First let me point out that this piece is my personal opinion. We have brods who are doctors and working or connected with my previous industry, my apologies to them and marketers are known to conceptualize things from their “out of the box” thinking. I have been in pharmaceutical business for 18 years, this I observed and had done. How I wish that I made no offense from this write up bato-bato sa langit ang tamaan wag magagalit hehehe!!!! Pharma companies are your partner in the quest for better life. May this serve as your guide in understanding how Pharma companies works and eventually erased those misconceptions why they should not be blame for all the sins why your drug is expensive?
Drugs are of course important on the average how many pesos you spend for alcohol and cigarettes while spending then instead in the future to treat your heart attack or cancer? Let’s dissect why drugs are expensive and how should they become affordable.
First let me point out that drug discovery and drug development are not the same. The first dealt with isolating an active ingredient from potential compounds (we call them breakthrough) and the latter determining the appropriate formulation and dosage as well as safety through various clinical trials.
What is the cost of development of a drug? The Tufts Center for Study of Drug Development estimates in 2001 that a drug company spends typically $800M over the course of 10-15 years research coupled with uncertainty if it will be approved or not by the US Food and Drug Administration (FDA). The estimates that at this point in time one compound can cost a company of about $1B to $1.2B at present without the seal of approval a company cannot market the drug. And over of the 5,000 to 10,000 compounds tested, only about 250 will enter in pre-clinical animal trial to 5 on average are tested for human clinical trials. What does this mean? It simply means that out of thousands molecules that are studied in the laboratory (in cells and animal) or studied pre-clinical it will take many years to be tested to humans. The drug development will then go into 4 phases (4 to 6 years).
Phase I or prototype study (is the drug safe?) and will test the safety of a drug in a small group of human subjects (less than 100) and identify administration doses and side effects of a drug.
Phase II (does the drug work?) will assess the efficacy of the drug in a given indication. The studies are often expansions of phase I trials (scale-up in more patients). Only 25% of experimental drugs in this phase will go phase III.
Phase III (How does the drug stack up to current treatment?): Phase III trials are sometimes called comparative trials or head-to-head trials. Patients are usually randomized to prevent selection bias, which can skew trial results. Comparisons may be open-label (patient knows which drug is taken), blinded (patient does not know which drug is taken), double-blinded (neither patients nor researchers know which drug is taken) or placebo-controlled (test drug versus placebo) and can involve two or more comparison arms. The trials involve large numbers of patients, sometimes in the thousands and across many countries. It is not surprising that phase III trials are extremely costly and that it can take a long time to complete recruitment, data collection and data analysis for these trials.
Phase IV (How is the drug best utilized?): Phase IV trials are conducted after the drug has been approved. These post-marketing studies (marketing stage) add data to support existing drug utility and safety, often as required by the Food and Drug Administration. It does not mean when a drug reaches phase IV it can be marketed till it reaches its end product life cycle. Notable drugs withdrawn because of safety issues are Hismanal (Astemizole), Prepulsid (cisapride) Baycol (cerivastatin) etc.
Top Companies in the Philippines:
1. Unilab 2.Pfizer 3. Glaxo 4.Sanofi –Aventis 5. Astra Zeneca
What are generic drugs? Simply means a me-too drug or a copycat. It has been referred as a new drug entity with similar chemical structure. Generic drug companies do not incur the cost of drug discovery and development. They are allowed to manufacture, distribute and market after the original loses market exclusivity or the patent had expired after registration. With this generic drugs therefore are lower in cost. Since the innovator already loses the monopoly. Last year, $18 billion in branded drug sales were lost in the U.S. after patents ended and generic versions became available. Generic-drug makers last year submitted the most applications, and got approval, for the highest number of drugs in 10 years, according to the FDA's Center for Drug Evaluation and Research. The agency received 882 applications and gave full or tentative approval for 683. In contrast, brand-name drug makers made 110 filings for new drugs or biologics and got approvals for 78 products, 18 of which the agency categorized as being ``truly new.''
