Wednesday, March 18, 2009

Letters to the editor: Generic vs Branded Drugs

This is a copy of a letter sent to the editor of The Star

Dear Editor,

I refer to the article by Ms Cecilia Kok, titled "Generic Drugs vs Branded ones" that appeared in the Star (14th March 2009 Biz Week). I must say that this piece of investigative journalism is rather incomplete. No doctor (referring to the people who sees patients and treat them), were interviewed. With all due respect to the dons from USM, their eye is only focused on the theoretical and not the practical. You cannot blame them. They live in ivory towers. I would like to declare from the offset, that I have no conflict of interest to declare. I am not employed nor do I receive any renumeration from any drug company to write this response.

Let us take the first issue. There is no doubt that generic drugs are cheaper. After all, they are essentially copycats, waiting for patents to expire and then to produce the drugs as if it is the equivalent (they call it bio-equivalenc ). When branded companies spend millions of dollars to research a drug and then do clinical trials to make sure the drugs are safe and efficacious, the end product will certainly be expensive. Of course when you copy their drugs, without the need to do research and clinical trials, your drug will be cheaper. What will happen when branded drug companies, because of a price war with generic companies, stop doing research on new drugs for new treatment of disease? We will end up with the same old treatment for the same old condition. Medical therapy will be stunted and patients will suffer. The branded companys also fulfill a role of helping to update and refresh doctors. We depend on drug companys to help sponsor CMEs (continual medical education) for doctors. Generic drug companys have not stepped up to provide such education. Perhaps in a world where there are only generics, you will less for less choice and then pay more to the doctor who has to pass on his cost of CME.

Of course, cost of drugs is important. But so is the issue of efficacy and safety. Generic companies, and so also my learned dons, assume that my copycat drug is like the real thing. Let's get something very clear from the outset. Copycat drugs were never subjected to large, randomised clinical trials. Generic drug manufacturers like us to believe that because their drug contain, for example amlodipine besylate, it must behave (in the human patient) the same as amlodipine besylate of Pfizer. Nothing can be further from the truth. Oh yes, they will tell me that they have done "bio-equivalence studies" on their amlodipine besylate and they behave the same, in their laboratory. Well, it may be important to note that, there are many steps in the production of a medical drug. The important active substance, in this example, amlodipine besylate, is important. The chemical must have enough shelf life, to remain active for the period that it is listed for. But besides that active compound, other chemicals are added which are important to stabilised the drug and also to allow it to be safely delivered into the body and also to the target organ site of action. With that many steps involved in the manufacturing, quality control is of paramount importance. Any "short-cuts" taken by the manufacturer may result in a drug that may be inactive by the time that it is ingested, or worse still, may be harmful to the body. Manufacturers sometimes buy chemicals that are near expiry dates, to cut down cost, so as to improve profit margin. The active ingredients are near expiry dates, the preserving chemicals, the stabilising chemicals, and even the coating material, may all be near expiry dates. Chemicals near expiry dates are obviously cheaper, thereby enhancing profit margin. Of course, in a way, it all boils down to quality control and enforcement of safety standards in the manufacturing of generic drugs, two aspects where Malaysia does not exactly excel. It is a common joke in our circle, that the first batch of generic drugs, that are to be tested by the Drug Control Authority of Malaysia, will be manufactured with the highest stringent standards and all the chemicals are top quality without any compromise. Of course, that first batch will be costly. But once approved, the post-marketing surveillance is so weak , that the subsequent batches (these ones makes profit) will have compromised quality. It is well known that many of the drugs sent to sub-Saharan Africa for AIDS treatment contain "duds". Looks like the right pills, may taste like the right pills, but it is not the right pill. It is as useful as flour powder or sugar.
I may agree that as a cost saving measure, some non-life threatening condition may be treated with generic drugs, for example anti-fever pills or pain-killers, OTC (over the counter) drugs, etc. If those generic drugs do not work, the patient may not die. They may have fever or the pain continues, that is all. However, if the patient is suffering from life threatening conditions like hypertension, or needs blood thinners for drug-coated stents, one or two "dud" generic tablets could make the difference between life and death.

