In India, Drugmakers, Gifts & ‘The Poor Patient’

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gift-giving.jpgBest known for producing generics, the country’s drugmakers actually operate in a murky regulatory environment where there’s no single government agency charged with looking after patients’ well-being, BusinessWeek reports.

Free from the scrutiny of regulators, drugmakers sometimes engage in aggressive marketing tactics, including showering physicians, pharmacists, and wholesale distributors with expensive gifts, the mag writes. In return doctors may prescribe drugs based on incentives rather than patient needs. “The drug regulator, producer, and prescriber are on one side, and the illiterate, poor patient is on the other,” Chandra Gulati, a health-care activist in New Delhi and publisher of the medical journal Monthly Index of Medical Specialties India, tells the mag. “It’s an equation where the patient can never win.”

A year ago, the Indian Journal of Medical Ethics highlighted the problem and found that reps sometimes provide docs and pharmacists with gifts ranging from jewelry and consumer electronics goods to automobiles; drugmakers target influential doc at teaching hospitals by paying for them and their spouses to travel to international conferences; and some drugmakers printed out “rate cards” for docs in small towns and cities: prescribing 1,000 tablets per month of a particular med is worth a cell phone; 5,000 tabs confers an air-conditioner; 10,000 tabs wins a motorcycle.

Recently, some have begun pushing for change, such as Gopal Dabade, 51, a general practitioner in the small town of Dharwar in Karnataka, not far from Bangalore. He says the corruption of doctors begins early in their careers. “It starts from the time you are an intern,” he tells BusinessWeek. “You are given a pen, a scale, a notebook. You see your teachers taking gifts.” Then the docs become the instigators. On one occasion, he recalls, interns at the local medical college called for a boycott of one drugmaker for not giving gifts at a party. “It has become more rampant now,” he tells the mag.

Unhappy with the publicity, this past January, the Organization of Pharmaceutical Producers of India published a voluntary “Code of Pharmaceutical Marketing Practices,” which calls for maintaining strict ethical standards when conducting promotional activities, BusinessWeek notes. That means “no financial benefit or benefit-in-kind may be provided or offered to a health care professional…in a manner that would have an inappropriate influence on the professional’s prescribing practices.”

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  1. So, how does this differ from the U.S.? OPPI–good luck with that voluntary, regulatory ‘code.’

  2. Melody,

    Very good point. All the more reason why India should stay on track with compulsory licensing of drugs. Our big pharma business has totally corrupted their system, much like it has corrupted ours..

    The generic drugs India makes for its patients, at one tenth of the cost mind you, doesn’t leave too much for marketing to play with.

    We need to watch this a bit closer. India is on to something, and maybe we should give this much more attention.

  3. Melody,
    To conflate the gift of a cheap ballpoint pen with that of an automobile is just fatuous. This is not at all like the US, and you are being disingenuous to suggest otherwise.

    And FPME, just where is all the innovation in the drug industry coming from? Not from India. The generic drugs not only don’t leave much for marketing, they don’t leave anything for R&D.

    And what is so great about taking someone else’s intellectual property and stealing it? People who take risks and invest time and money in developing products deserve to reap full benefits from that investment. Drugs are no exception–why is it that Americans seem to think that medicine and drug development somehow ought to be “noble” and those involved in them unintereted in financial gain?

  4. HorusCat, I agree in that an Indian pharma company has never produced a new drug from R & D. They have an excellent manufacturing and distribution infrastructure but their history is entirely one of stealing intellectual property. Added to that you have a corrupt government that is not transparent, treats foreign and domestic firms differently, and is constantly under review from the WTO.

    Yes, industry is outsourcing to India but the lack of quality in clinical trial conduct is a high risk.

  5. HorusCat . . .

    I read several of your pandabearmd blog postings. If this is your source of information, I can understand that you believe U.S. drug reps, and the doctors they serve, are irreproachable. Try some other sites–perhaps HealthCareRenewal or Gooznews. I don’t thinks the ‘perks’ you and your profession pass out to the good doctors consist only of cheap ballpoint pens!

    Let me understand this: Indian companies steal U.S. intellectual property, and contribute nothing. BAD! But U.S. companies who do the same thing, GOOD! Tell me, who’s being disingenuous. You can go all the way back to Genentech’s theft of rDNA insulin from UCSF to ascertain the integrity of our pharmaceutical companies. You can also consider that in recent decades “innovation” consists more of me-too drugs, with only marginal changes from their me-too-mama, than any major breakthroughs. Or, have diabetes, AIDS, MS, Parkinson, ALS, Crohn’s and cancer been cured and I just haven’t read the headlines.

