Månad: oktober 2012

10 största fällningar av drogbolag

Översatt och anpassat från en amerikansk artikel, från minst till största skadestånd/böter:

10. 2007: Bristol-Myers Squibb betalade $ 515.000.000 för olagligt ha rekommenderat antipsykotiskt läkemedel Abilify för barn och seniorer (trots en svart låda varning för potentiellt livshotande biverkningar hos äldre). Andra anklagelser gällde olagliga belöningar (som dyra semestrar) för vårdpersonal och apotekare för att få ut sitt läkemedel.

9. 2010: AstraZeneca fick betala $ 520.000.000 för att de försökte övertyga läkare att förskriva sitt Seroquel psychotropiskt läkemedel för icke godkända användningsområden från Alzheimers sjukdom och ADHD till sömnlöshet och posttraumatiskt stressyndrom (PTSD). Felaktig användning Seroquel är kopplad till ökad risk för död.

Företagchefer också propagerade för läkemedlet för viktminskning, genom att lyfta en gynnsam studie medan de gömde undan andra studier som kopplade det till betydande viktökning.

8. 2007: Purdue Pharma betalade $ 634.500.000 för bedrägligt marknadsföring av Oxycontin, de sade det var mindre beroendeframkallande än andre smärtstillande medel. Företaget fälldes för vilseledande försäljning taktik, underskattning av risker och att propagera för användningsområden som inte hade studerats.

7. För närvarande väntar: Amgen, skaparna av anemi läkemedlen Aranesp och Epogen, anklagad för att överlämna extra vinster till läkare som föreskriva läkemedlet (genom överfyllning av flaskor, och helt enkelt låta läkarna debitera försäkringsbolag för de läkemedel de fick gratis). Andra anklagelser inkluderar tjänstefel för påståenden om säkerhet och effektivitet, marknadsföring, prissättning och dosering av läkemedel. Amgen betalade utanför rätten $ 760.000.000 för att reglera tvisten.

6. 2011: Merck betalar $ 950.000.000 för att slippa rättegång för bedrägliga marknadsföring anklagelser och säkerhet anspråk relaterade till Vioxx. Vioxx drogs från marknaden 2004 efter det visades fördubbla risken för hjärtinfarkt och stroke. Utöver de $ 950 miljoner, betalade Merck hundratals miljoner mer till skadade patienters och deras familjer (Vioxx bidrog i att orsaka hjärtinfarkt i upp till 140.000 personer, varav hälften som var dödliga).

5. 2009: Eli Lilly betalar 1,4 miljarder dollar för att lansera Zyprexa för användning för ej godkända ändamål, ofta till barn och äldre, och att inte ge riktig information om biverkningar. Till exempel Zyprexa marknadsfördes som en sovstöd för äldre då  en av sina biverkningar är sedering, men läkemedlet också skapar risken för dödsfall.

4. 2012: Abbott Laboratories betalar $ 1,5 miljarder för att aggressivt marknadsfört sitt anfallsläkemedel Depakote för ej godkänd användning hos äldre dementa patienter,  trots att det  saknades belägg för säkerhet eller effektivitet (och en känd ökning av allvarliga biverkningar, såsom anorexi, hos äldre).

3. För närvarande på gång (2012): Johnson & Johnson Ska betala allt från $ 1,5 till $ 2 miljarder för olaglig marknadsföring av Risperdal och andra droger. Företaget inte bara kraftigt marknadsförde läkemedel till barn och äldre trots otillräckliga bevis för säkerhet och effekt. De gömde också data om drogens biverkningar.

2.  2009: Pfizer pays $2.3 billion for marketing fraud related to Bextra, Lyrica and other drugs. Charges included marketing drugs to doctors for uses for which they had not been approved and giving kickbacks to doctors and other health care professionals for prescribing their drugs. This was Pfizer’s fourth settlement numbering in the multimillions in less than a decade.

2. 2009: Pfizer betalar $ 2,3 miljarder för marknadsföringsbedrägerier i samband med Bextra, Lyrica och andra droger. I anklagelserna ingår marknadsföring av droger till läkare för användningsområden för vilka de  inte hade godkänts och givande kick-backar (en ekonomisk belöning) till läkare och andra hälso-och sjukvårdspersonal för att förskriva läkemedlen. Detta var Pfizers fjärde uppgörelse  i Multi-miljon($)klassen på mindre än ett decennium.

Första platsen: 2012: GlaxoSmithKline (GSK) skall betala $ 3 miljarder för illegala marknadsföring av Paxil och Welbutrin och för att ha undantryckt kännedom om säkerhetsrisker med Avandia, bland andra brott. Företaget gömde uppgifter om läkemedelsrisker, marknadsförde läkemedel för icke godkända användningsområden, och betalade läkare (eller gav dem påkostade gåvor som dyra semestrar) för förskrivning av läkemedlen.

Ett av de mest uppmärksammade fallen gällde TV doktorn Dr Drew, som tog emot $ 275.000 från GSK för att vitsorda Welbutrin för att behandla sexuell dysfunktion associerad med depression, även om det inte har visats vara effektiv för detta ändamål.

