There have also been cases of available treatment being withheld during clinical trials.  In 1996 in Kano, Nigeria , the drug company  Pfizer  compared a new antibiotic during a  meningitis  outbreak to a competing antibiotic that was known to be effective at a higher dose than was used during the trial. Goldacre writes that 11 children died, divided almost equally between the two groups. The families taking part in the trial were apparently not told that the competing antibiotic at the effective dose was available from  Médecins Sans Frontières  in the next-door building. [ 15 ]


Chapter three describes the concept of " regulatory capture ," whereby a regulator – such as the  Medicines and Healthcare products Regulatory Agency  (MHRA) in the UK, or the  Food and Drug Administration  (FDA) in the United States – ends up advancing the interests of the drug companies rather than the interests of the public. Goldacre writes that this happens for a number of reasons, including the  revolving door  of employees between the regulator and the companies, and the fact that friendships develop between regulator and company employees simply because they have knowledge and interests in common. The chapter also discusses  surrogate outcomes  and  accelerated approval , and the difficulty of having ineffective drugs removed from the market once they have been approved. [ 16 ]  He argues that regulators do not require that new drugs offer an improvement over what is already available, or even that they be particularly effective. [ 17 ]


"Bad Trials" examines the ways in which clinical trials can be flawed. Goldacre writes that this happens by design and by analysis, and that it has the effect of maximizing a drug's benefits and minimizing harm.
There have been instances of fraud, though he says these are rare. More common are what he calls the "wily tricks, close calls, and elegant mischief at the margins of acceptability." [ 18 ]


These include testing drugs on unrepresentative, "freakishly ideal" patients; comparing new drugs to something known to be ineffective, or effective at a different dose or if used differently; conducting trials that are too short or too small; and stopping trials early or late. [ 19 ]  It also includes measuring uninformative outcomes; packaging the data so that it is misleading; ignoring patients who drop out (i.e. using  per-protocol analysis , where only patients who complete the trial are counted in the final results, rather than  intention-to-treat analysis , where everyone who starts the trial is counted); changing the main outcome of the trial once it has finished; producing  subgroup analyses  that show apparently positive outcomes for certain tightly defined groups (such as Chinese men between the ages of 56 and 71), thereby hiding an overall negative outcome; and conducting " seeding trials ," where the objective is to persuade physicians to use the drug. [ 20 ]


Another criticism is that outcomes are presented in terms of  relative risk reduction  to exaggerate the apparent benefits of the treatment. For example, he writes, if four people out of 1,000 will have a heart attack within the year, but on statins only two will, that is a 50 percent reduction if expressed as relative risk reduction. But if expressed as  absolute risk reduction , it is a reduction of just 0.2 percent. [ 21 ]


In chapter five Goldacre suggests using the  General Practice Research Database  in the UK, which contains the anonymized records of several million patients, to conduct  randomized trials  to determine the most effective of competing treatments. For example, to compare two statins,  atorvastatin  and  simvastatin , doctors would randomly assign patients to one or the other. The patients would be followed up by having data about their cholesterol levels, heart attacks, strokes and deaths taken from their computerized medical records. The trials would not be  blind  – patients would know which statin they had been prescribed – but Goldacre writes that they would be unlikely to hold such firm beliefs about which one is preferable to the extent that it could  affect their health . [ 22 ]


In the final chapter, Goldacre looks at how doctors are persuaded to prescribe "me-too drugs," brand-name drugs that are no more effective than significantly cheaper off-patent ones. He cites as examples the statins atorvastatin (Lipitor, made by Pfizer) and simvastatin (Zocor), which he writes seem to be equally effective, or at least there is no evidence to suggest otherwise. Simvastatin came off patent several years ago, yet there are still three million prescriptions a year in the UK for atorvastatin, costing the  National Health Service  (NHS) an annual £165 million extra. [ 23 ]


He addresses the issue of  medicalization  of certain conditions (or, as he argues, of personhood), whereby pharmaceutical companies "widen the boundaries of diagnosis" before offering solutions.  Female sexual dysfunction  was highlighted in 1999 by a study published in the  Journal of the American Medical Association , which alleged that 43 percent of women were suffering from it. After the article appeared, the  New York Times  wrote that two of its three authors had worked as consultants for Pfizer, which at the time was preparing to launch  UK-414,495 , known as female  Viagra . The journal's editor said that the failure to disclose the relationship with Pfizer was the journal's mistake. [ 24 ]


The chapter also examines celebrity endorsement of certain drugs, the extent to which claims in advertisements aimed at doctors are appropriately sourced, and whether  direct-to-consumer advertising  (currently permitted in the US and New Zealand) ought to be allowed. [ 25 ]  It discusses how PR firms promote stories from patients who complain in the media that certain drugs are not made available by the funder, which in the UK is the NHS and the  National Institute for Health and Clinical Excellence  (NICE). Two breast-cancer patients who campaigned in the UK in 2006 for  trastuzumab  (Herceptin) to be available on the NHS were being handled by a law firm working for  Roche , the drug's manufacturer. The historian  Lisa Jardine , who was suffering from breast cancer, told the  Guardian  that she had been approached by a PR firm working for the company. [ 26 ]


The chapter also covers the influence of  drug reps , how  ghostwriters  are employed by the drug companies to write papers for academics to publish, how independent the academic journals really are, how the drug companies finance doctors' continuing education, and how patients' groups are often funded by industry. [ 27 ]


In the afterword and throughout the book, Goldacre makes suggestions for action by doctors, medical students, patients, patient groups and the industry. He advises doctors, nurses and managers to stop seeing drug reps, to ban them from clinics, hospitals and medical schools, to declare online and in waiting rooms all gifts and hospitality received from the industry, and to remove all drug company promotional material from offices and waiting rooms. (He praises the website of the  American Medical Student Association  – www.amsascorecard.org – which ranks institutions according to their  conflict-of-interest  policies, writing that it makes him "feel weepy.") He also suggests that regulations be introduced to prevent pharmacists from sharing doctors' prescribing records with drug reps. [ 28 ]


He asks academics to lobby their universities and academic societies to forbid academics from being involved in ghostwriting, and to lobby for "film credit" contributions at the end of every academic paper, listing everyone involved, including who initiated the idea of publishing the paper. [ 29 ]  He also asks for full disclosure of all past clinical trial results, and a list of academic papers that were, as he puts it, "rigged" by industry, so that they can be retracted or annotated. [ 30 ]  He asks drug company employees to become whistleblowers, either by writing an anonymous blog, or by contacting him. [ 31 ]


He advises patients to ask their doctors whether they accept drug-company hospitality or sponsorship, and if so to post details in their waiting rooms, and to make clear whether it is acceptable to the patient for the doctor to discuss his or her medical history with drug reps. Patients who are invited to take part in a trial are advised to ask, among other things, for a written guarantee that the trial has been publicly registered, and that the main outcome of the trial will be published within a year of its completion. He advises patient groups to write to drug companies with the following: "We are living with this disease; is there anything at all that you're withholding? If so, tell us today." [ 32 ]


The book was generally well received. The  Economist  described it as "slightly technical, eminently readable, consistently shocking, occasionally hectoring and unapologetically polemical". [ 33 ]   Helen Lewis  in the  New Statesman  called it an important book, [ 34 ]  while Luisa Dillner, writing in the  Guardian , described it as a "thorough piece of investigative medical journalism". [ 1 ]


Andrew Jack wrote in the  Financial Times  that Goldacre is "at his best in methodically dissecting poor clinical trials. ... He is less strong in explaining the complex background reality, such as the general constraints and individual slips of regulators and pharma companies' employees." Jack also argued that the book failed to reflect how many lives have been improved by the current system, for example with new treatments for HIV, rheumatoid arthritis and cancer. [ 35 ]


Max Pemberton , a psychiatrist, wrote in the  Daily Telegraph  that "this is a book to make you enraged ... because it's about how big business puts profits over patient welfare, allows people to die because they don't want to disclose damning research evidence, and the tricks they play to make sure doctors do not have all the evidence when it comes to appraising whether a drug really works or not." [ 36 ]


The  Association of the British Pharmaceutical Industry  (ABPI) replied in the  New Statesman  that Goldacre was "stuck in a bygone era where pharmaceutical companies wine and dine doctors in exchange for signing on the dotted line". [ 37 ]  The ABPI issued a press release, writing that the pharmaceutical industry is responsible for the discovery of 90 percent of all medicines, and that it takes an average of 10–12 years and £1.1bn to introduce a medicine to the market, with just one in 5,000 new compounds receiving regulatory approval. This makes research and development an expensive and risky business. They wrote that the industry is one of the most heavily regulated in the world, and is committed to ensuring full transparency in the research and development of new medicines. They also maintained that the examples Goldacre offered were "long documented and historical, and the companies concerned have long addressed these issues". [ 5 ]  Goldacre argues in the book that "the most dangerous tactic of all is the industry's enduring claim that these problems are all in the past". [ 38 ]


Humphrey Rang of the  British Pharmacological Society  wrote that Goldacre had chosen his target well and had produced some shocking examples of secrecy and dishonesty, particularly the nondisclosure of data on the antidepressant  reboxetine  (chapter one), in which only one trial out of seven was published (the published study showed positive results, while the unpublished trials suggested otherwise). He argued that Goldacre had gone "over the top" in devoting a whole chapter (chapter five) to recommending large clinical trials using electronic patient data from general practitioners, without fully pointing out how problematic these can be; such trials raise issues, for example, about informed consent and regulatory oversight. Rang also criticized Goldacre's style, describing the book as too long, repetitive, hyperbolic, and in places too conversational. He particularly objected to the line, "medicine is broken", calling it a "foolish remark". [ 39 ]


Following the book's publication, Goldacre co-founded  AllTrials  with David Tovey, editor-in-chief of the  Cochrane Library , together with the  British Medical Journal ,  the Centre for Evidence-Based Medicine , and others in the UK, and  Dartmouth College 's  Geisel School of Medicine  and the  Dartmouth Institute for Health Policy and Clinical Practice  in the US. Set up in January 2013, the group campaigns for all past and current clinical trials to be registered and reported, for all treatments in use. [ 6 ]


The British House of Commons  Public Accounts Committee  produced a report in January 2014, after hearing evidence from Goldacre,  Fiona Godlee , editor-in-chief of the  British Medical Journal , and others, about the stockpiling of Tamiflu and the withholding of data about the drug by its manufacturer, Roche. The committee said it was "surprised and concerned" to learn that information from clinical trials is routinely withheld from doctors, and recommended that the Department of Health take steps to ensure that all clinical-trial data be made available for currently prescribed treatments. [ 40 ]


Ben Adams,  "Goldacre takes ABPI to task over book snub"   Archived  7 January 2014 at the  Wayback Machine ,  Pharma Times , 12 October 2012.


