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.
If by cure you mean cancer being no more serious than a sore throat then no, not in this or any future lifetime. Cancer will always be a complicated condition that will require accurate diagnosis, careful characterization, appropriate treatment and exhaustive monitoring. As you know there are some cures already. Some cancers are successfully treated with surgery. Bone marrow transplants work for some leukemias. And targeted therapies, molecules or antibodies that are designed to be killers of very specific types of cancer cells, are emerging. One in particular has been on the market for over 10 years. It works, but the downside is its specificity.... Read More +
I have SOOOOO many thoughts on this. I won’t be able to say everything. How’s this for a start? “When you buy a brand name drug you’re not paying for the pill, but rather the intelligence that’s behind it. When you buy a generic drug you’re paying for the pill.” ….. me It’s well known that drug development costs are enormous. It may cost over a billion dollars to bring a new drug to market, but what’s not understood is that as much as ten times that amount may also have been spent at the same time on drug candidates that never make it to market for various reasons. This is the true cost of drug development and the tab must be paid in order... Read More +
Pharmaceutical companies are not sinister enterprises. They are however, opportunistic. When considering where to invest their resources, they look first at the size of the affected population then determine how best to rapidly develop a market. Trust me, if a curative drug target presented itself as the most tractable they would pursue it, not only because it would be the quickest path to market, but it would also be the most competitive. Big Pharma continues to hunt for cures in infectious diseases with drugs and vaccines. Consider the recent registration of drugs for the hepatitis C virus and vaccines for HPV. Targeted anti-tumor drugs... Read More +
No drug is safe. There are safety concerns with every medicine on the market. One of the requirements for approval of a new medicine by the FDA is for the drug company to reveal at what dose level the probable toxicities will appear and to prove that the doses used in therapy will be far lower. That means that the drug companies will push the safety envelope in animal studies to determine what bad things might happen.[Sounds cruel, but it’s not. Readouts are no worse than you having lab tests done on your blood.] Prescribers are then required to inform patients about the particular risks and monitor the patient during therapy if necessary.... Read More +
Special Education Teacher
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"The Onion" Contributors
By pranks you mean ‘dead mouse in the secretary’s lunch’ or ‘slipping an inappropriate slide into someone’s presentation’? No, that doesn’t happen where I work now. I remember working in an academic lab in the 70s where a guy tamed a lab rat. He would put it in a drawer or a cabinet or the pocket of his lab coat and watch people freak out when they saw it. He got me once. You can’t do that kind of thing now. There aren’t many gags that you can pull today that wouldn’t violate some ethical, safety, or PC standard.
In some companies there’s a strict dichotomy between PhD and non-PhD researchers, much like an academic environment. Non-PhDs can only ascend up through a series of “associate” positions and their roles are always in support of a PhD lab head. For PhDs the sky’s the limit in terms of advancement and one could characterize their attitude towards associates as superior. My company has not been like that. While PhDs enter at a higher level, non-PhDs can advance based on merit without restriction. I can think of three, two for whom I’ve worked directly, who achieved very high levels of responsibility and are responsible for some very important... Read More +
The US does the most, however a lot of innovative research also goes on in western Europe, particularly in the UK, Switzerland, France and Germany. There’s a large drug company in Israel that does a lot of generic work and some innovative work. In India there are companies that do mostly generic work along with contract work on behalf of western companies. China does a lot of contract work in chemistry and biology and will likely soon become a force in innovative drug development.
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... Read More +
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.
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... Read More +
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.
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.
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... Read More +
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... Read More +
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... Read More +
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... Read More +
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... Read More +
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... Read More +
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... Read More +
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... Read More +
I’m not sure I understand the question. If by “Chemist Online” you mean online pharmacies, more specifically those not in compliance with all pharmacy laws and practice standards, and how they get away with that, then the answer is simple ... enforcement. The DEA is on the case, but decide for yourself how well they’re doing. There’s no reason why a legitimate pharmacy cannot operate online in the US just the same as your local drugstore or your mail-order benefit manager. There are some. Those are the ones sanctioned by the NABP, the National Association of Boards of Pharmacy and licensed by the state in which they operate. Most are not.
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.
Not a big difference. Broadly defined, a pharmacologist studies the behavior of drugs in the body. That ranges from where the drug goes, how it leaves and how well it interacts with its target. Once determined in humans to behave satisfactorily, medical folks take over (clinicians) to evaluate disease efficacy. For example, the pharmacologist determines how well it lowers cholesterol. The clinician determines how well it treats heart disease. As a prerequisite to human studies, my role as an analytical biochemist in early drug discovery supported studies of pharmacology in animals. I measured drug... Read More +
My advice to you is to first not think of this “job” as a job, but rather as a career. By that I mean consider that most pharmaceutical research is broadly science based. Don’t limit your thinking to the biology examples that I described. You can be a chemist or a statistician or even a doctor. Go to a university with a strong science reputation and get a B.S. in biology, chemistry or math. Decide where your strengths and passions lie and follow them. The list is long of things you can major in. There’s biochemistry, physiology, microbiology, cell biology, genetics, synthetic chemistry, analytical chemistry,... Read More +
Pharma executives LOVE credentials! They generally tend to be quite risk averse so multiple certifications induce greater confidence in a hiring manager’s decision to support the candidacy of an individual. It sort of lessens the burden of accountability (ass covering). Of course this is not a sound principle as it often leads to failure. Nevertheless, more diplomas might get you the interview, particularly in this era of downsizing and reorganizing. I am not advocating that you seek a dual degree for that reason. I don’t know anyone with a PharmD/PhD dual degree and I’m not quite sure where such a person would fit in my company. In... Read More +
Nonsense.