Are generic drugs the same with the original equivalent? Still very controversial but so far only a few generic drug could prove to be the same when it comes to bioequivalence study (the same with the innovator). That is why, only few generic drugs are included in Makati Med, St. Lukes and UST hospital formularies because they require generic companies to submit bioequivalence studies. When they could not the same in the bioequivalence study, then ergo they will have different efficacy and safety. Why the U.S don’t we have a strict protocol on generic equivalents? In 1984 when U.S Congress passed the Waxman-Hatch Amendment, a new generic drug no longer needs to complete the same efficacy and safety testing procedures as a pioneer drug. Instead, generics must be proven to be bioequivalent to the brand-name, pioneer drugs.
From the above explanation we mention it takes 10-15 years (minus the phase IV which can be 2-4 years) for a drug to reach phase III studies without certainty if it will be approved for sales licensing. The patent of a drug will last only for 20 years. So a drug company can only recoup at present estimate 2-5 years in marketing the drug to recoup his research and development cost, making drugs more expensive. In general, generic drugs are safer than branded drugs simply because more information is available about them. So only your doctor knows if branded drug is safe for you since they are the ones who have access information from Pharma companies. There had been numerous litigation regarding Rofecoxib (Vioxx) that one jury concluded that Merck "recklessly [sold] Vioxx with knowledge of the risks associated with taking the drug" and held the company liable in a patient's death because of inadequate disclosure of the drug's risk.
Biotechnology and biotech companies:
Very few drugs live forever. Due to competitiveness of Pharma industry and the Pharma companies were pressured to cut cost, to look for niche opportunities (innovation) at the same time and brought by advent of new cutting-edge technologies (especially nano-tech and genetic engineering, bioinformatics etc. ) leads to more compounds being discovered easily . Pharma companies are now turning to biotech companies (outsourcing) for R & D. Like buying (through licensing and acquisition) of early stage compounds and collaborate later on marketing. Coupled with major risk involve it is really a big gamble for both, with biotech wanted the needed cash and for big Pharma eager need for new products. Biotech companies are funded by institutional investors and some Pharma companies. The business model had change virtually the Pharma industry. Before the marketing disadvantage is, the first to lunch is first to fail. Coxibs for instance was initially discovered by Pfizer by their Celexocib or Celebrex, due to initial success of these compound in such a short period of time other companies had launch same family compound like vioxx etc. putting Pfizer on the defensive and had only recoup little profit from its R & D. Now the trends are on the reverse side because of the “unmet medical need”. There is an increasing trend of people developing cancer and Alzheimer’s disease. There is a perception that Pharma prioritize marketing over science. But let put it this way, without Pharma ingenuity through their R & D alternative treatment for certain type of disease could not be brought to market easily.
Same Drug do not work for the same individual
We may have the same age or the same race but if we took same drug we may have different outcome or response. Just a little review in pharmacology. Drugs are metabolized in the liver. If you happen to be taking more than one drug, they may interact to each other. That is the effect of one may potentiate the effect of the other or simply one can induce or inhibit the other. Same drug do not work for the same individual because simply because of our genetic abnormalities. It is called pharmacogenomics or how do you respond to a drug with your genes. There are defective enzymes in our liver that reduce the effectiveness of drugs. Please see future trends below about pharmacogenomics. Anything in excess taken by your body is excreted even your simple vitamins or in accounting we call it GIGO - garbage in is garbage out. Because of poor government regulation there are some OTC (advertised in print and broadcast) drugs that maybe working but is killing you softly. Alaxan for example contains paracetamol (analgesic) and ibufropen (anti-inflamatory). Poor Mang Pandoy maybe taking the drug when he feels body ache and pain because he sees Manny Pacquiao as an idol without knowing that it should be taken with food since ibufropen can cause gastric irritation and because of his age producing low gastric output he may eventually suffer ulcer later. Beware of drugs advertised when it carried a notice of “no approved therapeutic claims”. Because Doctors knows bests, it is advisable that do not just take drugs. See first your doctor.
Why drugs in India are not so expensive? Because only in 2005 when India decided to sign WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. Before 2005, Indian pharmaceutical companies have all the freedom in this world to copy and manufacture any drug patent without any threat or challenge from litigation. Plus the fact that Indian companies are supported by their government with protection and support with loans. Are Indian drugs effective? It depends of course on the manufacturer. Indian companies source also their raw materials. Where? In China, that is why we expect in the next quarter that drug prices (supply situation) will become higher because China closes (to avoid pollution) some manufacturing plant at the onset of Beijing Olympics. The Indian drug industry when supported strongly by its government during its infancy has already matured that top generic companies in the US and around the world are Indian companies.
