UK House of Commons Hammers GlaxoKline

April 5, 2004

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Seroxat

Motion made, and Question proposed, That this House do now adjourn.

—[Ms Bridget Prentice.]

9.11 pm

Flynn (Newport, West) (Lab): The Seroxat scandal is one of gigantic

proportions, which affects millions of people. There has been

over-prescribing and misprescribing of this antidepressant on a scale

equalled only by the over-prescription of tranquilisers 40 years ago. It is

likely that the legacy—

[interruption.]

Madam Deputy Speaker (Sylvia Heal): Order. Will Members please leave the

Chamber as quickly and quietly as possible?

Flynn: Thank you, Madam Deputy Speaker.

It is likely that the legacy of the misery created by what has happened with

antidepressants will be at least as severe as what happened with

tranquilisers.

The pharmaceutical industry has achieved miracles in disease control and

elimination in the past century. It is not my intention to attack the

science of that industry, but it is my intention to attack the spin, the

marketing and the propaganda, all aimed at maximising profits, and the

ineffective regulatory control that has failed to protect the public.

GlaxoKline, the manufacturer of Seroxat, has been exposed as

duplicitous, profit-driven and irresponsible over the 14 years that the drug

has been available. It prizes its profits above the health of its customers.

Where there should have been scientific objectivity there has been voodoo

medicine; patients who have sought care have had their trust abused. Seroxat

has turned mild stress in to suicidal despair, and in many cases a passing

anxiety has become a lifelong addiction, leading to self-harm, suicide and

even murder. Those who have long questioned the safety and efficacy of

Seroxat were ridiculed and undermined by the pharmaceutical giant

GlaxoKline.

That company is the villain in those tragedies, but happily there are

heroes—those who fought to expose the truth about the dangers, addictiveness

and ineffectiveness of Seroxat. The heroes include Dr. Healy,

professor of psychiatry at the university of Wales, Bangor, the " Panorama "

programme, which produced two splendid accounts about the effects of the

drug, Boseley of the The Guardian, the charity Mind, one of the few

charities that takes no money from the pharmaceutical industry—a significant

point in this case—The Citizen, a local Gloucester newspaper which is to be

congratulated on conducting a campaign with national results, and my hon.

Friends the Members for Gloucester (Mr. Dhanda), for Dundee, East (Mr. Luke)

and for Edinburgh, North and Leith (Mr. Lazarowicz) who have also been

involved.

Seroxat is a selective serotonin reuptake inhibitor. The drug appeared only

in the 1990s and took over from the tricyclic antidepressants that had been

available since the 1940s. I believe that need for the drug is based on a

great myth: the idea that we can go through our entire life in a state of

continuous euphoria and that if we suffer a moment of discomfort, pain,

boredom, grief or anxiety we should be classified as ill and in need of

medicine. If any of our loved ones feel similar unhappiness, we are supposed

to feel guilty unless we provide them with a pill. If we are sadder today

than we were yesterday, there must be something wrong with us. Humankind has

progressed through many millennia without using antidepressants, yet the

myth has been perpetrated and we are conditioned to believe it.

I wrote to GlaxoKline more than a week ago to tell the company what I

planned to say in the debate and asked for its comments. It has not had the

courtesy to reply although I have received a number of letters from it over

the last four years. The company has expressed the view that antidepressants

should be taken by half the female population of the United Kingdom and a

third of the male population; it wants to see 25 million people on

antidepressant drugs. That is certainly not the number of people who suffer

from the type of depression that needs medical intervention—serious,

pathological, clinical depression. I do not want to minimise the effects of

that dangerous illness, which can lead to self-loathing or self-destruction

and certainly requires the attention of the medical profession.

We have been conditioned to believe that we need those drugs, but there are

far better alternatives. For example, counselling does not involve chemical

drugs; it is over-prescribed at present, but if people are looking for a way

out of the hell of clinical depression, they would be well advised to study

the work of Dr. Dorothy Rowe, who has written a splendid book about clinical

depression, " Depression: the Way Out of Your Prison " . She gives vivid

descriptions of people's reaction to deep depression—their feelings of

hopelessness, of being locked inside a room and that no one can help them.

