Do you think the pharmaceutical industry is focusing too much on "quality of life" drugs and not enough on therapeutic cures?
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Answers (18)
I'll be honest. Today's idea of Health has changed and WHO knows it when defines "Health a wellness status and not only lack of disease". So Quality of life is fundamental, and most of people consider it in their evaluation of their healt status.
Anyhow I guess we are not focusing too much on quality of life. We are giving it the right importance. Quality is multifactorial and difficult to asses but any harder to assess is cure. It's also harder and harder promote new cures in a market were the most interesting areas are those of neglected and orphans disases!
I also think that the more we will focus on quality the more people will give it an eccessive importance..
Greta:
This is an interesting question. However, we need to address both systems and both are also interconnected. We still need the industry invovled in the new drug development domain. That is the only way we can address new paradigms on drug development issues in the current biomedical environment.
Mahadev
Matthew S
JD/MBA Candidate, Washington University
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When we define pharma marketing as a value proposition that affects choice, lifestyle drugs are inherently more marketable and obviously ever-present from a DTC standpoint, whereas for disease states, the doctor is in much more in control.
The breadth of choice for a lifestyle drug is driven primarily by the patient - the patient is typically aware of the condition (ED, overactive bladder, etc.). The patient says to the doctor, "I think I have X, I've heard Y can treat it." For a disease, the situation is reversed; the doctor says to the patient, who has little idea what is going on, "I think you have A. Drugs B, C, and D can treat it, and I usually prescribe B." Consequently, if Big Pharma is spending its money wisely, a consumer gets proportionally more exposure to lifestyle drugs (TV) and a doctor gets proportionally more exposure to disease state drugs (journals). It should be noted that docs are also consumers.
As such, I think if I were a pharma company and I had a choice, I would choose the lifestyle path first, because in that realm I can differentiate away from competition through marketing and enjoy high profits. Ultimately, however, I would get involved in disease-state drugs if one in my portfolio was efficacious enough so that I could differentiate using efficacy.
So it comes down a firm can choose to differentiate away from competition, and to whom. I think that's a decent start in terms of contextualizing the question, but I could be wrong.
Krishna T
Independent experienced pharmaceutical research and development executive
It is a great question I used to ask repeatedly, but not anymore.
To answer your question, this day and age where the efficacy and safety profiles of many new drugs are similar to those of the existing drugs, one of the best ways to look at the superiority of your drug is to look at the quality of life while your drug is being used. It is one of the acceptable ways to market your drug. The practice has become so main stream now the health care providers look for these data before they consider placing a drug in their formulary. Given the circumstances pharmaceutical industry has no choice but to focus on these parameters once the drug’s efficacy and safety are proven. In addition to that marketing initiated this pattern to have an edge originally.
Paul S. R. C
Software developer / manager; formerly with dynamicsoft/Cisco, Ascend/Lucent, AT&T Bell Labs, now at Google
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Yes! The classic example is peptic ulcers. A huge business was built on acid reducers such as cimetidine (Tagamet), ranitidine (Zantac) and famotidine (Pepcid), prescription drugs that all did an effective job of managing the disease ... if you took one a day for the rest of your life. (See first link below: "Cimetidine became the first drug ever to reach more than $1 billion a year in sales, thus making it the first blockbuster drug.") It was since discovered that the root cause is bacterial infection, which can be CURED with antibiotics. (See second and third links below.)
It's tempting to blame Big Pharma, but they're doing what makes good economic sense for them to do. If we want different results, we need different incentives. (Anyone have any ideas?-)
Hope this helps. --PSRC
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Raili K
Sr. Director, Specialty Pharmacy Strategy at Express Scripts
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One sees this question a lot posed as a criticism of pharmaceutical industry to demonstrate it's veering away from its "true" mission to alleviate disease and human suffering. The truth is that most pharmaceutical companies do not have quality of life therapeutic areas as major areas of drug discovery and development, but that if a drug turns out to be developable in those areas, they will try to make it work. This can be seen from the fact that many "lifestyle" drugs, such as Viagra that now is sold for erectile dysfunction, started their histories as attempts to go after more noble causes, such as heart disease. Given the rotten odds of coming up with a marketable drug to begin with, they develop the indications they get. This is due to the fact that unlike in product development projects in engineering, where you usually get a product you set out to develop at the outset, pharmaceuticals and biotech projects are dictated by science that you discover along the way. That the multi-year efforts will ultimately yield a drug is a hypothesis-driven science experiment whose outcome, both whether you get anything and what you get, is unknowable at the outset.
