This week on the Paul Murray show on 6PR we spoke about the Australian class action against Bayer over the contraceptive pills Yasmin and Yaz. Legal cases have been conducted in the USA. It centre’s on the risks of side effects particularly the risks of blood clots forming.
This case illustrates much that is wrong in medicine.
All contraceptives can cause blood clots such as deep vein thrombosis as a side effect. This is not a huge risk but a definite one. For that reason some women are not advised to use it. In particular smokers are at a bigger risk, as are women over the age of 35
The contraceptive pill is over 50 years old now so its overall safety record is actually very good. Most pills have been around for over 20 years so are off patent. Hence the desire to bring new pills to market is so that market share can be increased. Also new medications will have patent protection from generic copies, while those where the patent has expired do not .
Thus Yasmin and Yaz have the same oestrogen but different progesterone, called drospirenone. Hence it is a different and new pill not a better pill. The manufacturers with new variations on a theme such as this will generally promote the tablet as having less side effects or some other benefit.
The problem is that studies showed an up to six-fold increase in rates of blood clots on these pills compared to other contraceptive pills. It is worth noting that it works as well as the others but no better.
And this is where is gets really tricky. In 2011 the FDA in the USA considered new warnings about the pill based on the studies showing increased rates of side effects. The panel decided that the benefits of the tablet outweighed the risks so it was kept on the market. The manufacturer was required to have a warning about the risks of blood clots on the box.
The FDA panel voted 15-11 to keep it on the market. Four members of the panel had significant financial ties to the drug maker. They were either advisors or consultants. Given that it would have taken only three people to vote the other way, the votes of these four are highly significant.
Let me be blunt – they should not have been on the panel and should not have been able to vote on this matter.
How can people who are paid by the company, which makes the product, vote impartially on whether the product should stay on the market? They cannot. No doubt these doctors will claim that they are capable of separating their roles. At one level this is true. People can compartmentalize what they do and focus at different times on different things.
However subconsciously you cannot. If you work for a company you will have a favourable opinion of them or at the very least have a relationship with them. This means you are not independent. It goes further as it is almost certain that these doctors are on the panel because of their expertise in the area under discussion.
So their role at the company will be in the same area. They may have been involved in the development of the drug. They may have advised on trials. They may have advised on taking it to approval stage and in taking it to market. Some may have given talks to other doctors about the drug.
It is entirely wrong for them to have any say as to whether the same drug should be approved for use. This needs to be done by people who have no connection to the manufacturer.
Too many doctors wear too many hats. There is nothing wrong in working for, advising or consulting to industry. This is a legitimate pursuit for doctors and many advances have come from doctors engaging with industry.
There is also the need for doctors not bureaucrats to sit on panels, which make decisions about the approval of drugs. Doctors will be best placed to understand the risks and benefits as well as the scientific claims and counter claims.
The same doctors cannot do both. You cannot play football for a team and be the umpire. It is either or! We seem to get this concept in sport but not in medicine. Health departments also fail to grasp this very simple concept.
The case of Yasmin and Yaz shows what happens when lines get blurred.
The medical industry needs a clean up.
As I shall reveal in an upcoming post there is worse going on than what is described above.