She offers practical ways of dealing with depression through self-knowledge,

meditation and exercise, which is very much in line with current Government

thinking. Having spent the better part of my life ignoring exercise, I am a

late convert to its joys. After discovering the great pleasure of

endorphin-releasing exercise, I can go along with what is said about it.

The effect of Seroxat is not to free people from the prison of depression,

but to create a new prison wall around them; that wall is all-encompassing

and often encloses them in a prison of addiction. At the heart of the debate

is ensuring that the Government do two things: the benefits of new medical

discoveries should be enjoyed by all who need them, but the public should be

guarded against the serious side-effects that such drugs can often cause.

We do not want to return to the terrible scandals of the past such as

tranquillisers, thalidomide, Eraldin, Opren and others that have resulted in

wasted lives. The charge against GlaxoKline could not be graver: it has

deliberately suppressed information on the danger of Seroxat and its lack of

utility.

Two years ago, GlaxoKline wrote me a letter that contains very little

that is truthful apart from the date. We know that its spokesmen made

preposterous claims on " Panorama " , and the letter states:

" The safety and efficacy profiles of Seroxat has been confirmed through

clinical trials involving thousands of individuals and the experience of

tens of millions of patients over the 10 years the medicine has been

available. "

The letter does not mention the number of reports that GlaxoKline has

disregarded, ignored or, as happened recently, actually suppressed.

The issue is not new, but we learned about the worst case very recently.

Studies have been conducted that prove that Seroxat is no more effective

than a placebo, and that in many cases it is less effective. Such claims

have been around for a long time, but in spite of that Seroxat was

increasingly prescribed, and it overtook Prozac as the No. 1 antidepressant

in the UK, with four million prescriptions a year at one time, and now that

figure has greatly increased.

It is difficult to get precise figures about how many prescriptions are

issued and how many people are on Seroxat, but, as with many things, we are

following the United States line. We know that there are three million

children on antidepressants in Canada and that there are 10 million children

on antidepressants in the United States. Dr. Healy says

" There is probably no area of medicine in which the academic literature is

so at odds with raw data. "

After many denials, a particular report, headed " Confidential. For internal

use only " , has been revealed. It was prepared not a couple of weeks ago,

although that is when it was published, but in October 1998. It refers to

studies conducted in 1993 and 1996 of children and adolescents who were

given courses of either Seroxat or a placebo. In one trial, there was no

beneficial difference in the outcome between the placebo and Seroxat; in the

other, the placebo produced superior results, which was not unexpected. The

studies demonstrated that there is no beneficial effect in treating

adolescents with Seroxat.

One difference was noticed in children: suicidal behaviour was 1.5 to 3.2

times higher on Seroxat than on a placebo. It was not until 2003 that the

body responsible for regulating medicine, the Medicines and Healthcare

products Regulatory Agency, issued guidance to doctors that Seroxat should

not be prescribed to people under 18.

However, a parliamentary answer that I have received in the last half an

hour says that the Government do not intend to change the rules on

prescribing unlicensed drugs to children. The Government seem to say that,

if a drug works for adults, it should work for children. If so, it must also

be true that, if there are increased suicidal tendencies among children,

there is a similar effect on adults. Dr. Healy reports that

GlaxoKline had evidence that approximately one in every 60 adults on

Seroxat made a suicide attempt, while the figure for those on the placebo

was one in 550 adults. That is an extraordinary difference.

Healy gave evidence to the regulatory body, when it investigated

Seroxat last year, and there is a rather bizarre story to tell about what

happened. About nine months before, Dr. Healy had applied for a meeting with

the regulatory body. When the meeting eventually took place, he was

surprised that no one questioned the evidence that he gave to the regulatory

body, although he was a long-time critic. Although some agreed minutes were

supposed to be prepared, they were never sent out because many of the

members of that committee had financial and other interests in

GlaxoKline and in other selective serotonin reuptake inhibitors. That

is a deplorable situation.

I am sure that the Minister will say—it was said at the time—that the body

is beyond suspicion and that those professional people will act in a

disinterested way and reach conclusions. That may be so, but it is unlikely

that the public will trust such a body, when so many of those who judge the

safety of medicines have dual interests of that kind, as well as an

alternative duty as a regulatory body to ensure the success of the British

pharmaceutical industry. If we are to have full trust in our regulations on

such matters, we need a body that has only one commitment: the safety of the

public and those who take the drugs.