    Bob Freeman, above, states that India has “a corrupt government that is not transparent, treats foreign and domestic firms differently, and is constantly under review from the WTO.” Again, I would ask–how does this differ from the U.S.?

  6. Geez, Melody, go meditate or something.

    1. I never stated doctors and drug reps are irreproachable. By claiming that I did, you are just trying to impugn my credibility.

    2. I went to Gooznews. First, he is also a biased source, so you are committing the same “sin” of which you accuse me. Second, I did not find evidence on there of the kind of gifts to doctors that the article about India discusses. Are you trying to equate a meal with a car?

    3. You don’t do my job, so you really have no idea what you are talking about, do you? My company recently severed ties with a physician who was demanding more money for speaking for us in return for prescribing more of our drugs, and disseminated the story throughout the company as an example of unethical behavior that could result in termination.

    4. Despite what Goozer says, companies don’t pay for doctors’ CME. That is against pharma guidelines.

    If you bothered to read anything else I have posted on this site, you would see that I lament the creation of me-too drugs that don’t advance medicine. I point to the attitude of Wall Street and shareholders as part of the problem–companies are rewarded for coming up with a me-too product that guarantees $500 million to the bottom line. They are not incentivized to invest possibly billions of dollars in innovative treatments for devastating diseases. Wall Street expects 15% profits and immediate pay-off. As pharmaceutical R&D increasingly turn to pharmacophenomics and biologics, the time to market for new compounds is going to increase and there will be more spectacular failures of once seemingly-promising therapies. Investor expectations are going to have to change to accommodate this reality, and US law may have to change to allow companies to profit from innovations that do make it to market, but with a much-shortened patent life.

    Another piece of the me-too puzzle is that those drugs are easier to get to market, and their sales may help fund the less successful research being done into new areas. You aren’t privy to pipeline information, but I am. Companies are doing tons of research into areas like Parkinson’s, all types of cancer, MS, Alzheimer’s, etc. There are a lot of failures–compounds that make it through Phase I or II, but turn out to be unsuccessful. We are finding increasingly that pharmaceuticals for diseases like some cancers may have to be tailored to a person’s genetic profile. What works in one subset of people may fail to show significance in a trial that encompasses the entire population. Studies that target specific genetic groups are very difficult–and genetic targetting raises privacy issues and other ethical questions.

    We are also finding that developing meds for auto-immune diseases like MS and Crohn’s is a double-edged sword: the more effective the medication against the disease (i.e., by shutting down the immune process), the more likely there are to be significant opportunistic disease side effects. An example of that would be Tysabri, used in Crohn’s and MS. Though there are no head-to-head trials, it seems to work better than other therapies. Unfortunately, there were several deaths associated with the medication from a virus being activated that normally resides dormant within all of us.

    Clearly, you don’t know much about the drug development process or what is happening in the industry now, just as you don’t really know what goes on day-to-day in the life of a pharmaceutical rep and your average doctor. I am sure my brother-in-law, who is a doctor, would like it if I could get him a new car or a new major appliance, as you seem to suggest.

    You have a very cynical and unhappy view of the U.S. I feel sorry for you.

  7. All,

    If it were not for the generic mfg in India there would be many more deaths from AIDS in Africa and other poor countries. Now, Horus, I don’t expect you to be concerned about this as you have stated that we all need to just look after ourselves. However, we know that if you do not treat the diseases over there, they do come over here. We are not immune.

    Currently, people are so busy walking away from their homes (foreclosures) loosing their retirement funds on the stock market fiasco, or trying to hold on to their jobs? All of this is from our own greed.

    Community based MRSA is also wreaking havoc with our youth. Why? We’ve over used antibiotics - the magical cure alls! Pharma is to blame for a lot of this. The attitude of more is better - sell, sell, sell, buy, buy, buy. We have over extended ourselves financially. We do not know how to moderate ourselves. We do not think about tomorrow and very often the great masses of people believe that all of these problems are “someone else’s” and they don’t have to fix it. Well it is all our problem.

    So, getting back to India, not only does India provide for their own citizens, they are doing something about the worlds poor and sick. As for India and WTO, in the last few cases that I know about the WTO has sided with India. Rightfully so.