I don’t know what kind of career advice I could give you. PT and biotech seem rather disconnected. Bioengineering could serve you in developing therapeutic devices. Most scientists turned entrepreneurs often stay involved in research in a management role and provide intellectual input as well.
I am not an academic so I can’t say one way or another if you would qualify. My guess is that you might find a place, but may have to take a more extensive set of basic courses in order to elevate yourself to the level of other students in the program.
This is really not in my wheel house, but I’ll tell you what I think I know. Clinical researchers in big pharma are typically MDs. They interface between scientific groups in house and outside physicians who run the trials. They have a non-MD support staff which is more or less a dead end. One simply can’t advance without an MD. This sort of work does not fit with your business training. Surely, clinical research has a management arm, but I’m sorry, I can’t tell you how to get there. Increasingly, big pharma tends to outsource a lot of their clinical work to CROs (contract research organizations). Search for them. Breaking in to the business... Read More +
Initial patent applications are filed early in the discovery process. As soon as a novel chemical structure is identified as having pharmacological properties a very lengthy, general application is authored that claims therapeutic benefits for every conceivably related medical condition and includes every imaginable chemical modification to that structure. During the development process additional patents might be filed for hitherto unexpected uses and for novel formulation and manufacturing processes.
Sorry for the late response. I have no expertise in this area. I hope by now you have resolved your issue. Best of luck.
I can't answer because I pay no attention to him.
Trump spoke without thinking - disinfectants are poisons. Hydroxychloroquine was a silly attempt at being a hero. A swing and a miss, not a home run. Your question is vague. Are you asking about killing the virus in the air or on surfaces, or how to best avoid infection, or what's the best treatment for the disease? Answers to the first two are described in the media daily, as for the last my opinion is oxygen, anti-inflammatories and an appropriate anti-viral (not yet invented).
Ask the person about the last presentation that he or she made and to send you a copy of the slide deck. If you receive it, look it over and ask questions about it. You'll be able to tell from the answers whether he/she is legit.
Sorry for the late response. I believe that taste is not the major driver of appetite. In fact, dulling the senses might encourage further eating. Just my 2 cents.
Thank you for bringing this to my attention. I hadn't seen this. I'm very familiar with this drug, ivermectin, IVM. It was discovered and developed in the U.S. in the 70's. Its primary use is in animal medicine for the treatment of worms in the GI tract. The Australian discovery is very exciting. They showed that IVM blocks COVID-19 in vitro (petri dish) and clinical trials are underway to test its effectiveness in humans with the disease. From what little I've read, the levels of IVM used in vitro will be difficult to achieve in the blood of patients when dosed orally, the only route of administration currently approved. Nevertheless, it... Read More +
I have the same questions. The answers are not very clear. The FDA has approved its use for certain rare seizure disorders and is useful in reducing nausea and vomiting in cancer chemotherapy patients. Other common claims, not formerly established indications, are chronic pain, inflammation, anxiety, appetite and several mental health conditions. Best usage - replace opiates for chronic pain. Judging effectiveness clinically has got to be difficult since therapeutic success is subjective. I imagine it's hard to identify a patient's true need versus desire for it. As far as safety goes, there are the dangers associated with intoxication and... Read More +
Sorry for the late response. I hope you're doing well and enjoying the program. I think that your training would prepare you well for your goal. I have seen Pharm. D.s working at all levels, but I must say that research leadership tends to be composed mainly of PhDs and MDs. Still, your success will depend entirely on your skills and ambition. Good luck!
No I haven't. I never worked with patients nor am I aware of any one dying from an adverse event while on a drug that I was involved in developing.
Millions of people around the world rely on plant-based remedies for treating their ailments and I would never say that they are making a mistake. There's often thousands of years of experience behind this practice. It's well known that a vast number of pharmacological agents originated from biology. I myself prefer only to use the specific compounds derived from these materials for two reasons. First, it avoids the complications that might exist from other components in the material. For example, I wouldn't eat a fungus for the penicillin. And second, I'm confident that the pure drug has been demonstrated to be safe, is appropriate for my... Read More +
This is not a pharma question.No numbers have been changed. Evidently, a CDC report on comorbidities was the source of this misinformation.