GlaxoKline has repeatedly failed to respond to patient reports of

withdrawal difficulties and refused to publish reports that demonstrated

that 85 per cent. of healthy volunteers in a controlled experiment suffered

from agitation, abnormal dreams and insomnia, and there was one suicide. Let

me make it clear what that shows: 85 per cent. of that control group of

healthy people were not suffering from depression, even mild depression, but

they experienced those problems. Time and again, we hear evidence of people

whose behaviour is modified tragically by Seroxat.

Last year, the Brecon coroner, Geraint , wrote to the Secretary of

State for Health to ask for an inquiry into the drug after one such case.

The family wished people to know about that case because they hoped that

some good might come from the tragedy that had engulfed them. The case

involved a retired head teacher, Colin Whitfield, who took his life after he

was prescribed Seroxat. His wife said in court that that was totally out of

character and that she believed that his mind had been affected by the drug.

The coroner said that he was profoundly disturbed by the effect that Seroxat

had had on Mr. Whitfield, and he accepted expert opinion that Seroxat could

induce agitation and lead to people having suicidal thoughts.

Sadly, there are many cases of that kind. The Tobin case in America has

become very well known. Again, the behaviour of a man who had taken just a

few tablets changed in a way that his family said was completely

uncharacteristic of him. He killed the three women in his life—the three

people whom he loved the most—a wife, a mother and a granddaughter. He then

killed himself. That was reported in the first " Panorama " programme on the

subject.

Another case, which emerged in the second programme, involved someone in

this country who suffered a similar character change after taking a few

tablets of Seroxat. He tried to take the lives of his wife and daughter, and

he then tried to take his own life.

It is difficult to see these cases as coincidental, because they are so

similar. However, we must examine them and ask ourselves why such terrible

tragedies have taken place. The clinical evidence suggests that the drug

must take the blame.

The defence put up by GlaxoKline is that the people involved are

depressed anyway and that there is a chance that their taking the drug may

lead them to self-harm. When GlaxoKline examines the results of the

trials, it gives the credit for beneficial results to the use of Seroxat.

However, when there is a bad result, that is blamed on the depression

suffered by those involved. The company cannot have it both ways.

Other side effects have been reported by the volunteers who took part in one

of the trials. They reported difficulty in withdrawing from the drug and one

peculiar effect of this drug and no other was electric " zaps " . They reported

difficulty in walking, co-ordination problems, aggression, confusion, memory

difficulties and lethargy. Yet the published account of that report never

mentioned any of those things. The information was obtained because, in the

court case in America, Dr. Healy was allowed access to the files of

GlaxoKline, which did not include these results in its report.

That contrasts with the response received by " Panorama " following the

broadcast of its first programme on Seroxat. It received 67,000 phone calls

and 1,400 e-mails, almost of all of which reported problems with side

effects and difficulties of withdrawal. Among the cases reported were 16 of

accomplished suicide and 47 of attempted suicide. Those responses came from

just the group of people who happened to be watching BBC 1 on the Sunday

evening when the programme was broadcast. A follow-up survey by Panorama and

Mind of 229 people using Seroxat found that 83 per cent. experienced

withdrawal symptoms. The symptoms were " intolerable " for 44 per cent. and

" severe " for 32 per cent. Therefore the use of the drug did not succeed for

76 per cent.

Seroxat heads the World Health Organisation's league table of drugs from

which it is difficult to withdraw; it is higher than Valium. Our Department

of Health agrees, and a reply that I received from one of the Minister's

colleagues last year pointed out that, in her view, Seroxat makes the

symptoms of depression more severe in the early stages. That point is widely

recognised.

In spite of that, GlaxoKline repeatedly failed to remove the words on

the side of the packet that said in unambiguous terms:

" These tablets are not addictive . . . You cannot become addicted to

Seroxat " .

The company changed its mind, but only in April 2003, 13 years after the

problems began to emerge. In the first television programme, it was adamant

that the drug was not addictive; in the second one, it blamed the patients

for not understanding the warning. However, it is hard to imagine words that

could be more explicit or less unambiguous. To this day, the company still

gives the same advice on dependency to doctors. It argues that Seroxat does

not cause dependency, but it certainly does, as the World Health

Organisation and our Government agree.

