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.
I agree with you. Your example of AIDS drugs donated, sold at cost or licensed for free is an extreme example of pharma’s mission of fulfilling unmet medical needs. As you know, what you describe is actually happening although it took a bit of negotiating to get control of it. There are a lot of unlicensed generics of all kinds of drugs being manufactured worldwide and it’s a problem that pharma cannot ignore. I say extreme because this same moral obligation extends to the distribution of medicines to countries around the world who’s governments regulate prices. Companies sell drugs in Canada for less because the Canadian government demands it. What choice do they have but to accept these market conditions in order to fulfill that mission? Pharma gets an undeserved bad rap for this from US consumers. It’s strange that no one speaks on their behalf on this. Yes, Big Pharma is a business driven by profits, but willingness to take a hit for moral reasons is good business and they know it.
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I would say they pay pretty well. A researcher with a Master’s degree and 5 or more years of experience might earn 90 ± 20k and PhDs 10 to 20k more. In New Jersey, it’s a little tough for a single bread-winner, but for a two salary household it’s comfortable. High level scientists and managers make a lot more. Attaining those positions by advancement has become increasingly difficult. You’d be better off changing employers. There are comprehensive benefit packages including pension and savings plan with matching contributions. No special perks other than free company medicines through the prescription plan. High level exposure to science and medicine is a plus. I’ve met Nobel Laureates and other top scientists and the overall awareness of medical conditions and progress has clearly benefitted my own health and my family’s.
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Not having worked directly in clinical operations I don’t know all the particulars regarding patient recruitment for experimental drug trials, but I can give you some general information. There are two types of trials. The first is an initial experiment with certifiably healthy volunteers to observe properties of the drug once administered and to identify any safety and tolerability issues that might be present. Also, if possible, researchers will test for the drug’s access to the desired molecular target. The patients in these trials are often treated and observed in an in-patient hospital-like setting where they are closely monitored for at least a day, fed a controlled diet and repeatedly sampled for blood and possibly other specimens. They are also often called back for control tests. The incentive for participation is cash. Given the intensity of this commitment, payment is significant. I can’t tell you how much, but I would imagine it to be scaled based on geography, length of study and historical rates. Past participants are often invited back and new recruits are obtained through the most efficient local channels. The second type, and by far the largest in terms of participants, is an efficacy trial in which people with the targeted illness are treated and evaluated. The incentive for participation is free treatment, however involved that may be, and of course the medical benefit offered. Some compensation may be available to cover incidental expenses. The commitment is usually not more involved than taking the medication, reporting your experience and periodic visits to the clinic.
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In college I was aware that my professors not only taught classes, but also had laboratories in which they did the research which advanced their reputations and contributed new knowledge to science. I thought, “Who wouldn’t be attracted to this noble endeavor?”, and soon found my way into my organic chemistry professor’s lab working alongside PhDs and graduate students. I learned a lot, performed well, enjoyed the collegial experience and within a semester had accomplished work worthy of publication. I was hooked. I had begun my research career. In advancing from chemistry to biology to drug research one overall concept has continued to provide fulfillment for me. That is, when you do research, you have the opportunity to be the first person on earth to behold a new bit of knowledge. It may only be a small piece of information, but you’re the first and it’s yours to own and report. I’m still hooked.
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Farmer
Do friends with office jobs look down on what you do?
Pharmacist
Why is an advanced degree required to dole out pills at a pharmacy?
Navy Officer (Former)
What's the most dangerous situation you were ever in?
You are exactly right. A modern pill is actually a cluster of thousands of tiny pills. Each of these tiny pills is engineered to release their contents in a controlled way based on the chemical properties of the drug in order to optimize the therapeutic benefit. Most time-release formulations contain two types, one that dissolves immediately and one that releases slowly or only in another part of the GI tract. With regard to vitamins, most nutritionists are not convinced we need supplements at all. We get all we need from a healthy diet. Supplementing a poor diet is like multiplying by zero. Time release is probably not particularly beneficial for vitamins. After all, our natural intake of vitamins is not time released.
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Chemically they are essentially the same. It’s how they are administered that makes the difference. Adderall is a carefully engineered mixture of the d & l forms of methamphetamine in a ratio designed to produce the desired norepinephrine driven stimulus with a minimum of dopamine euphoria when taken orally. The drug enters the blood slowly, maximizing at 3 hours (standard form) or 7 hours (XR). I’m guessing that street meth is an uncontrolled mixture. When taken at a higher dose either intranasally or by inhalation, peak levels appear in minutes and are thus extremely high. Not only is the dopamine effect profound, repeated exposure will irreversibly damage the nerve cells that are targeted.
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My understanding of the acceptable limits of variation in dosage units is specified for each drug as part of the FDA review process. The range limit is typically 80% to 130% of targeted content. In order to guarantee keeping within that range the manufacturer will shoot for statistical variation of no more than 10% and may bump a little to the higher end to increase shelf life. I could not say for sure if the possible variation in Adderall content could be therapeutically detectable as you suggest, but it would not be expected based on general pharmacological principles. That said it remains possible.
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