This a very interesting issue, since both are so critical to overall "quality of life" for patients, families, and caregivers...One of the biggest challenges is in defining "What is quality of life" (QOL)?...For some, it'simply being able to get through a day without pain...For others, it's being able to work so they can provide for their family...And for others, it's being able to do everything they normally do...When we extend the discussion to families and caregivers, even more issues come into play...Suffice it to say that QOL and Therapy drugs need to go hand-in-hand...
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With medical science advanced to the point that people are living longer, and people who wouldn't have lived as long are expecting not to spend the final years of their lives as invalids, a focus on drugs that aren't for life-threatening conditions, but for more 'annoyance' (and please note the quotation marks, no condition is an 'annoyance' if you're the one suffering from it) conditions. Look at hypertension and erectile dysfunction. One of the most common causes of ED is untreated hypertension. For decades, a person with HTN would simply have suffered heart failure or a stroke at an early age before the ED became a significant life issue, but with the advent of ACE inhibitors, beta blockers and diuretics for the HTN, patients are living longer and having to deal with the side effects of HTN (namely ED) for longer.
Consider prostate cancer. Early stage prostate cancer has a phenomenally high 5-year survival rate, but with this survival rate, more and more patients are surviving and having to live with the consequences of prostate surgery or high dose radiation therapy. Companies can either say "hey, you're alive, be happy with that" or they can make an effort to alleviate the symptoms that patients who will live another 10 or 20 years with 'QOL' drugs.
The seeming lack of cures for life-threatening conditions comes down to three major factors:
1. People expect more from treatments (two more months of life isn't adequate anymore) so companies have to aim for the fences with each product and it's harder to hit a homer ever time
2. Drug/biologic/medical device development and testing gets more and more expensive and complicated every year and a drug that cures a disease, but can't pay for the costs of development is a loser from a business perspective (for years no one focused on antibiotics because the 'superbugs' weren't in the news yet so no patient or insurer would pay for an expensive new antibiotic, now it's a big deal and companies are plowing billions into development because there's a market and providers/insurers will now pay high prices)
3. There just aren't enough companies with enough bandwidth to take on everyone's condition of concern. Companies aim at the low hanging fruit first. A former employer has a unique anti-microbial technology, but the first target was periodontal disease, not MRSA or VRE because there was better patent coverage, alot of the non-clinical work had already been done, and it was an easier target to help fund the later development.
Just my two cents worth.
I honestly have no opinion. I have become a bit cynic about this. Let's face facts. Basically money rules. There is more money in life quality drugs than therapeutic ones and if you do not get funding you can not do any research. The industry is run in a capitalistic world and must make money. Those who don't will cease to exist. Therefore I think the focus will be even stronger on life quality drugs in the future. In a way I can make argumentation for this fact by saying that it is better to have a drug that will improve life quality and make people live good lives than a drug that will be therapeutic but maybe have side effects making people live but maybe not a good life. I know that is not a very Christian way of looking at it but as I wrote I am a bit cynic.
When you are sick you buy a medicin that makes you better and the alternative is not getting better which makes it a good thing but you can still say that "We work in an industry that takes from the sick and gives to the rich". Think about that statement.
Murali Krishna A
Incharge - CRAMS Business
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Hi
As always, this question elicits lot of passionate reaction…
Like many said here, since monetary considerations dictate private research, there IS a definite need for some public funded research in priority areas for 'real' diseases..... Yes there could be one motivation, albeit negative, for the Private Industry to shift away from "quality of life drugs' as increasingly the very conditions these drugs address are being shown to be very manageable in the 'bio-friendly' alternative medicine systems…
I've posted this as a topic in the PhDG discussion forums http://phdig.collectivex.com/discussion/topic/show/74228
I welcome you all to join us there and take the debate forward.
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Emrah A
Business Development and Reimbursement Consultant; emrah@emraharas.com; Istanbul
Quality of Life is the only outcome that we are close to measure. The other things that measure actually outputs. If you think about pain as the most effective indicator, then you are only quality of life but nothing else. A patient that I know told me once if you take away the pain who cares about being sick? Let's think about cholesterol level, if you feel uncomfortable about it, then you seek treatment. Hmmmmm, perceptions, culture... call it whatever you want, at the end it is the thing you know that makes you sick :)
Best wishes.
Emrah.
David S
Signe BioPharma Inc (dasirbasku@signebiopharma.com) [LION] [TOPLINKED.COM]
This question has both answers. Yes to quality of life for the those with health issues that are likely to be chronic and likely not immediately life threatening. But, for those with life threatening conditions, those with a very serious diagnosis, therapeutics, or the cure, is the quest. A company that decides to provide either service is helping mankind. There are markets for both approaches. Each company must decide if one or the other is the best market for them to serve. In both cases, they can offer useful/important products that benefit the quality of life.
