Did drug regulators fail us again?

 3.41 pm 19/10/2017

• Paul Flynn (Newport West) (Lab)

   

   Share this contribution

  It was heartbreaking and infuriating to read the news that 68% of the women who are taking valproate today were not aware of the risks. That is a failure for all of us. We debated this issue in March 2013, and we have put down early-day motions. There was a television programme, chaired by Huw Edwards, in which the victims took part. We thought we had cracked it: we thought we had advertised enough so that no one, after 2013, could be in the position of not realising the terrible risks caused by taking valproate in pregnancy.

   

  I am not making any criticism of anyone, except the MHRA, and we must look at our relationship with the regulatory body. The former Minister, the right hon. Member for North Norfolk (Norman Lamb), did all he could. He has a great and honourable record as a compassionate campaigner on many issues. It is a shock to all of us in that we did not expect there to be compensation, but it should now be coming along. It is not compensation in any serious way, but it is some admission that a terrible mistake has been made—not by the mothers, but by the system.

   

  It is helpful to look back at what happened with thalidomide, which I remember vividly. There were 2,000 cases of birth defects in the United Kingdom; there were 20 in the United States. Why? The reason is that we went on prescribing Destobel for a year after the birth defects were suspected, because the drug company was adamant about it. It had tested the drug on animals, including pregnant animals—pregnant rabbits, even—and only when it went back to do another test of a particular strain of the drug on pregnant rabbits were the birth defects reproduced. That shows the limits of animal testing. The real difference was that the regulatory body in the United States would not accept thalidomide in that form, and its use produced a very small number of cases: 20 compared with 2,000.

   

  We have had the effect of a drug called Vioxx for arthritis sufferers. According to the Food and Drug Administration in America, it caused 60,000 deaths; imagine it—60,000 deaths. How many bad reactions did the MHRA have in this country? About six. We would still be using it if the FDA had not discovered that death was one of the side effects of the drug, which was taken by millions.

   

  GlaxoSmithKline in America has been fined—it is hard to believe—$3.5 billion. What was the fine for? It had suppressed the evidence of the trials it had carried out. It did not publish any of the negative results of the trials it carried out, and only the ones that were neutral ​or favourable. Drugs that were killing people were getting on to the market—this is a British company. What did the MHRA do in this country? Nothing! I wrote to them saying, “For goodness’ sake, you have to act against GlaxoSmithKline.” It is no coincidence that the person who chaired the regulatory body for more than a decade was a previous employee of that company. I am not saying that in this instance the body did absolutely nothing; it did produce the tools and provided advice, but that clearly did not work—how could it have done if 68% of the women still taking the drug did not know?

   

  This issue applies to all Governments; it has been raised many times before. What we need is a regulatory body that is not paid for or controlled by the pharmaceutical industry but is independent and controlled nationally. Some years ago in Italy, the system changed. The pharmaceutical industry still pays for running the body, but for the past 20 years each Government have said that they would not have a fully independent body because they did not want to pay for it, although it was fine if the burden was taken by the pharmaceutical industry itself.

   

  I do not want to say that we are all against the pharmaceutical industry, which has produced miraculous results this century. Valproate is a very good drug: everyone I have spoken to who has used it says that it is very effective and that it reduces seizures, epileptic fits and the incidence of bipolar disorders. We do not want to stop its use at all and we want to appreciate its quality, but after these four years, when the evidence from parents who have suffered has been there, clearly nothing has worked. We must look to reform our regulatory system, appreciating the value of the drug but at least setting up a fund that can express the sorrow of the country and the regret that we have not sorted this matter out or given warnings to future parents. We must make sure that the reforms suggested by the right hon. Member for North Norfolk proceed as a matter of great urgency.

Comments

[Ad]

You have to cut it off at the head. Regulators bear responsibility, but the people who are driving these inadequate poorly tested products through need to be stopped. Sometimes you have to look the good ol' boys in the face and send them to jail. Or at least destroy them financially. And I'm aware that will have knock on effects, that is what I'm saying.

Those who approve it? The state should not be subordinate to business. Its a backwards system.