Not Plotting Against You

Discussion in 'Fibromyalgia Main Forum' started by mme_curie68, Apr 28, 2006.

  1. mme_curie68

    mme_curie68 New Member

    Okay, gang. Not all of us who work for drug companies are evil, money hungry wretches.

    I have worked for family owned and operated generic drug companies and also cutting edge biotech. I've spent nearly my entire career in the pharmaceutical industry.

    We do NOT sit around trying to figure out how to SCR@W sick people. I got into this field because it was interesting, used my chemistry degree to the fullest potential AND I could do work that might actually benefit other people.

    Drug development costs big money. I had absolutely no idea HOW much until I worked for a new drug discovery company for 3 years.

    Research (and I mean cool hunt it down and find it and cure a disease) kind of research costs in the high hundred million to billions of dollars a year. The research people at these companies - this is all they do - and you get a pretty free hand to do it. You get the equipement you need - state of the art. But guess what? It's still pretty freakin' darn hard to find good drugs.

    Companies that are "Big Pharma" - the Lillys, Mercks, Glaxo Smith-Kline have loads of money - this is true - but the money they are making are on drugs that were discovered and put on the development pathway twenty years ago or more.

    The average developement lifecycle of a "new drug" is 10 - 15 years. The average development lifecycle of a "generic drug" is anywhere from 2 to 5 years.

    "Big Pharma" has the money to spend but in general lacks the cutting edge researchers - they are large bureaucracies, like large lumbering dinosaurs - they have the money, so they use it to pursue the intellectual property that some little cash strapped company is making a run at.

    The cutting edge stuff comes out of startups. So Big Pharma does something that is called "strategic partnership" - where they cherry-pick which research and discovery stuff they want to buy. They give the smaller company a wad of cash to get a candidate to Phase II or III clinical trials. Then they sit on it. Literally.

    Why? Well, first off, to get a new drug approved by the FDA in the United States, it has to be BETTER than what is already the accepted standard of care. Just as good as (the standard for generics" isn't good enough. For every ten candidates you may have in the development pipeline, literally thousands fell by the wayside, and probably only 2 out of the 10 will make it to the commercial market.

    The drug discovery company I worked at had a "burn rate" of 74 million dollars EVERY THREE MONTHS.

    The pipeline has to be fed continuously. If it isn't, your company will fail. So as a smaller company, you're more likely to partner with a behemoth, because the behemoth can pay for the clinical trials that your company cant afford and will actually enable people who need the drug to get it.

    So what do you do? Say that you would rather that your company fails and people that you know you could help with your drug die so that you remain "untainted" by big business?

    The "gold-standard" of clinical trials is the Phase III arena. This involves thousands of patients all over the country and possibly also the world. One trial, you're looking at hundreds of millions of dollars.

    So, if you're a "Big Pharma" drug company, and you just spent somewhere in the 2 - 4 billion dollar range for clinical development and you have to do this for each drug that makes it to market, how do you recoup your development costs? Pricing, Sales and Marketing, and Patent Protection - hoping that you get a "Blockbuster" so that everyone who worked their @sses off day in and day out might make money also through shareholder value.

    Yes, a company would like to make a profit. Here again, there is more of a back story. If you partner with someone in your development process to get a drug approved - they get a chunk of the money. The pricing is recouping your investment plus "x" profit margin.

    In the world of generic drugs, take a haystack and zoom in to find the needle. That pinpoint is your profit margin. It is virtually nonexistent. So how do you make money as a generic company? - be the first to market as a generic, make a generic that is very hard to make so other companys will be discouraged in the attempt, and my personal favorite, get around the big drug maker's patent.

    Nearly every generic to come on the market will be the subject of a lawsuit by the Big Pharma company that owns the "Branded" drug. You name it, you can sue on it. We got sued by a big company on the color of the pill. Their contention was that the color was "too similar" and infringed on their patent.

    This strategy for sueing on whatever you can think of to tie up your rival in court drains the cash of the generic company - unless you are really certain you can win a court battle you may back off or you'll be out of business because you won't have the money to run it.