The patient information leaflet that GlaxoKline puts out now states

that 25 per cent. of those taking Seroxat will suffer a withdrawal reaction.

That is an extraordinary change when compared with what it previously said.

It declared the figure to be 0.2 per cent. until 2002, but it then increased

the figure to 0.7 per cent. Now it has decided, after years of misleading

everyone, that the true rate for addiction is about 25 per cent.

It is disappointing that the United Kingdom regulatory authority has failed

to protect patients from the profiteering of GlaxoKline. Even moves by

the US Food and Drug Administration to warn patients about the potential

problems associated with seroxat amount to a slow reaction, and almost to a

dereliction of duty. Patient complaints have been ignored by GlaxoKline

and by doctors, and by the regulatory body and its predecessors in this

country. This is a familiar story.

One constituent wrote to me, saying that she reported a bad reaction to her

doctor, who declined to report it under the existing yellow card scheme.

That scheme, which was introduced after thalidomide, is ramshackle, does not

work and is hopelessly ineffective. I remember receiving an answer from

Gerry Malone, the then health Minister of a previous Government, in which he

told me that the number of deaths arising from paracetamol in Britain were

46 in one year and 52 in another. I was astonished by that reply, because

according to the coroner's report, there were between 500 and 600 deaths in

each of those years. Mr. Malone was quoting the number of deaths reported

through the yellow card system, but it understated the number; in fact,

there were 12 times as many. Yet we are relying on that system to guide us

on adverse reactions to drugs. It is no surprise that a system that is 40

years old is working in such an inadequate way. Only a tiny fraction of the

reportable adverse effects are actually reported. It is nonsense to continue

to rely on that system in this way. That is why there is a huge understating

of adverse reactions, suicides and addictions. When the Minister sums up, I

hope that she will say that we need to look seriously at any reliance that

we place on the yellow card system.

In the television programme to which I referred, Dr. Healy said that

the evidence shows that roughly one person in 60 who uses seroxat makes a

suicide attempt. On the same programme, a GlaxoKline representative

gave a transparently dishonest account of its position. We are talking about

a drug that is probably ineffective. There are few reports to suggest that

it achieves markedly better results than placebos. As we know, it is

addictive, and I should also point out—this is an important factor for the

Government—that it is ruinously expensive. There has been a huge increase in

the prescription of antidepressants, and few people who spend long spells in

hospital can escape the well-meaning attentions of hospital staff, who

regularly come round with their medicine trays and announce that one has

been prescribed this pill and that pill.

A constituent of mine told me that when she was in hospital, she demanded to

know what each of the types of pill that she was taking was. She was

regularly told, " This is a painkiller " , to which she replied, " Well, I'm not

in pain, so I'm not taking it. " On being told, " This is an anti-depressant " ,

she said, " I'm not depressed either, so I'm not taking that. " The excuse for

prescribing such drugs is that one might well be in pain or become depressed

later, so one must take them in anticipation of future pain or depression.

Now that we know beyond any doubt that such pills are addictive, why on

earth do we continue with this approach? Why do we still measure the

efficiency of hospitals not by how much pain is relieved—admittedly, that is

impossible to measure—or how much depression is dealt with, but by how many

pills are prescribed? That is an extremely ineffective method, and it is

also extremely wasteful. One of the current problems is that although

funding for the health service has gone up by 40 per cent., outcomes have

increased by a much smaller percentage. One main reason for that is the

extraordinary inflation of the drugs bill, which has increased at a far

greater rate.

Many of the drugs that are prescribed are probably useless or damaging.

Medawer, the director of the medical research group Social Audit,

said many years ago—before the latest announcement—that a study at the

university of California's neuropsychiatric institute found that just over

50 per cent. of patients who were given Prozac, which is a similar drug,

reported an improvement in their symptoms, but that an identical proportion

of patients who were given a placebo drug reported the same results. That is

nothing new because it has been known for a long time that SSRIs have a poor

outcome for patients, so why on earth do we continue to espouse them and

support their use?