Rajeev Syal,  "Drug companies accused of holding back complete information on clinical trials" ,  The Guardian , 3 January 2014.


Staa, TP; Goldacre, B; Gulliford, M; Cassell, J; Pirmohamed, M; Taweel, A; Delaney, B; Smeeth, L (2012).  "Pragmatic randomised trials using routine electronic health records: putting them to the test" .  BMJ .  344 : e55.  doi : 10.1136/bmj.e55 .  PMC   3934788 .  PMID   22315246 .


For the 1999 study,  Laumann, EO; Paik, A; Rosen, RC (February 1999).  "Sexual dysfunction in the United States: prevalence and predictors" .  JAMA .  281  (6):  537– 44.  doi : 10.1001/jama.281.6.537 .  PMID   10022110 .


Denise Grady,  "Sure, We've Got a Pill for That" ,  The New York Times , 14 February 1999.


Charlie Cooper,  "Drugs companies 'routinely withhold results of medical trials' from doctors, researchers and patients" ,  The Independent , 3 January 2014.


Big Pharma: How the World's Biggest Drug Companies Control Illness  is a 2006 book by British journalist Jacky Law. The book examines how major  pharmaceutical companies  determine which  health care  problems are publicised and researched. [ 1 ]


Outlining the history of the  pharmaceutical industry , Law identifies what she says is the failure of a regulatory framework that assumes pharmaceutical companies always produce worthwhile products that society will want. [ 1 ]


Law has written about healthcare for 25 years, seven of them as associate editor of  Scrip Magazine , a monthly magazine for the drugs industry. [ 2 ]


Ike Iheanacho writes about the book that "The author is clearly no great fan of the industry. But, refreshingly, she avoids the sort of lazy polemic that casts major pharmaceutical companies as an evil empire that continually foists its products on unwilling and unsuspecting healthcare professionals and patients." [ 3 ]


Big Pharma conspiracy theories  are  conspiracy theories  that claim that  pharmaceutical companies as a whole , especially big  corporations , act in  dangerously secretive  and sinister ways that harm  patients . This includes concealing effective treatments, perhaps even to the point of intentionally causing and/or worsening a wide range of  diseases , in the pursuit of  higher profits  and/or other nefarious goals. The  general public  supposedly lives in a state of  ignorance , according to such claims. [ 1 ] [ 2 ]


Some theories have incorporated the assertions that natural, alternative remedies to multiple  health  struggles are being suppressed, that  medications  for the treatment of  HIV/AIDS  are ineffective and harmful, that an effective cure for all  cancers  has been discovered but concealed from the public, that  vaccines for COVID-19  are ineffective, and that alternatively understood  cures  exist for  COVID-19  itself. In most cases, the conspiracy theorists have blamed pharmaceutical companies' search for increased  profit margins . A range of authors have shown these claims to be false, though some of these authors nevertheless maintain that other  criticisms of the pharmaceutical industry  are legitimate. [ 3 ] [ 4 ] [ 5 ] [ 6 ] [ 7 ] [ 8 ] [ 9 ]


According to  Steven Novella , the use of  terminology  such as  Big Pharma  has come to connote a  demonized  form of the  pharmaceutical industry , described in an  emotional fashion , which exists disconnected from the real-life complexity of  business  history. [ 5 ]  Professor of writing Robert Blaskiewicz has written that conspiracy theorists use the term  Big Pharma  as "shorthand for an abstract entity comprising corporations, regulators, NGOs, politicians, and often physicians, all with a finger in the trillion-dollar prescription pharmaceutical pie". [ 1 ]


According to Blaskiewicz, the Big Pharma conspiracy theory has four classic traits: first, the assumption that the conspiracy is perpetrated by a small malevolent cabal; secondly, the belief that the public at large is ignorant of the truth; thirdly, that its believers treat lack of evidence as evidence; and finally, that the arguments deployed in support of the theory are irrational, misconceived, or otherwise mistaken. [ 1 ]


In the 1970s and 1980s, the conspiracy theory was promoted by  Ann Wigmore  who held that diseases, including cancer and  HIV/AIDS , could be effectively treated with a  raw food diet . In this context, Wigmore believed that the pharmaceutical industry was part of a conspiracy to keep the population at large ill. [ 10 ]


André Picard  wrote in 2009 that the internet had radically changed the nature of popular scientific discourse from being infrequent and deferential to widespread and conspiracy based: scientific debate was often supplanted by dismissal of science as being "part of some vast conspiracy". In the conspiracist world view, "Doctors, nurses, pharmacists, pharmacologists, biochemists, immunologists, geneticists and journalists are not to be trusted. They are all on the take". [ 11 ]


Research in Italy in 2016 found that nearly half the adult population believed that pharmaceutical companies hinder the development of effective medications to heal serious diseases, which according to the authors is a conspiracy theory, and that such beliefs were negatively correlated to mainstream religion while having anti-science and anti-elitism bases. [ 2 ]


The conspiracy theory has a variety of different specific manifestations. Each has different narratives, but they always cast "Big Pharma" as the villain of the piece. [ 1 ]


Since the beginning of the  AIDS epidemic , many dangerous hypotheses have been put forward to explain the origin and nature of the disease. One conspiracy theory claims that AIDS was created by the  US government  to control and/or wipe out  gays  and  African Americans . Also, there is a cure for HIV/AIDS that is withheld from the poor. [ 12 ] [ 13 ]  Other theories say that although the virus is harmful, the risks of  antiretroviral drugs  outweigh the benefits. The drugs are said to be toxins that are spread by doctors who have been corrupted by the pharmaceutical industry. [ 14 ]


In a 2006 column for  Harper's Magazine , journalist  Celia Farber  claimed that the antiretroviral drug  nevirapine  was part of a conspiracy by the "scientific-medical complex" to spread toxic drugs. [ 15 ]  Farber said that AIDS is not caused by HIV and that nevirapine had been unethically administered to pregnant women in clinical trials, leading to a fatality. [ 15 ]  Farber's theories and claims were refuted by scientists, but, according to researcher  Seth Kalichman , the resulting publicity represented a breakthrough moment for  AIDS denialism . [ 16 ]


The former president of  South Africa ,  Thabo Mbeki , influenced by AIDS denier  Peter Duesberg , introduced policies that denied treatments to AIDS patients. According to estimates this led, among other things, to more than 300,000 people dying prematurely. [ 17 ] [ 18 ]


A recurring conspiracy theory claims that the pharmaceutical industry has a cure for  cancer , but suppresses it so that they can continue to make billions on the "ineffective" treatments currently given to cancer patients. [ 19 ]  This was believed by 27% of the American public according to a 2005 survey. [ 20 ]  The argument is that pharmaceutical companies are slowing down research for a comprehensive cure for cancer by developing high-profit, single-purpose treatments rather than focusing on a supposed cure-all for all cancers. [ 21 ]


Following the crash of  Voepass Linhas Aéreas Flight 2283  in August 2024, social media posts appeared naming Leonardo Ferreira, a cancer researcher, as one of the passengers. The  Brazilian College of Radiology and Imaging Diagnosis  published an obituary and conspiracy theories spread about how big pharma had engineered the supposed death of somebody close to finding a breakthrough cancer cure. Ferreira confirmed he was not dead; nobody of that name was on the aircraft's passenger list. [ 22 ]


The idea that vaccines were created by the pharmaceutical industry to make people sick, or to alter  human DNA , [ 23 ] [ 24 ]  has been around for a long time but has been given new life during the COVID-19 pandemic. [ 25 ] [ 26 ]


The conspiracy theory that  vaccines make people autistic  can be traced back to a study published in  The Lancet  in February 1998. [ 27 ] [ 28 ]   Andrew Wakefield  claimed that there is a link between  MMR vaccine and autism . The study later  turned out to be fraudulent , and led to Wakefield being struck off the medical register. The Lancet also withdrew the article. [ 29 ]  Although a number of studies have disproved the link between autism and vaccines, [ 30 ]  the conspiracy theory has survived in various forms, and it has been spread by, among others,  Donald Trump . [ 31 ] [ 32 ]


Other conspiracy theories suggest that vaccines are used to implant  microchips  for  surveillance  and  thought control . [ 33 ]  Among others, the  Bill & Melinda Gates Foundation  has been accused of wanting to microchip the world's population through global vaccination programs. [ 34 ] [ 35 ] [ 36 ]


The  COVID-19 pandemic  is surrounded by a wide range of conspiracy theories, including the postulation that COVID-19 does not exist at all or is just a mild  flu . [ 37 ] [ 38 ]


During the pandemic, there was a surge of conspiracies about  the origins of the disease , such as claiming that the virus was created in a laboratory. However, strong evidence suggests that the disease-causing virus,  SARS-CoV-2 , is a naturally evolved strain belonging to the  coronavirus subfamily . [ 39 ] [ 40 ]


The 2020 video  Plandemic: The Hidden Agenda Behind Covid-19 , promotes the conspiracist claim that vaccines are "a money-making enterprise that causes medical harm". In the video, former research scientist  Judy Mikovits  spread the notion that "Big Pharma",  Bill Gates  and the  World Health Organization  led a conspiracy, in which they acted together as a "circular cabal" with the aim of killing Americans. [ 41 ]  The video was released on May 4, 2020, and garnered millions of views, making it one of the most widespread pieces of COVID-19 misinformation.