    I think that well-developed pricing programs for patients in need (very reduced cost or free drugs) is the way to keep everyone happy and yes I do think they should be and can be expanded significantly without impact to the "bottom line".

    Company can make some money by selling drugs to people who can afford them at higher prices - enabling them to give the drugs away to the needy. That's not an unconcionable way of doing business.

    Since I am a patient myself, I can and do feel the impact to my wallet as well. It is in my best interests to have safe, affordable medicine, and I care that other people should have that too.

    If my work has helped to save one person then my career has been successful. If I could make a little money in stock options so that I could afford not to work as much as I do, I wouldn't mind that either.

    Madame Curie

  2. findmind

    findmind New Member

    Thank you so much for that info...I guess we don't think much about the worker-bees who work so hard, and I really couldn't disagree with anything you related.

    Its always wonderful to have "both sides of the story"!

    Thank you again for a very enlightening and useful post...I'm printing it.

  3. matthewson

    matthewson New Member

    Thanks for the post Madame Curie. I think the other side needs to be shown!

    Take care, Sally
  4. NyroFan

    NyroFan New Member

    Madame Curie:
    What an interesting post. It was certainly and an education.
    Thank you for taking the time to post it and put the spotlight on drug companies.

  5. Mikie

    Mikie Moderator

    I think we need info from all perspectives and your post was very informative. That said, however, pharmaceutical companies, regardless of how much they must spend on R&D, are some of the most profitable businesses in the world. Because they spend so much lobbying congress, Americans pay more for our drugs than those in other countries. The fingerprints of the pharmaceutical lobby are all over the new Part D Medicare Bill. Medicare recipients are a huge buying group but instead of getting pharmaceutical companies to provide price breaks to all on Medicare, the burden has shifted to the Medicare patients and taxpayers and the costs of the drugs are still astronomically high (again, higher than in other countries).

    During the lawsuits, it has come out that the companies cherry pick the research which shows the drugs in the best light and ignore warnings of possible problems. In the case of Neurontin, reps presented themselves as "experts" to docs and persuaded them to use this drug for off label purposes for which it was not intended and for which it did not work. Some patients suffered from this fiasco.

    I think we all understand that R&D is very expensive and the pharmaceutical companies are entitled to profits. They are entitled to lobby congress as well. Still, in many cases they have not acted ethically and the relationship they maintain with government is not healthy. This does not mean that employees of pharmaceuticals are at fault. Most employees are not privvy to what happens at the top levels of companies.

    Again, thank you for providing your perspective to help balance out the info we have on the drug industry.

    Love, Mikie
  6. suzette1954

    suzette1954 New Member

    Thanks for the article and the info. Its just so hard for those who have limited funds to decide, do we eat or do I get the drug. Have a great day

  7. shootingstar

    shootingstar New Member

    unfortunately we have a HUGE problem of affordability for medical care in the U.S. If you are wealthy or well-insured you have access to care. If you are very poor you may qualify for government assistance. If you are lower middle class working two part time jobs to make ends meet you very possibly do without, postpone, even die. The system is broken and it needs to be fixed on many levels.
  8. pam_d

    pam_d New Member

    ...I'm very grateful for "big drug companies" right now, very grateful.

    Thank you for a different perspective than we often see here!

  9. libra55

    libra55 New Member

    Well said. Thank you for bringing this to light.

    As a person who must take daily immunosuppressive drugs to stay alive (metastatic Crohn's - eyes, GI tract, skin, and joints)I, like the previous poster on chemotherapy, am very appreciative of the drug companies. Half a century ago these medicines weren't available for Crohn's. People ended up with surgery after surgery and sometimes colostomies. Nowadays a lot of that can be avoided. Sometimes unfortunately it can't, but we are on the right road.

    Now maybe this is an overly simplistic view, and it's only one person's little individual perspective on this subject, but I sure am appreciative for the companies that make the stuff that enables me to live a halfway normal life.

    If only they would come up with something to cure FM.....But that's a different story..

    Thanks again,
  10. kjfms

    kjfms Member

    ...I must have missed something. I never thought that to start with.