Twenty-six new SSRI drugs are under development, so they will come later. We

are undertaking an extraordinary experiment with human beings on a massive

scale. There are rightly complaints about the drug ecstasy because it is

used recreationally. It disturbs the chemistry of the brain, and no one can

say what the long-term effect of that on the mental health of those who take

the drug will be. The argument is precisely the same for altering the

serotonin levels of the brain in the way in which SSRIs do. No one can say

what the long-term effects will be after 40, 50 or 60 years. The experiment

is being carried out for the long-term interests of drug companies' profits.

I would like my hon. Friend the Minister to deal with several points.

Although research is continuing, Medawar says:

" I see antidepressants as the biological equivalent of thumping a TV on the

top to help improve the picture " —

we know that that works, but we do not know how it works. However, in this

case, we know that the drug does not work, but we still go on thumping. He

said:

" My belief is that in 30 years, our grandchildren will look at the way we

treated depression in the 20th century with the same disbelief as we look at

the way we prescribed tranquillisers 30 or 40 years ago " .

That is the position that we are in now.

When will the inquiry on selective serotonin reuptake inhibitors that ended

in such confusion be re-established, and when will it report its findings?

What are my hon. Friend's proposals to restore full confidence in the

Medicines and Healthcare products Regulatory Agency, which is, strangely

enough, entirely funded by the drug companies—only two countries in the

world are in that position? The Public Accounts Committee was critical of

the situation last year, and said that stakeholders would have a lack of

trust because the agency is entirely funded by the companies—that is like

getting Arthur to audit Enron.

What action does my hon. Friend propose to take to ensure that the

pharmaceutical companies publish all results of their drug trials? We know

that two trials took place that proved beyond doubt that the drugs had no

utility and that Seroxat was useless. We also know that the results were not

published, and the drug company made it clear why it was not publishing the

results by saying:

" it would be commercially unacceptable to include a statement that the

efficacy had not been demonstrated, as this would undermine the profile of "

Seroxat.

That is an indication—a confession—that the suppression of the truth of the

report has nothing to do with health or safety; it was done only for

commercial considerations.

No one else is carrying out such trials on a similar scale. We give a free

hand to the drug companies to carry out trials. If they do not like the

results, perhaps because they are likely to reduce their profits, they

suppress them and keep them secret. We must ensure that the regulatory

bodies have the power to insist that the results of all trials are

published. They might claim that they already have that power, and that may

be the case, but the results of the trials, which finished in 1998, should

be available; otherwise, there is no way of informing patients.

Will the Minister act now to at least reduce the prescription of unlicensed

drugs to children? That continuing scandal has gone on for a long time. I

know there are many reasons for it, but some drugs are prescribed to

children which are almost certainly harmful because of a child's different

metabolism. Does she have proposals to end the under-reporting of the yellow

card scheme? Will she consider developing a scheme to allow testimonies from

patients to be considered along with those from doctors? Under-reporting is

serious, but when the patient that I mentioned tried to persuade a doctor to

report her problems, the doctor refused.

Seroxat should be withdrawn from use, certainly for new prescriptions. That

might cause difficulties for those who have been on it for a long time

because of withdrawal symptoms. It would be cruel to take them off the drug

to which they are addicted overnight, but for new patients it should be

withdrawn. The evidence is there to support that. There should be an urgent

review, not the relaxed leisurely review of the past two years, of Seroxat

and the other SSRIs to determine their safety, the possibility of addiction

and the other severe reactions that have taken place in a significant group

of people, in particular those who have felt suicidal.

There has been a major failure by the regulatory authorities, especially in

the light of the fact that they refused to take patients' testimonies. The

new MHRA should be far more proactive in seeking adverse reaction reports

and establish further ways of using direct experience of medicines in drug

safety monitoring. It was shocking to discover that the MHRA and its

predecessor often only looked at summaries of conclusions rather than at the

conclusions themselves. All those patients who are taking drugs need better

information from manufacturers and doctors on possible side effects and

withdrawal effects and need advice on how to manage and support withdrawal.

There has been an immense scandal, involving many millions of people. Those

patients who have gone on to Seroxat, who have sought solace and care, have

been abused by the system and GlaxoKline, and have been let down by us

as parliamentarians and the regulatory authority.

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April 5, 2004