2021 Jag hade bara översatt denna artikel från en Amerikansk sida. Först nu kollade om innehållet stöds av sidor som inte är vaccinkritiska. Tog och sökte om nr 1: GSK. Och det stämde, enligt bl a BBC och Reuters.  BBC:
”GlaxoSmithKline is to pay $3bn (£1.9bn) in the largest healthcare fraud settlement in US history.

The drug giant is to plead guilty to promoting two drugs for unapproved uses and failing to report safety data about a diabetes drug to the Food and Drug Administration (FDA).
…
The case concerns 10 drugs, including Paxil, Wellbutrin, Avandia and Advair.”

original:

8.  2007: Purdue Pharma paid $634.5 million for fraudulently misbranding Oxycontin, and suggesting it was less addictive and less abused than other painkillers. The company was charged with using misleading sales tactics, minimizing risks and promoting it for uses for which it was not appropriately studied.

7.  Currently pending: Amgen, the makers of anemia drugs Aranesp and Epogen, has been accused of handing extra profits to doctors who prescribe the drugs (by overfilling vials, then allowing doctors to charge insurance companies for drugs they got for free). Other accusations include misconduct involving claims of safety and efficacy, marketing, pricing and dosing of the drugs. Amgen has set aside $760 million to settle the suits.

6.  2011: Merck settles for $950 million to resolve fraudulent marketing allegations and safety claims related to Vioxx. Vioxx was pulled from the market in 2004, after it was shown to double the risk of heart attack and stroke. In addition to the $950 million, Merck paid hundreds of millions more to harmed patients and their families (Vioxx contributed to causing heart attacks in up to 140,000 people, half of which were fatal).

5.  2009: Eli Lilly pays $1.4 billion for promoting Zyprexa for off-label uses, often to children and the elderly, and not properly divulging side effect information. For instance, Zyprexa was marketed as a sleeping aid for the elderly because one of its side effects is sedation, even though the drug also increases the risk of death.

4.  2012: Abbott Laboratories settles for $1.5 billion for aggressively promoting their seizure drug Depakote for off-label use in elderly dementia patients, despite lacking evidence of safety or effectiveness (and a known increase of serious side effects, like anorexia, in the elderly).

3.  Currently pending: Johnson & Johnson will pay anywhere from $1.5 to $2 billion for illegal marketing of Risperdal and other drugs. The company not only heavily marketed drugs to children and the elderly despite inadequate evidence of safety or efficacy, they also hid data about drugs’ side effects.

2.  2009: Pfizer pays $2.3 billion for marketing fraud related to Bextra, Lyrica and other drugs. Charges included marketing drugs to doctors for uses for which they had not been approved and giving kickbacks to doctors and other health care professionals for prescribing their drugs. This was Pfizer’s fourth settlement numbering in the multimillions in less than a decade.

1.  2012: GlaxoSmithKline (GSK) to pay $3 billion for illegal marketing of Paxil and Welbutrin and downplaying safety risks of Avandia, among other charges. The company hid data about drug risks, marketed drugs for unapproved uses, and paid doctors (or gave them lavish gifts like expensive vacations) for prescribing their drugs. One of the most high-profile accounts involved tv’s Dr. Drew, who reportedly received $275,000 from GSK to promote Welbutrin to treat sexual dysfunction associated with depression even though it hasn’t been proven effective for this purpose.

Den expanderande vaccin marknaden

Följde en länk om genmodifierade vacciner och kom till denna:

http://www.pharmpro.com/articles/201201/business-The-Expanding-Vaccine-Market/

Jag har kopierat det ifall det skulle försvinna:

The Expanding Vaccine Market

By Bruce Carlson, Publisher, Kalorama Information

Monday, January 16, 2012

Vaccines continue to be one of the brighter spots for  pharmaceutical companies in the current market, and revenues for vaccine products are expected to continue their double-digit growth in the future. Driving that growth is an increasing acceptance of adult vaccines and the public health focus on flu prevention, as well as introductions of new vaccines. Improved production techniques will also play a role in enabling the products to come to market.

The Market for Vaccines

The vaccine market is generally separated into two segments: pediatric and adult. Pediatric is larger but adult vaccine revenues have grown faster. Kalorama Information estimates that world sales of adult vaccines reached $12.5B in 2010, up from $10.1B in 2009 largely on strong growth of influenza vaccines. Sales of adult vaccines are projected to increase at a compound annual rate of 10.3% from 2010 to 2015. World sales of pediatric vaccines exceeded $12.7B in 2010, increasing 10.1% over 2009 sales of $11.5B on rising sales of combination, varicella and other products. Sales of pediatric vaccines are projected to increase at a compound annual rate of 8.4% from 2010 to 2015.

Most vaccine revenues are earned by five companies: Sanofi Pasteur, GlaxoSmithKline, Merck & Co., Pfizer, and Novartis. They held nearly 80% of the market as of 2010. All of these companies have seen growth in their vaccine business. In 2010, Sanofi Aventis subsidiary Sanofi Pasteur was the leading manufacturer with 22.2% share and more than $5.6B in sales. The company’s position was largely due to its influenza products, although its polio/pertussis/Hib products also account for a significant portion of its vaccine sales. GlaxoSmithKline followed.