What are the corporate strategies of drug companies to minimize the damage effect of patent expiration? Typically their strategies are: continuing to promote the product as usual; slowly reducing the amount of product promotion; dropping the product; licensing it to competing generic houses; considering prescription to over-the-counter strategies; and patenting the manufacturing process. When Zantac and Zovirax went off patent in 1997, for example, Glaxo Wellcome decided to slow in promoting both products. One method use by pharma companies to outwit competition is reformulating the molecule to avoid patent expiration. Different but the same. How they do this? They just twist the optical isomer or a mirror of the original and register the compound again but as a new formulation. Example: AstraZeneca Omeprazole when the drug patent is expiring. AZ reformulated the drug the s-isomer of Omeprazole to become Esomeprazole. Same molecule because of the same optical isomer and had the same mode of action and adverse event. Beware major companies are registering same compound just to skirt patent exclusitivity.
What are the survival strategies of companies facing patent expiration? The two main problems facing the industry today are lagging innovation and costly drug development. Innovation means marketing a new product over an unmet medical need where the competition is few. Pfizer had in fact leaving the heart drug market which it dominated for many years to look for another opportunity. Examples are: cancer, Alzheimer’s disease and diabetes. The high cost and the complexities development is taxing to a pharma company. Consider the statistics on how many new drug that came to the market. The FDA granted first-time approvals to 31 new drugs in 2006, in 2005, the FDA gave the nod to 18 drugs. In 2004, 27 new medicines and in 2003, 25 therapies won first-time approvals. The Pharmaceutical Research and Manufacturers of America (PhRMA) member companies alone spent an estimated $44.5 billion on pharmaceutical R&D last year – up from the previous record of $43.4 billion in 2006. The impending fall of revenue since blockbuster drugs ($1B annual sales) are expiring and since only few drugs is introduced. With the expensive cost of development companies are turning to outsource to biotech companies for drug development. It is estimated that more companies to improve efficiency and cut costs will consolidate or the time again of mega-mergers. The big deal came last 2000 when Pfizer bought Warner-Lambert for $87B and Glaxo bought SmithKlineBeecham for $78B.
But what happens if a branded drug expires, does it have any impact in future treatment.
In managing hypertension, a group of cardiologists formulated the bible of every cardiologist called JNC-7 or (The Seventh Report of the Joint National Committee on Prevention of Detection, Evaluation and Treatment of High Blood Pressure). Wherein, they proposed a new definition of blood pressure from the predecessor of JNC-7 which is JNC-6. What spells the difference between the two? Well they recommend that a hypertensive patient should start with a thiazide diuretic if single therapy is being initiated and another medication is not indicated. Thiazides with patent long have been expired and are rarely promoted by the drug industry. No clinical trial being done about its efficacy because it is considered as cheap and so rarely used before JNC-7 but is actually a wonder drug. Who conducted the JNC-7 study, it’s the US NIH. ? Normally an innovator company will no longer put money to an patent expired blockbuster drug because it can automatically marketed by generic companies. That’s how the market works. But who was at the losing end from this paradox. It’s the patient.
The Impact of Technology: Before to produce insulin for diabetes it was extracted from the pancreas glands of cattle, pigs, and other farm animals. When recombinant DNA was formulated it steadily improved the research of genetic engineering. Making possible to develop new drugs thru biotechnology like growth hormone, human insulin etc.
The Cost of Promotion:
I have no data with regards to Philippine market but let us take U.S as an example. Consider the following: In 2004 the cost of promotion of Rx (or prescribed) drug was almost $30B and about $7B of these is spent on detailing (face to face promotion). The budget of National Institute of Health (US Dept of Health) for 2008 is $29B and the US FDA is $2B. We expect that the cost of RX promotion would be much higher for 2008 than the NIH budget.
Are doctors can be bought by a slice of pizza by Pharma companies?
Even though Pharma companies spoiled Doctors with gifts, free meals, travel subsidies, sponsored teachings, and symposia they cannot be bought for a song. The answer is a big No. Although promotion by Pharma companies affects prescribing pattern, studies done also shows that physicians do not believe that promotion affects prescribing.