    Enjoyed you post.


  11. tlayne

    tlayne Member

    Thank you for your post! It is so refreshing to see companies that are honestly trying to serve their fellow man. On the other hand it is sad to see that it is the giant coorperations that are thriveing.
    As a nurse that was working in a Doctor's office, I was amazed to see all the drug reps that come in daily. They spend a TON of money to buy us lunches, just for the chance to tell us about their drugs. I worked for an office that had three Doctors, and we were booked for three months in advance by reps waiting to buy lunches. I was told that before they started advertising on TV they used to pay for the Dr.'s vacations.
    One of the reasons why I am so thankful for this message board is because I can see what real people are doing and taking to help themselves w/ fibro and CFS. There is a wealth of information here!
    One of the drugs I am investigating now is Low Dose Naltrexone. So far it seems real promising. As far as treating MS, it has stopped in it's tracks! And due to its immune enhancing abilities it could be the next wonder drug. But the Pharms are not promoting it, because it is cheap, and not the hugh money maker that the other drugs currently being used to treat MS are. Please look into this & let me know what you think. I would be very interested to know your opinion on this with your education and professional background. Thanks, Tam
  12. Cromwell

    Cromwell New Member

    Although I do think the big drug companies need to spend less courting doctors and in advertising, I for one always thank God for the researchers and chemists who saved the life of my brother, my DH, my preeemie son, and probably myself as without PPI's I think my gastritis would have progressed to something a lot worse. Also for the drugs that gave my dad another 12 years of life.

    Also, I thank God for the anaesthetics and dental materials-not many people realize how many lives dentists save each year BTW.

    I also thank God for the surgeons and for the people who design the equipment we have all come to take for granted-from drips to MRI machines.

    I lived for a short while in a third world country that had none of these things, you got sick with even a sore that festered and you died, half the children never lived to see their first birthday. Even things like clean water (that we complain about the cost of), was not available.

    I have a friend who yells at me for using Prilosec, and for "letting" my DH use anti seizure meds. She carps on all the time about these things, yet she sells really expensive oils that cost more than the pills either of us take, with only anecdotal evidence that they actually do any good at all for serious illness.

    She says if we "are ill" we only have ourselves to blame for not living on herbs and raw foods. I really object to that sort of mentality. Everything has its place, and people are free to use whatever they wish, but we have no right to go around making statements that are not only not true, but can do real harm. I recently saw a group urging a diabetic to go off insulin and use some oil concoction instead for eg. I am not denouncing oils, but some groups involved in them DO denounce good meds that save lives.

    This thing about "all or nothing" is wrong-gee who WANTS life without icecream??? Or Thanksgiving Dinner??? We have to start being sensible, and realize that we can use moderation in all things. I suggest that next time someone needs a deep filling or root canal they rub oil on the gum instead of getting novacaine and see how it works for them.

    I also see that some people here feel guilt ridden when they use meds. as if they are wrong to be using them. It really upsets me when I read how they are suffering rather than taking a pill that would put them right in a couple of days. I also think the supplementals they sell here are very good and are intended AS supplementals.

    So I thank you very much for your post. I always appreciate your comments and help re meds. It is great to have you as part of the team. I think your post is important for people to read.

    Even life has unexpected side effects, one of them being that most of the drug companies will give free meds for those who are poor-my DH got them for several years until the Medicare Presecription plan kicked in.

    Love Anne C
    [This Message was Edited on 04/29/2006]
    [This Message was Edited on 04/29/2006]
  13. mme_curie68

    mme_curie68 New Member

    I am certainly grateful as heck to my endodontists. I had a crack in one of my back teeth that bothered me for years.

    First time I had had extensive work done after Fibro dx.

    I needed 3 times the normal amount of novacaine, and had to be on Vicodin ES about twice as long as a "normal" patient.

    But thank goodness for for both of them! With my new crown in place I have no more pain in THAT area at least.

    I also do not understand why some people feel guilty about taking medication that helps them to feel better. I would not be alive if it wasn't for the medication I need to manage my bipolar disorder.