[Diagrammet som var länkad här har försvunnit. Jag lägger in några nyare diagram längre ner på sidan]

World Market for Vaccines by Type 2006-2015. Source: Kalorama Information

[måste vara millioner $ på y axeln, så $5,000 innebär 5000 millioner dvs 5 miljard]

New Products and Production TechniquesIt’s not likely that the vaccine market will be limited to the products on the market today. Most companies have increased their R&D programs in this area in recent years. Kalorama Information has estimated a $10B market potential in the next six years for vaccines currently in Phase III. Diabetes, allergies, dengue fever, herpes and malaria are among the conditions for which there is a need and a vaccine in late-stage development.

These vaccines can only impact public health and pharmaceutical businesses if they can reach the market. To meet the demand for vaccines, production techniques are an important but overlooked area of vaccine development. Improvements in production methods can significantly impact both speed to market and cost. At present, many vaccines, such as flu vaccine, are grown in chicken eggs. Although it has been reliably used for more than 60 years, this technique is slow and expensive. With roughly a 6 month lead time from final sequencing of the seasonal/pandemic virus to production, the virus has already done significant damage. Furthermore, initial investment in production can reach $150M or more. This technique can also raise issues of allergic reactions to egg proteins and biosafety concerns.

Certain plants, particularly tobacco, have shown promise as they have been extensively researched, are inexpensive to grow and can yield very large amounts of vaccine quickly. In this process, proteins from the H1N1 virus known to trigger a protective immune response in a patient, without causing an infection, are isolated. A gene for this protein is then introduced into a bacterium. Tobacco plants are exposed to the bacteria, which causes the plants to become infected with the gene-carrying bacteria. The infected plants then begin to produce the protein from H1N1 in large quantities. After about a week of growth, the leaves of the plants are harvested and crushed so that the H1N1 protein, which becomes the basis of the vaccine, can be extracted and purified. In 2010, Medicago reported positive results for a tobacco-based H5N1 vaccine and announced an agreement with PT BIO FARMA to build a plant-based vaccine manufacturing facility in Indonesia which could potentially supply the global market. The company has also signed agreements with vaccine producers in France, Japan, India and Saudi Arabia and subsequently announced the construction of a 90,000 square foot cGMP facility in North Carolina to manufacture vaccines.

Arizona-based VAXX has completed preclinical testing and will soon initiate a human trial of a tobacco-based vaccine for Norwalk norovirus, which causes gastroenteritis in as many as 74M Americans each year. If successful, the company will likely extend its technology to other vaccines.

Like the usage of tobacco plants to cultivate recombinant virus-like particles, some scientists are using insects to circumvent the traditional chicken-egg production process. Research appearing in a January 2010 issue of the Biotechnology Journal from scientists at the University of Natural Resources and Applied Life Science in Vienna, Austria described a new technique for producing H1N1 vaccines using insect cells. The process took just ten weeks to produce H1N1 swine flu cells for subsequent study in mice. The paper noted that immunization with the cells induced high serum antibody titers against A/California/04/2009 as well as hemagglutination inhibiting antibodies for two different insect cell lines, Sf9 and BTI-TN5B1-4 (High Five).

Novavax also infects insect cells with VLPs. The company’s VLPs contain 3 surface antigens (HA, NA and M1) to induce broader, more effective antibodies against disease rather than just the HA antibodies present in most vaccines. In early stage clinical studies of an influenza vaccine, results were favorable with strong immune response and good treatment toleration across thousands of patients in all doses. Novavax is able to prepare the first doses approximately 11 weeks after the receipt of the sequence.

Nanoparticles, defined as very fine particles ranging in size from one to 100 nanometers, are increasingly being used in a variety of medical and other applications as a means to achieve goals that were previously unattainable. The particles are of great scientific interest because their properties are often distinct from those of the larger amounts of the same material. Depending upon the material, these properties include color, melting points, electromagnetic characteristics, etc. In vaccine delivery, some developers are using nano particles to more precisely deliver vaccine payloads. For example, privately-held Liquidia Technologies uses its Particle Replication In Non-Wetting Templates (PRINT) technology to create nanoparticles that can improve the safety and efficacy of injected vaccines, using less antigen without an additional adjuvant. The PRINT Platform creates rationally designed nanoparticles with complete control over particle size, shape, composition and surface chemistry in a controlled and scalable manufacturing process. Each of these variables can be optimized for a specific immunogenic response. For conjugate polysaccharide vaccines, PRINT can simply mold a protein and polysaccharide together in a single particle, improving production. In early 2011, Liquidia announced a collaboration with the PATH Malaria Vaccine Initiative to explore the use of PRINT to design next generation malaria vaccines as well as a $10M investment to support this research by the Bill & Melinda Gates Foundation.

These promising developments in new vaccines and the way they are produced and delivered should make for a robust market opportunity in years to come.