    We here in America, are not part of the solution anymore, we are definitely THE problem….The rest of the world should start to hold us accountable…

  8. I did not find evidence on there of the kind of gifts to doctors that the article about India discusses. Are you trying to equate a meal with a car?

    Perhaps millions of dollars in non-consulting “consulting” fees would buy more than a meal . . . maybe a car or two?

    http://hcrenewal.blogspot.com/2008/03/blogscan-continuing-investigation-of.html#links

    http://hcrenewal.blogspot.com/2008/03/smoked-out-funding-lung-cancer.html#links

    http://hcrenewal.blogspot.com/2008/03/what-drug-reps-really-care-about.html#links

    FPME–agree with your points. If, as you say, we are THE problem, it may be of a self-correcting nature. Perhaps when we are so busy trying to feed and house our own citizens, we won’t have time to consider how best to exploit the people and resources of third world countries.

  9. The business strategy of the major manufacturers in India is to use their generic profitability to build a research base. They have access to some of the best trained scientists, an increasingly robust legal structure (IP) as well as a massive home market (the middle class in India is about the size of the entire US population). This strategy will take time to work through, but Indians do not suffer from the short-termism of the US market and are very patient (whilst remaining aggressive in their ambition).

    The availability of capital in India is leading to an increasing spread of their economic tentacles (take a look at the steel market or cars for examples); India is a nuclear power and an independent satellite power (i.e. they can paunch their own), and they do not have the significant demographic problems of China. They may have some pretty substantial infrastructure issues, but India is going to be the major economic powerhouse of this century, and the sooner we gain greater understanding of their business practices the better placed we shall be to participate - unless we just want to watch them succeed from the sidelines.

  10. Sorry, I meant “launch” their own satellites.

  11. Melody,

    I agree, we are very concerned, and we should be at the moment. We should spend more time getting our own house in order.

    As for exploiting the third world poor. My comments were strictly related to AIDS, but that isn’t clear in my post. I was thinking about MSF being able to buy the cheaper versions of AIDS drugs to deliver FREE health care to the worlds poor in conflicted areas. I was also thinking about the latest move by some Pharma’s in recognizing the seriousness of the problem, to actually partner with some of these countries and allow them to produce generic drugs. This allows them to employ local citizens as long as the drugs do not flow back into developed markets. So, I can actually offer a tip of my hat when it is needed…

    Outside of the Box: Your comments are quite astute about India.

    We here in the US need to open our minds and look around us, they have one billion people… Somehow China and India are doing a fairly good job of educating, or at least providing access to education for their people. They will not be able to employ them all, I think we see that already…

  12. yes, I agree with Outside the Box, Indian generic houses are trying to leverage their their resources toward patented drugs, but I suspect it will be 7-10 years before a global product emerges. I am not aware of any NME beyond Phase II testing and I believe it’s a statin (like we need another one of those). I certainly agree they have intellectual capital; it’s the drug development skills I question.

    As far as the Indian government goes, even the Indian companies have complained bitterly that price controls are damagin their ability to innovate. It’s their industry’s ability to manufacture finished goods cheaply and distribute them efficiently that makes the industry profitable.

    Having consulted for a global trade association dealing with Indian, among other Asian countries, I hold to my claim that the India is not a good pharma market.

  13. Bob

    I agree if you add “yet” to the end of the sentence. I don’t think it is a coincidence that the new IP laws in India came into being just at the time when many of their industries (ours included) were shifting into an R&D mode and so they wanted protection for their own inventions. I agree that we don’t need another statin, but what an excellent way to get your feet wet. They know that it will be decades before they have all the necessary skills and experience, but they are incredibly patient. By mid-century we should expect to see and Indian company well established in the top-10 (and given thei access to capital I would not be surprised to see an Indian based major acquisition before then).

  14. Melody,
    No pharma company or rep would deny that we are in the business of developing, marketing and selling our products. So what? Where do you think R&D money comes from? I just don’t agree with you that somehow medicine and pharmaceuticals are supposed to be outside of the normal realm of capitalism. Your self-righteous indignation (and that of Former, who sounds like a particularly obnoxious ex-smoker) at the drug industry is hypocritical, given that I am sure you benefit in your life from 1) medication and 2) other products that are marketed in the same way as medicine.