    I am not ashamed that I have a chemical imbalance in my brain. I have been aware of it for 30 years now, but have only been treated for about 16 years - I wish I could have started sooner - maybe I wouldn't have become the alcoholic I was if I had had drug treatment sooner.

    I notice that people really beat themselves up about medication and needing a medication when the medication is a psych. med.

    BP meds and diabetes meds don't seem to bother people. Never hear about anyone weaning off a BP med or a diabetes med. There is still a HUGE self-stigma about psych. meds. in addition to societal stigma - I think its a bigger deal.

    I understand that these meds. are not for everyone but I also know that they have saved so many lives - my own among them. I would have killed myself with alcohol or found another way to commit suicide. My brain just doesn't function "normally" without help.

    I believe in supplements, dietary changes and alternative medicine like bodywork, acupuncture, chiropractic. Mind-body exercise like yoga. If someone can find ANYTHING that helps them to feel better and have a good quality of life - then use it or do it.

    Madame Curie
  14. mme_curie68

    mme_curie68 New Member

    Naltrexone is currently marketed as an opioid antagonist (blocks opioid receptors in the brain). It is frequently give n by paramedics in the field to drug overdose patients who are on their way to dying.

    The effect is so rapid, that a patient will go from out and crashing to sitting up swinging within a minute or so. Which is usually why OD patients get really strapped into a stretcher BEFORE a fully reviving dose of naltrexone is administered.

    It has also been shown to reduce heroin cravings and alcohol cravings once a person has been detoxed from these substances - it helps people to stay sober.

    I had not heard about low dose naltrexone, but I did find an interesting website that discussed those applications.

    Basically, the LDN theory states that by blocking some endorphin receptors in the brain, it forces the brain to make more which then increases the overall level of endorphins - so you "feel better" from a neurotransmitter level up.

    No major studies have yet been conducted at the "randomized, double-blind" clinical level though. This means that the current information is anecdotal only.

    I certainly don't think that trying the dose they are suggesting could hurt any more than any other CNS medication.

    I use low dose Adderall to combat my chronic fatigue. It does help me - so I'm going to keep using it. It's what you would call "off-label" use - when a drug is used for something other than its approved indication. Psychiatrists probably use "off-label" drug therapy more than any other type of doctor.

    But there are some famous drug treatments out there that started out as "off-label" uses. Minoxidil was originally investigated as a cardiac drug. Cardiac patients started re-growing hair they had lost. This off-label effect was what led to the blockbuster Rogaine.

    Another famous drug that started out as an "off-label" is Viagra. Viagra was initially used as a drug to treat pulmonary arterial hypertension. Then so many reports came in from guys who got their "Boing" back by using it that it was studied and became an approved drug therapy for Erectile Dysfunction.

    Hope this helps,
    Madame Curie
  15. shootingstar

    shootingstar New Member

    but wish the advantages of modern medicine were equally available to all in a way that was not demeaning to those needing help. I am not referring specifically to pharmeceuticals here, but to medical care in its entirety.

    When I think back to what medicine was fifty years ago the accomplishments in the field have been truly miraculous. The problem is that too many people can't afford it. The gap between the wealthy and/or insured and those who are uninsured is becoming wider fast.

    Applying for help with individual prescriptions to individual pharmaceutical companies involves a wait, forms, stating you're nearly insolvent etc.

    Many employers do not provide access to health insurance. Once you've been sick, in most cases, you can forget about being able to get coverage on your own.

    I know we're infinitely better off than third world countries, I know this is a complex problem, but I also know in my heart we can do better.
  16. jhmitch

    jhmitch New Member

    Thank you for your informative posts, Madame Curie!

    Like you, Shootingstar, I believe our technology is phenomenal but we, as a country, can do better in providing medical care.
  17. matthewson

    matthewson New Member

    You are my heroes! Very well written posts! I wish I could write half as good as you two! I agree with everything you said!

    Take care, Sally
  18. mme_curie68

    mme_curie68 New Member

    If they glowed, I'd probably not stub them as much as I do in the dark...LOL!!!!

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