In the book  Natural Cures "They" Don't Want You to Know About , author  Kevin Trudeau  claims that there are all-natural cures for serious illnesses including  cancer ,  herpes ,  arthritis ,  AIDS ,  acid reflux disease ,  diabetes ,  multiple sclerosis ,  lupus ,  chronic fatigue syndrome ,  attention deficit disorder ,  muscular dystrophy , and that these are all being deliberately hidden and suppressed from the public by the  Food and Drug Administration , the  Federal Trade Commission , and major food and drug companies. [ 42 ]  The book has been the focus of much controversy since its publication, with widespread allegations of fraud. [ 43 ] [ 44 ]


A common claim among proponents of the conspiracy theory is that pharmaceutical companies suppress negative research about their drugs by financially pressuring researchers and journals. Skeptic  Benjamin Radford , while conceding there is "certainly a grain of truth" to these claims, notes that there are in fact papers critical of specific drugs published in top journals on a regular basis. [ 3 ]  A prominent example noted by Radford is a systematic review published in the  British Medical Journal  showing that  paracetamol  is ineffective for lower back pain and has minimal effectiveness for  osteoarthritis . [ 3 ] [ 45 ]


In his 2012 book  Bad Pharma ,  Ben Goldacre  heavily criticises the pharmaceutical industry but rejects any conspiracy theories. He argues that the problems are "perpetrated by ordinary people, but many of them may not even know what they've done". [ 4 ]


Steven Novella  writes that while the pharmaceutical industry has a number of aspects which justly deserve criticism, the "demonization" of it is both cynical and intellectually lazy. [ 5 ]  He goes on to consider that overblown attacks on "Big Pharma" actually let the pharmaceutical industry "off the hook" since they distract from and tarnish more considered criticisms. [ 5 ]  He has also written, on  Skepticblog , about the general misunderstanding and sensationalizing of cancer research that typically accompanies a conspiratorial mindset. He points out that cures for cancer, rather than being hidden, are not the cures they are initially touted to be by the media and either result in a dead end, further research goals, or a decrease in the mortality rate for a specific type of cancer. [ 6 ]


Dave Roos and Oliver Childs have criticized the idea that holding back a cure for cancer would result in more profit than presenting one. [ 7 ] [ 8 ]  Dina Fine Maron further notes that this view largely ignores the fact that cancer is not a single disease but instead many, and the fact that large strides have been made in the fight against cancer. [ 9 ]


In 2016,  David Robert Grimes  published a research paper elaborating about the mathematical non-viability of conspiracy theories in general. [ 46 ]  He estimated that if there were a big pharma conspiracy to conceal a cure for cancer, it would be exposed after about 3.2 years due to the sheer number of people required to keep it secret. [ 47 ]


Biodollars , sometimes called  biobucks , is a term commonly used in business transactions between large  pharmaceutical  and smaller  biotechnology companies  to describe the total possible value of the transaction, excluding royalty payments.  While public announcements of these deals often state a single lump-sum figure as a representation of the entire deal-value, often only a small fraction of the amount is certain, while the remaining amount is highly uncertain. [ 1 ] [ 2 ]


Common transactions in this industry are based on the grant of a  license  for products emerging from a  drug discovery  program or for a candidate drug that is already in  development  in exchange for money.  The risk for both parties is managed in the license agreement by spreading the payments over time, and making most of the payment contingent on sales through  royalty payments , and on reaching  milestones  such as completion of a  clinical trial phase , regulatory marketing approval in various jurisdictions, or a reaching some level of sales, through so-called "milestone payments".  The licensee may also agree to make payments to the licensor specifically to fund continued work on the licensed product (research funding). [ 3 ] [ 4 ]


Only the upfront payment and research funding are paid out when the deal is signed; the rest is all contingent and may never be paid or received. [ 1 ] [ 5 ] [ 6 ]


Biosplice Therapeutics, Inc.  (formerly  Samumed, LLC ) is a private  biopharmaceutical  company based in  San Diego, California . [ 1 ]  It was founded in 2008 by  Osman Kibar . [ 2 ]


Samumed's products in development target novel components of the  Wnt signaling pathway . [ 3 ] [ 4 ] [ 5 ]  The company focuses on potential treatments for several diseases; its  osteoarthritis  program is its most advanced. [ 4 ] [ 6 ]


Biotechnology industry in Italy  is a highly innovative and fast-growing sector dedicated to research.
At the end of 2019, there are 696  biotech  companies active in Italy. [ 1 ]


The turnover exceeds 12 billion euros, the number of employees exceeds 13,000 units. Between 2017 and 2019, over 50 new innovative  start-ups  active in biotechnology were registered. [ 2 ]


In the laboratories of the IRBM Science Park a team of Italian and American researchers has developed the Chad3Ebola-Zaire anti-ebola vaccine, a monovalent adenovirus capable of neutralizing the «Zaire» strain of the virus, conceived and produced by OKAIROS, a biotech company founded by Prof. Riccardo Cortese, with whom IRBM set up the Advent equal joint venture.


The research intensity of the biotech sector is significantly higher than that found for the  Italian industry  as a whole. [ 9 ]


A  black triangle  appearing after the trade name of a British  medicine  (or  vaccine ) indicates that the medication is new to the market, or that an existing medicine (or vaccine) is being used for a new reason or by a new route of administration. [ 1 ] [ 2 ] [ 3 ]


Examples of how it might appear:


The black triangle also highlights the need for surveillance of any  Adverse Drug Reactions  (ADRs) that might arise from the use of a new medication. The  Medicines and Healthcare products Regulatory Agency  (MHRA) encourage anyone to voluntarily report ADRs (however minor) via the  Yellow Card Scheme  to gather more information and gain more understanding of a new medication.


After a new medicine (or vaccine) has been brought to the market there is still a lot that can be learned about the drug from its widespread use. Similarly, if an existing drug is being used in a situation where it was not used before or if it is being given by a different route of administration much can still be learned about its new or modified use.


The black triangle label generally stays with the new drug (or new use of an existing drug) for at least 5 years, when it is reviewed, and after this time the black triangle label may or may not be discontinued.


Blow-Fill-Seal , also spelled as  Blow/Fill/Seal , in this article abbreviated as  BFS , is an automated manufacturing process by which plastic containers, such as bottles or ampoules are, in a continuous operation, blow-formed, filled, and sealed. [ 1 ] [ 2 ]  It takes place in a sterile, enclosed area inside a machine, without human intervention, and thus can be used to  aseptically manufacture  sterile pharmaceutical or non-pharmaceutical liquid/semiliquid unit-dosage forms. [ 3 ] [ 4 ]  BFS is an advanced aseptic processing technology that is typically used for filling and packaging of certain sterile liquid formulations like  liquid ophthalmics ,  inhalational anesthetics , or  lavaging agents , but can also be used for  injectables , [ 1 ]   parenteral medicines , [ 5 ]  and several other liquid or semiliquid medications, [ 6 ]  with fill volumes ranging from 0.1...1000 cm³. [ 7 ] [ 8 ] [ 9 ]  Compared against traditional glass ampoules, BFS ampoules are inexpensive, lightweight, and shatterproof. [ 10 ]


BFS was developed in the early 1960s [ 11 ]  at Rommelag. [ 12 ]  In 1963, Gerhard Hansen applied for a patent on the BFS process. [ 13 ]  Originally, it was used for packaging of non-sterile products, such as non-sterile medical devices, food, and cosmetics. [ 10 ]  In the early 1970s, Rommelag's Bottelpack system was first used for packing large volume pharmaceutical solutions. [ 12 ]  By the late 1980s, BFS had been well-established in the packaging industry, especially for packaging pharmaceutical and healthcare products. [ 14 ]  During the 1980s and 1990s, BFS came into use for the now common small volume unit-dosage forms. [ 12 ]  Since the early 2000s, BFS has been emerging as the preferred packaging process for parenteral products. [ 7 ]


The BFS process functions similarly to conventional extrusion blow molding, and takes place within a BFS machine. [ 6 ]  First, a plastic polymer resin is heated to >160 °C and compressed to 35 MPa, [ 11 ] [ 15 ]  allowing it to be extruded in tubular form, [ 1 ]  and be taken over by an open two-part [ 16 ]  mold to form the container. Then, the mold closes which welds the bottom of the container. Simultaneously, the parison above the mold is cut, or the filling needles are placed in the parison head without the parison being cut (rotary BFS type). Next, a filling mandrel with blowing air function is placed in the neck area that seals the container. Sterile compressed air is then introduced through the filling mandrel to inflate and form the container. In the BFS process for smaller ampoules the compressed air system is avoided by using vacuum forming the container instead. After the BFS container has been formed, the desired liquid is filled into the container through the filling mandrel unit. Then, the filling mandrel unit is lifted off, and the head mold hermetically seals the container. Simultaneously, the head contour is formed by vacuum. In the last step, the mold opens and the finished container leaves the mold. [ 6 ]


One process cycle takes a few seconds. [ 11 ]  The process speed and thus process output largely depends upon the BFS container size and the BFS machinery dimensioning. For instance, in the early 2000s, Rommelag's 3012, 305, and 4010 M machines had outputs of approximately 4000, 8000, or 20,000 containers per hour. [ 17 ]  These machines have been succeeded by the Rommelag 312, 321, 360, 364 and 460 machines with output ranges of up to 35,000 containers per hour.


The BFS processes is an aseptic filling process, which produces sterile products and thus needs to be sterile. [ 18 ]  Aseptic BFS machines must be designed in a way that prevents extraneous contamination. [ 19 ]  Thus, rotary-type BFS machines are placed in classified areas same as shuttle-type BFS machines (open parison), which have a cleanroom shroud  grade-A-compliant  provided with sterilised air and kept under overpressure. Automatic SIP programs are used to sterilise the BFS equipment and this avoids human interventions. Due to automatic start up and filling processes BFS machines require no human interaction during the actual BFS process. However, certain adjustments or interventions need to be carried out by personnel. Both particle and microbiological contamination monitoring are required in a BFS machine environment, as well as routine CIP/SIP processes. [ 20 ]  BFS machines are typically fitted with several different sterilising air filtration systems for the buffer air, support parison air and air shroud grade A air (if needed for shuttle machines, e. g. open parison type ones). [ 9 ]  Typically, the air is sterilised by filtration systems that have automatic filter integrity testing installed (i. e. automatic water intrusion or particle testing). The air systems are typically integrated into the SIP cycle of the BFS machine. [ 21 ]


The materials used in BFS packaging are usually  polyolefins , mainly  polyethylene  ( LDPE [ 22 ] [ 23 ]  or  HDPE ), [ 24 ]  and  polypropylene  (PP). [ 25 ] [ 26 ] [ 27 ]  These materials are robust and inert to ensure sterility and tightness during the product's shelf life. [ 5 ]  Diffusion tendencies can be reduced by using virgin polymers, but diffusion cannot be prevented entirely. This is due to the nature of polyolefins and their additives, if present. [ 25 ]  Several polyethylene suppliers have developed special EP or  USP  grade resin for BFS containers. Permeation into BFS containers and water loss may be an issue with some BFS resin. Therefore, in some applications, secondary packaging methods (laminate pouches) are used. [ 28 ]


BFS allows many different container designs, a consistent high process quality, a high process output, [ 7 ]  and is, compared against other packaging processes, inexpensive. [ 26 ]  In addition to that, BFS containers are lighter than glass containers, and shatterproof, which eases their transport. [ 10 ] [ 29 ]  Due to the single-dose nature of BFS containers, they are more convenient to use for patients. [ 30 ]  BFS technology assures high levels of sterility, [ 31 ] [ 32 ] [ 33 ]  especially compared against conventional filling, [ 34 ]  which is mainly achieved by the absence of human contact/interventions – a major source of contamination. [ 35 ]


BUKO Pharma-Kampagne  is an independent organization based in  Bielefeld ,  Germany , which watches over the marketing practices of German pharmaceutical companies.