    As for consulting fees…I have spoken about this on this site before. 99% of the physicians out there don’t speak for pharma; of those that do, most don’t do it very often. The truth is that most physicians aren’t very good speakers and aren’t candidates for the kind of speaking tours that a very few docs make. Those that do actually hurt the reps who have them in their territories, because while they are great advocates for a drug, they aren’t in the office enough to prescribe it. That aside, your average speaker program can be informative and helpful to doctors who choose to attend, as the discussion often veers completely away from the medication at issue and into other challenges and issues facing the physicians. But of course, you have never attended one of these–so you really aren’t competent to comment on them.

    As for ad boards and other “consulting” events. For most companies participating in PhARMA, these events are largely a thing of the past. My company seldom has these anymore, precisely because the publicity was so bad. But again, the number of physicians invited to attend one of these was small compared to the number of physicians in the country. Out of my region, encompassing several states and thousands and thousands of doctors, one or two would be invited. Most of those were so-called “thought leaders,” academics and medical directors. That’s a lot of doctors NOT being able to buy cars with so-called consulting fees.

    You attempt to take the example of a few physicians and generalize it to the whole industry. THAT is disingenuous. Not only that, but you excoriate the pharmaceutical industry for engaging in sales and marketing techniques that every single industry in the country utilizes. What you don’t, or won’t, see is that while there are abuses (and I think we do a pretty good job of highlighting them), we also benefit from this process.

    I will again hold up the example of the SSRIs: Despite what some fear-mongerers on this site claim, millions of people have benefitted from SSRIs. They are much safer and far better-tolerated than tricyclic anti-depressants. Yet when Prozac came out, doctors were skeptical and reluctant to try it. They had to be SOLD on the product. If you have ever taken a tri-cyclic and compared it to an SSRI, you would know that an SSRI is far better. And you can take grams of an SSRI and wake up in the morning. A couple of tablets extra of a tri-cyclic and…good-bye.

    So what is Lilly made billions off Prozac? Good for them. “Lilly” consists of tens of thousands of individuals who are able to buy houses, cars, food, clothes and other things for their families. “Lilly” consists of millions of shareholders who get paid dividends and will profit from the sale of Lilly stock. That is how America works. And it is a beautiful, beautiful thing.

  15. Outside the Box, yes, I agree with you. There are many positives about India now and in the intermediate- to long-terms.

  16. Horus,

    Your tendency to project your ego onto everyone and everything makes it difficult to take anything you say seriously. Why do you feel the need to do that? Just pay attention to what is being said here and leave your ego out of it. You might actually learn more.

    Melody and I are not being self righteous. We are simply stating that the Pharma industry should be made to stand up to higher standards.

    Does your DM know that you are spending all your time here? Hope you are not using the company computer, because you do know that IT can track it…

    It’s almost the end of the month, hope you make your budget…

  17. HorusCat,

    With such a breadth and depth of knowledge, I’m surprised (1) that you’re not a CEO of a major pharmaceutical; and (2) that you have time to spend proselytizing to the readers here, some of whom disagree with you. I expect you would find the community at CafePharma more welcoming and more aligned with your views. Their contributors embrace a more colorful vernacular, and discuss much weightier issues than you are likely to find here.

  18. Melody,
    You and Former obviously wish to engage in what might be called, to use the vernacular, a circle jerk. Rather than engage someone with views that differ significantly from yours, you resort to name-calling and petty sarcasm. Why is that what I have to say is proselytizing, but what you have to say is gospel? What is your big fear here? That someone else might see a side of things you don’t?

    Same with you Former. You do what you accuse me of doing. I think it is your ego that is hurt because someone on this site has the nerve to challenge you, the penitent oracle from the industry.

    If what you two want is to talk only to people who agree with you, you are no different than CafePharma. As far as I can tell from reading what you have to say, you never back away an inch from your righteous indignation. As others have noted, I am one of the few here who seems to have some sense of perspective and balance. I see the good and the bad. I believe the bad is being addressed appropriately; I fear that knee-jerk pharma-haters like you will succeed in tearing down an industry that has accomplished far more good than ill.

    Both of you seem to hate many things about America. You only see the bad, not the good. Everything is awful to you. I’m sure that your sour view of life extends beyond to pharma to many others things. I suspect that in the long run, it is not I who will be viewed as in-credible, but you; because in refusing to acknowledge improvement, change and accomplishment, you become Cassandras.