The Impact of Promotion:
In the US, there are about 100,000 medical representatives calling to about 600,000 doctors or 1:6 ratios. We could have same situation in the Philippines. Most reps target high end prescribers. We call that in sales promotion as “Pareto Principle or 80/20 rule”. You get 80% of your sales from the 20 of your clients or accounts. So if you are going to top MD in a key city normally your competitor in meeting your MD is not other patients but a Medrep. The sales force cost vs. revenue in the US is 5-8%. What does this mean? If a rep has a 1M sales target , the Pharma company is spending 50,000-80,000 worth of samples and product literatures on that rep alone. You will even exclude from that the depreciation allowance for the Toyota Vios or Honda City, the daily per diem, housing and gasoline allowance and sales incentive which normally amount to 3 to 5% of gross sales. What is worst now is? Doctors do not want to meet rep without samples. More often than not if you have no sample corollary there would be no prescription. Samples serves as marketing tool to gain access to Doctors, Pharma has no choice but to provide samples. The purpose of samples is actually a starter dose for the patient. Meaning it was to provide patient with initial dose, to encourage habit for Doctors to prescribe the drug, to increase goodwill and serve as acknowledge gift. Who’s to blame why your medicine is expensive? Maybe the samples hehehe…
Are Samples better than the drug you’re buying in the drug store?
Every time I went home to my hometown in Santa, Ilocos Sur I am very popular coz people would like to befriend me and request for samples. Sample naman dyan hehe…If I could only tell them, samples are sometimes are near expiry product which our company to lessen on cost ( as sayang naman to that effect) convert 1 year (some companies even gave 6 months before expiry) before expiry product to samples. The product was already exposed on the heat at my car, lessening therefore its potency. When be given with samples I would advised check if carries expiry date of the label.
What are the current Marketing Strategies that make your medicine more expensive?
CME or Continuing Medical Education.
Pharma companies are paying Doctors to speak (by hiring top medical specialists in marketing talk) and to listen. These include booking the Doctors to spend the night and can include accommodating their families in a 5 star hotel or in a luxury resort not only in the country but abroad. Usual Pharma companies extend their accommodation to not only to expensive rooms but to a well fine dinner, breakfast and lunch to expensive hotels and resort. They also give expensive raffles like top of the line cell phone, foreign trips for two abroad etc. But things have changed when others learn these amenities that some Doctors are pressuring Pharma companies to extend same favor also to them. So, Pharma companies were forced to self-regulate to avoid the expensive cost of pleasing Doctors. In the U.S, strict enforcement of ethical standards like conflict of interest have pushed Doctors and Pharma companies to fully disclose the actual proof of payment made by Pharma companies when they will speak in their behalf on a convention. Some Doctors are not only pushing one product but some don’t take sides but also pushing competitive products as well.
Pharma companies are sometimes hostage by situation when it comes to sponsoring medical conventions which are generally done at expensive hotels and resorts. Doctors depending on specialties have various (non-profit) associations. An orthopedic surgeon is a member of Philippine Orthopedic Association and Philippine College of Surgeon. There may other sub-federation of this associations like spine, cancer surgery etc. Normally they don’t hold only annual convention but also mid-year convention or two conventions in a single year. Before every convention they will send letters to Pharma companies asking for sponsorship to source out for funds. Siempre Pharma companies needing the marketing exposure ay naguunahan. In exchange for booth exhibit, to show their product lines plus advertisement on these products. But do you know how much the cost per exhibit. The amount could range per table (per company) from 100 to 500K depending on what standard (gold, silver or bronze). Normally we have a low of 10 as high as 40 participating companies per convention.
Why CME’s are important?
Doctors need to updated regarding new studies, new clinical research being done. Predictive models show that while Doctors are lessening their time to see medical representatives. It is the only chance for Pharma to share new educational information and currents events to Doctors especially to hard-to-see ones. When Doctors are better equipped it will ultimately redound to patient benefits.
Study Grant – A newly graduated Resident cannot afford the cost of furthering his studies abroad that even with the assistance of a Hospital donor and cannot mitigate the expenses the daily cost of living, transportation and food if he chooses to undergo further studies in Singapore, Australia, U.S or Japan. Pharma companies often in connivance with the department chair or with the hospital director will shoulder the cost of the said expenses. But take note that the department chair will not only seek assistance from one company but also to others. Making the poor resident practiced already mortgage once he will return home to pay the cost of sponsorships and already beholden to the sponsor. Pharma companies usually give cold dollar cash from 4 to 5 figures.