It has gained wider recognition after being described in a bestselling novel,  The Constant Gardener  by  John le Carré . BUKO was mentioned explicitly in the author's afterword as a real counterpart to the novel's fictitious Hippo organisation (also based in Bielefeld, Germany).


BUKO is partially financed by the  European Union  and mostly by private supporters.


In early 1981 following a conference in  Geneva , co-sponsored by the  International Organization of Consumers Unions  and by  BUKO , it set up  Health Action International . [ 1 ] [ 2 ] [ 3 ]


This article about a medical organization or association is a  stub . You can help Wikipedia by  expanding it .


In the manufacture of pharmaceuticals,  encapsulation  refers to a range of  dosage forms —techniques used to enclose medicines—in a relatively stable shell known as a  capsule , allowing them to, for example, be taken orally or be used as  suppositories . The two main types of capsules are:


Both of these classes of capsules are made from aqueous solutions of  gelling agents , such as animal  protein  (mainly  gelatin ) or plant  polysaccharides  or their derivatives (such as  carrageenans  and modified forms of  starch  and  cellulose ). Other ingredients can be added to the gelling agent solution including  plasticizers  such as  glycerin  or  sorbitol  to decrease the capsule's hardness,  coloring agents ,  preservatives , disintegrants,  lubricants  and  surface treatment .


Since their inception, capsules have been viewed by consumers as the most efficient method of taking medication. [ citation needed ]  For this reason, producers of drugs such as  OTC  analgesics wanting to emphasize the strength of their product developed the "caplet", a  portmanteau  of "capsule-shaped tablet", [ 1 ]  to tie this positive association to more efficiently produced  tablet  pills, as well as being an easier-to-swallow shape than the usual disk-shaped tablet medication.


In 1833, Mothes and Dublanc were granted a patent for a method to produce a single-piece gelatin capsule that was sealed with a drop of gelatin solution. They used individual iron molds for their process, filling the capsules individually with a medicine dropper. Later on, methods were developed that used sets of plates with pockets to form the capsules. Although some companies still use this method, the equipment is no longer produced commercially. All modern soft-gel encapsulation uses variations of a process developed by  R. P. Scherer  in 1933. His innovation used a rotary die to produce the capsules. They were then filled by  blow molding . This method was high-yield, consistent, and reduced waste. [ citation needed ]


Softgels can be an effective delivery system for oral drugs, especially poorly soluble drugs. This is because the fill can contain liquid ingredients that help increase the solubility or permeability of the drug across the membranes in the body. Liquid ingredients are difficult to include in any other solid dosage form, such as a tablet. Softgels are also highly suited to potent drugs (for example, where the dose is <100 μg), where the highly reproducible filling process helps ensure each softgel has the same drug content, and because the operators are not exposed to any drug dust during the manufacturing process.


In 1949, the Lederle Laboratories division of the  American Cyanamid Company  developed the "Accogel" process, allowing powders to be accurately filled into soft gelatin capsules.


James Murdoch of London patented the two-piece telescoping gelatin capsule in 1847. [ 2 ]  The capsules are made in two parts by dipping metal pins in the gelling agent solution. The capsules are supplied as closed units to the pharmaceutical manufacturer. Before use, the two halves are separated, and the capsule is filled with powder or more normally pellets made by the process of extrusion and spheronization  (either by placing a compressed slug of powder into one half of the capsule or by filling one half of the capsule with loose powder) and the other half of the capsule is pressed on. With the compressed slug method, weight varies less between capsules. However, the machinery required to manufacture them is more complex. [ 3 ]


The powder or spheroids inside the capsule contains the  active ingredients  and any  excipients , such as  binders , disintegrants,  fillers ,  glidant , and preservatives.


Gelatin capsules , informally called  gel caps  or  gelcaps , are composed of  gelatin  manufactured from the  collagen  of animal skin or bone. [ 4 ]


Vegetable capsules , introduced in 1989, [ 5 ]  are made from  cellulose , a structural component in plants. The main ingredient of vegetarian capsules is  hydroxypropyl methyl cellulose . In the 21st century, gelatin capsules are more broadly used than vegetarian capsules because the cost of production is lower. [ citation needed ]


The process of encapsulation of hard gelatin capsules can be done on manual, semi-automatic, and automatic capsule filling machines. Hard gelatin capsules are manufactured by the dipping method which is dipping, rotation, drying, stripping, trimming, and joining. [ 6 ]  Softgels are filled at the same time as they are produced and sealed on the  rotary die  of a fully automatic machine. Capsule fill weight is a critical attribute in encapsulation and various real-time fill weight monitoring techniques such as  near-infrared spectroscopy  (NIR) and  vibrational spectroscopy  are used, as well as in-line weight checks, to ensure product quality. [ 7 ]


Volume is measured to the full line, which is customary to the top of the smaller-diameter body half. [ citation needed ]  After capping, some  ullage  volume (airspace) remains in the finished capsule.


The  Clinical Practice Research Datalink  ( CPRD ) is an observational and interventional research service that operates as part of the  Department of Health and Social Care . It is jointly funded by the  National Institute for Health and Care Research  (NIHR) and the  Medicines and Healthcare products Regulatory Agency  (MHRA). CPRD is working closely with the extensive primary care, topic specific and comprehensive NIHR research networks and with  NHS Digital .


The programme that would develop into the current organisation was initially developed by an Essex  general practitioner , Dr  Alan Dean , to facilitate day-to-day management of his own general practice, in collaboration with IT staff at the BATA shoe factory in East Tilbury near to his practice. Early programmers included a Czech programmer  Jan Boda . [ 1 ] [ 2 ]  In 1987 a  venture capital company  was set up, named Value Added Information Medical Products Ltd (VAMP) to recruit other practices and form an information base. The early development team of three, Marcella Devenish (formerly a midwife), Philip Lee-Warren (formerly a Senior Medical Laboratory Scientific Officer), under the leadership of Kieran O'Mally, developed further the computerised system using the  BOS Microcobol  development environment. During this period the number of UK practices using the software product IGP (Integrated General Practice) expanded from a few hundred to over two and a half thousand. In return for anonymous Healthcare data, VAMP Ltd offered GPs the cash equivalent of GBP 500 a month in order to build the VAMP research databank for research purposes. As of 1988, the VAMP research databank comprised 57 practices and 543,100 patients. [ 3 ]  This figure was doubled to 1.2 million in 1990. [ 4 ]  One year later, 970 practices allowed VAMP to access their data, while about 1000 practices had a straightforward maintenance agreement with VAMP. [ 5 ]


In November 1993, its parent company was acquired by  Reuters Health Information , which donated the database to the  Department of Health  in 1994, at which time it became General Practice Research Database (GPRD) and contained data from 650 practices (4.4 million active patients). At this time, there were two licensees of the data: Dr Alan Dean, and Professor  Hershel Jick . [ 6 ]  Then the database was operated by the  Office for National Statistics  until 1999, at which point the  Medicines Control Agency  (MCA) took over. This agency became the  Medicines and Healthcare products Regulatory Agency  (MHRA) on 1 April 2003 following a merger with the  Medical Devices Agency  (MDA).  Since then, use of the database has expanded within the  UK  and overseas.  The GPRD was run as a sub-division of the MHRA. [ 7 ] [ 8 ]


Following initiatives by the Director, Dr John Parkinson, the utility of GPRD was dramatically enhanced by linkage to other datasets on an individual patient level. External datasets included the  Hospital Episode Statistics , death certificates, the national cancer registry and MINAP (cardiovascular disease) registry. Additionally the dataset became that of choice by the FDA and most major pharma companies.


In March 2011, The Government launched its ‘Plan for Growth’ which details steps needed to enable the British economy to become more internationally competitive. As part of this initiative The Government pledged to build a consensus on using e-health record data to create a unique position for the UK in health research.


Following the announcement by the chancellor on the "Plan for Growth", a commissioned study entitled the "Research Capability Programme" was initiated with the aim of assessing the available research capabilities of the UK and future potential growth areas in this sector. An opportunity was identified for the collaboration of the Department of Health and the MHRA in creating a joint research service, based upon consolidating and expanding existing independent services. The new service, known as the CPRD has been developed to meet the expectations and criteria outlined by the "Plan for Growth".


On 29 March 2012, the Medicines and Healthcare products Regulatory Agency and the Department of Health's  National Institute for Health and Care Research  (NIHR) launched the Clinical Practice Research Datalink (CPRD). [ 10 ]   On the launch of CPRD,  Sir Kent Woods , Chief Executive of the MHRA said, "The Clinical Practice Research Datalink will provide new data and research services that will improve the health of patients and also make the UK a world leader in life sciences research." [ 10 ]   David Willetts , Minister for Universities and Science, said, "The UK is a world leader in life sciences, but both the research base and industry tell us that we could make better use of data in order to drive medical breakthroughs. The Clinical Practice Research Datalink will provide researchers with access to safeguarded data that respects patient confidentiality. This will give valuable insights into serious health conditions and ultimately help reduce the time it takes to develop new treatments." [ 10 ]  The GPRD became part of the data services provision from CPRD.


At its launch in April 2012, CPRD was established as the new, England-wide NHS observational and interventional research service. It has built on the research developments of the GPRD, and also the Health Research Support Service (HRSS) previously managed by the NIHR Research Capability Program.


CPRD remains housed within the Medicines and Healthcare products Regulatory Agency.


The CPRD builds on its predecessors' capabilities and aims to provide a range of services and products in the areas of medical research and public health care. Fundamental to the work of the CPRD is the collection and linkage of anonymised data sets and provision of research services.


The CPRD utilises the maximum benefit of linked data sets and the UK's health system to provide researchers with access to high quality anonymous primary and secondary health care data. The data collected allows researchers access to a wealth of information including;


The NHS provides, free at the point of delivery, healthcare to a population of 52 Million in England. With access to the data sets of NHS in England, Wales, Scotland and Northern Ireland the CPRD can provide a population of potentially up to 64 Million patients in the UK. Further access and partnerships have been established to include data sets from other European countries. The linking of anonomysed primary care data with large data registries and related data sets means the CPRD can offer a huge array of data and information for the inclusion in medical research studies. This will include areas such as; prescription drugs uses and effect, long term patient treatment strategy, long-term health benefit studies, epidemic and pandemic studies and demographic health and welfare studies.