  19. HorusCat–

    As a pharma rep, I expected, sooner or later, to see YOU devolve into name-calling. I’ve seen the same thing at CafePharma . . . if you don’t like the message, impugn the messenger.

    Your message: Pharma is great, we now have a plethora of me-too drugs, each of which enriches a host of pharma reps. Additionally, YOU feel that the ills of pharma are being adequately addressed. What does this mean? When they get caught, they issue a mea culpa, pay a fine, and seek ways to not get caught in the future?

    You cherrypick your arguing points. You failed to answer a previous post: where are all the cures from Pharma? Or . . . is it that CURES are self-defeating for the industry. Where would sales reps BE if diseases were actually cured?

    Perhaps I have a sour view of America (as it is now). Possibly that’s because I’ve experienced more and have a broader basis for comparison. I never thought of myself as a liberal or a conservative; I’ve embraced capitalism. What I don’t accept, in moving toward a ‘better America’ is a class system of ‘haves’, ‘have-mores’ and ‘have-nothings.’ In the past decades I’ve seen the rise of UNBRIDLED capitalism, where ‘everything goes’ as long as I get mine.

    Last graph above you indicate that ‘change’ somehow automatically equals ‘improvement’ and ‘accomplishment.’ Yet, you have formerly bemoaned the expense associated with prolonging the life of your mother-in-law? Just because scientists/researchers have found artificial means to prolong life–CHANGE–does not necessarily mean such CHANGE is a good thing, does it?

    Zyprexa brought us CHANGE. I imagine those sales reps whose paychecks were enhanced by selling this CHANGE saw Zyprexa as an improvement, an accomplishment. On the other hand, those patients who now face a LIFETIME coping with diabetes probably have a different opinion.

  20. Melody,
    Your bitterness and venom are astonishing. I do think pharma is great. Pharma has extended the lives of millions of people and made the lives of countless more better. Pharma has employed hundreds of thousands of people who then need the goods and services of others, thus providing further employment. Unless chicken littles like you destroy the industry, pharma will go on to save many more lives.

    You must be illiterate. I have said in numerous previous posts that the me-too drugs need to go by the wayside; I have also pointed out that me-too drugs are what Wall Street rewards. Drug companies are legally bound to do what is best for their shareholders. Anyway, if a me-too drug produces $750 million, then so what? Why do you really care if they come out with a me-too drug? What skin is it off your nose? You don’t have to use it. If insurance companies don’t want to pay for it and doctors don’t want to use it, it won’t make a profit, and the company will have wasted its money. It seems to stick in your craw that the pharmaceutical industry actually makes a profit.

    Have you ever talked to a chronic schizophrenic who responds to Zyprexa? There are many people who take Zyprexa who would rather deal with the metabolic side effects than give up the functional improvements it affords them. And there are many people who do not gain weight or become diabetic on Zyprexa. As with all things in life, there is a balance to be struck between risks and benefits.

    In the meantime, I happen to know that billions are being spent in pursuit of treatments for MS, Crohns, cancers of various sorts, Alzheimer’s, you name it. As I have noted on previous posts, new treatments are getting more scarce–requiring the companies to explore biologics, monoclonals, pharmacophenomics…these drugs will take more time and money to develop. Wall Street will have to rearrange its expectations.

    As for where are all the “cures” from pharma? Since we are all going to die someday, I would say that there are no cures, only postponements. It takes a really cynical and bitter person to suggest that human beings would withhold a “cure” in order to make more money. I for one am pretty sure there is no cure for a disease like MS hidden in one of Merck’s vaults.

    Do you make money at what you do? That was a rhetorical question. But in your sanctimonious harping, you imply that a pharma rep making a living is immoral. You only embrace capitalism for people and industries you approve.

    America is not becoming a land of haves and have-nots. Do some basic research and you will see that more people are making more money than ever before. Anyone who wants to can make it in this country. Millions of immigrants speak to that every day. America is the best place on the planet. Americans are the most generous and most open people on earth. It is too bad that you are so wrapped up in your bitterness and cynicism that you can’t see that.

    As I told Former, I am done with you. You are not interested in a different viewpoint, you just want someone to echo your jeremiads against evil pharma. Pharma will have the last laugh on you, though. Sooner or later you, or someone you love, will need us. You or someone you love will have cancer, or hepatitis, or bacterial meningitis, or MS…You will not be too proud at that point to accept what pharma has to offer. You’ll just be pissed off that they’re making money off it.

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