UK drug regulator destroys all the evidence after 15 years
It took us 3.5 years to get access to the clinical study reports and
trial protocols of the placebo-controlled clinical trials of two anti-
obesity drugs at the European Medicines Agency (EMA) (1), but our
breakthrough created an important precedent. Subsequently, it took only
3.5 months before we received similar documents for an antidepressant
drug, duloxetine. We had applied for access to eight antidepressant drugs,
but the EMA advised us to contact the relevant national drug agencies for
the other drugs, as these had not been approved centrally.
For one of the drugs, fluoxetine, the United Kingdom acts as
Reference Member State according to the Mutual Recognition Procedure in
the EU, and we therefore wrote to the UK Medicines and Healthcare products
Regulatory Agency (MHRA). The MHRA informed us on 25 May 2011 that it no
longer holds the requested reports:
"Under MHRA record management policy, all application files and data
for licences are held for 15 years. After this period, files are destroyed
unless there is a legal, regulatory, or business need to keep them, or
unless they are considered to be of lasting historic interest." (The MHRA
does hold some study reports on fluoxetine, however, submitted later "for
a variation to the Marketing Authorisation.")
The European Commission held a public hearing on scientific
information in Luxembourg on 30 May. I informed the attendants that the
MHRA destroys the clinical evidence about the benefits and harms of the
products it approves after 15 years, and I also informed a member of the
European Parliament about it. In both cases, the reaction was shock and
disbelief.
How can a drug regulator be allowed to destroy all the evidence? In
particular when it is the Reference Member State for that drug in the EU?
From where would we then get the evidence?
Court cases in the United States that have provided access to
internal company archives have revealed serious scientific misconduct in
placebo-controlled industry-sponsored trials of antidepressant drugs,
including those of fluoxetine. This misconduct includes recoding of
suicidal events on the antidepressant drug as "emotional lability,"
"hospital admission," "lack of effect," or "drop-out," and adding suicides
to the placebo group, although they had not occurred while the patients
were randomised to placebo (2,3).
The new openness at the EMA is unique. As far as I know, it has not
been possible to get access to unredacted clinical study reports and
protocols at any other drug agency allowing independent evaluation of the
adverse events at the patient level. Drug companies do not grant
researchers access either. The action of the MHRA may therefore mean that
it is impossible for independent researchers to correct the seriously
flawed publication record on fluoxetine, which, ironically, is the only
drug approved for use in childhood depression, despite the fact that we
already know that SSRIs as a drug class increase the risk of suicide in
children and adolescents (2,3).
As citizens in the EU, we should not accept this state of affairs. I
will therefore send this letter to the Department of Health in the UK and
to the EMA, requesting a response as to how we can obtain the data the
MHRA has destroyed. The UK government should introduce legislation that
will prevent the MHRA in future from destroying the evidence in its
possession. Applications for marketing authorisation should, in the first
place, be submitted electronically, e.g. as searchable pdf-files, and if
this is not the case for older drugs, it is fairly easy to scan the
documents. Lack of space is therefore no excuse for destroying the
evidence.
References
1. G?tzsche PC, J?rgensen AW. Opening up data at the European
Medicines Agency. BMJ 2011;342:d2686.
2. Healy D. Did regulators fail over selective serotonin reuptake
inhibitors? BMJ 2006;333:92-5.
3. Healy D. Let them eat Prozac. New York: New York University Press,
2004.
Rapid Response:
UK drug regulator destroys all the evidence after 15 years
It took us 3.5 years to get access to the clinical study reports and
trial protocols of the placebo-controlled clinical trials of two anti-
obesity drugs at the European Medicines Agency (EMA) (1), but our
breakthrough created an important precedent. Subsequently, it took only
3.5 months before we received similar documents for an antidepressant
drug, duloxetine. We had applied for access to eight antidepressant drugs,
but the EMA advised us to contact the relevant national drug agencies for
the other drugs, as these had not been approved centrally.
For one of the drugs, fluoxetine, the United Kingdom acts as
Reference Member State according to the Mutual Recognition Procedure in
the EU, and we therefore wrote to the UK Medicines and Healthcare products
Regulatory Agency (MHRA). The MHRA informed us on 25 May 2011 that it no
longer holds the requested reports:
"Under MHRA record management policy, all application files and data
for licences are held for 15 years. After this period, files are destroyed
unless there is a legal, regulatory, or business need to keep them, or
unless they are considered to be of lasting historic interest." (The MHRA
does hold some study reports on fluoxetine, however, submitted later "for
a variation to the Marketing Authorisation.")
The European Commission held a public hearing on scientific
information in Luxembourg on 30 May. I informed the attendants that the
MHRA destroys the clinical evidence about the benefits and harms of the
products it approves after 15 years, and I also informed a member of the
European Parliament about it. In both cases, the reaction was shock and
disbelief.
How can a drug regulator be allowed to destroy all the evidence? In
particular when it is the Reference Member State for that drug in the EU?
From where would we then get the evidence?
Court cases in the United States that have provided access to
internal company archives have revealed serious scientific misconduct in
placebo-controlled industry-sponsored trials of antidepressant drugs,
including those of fluoxetine. This misconduct includes recoding of
suicidal events on the antidepressant drug as "emotional lability,"
"hospital admission," "lack of effect," or "drop-out," and adding suicides
to the placebo group, although they had not occurred while the patients
were randomised to placebo (2,3).
The new openness at the EMA is unique. As far as I know, it has not
been possible to get access to unredacted clinical study reports and
protocols at any other drug agency allowing independent evaluation of the
adverse events at the patient level. Drug companies do not grant
researchers access either. The action of the MHRA may therefore mean that
it is impossible for independent researchers to correct the seriously
flawed publication record on fluoxetine, which, ironically, is the only
drug approved for use in childhood depression, despite the fact that we
already know that SSRIs as a drug class increase the risk of suicide in
children and adolescents (2,3).
As citizens in the EU, we should not accept this state of affairs. I
will therefore send this letter to the Department of Health in the UK and
to the EMA, requesting a response as to how we can obtain the data the
MHRA has destroyed. The UK government should introduce legislation that
will prevent the MHRA in future from destroying the evidence in its
possession. Applications for marketing authorisation should, in the first
place, be submitted electronically, e.g. as searchable pdf-files, and if
this is not the case for older drugs, it is fairly easy to scan the
documents. Lack of space is therefore no excuse for destroying the
evidence.
References
1. G?tzsche PC, J?rgensen AW. Opening up data at the European
Medicines Agency. BMJ 2011;342:d2686.
2. Healy D. Did regulators fail over selective serotonin reuptake
inhibitors? BMJ 2006;333:92-5.
3. Healy D. Let them eat Prozac. New York: New York University Press,
2004.
Competing interests: No competing interests