For example, an analysis of 100 million GP consultations using CPRD data in 2016 provided the first substantial evidence of the increase in GP clinical workload in England. [ 11 ]


The CPRD has a range of research experience and expertise including:


The CPRD provides consulting services for a range of research activities. Provided by an experienced internal team, the research service offers advice on research methodology and research governance as well as a host of other services. Drawing from its expertise and predecessors' experience the CPRD research team has built a reputation for conducting high-end research projects, from protocol development, gaining approvals for research, data analysis and report and publication writing. The research capacity is such that the CPRD has the resource and expertise to undertake research projects on behalf of customers or independently, for a variety of undertakings from the commercial regulatory, charitable and academic sectors. A huge range of studies from the CPRD and predecessors have been published and a list of published papers can be found at  CPRD Research


The CPRD offers a range of interventional research services to facilitate the running of clinical trials.


The primary health care data collected by the CPRD is taken from participating  GP surgeries  in the  United Kingdom .  Personal identifiers are not collected, protecting the privacy of the individuals from whom the data comes. Data collected includes;


The  co-pay  card appeared in 2005 as a means by which pharmaceutical marketers could, by offering an instantaneous rebate to patients, combat their challenges to prescription pharmaceuticals, including generic competition, lack of patient compliance and persistency, and an access to the physician population. As of January 2017, in the United States, coupon cards for more than 600 prescription medications are available. [ 1 ]


Based on the National Council for  Prescription Drug  Programs standard, all pharmacy software systems contain information fields for both a primary and secondary insurer to pay for patient's prescription.


Typically, a patient will receive his/her co-pay card from their physician along with a prescription for the medicine.  The patient takes the card and prescription to a pharmacy where the pharmacist enters processing information into his/her pharmacy  management system  to submit a claim.


If a patient has insurance, the pharmacist will key in the patient's insurance number in the  primary field  and an identifier from the co-pay card into the secondary insurer field.  Instantaneously the pharmacy benefit manager provides  coverage data , relaying the patient's out of pocket, or co-pay to the secondary insurer's benefit manager, who then provides a discount accordingly. [ citation needed ]


An example:  A brand offers a co-pay card giving patients the opportunity to save up to $20 off each prescription fill.  A patient receives the co-pay card and visits their pharmacy.  The patient provides his/her insurance card and co-pay card to the pharmacist. The pharmacist enters information into his/her pharmacy management system from both cards.  The insurance benefit manager recognizes the drug as a TIER 3 brand for the patient and relays the patient co-pay to be $30.00.  The co-pay card benefit manager recognizes the $30.00 and covers the $20.00 of co-pay, leaving $10 for the patient to pay out of pocket.  Another patient without prescription insurance coverage follows the same process.  The co-pay card takes the primary insurer position where it recognizes the claim as that of a cash-paying patient and applies $20.00 discount to the patient's out-of-pocket costs. [ citation needed ]


In most cases the  service provider  of the co-pay card program holds a reimbursement account for the  pharmaceutical marketing  client, which is used to remit to pharmacies the cost reductions through co-pay card programs.  The co-pay service provider remits to pharmacies every 14 to 28 days and deducts these remittances via this account.


Some providers have attempted a variation on the original co-pay card by going to a magnetic strip swipe process, by which the card runs through both the pharmacy software and  financial software  (e.g. Visa/MasterCard and Debit networks).


Debit cards  are another reimbursement method for co-pay in pharmacies because they offer real-time reimbursement of co-pay claims.  However, with new prompt-pay regulations for adjudicators, required for Medicare Part D and implemented by most PBMs, few pharmacies wait more than one week for reimbursement. Pharmacies used to prefer real-time Debit payments because they didn't require the pharmacies to carry the "float" of the 14 to 28 days payment cycles. This is no longer true.


A  cold chain  is a  supply chain  that uses  refrigeration  to maintain perishable goods, such as pharmaceuticals, produce or other goods that are temperature-sensitive. [ 1 ]  Common goods, sometimes called  cool cargo, [ 2 ]  distributed in cold chains include fresh agricultural  produce , [ 3 ]  seafood,  frozen food ,  photographic film , chemicals, and  pharmaceutical products . [ 4 ]  The objective of a cold chain is to preserve the integrity and quality of goods such as pharmaceutical products or perishable good from production to consumption.  [ 5 ]   [ 6 ]


A well functioning, or unbroken, cold chain requires uninterrupted sequence of refrigerated production, storage and distribution activities, along with associated equipment and logistics, which maintain a desired low-temperature interval to keep the safety and quality of perishable or sensitive products. Unlike other goods or merchandise, cold chain goods are  perishable  and always en-route towards end use or destination. Adequate cold storage, in particular, can be crucial to prevent   food loss and waste . [ 7 ]


Mobile  refrigeration  with  ice  from the  ice trade  began with  reefer ships  and  refrigerator cars  ( iceboxes  on wheels) in the mid-19th century. [ 8 ]  The term  cold chain  was first used in 1908. The first effective cold store in the UK opened in 1882 at  St Katharine Docks . [ 9 ]  It could hold 59,000 carcasses, and by 1911 cold storage capacity in London had reached 2.84 million carcasses. [ 9 ]  By 1930 about  a thousand refrigerated meat containers were in use which could be switched from road to railway. [ 9 ]


Mobile mechanical refrigeration was invented by  Frederick McKinley Jones , who co-founded  Thermo King  with entrepreneur Joseph A. "Joe" Numero. In 1938 Numero sold his Cinema Supplies Inc. movie sound equipment business to  RCA  to form the new entity, U.S. Thermo Control Company (later the  Thermo King Corporation ), in partnership with Jones, his engineer. Jones designed a portable air-cooling unit for trucks carrying perishable food, [ 10 ]  for which they obtained a patent on 12 July 1940, [ 11 ]  subsequent to a challenge to invent a refrigerated truck over a 1937 golf game by associates of Numero's, Werner Transportation Co. president Harry Werner, and United States Air Conditioning Co. president Al Fineberg, [ 12 ] [ 10 ] [ 11 ] [ 13 ]


This technology has been frequently in use since the 1950s, when it was most often used for preserving animal-based cells or tissue. As medical breakthroughs, such as in cancer treatment, have taken place, the demand for cold chain systems has grown. The  COVID-19 pandemic  and its associated  vaccinations , have caused vastly increased need. [ 14 ]


Cold chains are common in the food and  pharmaceutical  industries and also in some chemical shipments. One common temperature range for a cold chain in pharmaceutical industries is 2 to 8 °C (36 to 46 °F), but the specific temperature (and time at temperature) tolerances depend on the actual product being shipped. [ citation needed ]


Unique to fresh produce cargoes, the cold chain requires to additionally maintain product specific environment parameters [ 3 ]  which include air quality levels (carbon dioxide, oxygen, humidity and others). [ citation needed ]


The cold chain is used in the supply of  vaccines  to distant clinics in hot climates served by poorly developed transport networks. Vaccines can lose their efficacy if cold chain management fails. [ 15 ]  Disruption of a cold chain due to war may produce consequences similar to the  smallpox  outbreaks in the Philippines during the  Spanish–American War , during which the distributed vaccines were inert due to lack of temperature control in transport. [ 16 ]


For vaccines, there are different types of cold chains. There is an ultralow, or deep freeze, cold chain for vaccines that require -70 degrees C, such as the Ebola and  Pfizer–BioNTech COVID-19  vaccines, and some animal vaccines, such as those for chickens. Next the frozen chain requires -20 degrees C. Varicella and zoster vaccinations require this level. Then the refrigerated chain, which requires temperatures between two and eight degrees C. Most flu vaccinations only require refrigeration. [ 17 ]


In 2020, during the  COVID-19 pandemic , vaccines being developed may need  ultracold storage  and transportation temperatures as cold as −70 °C (−94 °F), requiring what has been referred to as a "colder chain" infrastructure. [ 18 ]  This creates some issues of distribution for the  Pfizer vaccine . It is estimated that only 25 to 30 countries in the world have the infrastructure for the required ultracold cold chain. [ 17 ]


The cold chain distribution process is an extension of the  good manufacturing practice  (GMP) environment that all drugs and biological products are required to follow, and are enforced by the various health regulatory bodies. As such, the distribution process must be validated to ensure that there is no negative impact to the safety, efficacy or quality of the drug substance. The GMP environment requires that all processes that might impact the safety, efficacy or quality of the drug substance must be  validated , including storage and distribution of the drug substance. [ 18 ] [ 1 ]


A cold chain can be managed by a  quality management system .  Temperature data loggers  and  RFID  tags help monitor the temperature history of the truck,  reefer container , warehouse, etc. and the temperature history of the product being shipped. [ 19 ]  They also can help determine the remaining  shelf life . [ 20 ]  Also, temperature sensors may need to be  National Institute of Standards and Technology  (NIST) traceable depending on the body monitoring the cold chain. [ 21 ]


This article incorporates text from a  free content  work. Licensed under CC BY-SA 3.0 ( license statement/permission ). Text taken from  The State of Food and Agriculture 2019. Moving forward on food loss and waste reduction, In brief , 24, FAO, FAO.


Corporate Crime in the Pharmaceutical Industry  is a 1984 book on  corporate crime  and the  pharmaceutical industry  by  criminologist   John Braithwaite . [ 1 ]


The author writes from the perspective of a criminologist and not from a perspective of expertise in drug law or pharmacology. [ 2 ]


Various reviewers commented on the book. [ 3 ] [ 4 ]


The author produced a follow-up book 30 years later titled,  Pharmaceuticals, Corporate Crime and Public Health . [ 5 ]  At the release of that new book a reviewer reconsidered the 1984 book in retrospect and reported that the book's ideas were still relevant. [ 6 ]


The book is  available  at the  Internet Archive .


