This week on my segment on the Paul Murray show we spoke about the way new drugs are viewed and used a “live” example of how this plays out. A study has shown that 25% of people believe that the FDA only approves drugs, which do not have serious side effects, and that 39% believe it only approves extremely effective drugs.
It was also shown that both patients and doctors tended to think newer drugs were better. This was even when people were informed that the newer drug had a poorer safety record!
There are many drugs, which come to market, but relatively few offer anything new. For example newer cholesterol lowering medications do not lower cholesterol any better than existing ones but if a company can get a percentage of the market for such a drug it translates to big dollars. Same in reflux where there are five drugs which are essentially all “me too” products.
A “new” anti-coagulant (or blood thinning) drug has come to market. Currently for people with artificial heart valves or atrial fibrillation the only drug available is warfarin. This is an old drug and is not without problems. People need regular blood tests and there is no set dose so dosage often needs to be adjusted. There is the risk of it working too well and people bleeding as a result. And to cap it off many other drugs can interact with it.
That said it has been used for a long time and the problems are manageable. The new drug dabigatran(trade name Pradaxa) offers “advantages “ in that no blood testing is needed and there are two set doses with no need for ongoing adjustment. In theory this makes it an advance on warfarin.
However nothing is as simple as it seems. The new drug has been approved for one use in Australia-prevention of stroke in patients with atrial fibrillation. It has not been approved for other uses where warfarin is currently prescribed. Yet the drug is yet to be listed on the Pharmaceutical Benefits Scheme (PBS) as the government has three concerns. One is that an approved drug may well be prescribed for non-approved uses (called off label prescribing) and secondly that the drug is far more expensive than the older one. This is a major issue if the new drug has no net advantage over the old one
Yet the critical issue is that safety is looming as a major concern with Pradaxa. In New Zealand authorities have been criticized for rushing approval after two deaths and 36 severe adverse effects were reported. In Japan five deaths have been associated with the drug.
It is important to note that given its use, people taking these medications are at greater risk of death than the average person. They are older and have a heart condition and may have had a stroke or are at increased risk of one.
Nevertheless the Australian TGA issued an alert stating that over two years there have been 124 serious adverse events reported. Remember this is in a drug not in widespread use and not all events get reported.
It is not unreasonable then for the regulatory agency to hold off the approval, pending more safety analysis, given the problems with adverse events.
The plot gets thicker. The company, which makes the drug, has been expecting a PBS listing pursuant to its approval for use. It has enrolled doctors and patients in a “familiarization” program. The company provides free medication for patients, via their doctor, so that they can get familiar with the drug. The idea being that when on the PBS list patients are already taking it and will continue to use it, as paying customers! These programs commence a few months ahead of an anticipated listing, which allows for budgeting.
An estimated 25,000 Australians are taking Pradaxa supplied by the company via their doctor. On news of the TGA warning and a delay in listing the company closed the familiarization program early. It also will end it in July 2012.
If the drug does not list by then all 25,000 will have to stop the drug and go on to warfarin. The vast majority would have been on this previously.
Some obvious questions arise. Why are so many people on this drug via such a program? Whilst it can be defended as helping people try a new medication it can be criticized as naked marketing. How have so many doctors been persuaded to put patients on a new drug with a yet to be established safety record? And the ultimate question-is the new drug actually any better or is it just newer?
In my opinion doctors and patients need to be more questioning of new drugs and perhaps more suspicious of companies launching drugs bearing the gift of free medication.
Meanwhile in a busy week for “pharma” it emerged that chemists are being paid $7 per patient to enroll them in “patient support” programs run by Pfizer. Naturally this will only apply if a Pfizer drug is dispensed. Its biggest selling drug, Lipitor, is soon to go off patent and face generic competition so locking in loyalty could be seen as smart marketing.
A few weeks earlier the vitamin company Blackmores was roundly criticized for a program whereby chemists would recommend its products as an “up sell” causing the program to be scrapped. The noise over the Pfizer program has been much more muted.
In my opinion it is worse as patients do not know that their personal data has been “sold” for $7. Does this payment influence which brand the chemist dispenses. Who knows? What I do know is that patient support programs are all about compliance, which means getting people to take their tablets regularly. This may be a good thing but it is also good business for both the chemist and the company. And of course the company gets valuable information about patients that they would not otherwise have.
It is way too easy to dress up marketing as being about your health. Patients, doctors and chemists need to get a bit savvier about the marketing of drugs.