Some Bad Practices
Clinical studies are published for future reference in research, for grant in approval and marketing purposes. Studies are usually compared to a dummy drug or placebo (meaning gawgaw) or to drug-to-drug comparison in the same class. However many clinical studies that didn’t work to the patient are never published. The result were either suppressed if the study found out that the drug has only modest result and those with good results are the ones being shown.
Off-label promotion - Some drugs are marketed with an unapproved indications. Because of aggressive marketing strategies it is unfortunate that some drug companies are promoting (they call it scripted education) their products to the Doctors in the absence of US FDA seal of approval by just the results of positive clinical studies which are unethically wrong. As a result drug companies tend to invent name of diseases just to suit their profit motive. For example, Viagra was originally research for heart disease but the side effect of it is erection. Take note even the popular methathione, making your skin whiter is the adverse effect and not because of its positive effect. So Pfizer created a disease called Erectile Dysfunction which is not known in medical terminology 10 years ago when Sir Rory Tuazon of 85’ was still in medical school. Neurontin another Pfizer product was originally approved for epilepsy but is marketed for neuropathic pain. Pfizer (Warner-Lambert at that time) was fine by US FDA in 2004 to the tune of $430 in promoting Neurontin (Gabapentin) off label. And so, with Johnson & Johnson; Topamax for epilepsy is now promoted for migraine. And about 25% of all drugs in the market today are prescribed on off-label uses. But we cannot fully blame the pharmaceutical companies in this fiasco considering the slow flow of drug approval and the rapid expiration of their top selling products to generic companies. It is also a marketing strategy for survival. In the U.S a company is liable if it is promoting drug for off-label use and insurance companies will not re-imbursed patients if prescribe with off-label drugs. The problem with off-label promotion is that it impedes Pharma companies to do a thorough research about the drug or insufficient scientific research. Since 70% of Rx (branded) drug are promoted off-label we do not know if such drugs may carry serious side effects in the future.
Self-regulation in Pharma Industry – just like in the US in the Philippines for Pharma companies to forestall government restriction on pricing etc. they have bonded together in unison primarily to lobby their interest and at the same consider ethical standards in their dealings they formed an organization called PHAP – pharmaceutical healthcare association of the Philippines of which most of multinational companies are members. Being a PHAP member, a company cannot sponsor in a single medical convention not more than 7 doctors abroad in U.S or Europe and should not be more than 15 in Asia. So to skirt the demands for more sponsorship abroad by doctors Pharma companies often reasoned out this PHAP policy but their sole consideration is just to cut cost. Big local companies such as Unilab are not a member of PHAP, making multinational companies sometimes irrelevant in prescription.
What makes your medicine more expensive? – The arrogance of Mercury Drug.
The big chunk of retail drug industry in the country is being cornered (about 60%)by Mercury Drug. Small players like Watson, Manson, Rose Pharmacy etc bonded together also to fight Mercury Drug dominance in the retail trade to formed DSAP or DrugStore Association of the Philippines. Just like any player in any industry the dominance of one is not good for the industry. For being a big retailer with presence in every corner street in Manila up to key town and cities in the provinces Mercury Drug dictates (monopolistic practice) the price of medicines from a Pharma company. How? By asking exorbitant product discount from the poor Pharma company. By how much? It depends but the range is between 20 to 40% discount. Why such a substantial discount? Mercury would tell you in the blame game. Blame our Senators and Congressman because they have passed a law giving 20% senior citizen discount. But only a portion of the products are discounted for my Lolo and Lola. So if your medicine is worth 10 pesos, you should be paying only 6 pesos instead but the 4 pesos was given to Mercury. Mercury drug is not receiving straight discounting but in the form of product deals. That’s why DSAP members are jealous because they are only small players, Pharma companies will only give them a measly 5 to 30% sales discount. If you do not subscribe to the whims and caprices of Mercury, chances that you will not see your product on their shelves. There is a big chance also that you will close shop. . Nakakasiguro ang gamot laging bago, di mo lang alam dahil sa kanila mahal din ito hehe!!!! Of all the discounts the retail price will still have the patong plus you must also include the 10% VAT. Big deal why your medicine is expensive?
Future trends: the shape things to come in the Pharma industry? In the future drug will be less expensive!