Critical Path Institute  (C-Path) is a non-profit organization created to improve the  drug development  process; its  consortia  include more than 1,600 scientists from government regulatory and research agencies,  academia , patient organizations, and bio-pharmaceutical companies. [ 2 ] [ 3 ] [ 4 ] [ 5 ]


The U.S.  Food and Drug Administration  (FDA) launched the  Critical Path Initiative  in 2004 to transform the way FDA-regulated medical products are developed, evaluated, and manufactured. [ 6 ]  C-Path was created as an independent organization to respond to the needs outlined in the FDA's initiative and with support and funding from the FDA,  Science Foundation Arizona , and the  Tucson, Arizona  community. It operates as a neutral third party to enable scientists from the regulated industry and international regulatory agencies to work together with scientists from academia and patient groups to improve the drug development process. [ 5 ] [ 7 ]


In the interest of national and global  public health , C-Path develops large databases of aggregated clinical trial data that can be used to study disease progression. These data are also used to develop and qualify  biomarkers  and clinical outcome assessment instruments that are shared with the greater community for use in drug development. C-Path also develops quantitative models to facilitate the design of efficient clinical trials. [ 5 ] [ 8 ] [ 9 ] [ 10 ]


C-Path programs are focused on reducing the time, cost, and risk of drug development and regulatory review. Where appropriate, C-Path forms consortia to improve the drug development process. [ 11 ] [ 12 ] [ 13 ] [ 14 ]


C-Path is headquartered in  Tucson, Arizona .  Raymond L. Woosley, M.D., Ph.D.  founded C-Path in 2005 and is President Emeritus. Kristen Swingle is currently C-Path's Interim President and Chief Operating Officer. The Board of Directors includes Robert M. Califf, Wainwright Fishburn, Timothy R Franson, Kay Holcombe, Jeffrey E Jacob, former Pfizer CFO  Alan Levin  and biochemist  Paula J. Olsiewski . [ 20 ]


The  Drug Industry Documents Archive  (DIDA) is a digital archive of  pharmaceutical industry  documents created and maintained by the  University of California, San Francisco ,  Library  and Center for Knowledge Management.  DIDA is a part of the larger UCSF  Industry Documents Library  which includes the  Truth Tobacco Industry Documents .  The archive contains documents about pharmaceutical industry  clinical trials , publication of study results, pricing,  marketing , relations with physicians and drug company involvement in  continuing medical education .


Most of the documents on DIDA were made public as a result of lawsuits against pharmaceutical companies  Parke-Davis ,  Warner-Lambert ,  Pfizer ,  Merck & Co. ,  Wyeth  and  Abbott Labs , among others.  DIDA was founded in 2005 with the support of a gift by Thomas Greene, the attorney for  David Franklin , whistleblower in United States ex rel. Franklin v. Parke-Davis, the case from which the first documents in the archive originated. [ 1 ]


Researchers as well as students, journalists, and the general public, use the archive to investigate the ways pharmaceutical companies market their products.  The  UCSF_Library  created this digital archive in an attempt to facilitate further research into the drug industry's practice of establishing close links with the medical community which has been shown to influence scientific research, drug approval, prescription practices, and ultimately, consumer health. [ 2 ] [ 3 ]


DIDA contains:


Documents come from a variety of sources including:


Drug Master File  or  DMF  is a document prepared by a  pharmaceutical  manufacturer and submitted solely at its discretion to the appropriate regulatory authority in the intended drug market. There is no regulatory requirement to file a DMF. However, the document provides the regulatory authority with confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Typically, a DMF is filed when two or more firms work in partnership on developing or manufacturing a drug product.  The DMF filing allows a firm to protect its  intellectual property  from its partner while complying with regulatory requirements for disclosure of processing details.


Drug Master File (DMF) is a document containing complete information on an   Active Pharmaceutical Ingredient  (API) or finished drug  dosage form . It is known as European Drug Master File (EDMF) or Active Substance Master File (ASMF) and US-Drug Master file (US-DMF) in Europe and United States respectively.


In the United States, DMFs are submitted to the  Food and Drug Administration  (FDA).  The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an  Investigational New Drug  Application (IND), a  New Drug Application  (NDA),As an  Abbreviated New Drug Application  (ANDA), another DMF, or an Export Application.


In United States there are 5 types of Drug Master file: [ 1 ]


The content and the format for drug master file used in United States differs from that used in European Countries to obtain market authorization (MA). The Main Objective of the EDMF is to support regulatory requirements of a medicinal product to prove its quality, safety and efficacy. This helps to obtain a Marketing Authorisation grant.


Drug nomenclature  is the  systematic naming  of  drugs , especially  pharmaceutical drugs . In the majority of circumstances, drugs have 3 types of names:  chemical names , the most important of which is the  IUPAC name ;  generic or nonproprietary names , the most important of which are  international nonproprietary names  (INNs); and trade names, which are  brand names . [ 1 ]  Under the INN system, generic names for drugs are constructed out of  affixes  and stems that classify the drugs into useful categories while keeping related names distinguishable. [ 2 ]  A marketed drug might also have a company code or  compound code . [ 3 ]


Drug names are often subject to legal regulation, including approval for new drugs (to avoid confusion with existing drugs) and on packaging to establish clear rules about  adulterants  and fraudulent or misleading labeling. A national  formulary [ 1 ]  is often designated to define drug names (and purity standards) for regulatory purposes. The legally approved names in various countries include:


The  World Health Organization  administers the  international nonproprietary name  list.


A company or person developing a drug can apply for a generic (nonproprietary) name through their national formulary or directly to the WHO INN Programme. [ 4 ]  In order to minimize confusion, many of the national naming bodies have policies of maintaining harmony between national nonproprietary names and INNs. [ 2 ]  The European Union has mandated this harmonization for all member states [ 5 ]  In the United States, the developer applies to United States Adopted Name (USAN) Council, and a USAN negotiator applies to the INN on the developer's behalf. [ 2 ]


The chemical names are the  scientific names , based on the  molecular structure  of the drug. There are various systems of  chemical nomenclature  and thus various chemical names for any one substance. The most important is the  IUPAC name . Chemical names are typically very long and too complex to be commonly used in referring to a drug in speech or in prose documents. [ 1 ]  For example, "1-(isopropylamino)-3-(1-naphthyloxy) propan-2-ol" is a chemical name for  propranolol . Sometimes, a company that is developing a drug might give the drug a company code, [ 3 ]  which is used to identify the drug while it is in development. For example, CDP870 was  UCB 's company code for  certolizumab pegol ; UCB later chose "Cimzia" as its trade name. [ 1 ]  Many of these codes, although not all, have  prefixes that correspond to the company name .


Generic names are used for a variety of reasons.  They provide a clear and unique identifier for active chemical substances, appearing on all drug labels, advertising, and other information about the substance. Relatedly, they help maintain clear differentiation between proprietary and nonproprietary aspects of reality, which people trying to sell proprietary things have an  incentive  to  obfuscate ; they help people  compare apples to apples . They are used in scientific descriptions of the chemical, in discussions of the chemical in the  scientific literature  and descriptions of  clinical trials . [ 2 ]  Generic names usually indicate via their stems what drug class the drug belongs to. [ 6 ]  For example, one can tell that  aciclovir  is an  antiviral drug  because its name ends in the  -vir  suffix.


The earliest roots of  standardization  of generic names for drugs began with  city pharmacopoeias , such as the London, Edinburgh, Dublin, Hamburg, and Berlin Pharmacopoeias. The  fundamental advances in chemistry during the 19th century  made that era the first time in which what we now call  chemical nomenclature , a huge profusion of names based on atoms, functional groups, and molecules, was necessary or conceivable. In the second half of the 19th century and the early 20th, city pharmacopoeias were unified into  national pharmacopoeias  (such as the  British Pharmacopoeia ,  United States Pharmacopeia , Pharmacopoeia Germanica (PhG or PG), Italian Pharmacopeia, and  Japanese Pharmacopoeia ) and  national formularies  (such as the  British National Formulary , the  Australian Pharmaceutical Formulary , and the National Formulary of India). International pharmacopeias, such as the  European Pharmacopoeia  and the  International Pharmacopoeia  of the   World Health Organization  (WHO), have been the next level.


In 1953 the WHO created the  International Nonproprietary Name  (INN) system, which issues INNs in various languages, including Latin, English, French, Spanish, Russian, Chinese, and Arabic. Several countries also have national-level systems for creating  generic drug  names, including the  British Approved Name  (BAN) system, the Australian Approved Name (AAN) system, the  United States Adopted Name  (USAN) system (which is mostly the same as the  United States Pharmacopeia  (USP) system), and the  Japanese Accepted Name  (JAN) system. At least several of these national-level Approved Name/Adopted Name/Accepted Name systems were not created until the 1960s, after the INN system already existed. In the 21st century, increasing  globalization  is encouraging maximal rationalization for new generic names for drugs, and there is an increasing expectation that new USANs, BANs, and JANs will not differ from new INNs without special justification.


During the first half of the 20th century, generic names for drugs were often coined by  contracting  the chemical names into fewer syllables. Such contraction was partially, informally, locally standardized, but it was not universally consistent. In the second half of the 20th century, the nomenclatural systems moved away from such contraction toward the present system of stems and affixes that show chemical relationships.


Biopharmaceuticals  have posed a challenge in nonproprietary naming because unlike smaller molecules made with  total synthesis  or  semisynthesis , there is less assurance of complete  fungibility  between products from different manufacturers. Just as  wine  may vary by  strain  of yeast and year of grape harvest, so each product can be subtly different because living organisms are an integral part of production. The WHO MedNet community continually works to augment its system for biopharmaceuticals to ensure continued fulfillment of the goals served by having nonproprietary names. [ 7 ]  In recent years the development of the Biological Qualifier system has been an example. [ 7 ]


The  prefixes  and  interfixes  have no pharmacological significance and are used to separate the drug from others in the same class.  Suffixes  or  stems  may be found in the middle or more often the end of the drug name, and normally suggest the action of the drug. Generic names often have suffixes that define what class the drug is. [ 2 ]


More comprehensive lists can be found in Appendix VII of the USP Dictionary or in the  WHO   INN  stembook. [ 8 ]


If the name of the drug solanezumab were to be broken down, it would be divided into two parts like this: solane-zumab. -Zumab is the suffix for humanized monoclonal antibody. [ 10 ]  Monoclonal antibodies by definition contain only a single antibody clone and have binding specificity for one particular epitope. [ 11 ]  In the case of solanezumab, the antibody is designed to bond to the  amyloid-β   peptides  which make up  protein plaques  on the  neurons  of people with  Alzheimer's disease .


See also  Time release technology > List of abbreviations  for formulation suffixes.


For combination drug products—those with two or more drugs combined into a single  dosage form —single nonproprietary names beginning with "co-" exist in both  British Approved Name  (BAN) form and in a formerly maintained  USP  name called the pharmacy equivalent name (PEN). Otherwise the two names are simply both given, joined by hyphens or slashes. For example, suspensions combining  trimethoprim  and  sulfamethoxazole  are called either  trimethoprim/sulfamethoxazole  or co-trimoxazole. Similarly,  co-codamol  is  codeine - paracetamol  (acetaminophen), and co-triamterzide is  triamterene - hydrochlorothiazide . The USP ceased maintaining PENs, but the similar "co"-prefixed BANs are still current.


Most commonly, a nonproprietary drug name has one widely agreed pronunciation in each language. For example,  doxorubicin  is consistently  / ˌ d ɒ k s oʊ ˈ r uː b ɪ s ɪ n /  in English. [ 12 ] [ 13 ]  Trade names almost always have one accepted pronunciation, because the sponsoring company who coined the name has an intended pronunciation for it.