This is a provocative question, and the replies have been uniformly thoughtful. However, the operative term here is "industry." Drugmakers are, with a handful of exceptions, profit-seeking entities first and foremost, which is understood by employees and investors, but perhaps not fully appreciated by all concerned. With a mandate to be profitable, and thus pay salaries and tax bills, and to be philanthropic where possible, drug manufacturers can only survive as market-driven entities. This is not to say that Big Pharma has not been generous in developing products and providing aid to those seeking therapeutic cures, even in cases when the aid is sought by those who can't afford to pay for their medicine. (Please note as one example Merck's programs in river blindness.) However, the current emphasis on creating and marketing QoL Rxs probably reflects a practical approach to the contemporary business climate, and societal priorities. It would be naive to imagine that the search for an efficacious cancer "cure" has been hindered by the western world's appetite for lifestyle remedies such as sildenafil, Botox, etc.
Tom B
Medical Writer & Patent Agent.
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All clinical trials have some sort of endpoint. The endpoint can be cure from cancer, prevention of heart attacks, or disappearance of pimples. For many types of drugs, the relevant clinical trial can take 5, 10, or more years. A lengthy clinical trial showing that a cure really occurs (the true endpoint) may therefore be impossible to run, due to expense, or due to confusing effects resulting from the patient changing to a different drug (other than the study drug). It is for this reason, that many trials use "quality of life" as an endpoint. This type of endpoint is called a "surrogate endpoint." Quality of life can be assessed by a number of established scales, depending on the disease. For cancer, an "ECOG" scale is available. Usually other surrogate endpoints are used in combination with quality of life, not just quality of life. These other endpoints include, for example, stability of tumor size, or reduction of tumor size, and so on. Of course, therapeutic cure is most ideal. However, for a drug such as statin drugs or some anti-cancer drugs, therapeutic cure is unworkable, as the goal of a clinical study.
Ajay M
Senior Manager - Branch Head
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I can suggest two experts on this topic...
Ajay M also suggests these experts on this topic:
Susan O
Sr. Technical Writer at Carl Zeiss Meditec
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I have thought a bout this question quite a bit, because I worked at a company that developed products that were purely cosmetic in nature. I often wondered why all that venture capital was not being put into companies working on more "important" products.
I believe that these "quality of life" products (including pharmaceuticals) is a good thing. Who knows what will be discovered as a result? Perhaps in the process other things will be developed that will result in cures of other conditions.
Also, it creates jobs for people who may go on to other positions where they might make important discoveries.
Geps M
Prize-winning novelist. Creator of quirky, funny, edgy, entertaining and original works.
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As some have already said QOL and therapeutic cure are closely intertwined. Has it not always been the case that the ultimate decisions to market and to treat with any drug has been the balance between therapeutic effect and side effect? And is that not directly related to demands, quite rightly, for quality of life and was it not the reason for being for the whole 'me too' approach which developed within the pharmaceutical industry. It's a given that the fewer side effects a drug has the better the quality of life of the patient.
Emrah makes a very good point. There are millions of patients out there who accept and cope with their illness so long as they do not have the pain. Simple analgesics also improve the quality of lives.
In the UK the National Health Service celebrates its 60th anniversary this year. It was founded to treat the health needs born from deprevation and sixty years on it struggles to cope with health needs born of plenty. In those years quality of life (a different kind of QOL) has improved enormously bringing with it a host of new problems such that today if you are too obese you cannot have your operation, even though you might have paid into the fund all your working life. Or if you don't stop drinking then you can't be treated. So much for the NHS being fee at the point of use for all, I am not judging here but these are not clinical decisions but moral pronouncements which suggests to me that the NHS is in a mess. But that's for another day.
However if by 'quality of life' drugs you mean what I would call 'lifestyle drugs' then I agree with Mitchell. The marketing of drugs to aid sexual performance or to help students sit up all night cramming for his/her exam ot to assist the obese to lose weight for that needed operation is not going to effect research into heart disease, cancer or Altzheimers and the industry's ability to market the fruits of such research. However they do eat up and will continue to eat up resources which the NHS cannot afford and should be taken off the prescribers list. In other words those who want life style drugs should pay for them.
Geps
the reality is that it is far easier and cheaper to develop a drug that focusses on quality of life simply because it involves biological pathways and systems that are easily accessable and do not pose as many side effects and so on (i.e. development risks).
in the realm of new patent protectable drugs for disease treatment you need to target 'new drugs that do old things' thus you need to target systems that are not as well understood and require very sophisticated new drugs and mechanisms that take much longer to perfect, get cleared for use and then market.
thus, if you are a drug developer or other biotech business which route would you focus primarily on...???
