At the University of Connecticut Health Center, it has been our policy to
insist that sponsors of investigational drug/device trials agree to
reimburse subjects for medical care costs associated with injuries sustained
as a result of participating in the clinical trial.  In most cases, the
sponsors agree to cover all costs which the subject's medical insurance will
not cover.

According to the Reuters article shown below, the insurance industry may be
increasing the cost of providing such indemnification to clinical trial
sponsors, and the result could be that arranging for such coverage in
clinical trial agreements will be more difficult in the future.

I am trying to collect information on this issue in preparation for an
evaluation of our policy, and would very much like to hear from other
institutions as to their policies on this matter.

Leonard P. Paplauskas
Associate Vice President for Research Administration
University of Connecticut Health Center
ASB-3, MC5355
Farmington, CT   06030-5355
xxxxxx@adp.uchc.edu (external e-mail)
xxxxxx@exchange.uchc.edu (internal e-mail)
860-679-3173 (phone)
860-679-2670 (fax)

*****************************

Insurance Companies Get Stricter on Clinical Trials
By Kate Fodor

SAN DIEGO (Reuters Health) - In preparation for what the insurance
industry believes will be a marked increase in the number of lawsuits
filed by subjects in drug and device trials over the next few years,
underwriters are tightening up their requirements for companies seeking
coverage of clinical trials, Chubb Insurance Life Sciences Casualty
Manager Jill Wadlund said during an interview with Reuters Health.

While litigation is not uncommon after a drug is approved, lawsuits
involving clinical trials appear to be increasing, said Wadlund, who is
slated to speak at the Biotechnology Industry Organization convention
here on Tuesday.

``Litigation in the clinical trial area is definitely already on the
upswing,'' and, for a number of reasons, Chubb believes the trend is
likely to continue.

``For a very long time, there wasn't much litigation...but there are
many more trials going on and the trials have gotten more complex,''
Wadlund explained. Simply put, more trials mean more opportunities for
lawsuits.

Several high-profile suits--including the one filed by the family of
Jesse Gelsinger, who died in 1999 in a gene therapy trial at the
University of Pennsylvania--have recently alerted trial participants and
plaintiffs' attorneys to the potential for litigation, Wadlund noted.

``In the past, plaintiffs' attorneys didn't see a huge opportunity
there,'' she said. ``Now, with all the media attention, they pay more
attention to it...Some plaintiffs' attorneys have actually set up
litigation units for clinical trials; that's how seriously they're
taking it. And they will look where they may not have bothered to look
before.

``Some new things that are coming up include what they are calling
dignity harm,'' or a violation of human dignity as established by the
Nuremberg Code and the Declaration of Helsinki, she said. Companies are
also vulnerable to complaints from subjects who lose access to therapies
they believe have been successful. ``When a study ends, maybe the
company has established provisions for compassionate use and maybe they
haven't--and you'll get lawsuits for not providing access to the drug,''
Wadlund said.

``You'll also get lawsuits where subjects didn't know they could be
expelled from a study. The investigators might really think a patient
needs to exit the program for his own safety, but the patient doesn't
see it that way.''

In addition, recruitment techniques are under increased scrutiny, and
companies must be careful not to leave themselves open to charges that
they provided ``too much temptation'' to enrollees, either through
monetary incentives or overblown promises about a therapy's efficacy.

In general, given the new legal climate, companies and individuals need
to be willing to rethink their established methods, she added. ``We're
looking for willingness to be open to the idea that maybe you could do
some things to tighten up your practices...If not, we're either going to
decide to cover you at a much higher price and on much more restrictive
terms or not to offer you coverage at all.''

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