It is very sad that medicine has become a business, where everything is driven by cost and profits. What about the patient? What about cost effective care? Are we going to sacrifice patient care just to cut down cost.

However, we should all appeal to the company that produces branded products, to be more responsible socially and corporately. Doctors who work with these companies to run CME (continual medical education) programs, must not abuse the money and trust placed on them, but use the drug companys' money responsibly. They must realise that CME budget, always goes back to cost of product. Senior consultants, who take the drug company for a ride whenever they are send overseas for a CME must behave more responsibly.


MBI said...

Your take on generic drugs falls short of the freshness and stimulation of previous posts. I beg to differ for four reasons:

1. You overestimate the big pharmaceutical companies' integrity in testing, manufacturing and marketing of their drugs. This is not always the case. You yourself wrote on 14 February 2008 concerning MSD's dragging its feet revealing less than complimentary results of its trial on Vytorin. On 23 February 2009 you hinted of underhand tactic used by Eli Lilly before FDA approval meeting of its drug Prasugrel - "a clear example of industry influencing medical decisions" you said.

2. You underestimate the the manufacturing integrity of the generic manufacturers. If their manufacturing process is questionable, how come, for example, Dr Reddy Laboratories of India is licensed by original holder MSD to produce its simvastatin; or that Ranbaxy Laboratories (another big generic boy of India) and Teva Pharmaceutical of Israel are given FDA's approval for simvastatin generics.

3. Indeed any drug sold in developed countries and many forward-looking developing countries (Malaysia included) is subject to approval of the relevant country's authority on bioequivalence and the like. Rather than throwing the baby with the bath water, it is the rigour and implementation of such approval that must be improved - something you too has voiced out - for the benefit of the populace. Indeed the generics enable access for millions throughout the world (India being a good example) to vital drugs.

4. In 2007, the sales of the three top drugs Lipitor, Plavix and Nexium were USD 13.3 billion, USD 7.3 billion and USD 7.2 billion respectively. Their proprietory manufacturers have been enjoying such incomes (or thereabout) every year for the last ten years or more. Now while it is admitted that the R&D of a new drug may run into hundreds of million USD, this cost will be recovered in just a few months of sales - the rest of the year and other years it's profit galore. Plavix sells about USD3 per tablet when its generic sells for as little as 3 US cents, which is indicative of its actual manufacturing cost and the monstrous profit that has been extracted. No wonder the big companies can sponsor CME, but why so tardy in reducing price when their patent expirers?

Kong said...

The better person to know about manufacturing drugs is obviously the manufacturer and not the user, doctor. To say otherwise is like saying a driver of a car knows more about car than the car manufacturers themselves. So the newspaper interviewing the School of Pharmaceutical Sciences at Universiti Sains Malaysia (USM) is more appropriate than interviewing the doctor (sorry for the bruised ergo) for the same reason.

If money is not a problem, I am sure everybody would want to drive an expensive Mercedes. But since money does not grow on trees, many people will settle for a Proton or Toyota and with for all intent and purpose, get the job done as well. This is the same with branded drug and generic. I see nothing wrong with that.

On integrity of branded drug manufacturer vs generic drug manufacturer. If they are both properly regulated, I don't see that as a problem because there are also enough scandals involving branded drug manufacturers in the past.

On Continual Medical Education. The branded drug companies are not angel and they do those things for a reason. Some may even called it bribe by flying doctor to overseas holiday thinly disguised as CME seminar.

On lack of incentive by the branded drug manufactures if their pricing are being challenged. This is absolutely rubbish because if that were so, those manufacturers would have deserted the Western market long ago but they haven't. Why? In Western market, price of branded drug are keep in control by the government and yet, those manufacturers are making enough profit to want to remain in those countries. But Malaysia is one of the few countries in the world that do not regulate or control branded drug price as mentioned in the Star newspaper. And it is high time we do.