Every drug carries risks of side-effects which are sometimes dangerous. Doctors are responsible for determining whether the curative value of a prescription outweighs these risks. A competent physician does this with full knowledge of the drug profile and an intimate knowledge of the patient’s condition. A drug manufacturer applies to the FDA for permission to market a drug for a particular indication by submitting clinical evidence proving safety and efficacy. A drug may have more than one indication in its ‘label.’ Doctors are free, however, to prescribe drugs ‘off-label’ for a condition not specifically approved by the FDA. There may be... Read More +
I answered a related question 7 years ago. Find it above and see if it answers your question.
I don’t know what you mean by fraudulent. Is it the most counterfeited, the most unauthorized generic, or the one that I would say does not perform as claimed? Frankly, I don’t have an answer for any of these. My pet peeve is the endless promotion of herbals, and formulations that promise better memory, vision, prostate health, weight loss, etc. I don’t believe their ‘clinical’ evidence.
Administering convalescent plasma, or for that matter monoclonal anti-covid antibody, is referred to as passive immunity. It will no doubt be useful for patients in whom virus is circulating in the blood stream. This may well be life-saving in these patients, but it would not be expected to prevent infection which is initiated outside of the blood stream. There's more to immunity than antibodies. There's a cellular component which serves to combat invading pathogens by surveillance and direct destruction. It's not clear how important this is for disease protection or whether vaccines will generate this cellular immunity. It's possible that... Read More +
I would say that if these physicians' claims of success in treating COVID-19 patients are accurate then their methods should, indeed, be adopted by others. Having said that, their belief that hydroxychloroquine and azithromycin are the keys to positive outcomes is dubious. There's more to patient care than drugs. Bona fide, well-controlled clinical studies have shown these two to be of no benefit. I'm a little on the fence, however, about zinc. Zinc has a number of roles in biology. The one I'm thinking of is its interaction with protein which can influence tertiary structure (shape) and in so doing interfere with virus binding. As you probably... Read More +
First there's development, then testing, then approval, then manufacture, then distribution and then WE have it. For COVID-19 most are still in development and a handful are now in testing with a few in late stage testing. Normally these steps would take a couple of years, but acceleration has been inserted in a couple of places, i.e. government funding of development, political pressure on approval (maybe), and manufacture on spec. These things could shave off several months. Also, if a vaccine works very well, interim analysis may reveal significant efficacy and safety and thus early approval. There are still unresolved hurdles to distribution... Read More +
These two drugs are not chemically related. Both have sedation as a side effect of their modes of action. Trazadone is an antidepressant. Etorphine is a powerful synthetic opiate significantly more potent than fentanyl. It's considered too dangerous to be used in human medicine. In veterinary medicine its use often requires reversal with an antidote. Thus, it's not practical as a treatment for insomnia.
Again, not really a pharma question. The CDC recommends a mask with two or more layers of breathable fabric. Wear one anytime you're around people not in your household. I wear inexpensive, disposable, 3-layer surgical masks available online.
This is complicated and not really a pharma question. More important than which body part is sampled is what exactly is being measured with each type of test and the reason why you seek testing. If you think you've been exposed wait a couple of days and get the PCR test (nose swab). It is sensitive enough to pick up the virus even before you become infectious to others, sick or asymptomatic. Unfortunately, test results arrive several days later so quarantine until then and hope for a negative. Antigen test - this is the best test if you're actually feeling sick. It's less sensitive than PCR, but if you're truly sick with COVID it will tell... Read More +
According to the FDA there is no effective HCQ regimen for the treatment of COVID-19. Its emergency use is no longer authorized. I refer you to the link below for answers to your three questions.https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or
In my view an OTC medication must satisfy two criteria. First, it must have a very well-established, excellent safety profile and second, it must be a proven remedy for a condition that the user can self-determine. For example, headache, heartburn, constipation, etc. Conditions like high BP, high cholesterol, and diabetes are not reliably monitored by patients and are thus appropriately not OTC. There are certain prescription medicines that treat self-determinable conditions that I believe could be OTC so long as they are dispensed by a professional capable of providing safety guidance for their use. Call it “pharmacist prescribing.” My list... Read More +
This is not a pharma question and I’m not expert in colligative properties, however, my understanding is that freezing point depression is a function of the molality of a solute in a solution. The molality represents the total number of dissolved particles. You’re obviously familiar with this since your list includes compounds of increasing molal potential. I submit that based on molality, aluminum chloride would be best so long as the solution was fairly dilute. While the others nicely dissolve in water, AlCl3 reacts with water and forms HCl, a dissolved gas. In a concentrated solution some of the HCl would degas and thus lower the molality... Read More +
Opioids have been around for a very long time. Their usages, i.e. pain relief and pleasure, historically have not changed. There always have been overdose deaths, sad as they were, but what’s different today is the sheer number of them. The causative issues that have been identified are the bloated and reckless supply chain of pharmaceutical grade pills and the incorporation of deadly fentanyl into the street drugs. There are no simple solutions. Government action against irresponsible manufacturers and distributers, tighter regulation of prescriptions, and the availability of rescue medicines in the field, while sensible, have actually only... Read More +
End which part? International cartels and their networks in the U.S.? No. Criminalization of users? Yes, unless they commit other serious crimes. Treat addiction as a medical problem with therapy and/or safe drugs with supervision.
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