The Impact of technology:
Less interaction with Pharma companies – The physicians of today learn about medicines through a wide assortment of sources – from their peers during meetings and seminars and from the internet. Increasing government regulations and restrictions for Pharma companies will hinder some of their promotions in the future. Plus the dwindling amount of time for doctors to meet medical representatives will become an extraordinary marketing challenge. Pharma companies as of today are in fact exploring many possibilities in how to overcome such challenge. They are creating marketing buzz such as message engineering (bago di ba hehe). It only means a creating a focus group discussion and all kinds of marketing promotion in line with technology trends among doctors to grab attention in presenting their product out of their busy schedules. Since there will be less time to be given by Doctors to rep, pharmaceutical companies will subscribe and enroll them to E-CME or E-detailing. The doctors will be paid by the hour in watching pre-formatted sales pitches. There will be an increase of internet protocols among doctors, Pharma companies, laboratories, HMO’s, hospitals and pharmacies. Business will be done through connectivity or E-business.
Telemedicine - the remote diagnosis, monitoring and treatment of patients via videoconferencing or the Internet. In India today, there about 120 telemedicine centers connecting the grid between inaccessible remote patients to the specialist. No wonder you will be operated in St. Patrick Hospital (the Hospital of Class 85” Dr. Mike Perez) while your chief surgeon (the one who call the shots at the operating table) would be in the U.S. using a computer on a remote operating scissors and machine.
Electronic prescribing - Doctors in the future will write prescription online. This will eliminate medication errors in handwriting prescription and will improve convenience and keep people in their homes rather than in care facilities. Sorry Doc Rory (Cl 85”) hehe no more house calls.
Patent Expiration of Wonder Drugs - 90% of Big Pharma (top pharma companies like Pfizer, GSK etc.) revenues in 2006 came from medicine that had been in market for 5 years yet many of the patents of these drugs will expire in the coming years exposing $157B worth of sales to generic erosion. The lack of R & D productivity plus pricing pressure will force the Big Pharma to merge or consolidate. The business model would be defined as specialist oriented marketing, company will outsource manufacturing from contract manufacturers (biotech) and there will be a greater collaboration and partnership initiative among pharmaceutical companies.
Increasing Public scrutiny – The sins of the past is haunting the Pharma industry. As healthcare cost continue to rise. The trend shows that there is an increasing government intervention ( R.A. 9502 also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008)on pricing, corporate accountability, regulatory compliance and even in promotion coupled by pressure to accelerate introduction of new drugs . With decreasing revenue and increasing cost in R & D and pressures from the government to discover better diagnostic and treatment. Between 1995 and July 2000, pharma and biotech companies established 2,661 alliances, collectively valued at more than $28 billion. How would the industry struggle to the challenge with continuing market pressures at the same time in producing new life-saving treatment? Only time will tell. The new business environment clearly shows that Pharma should innovate (life cycle management) to keep up with the challenge. In the 90’s we have seen consolidation or alliances but simply bigger is not the solution. The trend now is companies with new pipelines will likely to succeed.
Pharmacogenomics or the era of personalized medicine - when they are able to decode human genes it dramatically change Pharma business. Scientists are now discovering specified proteins (proteomics) which may be responsible for certain type of diseases like hypertension, cancer, diabetes, obesity +etc. Scientists in the Pharma industry are now making tailor-fit drug for this type of diseases making life in the future longer. We will be seeing drugs made precisely for you in the laboratory based on your genetics. We are now actually in the era of personalized medicine. Gone will be the empiric or clinical trial and error done on phase 1 to phase 4 studies. We will be seeing customized treatment that can have favorable outcomes especially to tough to treat patients. Chronically –ill diseases like HIV will be a thing of the past, it will be an era of therapeutic vaccines. We will also be seeing drugs in the future that repair genetic deformities by fusing genetic material of the other. Every individual will know their genetic profile (the era now of 666) which will enable doctors to prescribe the best drug for each patient. This will ultimately drive down health care cost. Advance imaging will be more precise and work in less time. The quantum physics of nanotechnology will change your outlook for oral vitamins, just like a car when pumped with gas in a station you will just visit your doctor clinic to be injected with revitalized form of energy from a nano-robot by a nano-doctor. Cultured cell will dominate the implant technology to replace tissues, bones and even arteries. Hospital can become like car repair facilities that repairs and replace any (spare) part of your body(organ transplant). Using smart card technology it does not matter if your family based physician is based in Davao that if you seek medical attention in Manila doctors here can have access your medical records from a centralized patient record warehouse.