However, it is also common for a nonproprietary drug name to have two pronunciation variants, or sometimes three. For example, for  paracetamol , both  / ˌ p ær ə ˈ s iː t ə m ɒ l /  and  / ˌ p ær ə ˈ s ɛ t ə m ɒ l / [ 13 ]  are common, and one  medical dictionary  gives  / p æ ˌ r æ s ɪ ˈ t æ m ɒ l / . [ 14 ]


Some of the variation comes from the fact that some stems and affixes have pronunciation variants. For example, the aforementioned third (and least common) pronunciation for  paracetamol  reflects the treatment of the  acet  affix as  / ˈ æ s ɪ t /  rather than  / ə ˈ s iː t /  (both are accepted for  acetyl [ 14 ] [ 12 ] ).


The  World Health Organization  does not give suggested pronunciations for its  INNs , but familiarity with the typical sounds and spellings of the stems and affixes often points to the widely accepted pronunciation of any given INN. For example,  abciximab  is predictably  / æ b ˈ s ɪ k s ɪ m æ b / , because for INNs ending in  -ciximab , the  / ˈ s ɪ k s ɪ m æ b /  sound is familiar. The  United States Pharmacopeia  gives suggested pronunciations for most  USANs  in its  USP Dictionary , which is published in annual editions.  Medical dictionaries  give pronunciations of many drugs that are both commonly used and have been commercially available for a decade or more, although many newer drugs or less common drugs are not entered. Pharmacists also have access to pronunciations from various  clinical decision support systems  such as  Lexicomp .


For drugs that make it all the way through development, testing, and regulatory acceptance, the  pharmaceutical company  then gives the drug a  trade name , which is a standard term in the pharmaceutical industry for a  brand name  or  trademark  name. For example,  Lipitor  is  Pfizer 's trade name for  atorvastatin , a  cholesterol -lowering medication. Many drugs have multiple trade names, reflecting marketing in different countries, manufacture by different companies, or both. Thus the trade names for atorvastatin include not only Lipitor (in the U.S.) but also Atocor (in India).


In the  scientific literature , there is a set of strong conventions for drug nomenclature regarding the  letter case  and placement of nonproprietary and  proprietary  names, as follows:


For example, the 2015  American Society of Hematology  (ASH) publication policies say, [ 15 ]  "Non-proprietary (generic/scientific) names should be used and should be lowercase." [ 15 ]  ... "[T]he first letter of the name of a proprietary drug should be capitalized." [ 15 ]  ... "If necessary, you may include a proprietary name in parentheses directly following the generic name after its first mention." [ 15 ]


Valid exceptions to the general pattern occur when a nonproprietary name starts a sentence (and thus takes a capital), when a proprietary name has  intercapping  (for example, GoLYTELY, MiraLAX), or when  tall-man letters  are used within nonproprietary names to prevent confusion of similar names (for example,  predniSONE  versus  predniSOLONE ).


Dublin Molecular Medicine Centre  (DMMC) was a charity set up in 2002, to create critical mass in molecular medicine research in Dublin, Ireland. Funding was provided by the  Higher Education Authority . [ 1 ]


The academic resources supporting the teaching hospitals include:


DMMC secured funding from the  Wellcome Trust  for a major clinical research centre to be led by Professor  Dermot P. Kelleher  for Dublin comprising two elements:


Dublin Molecular Medicine Centre evolved to become Molecular Medicine Ireland which was established in 2008. [ 7 ]


The  electronic common technical document  ( eCTD ) is an interface and international specification for the  pharmaceutical industry  to  agency  transfer of regulatory information.
The specification is based on the  Common Technical Document  (CTD) format and was developed by the  International Council for Harmonisation  (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG).


Version 2.0 of eCTD – an upgrade over the original CTD – was finalized on February 12, 2002, [ 1 ]  and version 3.0 was finalized on October 8 of the same year. [ 2 ]  As of August 2016 [update] , the most current version is 3.2.2, released on July 16, 2008. [ 3 ]


A Draft Implementation Guide (DIG) for version 4.0 of eCTD was released in August 2012. [ 4 ]  However, work stalled on the project. An additional Draft Implementation Guide was released in February 2015 [ 5 ]  The ICH and the FDA released draft specifications and guides in April 2016, and on May 13 there was an ICH "teleconference" to discuss the guidance and any queries or clarifications that might be necessary. [ 6 ]


On May 5, 2015, the  U.S. Food & Drug Administration  published a final, binding guidance document [ 7 ]  requiring certain submissions in electronic (eCTD) format within 24 months. The projected date for mandatory  electronic submissions  is May 5, 2017 for  New Drug Applications  (NDAs), Biologic License Applications (BLAs), Abbreviated New Drug Applications (ANDAs) and Drug Master Files (DMFs). [ 8 ]


Health Canada  was a sponsor and an early adopter of the eCTD workflow, especially for its  Health Products and Food Branch  regulator, but as of April 2015 had not yet fully automated it. [ 9 ]


The E.U. and its  European Medicines Agency  began accepting eCTD submissions in 2003. [ 10 ]  In February 2015, the "EMA announced it would no longer accept paper application forms for products applying to the centralized procedure beginning 1 July 2015." [ 11 ]  The EMA verified on that date that it would no longer accept "human and veterinary centralised procedure applications" and that all electronic application forms would have to be eCTD by January 2016. [ 12 ]


In November 2017,  China Food and Drug Administration (CFDA)  publishes draft eCTD structure for drug registration for public consultations. This is a big transition for China to move from paper submission to eCTD submissions. [ 13 ]


The  Japan   PhMDA  has been eCTD compliant at least since December 2017. [ 14 ]


The Electronic Common Technical Document Specification, the main ICH standard, largely determines the structure of an eCTD submission. [ 15 ]  However, additional specifications may be applied in national and continental contexts. In the United States, the  Food and Drug Administration  (FDA) layers additional specifications onto its requirements for eCTD submissions, including PDF, transmission, file format, and supportive file specifications. [ 16 ] [ 17 ]  In the European Union, the European Medicines Agency's EU Module 1 specification as well as other QA documents lay out additional requirements for eCTD submissions. [ 18 ] [ 19 ]


The eCTD has five modules:


A  full table of contents  could be quite large.


There are two categories of modules:


The CTD defines the content only of the common modules. The contents of the Regional Module 1 are defined by each of the ICH  regions  (USA, Europe and Japan).


The eCTD is a message specification for the transfer of files and metadata from a submitter to a receiver. The primary technical components are:


Each submission message constitutes one "sequence". A cumulative eCTD consists of one or more sequences. While a single sequence may be viewed with web browser and the ICH stylesheet provided, viewing a cumulative eCTD requires specialized eCTD viewers.


The top part of the directory structure is as follows:


The string  ctd-123456/0000  is just an example.


This is the file  index.xml  in the  submission sequence number folder .
For example:


The purpose of this file is twofold:


Stylesheets that support the presentation and navigation should be included. They must be placed in the directory:


See entry 377 in Appendix 4.


DTDs must be placed in the directory:


See entries 371–76 in Appendix 4.
They must follow a naming convention.


The DTD of the backbone is in Appendix 8.
It must be placed in the above directory.


The business process to be supported can be described as follows:


The  lifecycle management  is composed at least of:


An  epedigree  (sometimes referred to as  e-pedigree  or  electronic pedigree ) is an  electronic document  which provides data on the history of a particular batch of a drug.  It satisfies the requirement for a  drug pedigree  while using a convenient electronic form.


The  U.S. Food and Drug Administration  (FDA) in the 2006 Compliance Policy Guide for the  Prescription Drug Marketing Act  states that:


"A drug pedigree is a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to them." [ 1 ]


An epedigree  is simply an electronic document which satisfies the pedigree requirement.  The primary purpose of an epedigree is to protect consumers from any contaminated medicine or  counterfeit drugs .


On January 5, 2007  EPCglobal  ratified the Pedigree Standard [ 2 ]  as an international standard that specifies an  XML  description of the life history of a product across an arbitrarily complex supply chain.


As of 2008, most states have enacted some sort of pedigree requirement and many have also required an epedigree.  However, the existing epedigree requirements amount to little more than requiring that pharmaceutical supply chain companies be able to provide reports in formats such as  pdf , text files or  spreadsheets .


The basic data elements of an original epedigree are:


As the product moves down the supply chain, each company is required to carry forward all previous epedigree information.  In this way, the final point of sale has the complete lineage of every unit.


ePedigree laws were eventually replaced by a harmonized national standard called the  Drug Quality and Security Act .


ePedigree laws were in a rapid state of flux with states changing the "drop dead" date for compliance with tracking and authentication years beyond the original dates set by Florida and California.  The definitive requirements will include serialization.  Companies that focus purely on achieving compliance will miss the opportunity to use regulation as a business driver.  The ability to track and serialize unit level saleable packages (e.g. bottle of 25 pills) not just cases or pallets can create business value in knowing exactly where their products are purchased can do the following:
1) Minimize cost of chargebacks through 100% accurate adjudication. Chargebacks account for 2-15% of gross revenue for a pharmaceutical manufacturer.
2) Minimize risk by increasing accuracy in Medicare/Medicaid pricing calculations by fully knowing all fees, rebates, and chargebacks that should be applied to a specific unit sale.  Over $4B in fines have been handed down for improperly calculating Medicare/Medicaid pricing.
3) Limit liability of having to recall entire lots of product because a (non-serialized) shipment was stolen - see example:  [1]
4) Achieve visibility for manufacturers in the labyrinth that is the wholesale distribution network to more accurately forecast demand and measure sales & marketing programs.


Although simple epedigree systems are an important first step, significant improvement in public safety would result from a more standardized and automated approach.  The larger and more difficult task of providing for an Automated Epedigree System has been suggested, but not required by any state.  Such a system would require fairly significant changes to  supply chain  companies' data interchanges and would certainly require advanced Track and Trace technology (with  bar codes  or  RFID ).  The requirements that come closest to an Automated Epedigree System have been proposed by California.  In March 2008, the California Board of Pharmacy (CBOP) published its "E-Pedigree Requirements" which are scheduled to go into effect in a phased approach between 2015 and 2017 (since abandoned).  CBOP has proposed an  XML  standard document and the law requires an "interoperable electronic system". [ 3 ]


The  European Federation of Pharmaceutical Industries and Associations  (EFPIA) is a  Brussels -based trade association and  lobbying  organisation, founded in 1978 and representing the  pharmaceutical industry  operating in Europe. Through its membership of 36 national associations and 39 leading pharmaceutical companies, [ 1 ]  the EFPIA represents 1,900 European companies. [ 2 ]


EFPIA priorities include speeding up regulatory approval and reimbursement processes for new medicines, creating a strong science base in Europe, joining forces with key stakeholders on political issues concerning health and addressing safety concerns. EFPIA also includes specialised groups like Vaccines Europe [ 3 ]  who produce approximately 80% of vaccines used worldwide and European Biopharmaceutical Enterprises harness biotechnology to develop approximately one-fifth of new medicines.


