Monitor
What Monitoring? More likely the people who are at fault at the top will go unscathed but the overworked study monitors will get blamed for everything. Even get blamed for their bosses telling them to ignore observed fraud or regulatory non-compliance or get fired. I am sure monitoring reports were altered to eliminate unwanted observations made during monitoring visits.
The FDA collected data in 1999 to find out why the quality of clinical research monitoring is low. Unfortunately, they never analyzed the data. But the answer is obvious - it’s simply ludicrous that an industry be allowed to monitor itself. It is the “fox guarding the hen house” situation. Monitoring of active studies at investigational sites needs to be taken away from the study sponsors – otherwise it will never improve.
Monitoring has not been done for years. Instead our Big Pharma and CRO bosses expect us to focus on ensuring that sites are audit ready instead of ensuring the welfare of study subjects and the integrity of the data. Our bosses expect us to place “client” relationships above ensuring regulatory compliant research. Now, clinical trials are being used as marketing tools by the Regional Medical Scientists in the marketing divisions.
Monitors are evaluators. We should not be PR people or what has been coined “total site managers” because it causes conflicts of interest. We should not be selling studies or developing relationships with the investigational site staff that are promotional in nature. We get fired for reporting non-compliance to the FDA or with corporate auditors. The FDA rarely does anything and are very unresponsive to study monitors who try to report sponsors or sites who break the laws. CROs are even worse they only care about billable hours and “efficacy ratings”. Monitors are worked 14 hours a day, 7 days a week and travel 75% overnight. We have so many tasks and duties that monitoring has gone by the wayside. In addition to the travel that averages 5 flights a week, 3 hotels, and 3 rental cars, we do all of our own administrative tasks. This includes report writing, letter writing, tracking data in project management systems, making travel arrangements, filing expense reports, scheduling site visits, checking the FDA websites for sites that have warning letters, training site staff and helping them with their software problems, more and more data management duties, ensuring that all requlatory documents are processed and at the site, endless amounts of daily e-mail and online chat conversations, and constantly learning new software systems that change every week. All of these tasks need to been done within near to impossible timelines that force working every weekend. Some sponsors and CROs expect study monitors to be extensions of site staff (study coordinators) and do their work for them rather than evaluate the conduct of the trial. GSK, like most sponsors, has more than 56 software systems that study monitors are expected to use and update. The list is endless. Contract CRAs are not even paid for all of their actual travel and work for free while waiting endless hours in airports for delayed or cancelled flights.
The litany spewed in corporate SOPs and Good Clinical Practices about quality monitoring practices - forget about them. They are just window dressing for the FDA. Sponsors don’t even follow their own SOPs. Try to report regulatory non-compliance to your manager and just see how fast you get fired. We are treated like peons by everyone in-house including the administrative assistants. What is even worse is the aggressive, competitive, and hostile way that CRAs and study monitors treat one another. Study Monitor abuse is pervasive. When things go wrong then blame the study monitor.
Study Monitoring should be a respected occupation. Good Study Monitors know the medical aspects, understand the data, all of the regulations, and are experts at using a large variety of project management systems. Instead our bosses see us as an unwanted regulatory requirement for getting their products to market.
The only way study monitoring is going to improve is with changes in the Federal Regulations and more astringent definitions of what is required of quality study monitoring. The FDA’s guideline for Study Monitoring was created in 1988 and was last updated in 1998. The FDA needs to get active with enforcing quality monitoring while studies are being conducted beginning with the timely review of all monitoring reports. There needs to be a Safe Harbor program for Study Monitors and we need a Bill of Rights.
The FDA just complains about the lack of quality monitoring and they are correct it is very poor which results in the market approval of harmful products. Yet, the FDA has only themselves to blame. Big Pharma like J&J and CROs are not suddenly going to become altruistic or transparent and start putting adequate resources and time into ensuring quality monitoring. Plain and simple, study monitoring of active clinical research trials needs to be taken away from the sponsors and CROs because it is a conflict of interest. The FDA needs to be actively overseeing the conduct of active study trials at the investigational sites.
industry insider
Good points EM. With all due immodesty I will say that I was an excellent clinical monitor in the 1980’s, and so were my colleagues. It’s no secret why. This was before the era of Remote Data Entry, Electronic Case Report Forms, and Electronic CTMS-Clinical Trials Monitoring Systems. Note the key words “REMOTE” and “ELECTRONIC”.
In my day Before the study start the Medical Director MD would visit EACH prospective investigator and interview the investigator to his or own personal satisfaction that the PI was capable of doing the study. Company policy mandated ON-SITE monitoring no less often than every four weeks, more often if necessary, and that ALL queries on CRF had to be satisfactorily resolved before the monitor went home. The last thing we did was a REQUIRED site visit wrap up FACE-to-FACE meeting with the PI, 20-30 minutes long, during which the PI was appraised of all deficiencies requiring their attention. All of our monitoring reports IN LONGHAND had to be submitted within 24 hours of when the wheels of our plane hit the Tarmac. I am proud to say that in 10 years of site monitoring none of my sites ever came close to getting a Form 483.
With today’s electronic monitoring, remote data entry, and arm’s length working with CRO’S, monitoring today is a joke, and bears no relationship to the quality job that I and other monitors did in the 1980’s.