The Demanding patient - Since the future will also be dictated by managed care institutions (HMO’s) we will see an ever demanding patient that they must get the cost of what they pay for like immediate feedback about his medical condition, greater access to formularies etc. Because of increasing evolvement of information technology more and more people will have easy access to information. That led to more knowledge and easy accessible healthcare. More people will not go directly to hospitals for checkup but to the malls in MD clinics. Accessible and I can spend leisure time of waiting while shopping. Before a Doctor will say to a patient please take this and take that, the situation will become reverse in the future. It will be the patient that will say will I take this Doctor. I have read in the internet will it be good for me? Since the patient is the customer in the health care industry they will ultimately dictate how the market will shape up. It is not the doctor or the Pharma industry that will not be in spotlight. With less interaction between a medrep and a doctor what will happen now to the salesman. Arthur Miller predicted this one in his book the “Death of a Salesman”. We will also see the death of the Medrep.
New Emerging markets – since the cost of conducting clinical trials is 50% less in India compared to U.S and in Singapore would take only 2-3 months to gain approval. The West would be looking East (Asia) in the future by maximizing productivity and minimizing cost in research and drug development. So from Made in China, we will see in the future medicines discovered in China. Asia accounts 60% of the world population and about 1/3 live in China and India. Cheap labor and overhead cost from this countries. Medical tourism will be expected to rise here in the Philippines. In fact, major drug companies are now relocating to these countries. Our leverage would be well-educated English speaking medical staff, state of the art private hospitals and diagnostic facilities and low health cost compared to western spiraling health care costs.
Faster drug approvals - the digitization of human genome plus nanotechnology (biochips) will improve drug approvals to become quicker. Clinical trials will become speedier because of tailor made approach in drug development. The traditional selling made by medical rep will be replaced by E-detailing which will become cheaper when compared to former. E-detailing will be much better as a SFE or Sales force effectiveness that the doctor will be given the right information at the right place with right message at the right time.
Hospital management – Hospital beds will become docking station with a variety of computerized application that you can use your webcam and transact business with your friends, play web games. You can call your nurse from a decentralized nursing station on your fingertips. Hospitals will offer variety of personalize care.
What should be the Philippine pharmaceutical policy? Follow the Sri Lanka model. Maybe Yes and Maybe No. In Sri Lanka the stranglehold of MNC’s was broken after the government had allowed generic companies to compete with MNC’s. A government corporation was established to import raw materials from cheap sources for generic drug companies enabling the government much cheaper drugs. So drug prices drop by 1/3 to 2/3. Can we do it too in the Philippines? Yes, if we can minimize corruption. When, I do not know hehe….
There should be a law passed for Pharma companies to disclose publicly their expenses on advertising and promotion. BFAD should be strict in regulating the promotion of OTC drugs, promotion made by Pharma companies with regard to branded drugs that any paper or promotional material should carry a seal of BFAD approval. In the US, a Pharma company can be easily fine by US FDA only the use of some adjectives in the printed materials intended for (truthful) promotion.
Filipinos in the area of world drug discovery :
Unless you don’t know that the drug erythromycin, an anti-biotic promoted and patented by Eli Lilly under the brand name Ilosone was discovered by Filipino scientist Abelardo Aguilar. He sent carabao dung samples to Eli Lilly and found out to have anti-bacterial properties. Thus the brand name Ilosone, came from the word Iloilo.
The successor of morphine for chronic pain Ziconotide (Prialt) was discovered by another Filipino scientist , a UP grad named Baldomero Olivera from a marine cone snail or conotoxins now widely used on in neuroscience research for the study of ion channels and nuero-mascular synapses. The said drug has a high potent opiate analgesic for people with extreme pain that can be used in the management of pain and cancer.
With the emergence of empowered and well-educated consumer. All these are transforming the pharmaceutical industry today to evolve and become dynamic to meet the challenging needs of time. For the industry to survive it must follow the dictates of the consumer and not the other way around. Since the patients will be the end-user, the stakeholders, the Doctors and the Pharma industry will have to deliver a customer value of high quality health care. The conjunction of changes in technology and socio-economics will force both stakeholders to listen to the demand of consumers. Less expensive but high quality healthcare.
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