The Innovative Medicines Initiative (IMI) is a public-private partnership designed by the European Commission and EFPIA. It is a pan-European collaboration that brings together large biopharmaceutical companies, small- and medium-sized enterprises (SMEs), patient organisations, academia, hospitals and public authorities. The initiative aims to accelerate the discovery and development of better medicines by removing bottlenecks in the drug development process. It focuses on creating better methods and tools to improve and enhance the drug development process, rather than developing specific, new medicines.


From 1991 to 1998  Emer Cooke  worked for the EFPIA. [ 4 ]  She became executive director of the  European Medicines Agency  (EMA), an  agency of the European Union  (EU) in charge of the evaluation and supervision of  medicinal products , in November 2020. [ 5 ]


In a session of the  Austrian Parliament   member of parliament   Gerald Hauser  on 1 April 2021 publicly criticised a potential  conflict of interest , by her allowing the controversial  Oxford–AstraZeneca COVID-19 vaccine  to be approved, while having worked for the very same industry in the past as a lobbyist of the EFPIA. [ 6 ] [ 7 ]


The  European Forum for Good Clinical Practices  (EFGCP) is a European think tank which works on the ethical, regulatory, and scientific framework of  clinical research  in  Europe . The EFGCP is committed to the development of the standards for the protection of human subjects and data quality in clinical trials, both in Europe and abroad.


Expert Opinion on Therapeutic Patents  is a monthly  peer-reviewed   medical journal  covering  pharmaceutical  patent information across all therapy areas. Each review includes an "expert opinion" section, in which authors provide their personal view on the current status and future direction of the research discussed. The journal was established as  Current Opinion on Therapeutic Patents  in 1991, and changed to the current name in 1994. It is published by  Informa . The  editor-in-chief  is  Claudiu T. Supuran  ( University of Florence ).


The journal is abstracted and indexed in  Chemical Abstracts Service ,  Current Contents /Life Sciences,  EMBASE/Excerpta Medica ,  Index Medicus / Medline / PubMed , and the  Science Citation Index Expanded . According to the  Journal Citation Reports , the journal has a 2014  impact factor  of 4.297. [ 1 ]


This article about a  pharmacology   journal  is a  stub . You can help Wikipedia by  expanding it .


See tips for writing articles about academic journals . Further suggestions might be found on the article's  talk page .


Fire in the Blood  is a 2013  documentary film  by  Dylan Mohan Gray  depicting what it claims is the intentional obstruction of access to low-cost  antiretroviral drugs  used in the treatment of  HIV/AIDS  to people in  Africa  and other parts of the global south, driven by multinational pharmaceutical companies holding  patent  monopolies and various Western governments (above all those of the United States,  European Union  and Switzerland) consistently supporting these companies. The film claims that the battle against what it refers to as a "genocidal blockade," which it estimates to have resulted in no less than ten to twelve million completely unnecessary deaths, was fought and (at least temporarily) won.


Fire in the Blood  features contributions from former US President  Bill Clinton , intellectual property activist  James Love , global health reporter  Donald McNeil, Jr.  of  The New York Times , HIV/AIDS treatment activist  Zackie Achmat , pioneering generic drug maker  Yusuf Hamied , former  Pfizer  executive-turned- whistleblower   Peter Rost , Ugandan AIDS  physician   Peter Mugyenyi , and  Nobel Prize -laureates  Desmond Tutu  and  Joseph Stiglitz . [ 1 ] [ 2 ]


The film is narrated by  Academy Award -winning actor  William Hurt , who lent his voice to the film on a  pro bono  basis because he felt the story and subject matter were so important. [ 3 ]


In November 2013,  Fire in the Blood  set a new record for the longest theatrical run by a non-fiction feature film in India: five weeks. [ 4 ]


In November 2018, Australian journalist and documentary filmmaker  John Pilger  included  Fire in the Blood  among his selection of "26 landmark documentary films of the past seven decades." [ 5 ]


Filmmaker  Dylan Mohan Gray  first learned of the issue in 2004, after he read an article in  The Economist  about the battle between pharmaceutical companies and the global public health community over access to lower-cost AIDS drugs for Africa. [ 6 ]  He decided to make the film three years later. [ 7 ]


The film was shot on four continents from March 2008 to the end of 2010, while editing was completed in 2012. [ 2 ]


The film was first released theatrically in Ireland on 21 February 2013, with the UK premiere the following day. It was released theatrically in the US on 7 September 2013 and in India on 11 October the same year, to outstanding reviews. [ 7 ] [ 8 ]


The film was released on the  iTunes  UK Store in mid-2013, and worldwide on  VOD  via its website in 2014. It released in the UK and India on  DVD  in the first quarter of 2014.


Thus far the film has been broadcast on  television  in the following countries, beginning in late 2013: Finland ( YLE ), Israel ( Yes (Israel) ), Norway ( NRK ), Spain ( TVE ), Switzerland ( SRF ), Austria ( ORF ), Poland ( Telewizja Polska ), Ireland ( TG4 ), Brazil ( Globosat ), Denmark ( DR ), the United States ( Audience Network ) and Japan ( NHK ). Transnational broadcasters include  AJE ,  Al Jazeera Arabic  and  Al Jazeera Balkans , along with  DStv  and GOtv across Sub-Saharan Africa as part of the "AfriDocs" initiative.


Fire in the Blood  was the first Indian film to be selected for the World Cinema Documentary competition at the  Sundance Film Festival [ 9 ]  and subsequently participated in over 100 leading  film festivals  in dozens of countries all over the world. [ 10 ]


Fire in the Blood  received positive critical notices, both to its North American premiere at the 2013  Sundance Film Festival , as well as to its subsequent theatrical releases in Ireland,  Britain , the United States and India. [ 10 ] [ unreliable source? ]


The film  review aggregator  website  Rotten Tomatoes  has given  Fire in the Blood  a "92% fresh" rating based on 24 reviews as of January 2014. [ 16 ]  This ranks the film within the 5-10% best-reviewed films of 2013. [ 17 ]


Certain critics, such as Gary Goldstein of the  Los Angeles Times , while acknowledging the enormous importance of the topic, felt the film should have taken a more emotional approach to its "incendiary subject". [ 18 ]  The English critic  Philip French , in his review for  The Observer  described the film as "quietly devastating", praised Gray's choice in avoiding a  polemical  tone and allowing the material to speak for itself. [ 19 ]


Writing in  Sight & Sound , Ashley Clark called  Fire in the Blood  "stirring" and added "Gray deserves credit for his own restraint... Such is the clarity of his ideological stance that any grandstanding would feel redundant." [ 20 ]


David Rooney of  The Hollywood Reporter  echoed this view, stating that "the admirable balance between impassioned argument and clear-sighted reporting in Dylan Mohan Gray's chronicle of the why and how makes  Fire in the Blood  indispensable viewing", adding that the "very smart", "extremely moving" film is "a shocking account of international trade terrorism sanctioned by Western governments" and "a powerful documentary that demands to be seen by as wide an audience as possible." [ 21 ]


Author  John le Carré  (who became involved with the issue of pharmaceutical company abuses while researching his landmark 2001 novel  The Constant Gardener ) called  Fire in the Blood  "a blessing... full of conviction, passion and unanswerable argument". [ 22 ]


Australian-British journalist and documentary film maker,  John Pilger  wrote " Fire in the Blood  is one of the most powerful, important and humane documentaries I have ever seen. It's the story of ordinary people standing up to unaccountable power. The struggle to save millions from the ravages of untreated HIV is revealed as a struggle against the new lords of the world, transnational corporations, their greed and lies. Genuine hope is rare these days -- you'll find it in this film." [ citation needed ]


Former (2001–06)  United Nations  Special Envoy for HIV/AIDS in Africa  Stephen Lewis  said "I was enraged as I watched, thinking of those years I spent as the Envoy, watching people die...I rarely watch 'AIDS documentaries'; they're remarkably repetitive as a rule, largely uninspired and yielding almost nothing new. [Fire in the Blood] is in a wholly different category; a terrific, riveting documentary...dramatic, compelling, but most of all, wonderfully humane. [Gray is] a remarkably gifted documentary film-maker." [ citation needed ]


Special screenings of  Fire in the Blood  for policymakers have been held in such fora as the  United Nations  headquarters in  New York City  and  Vienna , the  European Parliament  in  Brussels , the  World Health Assembly  and  UNAIDS  headquarters in  Geneva , along with dedicated screenings for lawmakers in  Washington  and  New Delhi , and one hosted by the Indian Ministry of External Affairs (MEA) for ambassadors and consuls accredited to India.


First Databank  ( FDB ) is a major provider of drug and medical device databases that help inform healthcare professionals to make decisions. [ 1 ]  FDB partners with information system developers to deliver useful medication- and medical device-related information to clinicians, business associates, and patients. FDB is part of Hearst and the Hearst Health network.


First Databank was founded in 1977 as a company that published a quarterly magazine of drug prices. They were bought by  Hearst Corporation  in 1980. First Databank then evolved to become a provider of clinical and descriptive drug knowledge that is integrated into healthcare information systems globally. FDB has its headquarters in  San Francisco, California , and has other offices in  Indianapolis, Indiana ,  Exeter, England ,  Dubai, UAE  and  Hyderabad, India .


The firm's drug databases support pharmacy dispensing, formulary management, drug pricing analysis, claims processing, computerized physician order entry (CPOE), electronic health records (EHR), electronic medical records (EMR), electronic prescribing (e-Prescribing), electronic medication administration records (EMAR), population health and telemedicine/telehealth.


Beginning in 2011, First Databank's set of National Drug Codes (NDCs) have been integrated into RxNorm's standard clinical drug vocabulary that includes all medications available on the US market. [ 1 ]  RxNorm is produced and maintained by the  United States National Library of Medicine  (NLM).


In 2017, FDB acquired Polygot Systems, which simplifies drug information for patients and translates that information into 21 languages. [ 2 ]


In 2018, FDB partnered with  PetIQ  to release the first veterinary medication database to provide information on pet medications structured for integration into pharmacy systems. [ 3 ]