drugstr
Central, NJ
Male, 61
I have worked as a drug discovery scientist for over 30 years performing experiments to help identify novel chemical compounds for their potential in treating diseases in the areas of infection, inflammation and cardiovascular disorders. I have a good familiarity with the entire process from discovery to safety to clinical trials and even marketing. Ask me about the business of Big Pharma. I’m happy to comment on any and all hot-button issues. My opinions are quite often not pro-business.
It is well known that there is not. This is assuming that the definition of “cure” is a therapy that, subsequent to its administration, will no longer be necessary. A vaccine would fit this definition, but HIV-vaccine research has failed in several attempts. Nevertheless, some development is still ongoing. Current anti-HIV cocktails are maintenance therapy, probably for life. I say probably because there are a handful of patients that have been “seemingly” cured by them and are being studied. There are also some people who are immune to HIV due to certain genetic factors which are partially understood. One line of research being explored is the genetic modification of a sample of a patient’s own T cells with one of these factors and placing them back in the bloodstream. It’s an interesting concept, but not widely expected to be successful. So there is hope. But if your question is really aimed at revealing a hitherto unknown, secret cure that is being withheld for reasons nefarious, I’ll deal with that in the next question.
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Scientists interact infrequently with business partners whose responsibility is handling research budgets and operations. They almost never interact with corporate personnel, sales people and top executives. Higher level scientists will, on occasion, meet with executives representing various functions of the company to discuss experimental medicines and the pipeline portfolio. Silo is a term often used in my company as being undesirable, yet the transformation toward greater and greater specialization, an effort aimed at increasing performance, is only making them taller and narrower.
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When I think of cures I think of vaccines. Here’s a link I found on a search. http://www.news-medical.net/news/20100910/395-new-vaccines-being-developed-for-infectious-diseases-PhRMA.aspx which illustrates hundreds of vaccine programs in the works targeting all sorts of infectious agents. Current therapies for many of them like tuberculosis, MRSA, herpes and malaria are tough to take or only weakly effective.
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I’m not sure I can answer this question to your satisfaction. Sounds like you may have more information about this than I do. I may be an insider, but not so deep that I rub elbows with the field people. I’ve met a few at scientific meetings and I have observed the manner in which they host some of the physician attendees - not really very extravagant. The number of sales people has dwindled dramatically in recent years due marketing changes which emphasize sales to HMO and Pharmacy Benefit Managers who are now the largest customers. I’ve heard in the past about vacation junkets offered to medical opinion leaders and their families on which medical matters were discussed for all of about an hour so as to legally pass it off as a business trip. A practice recently disclosed in which eminent physicians publish favorable articles, doubtless in exchange for some consideration, that were actually written by drug company scientists. As far as rewarding prescribing physicians directly, I don’t know how companies would be able to enumerate the scripts these days given the privacy laws and the layers of drug distribution that currently exist.
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Yes, it happens. The USDA considers humane treatment as handling resulting in sensation no worse than a brief needle stick. Experiments are designed to adhere to this standard. However, there are situations, for example the first time a prospective medicine goes from the test tube into an animal, where an unanticipated toxic reaction may occur. When such a reaction occurs the animal is humanely euthanized immediately. There are exceptions to the standard in which some models of disease produce additional discomfort. For all animal experiments, an investigator must submit the intended experimental procedures to an expert review committee for approval. This committee, comprised of in-house scientists, veterinarians and community volunteers, monitors the experimental activities with particular interest in assuring that in these exceptional models, animals endure the least amount of discomfort in order to satisfy the scientific objective.
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To my knowledge, nothing like that has ever been proposed. We all understand the ethics of acknowledging our sources, but this is business and with no financial return this just can’t happen. Big Pharma knows the rules and is structured to play by them. It might interest you to know that there have been cases where the extreme opposite occurs. The former patent holder pays the generic company NOT to sell the drug. I won’t go into how this situation can arise (a bit complicated), but the ‘why’ is obvious (maintain profits). Legal anti-competitiveness is one of the things that gives Big Pharma a bad name.
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Ask that question to any pharmaceutical scientist and he/she will tell you that it’s the part played in contributing to the development of a marketed drug, particularly a life-saving one. In my own experience about 20 years ago I made some critical contributions to the discovery of a drug for the treatment of a somewhat rare, often deadly, lung infection. At the time, the only treatment available was not only frequently unsuccessful, but invariably caused severe, adverse side effects. Before large clinical trials of this drug were begun, the FDA allowed us to treat 60 “salvage” patients, i.e. people who failed standard-of-care therapy and were most likely destined to die. Our treatment saved all but 3 of them and the FDA quickly approved the drug for use in salvage therapy and soon after became the new standard-of-care for this condition. I can honestly say that the award I won for my efforts means less to me than the memory of my participation in that successful, life-saving project.
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